Latest Review Date: January 2024

Category: Durable Medical Equipment (DME) 

Note: Coverage may be subject to legislative mandates, including but not limited to the following, which apply prior to the policy statements:

• Federal Women's Health and Cancer Rights Act (WHCRA)

In accordance with the mandate listed above, non-powered negative pressure wound therapy (NPWT) devices, (mechanical) or single use (disposable) battery powered, are covered when used to treat wounds resulting from a mastectomy and ordered by the individual’s treating physician.

---

POLICY:

For dates of service April 5, 2021, and after:

Powered negative pressure wound therapy (NPWT) devices may be considered medically necessary for treatment of chronic wounds (defined as wounds or ulcers that have been open and show no progress toward healing for a minimum of 30 days) despite standard wound healing therapy for:

• Neuropathic ulcer (e.g., diabetic) when:
  • The individual has been on a comprehensive diabetic management program; AND
  • The individual  has been non-weight bearing if appropriate; OR
• Chronic  stage III or stage IV pressure ulcer when:
  • The individual has used an appropriate pressure relief device (e.g., low air loss bed, alternating pressure mattress) for pressure ulcers on the posterior trunk or pelvis; OR
• Chronic ulcer of mixed etiology; OR
• Venous or arterial insufficiency ulcer when:
  • Leg elevation and ambulation have been encouraged.

AND

• There is documentation of  participation in a wound therapy program of ALL the following;
  • Documentation in the medical record of evaluation of the wound; AND 
  • Care and wound measurements by a licensed healthcare professional [e.g., physician, physician’s assistant (PA), registered nurse (RN), licensed practical nurse (LPN), or physical therapist (PT)]; AND
  • Application of dressings to moist wound environment; AND 
  • Debridement of necrotic tissue if present; AND
  • Evaluation and provision for adequate nutritional status; AND
  • Appropriate turning and positioning; AND
  • Incontinence if present has been appropriately addressed; AND   
  • Documentation of any attempted and failed therapies and ruled out therapies prior to application of NPWT.

Powered negative pressure wound therapy (NPWT) devices may be considered medically necessary for treatment of acute wounds including the following:

• Complications of a surgically created or traumatic wounds; OR
  • Examples may include but not limited to:  dehisced wounds, flap or graft failure, post-operative union of abdominal wall, post-sternotomy disunion with exposed bone or post-sternotomy mediastinitis, wounds exposing tendons, bones, or joints, high-impact soft tissue injuries such as falls, motor vehicle or sports, degloving injuries that may require a graft or flap; OR
• Enterocutaneous fistulas, cutaneous gastrointestinal fistulas; OR
• A traumatic wound (e.g., preoperative flap or graft, exposed bones, tendons, or vessels) and a need for accelerated formation of granulation tissue not achievable by other topical wound treatments when the patient has comorbidities (e.g., morbid obesity, compromised wounds secondary to radiation or ischemia, immunocompromised patients, diabetes, scleroderma, malignancy) that will not allow for healing times usually achievable with other available wound treatments.

AND

• There is documentation of participation in a wound therapy program of ALL the following;
  • Documentation in the medical record of evaluation of the wound; AND 
  • Care and wound measurements by a licensed healthcare professional [e.g., physician, physician’s assistant (PA), registered nurse (RN), licensed practical nurse (LPN), or physical therapist (PT)]; AND
  • Application of dressings to moist wound environment; AND 
  • Debridement of necrotic tissue if present; AND
  • Evaluation and provision for adequate nutritional status; AND
  • Appropriate turning and positioning; AND
  • Incontinence if present has been appropriately addressed; AND
  • Documentation of any attempted and failed therapies and ruled out therapies prior to application of NPWT.

Initial coverage of the use of powered negative pressure wound therapy (NPWT) devices will be for 30 days. 

Continued Coverage of powered negative pressure wound therapy (NPWT) pump and supplies:

When an ulcer or wound meets criteria for initial coverage in order to continue coverage for NPWT for an additional 30 days when the therapeutic trial or subsequent treatment period has not resulted in documented objective improvement in the wound; a wound description for every 2 weeks must be documented by a licensed health care professional: 

• Wound measurement, including length, width and depth; AND
• Description of wound, including color, odor, etc.; AND
• Quantity and description of drainage; AND
• Presence of granulation and necrotic tissue; AND
• Debridement of necrotic tissue if present.

The use of non-powered negative pressure wound therapy (NPWT) system devices (mechanical) or single use (disposable) battery operated negative pressure wound therapy system devices, are considered investigational for all places of treatment and for all indications including but not limited to diabetic, venous, surgical, and traumatic wounds.

Powered negative pressure wound therapy (NPWT) devices and supplies is considered not medically necessary when:

• The criteria for continued coverage ceases to be met, OR
• Per the treating physician, adequate wound healing has occurred to the degree that powered NPWT may be discontinued; OR
• Any measurable degree of wound healing has failed to occur over the prior month. (Wound healing is defined as improvement occurring in either surface area (length times width) or depth of the wound; OR
• Four months (including the time powered NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using a powered NPWT pump in the treatment of the most recent wound; OR
• Once equipment or supplies are no longer being used for the individual.

Powered negative pressure wound therapy (NPWT) devices are considered not medically necessary and are contraindicated for individuals including, but not limited to the following:

• Non-enteric or unexplored fistulas
• Necrotic tissue with eschar
• Osteomyelitis (untreated)
• Malignancy in the wound
• Exposed nerves, arteries or veins
• Exposed anastomotic site
• Exposed organs

Powered negative pressure wound therapy (NPWT) devices should be used with caution in the following:

• Active bleeding or at high risk for bleeding and hemorrhage
• Individuals on anticoagulants or platelet aggregation inhibitors
• Difficult wound hemostasis
• When placing the VAC dressing in proximity to blood vessels, care should be taken to ensure that all vessels are adequately protected with overlying fascia, tissue or other protective barrier.  Greater care should be taken with respect to weakened, irradiated or sutured blood vessels.
• Infected wounds
• Osteomyelitis
• Sharp edges in the wounds (i.e., bone fragments)
• Spinal cord injury (stimulation of sympathetic nervous system)
• Enteric fistulas

For dates of service prior to April 5, 2021:

Powered and non-powered negative pressure wound therapy (NPWT) devices may be considered medically necessary for treatment of chronic wounds (defined as wounds or ulcers that have been open and show no progress toward healing for a minimum of 30 days) despite standard wound healing therapy for:

• Neuropathic ulcer (e.g., diabetic) when:

  • The patient has been on a comprehensive diabetic management program; AND

  • The patient has been non-weight bearing if appropriate; OR

• Chronic stage III or stage IV pressure ulcer when:

  • The patient has used an appropriate pressure relief device (e.g., low air loss bed, alternating pressure mattress) for pressure ulcers on the posterior trunk or pelvis; OR

• Chronic ulcer of mixed etiology; OR

• Venous or arterial insufficiency ulcer when:

  • Leg elevation and ambulation have been encouraged.

AND

• There is documentation of participation in a wound therapy program of ALL the following;

  • Documentation in the medical record of evaluation of the wound; AND

  • Care and wound measurements by a licensed healthcare professional [e.g., physician, physician’s assistant (PA), registered nurse (RN), licensed practical nurse (LPN), or physical therapist (PT)]; AND

  • Application of dressings to moist wound environment; AND

  • Debridement of necrotic tissue if present; AND

  • Evaluation and provision for adequate nutritional status; AND

  • Appropriate turning and positioning; AND

  • Incontinence if present has been appropriately addressed; AND

  • Documentation of any attempted and failed therapies and ruled out therapies prior to application of NPWT.

Powered and non-powered negative pressure wound therapy (NPWT) devices may be considered medically necessary for treatment of acute wounds including the following:

• Complications of a surgically created or traumatic wounds; OR

  • Examples may include but not limited to: dehisced wounds, flap or graft failure, post-operative union of abdominal wall, post-sternotomy disunion with exposed bone or post-sternotomy mediastinitis, wounds exposing tendons, bones, or joints, high-impact soft tissue injuries such as falls, motor vehicle or sports, degloving injuries that may require a graft or flap; OR

• Enterocutaneous fistulas, cutaneous gastrointestinal fistulas; OR

• A traumatic wound (e.g., preoperative flap or graft, exposed bones, tendons, or vessels) and a need for accelerated formation of granulation tissue not achievable by other topical wound treatments when the patient has comorbidities (e.g., morbid obesity, compromised wounds secondary to radiation or ischemia, immunocompromised patients, diabetes, scleroderma, malignancy) that will not allow for healing times usually achievable with other available wound treatments.

AND

• There is documentation of participation in a wound therapy program of ALL the following;

  • Documentation in the medical record of evaluation of the wound; AND

  • Care and wound measurements by a licensed healthcare professional [e.g., physician, physician’s assistant (PA), registered nurse (RN), licensed practical nurse (LPN), or physical therapist (PT)]; AND

  • Application of dressings to moist wound environment; AND

  • Debridement of necrotic tissue if present; AND

  • Evaluation and provision for adequate nutritional status; AND

  • Appropriate turning and positioning; AND

  • Incontinence if present has been appropriately addressed; AND

  • Documentation of any attempted and failed therapies and ruled out therapies prior to application of NPWT.

Initial coverage of the use of powered and non-powered negative pressure wound therapy (NPWT) devices will be for 30 days.

Continued Coverage of powered and non-powered negative pressure wound therapy (NPWT) pump and supplies:

When an ulcer or wound meets criteria for initial coverage in order to continue coverage for NPWT for an additional 30 days; a wound description for every 2 weeks must be documented by a licensed health care professional:

• Wound measurement, including length, width and depth; AND

• Description of wound, including color, odor, etc.; AND

• Quantity and description of drainage; AND

• Presence of granulation and necrotic tissue; AND

• Debridement of necrotic tissue if present.

Powered and non-powered negative pressure wound therapy (NPWT) devices and supplies is considered not medically necessary when:

• The criteria for continued coverage ceases to be met, OR

• Per the treating physician, adequate wound healing has occurred to the degree that powered NPWT may be discontinued; OR

• Any measurable degree of wound healing has failed to occur over the prior month. (Wound healing is defined as improvement occurring in either surface area (length times width) or depth of the wound; OR

• Four months (including the time powered NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using a powered NPWT pump in the treatment of the most recent wound; OR

• Once equipment or supplies are no longer being used for the patient.

Powered and non-powered negative pressure wound therapy (NPWT) devices are considered not medically necessary and are contraindicated for patients including, but not limited to the following:

• Non-enteric or unexplored fistulas

• Necrotic tissue with eschar

• Osteomyelitis (untreated)

• Malignancy in the wound

• Exposed nerves

• Exposed anastomotic site

• Exposed organs

Negative pressure wound therapy dressings should not be placed over exposed arteries or veins.

Powered and non-powered negative pressure wound therapy (NPWT) devices should be used with caution in the following:

• Active bleeding or at high risk for bleeding and hemorrhage

• Patients on anticoagulants or platelet aggregation inhibitors

• Difficult wound hemostasis

• When placing the VAC dressing in proximity to blood vessels, care should be taken to ensure that all vessels are adequately protected with overlying fascia, tissue or other protective barrier. Greater care should be taken with respect to weakened, irradiated or sutured blood vessels.

• Infected wounds

• Osteomyelitis

• Sharp edges in the wounds (i.e., bone fragments)

• Spinal cord injury (stimulation of sympathetic nervous system)

• Enteric fistulas

Other indications that may interfere with powered NPWT: MRI, hyperbaric chamber, defibrillation, size and weight, use near vagus nerve (bradycardia), circumferential dressing application and mode of therapy (intermittent versus continuous negative pressure).

DESCRIPTION OF PROCEDURE OR SERVICE

Negative pressure wound therapy (NPWT) consists of the use of a negative pressure or suction device to aspirate and remove fluids, debris, and infectious materials from the wound bed and to promote the formation of granulation tissue and wound healing.  The devices may also be used as an adjunct to surgical therapy or as an alternative to surgery in a debilitated patient.

Chronic Wounds

Management

The management and treatment of chronic wounds, including decubitus ulcers, remain a treatment challenge. 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; one device is the Smart Negative Pressure (SNaP) ® Wound Care System. This device 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. This system is fully disposable.

The focus of this document is on use of NPWT in the outpatient setting.

KEY POINTS

This evidence review was created with a search of the PubMed database. The most recent literature update was performed through November 14, 2023.

Summary of Evidence:

For individuals who have diabetic lower-extremity ulcers or amputation wounds who receive outpatient NPWT, the evidence includes systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life (QOL), and treatment-related morbidity.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 non inferiority for wound area reduction. A statistically significant benefit in complete wound closure was noted for patients with DFUs, but was not duplicated in the per protocol population due to a high number of exclusions. One study of the SNaP showed non inferiority 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, quality of life, and treatment-related morbidity. All trials are of low quality and at high risk of bias. In addition, most study populations were treated in inpatient settings. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have lower-extremity ulcers due to venous insufficiency who receive outpatient NPWT, the evidence includes 1 RCT and a systematic review. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, 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 use of NPWT in the outpatient setting. The evidence is insufficient to determine the effects of the technology on health outcomes.

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 wound area reduction. No significant benefit in complete wound closure was found in patients with 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 a 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 and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, 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 in partial-thickness burns. 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 functional outcomes for most patients who were treated with NPWT at a single center. The evidence is insufficient to determine the effects of the technology on health outcomes.

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 RCT 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.

Practice Guidelines and Position Statements

American Academy of Orthopaedic Surgeons

The American Academy of Orthopaedic Surgeons (AAOS) 2022 guidelines for prevention of surgical site infections after major extremity trauma included recommendations for NPWT.

The recommendations from AAOS do not support the continued use of NPWT in patients undergoing fracture fixation due to similar outcomes to standard wound care but with an increased healthcare burden. In patients with high-risk surgical incisions the AAOS recommends that limited evidence suggests NPWT may be an option; however, its use will be influenced by cost. Importantly, these guidelines do not specifically address use in the outpatient setting.

International Multidisciplinary Consensus Recommendations

In 2017, Willy et al. presented evidence-based consensus guidelines on the use of closed incision negative pressure therapy (ciNPT) following surgery. Among the studies found were 100 randomized controlled studies on ciNPT, most of which found an association between the use of ciNPT and improved outcomes. Based on the evidence, the consensus panel recommended that surgeons evaluate risk in patients prior to surgery to determine whether patient comorbidities (i.e., obesity or diabetes) or the nature of the surgery in question may present an increased danger of infection. In such cases, the panel recommended the use of ciNPT.

Infectious Diseases Society of America and International Working Group on the Diabetic Foot

A 2023 guideline from the Society for the diagnosis and treatment of diabetic-related foot infections (DFIs) makes the following recommendation relevant to NPWT: "We suggest not using the following treatments to address DFIs: (a) adjunctive granulocyte colony-stimulating factor (G-CSF) treatment or (b) topical antiseptics, silver preparations, honey, bacteriophage therapy, or negative-pressure wound therapy (with or without instillation)." This was graded as a conditional recommendation with low-quality evidence.

American College of Physicians

In 2015, the American College of Physicians (ACP) published guidelines (now inactive) on the treatment of pressure ulcers. The guidelines stated that there was low-quality evidence that the overall treatment effect of NPWT did no differ from standard of care. Of note, the American College of Physicians considers these guidelines inactive since they are more than 5 years old.

National Institute for Health and Clinical Excellence

In 2013, the National Institute for Health and Clinical Excellence (NICE) issued guidance on NPWT for surgical wounds, concluding that “current evidence on the safety and efficacy of negative pressure wound therapy (NPWT) for the open abdomen is adequate to support the use of this procedure.”

A 2015 NICE guidance on diabetic foot problems, updated in October 2019, has recommended consideration of NPWT after surgical debridement for diabetic foot ulcers on the advice of the multidisciplinary foot care service. It was noted that the evidence reviewed for NPWT was limited and of low-quality, and that it would be useful to have more evidence for this commonly used treatment.

In 2014, the NICE issued guidance on the prevention and management of pressure ulcers. The guidance stated, “Do not routinely offer adults negative pressure wound therapy to treat a pressure ulcer, unless it is necessary to reduce the number of dressing changes (for example, in a wound with a large amount of exudate).” Also, the guidance did not recommend NPWT for neonates, infants, or children.

A 2019 NICE guidance recommends the use of the PICO7 negative pressure wound dressing for closed surgical incisions due to their association with fewer surgical site infections and seromas compared to standard wound dressings. The device is considered an option for those who are at high risk for surgical site infections, which may be driven by several factors (e.g., age, underlying illness, obesity, smoking, wound classification, and site and complexity of procedure). The device is recommended for those with low to moderate levels of wound exudate who will require infrequent dressing changes.

A 2021 NICE guidance on cesarean birth recommends considering the use of NPWT for women with a body mass index ≥35 kg/m² to reduce the risk of wound infections. Routine use of NPWT following cesarean delivery is not recommended.

A 2021 NICE guidance states that while the V.A.C. Veraflo Therapy system shows promise in the treatment of acute infected or chronic non-healing wounds, there is not enough high-quality evidence to support the case for routine adoption. The guidance recommends research in the form of an RCT comparing the V.A.C. Veraflo Therapy system (NPWT with wound instillation) to NPWT alone. These recommendations were unchanged in a 2023 update to this guidance.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS

Wound V.A.C.®, VAC® device, negative pressure wound therapy, Versatile 1™, Chariker-Jeter wound sealing kit®, chronic wounds, dehisced wounds, enteric fistula, enterocutaneous fistula, cutaneous gastrointestinal fistula, ITI pump, non-powered (mechanical), Smart Negative,  Pressure (SNaP)® Wound Care System, NPWT, RENASYS® EZ Plus and RENASYS™ Go, PICO™, XLR8 PLUS, Extricare® 2400 NPWT System, Prevena™, VERAFLO™,Single Use Negative Pressure Wound Therapy, V.A.C.Via™ Therapy System, ciSNaP Closed Incision System, myNeWT, AVELLE ,UNO, WHCRA

APPROVED BY GOVERNING BODIES

Negative pressure therapy or suction devices cleared by the U.S. Food and Drug Administration (FDA) for the purpose of 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), and PICO Single Use Negative Pressure Wound Therapy System (Smith & Nephew).

Portable systems include the RENASYS™ GO (Smith&Nephew), XLR8 PLUS (Genadyne Biotechnologies), Extricare® 2400 NPWT System (Devon Medical, Inc.), the V.A.C. Via™ (KCI) 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 non-powered NPWT device, the SNaP® Wound Care System (now SNAP™ Therapy System) (3M™/ from Spiracur, acquired by Acelity in 2015), is a Class II device requiring notification to market but not having FDA premarket approval. It received 510(k) marketing clearance from the FDA in 2009 (K081406) and is designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute, subacute wounds and diabetic and pressure ulcers.

NPWT devices with instillation to 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.

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

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

BENEFIT APPLICATION

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS:  No special consideration.

FEP contracts: Special benefit consideration may apply.  Refer to member's benefit plan.

CURRENT CODING:

CPT codes:

97605	Negative pressure wound therapy, (e.g., vacuum assisted drainage collection), utilizing durable medical equipment including 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
97606	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

HCPCS codes:    

A6550	Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories
A7000-A7001	Canister for use with suction pump
A9272	Wound suction, disposable, includes dressing, 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-K0746	Code range for absorptive wound dressings to be used with home suction pump coded with K0743

REFERENCES:

1. American Academy of Orthopaedic Surgeons. Prevention of Surgical Site Infections After Major Extremity Trauma Evidence-Based Clinical Practice Guideline. www.aaos.org/SSItraumacpg. Published 03/21/22. 
2. American Society of Plastic Surgeons (ASPS). Evidence-based Clinical Practice Guideline: Chronic Wounds of the Lower Extremity. 2007. Available online at: www.plasticsurgery.org/Documents/medical-professionals/health-policy/evidence-practice/Evidence-based-Clinical-Practice-Guideline-Chronic-Wounds-of-the-Lower-Extremity.pdf.
3. Association for the Advancement of Wound Care (AAWC). International Consolidated Venous Ulcer Guideline (ICVUG). Update of AAWC Venous Ulcer Guideline, 2005 and 2010. 2015;https://aawconline.memberclicks.net/assets/appendix%20c%20guideline%20icvug-textformatrecommendations-final%20v42%20changessaved18aug17.pdf.
4. Armstrong DG, Marston WA, et al., Comparative Effectiveness of Mechanically and Electrically Powered Negative Pressure Wound Therapy Devices: A Multicenter Randomized Controlled Trial. Wound Repair Regen 2012 May-Jun; 20(3):332-41.
5. Armstrong DG, Marston WA, Reyzelman AM et al. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized controlled trial. Wound Repair Regen 2011; 19(2):173-80.
6. Association for the Advancement of Wound Care (AAWC). Guideline of Pressure Ulcer Guidelines. 2010; //aawconline.org/wp-content/uploads/2015/11/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf.
7. Association for the Advancement of Wound Care (AAWC). Venous Ulcer Guideline. 2010; //aawconline.org/wp-content/uploads/2015/11/AAWC-Venous-Ulcer-Guideline-Update-Algorithm-v28-updated-11Feb2014.pdf.
8. Bertges DJ, Smith L, Scully RE, et al. A multicenter, prospective randomized trial of negative pressure wound therapy for infrainguinal revascularization with a groin incision. J Vasc Surg. Jul 2021; 74(1): 257-267.e1.
9. Biter LU, Beck GM, Mannaerts GH, et al. The use of negative-pressure wound therapy in pilonidal sinus disease: a randomized controlled trial comparing negative-pressure wound therapy versus standard open wound care after surgical excision. Dis Colon Rectum. Dec 2014; 57(12):1406-1411.
10. Bloemen MC, van der Wal MB, Verhaegen PD et al. Clinical effectiveness of dermal substitution in burns by topical negative pressure: a multicenter randomized controlled trial. Wound Repair Regen 2012; 20(6):797-805.
11. Borys S, Hohendorff J, Koblik T, et al. Negative-pressure wound therapy for management of chronic neuropathic noninfected diabetic foot ulcerations - short-term efficacy and long-term outcomes. Endocrine. Dec 2018;62(3):611-616.
12. Ceppa EP, Kim RC, Niedzwiecki D, et al. Closed Incision Negative Pressure Therapy to Reduce Surgical Site Infection in High-Risk Gastrointestinal Surgery: A Randomized Controlled Trial. J Am Coll Surg. Apr 01 2023; 236(4): 698-708.
13. Chio EG and Agrawal A. A randomized, prospective, controlled study of forearm donor site healing when using a vacuum dressing. Otolaryngol Head Neck Surg 2010; 142(2):174-8.
14. Dalla Paola L, Carone A, Ricci S, et al. Use of vacuum assisted closure therapy in the treatment of diabetic foot wounds. Journal of Diabetic Foot Complications. J. Diabetic Foot Complications. 2010; 2:33-44.
15. Damiani G, Pinnarelli l, Sommella L et al. Vacuum-assisted closure therapy for patients with infected sternal wounds: a meta-analysis of current evidence. J Plast Reconstr Aesthet Surg 2011; 64(9):1119-23.
16. Danne J, Gwini S, McKenzie D, et al. A retrospective study of pilonidal sinus healing by secondary intention using negative pressure wound therapy versus alginate or gauze dressings. Ostomy Wound Manage. Mar 2017; 63(3):47-53.
17. De Vries FE, Wallert ED, Solomkin JS, et al. A systematic review and meta-analysis including GRADE qualification of the risk of surgical site infections after prophylactic negative pressure wound therapy compared with conventional dressings in clean and contaminated surgery. Medicine (Baltimore). Sep 2016; 95(36):e4673.
18. Dumville JC, Hinchliffe RJ, Cullum N et al. Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus. Cochrane Database Syst Rev 2013; 10:CD010318.
19. Dumville JC, Land L, Evans D, et al. Negative pressure wound therapy for treating leg ulcers. Cochrane Database Syst Rev. 2015; 7:CD011354.
20. Dumville JC, Munson C. Negative pressure wound therapy for partial-thickness burns. Cochrane Database Syst Rev 2012; 12:CD006215.
21. Dumville JC, Munson C, Christie J. Negative pressure wound therapy for partial-thickness burns. Cochrane Database Syst Rev. 2014; 12:CD006215.
22. Dumville JC, Owens GL, Crosbie EJ, et al. Negative pressure wound therapy for treating surgical wounds healing by secondary intention. Cochrane Database Syst Rev. 2015; 6:CD011278.
23. Dumville JC, Webster J, Evans D, et al. Negative pressure wound therapy for treating pressure ulcers. Cochrane Database Syst Rev. 2015; 5:CD011334.
24. Ehrl D, Heidekrueger PI, Broer PN, et al. Topical negative pressure wound therapy of burned hands: functional outcomes. J Burn Care Res. Mar 31 2017.
25. Fong KD, Hu D, Eichstadt SL et al. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds 2010; 22(9):230-6.
26. Grauhan O, Navasardyan A, Hofmann M, et al. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. May 2013; 145(5):1387-1392.
27. Gdalevitch P, Afilalo J and Lee C. Predictors of vacuum-assisted closure failure of sternotomy wounds. J Plast Reconstr Aesthet Surg 2010; 63(1):180-3.
28. Ho CH, Powell HL, Collins JF et al. Poor nutrition is a relative contraindication to negative pressure wound therapy for pressure ulcers: preliminary observations in patients with spinal cord injury. Adv Skin Wound Care 2010; 23(11):508-16.
29. Hospenthal DR, Murray CK, Andersen RC et al. Guidelines for the prevention of infections associated with combat-related injuries: 2011 update: endorsed by the Infectious Diseases Society of America and the Surgical Infection Society. J Trauma 2011; 71(2 Suppl 2):S210-34.
30. Hussamy DJ, Wortman AC, McIntire DD, et al. Closed Incision Negative Pressure Therapy in Morbidly Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. Oct 2019; 134(4): 781-789.
31. Iheozor-Ejiofor Z, Newton K, Dumville JC, et al. Negative pressure wound therapy for open traumatic wounds. Cochrane Database Syst Rev. Jul 03 2018; 7: CD012522.
32. Javed AA, Teinor J, Wright M, et al. Negative Pressure Wound Therapy for Surgical-site Infections: A Randomized Trial. Ann Surg. Oct 10 2018
33. Karlakki SL, Hamad AK, Whittall C, et al. Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: A randomised controlled trial. Bone Joint Res. Aug 2016; 5(8):328-337.
34. Kirsner R, Dove C, Reyzelman A, et al. A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities. Wound Repair Regen. Sep 2019; 27(5): 519-529.
35. Kirsner RS, Zimnitsky D, Robinson M. A prospective, randomized, controlled clinical study on the effectiveness of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of diabetic ulcers of the lower extremities. Wound Repair Regen. Nov 2021; 29(6): 908-911.
36. Krug E, Berg L, Lee C, et al. Evidence-based recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery: steps towards an international consensus. Injury. Feb 2011; 42 Suppl 1: S1-12.
37. Landsman A. Analysis of the SNaP Wound Care System, a negative pressure wound device for treatment of diabetic lower extremity wounds. J Diabetes Sci Technol 2010; 4(4):831-2.
38. Lerman B, Oldenbrook L, Eichstadt SL et al. Evaluation of chronic wound treatment with the SNaP wound care system versus modern dressing protocols. Plast Reconstr Surg 2010; 126(4):1253-61.
39. Lerman B, Oldenbrook L, Ryn J et al. The SNaP Wound Care System: a case series using a novel ultraportable negative pressure wound therapy device for the treatment of diabetic lower extremity wounds. J Diabetes Sci Technol 2010; 4(4):825-30.
40. Li HZ, Xu XH, Wang DW, et al. Negative pressure wound therapy for surgical site infections: a systematic review and meta-analysis of randomized controlled trials. Clin Microbiol Infect. Nov 2019; 25(11): 1328-1338.
41. Liu X, Zhang H, Cen S, et al. Negative pressure wound therapy versus conventional wound dressings in treatment of open fractures: A systematic review and meta-analysis. Int J Surg. May 2018; 53: 72-79.
42. Marston WA, Armstrong DG, Reyzelman AM, et al. A multicenter randomized controlled trial comparing treatment of venous leg ulcers using mechanically versus electrically powered negative pressure wound therapy. Adv Wound Care (New Rochelle). Feb 1 2015; 4(2):75-82.
43. Masden D, Goldstein J, Endara M Et al. Negative pressure wound therapy for at-risk surgical closures in patients with multiple comorbidities: a prospective randomized controlled study. Ann Surg 2012; 255(6):1043-7.
44. Mir A, Guys N, Arianpour K, et al. Negative Pressure Wound Therapy in the Head and Neck: An Evidence-Based Approach. Laryngoscope. Aug 22 2018.
45. Monsen C, Acosta S, Mani K, et al. A randomized study of NPWT closure versus alginate dressings in peri-vascular groin infections: quality of life, pain and cost. J Wound Care. Jun 2015; 24(6):252, 254-256, 258-250.
46. Murphy PB, Knowles S, Chadi SA, et al. Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE): A Randomized Controlled Trial. Ann Surg. Jul 2019; 270(1): 38-42.
47. National Institute for Health and Clinical Excellence (NICE). Pressure ulcers: prevention and management [CG179]. 2014; https://www.nice.org.uk/guidance/cg179.
48. National Institute for Health and Clinical Excellence (NICE). Negative Pressure Wound Therapy for the Open Abdomen. Interventional procedure guidance 322. 2009. Available online at: www.nice.org.uk/nicemedia/pdf/IPG322Guidance.pdf.
49. National Institute for Health and Care Excellence (NICE). NICE Clinical Guideline NG19. Diabetic Foot Problems: Prevention and Management. 2015; www.nice.org.uk/guidance/ng19/evidence.
50. National Institute for Health and Care Excellence (NICE). PICO negative pressure wound dressings for closed surgical incisions[MTG43]. 2019; https://www.nice.org.uk/guidance/mtg43.
51. National Institute for Health and Care Excellence (NICE). The VAC Veraflo Therapy system for acute infected or chronic wounds that are failing to heal [MTG54]. 2021; https://www.nice.org.uk/guidance/mtg54.
52. National Institute for Health and Care Excellence (NICE). Cesarean birth [NG192]. 2021;https://www.nice.org.uk/guidance/ng192. Accessed December 5, 2021.
53. Norman G, Goh EL, Dumville JC, et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. Jun 15 2020; 6: CD009261.
54. Norman G, Shi C, Goh EL, et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. Apr 26 2022; 4(4): CD009261.
55. O'Leary DP, Peirce C, Anglim B, et al. Prophylactic negative pressure dressing use in closed laparotomy wounds following abdominal operations: a randomized, controlled, open-label trial: The P.I.C.O. Trial. Ann Surg. Jun 2017; 265(6):1082-1086.
56. Pauser J, Nordmeyer M, Biber R, et al. Incisional negative pressure wound therapy after hemiarthroplasty for femoral neck fractures - reduction of wound complications. Int Wound J. Aug 14 2014.
57. Pauser J, Nordmeyer M, Biber R, et al. Incisional negative pressure wound therapy after hemiarthroplasty for femoral neck fractures - reduction of wound complications. Int Wound J. Oct 2016; 13(5): 663-7.
58. Peinemann F, Sauerland S. Negative-pressure wound therapy: systematic review of randomized controlled trials. Dtsch Arztebl Int 2011; 108(22):381-9.
59. Peterson AT, Bakaysa SL, Driscoll JM, et al. Randomized controlled trial of single-use negative-pressure wound therapy dressings in morbidly obese patients undergoing cesarean delivery. Am J Obstet Gynecol MFM. Sep 2021; 3(5): 100410.
60. Peterson AT, Bakaysa SL, Driscoll JM, et al. Randomized controlled trial of single-use negative-pressure wound therapy dressings in morbidly obese patients undergoing cesarean delivery. Am J Obstet Gynecol MFM. Sep 2021; 3(5): 100410.
61. Petkar KS, Dhanraj P, Kingsly PM et al. A prospective randomized controlled trial comparing negative pressure dressing and conventional dressing methods on split-thickness skin grafts in burned patients. Burns 2011; 37(6):925-9.
62. Qaseem A, Humphrey LL, Forciea MA, et al. Treatment of pressure ulcers: a clinical practice guideline from the American College of Physicians. Ann Intern Med. Mar 03 2015; 162(5):370-379.
63. Rhee SM, Valle MF, Wilson LM, et al. Negative Pressure Wound Therapy Technologies for Chronic Wound Care in the Home Setting. Evidence Report/Technology Assessment. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-201-200007-I.) Rockville, MD: Agency for Healthcare Research and Quality. September 15, 2014. www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/id96ta.pdf.
64. Rhee SM, Valle MF, Wilson LM, et al. Negative pressure wound therapy technologies for chronic wound care in the home setting: A systematic review. Wound Repair Regen. Jul 2015; 23(4):506-517.
65. Runkel N, Krug E, Berg L Et al. Evidence-based recommendations for the use of negative pressure wound therapy in traumatic wounds and reconstructive surgery: Steps towards an international consensus. Injury 2011; 42(Suppl 1):S1-12.
66. Sahebally SM, McKevitt K, Stephens I, et al. Negative Pressure Wound Therapy for Closed Laparotomy Incisions in General and Colorectal Surgery: A Systematic Review and Meta-analysis. JAMA Surg. Nov 1 2018;153(11):e183467.
67. Schwartz JA, Goss SG, Facchin F, et al. Single-use negative pressure wound therapy for the treatment of chronic lower leg wounds. J Wound Care. Feb 2015; 24 Suppl 2:S4-9.
68. Seidel D, Diedrich S, Herrle F, et al. Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial. JAMA Surg. Jun 01 2020; 155(6): 469-478.
69. Seidel D, Lefering R. NPWT Resource Use Compared with Conventional Wound Treatment in Subcutaneous Abdominal Wounds with Healing Impairment After Surgery: SAWHI Randomized Clinical Trial Results. Ann Surg. Feb 01 2022; 275(2):e290-e298.
70. Senneville É, Albalawi Z, van Asten SA, et al. IWGDF/IDSA guidelines on the diagnosis and treatment of diabetes-related foot infections (IWGDF/IDSA 2023). Diabetes Metab Res Rev. Oct 01 2023: e3687.
71. Shi J, Gao Y, Tian J, et al. Negative pressure wound therapy for treating pressure ulcers. Cochrane Database Syst Rev.May 26 2023; 5(5): CD011334.
72. Stannard JP, Volgas DA, McGwin G, 3rd et al. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma 2012; 26(1):37-42.
73. Tanaydin V, Beugels J, Andriessen A, et al. Randomized Controlled Study Comparing Disposable Negative-Pressure Wound Therapy with Standard Care in Bilateral Breast Reduction Mammoplasty Evaluating Surgical Site Complications and Scar Quality. Aesthetic Plast Surg. Aug 2018;42(4):927-935.
74. Tuuli MG, Liu J, Tita ATN, et al. Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial. JAMA. Sep 22 2020; 324(12):1180-1189.
75. U.S. Food and Drug Administration (FDA). FDA preliminary public health notification: Serious complications associated with negative pressure wound therapy systems. November 13, 2009, www.fda.gov.
76. U.S. Food and Drug Administration. UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems: FDA Safety Communication. 2011 Feb; http://wayback.archive-it.org/7993/20170722215801/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm.
77. The V.A.C. (Vacuum Assisted Closure) Clinical Guidelines. KCI, Inc., July 2004.
78. Vig S, Dowsett C, Berg L Et al. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: steps towards an international consensus. J Tissue Viability 2011; 20 Suppl 1:S1-18.
79. Webster J, Scuffham P, Sherriff KL et al. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev 2012; 4:CD009261.
80. Webster J, Scuffham P, Stankiewicz M, et al. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2014; 10:CD009261.
81. Willy C, Agarwal A, Andersen CA, et al. Closed incision negative pressure therapy: international multidisciplinary consensus recommendations. Int Wound J. Apr 2017; 14(2):385-398.
82. Wynn M, Freeman S. The efficacy of negative pressure wound therapy for diabetic foot ulcers: A systematized review. J Tissue Viability. Aug 2019; 28(3): 152-160.
83. Xie X, McGregor M, Dendukuri N. The clinical effectiveness of negative pressure wound therapy: a systematic review. J Wound Care 2010; 19(11):490-5.

POLICY HISTORY:

TEC Manual information

Medical Policy Group, January 2003

Medical Policy Group, August 2004 (1)

Medical Policy Administration Committee, September 2004

Available for comment September 7-October 21, 2004

Medical Policy Group, August 2006 (4)

Medical Policy Administration Committee, August 2006

Medical Policy Group, August 2008 (1)

Medical Policy Group, November 2009 (1)

Medical Policy Administration Committee, December 2009

Available for comment December 4, 2009-January 19, 2010

Medical Policy Group, February 2010 (1)

Medical Policy Administration Committee April 2010

Available for comment March 24-May 7, 2010

Medical Policy Group, April 2011 (1): Update to Description, Policy, Key Points, Key Words, Approved by Governing Bodies, Coding and References relating to non-powered (mechanical) NPWT

Medical Policy Administration Committee May 2011

Available for comment May 11 – June 27, 2011

Medical Policy Group, September 2011 (2): Update to Description, Key Words, Approved by Governing Bodies with new brand name devices.

Medical Policy Group December 2011 (3): Added Code A9272 – 2012 Coding Update

Medical Policy Group, November 2012 (1): Updated Policy, Key Points and References to include coverage criteria for non-powered NPWT (e.g., SNaP wound care system)

Medical Policy Administration Committee, November 2012

Available for comment November 14 through December 28, 2012

Medical Policy Panel, January 2013

Medical Policy Group, April 2013 (1): 2013 Update to Key Points and References; no change in policy statement

Medical Policy Group, January 2014 (1): Update to Key Points and References; no change in policy statement

Medical Policy Group, November 2014: 2015 Annual Coding update. Added codes 97607 and 97608 to current coding. Also added already existing codes 97605 and 97606 to current coding. Moved deleted HCPCS codes G0456 and G0457 to previous coding section.

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (6): 2015 Update to Key Points, Approved by Governing Bodies, Key Words and References; no change in policy statement.

Medical Policy Panel, January 2016

Medical Policy Group, January 2016 (6):  Updates to Description, Key Points, Key Words, Approved by Governing Bodies and References; no change to policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (6): Updates to Description, Key Points, Summary, Practice Guidelines, Governing Bodies and References.

Medical Policy Panel, January 2018