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Negative Pressure Wound Treatment

Policy Number: MP-003

Latest Review Date: February 2021                                                                                                                                                                                 

Category:  DME 

Policy Grade:  C

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 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 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 measureable 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, whether or not by the physicians order.

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, 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
  • 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

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 measureable 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, whether or not by the physicians order.

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

The most recent literature update was performed through October 19, 2020.

Portable, Single-Use NPWT

Author, year, country

 

Study Design

 

Population Characteristics

 

Interventions

Comparators

Clinical Outcomes, Length of Follow up

Kirsner et al 2019

RCT

164 patients with venous leg ulcers (VLU; n=104) or diabetic foot ulcers (DFU;n=60) to treatment with PICO single-use NPWT (s-NPWT; N=80) or traditional, reusable NPWT systems (t-NPWT; N=84).

The PICO dressing was set to provide -80 mmHg of negative pressure. Choice of traditional, NPWT device manufacturer and pressure setting was at the discretion of the treating physician, with an average pressure of -118.3 mmHg (median, -125 mmHg; SD, 23.4 mmHg) applied.

Comparators of interest include standard wound care and standard, reusable NPWT devices.

12 week treatment

Confirmed wound closure (ITT) was achieved in 54 (33.5%) patients (s-NPWT, 36 [45%]; t-NPWT, 18 [22%]), with an adjusted odds ratio of 0.294 (95% CI, 0.135 to 0.638; P=0.002) for all wound types and 0.161 (95% CI, 0.035 to 0.744; P=0.020) for DFU. The subgroup analysis for DFU patients in the PP population was not significant.

Armstrong et al 2011

RCT

132 patients with lower-extremity venous or diabetic ulcers with a surface area between 1 cm²

and 100 cm²

and diameter less than 10 cm present for more than 30 days despite appropriate care

Dressings were changed per the manufacturer’s direction: 2 times per week in the

SNaP

group and 3 times per week in the V.A.C. group.

Comparator: V.A.C therapy

Patients were assessed for up to 16 weeks or until complete wound closure; 83 (63%) patients completed the study.

At the final follow-up, 65.6% of the V.A.C. group and 63.6% of the

SNaP

group had wound closure.

Marston et al. 2015

Multicenter RCT

Forty patients (n=19 MP NPWT and n=21 EP NPWT) with venous leg ulcers

Each patient was randomly assigned to treatment with either MP NPWT or EP NPWT and evaluated for 16 weeks or complete wound closure.

Compares two different negative pressure wound therapy (NPWT) modalities in the treatment of venous leg ulcers (VLUs), the ultraportable mechanically powered (MP) Smart Negative Pressure (SNaP®) Wound Care System to the electrically powered (EP) Vacuum-Assisted Closure (V.A.C.®) System.

Patients who completed the study showed a significant improvement in the percentage of those with complete wound closure treated with SNaP (57.9%) compared with the V.A.C. system (38.2%; p=0.008).

However, this study had a high loss to follow-up and lacked a comparison with standard treatment protocols.

Lerman et al 2010

Retrospective Study

Patients with lower extremity ulcers using either the SNaP

device (n=28) or

skin grafting (n=42)

SNaP System NPWT

Comparators:

NPWT using the

SNaP

device (n=28) with wound care protocols using

Apligraf,

Regranex, and skin grafting (n=42) for the treatment of lower-extremity ulcers

Seven (25%) patients in the

SNaP

-treated group could not tolerate the treatment and were discontinued from the study because of complications; they were considered treatment failures. Between-group estimates of time-to-wound healing by Kaplan-Meier analysis favored the

SNaP

treatment group. This study is limited by the use of historical controls, multiple modalities to treat controls, and a large number of dropouts. Subgroup analyses for patients with diabetic (50%) and venous (50%) ulcers were not available.

Karlakki et al 2016

RCT

220 patients evaluating use of PICO device after hip and knee arthroplasties

The PICO NPWT device was left on for 7 days, including the

time

after the hospital stay

Comparator: standard wound dressings

There were trends toward reductions in hospital length of stay(0.9 days; 95% CI, -0.2 to 2.5 days; p=0.07) and postoperative surgical wound complications (8.4% control

vs.

2.0% PICO, p=0.06).However, most of the difference in length of stay was due to wound complications in 2 outliers in the control group (up to 61 days).The level of wound exudate was significantly reduced by the PICO device (p=0.007), with 4% of the study group and 16% of the control group having grade 4 (scale grade, 0-4) exudate.

Pauser et al 2016

RCT

Patients who had

hemiarthroplasty

for femoral neck fractures. (n=21)

Incisional negative pressure wound therapy

Comparator: standard wound dressings

Group A (11 patients, 81·6 ± 5·2 years of age) developed a seroma of 0·257 ± 0·75 cm(3) after 5 days and had a secretion of 0·9 ± 1·0 days, and the total time for dressing changes was 14·8 ± 3·9 minutes, whereas group B (ten patients, 82·6 ± 8·6 years of age) developed a seroma of 3·995 ± 5·01 cm(3) after 5 days and had a secretion of 4·3 ± 2·45 days, and the total time for dressing changes was 42·9 ± 11·0 minutes.

Murphy et al 2019

Single-center, superiority designed prospective randomized open blinded endpoint controlled trial

Patients undergoing colorectal resection via laparotomy (n=300)

Incisional negative pressure wound therapy

Comparator: standard gauze dressings

The was no significant difference in the incidence of SSI at 30 days post-surgery between the Prevena and control groups (32% vs. 34%; p=0.68). No significant difference in length of hospital stay was reported.

Hussamy et al 2019

RCT

Prevena System for incisional NPWT following cesarean delivery in women with class III obesity (Body Mass Index ≥ 40; n=222) compared to standard dressings (n=219)

Incisional negative pressure wound therapy

Comparator: standard dressings

The overall composite wound morbidity rate was not significantly different between the Prevena and control cohorts (17% vs. 19%; RR 0.9; 95% CI, 0.5 to1.4).

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 randomized controlled trials (RCTs) and a systematic review of RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, 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 a meaningful 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 DFUs, but was not duplicated in the per protocol population due to a high number of exclusions. One study of the Smart Negative Pressure nonpowered Wound Care System (SNaP) 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, 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 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. There are limited data on NPWT as a primary treatment of partial-thickness burns. One RCT found no benefit of NPWT on graft take and wound epithelialization in patients with full-thickness burns. NPWT showed no benefit in the treatment of patients with surgical wounds or skin grafts healing by primary intention, and a systematic review of NPWT for traumatic and surgical wounds found no differences between standard dressing and NPWT for any wound outcome measure. However, 1 small RCT has suggested that prophylactic NPWT may reduce the number of dressing changes and pain when used in an outpatient setting. Additional study in larger samples is needed to evaluate this outcome measure. A small retrospective study indicated improved epithelialization in patients free of comorbidities treated with NPWT. The evidence is insufficient to determine the effects of the technology on health outcomes.

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. The evidence base for the Prevena System 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

International Expert Panel on Negative Pressure Wound Therapy

In 2011, an international expert panel on NPWT provided evidence-based recommendations for the use of NPWT in chronic wounds.  The panel made the following recommendations for use of NPWT (see Table 1).

Table 1: Recommendations for use of NPWT

Condition

Recommendation

Grade

Pressure ulcers, grade 3-4

“NPWT may be used until surgical closure is possible/desirable”

C

 

“NPWT should be considered to achieve closure by secondary intention…. to reduce wound dimensions…. [and] to improve the quality of the wound bed.”

B

Diabetic Foot Ulcers

“NPWT must be considered as an advanced wound care therapy…. [and] must be considered to achieve healing by secondary intention.”

A

 

“NPWT should be considered in an attempt to prevent amputation or reamputation.”

B

Ischemic lower-limb wounds

“… NPWT … may be considered in specialist hands and never as an alternative for revascularization.”

C

 

“… NPWT is NOT indicated in acute limb ischemia.”

D

Venous Leg Ulcers

“If first line therapy (compression) is not efficacious, NPWT should be considered to prepare the wound for surgical closure….”

B

Grade A: based on high-quality meta-analyses, systematic reviews of randomized controlled trials [RCTs], or RCTs with very low risk of bias.

Grade B: based on high-quality systematic reviews of case-control or cohort studies

Grade C: based on well-conducted case-control or cohort studies

Grade D: based on case series or expert opinion.

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 Surgical Infection Society

Guidelines for the prevention of infections associated with combat-related injuries were endorsed in 2011 by the Infectious Diseases Society of America (IDSA) and the Surgical Infection Society.  The guidelines provide an IB recommendation (strong recommendation, moderate-quality evidence) that NPWT should be used in the management of open wounds (excluding central nervous system (CNS) injuries) to include during aeromedical evacuation of patients.

The 2012 guidelines from IDSA for the diagnosis and treatment of diabetic foot infections state that no adjunctive therapy has been proven to improve resolution of infection, but for selected diabetic foot wounds that are slow to heal, clinicians might consider using negative wound therapy (weak recommendation, low quality evidence).

American College of Physicians

In 2015, the American College of Physicians (ACP) published guidelines 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.

Association for the Advancement of Wound Care

In 2010, the Association for the Advancement of Wound Care (AAWC) published guidelines on care of pressure ulcers. NPWT was included as a potential second-line intervention if first-line treatments did not result in wound healing (level B evidence). The guidelines indicated that patients must be selected carefully for this procedure.

In 2010, AAWC also issued guidelines on care of venous ulcers. The guidelines listed NPWT as a potential adjunctive therapy if conservative therapy does not work in 30 days. The guidelines noted that there is limited evidence for NPWT (level B) compared to other adjunctive therapies

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.

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

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; 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 from Spiracur, 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 (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 Dressing set for negative pressure wound therapy electrical pump, stationary or portable, each
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:

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  124. 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.
  125. 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.
  126. Wynn M, Freeman S. The efficacy of negative pressure wound therapy for diabetic foot ulcers: A systematised review. J TissueViability. Aug 2019; 28(3): 152-160.
  127. 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.
  128. Yang CC, Chang DS, Webb LX. Vacuum-assisted closure for fasciotomy wounds following compartment syndrome of the let. J Surg Orthop Adv 2006; 15(1):19-23.
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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

Medical Policy Group, January 2018 (6): Updates to Key Points, Practice Guidelines, Governing Bodies and References.

Medical Policy Panel, January 2019

Medical Policy Group, February 2019 (6): Updates to Key Points, Coding (A7000-A7001) and References. No change to policy statement.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (6): Updates to Key Points, Governing Bodies, Key Words (VERAFLO™). No change to policy intent.

Medical Policy Panel, January 2021

Medical Policy Group, February 2021 (6): Revised Policy statement to include non-coverage of single use/disposable NPWT systems, Key Points, Key Words (Single Use Negative Pressure Wound Therapy, V.A.C.Via™ Therapy System, ciSNaP Closed Incision System, myNeWT, AVELLE ,UNO), Practice Guidelines and References.

On DRAFT through April 5, 2021.

Medical Policy Group, July 2021 (6): Clarified Policy statement for non-powered negative pressure wound therapy devices. Title change to Negative Pressure Wound Treatment .

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts. plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination. As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage. The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.​​​​​​