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Name of Policy:

Negative Pressure Wound Treatment in the Outpatient Setting


Policy #: 003 Latest Review Date: January 2017
Category: DME Policy Grade: C

Background/Definitions:
As a general rule, benefits are payable under Blue Cross and Blue Shield of Alabama 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.

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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.

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.

Policy:
Effective for dates of service on or after November 1, 2012:
Powered and non-powered negative pressure wound therapy (NPWT) devices meet Blue
Cross and Blue Shield of Alabama’s medical criteria for coverage 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:
o The patient has been on a comprehensive diabetic management program; AND
o The patient has been non-weight bearing if appropriate; OR
• Chronic stage III or stage IV pressure ulcer when:
o 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:
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o Leg elevation and ambulation have been encouraged.

AND

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


following;
o Documentation in the medical record of evaluation of the wound; AND
o 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
o Application of dressings to moist wound environment; AND
o Debridement of necrotic tissue if present; AND
o Evaluation and provision for adequate nutritional status; AND
o Appropriate turning and positioning; AND
o Incontinence if present has been appropriately addressed; AND
o 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 meet Blue
Cross and Blue Shield of Alabama’s medical criteria for coverage for treatment of acute
wounds including the following:
• Complications of a surgically created or traumatic wounds; OR
o 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;
o Documentation in the medical record of evaluation of the wound; AND
o 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
o Application of dressings to moist wound environment; AND
o Debridement of necrotic tissue if present; AND
o Evaluation and provision for adequate nutritional status; AND
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o Appropriate turning and positioning; AND
o Incontinence if present has been appropriately addressed; AND
o 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
do not meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage 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 do not meet
Blue Cross Blue Shield of Alabama medical criteria for coverage 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

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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)

Blue Cross and Blue Shield of Alabama 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. Blue Cross and Blue Shield of Alabama 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.

Key Points:
This policy was initially developed from a 2000 TEC Assessment that evaluated negative
pressure therapy of pressure ulcers, venous ulcers, and diabetic ulcers. Literature updates for this
policy, using the MEDLINE database, have focused on comparative trials with the features
described in the 2000 TEC Assessment, e.g., enrollment of patient with wounds refractory to
standard treatment, randomization, optimal standard wound care treatment in the control arm,
and clinically important end points. In addition, literature has been sought on potential benefits
of negative pressure wound therapy (NPWT) for healing of acute wounds. The most recent
literature update was performed through November 28, 2016.

NPWT devices can be classified as either powered, i.e., requiring an electrical power source, or
mechanical. Most evidence is for electrically powered devices with large canisters such as the
V.A.C.® and the main discussion of evidence refers to this type of device. A number of portable
devices have entered the market, and are particularly relevant for use in the outpatient setting.
Some portable devices are mechanically powered while others are designed specifically for
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surgical incisions. Evidence on the newer portable devices is discussed separately following the
review of evidence on the larger electrically powered devices.

The primary end points of interest for trials of wound closure are as follows, consistent with
guidance from the U.S. Food and Drug Administration for industry in developing products for
treatment of chronic cutaneous ulcer and burn wounds:
1. Incidence of complete wound closure.
2. Time to complete wound closure (reflecting accelerated wound closure).
3. Incidence of complete wound closure following surgical wound closure.
4. Pain control.

Mixed Wound Types

Systematic Reviews
Particularly relevant for this evidence review is the effect of NPWT when used in the home
setting. In 2014, authors of a systematic review from the Johns Hopkins University Evidence-
based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) and the
Medicare and Medicaid Services (CMS) reported due to insufficient evidence, they were unable
to draw conclusions about the efficacy or safety of NPWT in the home setting. There were 3
retrospective cohort studies on diabetic foot ulcers and arterial ulcers, 1 randomized controlled
trial (RCT) and 2 retrospective cohort studies on pressure ulcers, and 1 retrospective cohort on
venous ulcers. Six studies used the V.A.C. and 1 used the SNaP device. Reviewers found that
interpretation of the data available was limited by variability in the types of comparator groups,
methodologic limitations, and poor reporting of outcomes.

Another AHRQ assessment was performed to inform the HCPCS coding decisions for NPWT
devices. This 2009 assessment found no studies showing a therapeutic distinction between
different NPWT devices.

Evidence on the efficacy of NPWT in an inpatient setting might provide indirect evidence of
NPWT efficacy in an outpatient setting. However, a 2004 systematic review from the Blue Cross
and Blue Shield Technology Evaluation Center (TEC) that was prepared for AHRQ concluded
that available published trials “did not find a significant advantage for the intervention on the
primary end point, complete healing, and did not consistently find significant differences on
secondary end points and may have been insufficiently powered to detect differences.” Four
years later a Cochrane review concluded that “trials comparing NPWT with alternative
treatments for chronic wounds have methodologic flaws and data do demonstrate a beneficial
effect of NPWT on wound healing; however, more, better quality research is needed. More
recent Cochrane reviews have been conducted separately on NPWT for pressure ulcers, diabetic
ulcers, venous insufficiency ulcers, burn wounds, skin grafts, and surgical wounds. These
systematic reviews have reached similar conclusions about a lack of high quality evidence. They
are described in greater detail next.

Randomized controlled studies


Examples of individual randomized controlled trials (RCTs) include a 2004 study by Moues et al
on the time to readiness for surgical closure among patients with full-thickness wounds of

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various etiologies. Log-rank test analysis of Kaplan-Meier method time to readiness did not
show any statistically significant differences between groups. The median time to readiness for
surgical closure was six days for negative pressure therapy patients and seven days for
conventionally treated patients (p=0.19).

Braakenburg et al (2006) compared NPWT using the V.A.C.® system (n=32) with conventional
moist wound therapy (n=33) in patients with different types of wounds (operation wounds,
diabetic ulcers, pressure sores) that ranged in duration from less than 48-hours-old to longer than
six weeks. Twenty-six (81%) NPWT patients and 19 (58%) conventional therapy patients
reached an end point of wound healing (p<0.05). The median healing time was four days shorter
in the NPWT group (16 days) compared with controls (20 days), a nonsignificant difference.
Substantial, unaccounted loss to follow-up (NPWT, 19%; controls, 36%) and ill-defined wound
characteristics confound the results.

A publication from 2008 describes an RCT of NPWT carried out in India using a locally
constructed device. In this study, 48 patients with diabetic foot ulcers, pressure ulcers,
cellulitis/fasciitis, and “other” were randomized to NPWT or moist dressings. One patient in the
NPWT group and 12 in the conventionally treated group were lost to follow-up. No statistically
significant differences in time to closure were observed between groups, except in a subset
analysis of pressure ulcers (mean 10 [+/- 7.11] days for the treatment group and 27 [+/- 10.6]
days in controls [p=0.05]). The high drop-out rate prevents drawing clear conclusions from this
study.

Chronic Pressure Ulcers


A 2015 Cochrane review included 4 RCTs (N=149) of NPWT for treating pressure ulcers in any
care setting, although most of the patients were treated in a hospital setting. Three studies were
considered to be at high risk of bias and all evidence was considered to be of very low quality.
Only one study reported on complete wound healing, which occurred in only 1 of the 12
participants in the study. The review concluded that there is high uncertainty about the potential
benefits or harms for this indication.

One representative trial (noted as awaiting further information from the authors in the 2015
Cochrane review) randomized 24 patients with pressure ulcers of the pelvic region to NPWT or
standard wound care. All patients with pelvic pressure sores were eligible for enrollment and
were not required to be refractory to standard treatment. There were no significant group
differences for the main outcome measure, time to 50% reduction of wound volume (mean 27
days in the NPWT group vs. 28 days in the control group). Limitations include the small number
of patients in the study, the possibility that the control group may not have received optimal
wound management, and lack of information on the time to complete wound healing.

Section Summary: Chronic Pressure Ulcers


The evidence on outpatient NPWT for chronic pressure ulcers includes RCTs and systematic
reviews, however, all trials are of low quality and at high risk of bias. In addition, most patients
were treated in an inpatient setting.

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Diabetic Lower Extremity Ulcers and Amputation Wounds
A 2013 Cochrane review of NPWT for treating foot wounds in patients with diabetes mellitus
included 5 randomized trials with a total of 605 participants. Two of the 5 studies had a total of
502 participants; the remaining 3 were small, with limited reporting, and with an unclear risk of
bias. One of the larger studies (described below) was conducted in patients with diabetic foot
ulcers and the second was in patients with postamputation wounds. Both studies showed a
benefit of NPWT but were considered to be at risk of performance bias due to lack of blinding.

The largest study of NPWT for diabetic foot ulcers is a 2008 multicenter randomized controlled
comparison of NPWT versus moist wound therapy by Blume et al. Included were 342 patients
with Wagner’s stage two or three foot ulcers equal to or greater than 2cm; the chronicity of the
ulcers was not described. Based on intent-to-treat analysis, a greater proportion of NPWT-treated
foot ulcers achieved the primary end point of complete ulcer closure (43.2% vs. 28.9%) within
the 112-day active treatment phase. For the 240 patients (72%) who completed the active
treatment phase, 60.8% of NPWT-treated ulcers achieved ulcer closure compared to 40.0% of
ulcers treated with moist wound therapy. NPWT patients experienced significantly fewer
secondary amputations (4.1% vs. 10.2%, p=0.035).

In 2005, Armstrong et al reported an RCT of NPWT using the V.A.C® system (n=77) and
standard moist wound care (n=85) to treat non-healing partial foot amputation wounds (average
wound duration: 1.5 months) in diabetic patients. Forty-three (56%) of NPWT patients achieved
complete closure during the 16-week assessment period versus 33 (39%) of controls (p=0.040).
Log-rank analysis showed the rate of complete closure was significantly faster with NPWT
compared with controls. Frequency and severity of adverse events, most commonly infection
(32% in both groups), were similar. Dalla Paola et al also reported more rapid development of
granulation tissue, more rapid control of infections, and reduced time to complete closure (65
days vs 98 days) in patients with infected open minor amputations. Interpretation of this study is
limited, as the size and chronicity of wounds prior to treatment were not recorded, and the
assessments were nonblinded.

Section Summary: Diabetic Lower-Extremity Ulcers and Amputation Wounds


The evidence on NPWT for diabetic lower-extremity ulcers and amputation wounds includes
RCTs and a systematic review of RCTs. Although there is some uncertainty due to risk of bias in
the unblinded studies, there was a higher rate of wound healing and fewer amputations with
NPWT, supporting its use for diabetic lower-extremity ulcers and amputation wounds.

Lower Extremity Ulcers Due to Venous Insufficiency


A 2015 Cochrane review identified a single RCT with 60 patients. This study (described next)
was performed in an inpatient setting in conjunction with skin grafts. Vuerstaek et al (2006)
compared the efficacy of NPWT using the V.A.C® system (n=30) with conventional moist
wound care (n=30) in patients hospitalized with chronic venous and/or arterial leg ulcers of
greater than six months’ duration. Full-thickness punch skin grafts from the thigh were applied
followed by four days of negative pressure wound therapy (NPWT) or conventional care to
assure complete graft adherence. Each group then received standard care with nonadhesive
dressings and compression therapy until complete healing (primary outcome) occurred. The
median time to complete healing was 29 days with NPWT and 45 days in the controls

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(p=0.0001). Ninety percent of the ulcers treated with NPWT healed within 43 days, compared
with 48% in the control group. These results suggest NPWT significantly hastened wound
healing, but the use of skin autografts makes it difficult to discern the contribution of NPWT to
the primary outcome. The 2015 Cochrane review did not identify any RCT evidence on the
effectiveness of NPWT as a primary treatment for leg ulcers nor any evidence on the home use
of NPWT.

Section Summary: Lower-Extremity Ulcers due to Venous Insufficiency


A single RCT has been identified on NPWT for the treatment of lower-extremity ulcers due to
venous insufficiency in the hospital setting. No evidence was identified on treatment in the home
setting.

Burn Wounds
A 2014 Cochrane review identified one interim report (abstract) of an RCT on NPWT in patients
with partial thickness burns. There was not enough evidence to permit any conclusions regarding
the efficacy of NPWT on partial thickness burn wounds.

Not included in the Cochrane review was a 2012 study by Bloemen et al on the effect of NPWT
on graft take in full thickness burn wounds. This was a multi-center four-armed randomized trial
with 86 patients that compared a split-skin graft with or without a dermal substitute (Matriderm),
with or without NPWT. Outcome measures included graft take at 4 to 7 days after surgery, rate
of wound epithelialization, and scar parameters at three and 12 months postoperatively. Graft
take and wound epithelialization did not differ significantly between the groups. Most measures
of scar quality also did not differ significantly between groups.

An expert panel convened to develop evidence-based recommendations for the use of NPWT
reported that the evidence base in 2011 was strongest for the use of NPWT on skin grafts and
weakest as a primary treatment for burns.

Section Summary: Burn Wounds


The evidence on NPWT as a primary treatment of partial-thickness burns is limited. One RCT on
NPWT for skin grafts showed no benefit for graft take, wound epithelialization, or scar quality.

Traumatic and Surgical Wounds


Identified studies describe a variety of wound types treated over periods ranging from several
days to several months. Studies also differ in whether NPWT was used for nonhealing wounds or
as a prophylactic treatment for surgical wounds in patients at high risk for nonhealing.

A 2014 Cochrane review evaluated the evidence on NPWT for skin grafts and surgical wounds
expected to heal by primary intention. Healing by primary intention occurs when the wound
edges are brought together with sutures, staples, tape, or glue, and contrasts with healing by
secondary intention, where the wound is left open to heal from the bottom up (e.g., for chronic or
infected wounds). Nine randomized trials with a total of 785 patients were included in the
review. Three trials involved skin grafts, 4 included orthopedic patients, and 2 included general
surgery and trauma surgery patients. All of the trials had unclear or high risk of bias. There were
no differences between standard dressing and NPWT in surgical site infections, wound

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dehiscence, reoperation (in incisional wounds), seroma/hematoma, or failed skin grafts. Pain
intensity was reported to be lower with “home-made” NPWT compared with commercial
devices. Most or all studies appear to have used short-term application of NPWT in an inpatient
setting.

A 2015 Cochrane review evaluated the evidence on surgical wounds healing by secondary
intention in any care setting. Two studies (total N=69 patients) were identified for the review.
Both studies reported a reduction in the median time to healing with NPWT, but there were
limited outcome data on the number of wounds healed, adverse events, and resource use. The
authors concluded that there is currently no rigorous RCT evidence available regarding the
clinical effectiveness of NPWT in the treatment of wounds healing by secondary intention.

A 2016 systematic review and meta-analysis by De Vries et al included 6 RCTs and 15


observational studies of surgical site infections after prophylactic NPWT. One study selected
used a portable device (PICO, described below), while the others used a V.A.C. Unlike the 2014
Cochrane review, studies on skin grafts were not included. Meta-analysis of the RCTs showed
that use of NPWT reduced the rate of surgical site infections (odds ratio, 0.56; 95% CI, 0.32 to
0.96; p=0.04), and reduced the surgical site infection rate from 140 to 83 per 1000 patients.
However, the quality of evidence was rated as low due to high risk of bias in the nonblinded
assessments and imprecision in the estimates.

The largest trial on prophylactic NPWT for surgical wounds is a 2012 report from an
investigator-initiated, industry-sponsored multicenter RCT of in-patient NPWT for closed
surgical incisions. (A preliminary report was published in 2006.) Included were 249 blunt trauma
patients with 263 high-risk fractures (tibial plateau, pilon, calcaneus) requiring surgical
stabilization. The patients were randomized to NPWT applied to the closed surgical incision or
to standard postoperative dressings. All patients were maintained as inpatients until wound
drainage was minimal, at which time the NPWT was discontinued (mean 59 hours; range 21 to
213 hours). Patients in the NPWT group were ready for discharge in 2.5 days compared with 3.0
days for the control group; this was not significantly different. The NPWT-treated group had
significantly fewer infections than the control group (10% vs. 19% of fractures, p=0.049).
Wound dehiscence after discharge was observed less frequently in the NPWT group than the
control group (8.6% vs. 16.5%). These results may reflect the efficacy of short-term use of
NPWT under highly controlled conditions of inpatient care, but do not address the effectiveness
of NPWT in the outpatient setting. A small RCT (N=20) of NPWT in an outpatient setting
suggests that NPWT may impact the number of dressing changes, reduce pain, and improve
quality of life compared to standard wound care. Additional study in a larger number of patients
is needed to evaluate these outcomes.

Other randomized studies have reported no benefit of NPWT for surgical wounds, as reflected in
the conclusions of the Cochrane review described above. For example, Masden et al (2012)
reported a randomized trial of NPWT for surgical closures at high risk for non-healing in 81
patients with comorbidities that included diabetes and peripheral vascular disease. At a mean 113
days follow-up, there was no significant difference in the proportion of patients with wound
infection, time to develop infection, or dehiscence between NPWT and dry dressing groups. Chio
and Agrawal (2010) published results of a randomized trial of 54 patients comparing NPWT with

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a static pressure dressing for healing of the radial forearm free flap donor site in 2010. There
were no statistically significant differences in wound complications or graft failure (percentage
of area for graft failure was 7.2% for negative pressure and 4.5% for standard dressing). Biter et
al (2014) found no significant advantage of two weeks of NPWT in a study of 49 patients who
underwent surgical excision for pilonidal sinus disease. Complete wound healing was achieved at
a median of 84 days in the NPWT group and 93 days in controls.

Section Summary: Traumatic and Surgical Wounds


The evidence on NPWT for individuals who have traumatic or surgical wounds includes RCTs
and systematic reviews. One RCT found no benefit of NPWT on graft take and wound
epithelialization in patients with full-thickness burns. NPWT showed no benefit for 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 suggested that
prophylactic NPWT may reduce the number of dressing changes and pain when used in an
outpatient setting. Additional study in a larger sample is needed to evaluate this outcome
measure.

Portable Single-Use NPWT Devices


SNaP® Wound Care System
One portable, non-powered (mechanical) gauze based NPWT device (SNaP Wound Care
System) designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute,
subacute wounds and diabetic and pressure ulcers became available in 2009.

In 2011, Armstrong et al reported results of a planned interim analysis of an RCT comparing


SNaP and the KCI Wound V.A.C.® Therapy System for the treatment of chronic lower
extremity wounds. Final results of this industry-sponsored multicenter non-inferiority trial were
reported in 2012. The study randomized 132 patients with lower extremity venous or diabetic
ulcers with surface area between one and 100 cm2 and diameter less than 10cm and present more
than 30 days despite appropriate care. Dressings were changed per manufacturer direction, two
times per week in the SNaP group and three times per week in the VAC group. Patients were
assessed for up to 16 weeks or until complete wound closure; 83 patients (63%) completed the
study. Intention-to-treat analysis with the last observation carried forward showed non-inferiority
in the primary outcome of wound size reduction at 4, 8, 12 and 16 weeks. When adjusted for
differences in wound size at baseline, SNaP-treated subjects showed non-inferiority to the VAC-
treated subjects at 4, 12, and 16 weeks. Kaplan-Meier analysis showed no significant difference
in complete wound closure between the two groups. At the final follow-up, 65.6% of the VAC
group and 63.6% of the SNaP group had wound closure. Survey data indicated that dressing
changes required less time, and use of the SNaP device interfered less with mobility and activity
than the VAC device. Subgroup analysis of 40 patients with venous leg ulcers who completed
the study showed a significant improvement in the percentage of patients with complete wound
closure with SNaP® compared to the VAC® system (57.9% vs 38.2%, p=0.008). This study is
limited by the high loss to follow-up and the lack of comparison with standard treatment
protocols.

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A 2010 retrospective study with historical controls compared NPWT using the SNaP device
(n=28) with wound care protocols that included the use of Apligraf, Regranex, and skin grafting
(n=42) for treatment of lower extremity ulcers. Seven patients (25%) in the SNaP treated group
could not tolerate the treatment and were discontinued from the study because of complications
(allergic skin reaction [n=1], wound infection [n=1], bleeding after debridement preventing
reapplication [n=1], worsening lower extremity edema [n=1], and the development of maceration
severe enough to required discontinuation [n=3]) and were considered treatment failures.
Between-group estimates of time to wound healing by Kaplan-Meier analysis were statistically
significantly in favor of the SNaP treatment group. This study is limited by the use of historical
controls, the multiple modalities used to treat controls, and the large number of dropouts. The
authors noted that patients in the SNaP-treated group may have benefited from being in an
experimental environment, particularly because wounds in this group were seen twice per week
compared with variable follow-up in historical controls.

PICO Dressing
PICO is a portable single-use NPWT system that comes with two sterile dressings and has a life-
span of 7 days. In 2016, Karlakki et al reported an RCT with 220 patients that evaluated use of
the PICO device in the surgical center immediately after hip and knee arthroplasties. The device
was left on for 7 days, including time after the hospital stay. Strengths of the study included
power and ITT analysis, but evaluators were not blinded. 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). 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. Blisters were
observed in 11% of patients treated with the PICO system, although the occurrence of blisters
was reported to be reduced when the dressing was stretched less.

In 2015, Schwartz et al reported an industry-funded pilot study with 12 patients who had small
wounds of various types (total, 13 wounds). A key inclusion criterion was complete failure to
progress over the previous 4 weeks. During the 4 weeks of PICO application, wound size
decreased and wound appearance improved. There was no control group in this pilot study and
no wound closures during the short follow-up period. The authors noted that in unpublished data,
the device was not effective on skin- graft donor sites.

Prevena System
Prevena is a single-use NPWT system designed specifically for incisions. In 2013, Grauhan et al
reported a pseudo-randomized trial (alternating assignment) with 150 consecutive obese patients
who underwent cardiac surgery via a median sternotomy. Use of the Prevena system for six to
seven days beginning immediately after suturing led to a reduction in wound infections (4% vs
16%, p=0.027). Gram-positive skin flora was found in one patient in the Prevena group and 10
patients in the standard wound care group. This positive study was performed in an inpatient
setting. A randomized trial in a larger number of patients with sternal midline incisions is
scheduled to be completed in 2016.

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In 2014, Pauser et al reported a small RCT (N=21) of Prevena in patients who had undergone
hemiarthroplasty for femoral neck fractures. Use of the Prevena system resulted in a significant
reduction of seroma size, days of wound secretion, wound care time, and need for dressing
changes. Larger RCTs are needed to assess these outcomes.

Section Summary: Portable Single-Use NPWT Devices for Any Wound Type
The evidence on portable single-use NPWT includes an RCT of the PICO device, an RCT of the
nonpowered SNaP System, and a pseudorandomized study of the Prevena Incision Management
System. The PICO device was studied in an adequately powered but unblinded RCT of
combined in- and outpatient use after total joint arthroplasty. Results showed some benefits that
approached statistical significance. Further study in an outpatient setting is needed. One study of
the SNaP nonpowered Wound Care System showed noninferiority to a V.A.C. device. However,
interpretation of this study is limited by a high loss to follow-up and lack of a control group
treated with dressings. These studies are insufficient to draw conclusions about the impact of
single-use NPWT devices on the net health outcome compared with current care. Well-designed
comparative studies with larger numbers of patients are needed.

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 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 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

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NPWT with split-skin grafts in patients with full-thickness burns did not show differences in
graft take and wound epithelialization. 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. The evidence is insufficient to determine the effects of the
technology on health outcomes.

For individuals who have any wound type (acute or nonhealing) who receive portable single-use
outpatient NPWT, the evidence includes RCTs. Relevant outcomes are symptoms, change in
disease status, morbid events, quality of life, and treatment-related morbidity. The evidence
includes an RCT of the PICO Single Use Negative Pressure Wound Therapy System, an RCT of
the nonpowered Smart Negative Pressure (SNaP) Wound Care System, and a pseudorandomized
study of the Prevena Incision Management System. The PICO device was studied in an
adequately powered but unblinded RCT of combined in- and outpatient use following total joint
arthroplasty. Results showed some benefits that approached statistical significance. Further study
in an outpatient setting is needed. One study with the SNaP nonpowered Wound Care System
showed noninferiority to a vacuum-assisted closure device. However, interpretation of this trial
is limited by a high loss to follow-up and lack of a control group treated with dressings. These
studies are insufficient to draw conclusions about its efficacy. Well-designed comparative studies
with larger numbers of patients are needed to determine the effects of the technology with
greater certainty. The evidence is insufficient to determine the effects of the technology on health
outcomes.

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 expert panel made the following recommendations for
use of NPWT for the following indications:
• Pressure ulcers, grade 3 and 4: can be considered until surgical closure is
possible/desirable(Grade C) or to achieve closure by secondary intention, to reduce
wound dimensions, and to improve the quality of the wound bed (Grade B).
• Diabetic foot ulcers: must be considered as an advanced wound care therapy and must be
considered to achieve healing by secondary intention (Grade A), and should be
considered in an attempt to prevent amputation or re-amputation (Grade B).

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• Ischemic lower limb wounds: may be considered in specialist hands but never as an
alternative for revascularization (Grade C) and not indicated in acute limb ischemia
(Grade D).
• Venous leg ulcers: should not be considered as first-line therapy, but should be
considered to prepare the wound for surgical closure (Grade 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.

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


The U.K.’s National Institute for Health and Clinical Excellence (NICE) 2013 guidance on
NPWT for surgical wounds concluded 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.”

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A 2015 NICE Clinical Guideline on diabetic foot problems, updated in 2016, recommends
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, NICE issued guidance on the prevention and management of pressure ulcers. The
guidance states “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).” In addition, the guidance did not recommend NPWT for
neonates, infants, or children.

American Society of Plastic Surgeons


The 2007 guidelines from the American Society of Plastic Surgeons (ASPS) states that
maintaining a moist environment, while simultaneously removing soluble factors detrimental to
wound healing might logically provide optimal conditions for wound healing. Classic dressings
include gauze, foam, hydrocolloid, and hydrogels. Fluid-handling mechanisms include
absorption, gelling, retention, and vapor transmission. Bioactive dressings include topical
antimicrobials, bioengineered composite skin equivalent, bilaminar dermal regeneration
template, and recombinant human growth factor. Finally, negative pressure wound therapy
(NPWT) is a mechanical treatment that uses negative pressure to remove wound exudate.
Although the wound care literature is rife with uncontrolled studies reporting the effectiveness of
negative pressure wound therapy, few prospective randomized trials exist. Despite a lack of
strong evidence to support its use, negative pressure wound therapy has gained wide acceptance
by multiple specialties for a myriad of wounds.

American College of Foot and Ankle Surgeons


Included in the American College of Foot and Ankle Surgeons (ACFAS) 2006 guideline on
diabetic foot disorders is the following information on NPWT: Negative pressure wound therapy
(NPWT) has become a common adjunctive treatment modality for diabetic foot ulcerations. Use
of a vacuum-assisted closure® device (V.A.C.®, KCI, San Antonio, TX) promotes wound
healing through the application of topical, subatmospheric, or “negative” pressure to the wound
base. This therapy removes edema and chronic exudate, reduces bacterial colonization, enhances
formation of new blood vessels, increases cellular proliferation, and improves wound
oxygenation as the result of applied mechanical force. These actions are synergistic. Numerous
applications of this modality have proven successful, including use over exposed bone, tendons,
and hardware to generate granulation tissue. It is also frequently used to facilitate adherence of
split thickness skin grafts, rotational flaps, or tissue substitutes to a wound bed. A recent clinical
trial of the V.A.C.® device for the treatment of open amputation wounds in the diabetic foot
showed significantly faster healing and development of granulation tissue with NPWT compared
with standard moist wound care.

U.S. Preventive Services Task Force Recommendations


Not applicable.

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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™

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.

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. (Available online
at: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm.)

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.
Pre-procedure review not required

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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 (effective
01/01/15)
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 (effective 01/01/15)
HCPCS codes:
A6550 Dressing set for negative pressure wound therapy electrical
pump, stationary or portable, each
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

Previous Codes:
HCPCS Codes:
G0456 Negative pressure wound therapy, (e.g., vacuum assisted
drainage collection) using a mechanically-powered device, not
durable medical equipment, including provision of cartridge and
dressing(s), 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 (Deleted
01/01/15)
G0457 Negative pressure wound therapy, (e.g., vacuum assisted
drainage collection) using a mechanically-powered device, not
durable medical equipment, including provision of cartridge and
dressing(s), topical application(s), wound assessment, and
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instructions for ongoing care, per session; total wound(s) surface
area greater than 50 square centimeters (Deleted 01/01/15)

References:
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2. American Society of Plastic Surgeons (ASPS). Evidence-based Clinical Practice Guideline:
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49. 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.
50. Krasner DL. Managing wound pain in patients with vacuum-assisted closure devices,
Ostomy Wound Manage, May 2002; 48(5): 38-43.
51. Labler L, Keel M and Trentz O. New application of V.A.C. [sic] (vacuum assisted closure)
in the abdominal cavity in case of open abdomen therapy, Zentralblatt fur Chirurgie, May
2004; 129 Suppl 1: S14-19.
52. 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.
53. 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.
54. 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.
55. Lipsky BA, Berendt AR, Deery HG et al. Infectious Diseases Society of America.
Diagnosis and Treatment of Diabetic Foot Infections. Clin Infect Dis. 2004 Oct 1;
39(7):885-910. Available online at: www.idsociety.org/uploadedFiles/IDSA/Guidelines-
Patient_Care/PDF_Library/Diabetic%20Foot%20Infection.pdf. Last accessed December,
2012.
56. 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
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57. 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
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58. Mody GN, Nirmal IA, Duraisamy S, et al. A blinded, prospective, randomized controlled
trial of topical negative pressure wound closure in India. Ostomy Wound Manage 2008;
54(12):36-46.
59. 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.
60. Morris GS, Brueilly KE and Hanzelka H. Negative pressure wound therapy achieved by
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61. Moues CM, Vos MC, van den Bemd GJ et al. Bacterial load in relation to vacuum-assisted
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62. Nasraway Jr., S A., et al. Multidisciplinary care of the obese patient with chronic critical
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63. National Institute for Health and Clinical Excellence (NICE). Pressure ulcers: prevention
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64. National Institute for Health and Clinical Excellence (NICE). Negative Pressure Wound
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65. National Institute for Health and Care Excellence (NICE). NICE Clinical Guideline NG19.
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66. Noble-Bell G and Forbes A. A systematic review of the effectiveness of negative pressure
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67. Pauser J, Nordmeyer M, Biber R, et al. Incisional negative pressure wound therapy after
hemiarthroplasty for femoral neck fractures - reduction of wound complications. Int
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68. Peinemann F, McGauran N, Sauerland S et al. Negative pressure wound therapy: potential
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69. Peinemann F, Sauerland S. Negative-pressure wound therapy: systematic review of
randomized controlled trials. Dtsch Arztebl Int 2011; 108(22):381-9.
70. 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.
71. Ploumis A, Mehbod AA, Dressel TD, et al. Therapy of spinal wound infections using
vacuum-assisted wound closure: risk factors leading to resistance to treatment. J Spinal
Disord Tech 2008; 21(5):320-3.
72. Psoinos CM, Ignotz RA, Lalikos JF et al. Use of gauze-based negative pressure wound
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73. Qaseem A, Humphrey LL, Forciea MA, et al. Treatment of pressure ulcers: a clinical
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74. Rhee SM, Valle MF, Wilson LM, et al. Negative Pressure Wound Therapy Technologies
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77. Runkel N, Krug E, Berg L et al. Evidence-based recommendations for the use of negative
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78. Saklani AP and Delicata RJ. Vacuum assisted closure system in the management of
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79. Samson D, Lefevre F, Aronson N. Wound-healing technologies: low-level laser and
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80. Scherer, LA. The vacuum assisted closure device: A method of securing skin grafts and
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81. Schimmer C, Sommer SP, Bensch M and Leyh R. Primary treatment of deep sternal
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85. Stannard JP, Robinson JT, Anderson ER, et al. Negative pressure wound therapy to treat
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86. Stannard JP, Volgas DA, McGwin G, 3rd et al. Incisional negative pressure wound therapy
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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
Page 25 of 26
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An Independent Licensee of the Blue Cross and Blue Shield Association
Medical Policy #003
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.
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.

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Medical Policy #003

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