Download Negative Pressure Wound Therapy in the Outpatient Setting

MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
Original Issue Date (Created):
7/1/2002
Most Recent Review Date (Revised):
11/29/2016
Effective Date:
1/1/2017
POLICY
RATIONALE
DISCLAIMER
POLICY HISTORY
PRODUCT VARIATIONS
DEFINITIONS
CODING INFORMATION
DESCRIPTION/BACKGROUND
BENEFIT VARIATIONS
REFERENCES
I. POLICY
Powered negative pressure therapy systems should be used as part of a comprehensive
wound care program that includes attention to other factors that impact wound healing such
as diabetes control, nutritional status, relief of pressure, etc.
Initiation of a Powered Negative Pressure Wound Therapy (NPWT):
An initial therapeutic trial of not less than 2 weeks using a powered negative pressure wound
therapy (NPWT) system, as part of a comprehensive wound care program that includes
controlling factors such diabetes, nutrition, relief of pressure, etc., may be considered
medically necessary in the following indications:
• Chronic (> 90 days) stage III or IV pressure ulcers that have failed to heal despite optimal
wound care when there is high-volume drainage that interferes with healing and/or when
standard dressings cannot be maintained due to anatomic factors, OR
• Traumatic or surgical wounds where there has been a failure of immediate or delayed
primary closure AND there is exposed bone, cartilage, tendon, or foreign material within
the wound OR
• Wounds in patients with underlying clinical conditions which are known to negatively
impact wound healing which are non-healing (at least 30 days), despite optimal wound
care.
o Examples of underlying conditions include, but are not limited to diabetes,
malnutrition, small vessel disease, and morbid obesity.
o Malnutrition, while a risk factor, must be addressed simultaneously with the
negative pressure wound therapy.
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NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
It is not required that a patient be homebound to receive nursing services in the patient’s
home for wound care using NPWT.
Continuation of Powered NPWT:
Continuation of the powered NPWT system, as part of a comprehensive wound care
program, may be considered medically necessary following an initial 2-week therapeutic
trial if the treatment trial has resulted in documented objective improvements in the wound,
and if there is ongoing objective improvement during subsequent treatment. Objective
improvements in the wound should include the development and presence of healthy
granulation tissue, progressive wound contracture and decreasing depth, and/or the
commencement of epithelial spread from the wound margins.
Note: Continuation of healing during use of the NPWT system should be monitored on a
frequency not less than every 14 days.
Continuation of the powered NPWT system is considered not medically necessary when
any of the following occurs:
 The therapeutic trial or subsequent treatment period has not resulted in documented
objective improvement in the wound, OR
 The wound has developed evidence of wound complications contraindicating
continued NPWT, OR
 The wound has healed to an extent that either grafting can be performed OR
 The wound can be anticipated to heal completely with other wound care treatments.
Note: Complete healing of a wound would normally be anticipated if all bone, cartilage,
tendons, and foreign material were completely covered, healthy granulation were present to
within 5 mm of the surface, and the wound edges were reduced to 2 cm in width or diameter
Therapeutic trials of powered NPWT systems for the treatment of other acute or chronic
wounds except as noted above are considered not medically necessary.
Non-Powered NPWT
Use of non-powered NPWT systems for the treatment of acute or chronic wounds is
considered investigational. There is insufficient evidence to support a conclusion
concerning the health outcomes or benefits associated with this procedure.
Policy Guidelines
Contraindications to the use of NPWT systems include the following conditions as noted
by a November 2009 FDA alert: necrotic tissue with eschar, untreated osteomyelitis,
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nonenteric and unexplored fistulas, malignancy in the wound, exposed nerve, exposed
anastomotic site, and exposed organ.
In a 2011 update, the FDA noted additional deaths and injury reports with NPWT since
2009. Although rare, these complications can occur wherever NPWT systems are used,
including hospitals, long-term care facilities, and at home. Bleeding was the cause of the
most serious adverse events, including deaths. The majority of reports of wound infection
were related to the retention of dressing pieces in the wounds. FDA recommendations for
healthcare providers include the following: select patients for NPWT carefully knowing
that NPWT systems are contraindicated for certain wound types, and patient risk factors
must be thoroughly considered before use; assure that the patient is monitored frequently
in an appropriate care setting by a trained practitioner; be aware of complications
associated with dressing changes such as infection and bleeding; be vigilant for potentially
life-threatening complications, such as bleeding, and be prepared to take prompt action if
they occur. The FDA reported that the safety and effectiveness of NPWT systems in
newborns, infants and children has not been established at this time and currently, there are
no NPWT systems cleared for use in these populations.
Cross-references:
MP-4.028 Wound and Burn Care
MP-2.033 Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment
of Would Healing and Other Conditions.
MP-2.070 Hyperbaric Oxygen Pressurization
MP-1.017 Bio-Engineered Skin and Soft Tissue Substitutes
MP-1.004 Cosmetic and Reconstructive Surgery
MP-6.026 Durable Medical Equipment
MP-8.001 Physical Medicine and Specialized Physical Medicine Treatments
II. PRODUCT VARIATIONS
TOP
This policy is applicable to all programs and products administered by Capital BlueCross unless
otherwise indicated below.
BlueJourney HMO*
BlueJourney PPO*
FEP PPO**
*Refer to Durable Medical Equipment Regional Carrier (DME MAC JA) Region JA Noridian
Healthcare Solutions, LLC Local Coverage Determination (LCD) L33821 Negative Pressure
Wound Therapy Pumps.
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NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
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**Refer to FEP Medical Policy Manual MP-1.01.16, Negative Pressure Wound Therapy in the
Outpatient Setting. The FEP Medical Policy Manual can be found at: www.fepblue.org
III. DESCRIPTION/BACKGROUND
TOP
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 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.
Regulatory Status
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), and RENASYS™ EZ PLUS
(Smith & Nephew).
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Portable systems include the RENASYS™ GO (Smith & Nephew), XLR8 PLUS (Genadyne
Biotechnologies), extriCARE® 2400 NPWT System (Devon Medical), 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 nonpowered 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 FDA in 2009 (K081406) and is designed to remove small
amounts of exudate from chronic, traumatic, dehisced, acute, or subacute wounds and diabetic
and pressure ulcers.
No NPWT device has been cleared for use in infants and children.
In November 2009, FDA issued an alert concerning complications and deaths that had been
associated with NPWT systems. An updated alert was issued in February 2011 (available at:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm).
FDA product code: OMP
IV. RATIONALE
TOP
This policy was initially developed from a 2000 TEC Assessment1 that evaluated negative
pressure therapy of pressure ulcers, venous ulcers, and diabetic ulcers. Literature updates for this
review, using the MEDLINE database, have focused on comparative trials with the features
described in the 2000 TEC Assessment (e.g., enrollment of patients 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 December 3, 2015.
NPWT devices are classified as either powered (ie, requiring an electrical power source or
batteries) or nonpowered (mechanical). Most evidence found in the literature is for electrically
powered devices with large canisters, such as the V.A.C. system, and so 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 surgical incisions. Evidence on the newer
portable devices is discussed separately following the review of evidence on the larger
electrically powered devices.
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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 Evidencebased Practice Center for Agency for Healthcare Research and Quality (AHRQ) and the Centers
for Medicare and Medicaid Services reported that due to insufficient evidence, they were unable
to draw conclusions about the efficacy or safety of NPWT in the home setting.2 These authors
found that interpretation of the data available was limited by variability in the types of
comparator groups, methodological limitations, and poor reporting of outcomes.3
Another AHRQ assessment was performed to inform the HCPCS coding decisions for NPWT
devices. This 2009 assessment found no studies showing a therapeutic distinction among
different NPWT devices.4
Evidence on the efficacy of NPWT in an inpatient setting might provide indirect evidence of its
efficacy in an outpatient setting. However, a 2004 systematic review from the Blue Cross and
Blue Shield Association Technology Evaluation Center 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.”5 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.”6 More
recently, separate Cochrane reviews have been conducted on NPWT for pressure ulcers, diabetic
ulcers, venous insufficiency ulcers, burn wounds, skin grafts, and surgical wounds. These
systematic reviews have all reached similar conclusions on a lack of high-quality evidence. They
are described in greater detail below.
Randomized Controlled Trials
Examples of individual randomized controlled trials (RCTs) include a 2004 study by Moues et
al7 on the time to readiness for surgical closure among patients with full-thickness wounds of
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 6 days for NPWT patients and 7 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 ulcers) that ranged in duration from less than 48 hours old to longer than
6 weeks.8 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 4 days shorter in the
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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 these results.
Mody et al in 2008 reported an RCT of NPWT involving 48 patients, carried out in India using a
locally constructed device.9 In this study, patients with diabetic foot ulcers (n=15), pressure
ulcers (n=11), cellulitis/fasciitis (n=11), and “other” (n=11) 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 [SD], 10 [7.11] days for the
treatment group vs 27 [10.6] days in controls; p=0.05). The high drop-out rate prevents drawing
clear conclusions from this study.
Pressure Ulcers
A 2015 Cochrane review included 4 RCTs of NPWT (N=149) for treating pressure ulcers in any
care setting, although most of the patients were treated in a hospital setting .10 Three studies were
considered to be at high risk of bias and all evidence was considered to be of very low quality.
Only 1 study reported on complete wound healing, which occurred in only 1 of the 12 study
participants. The review concluded that there is high uncertainty about the potential benefits
and/or harms for this indication.
One representative trial (noted in the 2015 Cochrane review as “awaiting further information
from the authors”) randomized 24 patients with pressure ulcers of the pelvic region to NPWT or
standard wound care.11 All patients with pelvic pressure ulcers 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). Findings were limited by 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.
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.12 Two of the 5 trials had a total of
502 participants; the remaining 3 trials were small, with limited reporting, and with an unclear
risk of bias. One of the larger studies (described next) 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 was a 2008 multicenter RCT by Blume et al
that compared NPWT versus advanced moist wound therapy.13 Included were 342 patients with
Wagner grade 2 or 3 foot ulcers at least 2 cm2; the chronicity of the ulcers was not described.
Based on intention-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 (72%) patients who completed the active treatment phase, 60.8% of
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NPWT-treated ulcers achieved ulcer closure compared with 40.0% of ulcers treated with
advanced moist wound therapy. NPWT patients also experienced significantly fewer secondary
amputations (4.1% vs 10.2%, p=0.035). Although 28% of patients in the trial were lost to followup and chronicity of the ulcers was not described, this study is still of higher quality than most of
the literature in this area.
In 2005, Armstrong and Lavery reported an RCT of NPWT using the V.A.C. system (n=77)
compared with standard moist wound care (n=85) to treat nonhealing partial foot amputation
wounds (average wound duration: 1.5 months) in patients with diabetes.14 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 were similar between groups, with wound infection being the most commonly observed
(32% in both groups). A study published in 2010 by Dalla Paola et al also reported that NPWT
resulted in 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.15 Interpretation of this study is limited, as the size and chronicity of wounds prior to
treatment were not recorded, and the assessments were nonblinded.
Lower-Extremity Ulcers due to Venous Insufficiency
A 2015 Cochrane review identified a single RCT with 60 patients.16 This study, published by
Vuerstaek et al in 2006, was performed in an inpatient setting in conjunction with skin grafts,
and 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 6 months’ duration.17 Full-thickness punch skin grafts from the thigh were applied,
followed by 4 days of 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
in the NPWT group and 45 days in control group (p=0.001). Ninety percent of ulcers treated with
NPWT healed within 43 days, compared with 48% in the control group. These results suggest
that NPWT significantly hastened wound healing, although 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 was there any evidence on the use of NPWT in the home setting.
Burn Wounds
A 2014 Cochrane review identified 1 interim report (abstract) of an RCT on NPWT in patients
with partial-thickness burns.18 However, there was not enough evidence presented to allow any
conclusions to be drawn 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.19 This was a multicenter 4-armed RCT with 86
patients that compared a split-skin graft with or without a dermal substitute (MatriDerm), with or
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without NPWT. Outcome measures included graft take at 4 to 7 days after surgery, rate of wound
epithelialization, and scar parameters at 3 and 12 months postoperatively. Graft take and wound
epithelialization did not differ significantly between 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.20
Traumatic and Surgical Wounds
Identified studies describe various 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.21 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 (eg, 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
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 effects of NPWT on the healing of surgical wounds
healing by secondary intention in any care setting.22 Two studies (total N=69 patients) were
identified for the review. Although each study reported a reduction in the median time to healing
with NPWT, both provided 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 surgical wounds
healing by secondary intention.
The largest trial on prophylactic NPWT for surgical wounds is a 2012 report from an
investigator-initiated, industry-sponsored multicenter RCT of inpatient NPWT for closed
surgical incisions.23 (A preliminary report was published in 2006.24) Participants included 249
blunt trauma patients with 263 high-risk fractures (tibial plateau, pilon, calcaneus) requiring
surgical stabilization. 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 NPWT was discontinued (mean, 59 hours; range, 21-213
hours). Patients in the NPWT group were ready for discharge in 2.5 days compared with 3.0 days
for the control group (a nonsignificant difference). The NPWT group had significantly fewer
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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 in the control group (8.6% vs
16.5%). These results support the efficacy of short-term use of NPWT when used under highly
controlled conditions of inpatient care, but provide only indirect evidence of the effectiveness of
NPWT in the outpatient setting. A small RCT (N=20) of NPWT in an outpatient setting reported
that patients treated with NPWT required significantly fewer dressing changes, reported
significantly less pain, and experienced quality-of-life improvements compared to standard
wound care.25 Additional study among a larger sample of patients is needed to evaluate these
outcomes.
Other randomized studies report no benefit of NPWT for surgical wounds, as reflected in the
conclusions of the 2015 Cochrane review described above. For example, the RCT by Masden et
al (2012) examined the use of NPWT for surgical closures at high risk for nonhealing in 81
patients with comorbidities that included diabetes and peripheral vascular disease.26 At a mean of
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
a static pressure dressing for healing of the radial forearm free flap donor site.27 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 2 weeks of NPWT in a study of 49 patients who underwent
surgical excision for pilonidal sinus disease.28 Complete wound healing was achieved at a
median of 84 days in the NPWT group and 93 days in controls.
Portable Single-Use NPWT Devices
SNaP Wound Care System
The portable, nonpowered (mechanical) gauze-based Smart Negative Pressure (SNaP) Wound
Care System became available in 2009. The device is designed to remove small amounts of
exudate from chronic, traumatic, dehisced, acute, or subacute wounds and diabetic and pressure
ulcers.
In 2011, Armstrong et al reported results of a planned interim analysis of an RCT comparing the
SNaP Wound Care System and the Vacuum Assisted Closure (V.A.C.) Therapy for the treatment
of chronic lower-extremity wounds.29 Final results of this industry-sponsored multicenter
noninferiority trial were reported in 2012.30 The study randomized 132 patients with lowerextremity venous or diabetic ulcers present for more than 30 days despite appropriate care having
a surface area between 1 and 100 cm2 and diameter less than 10 cm. 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. 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 noninferiority 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
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showed noninferiority to V.A.C.-treated subjects at 4, 12, and 16 weeks. Kaplan-Meier analysis
showed no significant difference in complete wound closure between the 2 groups. At the final
follow-up, 65.6% of the V.A.C. 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 V.A.C. 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 V.A.C. system (57.9% vs
38.2%, p=0.008).31 This study is limited by high loss to follow-up and lack of comparison with
standard treatment protocols.
A 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.32 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 débridement preventing
reapplication [n=1], worsening lower-extremity edema [n=1], and development of maceration
severe enough to require discontinuation [n=3]), and so 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, 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 2 sterile dressings and has a
lifespan of 7 days. In 2015, Schwartz et al reported an industry-funded pilot study with 12
patients who had small wounds of various types (13 wounds in total).33 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. Additional study
is needed.
Prevena System
Prevena is a single-use NPWT system designed specifically for incisions. In 2013, Grauhan et al
reported a pseudorandomized trial (alternating assignment) with 150 consecutive obese patients
who underwent cardiac surgery via a median sternotomy.34 Use of the Prevena system for 6 to 7
days beginning immediately after suturing led to a reduction in rates of wound infection
compared with standard wound care (4% vs 16%, p=0.027). Gram-positive skin flora were found
in 1 patient in the Prevena group and 10 patients in the wound care group. This positive study
was performed in an inpatient setting. A randomized trial involving 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.35 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.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 1.
Table 1. Summary of Key Trials
NCT No.
Ongoing
NCT01191567
NCT02195310a
NCT02127281a
NCT02395159
NCT02064270a
NCT02289157a
NCT2509260
NCT02007018a
NCT02461433a
NCT01913132
NCT02309944a
NCT02348034a
NCT02467998
NCT01821664
Trial Name
Planned
Enrollment
Completion
Date
Negative Pressure Wound Therapy. Therapy Effects and the
Impact on the Patient’s Quality of Life
The Use of PrevenaTM Incision Management System on Clean
Closed Sternal Midline Incisions in Subjects at High Risk for
Surgical Site Occurrences
Randomized Controlled Trial of Wound Management With
Negative Pressure Dressing Versus Standard Dressing After
Knee and Hip Revision Arthroplasty
Reduction of Groin Wound Infections After Vascular Surgery in
Patients With Risk Factors by the Use a Negative Pressure
Wound Incision Management System (KCI Prevena)
A Prospective, Randomized, Controlled Clinical Study to Assess
the Prevention of Postsurgical Incision Healing Complications in
Patients Undergoing Primary or Revision Total Knee Arthroplasty
(TKA) or Total Hip Arthroplasty (THA), Treated With Either SingleUse Negative Pressure Wound Therapy (NPWT) or Standard
Postsurgical Dressings
Negative Pressure Wound Therapy in High Risk Patients
Undergoing Cesarean
A Randomized Controlled Trial of Prevena™ Incisional Negative
Pressure Wound Therapy to Reduce Surgical Site Infection in Reoperative Colorectal Surgery
Negative Pressure Wound Therapy Use to Decrease Surgical
Nosocomial Events in Colorectal Resections (NEPTUNE)
The SAVIOR Trial: Surgical Application of Vac Dressings In
Obese Patients to Reduce Wound Complications
PICO Versus Standard Dressing Above Groin Incisions After
Vascular Surgery - a Prospective Randomized Trial
Negative Pressure Wound Therapy in Obese Gynecologic
Oncology Patients: A Randomized Controlled Trial
A Randomized Controlled Trial Exploring the Ability of Negative
Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical
Site Infections (SSI)
The Registry of Negative Pressure Wound Therapy for Chronic
Wounds and Ulcers
Vascular Graft Infections - Epidemiology, Best Treatment Options,
Imaging Modalities and Impact of Negative Pressure Wound
Therapy
200
Jan 2016
504
Feb 2016
160
Mar 2016
204
Mar 2016
1000
Mar 2016
440
Jan 2017
298
Jul 2017
300
Sep 2017
108
Sep 2017
160
Dec 2017
200
Dec 2017
398
Dec 2017
50,000
Jan 2020
1800
Mar 2023
Unpublished
Page 12
MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
NCT01890720a
Use of Incisional Negative Pressure Wound Therapy for
Prevention of Postoperative Infections Following Caesarean
Section in Women With BMI >=30
NCT02020018a Negative Pressure Wound Therapy for Prevention of Wound
Infection After Heart Surgery
NCT01528033a Treatment of Subcutaneous Abdominal Wound Healing
Impairment After Surgery Without Fascial Dehiscence by Vacuum
Assisted Closure™(SAWHI-V.A.C.® Study) Versus Standard
Conventional Wound Therapy
NCT: national clinical trial.
a
Denotes industry-sponsored or cosponsored trial.
948
Apr 2015
950
Jun 2015
600
Nov 2015
Summary of Evidence
The evidence for negative pressure wound therapy (NPWT) in individuals who have chronic
pressure ulcers includes randomized controlled trials (RCTs) and systematic reviews. Relevant
outcomes are symptoms, change in disease status, morbid events, quality of life, and treatmentrelated morbidity. All trials are of low quality and at high risk of bias. In addition, most patients
were treated in an inpatient setting. The evidence is insufficient to determine the effects of the
technology on health outcomes.
The evidence for NPWT in individuals who have chronic wounds and comorbidities affecting
wound healing includes RCTs and systematic reviews. Relevant outcomes are symptoms, change
in disease status, morbid events, quality of life, and treatment-related morbidity. RCTs have been
published on diabetic lower-extremity ulcers of unknown duration, amputation wounds, and
nonhealing lower-extremity ulcers due to venous insufficiency. The largest body of evidence is
for foot ulcers in patients who have diabetes, showing a higher rate of wound healing and fewer
amputations with NPWT. A single RCT in patients with nonhealing leg ulcers who were treated
with skin grafts found a faster rate of healing with NPWT. The evidence is sufficient to
determine qualitatively that the technology results in a meaningful improvement in the net health
outcome.
The evidence for NPWT in individuals who have traumatic or surgical wounds (acute or
nonhealing) 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 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 in any wound outcome measure. However, 1
small RCT suggests 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. The evidence is insufficient to determine the effects of the technology on
health outcomes.
The evidence for single-use portable NPWT systems in individuals who have any wound type
includes an RCT of the nonpowered Smart Negative Pressure (SNaP®) Wound Care System and
Page 13
MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
a pseudorandomized study of the PrevenaTM Incision Management System. Relevant outcomes
are symptoms, change in disease status, morbid events, quality of life, and treatment-related
morbidity. One study with 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. RCTs with small numbers of patients using
portable electric NPWT systems are insufficient to draw conclusions about its impact on net
health outcome, both for the device itself and in comparison with current care. Well-designed
comparative studies with larger numbers of patients are needed. Results from larger RCTs are
expected. The evidence is insufficient to determine the effects of the technology on health
outcomes.
Clinical Input Received From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate
with and make recommendations during this process, through the provision of appropriate
reviewers, input received does not represent an endorsement or position statement by the
physician specialty societies or academic medical centers, unless otherwise noted.
2010 Input
In response to requests, input was received from 2 physician specialty societies and 3 academic
medical centers while this policy was under review in 2010. The input was near uniform in
support of a therapeutic trial of NPWT for chronic pressure ulcers that have failed to heal; for
traumatic or surgical wounds that have failed to close when there is exposed bone, cartilage,
tendon, or foreign material within the wound; and for nonhealing wounds in patients with
underlying clinical conditions known to negatively impact wound healing. Most of the input
agreed that therapeutic trials of NPWT for other acute or chronic wounds would be not be
medically necessary.
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.36 The expert panel gave a grade C recommendation (based
on well-conducted case-control or cohort studies) that NPWT may be used for grade 3 and 4
pressure ulcers until surgical closure is possible/desirable and a grade B recommendation (based
on high-quality systematic reviews of case-control or cohort studies) to achieve closure by
secondary intention, to reduce wound dimensions, and to improve the quality of the wound bed.
For diabetic foot ulcers, the expert panel gave a grade A recommendation (high-quality metaanalyses, systematic reviews of randomized controlled trials [RCTs], or RCTs with very low risk
of bias) that NPWT must be considered as an advanced wound care therapy and must be
considered to achieve healing by secondary intention, and a grade B recommendation that
NPWT should be considered in an attempt to prevent amputation or reamputation. Use of NPWT
in ischemic lower-limb wounds received a grade C recommendation that NPWT may be
considered in specialist hands but never as an alternative for revascularization, and a grade D
Page 14
MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
recommendation (based on case series or expert opinion) that the use of NPWT is not indicated
in acute limb ischemia. Use of NPWT in venous leg ulcers received a grade B recommendation
that as first-line therapy, (compression) is not efficacious; NPWT should be considered to
prepare the wound for surgical closure.
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.37 The guidelines provide a IB recommendation (strong recommendation, moderatequality evidence) that NPWT should be used in the management of open wounds (excluding
central nervous system injuries), including 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 NPWT (weak
recommendation, low quality evidence).38
National Institute for Health and Clinical Excellence
The U.K.’s National Institute for Health and Clinical Excellence (NICE) stated in 2009 that
current evidence on the safety and efficacy of NPWT for the open abdomen is inadequate in
quality and quantity, and clinicians should make special arrangements for audit of the
management of all patients with an open abdominal wound.39
A 2015 NICE Clinical Guideline on diabetic foot problems recommends consideration of NPWT
after surgical débridement for diabetic foot ulcers on the advice of the multidisciplinary foot care
service.40 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.
The 2005 guidance on the management of pressure ulcers in primary and secondary care from
the Royal College of Nursing and NICE stated that topical negative pressure treatment was only
assessed in one trial with a small sample size and methodologic limitations; while trial results
suggested that topical negative pressure treatment may increase healing rates of pressure ulcers
compared with saline gauze dressings, these findings must be viewed with extreme caution.
“Practitioners ought to make patients aware of the limited trial-based evidence for the
effectiveness of topical negative pressure for pressure ulcer healing and that further research is
required to validate the preliminary findings.”41
American Society of Plastic Surgeons
The 2007 guidelines from the American Society of Plastic Surgeons states that maintaining a
moist environment, while simultaneously removing soluble factors detrimental to wound healing,
might logically provide optimal conditions for wound healing.42 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
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MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
recombinant human growth factor. Finally, 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 NPWT, few prospective randomized trials exist. Despite a
lack of strong evidence to support its use, NPWT has gained wide acceptance by multiple
specialties for a myriad of wounds.
American College of Foot and Ankle Surgeons
Included in the 2006 guideline on diabetic foot disorders from the American College of Foot and
Ankle Surgeons is the following information on NPWT43: 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.
V. DEFINITIONS
TOP
ATMOSPHERIC PRESSURE is the pressure exerted by the weight of the atmosphere, also
known as barometric pressure.
COMPREHENSIVE WOUND CARE PROGRAM includes
a minimum of all the following general
measures:
 Documentation in the patient’s medical record of evaluation, care and wound
measurements by a licensed medical professional; and
 Application of dressings to maintain a moist wound environment; and
 Debridement of necrotic tissue when present; and
 Evaluation of and provision for adequate nutritional and vascular status
GRANULATING TISSUE refers to formation of granule-like projections on the internal
surface of the wound that represents the outgrowth of new capillaries, bringing a rich blood
supply to the wound, promoting healing.
Page 16
MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
PRESSURE (DECUBITUS) ULCER is a type of wound that forms as a result of prolonged
pressure against areas of the skin. This is commonly seen over the bony prominences, such
as sacrum and heels, in bedridden and/or wheelchair confined individuals. Pressure ulcers
are classified into four stages (and an unstageable category), to signify the degree of skin
damage:
 Stage I- Intact skin with non-blanchable redness of a localized area usually over a
bony prominence. Darkly pigmented skin may not have visible blanching; its color
may differ from the surrounding area.
 Stage II- Partial thickness loss of dermis presenting as a shallow open ulcer with a red
pink wound bed, without slough. May also present as an intact or open/ruptured
serum-filled blister.
 Stage III- Full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon
or muscle is not exposed. Slough may be present but does not obscure the depth of
tissue loss. May include undermining and tunneling.
 Stage IV- Full thickness tissue loss with exposed bone, tendon or muscle. Slough or
eschar may be present on some parts of the wound bed. Often include undermining
and tunneling.
 Unstageable- Full thickness tissue loss in which the base of the ulcer is covered by
slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the
wound bed. (Until enough slough and/or eschar is removed to expose the base of the
wound, the true depth, and therefore stage, cannot be determined.)
VASCULARITY is the state of blood vessel development and functioning in an organ or
tissue.
VI. BENEFIT VARIATIONS
TOP
The existence of this medical policy does not mean that this service is a covered benefit under
the member's contract. Benefit determinations should be based in all cases on the applicable
contract language. Medical policies do not constitute a description of benefits. A member’s
individual or group customer benefits govern which services are covered, which are excluded,
and which are subject to benefit limits and which require preauthorization. Members and
providers should consult the member’s benefit information or contact Capital for benefit
information.
Page 17
MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
VII. DISCLAIMER
TOP
Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical
advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of
members. Members should discuss any medical policy related to their coverage or condition with their provider
and consult their benefit information to determine if the service is covered. If there is a discrepancy between this
medical policy and a member’s benefit information, the benefit information will govern. Capital considers the
information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law.
VIII. CODING INFORMATION
TOP
Note: This list of codes may not be all-inclusive, and codes are subject to change at any time.
The identification of a code in this section does not denote coverage as coverage is determined
by the terms of member benefit information. In addition, not all covered services are eligible for
separate reimbursement.
Covered when medically necessary:
CPT Codes®
97605
97606
97607
97608
Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved .
HCPCS
Codes
A6550
A7000
E2402
K0743
K0744
K0745
K0746
Description
Wound care set, for negative pressure wound therapy electrical pump, includes all
supplies and accessories
Canister, disposable, used with suction pump, each
Negative pressure wound therapy electrical pump, stationary or portable
Suction pump, home model, portable, for use on wounds
Absorptive wound dressing for use with suction pump, home model, portable, pad size
16 sq in or less
Absorptive wound dressing for use with suction pump, home model, portable, pad size
more than 16 sq in but less than or equal to 48 sq in
Absorptive wound dressing for use with suction pump, home model, portable, pad size
greater than 48 sq in
Page 18
MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
Investigational; therefore not covered:
HCPCS
Code
A9272
Description
Mechanical wound suction, disposable, includes dressing, all accessories and components,
each
ICD-10CM
Diagnosis
Code*
Description
E10.621
E10.622
E11.621
E11.622
E13.621
E13.622
I70.231
I70.232
I70.233
I70.234
I70.241
I70.242
I70.243
I70.244
I70.245
I83.011
I83.012
I83.013
I83.014
I83.015
I83.021
I83.022
I83.023
I83.024
I83.025
L89.003
L89.004
L89.013
L89.014
Type 1 diabetes mellitus with foot ulcer
Type 1 diabetes mellitus with other skin ulcer
Type 2 diabetes mellitus with foot ulcer
Type 2 diabetes mellitus with other skin ulcer
Other specified diabetes mellitus with foot ulcer
Other specified diabetes mellitus with other skin ulcer
Atherosclerosis of native arteries of right leg with ulceration of thigh
Atherosclerosis of native arteries of right leg with ulceration of calf
Atherosclerosis of native arteries of right leg with ulceration of ankle
Atherosclerosis of native arteries of right leg with ulceration of heel and midfoot
Atherosclerosis of native arteries of left leg with ulceration of thigh
Atherosclerosis of native arteries of left leg with ulceration of calf
Atherosclerosis of native arteries of left leg with ulceration of heel and midfoot
Atherosclerosis of native arteries of left leg with ulceration of heel and midfoot
Atherosclerosis of native arteries of left leg with ulceration of other part of foot
Varicose veins of right lower extremity with ulcer of thigh
Varicose veins of right lower extremity with ulcer of calf
Varicose veins of right lower extremity with ulcer of ankle
Varicose veins of right lower extremity with ulcer of heel and midfoot
Varicose veins of right lower extremity with ulcer other part of foot
Varicose veins of left lower extremity with ulcer of thigh
Varicose veins of left lower extremity with ulcer of calf
Varicose veins of left lower extremity with ulcer of ankle
Varicose veins of left lower extremity with ulcer of heel and midfoot
Varicose veins of left lower extremity with ulcer other part of foot
Pressure ulcer of unspecified elbow, stage 3
Pressure ulcer of unspecified elbow, stage 4
Pressure ulcer of right elbow, stage 3
Pressure ulcer of right elbow, stage 4
Page 19
MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
L89.023
L89.024
L89.103
L89.104
L89.113
L89.114
L89.123
L89.124
L89.133
L89.134
L89.143
L89.144
L89.153
L89.154
L89.203
L89.204
L89.213
L89.214
L89.223
L89.224
L89.303
L89.304
L89.313
L89.314
L89.323
L89.324
L89.43
L89.44
L89.503
L89.504
L89.513
L89.514
L89.523
L89.524
L89.613
L89.614
L89.623
L89.624
Pressure ulcer of left elbow, stage 3
Pressure ulcer of left elbow, stage 4
Pressure ulcer of unspecified part of back, stage 3
Pressure ulcer of unspecified part of back, stage 4
Pressure ulcer of right upper back, stage 3
Pressure ulcer of right upper back, stage 4
Pressure ulcer of left upper back, stage 3
Pressure ulcer of left upper back, stage 4
Pressure ulcer of right lower back, stage 3
Pressure ulcer of right lower back, stage 4
Pressure ulcer of left lower back, stage 3
Pressure ulcer of left lower back, stage 4
Pressure ulcer of sacral region, stage 3
Pressure ulcer of sacral region, stage 4
Pressure ulcer of unspecified hip, stage 3
Pressure ulcer of unspecified hip, stage 4
Pressure ulcer of right hip, stage 3
Pressure ulcer of right hip, stage 4
Pressure ulcer of left hip, stage 3
Pressure ulcer of left hip, stage 4
Pressure ulcer of unspecified buttock, stage 3
Pressure ulcer of unspecified buttock, stage 4
Pressure ulcer of right buttock, stage 3
Pressure ulcer of right buttock, stage 4
Pressure ulcer of left buttock, stage 3
Pressure ulcer of left buttock, stage 4
Pressure ulcer of contiguous site of back, buttock and hip, stage 3
Pressure ulcer of contiguous site of back, buttock and hip, stage 4
Pressure ulcer of unspecified ankle, stage 3
Pressure ulcer of unspecified ankle, stage 4
Pressure ulcer of right ankle, stage 3
Pressure ulcer of right ankle, stage 4
Pressure ulcer of left ankle, stage 3
Pressure ulcer of left ankle, stage 4
Pressure ulcer of right heel, stage 3
Pressure ulcer of right heel, stage 4
Pressure ulcer of left heel, stage 3
Pressure ulcer of left heel, stage 4
Page 20
MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
L89.813
L89.814
Pressure ulcer of head, stage 3
Pressure ulcer of head, stage 4
Disruption of external operation (surgical) wound, not elsewhere classified, initial
T81.31XA
encounter
Disruption of external operation (surgical) wound, not elsewhere classified, subsequent
T81.31XD
encounter
Disruption of internal operation (surgical) wound, not elsewhere classified, initial
T81.32XA
encounter
Disruption of internal operation (surgical) wound, not elsewhere classified, subsequent
T81.32XD
encounter
T81.33XA Disruption of traumatic injury wound repair, initial encounter
T81.33XD Disruption of traumatic injury wound repair, subsequent encounter
T81.4XXA Infection following a procedure, initial encounter
T81.4XXD Infection following a procedure, subsequent encounter
Perforation due to foreign body accidentally left in body following surgical operation,
T81.530A
initial encounter
Perforation due to foreign body accidentally left in body following surgical operation,
T81.530D
subsequent encounter
*If applicable, please see Medicare LCD or NCD for additional covered diagnoses
IX. REFERENCES
TOP
1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Vacuumassisted closure in the treatment of chronic wounds. TEC Assessments. 2000;Volume 15, Tab 23.
2. Rhee SM, Valle MF, Wilson LM, et al. Negative Pressure Wound Therapy Technologies For
Chronic Wound Care in the Home Setting. Evidence Report/Technology Assessment. (Prepared
by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-201200007-I.) Rockville, MD: Agency for Healthcare Research and Quality. September 15, 2014.
http://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/id96ta.pdf.
Accessed December 5, 2016
3. Rhee SM, Valle MF, Wilson LM, et al. Negative pressure wound therapy technologies for
chronic wound care in the home setting: A systematic review. Wound Repair Regen. Jul
2015;23(4):506-517. PMID 25845268
4. Sullivan N, Snyder DL, Tipton K, et al. Technology assessment: Negative pressure wound
therapy devices. 2009; www.ahrq.gov/clinic/ta/negpresswtd. Accessed December 5, 2016.
5. Samson D, Lefevre F, Aronson N. Wound-healing technologies: low-level laser and vacuumassisted closure. Evidence Report/Technology Assessment No. 111. (Prepared by the Blue Cross
and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center,
under Contract No. 290-02-0026.) AHRQ Publication No. 05-E005-2. Rockville, MD: Agency
for Healthcare Research and Quality. Dec 2004. PMID 15663354
6. Ubbink DT, Westerbos SJ, Evans D, et al. Topical negative pressure for treating chronic
wounds. Cochrane Database Syst Rev. 2008(3):CD001898. PMID 18646080
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SETTING
POLICY NUMBER
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7. Moues CM, Vos MC, van den Bemd GJ, et al. Bacterial load in relation to vacuum-assisted
closure wound therapy: a prospective randomized trial. Wound Repair Regen. Jan-Feb
2004;12(1):11-17. PMID 14974959
8. Braakenburg A, Obdeijn MC, Feitz R, et al. The clinical efficacy and cost effectiveness of the
vacuum-assisted closure technique in the management of acute and chronic wounds: a
randomized controlled trial. Plast Reconstr Surg. Aug 2006;118(2):390-397; discussion 398400. PMID 16874208
9. 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. Dec
2008;54(12):36-46. PMID 19104122
10. Dumville JC, Webster J, Evans D, et al. Negative pressure wound therapy for treating
pressure ulcers. Cochrane Database Syst Rev. 2015;5:CD011334. PMID 25992684
11. Wanner MB, Schwarzl F, Strub B, et al. Vacuum-assisted wound closure for cheaper and
more comfortable healing of pressure sores: a prospective study. Scand J Plast Reconstr Surg
Hand Surg. 2003;37(1):28-33. PMID 12625392
12. Dumville JC, Hinchliffe RJ, Cullum N, et al. Negative pressure wound therapy for treating
foot wounds in people with diabetes mellitus. Cochrane Database Syst Rev. 2013;10:CD010318.
PMID 24132761
13. Blume PA, Walters J, Payne W, et al. Comparison of negative pressure wound therapy using
vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot
ulcers: a multicenter randomized controlled trial. Diabetes Care. Apr 2008;31(4):631-636.
PMID 18162494
14. Armstrong DG, Lavery LA. Negative pressure wound therapy after partial diabetic foot
amputation: a multicentre, randomised controlled trial. Lancet. Nov 12 2005;366(9498):17041710. PMID 16291063
15. Dalla Paola L, Carone A, Ricci S, et al. Use of vacuum assisted closure therapy in the
treatment of diabetic foot wounds. Journal of Diabetic Foot Complications. J Diabetic Foot
Complications. 2010;2:33-44.
16. Dumville JC, Land L, Evans D, et al. Negative pressure wound therapy for treating leg
ulcers. Cochrane Database Syst Rev. 2015;7:CD011354. PMID 26171910
17. Vuerstaek JD, Vainas T, Wuite J, et al. State-of-the-art treatment of chronic leg ulcers: A
randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound
dressings. J Vasc Surg. Nov 2006;44(5):1029-1037; discussion 1038. PMID 17000077
18. Dumville JC, Munson C, Christie J. Negative pressure wound therapy for partial-thickness
burns. Cochrane Database Syst Rev. 2014;12:CD006215. PMID 25500895
19. Bloemen MC, van der Wal MB, Verhaegen PD, et al. Clinical effectiveness of dermal
substitution in burns by topical negative pressure: a multicenter randomized controlled trial.
Wound Repair Regen. Nov-Dec 2012;20(6):797-805. PMID 23110478
20. Runkel N, Krug E, Berg L, et al. Evidence-based recommendations for the use of Negative
Pressure Wound Therapy in traumatic wounds and reconstructive surgery: steps towards an
international consensus. Injury. Feb 2011;42 Suppl 1:S1-12. PMID 21316515
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SETTING
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21. 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. PMID 25287701
22. Dumville JC, Owens GL, Crosbie EJ, et al. Negative pressure wound therapy for treating
surgical wounds healing by secondary intention. Cochrane Database Syst Rev.
2015;6:CD011278. PMID 26042534
23. Stannard JP, Volgas DA, McGwin G, 3rd, et al. Incisional negative pressure wound therapy
after high-risk lower extremity fractures. J Orthop Trauma. Jan 2012;26(1):37-42. PMID
21804414
24. Stannard JP, Robinson JT, Anderson ER, et al. Negative pressure wound therapy to treat
hematomas and surgical incisions following high-energy trauma. J Trauma. Jun
2006;60(6):1301-1306. PMID 16766975
25. Monsen C, Acosta S, Mani K, et al. A randomised study of NPWT closure versus alginate
dressings in perivascular groin infections: quality of life, pain and cost. J Wound Care. Jun
2015;24(6):252, 254-256, 258-250. PMID 26075373
26. Masden D, Goldstein J, Endara M, et al. Negative pressure wound therapy for at-risk
surgical closures in patients with multiple comorbidities: a prospective randomized controlled
study. Ann Surg. Jun 2012;255(6):1043-1047. PMID 22549748
27. Chio EG, Agrawal A. A randomized, prospective, controlled study of forearm donor site
healing when using a vacuum dressing. Otolaryngol Head Neck Surg. Feb 2010;142(2):174-178.
PMID 20115970
28. Biter LU, Beck GM, Mannaerts GH, et al. The use of negative-pressure wound therapy in
pilonidal sinus disease: a randomized controlled trial comparing negative-pressure wound
therapy versus standard open wound care after surgical excision. Dis Colon Rectum. Dec
2014;57(12):1406-1411. PMID 25380007
29. Armstrong DG, Marston WA, Reyzelman AM, et al. Comparison of negative pressure wound
therapy with an ultraportable mechanically powered device vs. traditional electrically powered
device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled
trial. Wound Repair Regen. Mar-Apr 2011;19(2):173-180. PMID 21362084
30. Armstrong DG, Marston WA, Reyzelman AM, et al. Comparative effectiveness of
mechanically and electrically powered negative pressure wound therapy devices: a multicenter
randomized controlled trial. Wound Repair Regen. May-Jun 2012;20(3):332-341. PMID
22564228
31. Marston WA, Armstrong DG, Reyzelman AM, et al. A Multicenter Randomized Controlled
Trial Comparing Treatment of Venous Leg Ulcers Using Mechanically Versus Electrically
Powered Negative Pressure Wound Therapy. Adv Wound Care (New Rochelle). Feb 1
2015;4(2):75-82. PMID 25713749
32. 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. Oct
2010;126(4):1253-1261. PMID 20885246
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MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
33. Schwartz JA, Goss SG, Facchin F, et al. Single-use negative pressure wound therapy for the
treatment of chronic lower leg wounds. J Wound Care. Feb 2015;24 Suppl 2:S4-9. PMID
25647506
34. Grauhan O, Navasardyan A, Hofmann M, et al. Prevention of poststernotomy wound
infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. May
2013;145(5):1387-1392. PMID 23111014
35. Pauser J, Nordmeyer M, Biber R, et al. Incisional negative pressure wound therapy after
hemiarthroplasty for femoral neck fractures - reduction of wound complications. Int Wound J.
Aug 14 2014. PMID 25125244
36. Vig S, Dowsett C, Berg L, et al. Evidence-based recommendations for the use of negative
pressure wound therapy in chronic wounds: steps towards an international consensus. J Tissue
Viability. Dec 2011;20 Suppl 1:S1-18. PMID 22119531
37. Hospenthal DR, Murray CK, Andersen RC, et al. Guidelines for the prevention of infections
associated with combat-related injuries: 2011 update: endorsed by the Infectious Diseases
Society of America and the Surgical Infection Society. J Trauma. Aug 2011;71(2 Suppl 2):S210234. PMID 21814089
38. Lipsky BA, Berendt AR, Cornia PB, et al. Infectious Diseases Society of America (IDSA),
Clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clinical
Infectious Diseases 2012;54(12):132–173.
http://cid.oxfordjournals.org/content/54/12/e132.full.pdf+html. Accessed December 5, 2016.
39. National Institute for Health and Clinical Excellence (NICE). Negative Pressure Wound
Therapy for the Open Abdomen. IPG 322. 2009;
http://www.nice.org.uk/nicemedia/pdf/IPG322Guidance.pdf. Accessed December 5, 2016.
40. National Institute for Health and Care Excellence (NICE). NICE Clinical Guideline NG19.
Diabetic Foot Problems: Prevention and Management. 2015;
https://www.nice.org.uk/guidance/ng19/evidence. Accessed December 5, 2016.
41. Royal College of Nursing and National Institute for Health and Clinical Excellence. The
Management of Pressure Ulcers in Primary and Secondary Care. Clinical Guidance 29. 2005;
http://guidance.nice.org.uk/CG29/Guidance/pdf/English. Accessed December 5, 2016.
42. American Society of Plastic Surgeons (ASPS). Evidence-based Clinical Practice Guideline:
Chronic Wounds of the Lower Extremity. 2007;
http://www.plasticsurgery.org/Documents/medical-professionals/healthpolicy/evidencepractice/Evidence-based-Clinical-Practice-Guideline-Chronic-Wounds-of-the-LowerExtremity.pdf. Accessed December 5, 2016.
43. American College of Foot and Ankle Surgeons (ACFAS). Diabetic Foot Disorders: A
Clinical Practice Guideline. 2006;[Website]: http://www.acfas.org/Research-andPublications/Clinical-Consensus-Documents/Clinical-ConsensusDocuments/ Listed as obsolete. Accessed December 5, 2016.
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MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004
Other:
Durable Medical Equipment Regional Carrier (DME MAC JA) Region JA Noridian
Healthcare Solutions, LLC Local Coverage Determination (LCD) L33821. Negative
Pressure Wounds Therapy Pumps. Effective 10/1/15. [Website]:
http://www.medicarenhic.com/dme/mrlcdcurrent.aspx
Accessed September 8, 2016.
X. POLICY HISTORY
MP 4.004
TOP
CAC 2/25/03
CAC 3/25/03
CAC 2/22/05
CAC 3/29/05
Retire Policy Use InterQual Criteria effective 7/1/06
CAC 2/27/07
CAC 5/27/08
CAC 11/25/08
CAC 11/24/09 Consensus Review
CAC 11/30/10 Medicare Variation
CAC 6/26/12 Consensus. FEP variation changed to reference FEP
Medical Policy Manual MP-1.01.16 Negative Pressure Wound
Therapy in the Outpatient Setting.
CAC 9/24/13 Minor.
Adopting BCBSA for the following changes.






Changed Vacuum Assisted Wound Closure (VAWCD) to negative
pressure wound therapy (NPWT).
Added the term “powered” to existing policy statements to specify
criteria is for the powered NPWT.
Added statement indicating coverage for non-powered NPWT is
investigational. Previously silent on non-powered VAWCD.
Added description for chronic wounds as > 90 days
Added medically necessary indication for Non-healing wounds
despite optimal wound care (at least 30 days) in patients with
underlying clinical conditions which are known to negatively impact
wound healing.
Expanded objective improvements of wound healing to include the
development and presence of healthy granulation tissue, progressive
wound contracture and decreasing depth, and/or the commencement
of epithelial spread from the wound margins.
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MEDICAL POLICY
POLICY TITLE
NEGATIVE PRESSURE WOUND THERAPY IN THE OUTPATIENT
SETTING
POLICY NUMBER
MP-4.004




BCBSA Description/Background adopted.
Added definition of comprehensive wound management program.
Deleted additional description of wound care for specific types of
wounds.
Deleted statement indicating The VAWCD may be considered
medically necessary in the presence of a fistula, except to an
organ or body cavity within the vicinity of the wound.




Added rationale section
Added policy guidelines which indicate the following --
Contraindications to the use of NPWT systems include the
following conditions as noted by a November 2009 FDA alert:
necrotic tissue with eschar, untreated osteomyelitis, nonenteric
and unexplored fistulas, malignancy in the wound, exposed
nerve, exposed anastomotic site, and exposed organ.
Deleted 2 statements related to earlier initiation of therapy.
Deleted the following statement “Use of a VAWCD may be
considered medically necessary at the time of hospital
discharge for the specific diagnoses listed above, and for
similar surgical wounds if wound care was begun in the
hospital. It is not required that a patient be homebound to
receive nursing services in the patient’s home for wound care
using a VAWD.”
Administrative code review completed.
CAC 9/30/14 Consensus review. Rationale and references updated.
No changes to the policy statements.
01/2015-New 2015 CPT code added to the policy.
CAC 9/29/15 Consensus review. No change to policy statements.
References and rationale updated. Coding reviewed.
04/04/16- admin add A6550
CAC 11/29/16 Consensus. No change to policy statements.
References and rationale updated. Variation reformatting. Coding
reviewed.
TOP
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance
Company®, Capital Advantage Assurance Company® and Keystone Health Plan® Central. Independent licensees of the
BlueCross BlueShield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs
and provider relations for all companies.
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