Medical Policy: 01.01.20 

Original Effective Date: September 2012 

Reviewed: April 2019 

Revised: April 2019 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

This policy applies to the use of non-powered negative pressure wound therapy (NPWT) systems (mechanical or single use (disposable) battery operated devices) in the outpatient setting.

 

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. Although the exact mechanisms 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.

 

Negative pressure wound therapy (NPWT) devices are classified as either powered (i.e. requiring an electrical power source) or non-powered (mechanical) or battery operated. Most evidence found in the literature is for electrically powered devices with large canisters (e.g. such as vacuum-assisted devices). A number of non-powered negative pressure wound therapy (single use) portable devices have entered the market for use in the outpatient setting. Some of these non-powered negative pressure wound therapy (single use) portable devices are designed specifically for surgical incisions.

 

Conventional NPWT using a powered negative pressure wound therapy system can be bulky and intrusive for patients who are ambulatory and active, disposable non-powered negative pressure wound therapy (NPWT) (mechanical) or single use (disposable) non-powered (battery operated) negative pressure wound therapy have been proposed for the treatment of small to medium sized, slow to heal wounds and also for the management of surgical incisions. The goal of these devices is to make it easier to use by both the clinicians and patients. Specifically, the device should be one that clinicians can take off the shelf like any other wound care dressing, it is quick and easy to apply, and the patients can wear under their clothes and will not impinge on their normal activities. The idea was to make it practical and cost effective, allowing more patients to benefit from NPWT in the outpatient/home setting.

 

Non-Powered Single Use Negative Pressure Wound Therapy (NPWT) Devices

In 2014, the Agency for Healthcare Research and Quality (AHRQ) completed a technology assessment i.e. systematic review regarding the efficacy and safety of negative pressure wound therapy (NPWT) for treatment of chronic wounds in the home setting. Two independent reviewers screened search results. They included studies examining the use of NPWT in patients with chronic wounds, including venous leg ulcers, arterial leg ulcers, diabetic foot ulcers, pressure ulcers, and mixed etiology chronic wounds. They searched for comparative trials that followed subjects in the home setting and extracted data into standardized forms and summarized results qualitatively. The reviewers retrieved 5,912 citations, and found seven studies which met criteria for inclusion. Six of the studies compared NPWT devices to other wound care methods. One study compared two different NPWT devices. Data were limited by variability in the types of comparator groups, variable quality in study design, and limited reporting of outcomes. The reviewers concluded, that they were unable to draw conclusions about the efficacy or safety of NPWT for the treatment of chronic wounds in the home setting due to insufficient evidence. Though NPWT has been used across the wound care spectrum, significant research gaps remain. Standardization of wound care research protocols, such as providing consistency in comparator groups, robust randomized study designs, larger trials, and common definitions of outcomes, would be helpful in providing evidence to inform decisions about the use of NPWT in the home setting.

 

SNaP® Wound Care System

The Smart Negative Pressure (SNaP)® Wound Care System (Spiracur, Sunnyvale, CA) is a disposable, ultraportable NPWT device that does not require an electrically-or-battery powered pump. The SNaP System is a mechanically-powered NPWT system comprising spring technology that reduces air density within an enclosure in a controlled manner. The specialized springs equilibrate even in the presence of exudate so that a constant controlled amount of negative pressure is delivered to the wound bed. Because there is no electrical pump, operation of the SNaP System is completely silent, and it is small enough to be worn on a patient's leg, arm or belt and hidden underneath clothing.

 

The (SNaP)® Wound Care System consists of three basic elements; the cartridge with activation/reset key, the hydrocolloid dressing layer, and the strap with attachment clip.

  • Cartridge with activation/reset key: Comes in three different pre-set pressure levels (-75mmHg, -100mmHg and -125mmHg). The cartridge has two functions: 1) it is a small canister that stores fluids removed from the wound (canister capacity of approximately 60mL of wound exudate) and 2) it generates the negative pressure or suction. The SNaP System also incorporates BioLock technology that isolyzes or gels the wound exudate that collects in the cartridge. This helps to control potential contamination and odor.
  • Hydrocolloid dressing layer with integrated nozzle and tubing and choice of foam or antimicrobial gauze wound interface layer: A proprietary hydrocolloid dressing provides protection to the often fragile peri-wound skin, improves dressing applications handling properties, and provides a robust seal around the wound for negative pressure delivery. The suction port and tubing (which can be cut to length) are fully integrated into the hydrocolloid dressing, simplifying the application process.

The hydrocolloid dressing is used over a wound filling material consisting of specialized SNaP Blue foam dressing or antimicrobial gauze dressing.

  •  
    • The Blue foam dressings allows for similar mechanical transduction of stress and strain to the wound bed as other foam wound interfaces. The bright blue color of the foam dressing also allows for easy visualization within the wound, helping to prevent retention of the foam at dressing changes. In general, the foam dressing is used when more robust granulation tissue formation is required or in deeper wounds.
    • The antimicrobial gauze dressing is used in more superficial wounds or in wounds at higher risk of infection.

 

Treatment Indications

The SNaP System is indicated for the removal of small amounts of exudate from the following types of wounds:

  • Chronic wounds such as diabetic foot ulcers, venous ulcers and pressure ulcers.
  • Traumatic/acute wounds
  • Subacute and dehisced
  • Partial-thickness burns
  • Surgically-closed incisions
  • Flaps and grafts

 

Contraindications

The SNaP System should not be used over:

  • Actively infected wounds
  • Inadequately drained wounds
  • Necrotic tissue such as eschar or adherent slough
  • Exposed blood vessels, anastomotic sites, organs, tendons or nerves
  • Wounds containing malignancy
  • Fistulae
  • Untreated osteomyelitis
  • Actively bleeding wounds

 

It is recommended that the dressing be changed at least two times per week by the patient’s healthcare provider. The frequency of the dressing changes will depend on a number of factors (e.g. the level of exudate, bacterial load and rate of granulation tissue).

 

In 2011, Armstrong and colleagues reported results of a planned interim analysis of a randomized controlled trial (RCT) comparing the SNaP® device and the V.A.C.® (Negative pressure therapy Assisted Closure®) Therapy™ (Kinetic Concepts, Inc., San Antonia, TX) for the treatment of chronic lower extremity wounds. The study randomized 132 patients with lower extremity venous or diabetic ulcers of varying size and present more than 30 days despite appropriate care. Dressings were changed per manufacturer 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 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 the use of the SNaP® device interfered less with mobility and activity than the V.A.C.® device. This study is limited by the high loss to follow-up and the lack of comparison with standard treatment protocols.

 

A 2010 retrospective study with historical controls compared negative pressure wound therapy using the SNaP® device (n=28) with wound care protocols that included the use of Apligraf® (Novartis), Regranex® (Healthpoint Ltd.), 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, wound infection, bleeding after debridement preventing reapplication, worsening lower extremity edema, and the development of maceration severe enough to require discontinuation) and were considered treatment failures. Between-group estimates of time-to-wound healing by Kaplan-Meier analysis favored the SNaP® treatment group. The study is limited by the use of historical controls, the multiple modalities used in treatment of controls, and the large number of dropouts. The authors noted that patients in the SNaP®-treated group may have benefitted from being in an experimental environment, particularly because wounds in this group were seen twice per week compared to variable follow-up in the historical controls.

 

Other publications have described use of the SNaP® device in case series with small numbers of patients, fewer than 15 patients.

 

PICO™ Single Use Negative Pressure Wound Therapy

PICO™ Single Use Negative Pressure Wound Therapy (Smith and Nephew, St. Petersburg, FL) is a pocket sized disposable single use negative pressure wound therapy system. The PICO™ device consists of a small, portable pump with a lifespan of up to 7 days. The PICO™ pump generates an effective negative pressure of 80mmHg yet is small enough to fit discretely into a pocket.

 

The PICO™ pump is connected to a specially designed dressing which: 1) maintains the negative pressure across the wound bed and 2) removes the exudate from the wound bed through absorbency and evaporation. In each carton there is one pump plus two AA lithium batteries and two separately packed dressings complete with fixation strips. This enables a dressing change to be carried out within the lifespan of the pump if this is clinically necessary.

 

PICO™ Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low levels of exudates and infectious materials. Examples of appropriate wound types include: chronic wounds; acute wounds; traumatic wounds; subacute and dehisced wounds; partial thickness burns; ulcers (such as diabetic or pressure); flaps and grafts; closed surgical incisions.

 

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 primary outcome was to measure the impact of single use iNPWTd (incisional negative pressure wound therapy dressing) on wound healing and effect on length of stay (LOS). 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. There were a number of limitations to this study: a) this was non-blinded study; b) the routine practice of changing wound dressings at second day post-surgery and working towards expected date of discharge (four days post-surgery at the time of study period) was difficult to control due to the number of nursing staff involved in patient care; c) the incidence of surgical wound complications was recorded rather than directly inspected as the information was obtained over the telephone at the two week telephone check; d) wound-related data were not collected following protocol failure, which meant an ITT analysis was not possible for LOS; and e) unable to standardize the wound closure methodology, as this would have meant changing surgeons’ practice.

 

In 2015, Schwartz et. al. reported an industry funded pilot study with 12 patients who had lower extremity chronic small wounds of various types (total 13 wounds) treated with single use negative pressure wound therapy (NPWT). The aim of this study was to assess the efficacy of single use NPWT on chronic lower extremity wounds that are usually deemed to small or superficial for traditional NPWT. 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 short follow-up period.

 

V.A.C.Via™ Therapy System

V.A.C.Via™ Therapy System (KCI, San Antonio, TX) is a portable single patient use negative pressure wound therapy device that offers 7 days of therapy. Provides dynamic pressure control and continuous negative pressure options of 75mmHg or 125mmHg.

 

The system is designed for moderate to lower-severity wounds and provides the same clinical efficacy as current V.A.C.® therapy products. The V.A.C.Via™ System creates an environment that promotes healing by: 1) maintaining a moist wound healing environment, 2) remove excess wound fluids and infectious material and 3) creating an environment that promotes perfusion and granulation tissue formation.

 

V.A.C.Via™ Therapy System is indicated for open wound types including: chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

 

When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

 

In a retrospective study, Gabrielle et al. (2013) evaluated use of the disposable, single-patient-use NPWT system (SP-NPWT) V.A.C.Via™ Therapy over dermal regeneration template (DRT) and/or skin grafts. SP-NPWT was initiated over a DRT and/or skin graft in 33 patients with 41 graft procedures. Endpoints were recorded and compared to a historical control group of 25 patients with 28 grafts bolstered with traditional rental NPWT (V.A.C.). Mean age was less for the SP-NPWT group versus the control and there were significantly more patients with peripheral vascular disease (PVD) in the SP-NPWT group compared with the control (12 versus 0, respectively). A greater number of acute wounds were present in the SP-NPWT group versus the control (26 versus 10, respectively). All other patient demographics and wound characteristics were similar. Mean follow-up time was 6.4 months for the SP-NPWT group and 12.7 months for the control group. Primary endpoint was time to hospital discharge, duration of SP-NPWT and graft take rate were collected and compared to a historical control group of patients who received traditional rental NPWT over dermal regeneration template (DRT) and/or skin grafts. Average length of inpatient hospital stay was 0 days for the SP-NPWT group and six days for the control group. The average duration of SP-NPWT post-DRT or skin graft was 5.6 days and 7.0 days for the control. This study is limited by small sample size, lack of a comparator and observer bias in estimating graft take. The authors reported that considerably more controlled research is necessary to measure efficacy of SP-NPWT in the adjunctive management of various wound types.

 

ciSNaP® Closed Incision System

ciSNaP® Closed Incision System (Spiracur, Sunnyvale, CA) is a single use portable, non-powered, disposable negative pressure wound therapy system that is intended for wound management through the removal of small amounts of exudate from surgical incisions that continue to drain following sutured or stapled closure.

 

The ciSNaP® Closed Incision System has a sterile cartridge that provides negative pressure therapy which increases blood flow to improve wound healing. There is proprietary spring mechanism that generates consistent, even levels of pressure. A visual indicator displays when cartridge is full or discharged. Silicone wings help to approximate wound edges, reducing potential risk of dehiscence and minimizing tension on staples and sutures which is customizable in length to fit a wide range of incisions. A proprietary hydrocolloid dressing and antimicrobial gauze offer a protective barrier to minimize potential for infection and eliminate the need for dressing changes. A soft strap enables the device to be conveniently worn on the extremity or belt.

 

The use of the ciSNaP®Closed Incision System over surgical incisions may results in:

  • Lowered rate of infection
  • Reduced risk of dehiscence
  • Improved cosmesis
  • Fewer complications and associated costs

 

Prevena Incision Management System (KCI, San Antonio, TX)

Prevena Incision Management System is a negative pressure wound therapy (NPWT) device designed specifically for management of closed surgical incisions that continue to drain following sutured or stapled closure. The single use system consists of a negative pressure therapy unit, a canister, and dressing. The therapy unit uses three AA batteries to deliver 125 mm Hg of negative pressure to the incision site and has an eight day life. Therapy may last for a minimum of two to seven days. The therapy unit has alerts for leaks, low battery, maximum capacity and system errors. There are two dressing options Prevena Peel and Place dressing for incisions fewer than 8 inches and the Prevena Customizable dressing for incisions up to 35 inches or nonlinear. NPWT applies a localized vacuum to draw the edges of the wound together while providing a moist environment conducive to wound healing.

 

Based on review of the literature there is one randomized controlled trial (RCT) and five nonrandomized studies, the studies suggest that patients experienced fewer postoperative wound related problems if they received the Prevena Incision Management System. However, confounders (bias) prevent drawing strong conclusions from this evidence. Further well designed comparative studies with larger numbers of patients are needed.

 

AVELLE Negative Pressure Wound Therapy System (ConvaTec)

The AVELLE negative pressure wound therapy (NPWT) system is designed to produce a continuous negative pressure of 80mmHg (+/- 20 mmHg) across the wound surface through the hydrated Hydrofiber Technology Dressing to the wound bed through 4 layers of AQUACEL Extra Dressing to a depth of 2 cm for over 7 days. It is a battery powered disposable pump with a 30 day lifetime. This NPWT system has a one way valve that helps maintain continuous pressure after removing the pump from the dressing for up to 1 hour +/- 10 mmHg, therefore, patients can keep the dressing in place by disconnecting the pump to shower.

 

The Hydrofiber Technology:

  • Locks in wound exudate and traps bacteria to help protect peri-wound skin and
    reduces maceration.
  • Micro-contours to the wound bed, minimizing dead space where bacteria can grow.
  • Balances wound fluid levels through gelling to maintain a moist wound healing environment.

 

The AVELLE NPWT system can be used for low to moderate exuding wound types:

  • Chronic wounds
  • Acute wounds
  • Traumatic wounds
  • Subacute and dehisced wounds
  • Flaps and grafts
  • Surgically closed incisions

 

myNeWT Negative Pressure Wound Therapy System (Stortford Medical LLC)

The myNeWT negative pressure wound therapy system is a portable, disposable, single use system for patients who have hard to heal wounds. Therapy is accomplished by the pump delivering a continuous negative pressure to the wound surface (80mm Hg +/- 20 mmHg), which draws exudate into a flexible canister, creating an environment that promotes wound healing via the removal of low to moderate amounts of exudate and infectious material from the wound. This disposable pump is battery operated and driven by a 2 AA primary lithium batteries which allows it to deliver therapy for 7 days. A sterile wound interface connects the wound dressing to the flexible canister.

 

The myNeWT system is indicated for patients with the following wound types:

  • Chronic wounds
  • Acute, sub-acute and dehisced wounds
  • Traumatic wounds
  • Partial thickness burns
  • Pressure or venous insufficiency ulcers
  • Diabetic ulcers
  • Flaps and grafts
  • Closed incision sites

 

UNO Single Patient Disposable Negative Pressure Wound Therapy System (Genadyne Biotechnologies, Inc)

The UNO single patient disposable negative pressure wound therapy system is battery operated and offers two options of therapy treatment time:

  • UNO 7 is a 7 day disposable negative pressure wound therapy system that includes 1 canister, 2 dressing kits, 1 carry pouch, and 2 sets of batteries; or
  • UNO 15 is a 15 day disposable negative pressure wound therapy system that includes 2 canisters, 5 dressing kits, 1 carry pouch, and 5 sets of batteries.

 

The UNO single patient disposable negative pressure wound therapy system has two modes of operation:

  • Continuous at either 125 mmHg or 80 mmHg; or
  • Variable at either 80 mmHg/30 mmHg or 125 mmHg/30 mmHg.

 

The indications for the UNO single patient disposable negative pressure wound therapy system:

  • Dehisced wounds
  • Trauma wounds
  • Partial thickness burns
  • Flaps and grafts
  • Chronic wounds – pressure ulcers, venous ulcers, and diabetic foot ulcers

 

The port and dressing for the UNO negative pressure wound therapy system consists of the following:

  • One luer-lock connection to the pump
  • Foam layer with quick absorption and maintaining a moist environment at the wound site
  • Super absorber layer that aids movement of exudate into the port
  • Silicone wound contact layer that is soft and gentle for application and removal, can be respositioned
  • Film layer that allows small amounts of air to pass through, transpires exudate away from the wound
  • Security strips for use if dressing adherence is difficult
  • Pump position works effectively above or below the wound site

 

Summary

Based on the peer reviewed medical literature and a systematic review by AHRQ there are few studies that address the effectiveness and safety of negative pressure wound therapy (NPWT) to treat chronic wounds (venous leg ulcers, arterial leg ulcers, diabetic foot ulcers, pressure ulcers and mixed etiology chronic wounds) in the home setting. The few studies found were of low quality. The prospective randomized studies had small sample sizes and short durations of follow-up. The larger studies were retrospective and based on administrative or patient record databases. The retrospective, administrative or patient record database studies were particularly problematic because they generally lacked details regarding patient characteristics, NPWT devices studied, treatments used by the comparison groups, and prior and concurrent wound treatments. Based on these studies, reviewers were not able to establish if consistent wound care protocols were being followed. The brand and model of the NPWT device was often not reported, and they were unable to determine if there were any differences in effectiveness and safety across the devices. Similarly, there were limited details reported regarding the comparison group. Often, the control group was simply patients who did not receive NPWT. Considering the wide range of treatment options for chronic wounds, reviewers were unable to determine what treatments the comparison groups received. Also, based on the systematic review by AHRQ six of the seven studies were supported at least partially by manufacturers; the other study did not report a funding source. In the studies that reported industry funding, few reported on the involvement of the sponsor in the design, analysis, and reporting of the study. With this limited information, it is hard to rule out the possibility of publication bias or other reporting bias. Regardless of the study design, most studies were deficient in reporting key characteristics to include describing the patient setting, level of training and expertise of the people applying the wound treatment, compliance, standardized descriptions of the patient population at baseline to include wound duration or size or prior and current treatments (compression, debridement, and dressings) the patient had or was receiving. Larger, prospective studies are needed for each of the different types of chronic wounds treated by NPWT, and to compare the different components of these devices, if not the devices themselves. Future studies of devices need to have methodological rigor, including attention to enrollment criteria; clear definitions of outcomes that are reproducible and easily measured; the addressing of potential confounding variables; randomized designs which minimize bias; and the studies should be sufficiently powered to determine clinically important effects. Patients need to be followed for an adequate length of time to ensure sustained outcomes. Definitions for adequate follow-up and durable outcomes need to be developed. The existing evidence is insufficient to draw any conclusions. There is a clear need for consensus on study methods, and the research community involved in NPWT devices should strive to standardize the conduct and reporting of studies, to provide stronger evidence to inform decisions about the utility and safety of these devices. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Regulatory Status

Numerous disposable negative pressure wound therapy systems have received Class II clearance by the FDA through the 510(k) process.

 

The SNaP® Wound Care System (Spiracur, Sunnyvale, CA) is a Class II device requiring notification to market but not having U.S. Food and Drug Administration (FDA) premarket approval. It received 510(k) marketing clearance from the FDA in 2009 (K081406) and is indicated for the removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.

 

The FDA granted 510(k) Class II clearance for the PICO™ Single Use Negative Pressure Wound Therapy System (Smith and Nephew, St Petersburg, FL) on December 15, 2011. PICO was cleared as substantially equivalent to predicate devices Renasys Go (Smith & Nephew), NPD 1000 NPWT System (Kalypto Medical, Hastings, MN), and Prevena Incision Management System (KCI, San Antonio, TX). The intended use, indications and instructions for use for the subject and predicate devices are similar. According to the 510(k) clearance document, “the PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. The PICO [single-use NPWT] System is suitable for use in both a hospital and homecare setting. Examples of appropriate wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts, closed surgical incisions.”

 

The FDA granted 510(k) Class II clearance for the V.A.C.Via™ Negative Pressure Wound Therapy System, (KCI, San Antonio, TX) on March 10, 2010. Equivalence is claimed to the KCI Acti V.A.C.™ Therapy System (KCI, San Antonio, TX). The intended use for the device states, “V.A.C.Via™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.”

 

The FDA granted 510(K) Class II clearance for the ciSNaP® Closed Incision System (Spiracur, Sunnyvale, CA) on February 25, 2014. This is a non-powered suction apparatus device intended for negative pressure wound therapy for patients who would benefit from wound management via the application of negative pressure, particularly as the device promotes wound healing through the removal of small amounts of exudate from surgical incisions that continue to drain following sutured or stapled closure.

 

The Prevena Incision Management System was cleared for marketing in June 2010 by FDA under the 510(k) process and is intended “to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of NPWT.” The predicate devie was KCI’s Acti V.A.C. (vacuum assisted closure) Therapy System. The customizable dressing was cleared for marketing in October 2012 and was designated as a combination product in March 2014.

 

The myNeWT Negative Pressure Wound Therapy System (Stortford Medical LLC) was cleared for marketing February 2017 by FDA under the 510(k) process and is intended to promote wound healing by removing low to moderate levels of exudate and infections materials. The appropriate wounds include: chronic wounds; acute, sub-acute and dehisced wounds; traumatic wounds; partial thickness burns, pressure or venous insufficiency ulcers, diabetic ulcers, flaps and grafts; and closed incision sites.

 

The AVELLE negative pressure wound therapy system (ConvaTec Limited) was cleared for marketing October 2018 by FDA under the 510(K) process and is intended to promote wound healing via removal of exudate and infectious material from low to moderately exuding wound such as: chronic wounds e.g. leg ulcers; acute wounds; subacute and dehisced wounds; traumatic wounds; flaps and graft; and surgically closed incisions sites.

 

The UNO negative pressure wound through system (Genadyne Biotechnologies, Inc) was cleared for marketing November 2018 by FDA under the 510(k) process and is intended to promote wound healing by the removal of low to moderate exudates and infectious material from the following wound types: chronic; acute; traumatic; subacute and dehisced wounds; partial thickness burns; ulcers (such as diabetic or pressure); flaps and grafts; and closed surgical incision.

 

 

Prior Approval:

Not applicable

 

Policy:

This policy applies to the use of non-powered negative pressure wound therapy (NPWT) systems (mechanical or single use (disposable) battery operated devices) in the outpatient setting.

 

The use of non-powered negative pressure wound therapy (NPWT) system devices (mechanical) or single use (disposable) battery operated negative pressure wound therapy system devices including but not limited to the following, is considered investigational for all indications:

  • SNaP® Wound Care System
  • PICO™ Single Use Negative Pressure Wound Therapy
  • V.A.C.Via™ Therapy System
  • ciSNaP® Closed Incision System
  • Prevena Incision Management System
  • myNeWT Negative Pressure Wound Therapy System
  • AVELLE Negative Pressure Wound Therapy System
  • UNO Negative Pressure Wound Therapy System (UNO Single Patient Disposable Negative Pressure Wound Therapy System)

 

Based on the peer reviewed medical literature and a systematic review by AHRQ there are few studies that address the effectiveness and safety of negative pressure wound therapy (NPWT) to treat chronic wounds (venous leg ulcers, arterial leg ulcers, diabetic foot ulcers, pressure ulcers and mixed etiology chronic wounds) in the home setting. The few studies found were of low quality. Based on the systematic review by AHRQ six of the seven studies were supported at least partially by manufacturers; the other study did not report a funding source. In the studies that reported industry funding, few reported on the involvement of the sponsor in the design, analysis, and reporting of the study. With this limited information, it is hard to rule out the possibility of publication bias or other reporting bias. Regardless of the study design, most studies were deficient in reporting key characteristics to include describing the patient setting, level of training and expertise of the people applying the wound treatment, compliance, standardized descriptions of the patient population at baseline to include wound duration or size or prior and current treatments (compression, debridement, and dressings) the patient had or was receiving. Larger, prospective studies are needed for each of the different types of chronic wounds treated by NPWT, and to compare the different components of these devices, if not the devices themselves. The existing evidence is insufficient to draw any conclusions. There is a clear need for consensus on study methods, and the research community involved in NPWT devices should strive to standardize the conduct and reporting of studies, to provide stronger evidence to inform decisions about the utility and safety of these devices. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • A9272 Wound suction, disposable, includes dressing, all accessories and components, any type, each.
  • 97607 Negative pressure wound therapy, (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters
  • 97608 Negative pressure wound therapy, (eg, 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

 

Selected References:

  • Lerman B, Oldenbrook L, Ryu 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.
  • 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.
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  • ECRI. Product Brief. PICO Single Use System (Smith & Nephew, Inc.) for Delivering Negative Pressure Wound Therapy. May 2012.
  • UpToDate. Negative Pressure Wound Therapy. Mark Gestring, M.D.. Topic last updated January 13, 2014.
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  • ECRI Product Brief, SNaP Wound Care System (Spiracur, Inc) for Delivering Negative Pressure Wound Therapy, September 2014.
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  • 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
  • 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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  • Dumville JC, Land L, Evans D, et al. Negative pressure wound therapy for treating leg ulcers. CochraneDatabase Syst Rev. 2015;7:CD011354. PMID 26171910
  • 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
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  • 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
  • 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
  • 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.
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  • National Institute for Health and Care Excellence (NICE). NICE Clinical Guideline NG19. Diabetic Foot Problems: Prevention and Management . 2015.
  • 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
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  • American College of Foot and Ankle Surgeons (ACFAS). Diabetic Foot Disorders: A Clinical Practice Guideline. 2006
  • Birke-Sorensen H, Malmsjo M, Rome P., et. al. Evidence based recommendations for negative pressure wound therapy: treatment variables (pressure levels, wound filler and contact layer) – steps toward an international consensus. J Plast Reconstr Aesthet Surg 2011 Sep;64 Suppl: S1-16. PMID 21868296
  • 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 Oct;126(4):1253-61. PMID 20885246
  • 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. PMID 27496913
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  • Department of Health and Human Services U.S. Food and Drug Administration 510(k) approval for UNO Negative Pressure Wound Therapy System (Genadyne Biotechnologies, Inc.) November 2018
  • Department of Health and Human Services U.S. Food and Drug Administration 510(k) approval for myNeWT Negative Pressure Wound Therapy System (Stortford Medical LLC) February 2017
  • Department of Health and Human Services U.S. Food and Drug Administration 510(k) approval for AVELLE Negative Pressure Wound Therapy System (ConvaTec Limited) October 2018
  • 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
  • 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 Feb 1 2015;4(2):75-82. PMID 25713749
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  • AVELLE Negative Pressure Wound Therapy.
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  • UNO Single Patient Disposable Negative Pressure Wound Therapy System
  • DeVries FE, Wallert ED, Solomkin JS, et. al. A systematic review and meta-analysis included GRADE qualification of the risk of surgical site infections after prophylactic negative pressure wound therapy compared with conventional dressings in clearn and contaminated surgery. Medlicine (Baltimore) 2016 Sep;95(36)e4673.
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Policy History:

  • April 2019 - Annual Review, Policy Revised
  • April 2018 - Annual Review, Policy Revised
  • April 2017 - Annual Review, Policy Revised
  • April 2016 - Annual Review, Policy Renewed
  • May 2015 - Annual Review, Policy Renewed
  • June 2014 - Annual Review, Policy Revised
  • August 2013 - Annual Review, Policy Renewed
  • September 2012 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.