Medical Policy: 01.01.20
Original Effective Date: September 2012
Reviewed: May 2015
Revised: June 2014
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.
Disposable non-powered mechanical negative pressure wound therapy or single use non-electrically powered negative pressure wound therapy have been proposed for the treatment of smaller wounds. These devices can be used in the hospital, outpatient and/or home settings.
SNaP® Wound Care System
The Smart Negative Pressure (SNaP)® Wound Care System (Spiracur, Sunnyvale, CA) is a non-powered, portable lightweight device and can be worn underneath clothing. It is a single-use/disposable device intended for wound management through the application of negative pressure to the wound for removal of fluids, including infectious material, irrigation fluids, and wound exudate. The (SNaP)® system has three components; the cartridge, the hydrocolloid dressing, and the interface layer.
- Cartridge: Comes in three different pressures from 75-125 mmHg. The cartridge has two functions: 1) it is a small canister that stores fluids removed from the wound and 2) it generates the negative pressure or suction. The cartridge uses proprietary springs to generate consistent, even levels of pressure without noisy motors, electronics or batteries. Inside the cartridge there is a gel that helps to lock in fluids and improve exudate containment.
- Hydrocolloid Dressing: Is applied over the interface layer to form a seal around the wound. The flexible and absorbent hydrocolloid material protects the delicate skin that surrounds wounds and absorbs moisture to help prevent maceration (wrinkly or soft skin that results from leaving a bandage on too long).
- Interface Layer: Can either be foam or antimicrobial gauze, with foam being more commonly used. Typically, the interface is cut to the size of the wound and then placed onto the wound. It helps distribute the negative pressure evenly and stimulates new tissue formation.
- Chronic wounds such as diabetic foot ulcers, venous ulcers and pressure ulcers.
- Acute wounds may be result of a traumatic injury or surgical wound that does not heal normally. Acute wounds also include some burns and wounds that are a result of toe, foot and low leg amputations.
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 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 a prospective multicenter study, Hudson et al. (2013) assessed overall functionality and performance of the disposable PICO NPWT system including the ability of the system to manage exudate without a canister, concomitant delivery of NPWT and wound progress towards healing during the treatment phase. The study included 20 individuals. Sixteen had closed surgical wounds, two had traumatic wounds and two received meshed split thickness skin grafts. The mean study duration was 10.7 days (range: 5–14 days) and the mean dressing wear time per individual patient was 4.6 days (range: 2–11). A total of 55% of the wounds had closed by the end of the 14-day study or earlier, with 40% of wounds progressing to closure. Two wounds were clinically infected and a further wound had clinical signs of infection at recruitment. Two of these wounds were successfully skin grafted during the treatment period. One device-related adverse event observed small blister-like lesions around the wound associated with the removal of adhesive film fixation strips. This study is limited by small sample size and lack of a comparator.
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 indicted 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 surgically closed incisions.
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 leg 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
Reports with small numbers of patients using the disposable non-powered mechanical or single use non-electrically powered negative pressure wound therapy systems are insufficient to draw conclusions about its impact on net health outcome, both for the device itself and in comparison with current care. There are important unanswered questions about efficacy and tolerability. Well - designed comparative studies with larger number of patients are needed. Conclusions about safety, efficacy and health outcomes cannot be made at this time and therefore is considered investigational.
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 use of non-powered mechanical negative pressure wound care systems or single use non-electrically powered negative pressure wound therap systemsy, including but not limited to the following, is considered investigational for the treatment of all indications:
- SNaP® Wound Care System
- PICO™ Single Use Negative Pressure Wound Therapy
- V.A.C.Via™ Therapy System
- ciSNaP® Closed Incision System
Reports with small numbers of patients using the disposable non-powered mechanical or single use non-electrically powered negative pressure wound therapy systems are insufficient to draw conclusions about its impact on net health outcome, both for the device itself and in comparison with current care. There are important unanswered questions about efficacy and tolerability. Well - designed comparative studies with larger number of patients are needed. Therefore, the use of disposable non-powered mechanical or single use non-electrically powered negative pressure wound therapy systems for any indication is considered investigational.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic 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
- 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.
- Armstrong DG, Marston WA, Reyzelman AM et al. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. Wound Repair Regen 2011;19(2):173-80.
- Lerman B, Oldenbrook L, Eichstadt SL, et al. Evaluation of chronic wound treatment with the SNaP wound care system versus modern dressing protocols. Plast Reconstr Surg 2010; 126(4):1253-61.
- Fong KD, Hu D Eichstadt S et al. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds 2010; 22(9):230-6.
- Hutton DW, Sheehan P. Comparative effectiveness of the SNaP&trade Wound Care System. Int Wound J. 2011 Apr;8(2):196-205. doi: 10.1111/j.1742-481X.2011.00775.x. Epub 2011 Mar 8.
- Fong KD, Marston W. Advances in Wound Care. February 2012, 1(1): 41-43. SNaP® Wound Care System: Ultraportable Mechanically Powered Negative Pressure Wound Therapy. Available at: http://ncbi.nlm.nih.gov
- ECRI. Hotline Response. Managing Acute and Chronic Wounds Using Negative Pressure Wound Therapy Systems from Smith & Nephew, Inc. March 2013. Available at http://www.ecri.org
- ECRI. Product Brief. PICO Single Use System (Smith & Nephew, Inc.) for Delivering Negative Pressure Wound Therapy. May 2012. Available at http://www.ecri.org
- UpToDate. Negative Pressure Wound Therapy. Mark Gestring, M.D.. Topic last updated January 13, 2014. Available at www.uptodate.com
- Spiracur.com. SNaP® Wound Care System and ciSNaP® Closed Incision System. Available at http://spiracur.com
- Smith & Nephew. PICO™ Single Use Negative Pressure Wound Therapy System. Available at www.smith-nephew.com
- KCI. V.A.C. Via™ Negative Pressure Wound Therapy System. Available at www.kci1.com
- FDA. U.S. Food and Drug Administration. 510(k) Summary V.A.C. Via™ Negative Pressure Wound Therapy System November 15, 2013 & March 10, 2010. Available at: http://www.fda.gov. Accessed June 19, 2014.
- FDA. U.S. Food and Drug Administration. 510(k) Summary PICO™ Single Use Negative Pressure Wound Therapy System December 15, 2011. Available at: http://www.fda.gov. Accessed June 19, 2014
- FDA. U.S. Food and Drug Administration. 510(k) Summary ciSNaP® Closed Incision System February 25, 2014. Available at: http://www.fda.gov. Accessed June 19, 2014
- FDA. U.S. Food and Drug Administration. 510(k) Summary SNaP® Wound Care System. Available at: http://www.fda.gov. Accessed June 19, 2014
- Donald A. Hudson, Kevin G. Adams, et. al. Simplified Negative Pressure Wound Therapy: Clinical Evaluation of an ultraportable, no canister system. International Wound Journal ISSN 1742-4801, May 7, 2013. Available at: http://onlinelibrary.wiley.com/doi/10.1111/iwj.12080/pdf
- Karen Shum, DPM and Kazu Suzuki, DPM, CWS, Emerging Insights on Negative Pressure Wound Therapy. Podiatry Today August 2013.
Available at www.podiatry today.com
- ECRI Product Brief, SNaP Wound Care System (Spiracur, Inc) for Delivering Negative Pressure Wound Therapy, September 2014. Also available at www.ecri.org
Date Reason Action
September 2012 New policy
August 2013 Annual review Policy renewed
June 2014 Annual review Policy revised
May 2015 Annual review Policy renewed
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.