Clinical Policy Title: Vacuum assisted closure in surgical wounds

Clinical Policy Title: Vacuum assisted closure in surgical wounds Clinical Policy Number: 17.03.00 Effective Date: September 1, 2015 Initial Review Date: June 16, 2013 Most Recent Review Date: August 17, 2017 Next Review Date: August 2018 Related policies: Policy contains: Vacuum assisted closure. Negative pressure wound closure. Negative pressure wound therapy. None. ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina s clinical policies are not guarantees of payment. Coverage policy Select Health of South Carolina considers vacuum assisted wound therapy (VAWT) clinically proven, and, therefore, medically necessary, when a wound despite conventional treatment and minimal activity of comorbidities is refractory to closure. Limitations: Select Health of South Carolina considers VAWT investigational and therefore not medically necessary where contraindications to its use exist (i.e., exposed organs and anastomoses, malignancy, necrotic eschar, fistulae, or osteomyelitis). VAWT is considered investigational and therefore not medically necessary for all other applications not meeting the criteria cited above. Alternative covered services: A primary care physician, surgeon, wound care specialist, or other qualified provider may evaluate a 1

patient for alternative covered services including routine office consultation and clinical investigation (i.e., laboratory, imaging, functional, testing and diagnostic procedures, specifically wound culture or biopsy). Background The merits of VAWT (also known as negative pressure wound therapy or NPWT) have been studied in a number of clinical contexts in the outpatient setting for a variety of wounds such as ulcers related to pressure sores, venous or arterial insufficiency, or neuropathy. It is important to note that these devices are adjunctive therapy that is not intended to replace good basic wound care (i.e., daily wound measurements of dimension and depth, wet dressing applications, necrotic debridement, adequate overall nutrition, and minimization of disease activity of comorbid conditions). Among the numerous indications for use of this technology are: decubitus (pressure) ulcers, neuropathic ulcers, ulcers related to venous or arterial insufficiency, dehisced wounds or wounds with exposed hardware or bone, post-sternotomy wound infection or mediastinitis, or complications of a surgically created wound where accelerated granulation therapy is necessary and cannot be achieved by other available topical wound treatment. Searches Select Health of South Carolina searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on June 27, 2017. Searched terms were: "vacuum wound closure" (MeSH), "negative pressure wound therapy" (MeSH), and "NWPT" (MeSH). We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. 2

Findings There is a growing body of evidence regarding NPWT as a therapeutic intervention following surgery. A prospective review (Selvagi, 2014) assigned 50 post-operative Crohn s disease patients to treatment with either portable VAWT (n = 25) or conventional dressings (n = 25). At one year of follow up, patients receiving VAWT had fewer surgical site complications, resulting in shorter hospital stays. At last follow up, readmission rates were lower. A Cochrane systematic review (Dumville, 2013) inclusive of 605 individuals with diabetes mellitus (DM) compared NPWT with standard moist wound dressings. Post-amputation wounds healed faster in the NPWT group compared with the moist dressing group: (risk ratio 1.44; 95 percent CI 1.03 to 2.01). The available evidence suggests that negative pressure wound therapy is more effective in healing postoperative foot wounds in people with DM compared with moist wound dressings. VAWT has also been studied as a prophylactic method of avoiding infections and wound dehiscence in high-risk extremity fractures below the knee. An industry-sponsored study (Stannard, 2012) reported the results of a randomized controlled trial (RCT) of 249 adult subjects with 263 lower extremity fractures undergoing open surgical repair. Subjects were randomized to receive post-operative NPWT (n = 130) or standard wound dressings (n = 119). There was a borderline statistically significant difference (P = 0.049) between groups with regard to post-operative infections, with the control group developing 5 (4 percent) acute and 18 (15 percent) late infections, and the NPWT group having 1 (0.7 percent) acute and 13 (9 percent) delayed infections. Wound dehiscence was reported in 20 (16.5 percent) of control subjects and 12 (8.6 percent) of NPWT subjects (p = 0.044). A Cochrane systematic review (Webster, 2012) of 162 patients with partial foot amputation wounds up to the transmetatarsal level found those assigned to NPWT (n = 77) delivered through the Vacuum Assisted Closure (VAC ) therapy system healed faster than controls (P = 0.005). The rate of granulation tissue formation, based on the time to 76 100 percent formation in the wound bed, was faster in the NPWT group than in controls (P = 0.002). The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups. An RCT (Doss, 2002) included 42 patients that developed post-sternotomy osteomyelitis and required open wound management. Twenty of these patients were treated by VAWT and the other 22 by conventional wound management. Patients treated by VAWT had a significantly reduced treatment duration (mean 17.2+/-5.8 vs. 22.9+/-10.8 days, P = 0.009) and total hospital stay (mean 27.2+/-6.5 vs. 33.0+/-11.0 days, P = 0.03). Evidence for the effectiveness of NPWT on complete healing of wounds expected to heal by primary 3

intention is convincing in multiple environments of care. There are clear cost benefits when noncommercial systems are used to create the negative pressure required for wound therapy, with no reduction in clinical outcome. Pain and readmission to the hospital is also diminished in patients receiving NPWT. Policy updates: The European Wound Management Association (EWMA) has published guidelines (Apelqvist 2017) for NPWT when used as a primary treatment of chronic wounds, in complex acute wounds and as an adjunct for temporary closure and wound bed preparation (e.g., preceding surgical procedures such as skin grafts and flap surgery). Despite an increasing number of papers on the efficacy of NPWT, due to the low evidence level the treatment remains controversial with regard to evidence-based medicine. Despite advances in surgical technique, ventral hernia repair (VHR) remains associated with significant post-operative wound complications. A systematic review and meta-analysis (Swanson, 2016) was performed to identify whether the application of NPWT following VHR reduces the risk of post-operative wound complications and hernia recurrence. Outcomes assessed included surgical site infection, wound dehiscence, seroma, and hernia recurrence. Five retrospective cohort studies including 477 patients undergoing VHR were included in the final analysis. The use of NPWT decreased surgical site infections (OR 0.33 [95 percent CI 0.20 to 0.55]; P<0.0001), wound dehiscence (OR 0.21 [95 percent CI 0.08 to 0.55]; P = 0.001), and ventral hernia recurrence (OR 0.24 [95 percent CI 0.08 to 0.75]; P = 0.01). There was no statistically significant difference in the incidence of seroma formation (OR 0.59 [95 percent CI 0.27 to 1.27]; P = 0.18). For patients undergoing VHR, current evidence suggests a decreased incidence in wound complications using incisional NPWT compared with conventional dressings. Summary of clinical evidence: Citation Apelqvist (2017) Content, Methods, Recommendations EWMA Document: Negative Pressure Wound Therapy. The ongoing controversy regarding high-level evidence in wound care in general is well known. There is a consensus that clinical practice should be evidence-based, which can be difficult to achieve due to confusion about the value of the various approaches to wound management. Reviews of the value of various treatment strategies for non-healing wounds, which have highlighted methodological inconsistencies in primary research. This situation is confounded by differences in the advice given by regulatory and reimbursement bodies in various countries regarding both study design and the ways in which results are interpreted. EWMA has been publishing a number of interdisciplinary documents with the intention of highlighting: o The nature and extent of the problem for wound management: from the clinical perspective as well as that of care givers and the patients 4

Citation Swanson (2016) Content, Methods, Recommendations o Evidence-based practice as an integration of clinical expertise with the best available clinical evidence from systematic research o The nature and extent of the problem for wound management: from the policy maker and healthcare system perspectives o The controversy regarding the value of various approaches to wound management and care is illustrated by the case of NPWT, synonymous with topical negative pressure or vacuum therapy and cited as branded vacuumassisted closure (VAC) therapy. Does negative pressure wound therapy applied to closed incisions following ventral hernia repair prevent wound complications and hernia recurrence? A systematic review and meta-analysis A systematic review and meta-analysis inclusive of 477 patients was performed to identify whether the application of NPWT to closed incisions following VHR reduces the risk of post-operative wound complications and hernia recurrence. The use of inpwt decreased SSI (OR 0.33 [95% CI 0.20 to 0.55]; P<0.0001), wound dehiscence (OR 0.21 [95% CI 0.08 to 0.55]; P = 0.001), and ventral hernia recurrence (OR 0.24 [95% CI 0.08 to 0.75]; P = 0.01). There was no statistically significant difference in the incidence of seroma formation (OR 0.59 [95% CI 0.27 to 1.27]; P = 0.18). The authors concluded that for patients undergoing VHR, current evidence suggests a decreased incidence in wound complications using incisional NPWT compared with conventional dressings. Selvaggi (2014) New advances in negative pressure wound therapy (NPWT) for surgical wounds of patients affected with Crohn's disease Dumville (2013) Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus Armstrong (2012) During 2010 2012, 50 patients with Crohn s disease were assigned to post-operative treatment with either NPWT (n = 25) or conventional dressings (n = 25). Parameters of interest were surgical site and operative complications, and readmission rates. Patients receiving NPWT had fewer wound complications, resulting in shorter hospital stays. No differences were observed in surgical complications between groups. No patients needed to come back to the hospital for device malfunctioning or inability to manage the device. Incisional NPWT was applied to the closed surgical incisions of patients randomized to the study treatment vice standard post-operative dressings to the control patients. There were a total of 23 infections in controls versus 14 in treated patients, a significant difference in favor of NPWT (P = 0.049). The relative risk of developing an infection was 1.9 times higher in control patients than in patients treated with NPWT (95% confidence interval, 1.03 3.55). Comparative effectiveness of mechanically and electrically powered A study of 162 diabetic patients considered whether NPWT improves the proportion and rate of wound healing after partial foot amputation in patients with diabetes. Inclusion criteria consisted of partial foot amputation wounds up to the transmetatarsal level and evidence of adequate perfusion. 5

Citation negative pressure wound therapy devices: a multicenter randomized controlled trial Webster (2012) Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention Doss (2002) Vacuum-assisted suction drainage versus conventional treatment in the management of poststernotomy osteomyelitis Content, Methods, Recommendations Patients who were randomly assigned to NPWT (n = 77) received treatment with dressing changes every 48 h. Control patients (n = 85) received standard moist wound care according to consensus guidelines. More patients healed in the NPWT group than in the control group (43 [56%] versus 33 [39%], P = 0.040). The rate of wound healing, based on the time to complete closure, was faster in the NPWT group than in controls (p = 0.005). The rate of granulation tissue formation, based on the time to 76% 100% formation in the wound bed, was faster in the NPWT group than in controls (P = 0.002). The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups. A Cochrane review of five eligible trials with a total of 280 participants compared standard dressings with NPWT and found the adverse event rate was similar between groups (negative pressure 33/86; standard dressing 37/103); risk ratio (RR) 0.97 (95% confidence intervals [CI] 0.33 to 2.89). There was significant heterogeneity for this result due to the high incidence of fracture blisters in the NPWT group in one trial. One trial (87 participants) compared a commercial negative pressure device VAC system with a negative pressure system developed in the hospital (GSUC). The adverse event rate was lower in the GSUC group (VAC 3/42; GSUC 0/45); the RR was 0.13 (95% CI 0.01 to 2.51). The mean cost to supply equipment for VAC therapy was USD 96.51/day compared to USD 4.22/day for the GSUC therapy (P = 0.01). Pain intensity score was also reported to be lower in the GSUC group when compared with the VAC group (p = 0.02). Post-operative VAWT was compared to conventional wound management in 42 patients that developed post-sternotomy osteomyelitis and required open wound management. The patients were comparable with regards to age, presenting post-operative day, infecting organism, and risk factors for osteomyelitis. The patients treated by VAWT had significantly reduced treatment durations (mean 17.2+/- 5.8 vs. 22.9+/-10.8 days, P = 0.009) and total hospital stays (mean 27.2+/-6.5 vs. 33.0+/- 11.0 days, P = 0.03). Perioperative mortality was similar, with one early death in each group. References Professional society guidelines/other: 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. 6

Webster J, Scuffham P, Sherriff KL, et al. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2012; (4):CD009261. Peer-reviewed references: Apelqvist J, Willy C, Fagerdahl AM, et al. EWMA Document: Negative Pressure Wound Therapy. J Wound Care. 2017;26(Sup3):S1-S154. Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Rep Reg. 2012; 20(3):332-341. Doss M, Martens S, Wood JP, et al. Vacuum-assisted suction drainage versus conventional treatment in the management of poststernotomy osteomyelitis. Eur J Cardiothorac Surg. 2002; 22(6):934-938. Selvaggi F, Pellino G, Sciaudone G, et al. New advances in negative pressure wound therapy (NPWT) for surgical wounds of patients affected with Crohn's disease. Surg Technol Int. 2014; 24:83-89. Swanson EW, Cheng HT, Susarla SM, Lough DM, Kumar AR. Does negative pressure wound therapy applied to closed incisions following ventral hernia repair prevent wound complications and hernia recurrence? A systematic review and meta-analysis. Plast Surg (Oakv). 2016; 24(2):113-118. CMS National Coverage Determination (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Codes Description Comments 97605 Negative pressure wound therapy (e.g., vacuum assisted drainage collection), utilizing durable medical equipment (DME), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters 7

CPT Codes Description Comments 97606 Negative pressure wound therapy (e.g., vacuum assisted drainage collection), utilizing durable medical equipment (DME), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters ICD 10 Codes Description Comments An appropriate ICD-10 diagnosis code describing the wound that is being treated should be used when reporting vacuum-assisted wound closure. HCPCS Level II Codes A6550 A9272 E2402 Description Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories Wound suction, disposable, includes dressing, all accessories and components, any type, each Negative pressure wound therapy electrical pump, stationary or portable Comments 8