Prior Authorization Review Panel MCO Policy Submission

Transcription

1 Prior Authorization Review Panel MCO Policy Submission A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review. Plan: Aetna Better Health Submission Date: 06/01/2018 Policy Number: 0334 Policy Name: Negative Pressure Wound Therapy Effective Date: Revision Date: 06/01/2018 Type of Submission Check all that apply: New Policy Revised Policy* Annual Review No Revisions *All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below: CPB 334 Negative Pressure Wound Therapy This CPB has been revised to state that the use of single-use NPWT devices (e.g., PICO Single Use Negative Pressure Wound Therapy System; Prevena Incision Management System) is considered experimental and investigational for: (i) management of closed sternal incision following thoracic artery grafting, (ii) management of wound sites following mammoplasty; and (iii) prophylaxis after lower extremity fracture surgery. Name of Authorized Individual (Please type or print): Signature of Authorized Individual: Dr. Bernard Lewin, M.D. Revised 06/01/2018

2 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 1 of 81 ( Negative Pressure Wound Therapy Number: 0334 Policy Aetna considers negative pressure wound therapy (NPWT) pumps medically necessary, when either of the following criteria (I or II) is met: I. Ulcers and Wounds in the Home Setting The member has a chronic Stage III or IV pressure ulcer (see Appendix below), neuropathic ulcer (e.g., diabetic ulcer), venous or arterial insufficiency ulcer, or a chronic ulcer of mixed etiology, present for at least 30 days. A complete wound therapy program described by criterion A and criterion B, C, or D below, as applicable depending on the type of wound, has been tried or considered and ruled out prior to application ofnpwt. Policy History Last Review 03/22/2018 Effective: 08/16/1999 Next Review: 03/28/2019 Review History Definitions Additional Information Clinical Policy Bulletin Notes A. For all ulcers or wounds, the following components of a wound therapy program must include a minimum of all of the

3 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 2 of 81 following general measures, which should either be addressed, applied, or considered and ruled out prior to application of NPWT: Application of dressings to maintain a moist wound environment, and Debridement of necrotic tissue if present, and Documentation of evaluation, care, and wound measurements by a licensed medical professional, and Evaluation of and provision for adequate nutritional status. B. For Stage III or IV pressure ulcers: The member has been appropriately turned and positioned, and The member has used a group 2 or 3 support surface for pressure ulcers on the posterior trunk or pelvis CPB Pressure Reducing Support (see Surfaces (../400_499/0430.html) ) (Note: a group 2 or 3 support surface is not required if the ulcer is not on the trunk or pelvis), and The member's moisture and incontinence have been appropriately managed. C. For neuropathic (e.g., diabetic) ulcers: The member has been on a comprehensive diabetic management program, and Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities.

4 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 3 of 81 D. For venous insufficiency ulcers: Compression bandages and/or garments have been consistently applied, and Leg elevation and ambulation have been encouraged. II. Ulcers and Wounds Encountered in an Inpatient Setting A. An ulcer or wound (described in section I above) is encountered in the inpatient setting and, after wound treatments described in I-A through I-D for the various types of ulcers above have been tried or considered and ruled out, it is necessary to initiate NPWT. B. The member has complications of a surgically created wound (e.g., dehiscence) or a traumatic wound (e.g., pre-operative flap or graft) where there is documentation of the medical necessity for accelerated formation of granulation tissue which can not be achieved by other available topical wound treatments (e.g., other conditions of the member that will not allow for healing times achievable with other topical wound treatments). In either situation, II-A or II-B, NPWT will be considered medically necessary when treatment continuation is ordered beyond discharge to the home setting. Note: NPWT pumps must be capable of accommodating more than 1 wound dressing set for multiple wounds on a member. Therefore, more than 1 NPWT pump billed per

5 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 4 of 81 member for the same time period is considered not medically necessary. See specifications of equipment and supplies in the Appendix. III. Contraindication: An NPWT pump and supplies is considered not medically necessary if one or more of the following contraindications are present: A. The presence in the wound of necrotic tissue with eschar, if debridement is not attempted; or B. Osteomyelitis within the vicinity of the wound that is not concurrently being treated with intent to cure; or C. Cancer present in the wound; or D. The presence of an open fistula to an organ or body cavity within the vicinity of the wound. IV. Continued Medical Necessity For wounds and ulcers described in sections I and II above, once placed on an NPWT pump and supplies, in order to document continued medical necessity, a licensed medical professional must do the following: A. On a regular basis, directly assess the wound (s) being treated with the NPWT pump, and supervise or directly perform the NPWT dressing changes, and B. On at least a monthly basis, document changes in the ulcer's dimensions and characteristics. V. DiscontinuationCriteria

6 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 5 of 81 For wounds and ulcers described in sections I and II above, an NPWT pump and supplies will be considered as not medically necessary with any of the following, whichever occurs earliest: A. Any measurable degree of wound healing has failed to occur over the prior month. Wound healing is defined as improvement occurring in either surface area (length times width) or depth of the wound. There must be documentation of quantitative measurements of wound characteristics including wound length and width (surface area), or depth, serially observed and documented, over a specified time interval. The recorded wound measurements must be consistently and regularly updated and must have demonstrated progressive wound healing from month to month; or B. Four months (including the time NPWTwas applied in an inpatient setting prior to discharge to the home) have elapsed using an NPWT pump in the treatment of any wound. The medical necessity of NPWT beyond 4 months will be given individual consideration based upon required additional documentation; or C. In the judgment of the treating physician, adequate wound healing has occurred to the degree that NPWT may be discontinued, or D. Once equipment or supplies are no longer being used for the member, whether or not by the physician's order; or E. When criteria under section on Continued Medical Necessity above, cease to be met. VI. Supplies

7 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 6 of 81 A. Up to a maximum of 15 dressing kits per wound per month is considered medically necessary unless there is documentation that the wound size requires more than 1 dressing kit for each dressing change. B. Up to a maximum of 10 canister sets per month is considered medically necessary unless there is documentation showing a large volume of drainage (greater than 90 ml of exudate per day). For high volume exudative wounds, a stationary pump with the largest capacity canister must be used. Excess utilization of canisters related to equipment failure (as opposed to excessive volume drainage) is not considered medically necessary. See specifications of equipment and supplies in the Appendix. Note: Staging of pressure ulcers used in this policy is as follows: Table: Stages of pressure ulcers stages Suspected Deep Tissue Injury Stage I Description Purple or maroon localized are of discolored intact skin or bloodfilled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue. Intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blancing; its color may differ from the surrounding area.

8 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 7 of 81 Stage II Partial thickness loss of dermis presenting as a shallow open ulcer with red or pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister. Stage III Stage IV Full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining or tunneling. 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. Aetna considers NPWT experimental and investigational for the following because its effectiveness for these indications has not been established (not an all-inclusive list): For use following cardiac surgery (e.g., internal thoracic artery grafting) not meeting criteria above For use following knee arthroplasty not meeting criteria above For use following surgical excision of pilonidal sinus disease and for recurrent pilonidal disease For use in kidney transplantion in recipients not meeting criteriaabove Prevention of complications in surgical wounds of the abdomen based upon presence of diabetes or obesity as risk factors

9 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 8 of 81 Prophylactic use after cesarean delivery Prophylactic use after ventral hernia repairs Treatment of deep sternal wound infection, partial-thickness burns, tibial fractures Aetna considers the use of chemotherapeutic agents (e.g. doxycycline and insulin) in continuousinstillation or intermittent-instillation NPWT experimental and investigational because its effectiveness has not been established. Aetna considers the use of non-powered (mechanical) NPWT devices (e.g., the Smart Negative Pressure [SNaP] Wound Care System) experimental and investigational because their effectiveness has not been established. Aetna considers the use of single-use NPWT devices (e.g., PICO Single Use Negative Pressure Wound Therapy System; Prevena Incision Management System) experimental and investigational for all indications (e.g., keloid scarring, wound care including management of closed sternal incision following thoracic artery grafting, management of wound sites following mammoplasty, and prophylaxis after lower extremity fracture surgery) because of insufficient evidence of their effectiveness. See also CPB Wound Care). (../200_299/0244.html) Background This policy is based in part upon Medicare DME MAC medical necessity criteria for negative pressure wound therapy (NPWT) pumps.

10 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 9 of 81 Negative pressure wound therapy is the controlled application of subatmospheric pressure to a wound using an electrical pump to intermittently or continuously convey subatmospheric pressure through connecting tubing to a specialized wound dressing which includes a resilient, open-cell foam surface dressing, sealed with an occlusive dressing that is meant to contain the subatmospheric pressure at the wound site and thereby promote wound healing. Drainage from the wound is collected in a canister. Negative pressure wound therapy has been used to promote healing of chronic wounds and pressure ulcers (decubitus ulcers) by creating controlled negative pressure over the wound that is thought to increase local vascularity and oxygenation of the wound bed, reduce edema by evacuating wound fluid, and remove exudate and bacteria. More than a dozen systematic evidence reviews produced by independent organizations have questioned the quality of the evidence supporting the use of NPWT, including systematic evidence reviews published by the Cochrane Collaboration (Evans and Land, 2001; Wasiak and Cleland, 2007; Ubbink et al, 2008), Washington State Department of Labor and Industries (2003), Canadian Coordinating Office for Health Technology Assessment (Fisher and Brady, 2003), Australian Safety and Efficacy Register of New Interventional Procedures -- Surgical (Pham et al, 2003), NHS Quality Improvement Scotland (NHS QIS, 2003), Centre for Clinical Effectiveness (Higgins, 2003), Agency for Healthcare Research and Quality (Samson et al, 2004), Technology Assessment Unit of McGill University Health Centre (Costa et al, 2005), Institute for Quality and Efficiency in Health Care (IQWiG, 2006), Ontario Ministry of Health and

11 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 10 of 81 Long-Term Care (MAS, 2004; MAS, 2006), Galician Agency for Health Technology Assessment (AVALIA-T, 2005), and BMJ Clinical Evidence (Nelson and Jones, 2006; Nelson and Penthrick, 2007). Control of intra-abdominal fluid secretion, facilitation of abdominal exploration, and preservation of the fascia for abdominal wall closure is a major challenge in the management of patients with an open abdomen. Vacuum-assisted therapy has been reported to help meet the challenges of managing the open abdomen and may be useful in patients with abdominal compartment syndromes, traumatic injuries, and severe intra-abdominal sepsis. In a review on the management of patients with open abdomen, Kaplan (2004) concluded that controlled clinical studies are needed to establish the safety and effectiveness of this treatment approach and to facilitate the development of treatment guidelines to help manage an increasingly common group of patients who might benefit from this treatment approach. A systematic evidence review by the National Institute for Health and Clinical Excellence (NICE, 2009) found inadequate evidence for the use of NPWT in open abdominal wounds. The NICE assessment concluded that "[c]urrent evidence on the safety and efficacy of negative pressure wound therapy (NPWT) for the open abdomen is inadequate in quality and quantity. There has been concern about the occurrence of intestinal fistulae associated with this procedure but there is currently no evidence about whether NPWT is the cause." Schimmer and colleagues (2007) stated that there are many primary modalities for managing deep sternal wound infection (DSWI) following cardiac surgery, namely surgical debridement with primary

12 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 11 of 81 re-closure in conjunction with irrigation, VAC, and primary or delayed flap closure. These researchers examined if there is consensus on the primary management of DSWI using one method as a single line therapy or a combination of these procedures. Therefore, a questionnaire with regards to the primary treatment modalities of DSWI was distributed to all 79 German heart surgery centers. All replied to the questionnaire - VAC is used in 28/79 (35 %) heart centers as the 'firstline' treatment, 22/79 (28 %) perform primary reclosure in conjunction with a double-tube irrigation/suction system, and in 29/79 (37 %) clinics both treatment options were used according to intra-operative conditions. Mostly, as a primary management of DSWI two treatment modalities are mainly in use: primary reclosure coupled with a double-tube suction/irrigation system and VAC. The current understanding is based purely on retrospective studies, not evidence-based medicine. Since prospective randomized controlled trials (RCTs) have not yet been performed, controlled clinical trials comparing these treatment modalities are pivotal to define evidence for patients presenting with DSWI. Morris et al (2007) noted that although NPWT appears effective, it remains unknown if it is more effective than other wound closure techniques. In addition, although many uncontrolled, nonrandomized studies describing the effectiveness of this therapy have been published, few prospective RCTs have been conducted. Small sample sizes, variable outcome measures across studies, and significant methodological problems in the available RCTs further limit the conclusions that can be drawn regarding the relative effectiveness of vacuum-assisted wound closure. Analysis of these data provided weak evidence to suggest that NPWT is superior to saline gauze dressings in

13 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 12 of 81 healing chronic wounds. The authors concluded that RCTs comparing healing, costs of care, patient pain, and quality-of-life outcomes of this treatment to non-gauze type dressings and other treatment modalities are needed. Gregor et al (2008) examined the clinical effectiveness and safety of negative NPWT compared with conventional wound therapy; RCTs and non-rcts comparing NPWT and conventional therapy for acute or chronic wounds were included in this review. The main outcomes of interest were wound-healing variables. After screening 255 fulltext articles, 17 studies remained. In addition, 19 unpublished trials were found, of which 5 had been prematurely terminated. Two reviewers independently extracted data and assessed methodological quality in a standardized manner. Seven RCTs (n = 324) and 10 non-rcts (n = 278) met the inclusion criteria. The overall methodological quality of the trials was poor. Significant differences in favor of NPWT for time to wound closure or incidence of wound closure were shown in 2 of 5 RCTs and 2 of 4 non-rcts. A metaanalysis of changes in wound size that included 4 RCTs and 2 non-rcts favored NPWT (standardized mean difference: RCTs, -0.57; non-rcts, -1.30). The authors concluded that although there is some indication that NPWT may improve wound healing, the body of evidence available is insufficient to clearly prove an additional clinical benefit of NPWT. Furthermore, the large number of prematurely terminated and unpublished trials is reason for concern. Vikatmaa et al (2008) conducted a systematic review of the literature on the safety and effectiveness of NPWT for problematic wounds. A total of 14 RCTs were included. Trials included patients with: (i) pressure wounds, (ii)

14 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 13 of 81 post-traumatic wounds, (iii) diabetic foot ulcers, and (iv) miscellaneous chronic ulcers. Only 2 trials were classified as high quality studies, whereas the remaining were classified as having poor internal validity. The authors concluded that (i) reliable evidence on the effectiveness of NPWT is scarce, (ii) tentative evidence indicates that the effectiveness of NPWT is at least as good as or better than current local treatment for wounds, and (iii) the need for large high-quality randomized studies is apparent. Blume et al (2008) evaluated the safety and clinical efficacy of NPWT compared with advanced moist wound therapy (AMWT) (predominately hydrogels and alginates) to treat foot ulcers in diabetic patients in a multi-center randomized controlled trial (n = 342). The mean age was 58 years and 79 % of subjects were male. Complete ulcer closure was defined as skin closure (100 % reepithelization) without drainage or dressing requirements. Patients were randomly assigned to either NPWT or AMWT (predominately hydrogels and alginates) and received standard off-loading therapy as needed. The trial evaluated treatment until day 112 or ulcer closure by any means. Patients whose wounds achieved ulcer closure were followed at 3 and 9 months. Each study visit included closure assessment by wound examination and tracings. A greater proportion of foot ulcers achieved complete ulcer closure with NPWT (73 of 169, 43.2 %) than with AMWT (48 of 166, 28.9 %) within the 112-day active treatment phase (p = 0.007). The Kaplan-Meier median estimate for 100 % ulcer closure was 96 days (95 % confidence interval [CI]: 75.0 to 114.0) for NPWT and not determinable for AMWT (p = 0.001). Patients who received NPWT experienced significantly (p = 0.035) fewer secondary amputations. The proportion of home care

15 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 14 of 81 therapy days to total therapy days for NPWT was 9,471 of 10,579 (89.5 %) and 12,210 of 12,810 (95.3 %) for AMWT. In assessing safety, no significant difference between the groups was observed in treatment-related complications such as infection, cellulitis, and osteomyelitis at 6 months. The authors concluded that NPWT appears to be as safe as and more efficacious than AMWT for the treatment of diabetic footulcers. A technology assessment report on NPWT (Sullivan et al, 2009) prepared for the Agency for Healthcare Research and Quality found that systematic reviews of NPWT reveal the following important points about the current state of the evidence on this technology: (i) all of the systematic reviews noted the lack of high-quality clinical evidence supporting the advantages of NPWT compared to other wound treatments; the lack of high-quality NPWT evidence resulted in many systematic reviewers relying on low-quality retrospective studies to judge the efficacy of this technology, (ii) no studies directly comparing different NPWT components (e.g., foam versus gauze dressings) were identified by any of the reviewers, and (iii) NPWT must be evaluated according to wound type; wound healing varies according to the type of wound being treated and NPWT benefits described for one wound type cannot be assumed to apply to other wound types. The assessment stated that the available evidence cannot be used to determine a significant therapeutic distinction of a NPWT system. In addition, due to the lack of studies comparing one NPWT system to another NPWT system the severity of adverse events for 1 NPWT system compared to another could not be determined. The report concluded, "Clinical research on NPWT capable of indicating if any one NPWT system or component

16 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 15 of 81 provides a significant therapeutic distinction requires study design and conduct that will minimize the possibilities for bias. Important study design features that were not typically reported such as concealment of allocation, reporting of randomization methods, use of power analysis to ensure adequate study size, blinding wound assessors, and reporting of complete wound healing data will improve the internal validity and the informativeness of the studies." More recently, the Johns Hopkins University Evidence-based Practice Center prepared a comprehensive technology assessment for the Agency for Healthcare Research and Quality (AHRQ) on the effectiveness of negative pressure wound therapy (NPWT) on the treatment of chronic wounds in the home care setting (Rhee et al, 2014). The goal of the assessment was to systematically review the efficacy and safety of NPWT for treatment of chronic wounds in the home setting. The authors 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 retrieved 5,912 citations, and found seven studies which met the criteria for inclusion. Six of the studies compared NPWT devices to other wound care methods. One study compared two different NPWT devices. Ultimately the assessment's authors were unable to draw any firm conclusions about the efficacy or safety of NPWT for the treatment of chronic wounds in the home setting due to insufficient evidence. The authors stated "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

17 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 16 of 81 common definitions of outcomes, would be helpful in providing evidence to inform decisions about the use of NPWT." Negative pressure wound therapy uses a reticulated sponge and subatmospheric pressure to facilitate healing of a variety of wounds. The therapy appears to assist wound healing by decreasing wound bacterial burden and edema while facilitating granulation tissue formation. The latest development in NPWT allows clinicians to instill continuously a treatment solution and suspension into the wound. A variety of wound chemo-therapeutic agents such as insulin, which acts as a growth factor, may prove helpful in this aspect. Scimeca and colleagues (2010a) presented a case report in which insulin was used as a chemotherapeutic agent in continuous-instillation NPWT. To the authors' knowledge, this is the first report in the literature describing this method of delivery. Furthermore, Scimeca et al (2010b) described a real-time streaming therapy of a variety of wound chemo-therapeutic agents through NPWT. Doxycycline, which acts as a competitive inhibitor of matrix metalloproteinases and tumor necrosis factor alpha and further decreases inflammation through the reduction of nitrous oxide production, may prove helpful when delivered in this manner. To the authors' knowledge, this is the first report in the literature describing this method of delivery of doxycycline. The clinical value of chemo-therapeutic agents in continuous-instillation NPWT nees to be ascertained in randomized, controlled clinical trials. A non-powered (mechanical) NPWT device, the Smart Negative Pressure (SNaP) Wound Care System from Spiracur, is a class II device that received 510(k) marketing clearance from the Food and Drug Administration in 2010 and is designed

18 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 17 of 81 to remove small amounts of exudate from chronic, traumatic, dehisced, acute, subacute wounds and diabetic and pressure ulcers. The lack of welldesigned comparative studies with large number of individuals using the non-powered NPWT system is insufficient to draw conclusions about its impact on health outcomes with the device and in comparison with current care. Armstrong et al (2012) compared the portable mechanically powered Smart Negative Pressure (SNaP) Wound Care System (Spiracur, Sunnyvale, CA) with the electrically powered Vacuum-Assisted Closure (VAC) Therapy System (Kinetic Concepts, Inc. [KCI], San Antonio, TX) in a multicenter, comparative efficacy, noninferiority-powered, randomized controlled trial. Investigators enrolled 132 people with noninfected, nonischemic, nonplantar lower extremity diabetic and venous wounds. Each subject was randomly assigned (1:1) to treatment with either system in conjunction with appropriate off-loading and compression therapy. The trial evaluated treatment for up to 16 weeks or complete wound closure (defined as complete reepithelialization without drainage). Primary end point analysis of wound size reduction found that SNaP-treated subjects demonstrated noninferiority to the VAC-treated subjects at 4, 8, 12, and 16 weeks (p = , , , and , respectively). Kaplan-Meier analysis showed no significant difference in complete wound closure between SNaP- and VAC-treated subjects at all time points. Device related adverse events and complications such as infection were also similar between treatment groups. An AHRQ assessment (Rhee et al, 2014) noted study limitations including lack of blinding, imbalanced study groups particularly in terms of wound size, and lack of reporting of intervention details. The ARHQ assessment downgraded study limitations to high

19 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 18 of 81 for the outcome of pain because of limited reporting of statistical details. All of the outcomes were direct, but the results were imprecise. The AHRQ assessment stated that they were unable to assess consistency or reporting bias. The AHRQ assessment noted that the study was funded by the manufacturer of one of the devices (SNaP) and two of the investigators reported receiving funding from manufacturers of both devices being evaluated. The European Pressure Ulcer Advisory Panel's clinical practice guideline on pressure ulcer treatment (2009) recommended conventional NPWT therapy, but did not mention non-powered NPWT. In a systematic review, Roberts et al (2012) determined the comparative safety and effectiveness of NPWT versus alternate temporary abdominal closure (TAC) techniques in critically ill adults with open abdominal wounds. These researchers reviewed published and unpublished comparative studies. They searched MEDLINE, PubMed, EMBASE, Scopus, Web of Science, the Cochrane Database, the Center for Reviews and Dissemination, clinical trials registries, and bibliographies of included articles. Two authors independently abstracted data on study design, methodological quality, patient characteristics, and outcomes. Among 2,715 citations identified, 2 RCTs and 9 cohort studies (3 prospective/6 retrospective) met inclusion criteria. Methodological quality of included prospective studies was moderate. One RCT observed an improved fascial closure rate (relative risk [RR], 2.4; 95 % CI: 1.0 to 5.3) and length of hospital stay after addition of retention sutured sequential fascial closure to the Kinetic Concepts Inc. (KCI) vacuumassisted closure (VAC). Another reported a trend

20 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 19 of 81 toward enhanced fascial closure using the KCI VAC versus Barker's vacuum pack (RR, 2.6; 95 % CI: 0.95 to 7.1). A prospective cohort study observed improved mortality (RR, 0.48; 95 % CI: 0.25 to 0.92) and fascial closure (RR, 1.5; 95 % CI: 1.1 to 2.0) for patients who received the ABThera versus Barker's vacuum pack. Another noted a reduced arterial lactate, intra-abdominal pressure, and hospital stay for those fitted with the KCI VAC versus Bogotá bag. Most included retrospective studies exhibited low methodological quality and reported no mortality or fascial closure benefit for NPWT. The authors concluded that limited prospective comparative data suggested that NPWT versus alternate TAC techniques may be linked with improved outcomes. Moreover, they stated that the clinical heterogeneity and quality of available studies precluded definitive conclusions regarding the preferential use of NPWT over alternate TAC techniques. Guidance from tne National Institute for Health and Clinical Excellence (NICE, 2013) stated that current evidence on the safety and efficacy of NPWT for the open abdomen is adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit and clinical governance. The guidance stated that NPWT for the open abdomen may be used to manage open abdominal wounds in which the gut and other intraperitoneal organs are exposed. In a Cochrane review, Dumville and Munson (2012) evaluated the effectiveness of NPWT for people with partial-thickness burns. For this third update we searched the Cochrane Wounds Group Specialised Register (searched May 18, 2012); the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2012, Issue 5); Ovid MEDLINE (2010 to week 2 of May 2012); Ovid

21 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 20 of 81 MEDLINE (in-process & other non-indexed citations May 17, 2012); Ovid EMBASE (2010 to week 19 of 2012); and EBSCO CINAHL (2010 to May 16, 2012). All RCTs and controlled clinical trials (CCTs) that evaluated the safety and effectiveness of NPWT for partial-thickness burns were selected for analysis. Two review authors used standardized forms, and extracted the data independently. They assessed each trial for risk of bias, and resolved differences by discussion. One RCT, that was an interim report, satisfied the inclusion criteria. These investigators undertook a narrative synthesis of results, as the absence of data and poor reporting precluded them from carrying out any formal statistical analysis. The trial was at high-risk of bias. The authors concluded that there was insufficient evidence available to permit any conclusions to be drawn regarding the use of NPWT for treatment of partial-thickness burn wounds. The PICO single-use negative pressure wound therapy device (Smith & Nephew, Inc., Andover, MA) is a single-use, canister-free, negative pressure wound therapy device. It is marketed for use in the following types of wounds: chronic; acute; traumatic;subacuteanddehisced wounds;partialthickness burns; ulcers (e.g., diabetic or pressure); flaps and grafts; and closed surgical incisions. The PICO system contains a disposable, 1-button pump, coupled with an advanced dressing that negates the need for a canister. The pump is pocket-sized and the dressing can be worn up to 7 days. Fraccalvieri et al (2013) stated that keloid scarring represents a pathological healing where primary healing phenomenon is deviated from normal. PICO is a single-use negative pressure wound therapy system originally introduced to manage

22 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 21 of 81 open or just closed wounds. PICO dressing is made of silicone, and distributes an 80 mmhg negative pressure across wound bed. Combination of silicon layer and continuous compression could be a valid method to manage keloid scarring. Since November 2011, 3 patients were enrolled and evaluated before negative pressure treatment, at end of treatment (1 month) and 2 months later, through Vancouver scar scale (VSS), visual analog scale (VAS) and a scoring system for itching. Ultrasound (US) and color- power- Doppler (CPD) examination was performed to evaluate thickness and vascularization of the scar. One patient was discharged from study after 1 week. In last 2 patients, VSS, VAS and itching significantly improved after 1 month therapy and the results were stable after 2 months without any therapy. At end of therapy, the appearance of palisade vessels disappeared in both cases at CPD exam; US showed a thickness reduction (average of 43.8 %). The authors proposed a well-tolerated, non-invasive treatment to manage keloid scarring. They stated that prospective studies are needed to confirm these preliminary findings. Bendewald et al (2007) stated that complex pilonidal disease, an uncommon manifestation of an anorectal condition, is characterized by chronic or recurrent abscesses with extensive, branching sinus tracts. Definitive treatment requires wide excision of all involved tissue followed by secondary intention healing or reconstructive surgery. All treatment options have unique advantages and disadvantages. Following recent reports that negative pressure wound therapy after surgery for complex pilonidal disease may be a useful alternative to moist saline dressing treatments, 5 patients (3 men and 2 women, median age of 21 years [range of 16 to 63 years]) with complex pilonidal disease (symptom duration

23 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 22 of 81 range of 6 months to 30 years) were treated on an outpatient basis. Following wide excision under general anesthesia, a portable negative pressure wound therapy device was applied. Mean wound defect size after excision was 11 cm x 4 cm x 5 cm, or 205 cm(3) (range of 90 cm(3) to 410 cm(3)). Negative pressure wound therapy was used for an average of 6 weeks (range of 4 to 9 weeks) and mean time to complete epithelialization was 12 weeks (range of 9 to 22 weeks), including use of moist saline dressings post-negative pressure wound therapy. Treatment was discontinued in 1 patient due to skin irritation. No other complications were observed. The authors concluded that long-term follow-up is needed to assess the risk of recurrent pilonidal disease or wound failure following negative pressure wound therapy. They stated that additional studies of negative pressure wound therapy in the management of pilonidal disease are warranted. Farrell and Murphy (2011) noted that pilonidal disease arises from hair follicles of the gluteal cleft and may result in a chronic exudative disorder. The management of pilonidal disease following surgical excision remains controversial, despite an abundance of research into different treatment options. Negative pressure wound therapy is an emerging treatment option for complex or recurrent pilonidal disease. These investigators performed a comprehensive literature search, using the electronic databases MEDLINE, Cochrane library, CINAHL, PubMed, and Web of Knowledge. All studies, case reports, and multiple case series evaluating the use of negative pressure wound therapy for treatment of pilonidal disease were included. Despite the breadth of the search parameters, these researchers identified limited studies addressing this issue; all were published between 2003 and Findings of 5 case reports

24 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 23 of 81 or multiple case series tentatively suggested that negative pressure wound therapy may be an emerging treatment option for pilonidal disease management. However, the authors recommended that more rigorous research, including randomized controlled trials, be conducted before implications can be drawn for evidence-based practice. Ousey et al (2013) stated that the management of post-operative spinal wound complication remains a challenge, with surgical site infection (SSI) incidence rates ranging from 0.4 % to 20 % after spinal surgery. Negative pressure wound therapy has been highlighted as an intervention that may stimulate healing and prevent SSI. However, the wound healing mechanism by NPWT and its effectiveness in spinal wounds still remain unclear. These researchers systematically searched, critically appraised, and summarized RCTs and non-rcts evaluating the effectiveness of NPWT in patients with a spinal wound. A systematic review based on search strategies recommended by the Cochrane Back and Wounds Review Groups was undertaken using Cochrane Library, MEDLINE, EMBASE, and CINAHL databases. Any publications between 1950 and 2011 were included. A total of 10 retrospective studies and 4 case studies of patients with spinal wound complication were included in this systematic review. No RCTs were found; only 1 study described more than 50 patients. Generally, a pressure of -125 mm Hg was used in adults. Duration of NPWT in-situ ranged from 3 to 186 days. Wound healing was assessed every 2 to 3 days and generally completed between 7 days and 16 months. Negative pressure wound therapy is contraindicated in the presence of active cerebrospinal fluid leak, metastatic or neoplastic disease in the wound or in patients with an allergy to the NPWT dressing and in those with a bleeding

25 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 24 of 81 diathesis. The authors concluded that published reports were limited to small retrospective and case studies, with no reports of NPWT being used as a prophylactic treatment. They stated that larger prospective RCTs of NPWT are needed to support the current evidence that it is effective in treating spinal wound complications. In addition, future studies should investigate its use as a prophylactic treatment to prevent infection and report data relating to safety and health economics. Karlakki et al (2013) stated that the period of postoperative treatment before surgical wounds are completely closed remains a key window, during which one can apply new technologies that can minimize complications. One such technology is the use of NPWT to manage and accelerate healing of the closed incisional wound (incisional NPWT). These investigators undertook a literature review of this emerging indication to identify evidence within orthopedic surgery and other surgical disciplines. Literature that supports the current understanding of the mechanisms of action was also reviewed in detail. A total of 33 publications were identified, including 9 clinical study reports from orthopedic surgery; 4 from cardiothoracic surgery and 12 from studies in abdominal, plastic and vascular disciplines. Most papers (26 of 33) had been published within the past 3 years. Thus far, 2 RCTs -- 1 in orthopedic and 1 in cardiothoracic surgery -- showed evidence of reduced incidence of wound healing complications after between 3 and 5 days of post-operative NPWT of 2- and 4-fold, respectively. Investigations showed that reduction in hematoma and seroma, accelerated wound healing and increased clearance of edema are significant mechanisms of action. The authors concluded that there is a rapidly emerging literature on the effect of NPWT

26 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 25 of 81 on the closed incision. Initiated and confirmed first with a RCT in orthopedic trauma surgery, studies in abdominal, plastic and vascular surgery with high rates of complications have been reported recently. They stated that the evidence from single-use NPWT devices is accumulating. There are no large randomized studies yet in reconstructive joint replacement. Selvaggi et al (2014) noted that surgical site complications (SSC) negatively affect costs of care and prolong length of stay. Crohn's disease (CD) is a risk factor for SSC; CD patients often need surgery, sometimes requiring stoma. These researchers compared the effects on SSC of a portable device for NPWT (PICO) with gauze dressings after elective surgery for CD. Secondary aims were manageability and safety of PICO and its feasibility as home therapy. Between 2010 and 2012, a total of 50 patients were assigned to treatment with either PICO (n = 25) or conventional dressings (n = 25). Each patient completed 12 month follow-up. Parameters of interests for primary aim were SSC, surgical complications, and re-admission rates. Data on difficulties in managing PICO and device-related complications were also collected. Patients receiving PICO had less SSC, resulting in shorter hospital stay. At last follow-up, re-admission rates were lower with PICO. No differences were observed in surgical complications between groups. No patients reported difficulties in managing the device. Among patients discharged with PICO, none needed to come back to the hospital for device malfunctioning or inability to manage it. PICO reduces SSC and length of stay in selected CD patients compared with conventional dressings. This was a small study (n = 25 for PICO); its findings need to be validated by well-designed studies.

27 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 26 of 81 In a Cochrane review, Webster et al (2014) evaluated the effects of NPWT on surgical wounds (primary closure, skin grafting or flap closure) that are expected to heal by primary intention. These investigators searched the following electronic databases to identify reports of relevant RCTs: the Cochrane Wounds Group Specialised Register (searched January 28, 2014); the Cochrane Central Register of Controlled Trials (CENTRAL; 2013, issue 12); Database of Abstracts of Reviews of Effects (2013, issue 12); Ovid MEDLINE (2011 to January 2014); Ovid MEDLINE (In-Process & Other Non- Indexed Citations January 24, 2014); Ovid EMBASE (2011 to Week 44 of January 2014); and EBSCO CINAHL (2011 to January 2014). These researchers conducted a separate search to identify economic evaluations. They included trials if they allocated patients to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with a different type of NPWT. They assessed trials for their appropriateness for inclusion and for their quality. This was done by 3 review authors working independently, using pre-determined inclusion and quality criteria. In this first update, these investigators included an additional 4 trials, taking the total number of trials included to 9 (785 participants) -- 3 trials involved skin grafts, 4 included orthopedic patients and 2 included general surgery and trauma surgery patients; all the included trials had unclear or high risk of bias for one or more of the quality indicators we assessed. A total of 7 trials compared NPWT with a standard dressing (2 of these were 'home-made' NPWT devices), 1 trial compared one 'home-made' NPWT with a commercially available device. In trials where the individual was the unit of randomization, there were no differences in the incidence of surgical site infections (SSI); wound dehiscence, re-operation (in incisional wounds);

28 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 27 of 81 seroma/hematoma; or failed skin grafts. Lower reoperation rates were observed among skin graft patients in the 'home-made' NPWT group (7/65; 10.8 %) compared to the standard dressing group (17/66; 25.8 %) (RR 0.42; 95 % CI: 0.19 to 0.92). The mean cost to supply equipment for VAC therapy was US$ 96.51/day compared to US$ 4.22/day for one of the 'home-made' devices (p value 0.01); labor costs for dressing changes were similar for both treatments. Pain intensity score was also reported to be lower in the 'home-made' group when compared with the VAC group (p value 0.02). One of the trials in orthopedic patients was stopped early because of a high incidence of fracture blisters in the NPWT group (15/24; 62.5 %) compared with the standard dressing group (3/36; 8.3 %) (RR 7.50; 95 % CI: 2.43 to 23.14). The authors concluded that the evidence for the effects of NPWT for reducing SSI and wound dehiscence remains unclear, as does the effect of NPWT on time to complete healing. Rates of graft loss may be lower when NPWT is used, but hospitaldesigned and built products are as effective in this area as commercial applications. There were clear cost benefits when non-commercial systems were used to create the negative pressure required for wound therapy, with no evidence of a negative effect on clinical outcome. In 1 study, pain levels were also rated lower when a 'home-made' system was compared with a commercial counterpart. The high incidence of blisters occurring when NPWT is used following orthopedic surgery suggested that the therapy should be limited until safety in this population is established. They stated that given the cost and widespread use of NPWT, there is an urgent need for suitably powered, high-quality trials to evaluate the effects of the newer NPWT products that are designed for use on clean, closed surgical incisions. Such trials

29 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 28 of 81 should focus initially on wounds that may be difficult to heal, such as sternal wounds or incisions on obese patients. Kostaras et al (2014) stated that NPWT has been suggested to have a positive impact on the healing of sternal or extremity wounds. However, few data deriving from breast surgery have been published. These researchers evaluated the available literature regarding the effectiveness of NPWT systems in the healing of breast tissues. The PubMed and Scopus databases were searched systematically, and all studies that provided relevant data were considered eligible for inclusion in the review. A total of 20 studies (154 female patients) met the inclusion criteria (4 cohort studies, 1 case series, and 15 case reports). The NPWT system was used alone in 17 patients and in combination with other techniques in the remaining 137. The lesion was secondary to plastic surgery in 107 women, other operations in 40 women (38 of them for breast cancer), and primary breast infection in 7 women. Infections (including necrotizing fasciitis), pyoderma gangrenosum, and necrosis were among the most common complications for which NPWT was used. In total, 150 of 154 patients receiving NPWT healed completely. Two patients died before complete closure for reasons unrelated to the wound, and NPWT failed in 2 patients who healed later with muscle flap coverage. The authors concluded that the scant published evidence suggested that NPWT systems might be useful in the healing of complicated breast wounds. However, they stated that larger studies are needed to investigate the effectiveness of this system further before it is established in breast surgery.

30 Negative Pressure Wound Therapy - Medical Clinical Policy Bulletins Aetna Page 29 of 81 The literature on the use of NPWT in surgical wounds has focused on its use in wound complications. There is only scant literature on the use of NPWT in preventing complications in surgical wounds of the abdomen based upon presence of diabetes or obesity as risk factors. In a pilot study, Mark et al (2013) assessed the effectiveness of incisional negative pressure therapy in decreasing post-operative wound complications when placed prophylactically over clean, closed incisions following cesarean section in obese patients. This was a retrospective cohort study comparing rates of wound complications following Cesarean sections in morbidly obese women prior to and following the institution of standard use of prophylactic incisional negative pressure therapy. All women with a body mass index (BMI) greater than 45 kg/m2 undergoing cesarean section in a 2-year period in a single institution were included. The exposure was incisional negative pressure therapy, which began in September 2009, versus standard wound dressing used in the previous year. The main outcome was wound complication identified by ICD-9 codes. Demographic and wound outcomes were compared with χ2 and t tests. Stata version 11.0 was used for all analysis. A total of 63 women met the inclusion criteria, 21 of whom received NPWT. The historical comparison and exposure groups were similar in all characteristics studied with the exceptions of length of surgery (64 versus 76 minutes, p = 0.03), length of labor (78 versus 261 minutes, p = 0.02), scheduled versus nonscheduled (77 % versus 52 %, p = 0.04), and mean age (29.5 versus 26.1 years, p = 0.04), respectively. There were 5 wound complications in the control group (10.4 %) and none (0 %) in the study group (p = 0.15). The authors concluded that the findings of this pilot study suggested a decrease in wound