Commercial

Medical Policy

Title:

Negative Pressure Wound Therapy Systems

Policy #:

05.00.38m

Policy

MEDICALLY NECESSARY

A powered or a nonpowered negative-pressure wound therapy (NPWT) system and supplies are considered medically necessary and, therefore, covered when:

the basic requirements for all wound types are met, and
the subsequent medical necessity criteria for specific wound types listed below are met

BASIC REQUIREMENTS FOR ALL WOUND TYPES PRIOR TO APPLICATION OF AN NPWT SYSTEM

All of the following program measures must apply or be considered and ruled out by the individual's professional provider prior to the application of an NPWT system for all wound types:

The individual’s medical record documents the wound assessments, care, and wound measurements, as written by a professional provider, at least weekly.
Dressings have been used to maintain a moist wound environment.
Necrotic tissue, if present, has been debrided.
The individual's nutritional status has been evaluated and appropriately treated.

REQUIREMENTS FOR SPECIFIC WOUND TYPES PRIOR TO APPLICATION OF AN NPWT SYSTEM

In addition to the requirements listed above for all wound types, the following wound-specific therapeutic measures (if applicable) must be applied, or considered and ruled out, by the individual's professional provider, prior to the application of an NPWT system, for the following specific types of ulcers and wounds:

Arterial insufficiency ulcers
For stage III or IV pressure ulcers, all of the following criteria must be met:

The individual is being appropriately turned and positioned.
The individual is using a group 2 or 3 support surface for pressure ulcers on the posterior trunk or pelvis. (A group 2 or 3 support surface is not required if the ulcer is not on the trunk or pelvis. For more information on support surfaces, refer to the Company policy addressing this topic.)
The individual's moisture and incontinence are being managed appropriately.

For neuropathic (diabetic) ulcers the following criterion must be met:

Pressure on the foot ulcer has been reduced using appropriate modalities (such as, but not limited to, the following: total contact casts; removable cast walkers; half shoes; saline wet-to-dry dressings; debridement of all necrotic, callus, and fibrous tissue; crutches).

For venous insufficiency ulcers, both of the following criteria must be met:

Compression garments and/or bandages have been consistently applied.
Leg elevation and ambulation have been encouraged.

For individuals who develop complications of a surgically created wound (e.g., dehiscence) or a traumatic wound (e.g., preoperative flap or graft), both of the following criteria must be met:

The wound requires accelerated formation of granulation tissue that cannot be achieved by other available topical wound treatments (e.g., comorbidities exist that prevent healing).
Results of previous wound treatments are documented.

REQUIREMENTS FOR ALL WOUND TYPES DURING TREATMENT WITH AN NPWT SYSTEM

In addition to the criteria above, the professional provider must demonstrate all of the following for coverage of NPWT:

The wounds being treated with a NPWT system are directly assessed and the findings are documented.
The NPWT dressing changes are supervised or directly performed and the findings are documented.
Changes in the wound's dimensions and characteristics (e.g., size [length, depth, and width], color, exudate type and amount, odor, and evidence of healing) are documented at least monthly.

LENGTH OF COVERAGE

NPWT systems may be applied in the hospital setting. All requests for continued use must meet all applicable medical necessity criteria upon review by the company.

When the above criteria are met, coverage for the NPWT system may be eligible for up to a maximum of 4 months (including the time NPWT was applied, regardless of the place of application [e.g., home, inpatient facility, skilled nursing facility]).

If it is determined during the course of treatment for an initial wound that the NPWT system will be applied to additional wounds, all additional wounds must meet the criteria listed in this policy to determine medical necessity. In the case of additional wound occurrence(s) after the initial NPWT is started, the 4 months maximum will apply to each wound.

SUPPLIES

HCPCS code A6550 describes an allowance for a dressing set that is used in conjunction with a stationary or portable NPWT pump (HCPCS code E2402). A single code A6550 is used for each single, complete dressing change, and contains all necessary components, including but not limited to any separate, nonadherent porous dressing(s), drainage tubing, and an occlusive dressing(s) that creates a seal around the wound site for maintaining a controlled negative pressure at the wound. An individual using a powered NPWT system is eligible for a maximum of 15 wound care sets (A6550) per wound per month, unless there is documentation that the wound size requires more than one wound care set for each dressing change. An individual is eligible for a maximum of 10 canisters (HCPCS code A7000) per month, unless there is documentation evidencing a large volume of drainage (i.e., ≥ 90 mL of exudate/day).

An individual using a nonpowered NPWT system is eligible for a maximum of 10 wound care sets (A6550) and 10 wound care cartridges (HCPCS code A9999) per month. Additionally, the individual is eligible to receive one strap (A9999) for the length of the therapy.

NOT MEDICALLY NECESSARY

Treatment with an NPWT system and supplies is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of illness or injury in any of the following circumstances:
More than 4 months have elapsed using an NPWT system (including the time NPWT was applied, regardless of the place of application [e.g., home, inpatient facility, skilled nursing facility])
There are surgical or traumatic wounds without complications
Adequate wound healing has occurred
Any measurable degree of wound healing has failed to occur during the prior month
Cancer is present in the wound
The NPWT equipment or supplies are no longer being used for the individual, regardless of the professional provider's orders to continue or discontinue use
The professional provider fails to perform and document all of the following on a monthly basis:

Direct assessment of the wound(s) being treated with the NPWT system
Supervision of, or directly performing, the wound dressing changes
Changes in the wound's dimensions and characteristics (e.g., size [length, depth, and width], color, exudate type and amount, odor, and evidence of healing)

Necrotic tissue with eschar is present if debridement has not been attempted
There is a fistula to an organ or body cavity within the vicinity of the wound
There are exposed vital organs (treatment may proceed after the organ has been covered by vicryl absorbable mesh)
The wound has been inadequately debrided (granulation tissue will not form over necrotic tissue)
Osteomyelitis that is present within the vicinity of the wound that is not concurrently being treated with intent to cure
Coagulopathy has not been treated
There are nonenteric and unexplored fistulas
The individual has an allergy to any component required for the procedure
A nonpowered NPWT system is being used to treat a wound greater than 13 cm at it widest diameter, or when wound exudate production exceeds 60 cc in 24 hours.

A powered NPWT system (HCPCS code E2402) must be capable of accommodating more than one wound care set for multiple wounds on an individual. Therefore, more than one E2402 billed per individual for the same time period will be denied as not medically necessary.

EXPERIMENTAL/INVESTIGATIONAL

Although the U.S. Food and Drug Administration (FDA) has approved devices for powered disposable NPWT systems, the Company has determined that the safety and/or effectiveness of the following systems (such as, but not limited to) cannot be established by review of the available published peer-reviewed literature. Therefore, they are considered experimental/investigational by the Company and not covered.

PICO™ Single Use Negative Pressure Wound Therapy System
Single use Prevena™ Incision Management System
RENASYS™ GO Negative Pressure Wound Therapy System
V.A.C.VIA™ Therapy System

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply.

For specified DME items, documentation of a face-to-face encounter, between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s), must be provided to and kept on file by the DME supplier.

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, a negative-pressure wound therapy (NPWT) system and supplies are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

Subject to the terms and conditions of the applicable benefit contract, powered disposable NPWT systems are not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

Codes that are a daily rental (E2402) are not subject to purchase maximum.

BILLING GUIDELINES

Although non-durable medical equipment (DME) such as NPWT systems are a benefit contract exclusion for all products of the Company, home health agencies (HHA) utilizing non-DME NPWT systems and services may be eligible for reimbursement when reported with the following Current Procedural Terminology (CPT) codes:

97607, 97608.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for powered and non-powered NPWT systems.

Description

Negative-pressure wound therapy (NPWT), also known as vacuum-assisted closure, is the application of controlled negative pressure (vacuum pressure) to a wound to remove exudate and debris from wounds. NPWT is delivered through an integrated system of a suction pump, separate exudate collection chamber, and/or dressing sets to a qualified wound.

In chronic nonhealing wounds (of at least 30 days' duration), the presence of fluid inhibits the healing process because it impedes granulation and provides a medium for the growth of microorganisms. An NPWT system uses negative pressure to drain wound exudates and excess interstitial fluid from the wound bed. The healing process is accelerated by the relief of fluid pressure in the area, which allows granulation, blood vessel formation, and healthy tissue growth to occur. Additionally, the negative pressure from the pump can draw the wound edges together. This, along with granulation and tissue growth, can promote wound closure. Even after receiving NPWT, an individual may still require skin grafts or additional therapies.

Once activated, the NPWT system begins drawing out the fluid that would normally hinder the wound-healing process. The duration of treatment with an NPWT system varies with the type and size of the wound being treated. A treatment period lasts an average of 8 weeks.

A general wound therapy program includes the measures listed below. All of the following should be applied prior to initiating treatment with an NPWT system:

Documentation in the individual's medical record of the evaluation, care, and wound measurements, written by a professional provider
Wound assessments (e.g., size [length, depth, and width], color, exudate type and amount, odor, evidence of healing, sinus tracking or tunneling, pain, type of dressing used) performed weekly by a professional provider
Application of dressings to maintain a moist wound environment
Debridement of necrotic tissue if present
Evaluation of and provision for adequate nutritional status

Types of wounds considered appropriate for NPWT systems are:

Stage III: Full-thickness skin loss involving damage to, or necrosis of, subcutaneous tissue that may extend down to, but not through, underlying fascia. The ulcer presents clinically as a deep crater with or without undermining and tunneling of adjacent tissue.
Stage IV: Full-thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule). Undermining and sinus tracks may also be present.
Neuropathic (diabetic) ulcer
Chronic (present for at least 30 days) ulcer of mixed etiology
Venous or arterial insufficiency ulcer
Complications of a surgically created wound
Traumatic wound

NEGATIVE PRESSURE WOUND THERAPY (NPWT) SYSTEMS

A powered NPWT vacuum pressure system (e.g., VAC Therapy®, Kinetic Concepts Inc., San Antonio, TX; Renasys™Systems, Smith and Nephew, St. Petersburg, FL; Avance® NPWT Pump, Baar, Switzerland) can apply between −25 and −200 mm Hg of pressure to a wound, either continuously or intermittently. A powered NPWT system generally requires the use of a porous sponge dressing (e.g., Avance® Foam Dressing Kit, Baar, Switzerland) that is attached by an evacuation tube to a collection container and a negative-pressure pump. The sponge dressing is placed directly on the wound and away from other areas of the skin (for large wounds, several dressings may be necessary). Transparent adhesive tape is applied to form an airtight seal around the sponge, and then the NPWT pump can be attached and treatment initiated.

PICO™ SINGLE USE NPWT SYSTEM

PICO Single Use NPWT System (Smith and Nephew, St. Petersburg, FL) is considered a powered NPWT vacuum pressure system. Saunders et al. (2021) performed a meta-analysis reviewing 29 studies of individuals treated with PICO compared to conventional dressings in various surgical specialties (e.g., orthopedics, obstetrics, colorectal, breast, vascular, and cardiothoracic). A total of 4530 individuals were represented between 11 randomized controlled trials (RCTs), 13 observational, and five abstracts. Surgical site infections (SSIs), time-to-healing, length of stay, and readmission rates were evaluated after surgery. Pooled odds of SSIs were significantly reduced by 63% in the PICO group compared with standard dressings (odds ratio [OR] 0.37; 95% confidence interval [CI] 0.28–0.50, P<0.001). An isolate analysis of RCTs also showed significantly reduced odds of SSI by 52% (OR, 0.48, 95% CI, 0.33–0.71). Results from 10 studies for individuals' length of hospital stay showed a significantly smaller mean difference of 1.75 days in the PICO cohort (P< 0.001). Despite clinically significant SSI and length of hospital stay reduction in the PICO group, the mean time-to-healing difference and readmission rates were comparable and not statistically significant. The majority of studies did not report an intention-to-treat (ITT) analysis and did not capture patients in an outpatient setting.

Tuuli et al. (2020) performed an open-label, multicenter RCT (n=1608) for prophylactic NPWT for obese women undergoing cesarean delivery using the PICO device compared with standard wound dressings. The authors reported comparable SSIs (3.6% vs 3.4%) and increased adverse skin reactions in the PICO group (7.0% vs 0.6%). Although a well-designed study, the authors terminated after collecting 50% of the planned sample size due to futility of primary outcome and adverse events. Conversely, Hyldig et al. (2019) performed a similar RCT (n=876). The authors collected data via questionnaires and patient/prescription registries (via Danish National key identifiers) to identify SSIs, as defined by individuals who were prescribed antibiotics. They reported significantly less SSI in women treated with PICO compared to standard dressings (4.6% vs 9.2%) (relative risk [RR] 0.50, 95% CI, 0.30–0.84; number needed to treat [NNT] 22; P=0.007). Although Hyldig et al. showed better outcomes, the data collection methods for determining SSI contribute to self-reported bias and study design flaws—initially randomized, but observational following surgery—that may underestimate the treatment’s true effect.

O'Leary et al. (2017) published an RCT that allocated 50 individuals to either standard wound dressing or negative pressure wound dressing after abdominal surgery; individuals had class I, II, or IIl wounds, and the treatment group was given the PICO dressing. SSI was evaluated at 4 and 30 days following surgery, and results were analyzed both on a per-protocol and intention-to-treat basis. Caregivers did not find a significant difference between groups after 4 days (P=0.516); however, at the 30-day follow-up, rates of SSIs were significantly lower for the group receiving negative pressure dressing than for the control group, both in per-protocol analysis (8.3% vs 32.0%; P=0.043) and intention-to-treat analysis (12% vs 32%; P=0.073). Univariate analysis showed a significant association between standard wound dressing and the likelihood of an SSI (P=0.040); for secondary outcomes (e.g., cosmetic outcome, individual satisfaction), the authors reported no difference between groups. The mean length of stay was shorter for individuals who received negative pressure dressings (6.1 days) than for control individuals; however, when all reasons for delayed discharge were accounted for, the difference was not statistically significant (P=0.89). While comparatively small, this trial would indicate that negative pressure dressings resulted in a beneficial outcome for individuals recovering from abdominal surgery regarding the occurrence of SSIs.

Strugala and Martin (2017) published a meta-analysis of comparative trials evaluating the PICO system for the prevention of surgical site complications. A total of 1863 individuals were represented by 10 RCTs and seven observational studies. The rate of SSI was reduced by 51% with the PICO system compared to standard care (10 RCTs; relative risk [RR], 0.49; 95% CI, 0.34–0.69; P<0.0001). There was a significant reduction in wound dehiscence (17.4% vs 12.8%; RR, 0.71; 95% CI, 0.54–0.92; P<0.01) and mean hospital length of stay (−0.47 days; 95% CI, −0.71 to −0.23; P<0.0001) with the PICO system. It is unclear whether included studies captured outpatient utilization of the device.

Karlakki et al. (2016) reported on an RCT with 220 individuals that evaluated the use of the PICO device in a surgical center immediately after hip and knee arthroplasties. The device was left on for 7 days, including the time after the hospital stay. Strengths of the trial included power and intention-to-treat analysis, but evaluators were not blinded. There were trends toward reductions in hospital length of stay (0.9 days; 95% CI, −0.2–2.5 days; P=0.07) and postoperative surgical wound complications (8.4% control vs 2.0% PICO, P=0.06). However, most of the difference in length of stay was due to wound complications in two outliers in the control group (up to 61 days). The level of wound exudate was significantly reduced by the PICO device (P=0.007), with 4% of the study group and 16% of the control group having grade 4 (scale grade, 0-4) exudate. Blisters were observed in 11% of individuals treated with the PICO system, although the blister occurrence was reported to be reduced when the dressing was stretched less.

In summary, the evidence for PICO Single Use NPWT System from comparative trials has demonstrated some statistically significant clinical benefit in prophylactic use of PICO for preventing surgical site infections for various surgical wounds. However, the majority of studies do not report on wound healing, a primary result of traditional NPWTs trials. Further, aside from surgical wounds, the studies do not address treatment of varying wound indications (e.g., diabetic foot ulcers, pressure ulcers). The limitations and potential safety concerns warrant further review and preclude from drawing definitive conclusions on the device's efficacy. Additional large, comparative studies evaluating wound healing in an outpatient setting for various indications other than surgical wound etiologies are needed.

SINGLE USE PREVENA™ INCISION MANAGEMENT SYSTEM
The Prevena™ Incision Management System (KCI, San Antonio, TX) is a single-use NPWT system intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of NPWT.

Cooper et al. (2023) expanded upon a meta-analysis performed by Singh and colleagues (2018) comparing Prevena™ System to traditional dressings for reducing SSI in closed incisions. The meta-analysis included additional comparative studies (n=84 total; 24 RCTs, 17 prospective, 43 retrospective) and outcomes. The authors found a statistically significant difference in the risk of developing SSI favoring Prevena™ (RR, 0.543, 95% CI, 0.448–0.657; P<0.001). Similar results were found in a subgroup analysis by study design. Readmission and reoperation rates, as well as length of stay (LOS) all favored Prevena™, although the LOS difference in means was less than a day (−0.901; 95% CI, −1.257 to −0.544; P<0.001). The strength of this analysis is limited by the inclusion of a large number of low-quality study designs, small study sample sizes, and heterogeneity in data reporting.

Murphy et al. (2019) published findings from the Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE) trial, a single-center, superiority designed, prospective randomized open-blinded endpoint controlled trial evaluating the use of the the Prevena™ System on closed incisions compared with standard gauze dressings in individuals undergoing colorectal resection via laparotomy (n=300). There was no significant difference in the incidence of SSI at 30 days postsurgery between the Prevena™ and control groups (32% vs 34%; P=0.68). No significant difference in length of hospital stay was reported.

Hussamy et al. (2019) reported on an open-label RCT evaluating the Prevena™ System for incisional NPWT following cesarean delivery in women with class III obesity (body mass index ≥40; n=222) compared with standard dressings (n=219). The overall composite wound morbidity rate was not significantly different between the Prevena™ and control cohorts (17% vs 19%; RR, 0.9; 95% CI, 0.5–1.4).

Gombert et al. (2018) published findings from the Closed Incision Negative Pressure Therapy Reduces SSI in Vascular Surgery (AIMS) trial, a prospective RCT evaluating Prevena™ in individuals undergoing vascular groin surgery for peripheral artery disease (n=204). The primary outcome was the rate of SSI with the Prevena™ System (n=98) compared with individuals receiving standard wound dressings (n=90). Ten individuals were excluded as screening failures and six individuals were excluded due to early occlusion of treated vessels requiring de novo surgery. The Prevena™ System was removed at 5 to 7 days postoperatively. Individuals were evaluated on the day of discharge (day 7), and again at 15 and 30 days postsurgery by blinded wound care nurses. Wounds were evaluated clinically according to Szilagyi classification criteria (grades I–III). Prophylactic antibiotics were administered to 13.2% of the Prevena™ group and 31.1% of the control group (P=0.004). The control group experienced more frequent SSI (33.3%; 30/90) than the Prevena™ group (13.2%; 13/98; P=0.0015). However, the absolute risk difference of −20.1 per 100 (95% CI, −31.9–8.2) was based on an increased rate of Szilagyi grade I SSI (24.6% vs 8.1%; P=0.0012). Bacterial swabs were performed in each case of suspected SSI. Only 10 of 43 suspected infections returned positive swabs, five in each treatment arm, suggesting the study may have been biased by methodological flaws relating to subjective SSI assessment.

Grauhan et al. (2013) reported on a pseudorandomized trial (alternating assignment) with 150 consecutive obese individuals who underwent cardiac surgery via a median sternotomy. Use of the Prevena™ System for 6 to 7 days beginning immediately after suturing reduced rates of wound infection (4%) compared with standard wound care (4% vs 16%; P=0.027). Gram-positive skin flora was found in one individual in the Prevena™ group and in 10 individuals in the wound care group. This study was performed in an inpatient setting. A randomized trial, The Use of Prevena™ Incision Management System on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences (NCT02195310), involving a larger number of individuals with sternal midline incisions, was terminated in early 2017.

In summary, the evidence base for the Prevena™ Incision Management System is insufficient to determine the effects of the technology on health outcomes. Unlike the PICO device, Prevena is indicated for secondary or tertiary wound healing, however the evidence is limited due to reporting on narrow wound indications. Future well-designed, comparative studies investigating a variety of wound types with larger numbers of participants are needed.

ALTERNATE DISPOSABLE NPWT SYSTEMS

Although PICO and Prevena are the most studied single-use devices on the market, there are additional US Food and Drug Administration–approved devices including but not limited to V.A.C.VIA™ Therapy System, RENASYS™ GO NPWT System, Avelle NPWT System, and Avance Solo NPWT System. The evidence among them are limited to several case series, and more comparative studies are needed to determine clinical efficacy.

NONPOWERED NPWT SYSTEM
A nonpowered NPWT vacuum system delivers from −75 to −125 mm Hg of pressure to a wound, using continuous suction. This system uses an adhesive hydrocolloid dressing layer with integrated nozzle and tubing and antimicrobial gauze wound interface layer. The saline-moistened gauze dressing is applied directly to the wound, and the hydrocolloid dressing is placed on top of the gauze. Together, these form an air-tight seal around the wound. The tubing is cut to a desired length and attached to a coupling, which then attaches to the cartridge, which doubles as the negative-pressure pump and collection canister with a capacity of approximately 60 mL of wound exudate. After use, the system is discarded.

A nonpowered NPWT system (e.g., SNaP® Wound Care System, Spiracur, Sunnyvale, CA) is designed to accommodate wounds that are generally less than 13 cm × 13 cm and that produce only small amounts of exudate (i.e., <60 cc per 24 hours). The system is very portable, usually weighing less than half a pound, and is secured to the body by means of a strap. This system can be used for more than one wound, if the wounds are close together, are less than 13 cm in diameter, and produce less than 60 cc of exudate per 24 hours.

References

Agency for Healthcare Research and Quality (AHRQ). Negative pressure wound therapy technologies for chronic wound care in the home setting. Technology assessment report. [AHRQ Web site]. 09/15/2014. Available at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/id96ta.pdf. Accessed July 21, 2023.

Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity? Int Wound J. 2007;4(1):79-86.

Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005;366(9498):1704-1710.

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):173-180.

Armstrong DG, Marston WA, Reyzelman AM, et al. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Repair Regen. 2012;20(3):332-341.

Association for the Advancement of Wound Care (AAWC). Guideline of pressure ulcer guidelines. [AAWC Web site]. 2010. Available at: https://aawconline.memberclicks.net/resources. Accessed July 21, 2023.

Association for the Advancement of Wound Care (AAWC). International consolidated venous ulcer guideline (ICVUG) [AAWC Web site]. 2015. Available at:https://aawconline.memberclicks.net/resources. Accessed July 21, 2023.

Bloemen MC, van der Wal MB, Verhaegen PD, et al. Clinical effectiveness of dermal substitution in burns by topical negative pressure: a multicenter randomized controlled trial. Wound Repair Regen. 2012; 20(6):797-805.

Braakenburg A, Obdeijn MC, Feitz R, et al. The clinical efficacy and cost effectiveness of the vacuum-assisted closure technique in the management of acute and chronic wounds: a randomized control trial. Plast Reconstr Surg. 2006;118(2):390-397.

Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network (MLN) Matters. SE17027: Clarification of billing and payment policies for negative pressure wound therapy (NPWT) using a disposable device. [CMS Web site]. Original: 01/01/2017. (Revised 06/11/2019). Available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE17027.pdf. Accessed July 21, 2023.

Centers for Medicare & Medicaid Services (CMS). Federal Register. Medicare Program; End-stage renal disease prospective payment system, payment for renal dialysis services furnished to individuals with acute kidney injury, end-stage renal disease quality incentive program, durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) fee schedule amounts, DMEPOS competitive bidding program (CBP) amendments, standard elements for a DMEPOS order, and master list of DMEPOS items potentially subject to a face-to-face encounter and written order prior to delivery and/or prior authorization requirements for calendar year (CY) 2020; Final Rule. [Federal Register Web site]. 01/01/2020. Available at: https://www.federalregister.gov/documents/2019/11/08/2019-24063/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis. Accessed July 21, 2023.

Cooper HJ, Singh DP, Gabriel A, et al. Closed incision negative pressure wound therapy versus standard of care in reduction of surgical site complications: A systematic review and meta-analysis. Plast Reconstr Surg Glob Open. 2023;11(3):e4722.

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.

Dumville JC, Munson C. Negative pressure wound therapy for partial-thickness burns. Cochrane Database Syst Rev. 2012;12:CD006215.

Dumville JC, Land L, Evans D, Peinemann F. Negative pressure wound therapy for treating leg ulcers. Cochrane Database Syst Rev. 2015;7:CD011354.

Fong KD, Hu D, Eichstadt SL, et al. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds. 2010;22(9):230-236.

Fong KD, Hu D, Eichstadt S, et al. The SNaP system: biomechanical and animal model testing of a novel ultraportable negative-pressure wound therapy system. Plast Reconstr Surg. 2010;125(5):1362-1371.

Gombert A, Babilon M, Barbati ME, et al. Closed incision negative pressure therapy reduces surgical site infections in vascular surgery: a prospective randomized trial (AIMS Trial). Eur J Vasc Endovasc Surg. 2018;56(3):442-448.

Grauhan O, Navasardyan A, Hofmann M, et al. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013;145(5):1387-1392.

Hussamy DJ, Wortman AC, McIntire DD, et al. Closed incision negative pressure therapy in morbidly obese women undergoing cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2019;134(4):781-789.

Hutton D, Sheehan P. Comparative effectiveness of the SNaP^TM wound care system. International Wound Journal. 2011;8(2):196-205.

Hyldig N, Vinter CA, Mogensen O, et al. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. BJOG. 2019;126:628-635.

Iheozor-Ejiofor Z, Newton K, Dumville JC, et al. Negative pressure wound therapy for open traumatic wounds. Cochrane Database Syst Rev. 2018;7:CD012522.

Karlakki SL, Hamad AK, Whittall C, et al. Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: a randomized controlled trial. Bone Joint Res. 2016;5(8):328-337.

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):831-832.

Lerman B, Oldenbrook L, Eichstadt SL, et al. Evaluation of chronic wound treatment with the SNaP wound care system vs. modern dressing protocols. Plast Reconstr Surg. 2010;126:1153-1161.

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):825-830.

Li HZ, Xu XH, Wang DW, et al. Negative pressure wound therapy for surgical site infections: a systematic review and meta-analysis of randomized controlled trials. Clin Microbiol Infect. 2019;25(11):1328-1238.

Liu Z, Dumville JC, Hinchliffe RJ, et al. Negative pressure wound therapy for treating foot wounds in the people with diabetes mellitus. Cochrane Database Syst Rev. 2018;10:CD010318.

Marston WA, Armstrong DG, Reyzelman AM, et al. A multicenter randomized controlled trial comparing treatment of venous leg ulcers using mechanically versus electrically powered negative pressure wound therapy. Adv Wound Care (New Rochelle). 2015;4(2):75-82.

Murphy PB, Knowles S, Chadi SA, et al. Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): A randomized controlled trial. Ann Surg. 2019;270(1):38-42.

National Institute for Health and Care Excellence (NICE). Cesarean birth [NG192]. 2021. https://www.nice.org.uk/guidance/ng192. Accessed July 21, 2023.

National Institute for Health and Care Excellence (NICE). Diabetic Foot Problems: Prevention and Management [NG19]. 2019. https://www.nice.org.uk/guidance/ng19. Accessed July 21, 2023.

National Institute for Health and Care Excellence (NICE). Negative pressure wound therapy for the open abdomen [IPG467]. [NICE Web site]. 2013. Available at: https://www.nice.org.uk/guidance/ipg467. Accessed July 21, 2023.

National Institute for Health and Care Excellence (NICE). Pressure ulcers: prevention and management [CG179]. [NICE Web Site]. 2014. Available at: https://www.nice.org.uk/guidance/cg179. Accessed July 21, 2023.

Noridian. Local Coverage Determination (LCD). Negative pressure wound therapy pumps (L33821): [Noridian Web site]. Original: 10/01/2015. (Revised: 05/01/2021). Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33821. Accessed July 21, 2023.

Noridian. Local Coverage Article (LCA). Negative pressure wound therapy pumps (A52511): [Noridian Web site]. Original: 10/01/2015. (Revised: 08/15/2021). Available at: Article - Negative Pressure Wound Therapy Pumps - Policy Article (A52511) (cms.gov). Accessed July 21, 2023.

Norman G, Goh EL, Dumville JC, et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2020;6:CD009261.

O'Leary DP, Peirce C, Anglim B, et al. Prophylactic negative pressure dressing use in closed laparotomy wounds following abdominal operations: a randomized, controlled, open-label trial: The P.I.C.O. Trial. Ann Surg. 2017;265(6):1082-1086.

Rhee SM, Valle MF, Wilson LM, et al. Negative pressure wound therapy technologies for chronic wound care in the home setting: a systemic review. Wound Rep Reg. 2015;23:506-517.

Samson D, Lefevre F, Aronson N. Wound-healing technologies: low-level laser and vacuum-assisted closure. Evid Rep Tech Assess (Summ). 2004;(111):1-6.

Saunders C, Nherera LM, Horner A, Trueman P. Single-use negative pressure wound therapy versus conventional dressings for closed surgical incisions: systematic literature review and meta-analysis. BJS Open. 2021;00:1-8.

Schwartz JA, Goss SG, Facchin F, et al. Single-use negative pressure wound therapy for the treatment of chronic lower leg wounds. J Wound Care. 2015;24(Suppl 2):S4-S9.

Seidel D, Diedrich S, Herrle F, et al. Negative pressure wound therapy vs conventional wound treatment in subcutaneous abdominal wound healing impairment. JAMA Surg. 2020;155(6):469-478.

Singh DP, Gabriel A, Parvizi J, et al. Meta-analysis of comparative trials evaluating a single-use closed-incision negative-pressure therapy system. Plast Reconstr Surg. 2019;143:41S-46S.

Strugala V, Martin R. Meta-analysis of comparative trials evaluating a prophylactic single-use negative pressure wound therapy system for the prevention of surgical site complications. Surg Infect (Larchmt). 2017;18(7):810-819.

Tuuli MG, Liu J, Tita ATN, et al. Effect of prophylactic negative pressure wound therapy vs standard wound dressing on surgical-site infection in obese women after cesarean delivery: A randomized clinical trial. JAMA. 2020;324(12):1180-1189.

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

97605, 97606, 97607, 97608

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT NPWT SYSTEM AND SUPPLIES

A6550 Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories

A7000 Canister, disposable, used with suction pump, each

E2402 Negative pressure wound therapy electrical pump, stationary or portable

THE FOLLOWING CODES ARE USED TO REPRESENT NONPOWERED DISPOSABLE NPWT SYSTEM AND SUPPLIES

NONPOWERED DISPOSABLE SYSTEM OR HYDROCOLLOID DRESSING WITH INTEGRATED NOZZLE AND TUBING

A4649 Surgical supply; miscellaneous

CARTRIDGE

A9999 Miscellaneous DME supply or accessory, not otherwise specified

STRAP

A9999 Miscellaneous DME supply or accessory, not otherwise specified

EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT POWERED DISPOSABLE NPWT DEVICES

A9272 Wound suction, disposable, includes dressing, all accessories and components, any type, each

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 05.00.38m:

01/22/2024

This version of the policy will become effective 01/22/2024.

This policy was updated to revise the experimental and investigational criteria to include additional powered non-durable medical equipment (non-DME).

Billing guidelines were incorporated to convey coverage of disposable NPWT systems when billed from Home Health Agencies (HHA) using CPT codes 97607 and 97608.

The following HCPCS codes have been deleted from this policy:

K0743 Suction pump, home model, portable, for use on wounds

K0744 Absorptive wound dressing for use with suction pump, home model, portable, pad size 16 sq in or less

K0745 Absorptive wound dresing for use with suction pump, home model, portable, pad size more than 16 sq in but less than or equal to 48 sq in

K0746 Absorptive wound dresing for use with suction pump, home model, portable, pad size greater than 48 sq in

Revisions From 05.00.38l:

10/10/2022

This version of the policy will become effective 10/10/2022.

Face-to-Face Requirements have been deleted from this policy for the following HCPCS code:

E2402 Negative pressure wound therapy electrical pump, stationary or portable

Revisions From 05.00.38k:

05/19/2021

The policy has been reviewed and reissued to communicate the Company’s continuing position on Negative-Pressure Wound Therapy (NPWT) Systems .

08/17/2020

This version of the policy will become effective 08/17/2020.

In accordance with the Final Rule 1713 (84 Fed. Reg Vol 217), a face-to-face encounter is required for specified the HCPCS code:

E2402 Negative pressure wound therapy electrical pump, stationary or portable

This policy was updated to communicate Company's continued position of experimental/investigational for a single-use negative pressure wound therapy system.

The following HCPCS code has been removed from this policy (pleural effusion is out of scope):

A7048 Vacuum drainage collection unit and tubing kit, including all supplies needed for collection unit change, for use with implanted catheter, each

The following CPT codes have been added to this policy (medically necessary):

97605. 97606

Revisions From 05.00.38j:

05/22/2019	This policy has been reviewed and reissued to communicate the Company's continuing coverage on Negative Pressure Wound Therapy (NPWT) Systems.
06/20/2018	Effective 6/20/18, this policy has been reviewed and reissued to communicate the Company’s continuing position on Negative-Pressure Wound Therapy (NPWT) Systems.
12/13/2017	This version of the policy will become effective 12/13/2017. This policy was updated to communicate the company's continuing position on Negative-Pressure Wound Therapy (NPWT) Systems.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

1/22/2024

Version Issued Date:

1/22/2024

Version Reissued Date: