Executive Summary

The Center for Medicare Management at the Centers for Medicare and Medicaid Services (CMS) requested this report from The Technology Assessment Program (TAP) at the Agency for Healthcare Research and Quality (AHRQ). AHRQ assigned this report to the following Evidence-based Practice Center: ECRI Institute EPC (Contract Number: 290-2007-10063).

Section 154 (c) (3) of the Medicare Improvements for Patient and Providers Act (MIPPA) of 2008 calls for the Secretary of Health and Human Services to perform an evaluation of the Healthcare Common Procedure Coding System (HCPCS) coding decisions for Negative Pressure Wound Therapy (NPWT) devices. Specifically, the evaluation of existing HCPCS codes for NPWT should:

• ensure accurate reporting and billing for items and services under such codes; and
• use an existing process for the consideration of coding changes and consider all relevant studies and information furnished pursuant to such processes.

The HCPCS Level II coding system is a comprehensive, standardized system that classifies similar products that are medical in nature into categories for the purpose of efficient claims processing. Products are classified based on similarities in function and whether the products exhibit significant therapeutic distinctions from other products. Currently, all NPWT devices are classified into the same HCPCS codes. The Healthcare Common Procedures Coding System (HCPCS) code E2402 applies to the pump (NEGATIVE PRESSURE WOUND THERAPY ELECTRICAL PUMP, STATIONARY OR PORTABLE) and HCPCS code A6550 applies to the dressing sets (WOUND CARE SET, FOR NEGATIVE PRESSURE WOUND THERAPY ELECTRICAL PUMP, INCLUDES ALL SUPPLIES AND ACCESSORIES). HCPCS code A7000 applies to the canister that goes with the pump.

Negative pressure wound therapy (NPWT) applies a localized vacuum to draw the edges of the wound together while providing a moist environment conducive to rapid wound healing. The development of negative pressure techniques for wound healing is based on two theories: (1) the removal of excess interstitial fluid decreases edema and concentrations of inhibitory factors, and increases local blood flow; and (2) stretching and deformation of the tissue by the negative pressure is believed to disturb the extracellular matrix and introduce biochemical responses that promote wound healing.

NPWT systems include a vacuum pump, drainage tubing, and a dressing set. The pump may be stationary or portable, may rely on AC or battery power, allows for regulation of the suction strength, has alarms to indicate loss of suction, and has a replaceable collection canister. The dressing sets may contain either foam or gauze dressing to be placed in the wound and an adhesive film drape for sealing the wound. The drainage tubes come in a variety of configurations depending on the dressings used or wound being treated. NPWT Systems currently available in the U.S. are listed in Table 1.

Table 1. Negative Pressure Wound Therapy Devices Marketed in the U.S.

Manufacturer	Trade or Brand Names of Negative Pressure Wound Therapy Devices
Blue Sky Medical Group 6965 El Camino Real, Suite 105-602 La Costa, CA 92009 (Blue Sky Medical Group is now owned by Smith & Nephew, Inc.)	V1STA Negative Wound Therapy (portable unit) EZCARE Negative Wound Therapy (stationary unit)
Boehringer Wound Systems, LLC P.O. Box 910 Norristown, PA 19404	Engenex® Advanced NPWT System (Boehringer Laboratory Suction Pump System) ConvaTec (Skillman, NJ) markets and distributes the Engenex® NPWT system
Innovative Therapies Inc. 10948 Beaver Dam Rd, Suite C Hunt Valley, MD 21030	SVEDMAN™ and SVED™ Wound Treatment Systems
Kalypto Medical 6393 Oakgreen Ave. Hastings, MN 55033 (Iasis Medical, Inc.)	NPD 1000 Negative Pressure Wound Therapy System (no manufacturer information currently available from a Web site)
KCI, USA Inc. (Kinetic Concepts, Inc.) 8023 Vantage Dr. San Antonio, TX 78230	InfoV.A.C.® Therapy Unit (stationary unit) ActiV.A.C.® Therapy Unit (portable unit) V.A.C.® Freedom™ V.A.C.® ATS™ V.A.C.® Instill System (delivery of topical solutions)
Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland; Medela Healthcare Medela Inc. 1101 Corporate Drive McHenry, IL 60050	Invia Liberty Wound Therapy (portable) Invia Vario 18 c/i Wound Therapy (stationary, mobile with battery)
MediTop BV Vlasakker 22 3417 XT Montfoort The Netherlands; The Medical Company P.O. Box 2116 3800 CC Amersfoort The Netherlands	Exusdex® wound drainage pump
Premco Medical Systems, Inc. 699 Main Street New Rochelle, NY 10801 USA	Prodigy™ NPWT System (PMS-800 and PMS-800V)
Prospera 2831 Bledsoe Street Fort Worth, TX 76107 (Prospera Technologies LLC owns the Prospera NPWT systems and brand)	PRO-I™ (stationary and portable) PRO-II™ (portable) PRO-III™(stationary and portable)
Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716	V1STA Negative Pressure Wound Therapy (portable unit) EZCARE Negative Pressure Wound Therapy (stationary unit) RENASYS™ EZ Negative Pressure Wound Therapy
Talley Group, Ltd. Premier Way Abbey Park Romsey, Hants SO 51 9 DQ England; U.S. Talley Medical 4740 Ladestone Dr. Williamston, MI 48895	Venturi™ Negative Pressure Wound Therapy (portable or stationary)

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Methods of the Review

The Centers for Medicare and Medicaid Services (CMS) have partnered with the Agency for Healthcare Research and Quality (AHRQ) to commission a review of NPWT devices as required by the MIPPA legislation. AHRQ contracted with one of its Evidence-based Practice Centers (EPCs), the ECRI Institute EPC, to perform the review. The purpose of this review is to provide information to CMS to consider along with other inputs in evaluating HCPCS coding for NPWT devices. CMS will use this review in its assessment of whether existing HCPCS codes adequately reflect the range of NPWT devices on the market today.

The process of systematic review as practiced by the EPC Program follows specific prescribed steps:

1. The investigators start with formulated "key" questions. These questions test hypotheses and are structured using the "PICO" framework: patients, intervention of interest, comparator, and outcomes. EPC are encouraged to focus on outcomes that are relevant and important to patients (patient-oriented outcomes). The framework is depicted visually in the "analytic framework" that the EPC program uses to show the relationship between the key questions and the outcomes used to address these questions. (See, for example, Figure 1.)
2. Inclusion and exclusion criteria for studies to be used in the review are determined based on the specific questions to be addressed. Criteria may vary for each question in the review.
3. Next, an objective and comprehensive search of the medical literature and "gray literature," (i.e., reports, monographs and studies produced by government agencies, educational facilities and corporations that do not appear in the peer-reviewed literature) is conducted. The reference lists of included studies are examined for any studies not identified by electronic searches.
4. Studies are compared to the inclusion criteria developed prior to examining the evidence, and those included in the review are then critically appraised, noting features of the design and conduct of the studies that create potential for bias. Bias, in this context, is a study feature that could impact whether the treatment being studied is responsible for the outcomes observed. Studies with a low potential for bias are typically described as being of "high quality," whereas those with high potential for bias are described as being of "low" or "poor" quality, and those of moderate quality as having intermediate potential for bias. The degree to which a study protects against bias is referred to as "internal validity." Following this appraisal, data are extracted from the included studies and analyzed or summarized as appropriate.

After receiving the work assignment for this review in December, 2008, we developed the following Key Questions:

1. Does any single NPWT system have a significant therapeutic distinction in terms of wound healing outcomes compared to any other NPWT system for the treatment of acute or chronic wounds?
2. Does any component of a NPWT system have a significant therapeutic distinction in terms of wound healing outcomes compared to any other similar component of a NPWT system for the treatment of acute or chronic wounds?
3. What are the reported occurrences of pain, bleeding, infection, other complications, and mortality for NPWT systems?
4. Do patients being treated with one NPWT system have a significant therapeutic distinction in terms of less pain, bleeding, infection, other complications, or mortality than other NPWT systems?

For the purpose of addressing these Key Questions, we considered any NPWT system or component commercially marketed within the past 20 years. In-house developed, noncommercial devices (what might be considered "home-made" negative pressure devices) were excluded. In addressing the questions, we sought the specific outcomes depicted in the analytic framework in Figure 1. According to guidance provided by the U.S. Food and Drug Administration (FDA), we considered improved wound healing and improved wound care to be the most important clinical outcomes associated with the use of a wound-treatment device. The most important outcomes to consider under the category of improved wound healing are percent of patients with complete wound closure and time to complete healing (partial healing for facilitation of surgical wound closure). Improvements in wound care can potentially reduce the occurrence of conditions such as infection that can interfere with proper wound healing. Thus, measuring the impact of NPWT on the occurrence or healing of infections, as well as its impact on the incidence of sepsis, edema, or amputation is important. In addition to these outcomes, we consider other outcomes important to patients, such as quality of life, satisfaction with treatment, duration of treatment, and survival, in keeping with the methods guidance for the EPC Program.

Figure 1. Analytic Framework

[D] Select for Text Description

Note:

• In keeping with guidance provided by the FDA, in this report we considered improved wound healing and improved wound care to be the most important clinical outcomes. The most important outcomes to consider under the category of improved wound healing are percent of patients with complete wound closure and time to complete healing (particularly when NPWT is used to prepare a wound for surgical closure). Please note: process indicators such as improved compliance, convenience and personal preference (and patient oriented outcomes such as quality of life or satisfaction with treatment) are considered by CMS to be significant distinctions only to the extent that they result in demonstrably improved clinical outcomes.
• Improved wound condition as presented in the Analytic Framework is defined as a reduction in wound exudate and infectious materials; the promotion of granulation tissue formation and perfusion; an improvement in graft appearance; a reduction in odor; and a greater rate of epithelialization.

Inclusion and exclusion criteria were then developed to specify the types of studies appropriate for addressing each of these Key Questions. These criteria are explained in detail in the Methods section of this report, but are briefly described here. To address the key questions that consider whether one NPWT system or its components has a significant therapeutic distinction compared to another NPWT system or its components, we included any controlled study that used a NPWT system for the treatment of chronic or acute wounds. (Components of a NPWT system include the pump, the tubing, the dressing kits, and the services provided as part of the NPWT system.) Questions 1, 2 and 4 require comparative studies of different NPWT systems or components. For Key Question 2, studies were required that compared different dressing sets, tubing, or pumps while maintaining identical components for the other parts of an NPWT system. In other words, both groups in the study would need to be receiving NPWT.

In keeping with the methods of the EPC Program, we planned to perform "adjusted indirect comparisons" if no studies directly comparing NPWT systems or components were available.(1,2) Appropriate indirect comparisons can only be performed when randomized controlled trials (RCTs) have compared the interventions of interest to a third, common comparator. In adjusted indirect comparisons, the comparison of the intervention of interest (i.e., different NPWT systems) is adjusted by the results of their direct comparison with a common control group (e.g., standard wound therapy).(3) The validity of an adjusted indirect comparison depends on the internal validity and similarity of the included trials. Thus, to be considered for inclusion in an indirect comparison, studies would be similar in terms of quality, similar for factors related to applicability (population, interventions, and settings), and similar in measurement of outcomes including the incidence of adverse events.(3-6) The use of nonrandomized studies for indirect comparisons is not considered scientifically valid because of the many confounding variables that cannot be accounted for in such comparisons.(7) Even when RCTs are available for indirect comparisons, the conclusions must be framed cautiously because of the difficulty in assuring that the trial features are truly similar enough.

To address Key Question 3 regarding reported occurrences of adverse events for NPWT, we included case series and uncontrolled trials.

Searches were undertaken of 13 electronic bibliographic databases from 1950 to the present for published primary clinical studies and any secondary publications. To supplement the electronic searches, we manually reviewed the reference lists of studies meeting inclusion criteria. In addition, we searched for ongoing clinical trials using ClinicalTrials.gov and Controlledtrials.com. In the interest of being certain that our searches identified all relevant studies, we invited manufacturers, professional organizations, the FDA and the Centers for Medicare & Medicaid Services (CMS) to submit the following:

• A current product label (requested of industry stakeholders only)
• Published randomized controlled trials, observational studies, or other compelling clinical evidence examining the use of NPWT devices to impact relevant clinical outcomes
• Unpublished randomized controlled trials, observational studies, or other compelling clinical evidence examining the use of NPWT devices to impact relevant clinical outcomes.

The materials received were then assessed against the a priori inclusion criteria for each Key Question. Over 1,400 individual items were submitted by interested stakeholders for possible inclusion in the report. All items were reviewed for their relevance to the key questions. None of the submissions were studies directly comparing different NPWT devices or systems. We identified one additional systematic review (8), three comparison studies evaluating NPWT vs. a comparator treatment (9-11), and 23 uncontrolled case series (12-34) that met the inclusion criteria for consideration but which had not been identified by our electronic searches. In addition, we included one unpublished case series submitted by Smith and Nephew (35) giving us a total of 24 additional case series included in this report. Figure 2 is an attrition diagram that provides a visualization of the disposition of materials as they were evaluated for possible inclusion in the report.

Figure 2 .  Disposition of Documents Identified by Internal Searches and Outside Submissions

[D] Select for Text Description

Note: Language has been corrected to reflect screening of meeting abstracts, poster presentations and other documents in addition to abstracts and full articles.

The most common reasons for exclusion of submitted materials were

• personal statements of support for specific NPWT systems that did not include data relevant to this review
• animal studies
• studies not relevant to negative pressure wound therapy
• narrative reviews
• poster presentations
• case studies (fewer than five patients)
• publications that duplicated an already included study

A listing of individual stakeholders with included and excluded submissions including reasons for exclusion are provided in Appendix D.

Next, an assessment of the potential for bias of the included studies was performed using a quality assessment instrument developed by ECRI Institute for comparative studies and the Assessment of Multiple Systematic Reviews (AMSTAR) measurement tool (36) for systematic reviews of the literature.

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Evidence for Negative Pressure Wound Therapy

Key Question 1: Does any single NPWT system have a significant therapeutic distinction in terms of wound healing outcomes compared to any other NPWT system for the treatment of acute or chronic wounds?

No studies directly comparing one NPWT system to another NPWT system that addressed this Key Question were identified by our searches or in the materials submitted by interested parties. We did identify one recently completed trial listed on ClinicalTrials.gov which appears to compare two different systems, but the investigators did not wish to share any information about the trial prior to publication.

Based on our pre-determined methodology, evidence for indirect comparisons was to be obtained from RCTs of commercially available NPWT systems versus a common comparator. Of 40 studies comparing a NPWT system to another wound care therapy, all were studies of the Kinetics Concepts Inc. (KCI) VAC® system, and only nine were RCTs. Therefore no indirect comparisons with other NPWT systems were possible. Despite the fact that we could not use the studies to answer the Key Question, we assessed the studies for risk of bias and extracted data on treatment procedures, patient characteristics, and study outcomes. We have provided tables with this information in Appendix C for the interested reader, and briefly discuss these studies here.

Our quality assessment of the 40 comparison studies indicated that the majority had significant potential for bias. None of the studies received a high-quality rating; seven (18%) were rated moderate, and 33 (82%) were rated low. Typical study limitations included lack of concealment of treatment allocation, lack of blinding of patients and assessors, failure to report patient characteristics, and small study populations. As explained below, these studies comparing NPWT systems to standard wound care did not meet the study design and conduct requirements needed for use in an indirect comparison analysis.

Blinding patients, treating physicians, and outcome assessors to treatment increases the internal validity of studies. In a situation where patients are being treated by NPWT systems, blinding the patient and the physician providing care is probably not feasible. To prevail over these limitations, van den Boogaard et al.(37) recommend overcoming all other potential shortcomings, i.e., wound assessors should be blinded to treatment, patient groups must be comparable, group allocation should be concealed, and full follow-up of a sufficient proportion of all included patients should be performed.

A majority of the studies did not overcome these deficiencies. None of the studies reported that the physicians were blinded to treatment assignment, and only five (12%) of the studies reported blinding of outcome assessors. In only 7% of studies was there concealment of allocation to treatment, one of the most crucial elements of any RCT, with failure to do so typically resulting in selection bias.(38-39)

Only 14 (35%) studies had similar populations, and 30% of the studies did not have similar follow-up times. Over 75% of the studies either reported a potential conflict of interest in terms of funding (k = 9) or made no report of their funding source (k = 22). Lastly, over 50% of the studies had a study size of fewer than 50 patients; 85% of the studies included fewer than 75 patients.

Key Question 2: Does any component of a NPWT system have a significant therapeutic distinction in terms of wound healing outcomes compared to any other similar component of a NPWT system for the treatment of acute or chronic wounds?

No studies directly comparing one NPWT component to another NPWT component (with both groups receiving negative pressure treatment) that addressed this Key Question were identified by our searches or in the materials submitted by interested parties.

Key Question 3: What are the reported occurrences of pain, bleeding, infection, other complications, and mortality for NPWT systems?

Adverse events were reported in 37 of 40 studies comparing NPWT to other treatments. Of the 37 studies reporting events, seven (19%) studies described NPWT as a safe treatment. Fewer complications were reported in the NPWT-treated patients than in those receiving other wound therapies in 19 (51%) studies (9-11, 40-55)) and similar complications were reported in 8 (22%) studies.(56-63) Adverse events reported in 103 case series included pain (k = 12), bleeding (k = 7), infection/bacterial colonization (k = 15), mortality (k = 4), and other complications (k = 18).

Key Question 4: Do patients being treated with one NPWT system have a significant therapeutic distinction in terms of less pain, bleeding, infection, other complications, or mortality than other NPWT systems?

No studies comparing one NPWT system to another NPWT system were identified by our searches, and none were submitted by interested parties. Consequently, we were not able to answer this Key Question. Adverse events described in the studies comparing NPWT to some other form of wound care and in case series are described under Key Question 3.

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Conclusion

Based on our defined search strategies and submissions from interested parties, no studies directly comparing one NPWT system to another NPWT system were identified that addressed Key Questions 1, 2 or 4. Thus, we were not able to identify a significant therapeutic distinction of one NPWT system or component over another through the use of head-to-head comparisons. A recently completed study listed on ClinicalTrials.gov (NCT00583141; NCT00590369) may address this question, but the investigators did not wish to disclose any details of the study design prior to publication. In the absence of head-to-head comparison studies, we examined comparison studies of NPWT systems or components versus a common comparator in hopes of assessing the relative efficacy and/or safety of different NPWT systems using adjusted indirect comparisons. Our review of 40 comparison studies found that all of the controlled trials involved the evaluation of one NPWT device, the V.A.C.® manufactured by KCI. Furthermore, to be considered for inclusion in an indirect comparison, studies must be RCTs and must provide sufficient information to determine their comparability in terms of patient characteristics, patient exclusion/inclusion criteria, methodology, outcome definitions, outcome measures, and application of the comparison treatment. Only nine of the KCI VAC® comparison studies were RCTs and none of these RCTs met the requirements necessary for the indirect comparison option had there been studies of more than one NPWT system. Consequently, at this time the available evidence cannot be used to determine a significant therapeutic distinction of a NPWT system.

Our searches did not identify any studies comparing one NPWT system component to another NPWT system component that addressed Key Question 2. This question was designed to examine studies that compared different dressing sets, tubing, or pumps while maintaining identical components for the other parts of an NPWT system. In particular, we were looking for studies that evaluated gauze versus foam dressing sets in various wound types.

While we were able to capture the severity of harms reported by case series and comparison studies evaluating NPWT to comparator treatments, due to the lack of studies comparing one NPWT system to another NPWT system, we were unable to determine the severity of adverse events for one NPWT system compared to another.

We identified a total of 22 other systematic reviews, all published between 2000 and 2008, that covered NPWT devices. These reviews included studies reporting data on NPWT for patients with a broad range of wound types and focused on comparison to other wound treatments (gauze, bolster dressings, wound gels, alginates, and other topical therapies). The systematic reviews of NPWT reveal several important points about the current state of the evidence on this technology. First, 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. Second, no studies directly comparing different NPWT components (such as foam vs. gauze dressings) were identified by any of the reviewers.

In their systematic review of clinical studies of NPWT, Peinemann et al.(64) sought to identify unpublished completed or discontinued RCTs to gain a broader knowledge of the NPWT evidence. The authors were concerned that previous systematic review conclusions on efficacy and safety based on published data alone may no longer hold after consideration of unpublished data. The authors invited two NPWT device manufacturers KCI. (V.A.C.®) and BlueSky Medical Group Inc. (Versatile 1 Wound Vacuum System) and authors of conference abstracts to provide information on study status and publication status of sponsored trials. Responses were received from 10 of 17 (59%) authors and both manufacturers. BlueSky Medical Group Inc., however, had not sponsored relevant RCTs and only provided case reports. The authors determined that of 28 RCTs, 13 had been completed, six had been discontinued, six were ongoing, and the status of three could not be determined. Nine trials were unpublished, and no results were provided by the investigators. Peinemann et al. concluded that the "lack of access to unpublished study results data raises doubts about the completeness of the evidence base on NPWT."(64)

Clinical research on NPWT capable of indicating if any one NPWT system or component 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.

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Abbreviations and Acronyms

Abbreviation / Acronyms	Full Term
ABI	Ankle brachial index
AF	Atrial fibrillation
AMWT	Advanced moist wound therapy
AS	Aortic stenosis
BMI	Body mass index
CA	Can’t answer
CABG	Coronary artery bypass surgery
CAD	Coronary artery disease
CAS	Carotid artery stenosis
CC	Cubic centimeter
CHF	Congestive heart failure
CD	Coronary disease
CDI	Closed drainage and irrigation
CDT	Closed drainage technique
CHD	Coronary heart disease
CHF	Congestive heart failure
CI	Confidence interval
CKD	Chronic kidney disease
CLD	Chronic lung disease
CM	Centimeter
CNP	Continuous negative pressure
COPD	Chronic obstructive pulmonary disorder
CRF	Chronic renal failure
D	Day(s)
DED	De-epidermalized dermis
DFU	Diabetic foot ulcer
DM	Diabetes mellitus
DSWI	Deep sternal wound infection
EQ-5D	EuroQol 5 Dimensions Index
ESRD	End stage renal disease
ESRF	End stage renal failure
F	Female
F/U	Follow-up
gm/dl	Grams per deciliter
HF	Heart failure
HP	Healthpoint System
ICG	Indocyanine Green
IDDM	Insulin dependent diabetes mellitus
IHD	Ischaemic heart disease
IQR	Interquartile range
ISS	Injury Severity Score
L	Length
LOS	Length of hospital stay
LVEF	Left ventricular ejection fraction
M	Male
mg/l	Milligram per liter
MI	Myocardial infarction
ml	Milliliter
mmHg	Millimeters of mercury
MRI	Magnetic resonance imaging
MW	Moist to wet
NA	Not applicable
NIDDM	Non insulin dependent diabetes mellitus
NPIT	Negative pressure instillation therapy
NPWT	Negative pressure wound therapy
NR	Not reported
NS	Not significant
OR	Operating room
PA	Peripheral arteriopathy
PAD	Peripheral arterial disease
PAOD	Peripheral artery occlusive disease
PM	Post-sternotomy mediastinitis
PPI	Present pain intensity
PU	Polyurethane
PVA	Polyvinyl alcohol
PVD	Peripheral vascular disease
QOL	Quality of life
RCT	Randomized controlled trial
RD	Renal disease
RF	Renal failure
ROCF	Reticulated open cell foam
RR	Risk ratio
SF-36	Short Form 36
SF-MPQ	Short Form-McGill Pain Questionnaire
SIGN	Scottish Intercollegiate Guideline Network
SOC	Standard of care
SOM	Post-sternotomy osteomyelitis
SR	Systematic review
SSD	Silver sulphadiazine crème
SSI	Surgical site infection
STSG	Split thickness skin graft
SWT	Standard wound therapy
TNP	Topical negative pressure
TPN	Total parenteral nutrition
um	Micrometer
VAC	Vacuum-assisted closure
VAS	Visual analogue scale
W	Width
WDS	Wounds
WM	Wet to moist
WMD	Weighted mean differences

 

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