Compliance with the provisions in this policy may be monitored and addressed
through post payment data analysis and subsequent medical review audits.  
  
**History/Background and/or General Information**  
  
This LCD does not address specific wound care procedures described by NCD's
and other items such as:

  * Hyperbaric Oxygen (HBO) Therapy (See NCD 20.29)
  * Initial physical therapy or occupational therapy evaluations (See LCD L35036)
  * Skin Substitutes for Wound Care (See LCD L35041)
  * Electrical Stimulation and Electromagnetic Therapy of Specified Wounds (See NCD 270.1)
  * Treatment of burns

For the purposes of this LCD, wound care is defined as care of wounds that are
refractory to healing or have complicated healing cycles either because of the
nature of the wound itself or because of complicating metabolic and/or
physiological factors. This definition excludes the following:

  * Management of acute wounds, or
  * The care of wounds that normally heal by primary intention such as clean, incised traumatic wounds, or
  * Surgical wounds that are closed primarily and other postoperative wound care not separately covered during the surgical global period.

Various methods to promote wound healing have been devised over time. A method
which is unproven by valid scientific literature would be considered not
reasonable and necessary. Wound care involves the evaluation and treatment of
a wound, including identifying potential causes of delayed wound healing and
the modification of treatment when indicated. Wound evaluations may require a
comprehensive medical evaluation, vascular evaluation, orthopedic evaluation,
functional evaluation, metabolic/nutritional evaluation, and a plan of care.
Reduction of pressure and/or control of infection have been shown to
facilitate healing and may reduce the need for repeated debridement services.

Medicare coverage for wound care on a continuing basis, for a given wound, in
a given patient, is contingent upon evidence documented in the patient's
medical record that the wound is improving in response to the wound care being
provided. Evidence of improvement may include measurable changes in the
following:

  * Drainage
  * Inflammation
  * Swelling
  * Pain and/or tenderness
  * Wound dimensions (surface measurements, depth)
  * Granulation tissue
  * Necrotic tissue/slough
  * Tunneling or undermining

Wound care must be performed in accordance with accepted standards for medical
and surgical treatment of wounds. The goal of most chronic wound care should
be eventual wound closure with or without grafts, skin replacements, or other
surgery (such as amputation, wound excision, etc.). Adjunctive measures
include but are not limited to appropriate control of complicating factors
such as pressure (e.g., off-loading, padding, and appropriate footwear),
infection, vascular insufficiency, metabolic derangement and/or nutritional
deficiency. While complete healing of the wound may be the primary objective;
a secondary desired objective is that, with appropriate management, a wound
may reach a state at which its care may be performed primarily by the patient
and/or the patient's caregiver with periodic physician assessment and
supervision.

In appropriate cases, due to severe underlying debility or other factors such
as operability, the goal of wound care provided in outpatient settings may be
only to prevent progression of the wound and prevention of prolonged
hospitalization.

Active wound care procedures involve selective and non-selective debridement
techniques and are performed to remove devitalized tissue and promote healing.
The provider is required to have direct (one-on-one) patient contact when
performing active wound care management.

The appropriate interval and frequency of debridement depends on the
individual clinical characteristics of the patient and the extent of the
wound.

It is highly recommended that the treatment plan for a patient who requires
frequent repeated debridement be reevaluated to ensure that issues including,
but not limited to, pressure reduction, nutritional status, vascular
insufficiency and infection control have been adequately addressed. Overall,
evaluation of the wound should be performed at a regular frequency to
determine whether the individualized treatment goals are being met for the
patient.  
  
 **Definition of terms for this policy:**  
  
Dressing Changes for Wound Debridement

  * Wet dressings: Water and medication may be applied to the skin with dressings (e.g., finely woven cotton or gauze) soaked in solution. Wet compresses, especially with frequent changes, may provide gentle debridement.
  * Dry dressings: Used to provide gentle debridement, protect the skin, hold medications against the skin, keep clothing and sheets from rubbing, or keep dirt and air away. Such dressings may also prevent patients from scratching or rubbing the wound.
  * Advanced dressings: Used with increasing frequency to provide gentle debridement in the treatment of acute wounds, chronic venous, diabetic and pressure ulcers.
  * Dressing changes (removal and subsequent reapplication) alone generally do not require the skills of physicians. They may be performed by physical therapists, occupational therapists, licensed professional nurses, or wound care nurses.

  
**Covered Indications**

  1. Medicare would expect that wound care may be necessary for the following types of wounds: 
    * Surgical wounds that must be left open to heal by secondary intention.
    * Infected open wounds induced by trauma or surgery.
    * Wounds with biofilm.
    * Wounds associated with complicating autoimmune, metabolic, and vascular or pressure factors.
    * Open or closed wounds complicated by necrotic tissue and/or eschar.
  2. Active Wound Care Management  
Debridement may be indicated whenever necrotic tissue as well as cellular or
proteinaceous debris is present on an open wound in order to keep the wound in
an active state of healing. Debridement may also be indicated in cases of
abnormal wound healing or repair. The routine application of a topical or
local anesthetic does not elevate active wound care management to surgical
debridement. Debridement may be categorized as selective or non-selective.

    * Wound Care Selective Debridement includes: 
      * Removal of specific, targeted areas of devitalized or necrotic tissue from a wound along the margin of viable tissue by sharp dissection utilizing scissors, scalpel, curettes, and/or tweezers/forceps. This procedure typically requires no anesthesia and generally has no or minimal associated bleeding.
    * Wound Care Non-Selective Debridement may include: 
      * Mechanical Debridement: This type of debridement is the removal of necrotic tissue by cleansing, or application of a wet-to-dry or dry-to-dry dressing technique. Wet-to-dry dressings should be used judiciously as maceration of surrounding tissue may hinder healing. Generally, dressing changes are not considered a skilled service.
      * Enzymatic Debridement: Debridement with topical enzymes is used when the necrotic substances to be removed from a wound are protein, fiber and collagen. The manufacturer's product insert contains indications, contraindications, precautions, dosage and administration guidelines; it is the clinician's responsibility to comply with those guidelines.
      * Autolytic Debridement: This type of debridement is indicated where manageable amounts of necrotic tissue are present, and there is no infection. Autolytic debridement occurs when the enzymes that are naturally found in wound fluids are sequestered under synthetic dressings.
      * Maggot / larvae therapy: Debridement with medical-grade maggots in wounds.
  3. Wound Care Surgical Debridements 
    * Conditions that may require surgical debridement of large amounts of skin may include but are not limited to: rapidly spreading necrotizing process (sometimes seen with aggressive streptococcal infections), severe eczema, extensive skin trauma (including large abraded areas with ground-in dirt), or autoimmune skin diseases.
    * Surgical debridement occurs only if material has been excised and is typically reported for the treatment of a wound to clear and maintain the site free of devitalized tissue including but not limited to necrosis, eschar, slough, infected tissue, biofilm, abnormal granulation tissue, etc., and should be accomplished to the margins of viable tissue.
    * These procedures can be very effective but represent extensive debridement.  They may be complex in nature and may on occasion require the use of anesthesia.
  4. Use of Evaluation and Management (E/M) Codes in Conjunction with Surgical Debridements 
    * Patients who have chronic wounds may frequently have underlying medical problems that require concomitant management in order to bring about wound closure. In addition, patients may require education, other services, and coordination of care both in the preoperative and postoperative phases of the debridement procedure. An E/M service provided and documented on the same day as a debridement service may be covered by Medicare only when the documentation clearly establishes the service as a "separately identifiable service" that was reasonable and necessary, as well as distinct, from the debridement service(s) provided.
  5. Negative Pressure Wound Therapy (NPWT) 
    * Negative pressure wound therapy (NPWT), utilizing either durable or disposable medical equipment, is a method of wound care to manage wound exudates and promote wound closure. The vacuum assisted drainage collection (i.e., NPWT) may be applied in an effort to cleanse the wound by removing fluids and stimulate the wound bed in order to reduce localized edema and improve local oxygen supply.
    * NPWT involves the application of controlled or intermittent negative pressure to a properly dressed wound cavity. Suction (negative pressure) is applied under airtight wound dressings to promote the healing of open wounds resistant to prior treatments.
    * NPWT for non-healing wounds is medically necessary when at least one of the following conditions is met: 
      * There are complications of a surgically created wound (e.g., dehiscence, post sternotomy disunion with exposed sternal bone, post sternotomy mediastinitis, or postoperative disunion of the abdominal wall).
      * There is a traumatic wound (e.g., preoperative flap or graft, exposed bones, tendons, or vessels) and a need for accelerated formation of granulation tissue not achievable by other topical wound treatments (e.g., the individual has comorbidities that will not allow for healing times usually achievable with other available topical wound treatments).
      * There is a chronic, non-healing ulcer with lack of improvement despite standard wound therapy, including the application of dressings, debridement of necrotic tissue (if present), maintenance of an adequate nutritional status, and weekly evaluations with documentation of wound measurements (i.e., length, width, and depth) in ONE of the following clinical situations: 
        * Acute wounds
        * Subacute and dehisced wounds
        * Traumatic wounds
        * Ulcers  (such as diabetic or pressure)
        * Chronic Stage III or Stage IV pressure ulcer
        * Chronic diabetic neuropathic ulcer
        * Chronic venous ulcer
        * Flaps and grafts
  6. Low-Frequency, Non-Contact, Non-Thermal Ultrasound (MIST Therapy) 
    * Low frequency, non-contact, non-thermal ultrasound describes a system that uses continuous low-frequency ultrasonic energy to produce and propel a mist of liquid and deliver continuous low-frequency ultrasound to the wound bed. This modality is often referred to as "MIST Therapy."
    * Low-Frequency, Non-Contact, Non-Thermal Ultrasound (MIST Therapy) is considered reasonable and necessary wound therapy and therefore eligible for coverage by Medicare when provided for any of the following clinical conditions: 
      * Wounds and ulcers which are too painful for sharp or excisional debridement and have failed conventional debridement with documentation supporting the same.
      * Wounds and ulcers meeting Medicare coverage for debridement but with documented contraindications to sharp or excisional debridement.
      * Wounds and ulcers meeting Medicare coverage for debridement but with documented evidence of no signs of improvement after 30 days of standard wound care.
    * Low-frequency, non-contact, non-thermal ultrasound (MIST Therapy) may be provided two to three times per week to be considered reasonable and necessary. The length of individual treatments will vary per wound size.
    * Observable, documented improvements in the wound(s) should be evident after six treatments. Improvements include documented reduction in pain, necrotic tissue, or wound size, or improved granulation tissue.
  7. Application of Paste Boot (Unna Boot) or Application of Multi-Layer Compression System may be useful adjuncts to wound care management.

**Limitations**

  1. Wound care should employ comprehensive wound management including appropriate control of complicating factors such as unrelieved pressure, infection, vascular and/or uncontrolled metabolic derangement, and/or nutritional deficiency in addition to appropriate debridement. Medicare coverage for professional wound care procedures requires that all applicable adjunctive measures are also employed as part of comprehensive wound management. Wound care in the absence of such measures, when they are indicated, is not considered to be medically reasonable and necessary.
  2. Debridement will be considered not reasonable and necessary for a wound that is clean and free of necrotic tissue/slough.
  3. Debridements are considered selective or non-selective unless the medical record supports that a surgical excisional debridement was performed.
  4. Debridements are best provided under an individualized plan of care.
  5. Wound care may be of a palliative nature. Optimally, the overall goal of care is healing, and it would be neither reasonable nor medically necessary to continue a given type of wound care if evidence of wound improvement leading to healing of the wound as outlined in this LCD cannot be shown. However, if it is determined that the goal of care is not wound healing, which would lead ultimately to wound closure, the patient should be managed following appropriate palliative care standards. Wounds of some Medicare beneficiaries residing in Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs) may not close, heal, or be amenable to self-care in spite of optimal therapy. In those patients where wound closure, healing, or self-care is not a likely outcome, the goals of wound care may include prevention of hospitalization and improvement in quality of life. As such, due to severe underlying debility or other factors, the goal of wound care provided in these settings may be only to prevent progression of the wound by stabilizing the wound by: 
    * Minimizing the risk of infection and further progression of the wound;
    * Managing the multiple issues that cause patient and family suffering; and
    * Optimizing the patient's function and quality of life.
  6. Complicating circumstances that support additional wound care services as reasonable and necessary must be supported by adequate medical record documentation.
  7. Autolytic debridement is contraindicated for infected wounds.
  8. Debridement of extensive eczematous or infected skin is not appropriate for debridement of a localized amount of tissue normally associated with a circumscribed lesion. Examples of this are ulcers, furuncles, and localized skin infections.
  9. Surgical debridement will be considered not reasonable and necessary when documentation indicates the wound is without devitalized, fibrotic, nonviable tissue, infection, necrosis, foreign matter, or if the wound has pink to red granulated tissue. When utilized, it is expected that the frequency of debridement will decrease over time.
  10. Wound debridement utilizing a method which is unproven by valid scientific literature would be considered investigational and not reasonable and necessary.
  11. If a treatment is investigational, under waiver of liability provisions of Medicare law, an Advance Beneficiary Notice must be obtained for the beneficiary.
  12. When performed in conjunction with another wound care service, the dressing change is considered an integral component of that service and is not a separately covered service.
  13. A wound that shows no improvement after 30 days may require a new approach, which may include a physician reassessment of underlying infection, off-loading, biofilm, metabolic, nutritional, or vascular problems which may inhibit wound healing.
  14. Procedures performed for cosmetic reasons or to prepare tissues for cosmetic procedures are statutorily excluded from coverage by Medicare.
  15. Local infiltration, metacarpal/metatarsal/digital block or topical anesthesia are included in the reimbursement for wound care services and are not separately covered.
  16. The following procedures are considered part of an E/M service and are not separately covered when an E/M service is performed: 
    * Removal of necrotic tissue by cleansing and dressing, including wet or dry-to-dry dressing changes,
    * Cleansing and dressing small or superficial lesions, and
    * Removal of coagulated serum from normal skin surrounding an ulcer.
  17. NPWT is contraindicated for any of the following wound types/conditions: 
    * Necrotic tissue with eschar present,
    * Untreated osteomyelitis,
    * Non-enteric and unexplored fistulas,
    * Malignancy in the wound,
    * Exposed vasculature,
    * Exposed nerves,
    * Exposed anastomotic site, or
    * Exposed organs.
  18. Continuing MIST treatments for wounds demonstrating no improvement after six treatments is considered not reasonable and necessary. 
    * Observable, documented improvements in the wound(s) should be evident after 2 weeks or 4-6 MIST treatments. Improvements may include documented reduction in pain, necrotic tissue, or wound size; or improved granulation tissue.
  19. The following services are considered to be not reasonable and necessary wound debridement services: 
    * Removal of necrotic tissue by cleansing or dry-to-dry or wet-to-dry dressing.
    * Washing bacterial or fungal debris from lesions.
    * Removal of secretions and coagulation serum from normal skin surrounding an ulcer.
    * Dressing of small or superficial lesions.
    * Paring or cutting of corns or non-plantar calluses.
    * Incision and drainage of abscess including paronychia, trimming or debridement of mycotic nails, avulsion of nail plates, acne surgery, or destruction of warts.
    * Removal of non-tissue integrated fibrin exudates, crusts, or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such.
  20. Wet-to-dry dressings, jet hydrotherapy, or wound irrigations should be used cautiously as maceration of surrounding tissue may hinder healing.
  21. Jet therapy and wound irrigation for wound debridement must be performed by skilled personnel in order to be considered reasonable and necessary.
  22. Medicare expects that with appropriate care: 
    * Wound volume or surface dimension should decrease, or
    * Wounds optimally will demonstrate granulation tissue.
  23. Debridements of the wound(s) if indicated must be performed judiciously and at appropriate intervals. It is expected that, with appropriate care, and no extenuating medical or surgical complications or setbacks, wound volume or surface dimension should decrease overtime. It is also expected the wound care treatment plan is modified in the event that appropriate healing is not achieved.

This LCD imposes frequency limitations. For frequency limitations, please
refer to the Utilization Guidelines section below.  
  
 **Notice:**  Services performed for any given diagnosis must meet all of the
indications and limitations stated in this policy, the general requirements
for medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services
performed outside of the reasonable and necessary requirements in this LCD.

An article was published in _Wound Repair and Regeneration_ on "Comparative
effectiveness of mechanically and electrically powered negative pressure wound
therapy devices: A multicenter randomized controlled trial" in January 2012 by
DG Armstrong, WA Marston, AM Reyzelman, and RS Kirsner. This was a 17-center
prospective, randomized controlled clinical trial designed to evaluate the
relative impact on wound closure using the "mechanically powered" Smart
Negative Pressure (SNaP) Wound Care System (Spiracur, Inc.) vs. the
"electrically powered" Vacuum-Assisted Closure (VAC) Therapy System (KCI, San
Antonio, TX). One hundred thirty-two (132) patients were enrolled with non-
infected, non-ischemic, non-plantar lower extremity diabetic and venous
wounds.  Eighty-three patients ( _n_ = 41 SNaP, _n_ = 42 VAC) completed the
study with either healing or 16 weeks of therapy. The study provides evidence
that treatment of wounds using a disposable NPWT device (SNaP System) compared
to a traditional NPWT device (VAC System) have similar results but have less
impact on the patient's quality of life. Potential conflict of interest is
that this study was sponsored by Spiracur Inc. and two of the authors received
research funding from both Spiracur (SNaP device) and K.C.I. (VAC device). The
quality of evidence is low; the strength of recommendation is weak.

"Comparison of high-frequency and MIST ultrasound therapy for the healing of
venous leg ulcers" by Beheshti A, Shafigh Y, Parsa H, and Zangivand AA was
published in the 2014 _Advances in Clinical and Experimental Medicine._ The
aim of the year-long randomized controlled study of 90 patients was to analyze
the effect of standard ulcer care alone (compression bandages) with high-
frequency ultrasound (HFU) and MIST ultrasound therapy (US) on venous leg
ulcers (VLUs). The patients were chosen from patients with VLUs who had
received wound care at the hospital outpatient vascular clinic of Shahid
Rajaii Hospital. Patients were instructed to contact the clinic monthly and
recurrence of VLUs was recorded for six months after complete wound healing.
Study results showed no significant differences in recurrence between groups
during a six-month follow-up after complete wound healing.  All VLUs in the
study healed within one year. Recurrence was observed in four cases in the
standard group (13.3%); two cases in the HFU group and two cases in the MIST
US group (6.6%). The authors stated their results were lower than similar
studies but state the 6-month follow-up is very short to truly decide about
the potential of prevention of recurrence in patients treated with US therapy.
Mean age was 58.5 years (SD 11.6 years).The authors concluded the study showed
significant effectiveness of ultrasound therapy; especially MIST therapy, in
wound healing as an adjuvant therapy. They noted differences between the two
ultrasound therapy groups were not statistically significant. Exclusion
criteria were listed. The design of this study presents limitations including
selection bias. The report states the patients were randomized but suggests
the study may not have been blinded. Other limitations to this study were a
small sample size and inconsistency across studies when comparisons were made.
The authors compare the results of their study to other studies of different
sample size, different ages, unknown co-morbidities and different wound types.
The authors remark that additional work on cost-effectiveness outcomes and
planning are greatly needed for the future studies. Note: This study was
conducted outside the U.S. and does not largely represent the Medicare
population. The quality of evidence is low; the strength of recommendation is
weak.

The 2007 _Journal of Palliative Medicine_ article by Ferris, Al Khateib, and
Fromantin, "Palliative wound care: managing chronic wounds across life's
continuum: a consensus statement from the International Palliative Wound Care
Initiative," is a consensus statement which recognizes that while most chronic
wounds will eventually heal if managed appropriately, some will not. In
patients with non-healable wounds, therapies that aim to heal the wound may
not be in anyone's best interest. The Initiative recognizes that the expertise
and skills in palliative wound care can improve the quality of life of all
individuals living with or affected by healing and non-healing chronic wounds
and  is guided by the philosophy that the opportunity exists to negotiate
personalized goals of care to optimize quality of life through an
interdisciplinary approach to care. Quality of evidence is low. Strength of
recommendation is weak.

The 2015 "Debridement for venous leg ulcers (Review)" by Gethin, Cowman, and
Kolbach is a Cochrane Database Systematic Review done through search of a wide
range of electronic data bases for randomized control trials (RCTs), either
published or unpublished, which compared methods of debridement or compared
debridement with no debridement. Ten RCTs were identified involving a total of
715 participants. These studies were selected independently by two review
authors who completed all study selection, data extraction and assessment of
trial quality; resolution of disagreements was completed by a third review
author. Eight RCTs evaluated autolytic debridement and included the following
agents or dressings: biocellulose wound dressing (BWD), non-adherent dressing,
honey gel, hydrogel (gel formula), hydrofibre dressing, hydrocolloid
dressings, dextranomer beads, Edinburgh University Solution of Lime (EUSOL)
and paraffin gauze. Two RCTs reported enzymatic preparations and one evaluated
biosurgical debridement. No RCTs evaluated surgical, sharp or mechanical
methods of debridement, or debridement versus no debridement. The systematic
review had the following weaknesses: study results were presented in a
narrative form, small populations, heterogeneity of outcomes, and lack of
comparability across trials, inconsistent methodology across trials and there
was a high risk of bias since most of the RCTs had high risk of bias. The
authors conclude there is limited evidence to suggest that actively debriding
a venous leg ulcer has a clinically significant impact on healing. The overall
small number of participants, low number of studies and lack of meta-analysis
in this review precludes any strong conclusions of benefit. Comparisons of
different autolytic agents (hydrogel versus paraffin gauze; Dextranomer beads
versus EUSOL and BWD versus non adherent dressings) and Larvae versus hydrogel
all showed statistically significant results for numbers of wounds debrided.
Larger trials with follow up to healing are required. The quality of evidence
is low; the strength of recommendation is weak.  

In 2015, "A Prospective, Randomized, Controlled Trial Comparing the Effects of
Noncontact, Low-frequency Ultrasound to Standard Care in Healing Venous Leg
Ulcers"  was published in _Ostomy Wound Management_ by Gibbons, Orgill,
Serena, et al. This article is a prospective, randomized, controlled,
multicenter (22 U.S. sites) trial that was conducted to compare percent wound
size reduction, proportions healed, pain, and quality-of-life (QOL) outcomes
in patients randomized to standard care (SC) alone or SC and 40 kHz
noncontact, low-frequency ultrasound (NLFU) treatments 3 times per week for 4
weeks.  One hundred twelve (112) eligible participants with documented venous
stasis, a VLU greater than 30 days' duration, measuring 4 cm2 to 50 cm2, and
demonstrated arterial flow were enrolled. Of these, 81 (72%) reduced less than
30% in size during the 2-week run-in study phase and were randomized (SC, n =
40; NLFU+SC, n = 41). Median age of participants was 59 years; 83% had
multiple complex comorbidities. After 4 weeks of treatment, average wound size
reduction was 61.6%  28.9 in the NLFU+SC compared to 45%  32.5 in the SC
group (P = 0.02). Reductions in median (65.7% versus 44.4%, P = 0.02) and
absolute wound area (9.0 cm2 versus 4.1 cm2, P = 0.003) as well as pain scores
(from 3.0 to 0.6 versus 3.0 to 2.4, P = 0.01) were also significant. NLFU
therapy with guideline-defined standard VLU care should be considered for
healing VLUs not responding to SC alone. The results of this study warrant
further research on barriers to healing and the changes occurring in the
tissue of the wound to explore theories that the microenvironment impacts
wounds that do not heal despite provision of guideline-defined care. This
study was sponsored by Celleration, Inc. The authors consulted on study
design, protocol development, and study oversight. The authors remained
blinded throughout the study. A limitation of this study was that the
investigators and participants were not blinded to treatment group assignment.
The study was limited to participant-reported measures such as QOL and VAS
pain scores. A second limitation was the treatment groups did not have the
same required frequency of treatment visits. Another limitation was that there
was a short-term (7-week) follow-up with a final ulcer measurement performed
at the last study visit, 11 weeks post randomization. The quality of evidence
is low; the strength of recommendation is weak.

In 2004, Gupta, Baharestani, Baranoski, et al. published "Guidelines of
Managing Pressure Ulcers with Negative Pressure Wound Therapy" in _Advances in
Skin & Wound Care_. In this article, a consensus panel of experienced wound
care clinicians reviewed the mechanism of action and research basis for
Negative Pressure Wound Therapy (NPWT). After answering key questions about
NPWT, an algorithm was developed to assist clinicians in decision making for
use of NPWT with Stage III/IV pressure ulcers. Therapy with NPWT lasted for a
mean of 35 days (range: 3-124 days). Panel members believe the role of NPWT as
an adjunctive therapy should be validated. The guideline states the numbers
should be interpreted cautiously, however, because of discrepancies in
methodology. Limitations include multiple studies with variable criteria,
and/or with study size, duration, population undefined. Some conclusions are
not statistically substantiated. This guideline was limited to "FDA-cleared
NPWT device (V.A.C. Therapy System)" and funded by a NPWT manufacturer. The
quality of evidence is low; the strength of recommendation is weak.

In 2005, _Home Health Care Management & Practice_ published "Palliative wound
care at the end of life" by Hughes, Bakos, O'Mara, et al. This source purports
that providing wound care, although often curative, is also palliative. It
further states that patients nearing the end of their lives may benefit from
the curative aspects of wound care and makes the following assertions.
Palliative care supports the health care needs of dying patients by focusing
on alleviating symptoms. Although wound care can be both healing and
palliative, it can impair the quality of the end of life for the dying if it
is done without proper consideration of the patient's wishes and best
interests. Wound care may be optional for dying patients. This article
discusses the ethical responsibilities and challenges of providing wound care
for surgical wounds, pressure ulcers, and wounds associated with cancer as
well as wound care in home health compared to end of life.  Quality of
evidence is low.  Strength of recommendation is weak.

"Use of a Portable, Single-use Negative Pressure Wound Therapy Device in Home
Care Patients with Low to Moderately Exuding Wounds: A Case Series" by Hurd,
Trueman, and Rossington was published in _Ostomy Wound Management_ in
2014.This case report is an 8-week study to evaluate outcomes of using a
single-use NPWT system for the treatment of exuding wounds. Data was
retrospectively abstracted from 326 patient medical records. The mean age of
patients treated was 57 years (median 61 years, range 17 to 91 years) with
mixed etiologies: 53 pressure ulcers, 21 venous leg ulcers, 16 diabetic foot
ulcers, 15 traumatic wounds, and 221 surgical wounds. There were 228 with
complete wound closure within 8 weeks of treatment. The mean wound area at
baseline was 20 cm2 (median 14 cm2, range 0.1-99 cm2). Mean wound volume at
baseline was 45 cm3 (median 31 cm3, range 0-269 cm3). At the baseline visit,
180 and 116 patients (91%) had low or moderate levels of exudate,
respectively. Although the portable device is indicated for low to moderately
exuding wounds, a small number of patients showed scant (12, 4%) and large
(18, 6%) levels of exudate, met local protocols for accessing NPWT, and were
deemed to be suitable for inclusion in the evaluation in the opinion of the
treating physician. The majority of patients (218, 68%) discontinued treatment
with portable NPWT as a result of their wound healing within the 8-week
evaluation period. The proportion of wounds completely healed during the
8-week evaluation was higher in surgical wounds (167 out of 219, 76%) than in
nonsurgical wounds (51 out of 104, 49%); 30 patients (9%) discontinued
treatment as a result of the study period ending. An additional 21 patients
(7%) discontinued therapy due to hospitalization and nine (3%) due to doctor's
orders. Twenty-six patients (26, 8%) discontinued treatment due to excessive
exudate. Excessive exudate was more commonly reported during treatment in
nonsurgical than in surgical wounds (14 out of 104 [13%] versus 12 out of 219
[6%], respectively). Device-related reasons for discontinuation were loss of
seal (10, 3.1%) and poor compliance (i.e., patient removed device or asked for
it to be removed; six [1.9%]). Poor compliance was reported more commonly in
nonsurgical wounds, although the numbers remained small (five out of 104, 5%).
For five patients, reason for discontinuation was unknown or unreported; there
was one death. Healing rates in the portable (disposable) and traditional NPWT
groups were similar (approx. 10%/week).  The mean reduction in wound area per
week was similar in both groups (11% /week, median = 10, range 0-66.7 for
portable NPWT compared to 10%/week, median = 9.4, range 1.7-31.7 for
conventional NPWT). Patient satisfaction for dressing performance was 97%.
Eighty-nine (89) percent who used the conventional NPWT (n=539) had an open
surgical wound with moderate or high levels of exudate. The findings of this
evaluation suggest the single-use; portable device may redefine access to NPWT
for patients with low exudating wounds. The decision to use conventional or
portable, single-use NPWT devices should start with wound characteristics such
as size and exudate levels. However, other criteria may be taken into account
-- particularly, the patient's mobility, lifestyle, and ability to adhere to a
treatment regimen. The design of this study presents inherent limitations,
including selection bias. This evaluation considered only patients eligible
for NPWT treatment according to local protocols, and nurses chose to use
portable NPWT on those patients who were most likely to benefit. The
comparison with the retrospectively collected data provides some context but
no control. In addition to the limitations of evaluating retrospectively
collected data, the patient population and wounds previously managed with
conventional NPWT were very different from those managed with the portable
device. Randomized, controlled clinical studies are needed to compare the
portable NPWT device to other treatment modalities indicated for these wounds
with respect to wound outcomes, cost-effectiveness, and patient quality of
life. The quality of evidence is low; the strength of recommendation is weak.  

The Hurd, Rossington, Trueman, et al., comparison article published in
_Advances in Wound Care_ in 2017 is a retrospective cohort study consisting of
a Canadian institution wide audit of basic, anonymized data derived of records
from patients with postsurgical wounds. A total of 1,107 patients were
analyzed, 808 of whom were treated with the RENASYS NPWT system (Smith &
Nephew) and 299 of whom were treated with the V.A.C. system (KCI, Inc.). The
two groups were well matched in terms of their demographics and baseline wound
characteristics. The majority of the wounds were postsurgical wounds that had
developed complications. The limitations of the study were variable treatment
protocols, subjective and objective end points measured and high risk of bias.
The findings of this analysis suggest that the RENASYS NPWT system and V.A.C.
therapy offer similar levels of performance in the management of challenging
wounds. Wound area reductions over the course of the evaluation period were
almost identical in both treatment groups and the overall rates of wound
closure and the time to achieve predefined treatment goals were comparable.
Nanocrystalline silver (ACTICOAT Flex 3) was used successfully as an adjunct
to either NPWT system. This retrospective, naturalistic analysis is believed
to be the largest case series of NPWT patients presented to date and as such
is a valuable complement to the existing evidence base on this therapy.
Potential conflicts of interest may include author honorarium and assistance
with data interpretation and manuscript preparation from Smith & Nephew. The
quality of evidence is moderate; the strength of recommendation is strong.

Krug, Berg, Lee, et al. had "Evidence-Based Recommendations for the Use of
Negative Pressure Wound Therapy in Traumatic Wounds and Reconstructive
Surgery: Steps towards an International Consensus" published in 2011 in
_Injury_. In addition to developing recommendations, the panel sought to
clarify treatment goals that can be achieved using NPWT. It is increasingly
recognized that NPWT can be used to achieve a variety of treatment goals,
which will vary according to the patient and wound characteristics. Currently,
there is a propensity to believe that the only valuable end-point with regards
to wound management is complete wound closure. However, the advent of NPWT has
introduced the concept that other treatment goals may act as staging posts
along the path towards complete closure, which may be useful end-points in any
clinical trial. A total of 208 papers that met the inclusion/exclusion
criteria were identified through the systematic review. Recommendations were
developed according to a modification of the SIGN (Scottish Intercollegiate
Guidelines Network) classification system. This classification system is
designed to reduce variation in practice and outcome through the development
and dissemination of clinical guidelines containing recommendations for
effective practice based on current evidence. Areas assessing NPWT use include
surgical repair of soft tissue traumatic wounds to provide temporary wound
cover, interim use of NPWT to progress a wound from that of a complex wound
which may require complex surgical closure (such as a microsurgical free flap)
to a smaller and simpler wound which may be adequately managed with a simpler
procedure.  Also assessed include cases in which wound closure by secondary
intention may be a viable option, Gustilo open fractures, burns, skin grafts
and flaps. The resulting evidence base is therefore weaker than the wide-
spread adoption of NPWT would suggest. In light of this, consensus becomes an
important part of recommendation generation. Potential conflicts may include
this review was funded by Smith and Nephew. Quality of evidence is low.
Strength of recommendation is moderate.

Lau, Tatsioni, Balk, et al., prepared "Usual care in management of chronic
wounds: A review of the recent literature" for ARHQ in 2005. This is a
systematic review of randomized controlled trials from 1997 to 2004, the
authors extracted information about the background care given to control
groups to identify treatment modalities that represent the standard of care. A
total of 148 RCTs were selected, the largest number of trials were on venous
ulcer, followed by diabetic ulcers and pressure ulcers. Just one trial
addressed arterial ulcers. The review had some limitations: Inconsistency
across studies, large degree of variation in the reporting of basic wound
treatment modalities and variation in the duration of usual care. The review
does not address outcomes. It has a low risk of bias. Relevant conclusions
from the authors were that there is little evidence to indicate which
dressings or topical agents are the most effective in the treatment of chronic
wounds and that there is evidence that hydrocolloid dressings are more
effective than wet to dry dressings in the treatment of pressure sores. In the
treatment of venous ulcers non adherent dressings are as effective as
hydrocolloid dressings beneath compressive bandages. There is no evidence to
support the use of systemic agents for chronic wound healing. Topical agents
may be helpful in chronic wound care but further research is required.
Compression is more effective than no compression in healing leg venous
ulcers. The quality of evidence is high. The strength of recommendation is
strong.

The 2013 "International Best Practice Guidelines: Wound Management in Diabetic
Foot Ulcers" in _Wounds International_ was compiled by an expert panel of
endocrinologists, podiatrists, and rehabilitation specialists. The guideline
offers a global wound care plan for practitioners which includes a series of
steps for preventing complications through active management combined with
appropriate patient education and integrated approach to care. Factors to
consider for dressing choice "must begin with a thorough patient and wound
assessment" and include location of the wound, extent of the wound
(size/depth), amount and type of exudate, the predominant tissue type on the
wound surface, condition of the periwound skin, compatibility with other
therapies, wound bioburden and risk of infection, avoidance of pain and trauma
at dressing changes, quality of life and patient well-being. Regularly
reviewing of patient's wound and dressing is vital. Adjunctive treatments such
as NPWT may be considered, if appropriate, where wound not healing.
Limitations are that information was collected from Europe and the United
Kingdom. The target population was patients with diabetic foot ulcers.
Statistics vary and the information appears to be not universally applicable
across healthcare systems to Medicare beneficiaries. Also, healthcare
providers are not necessarily equally trained and patient access to care
varies widely depending on region. The guideline was supported through an
educational grant from B Braun (a German medical and pharmaceutical device
company). The quality of evidence is low; the strength of recommendation is
weak.

A 2014 article in _Advances in Wound Care_ , "A Multicenter Randomized
Controlled Trial Comparing Treatment of Venous Leg Ulcers Using Mechanically
Versus Electrically Powered Negative Pressure Wound Therapy," discusses a 13
center non-blinded prospective randomized controlled clinical trial designed
to evaluate the relative impact on wound closure using a MP NPWT system (SNaP
Wound Care System; Spiracur, Inc., Sunnyvale, CA) versus an EP NPWT system
(V.A.C. Therapy System; KCI). The article does not identify the initial
population enrolled in the study it just addresses the 40 (n = 19 MP NPWT, n =
21 EP NPWT) patients that completed the study. Each subject was randomly
assigned to treatment with either MP NPWT or EP NPWT and evaluated for 16
weeks or complete wound closure. The study had the following weaknesses: small
sample, subject and investigator blinding was not performed. There were
significant differences in the mean initial wound size between the control and
the experimental groups, differences on dressing changes between groups. There
was a high risk of performance, detection and publication bias. The study
concluded that in this group of venous ulcers, wounds treated with MP NPWT
demonstrated greater improvement and a higher likelihood of complete wound
closure than those treated with EP NPWT. Potential bias includes this study
was sponsored by Spiracur Inc. Also, two authors received research funding
from both Spiracur (SNaP device) and other authors consulted for KCI (VAC
device). The quality of evidence is low; the strength of recommendation is
weak.

O'Donnell TF, Passman MA, Marston WA, et al., had "Management of venous
ulcers: Clinical practice guidelines of the Society for Vascular Surgery and
the American Venous Forum" in the _Journal of Vascular Surgery_ in 2014. This
is an evidence synthesis, Clinical Practice Guideline developed based on the
grading of recommendation assessment, development, and evaluation (GRADE)
system. When evidence is lacking, the committee relied on case series
supplemented by the best opinion of panel of experts and the recommendation
was labeled [BEST PRACTICE]. Such "best practices" from a guideline has
obvious advantages but implementation can be a challenge. Focus on "best
outcomes for the most reasonable health care dollar" stimulated SVS and AVF to
develop and promote a unified set of guidelines for treatment of chronic
diseases, such as VLUs. This guideline is presented from the Society for
Vascular Surgery and the American Venous Forum. Venous Ulcer Guidelines
Committee was divided into six sub-committee sections. The overall committee
developed a series of key clinical questions to guide the overall approach for
the guideline development; each section team determined the need for a
systematic and meta-analysis review which was then agreed on by the entire
committee. All guidelines were developed by building on existing guidelines
with a complementary literature search by the section sub-committee. It was
agreed that the studies reviewed should be published in peer-reviewed
journals. The following studies were reviewed: Edinburgh study, a multi-center
study of Polish patients, a cross-sectional study in France, the Bonn Vein
Longitudinal Study by German Ministry of Health. The sample size of the
studies varied widely from 84-40,000 participants. The sample age was unknown
or not consistently reported. The guideline is intended for specialists who
treat vascular disease and wounds limited to venous leg ulcers. The guideline
mentions that future research design should include patient-centered outcomes
measures which need to be incorporated into trial design. There is
insufficient evidence to generalize to the Medicare population. The quality of
evidence is low; the strength of recommendation is weak.

Rhee, Valle, Wilson, et al., with Johns Hopkins Evidence-base Practice Center,
prepared a Technology Assessment report, "Negative Pressure Wound Therapy
Technologies for Chronic Wound Care in the Home Setting," for the AHRQ. Johns
Hopkins University conducted research to systematically review the efficacy
and safety of negative pressure wound therapy (NPWT) for treatment of chronic
wounds in the home setting. The focus of this review was use of NPWT in the
home population, thus the results are not necessarily applicable to other
health care settings in which NPWT may be used. Two independent reviewers
screened search results. Studies examined 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. Comparative
trials were used that followed subjects in the home setting. The group was
unable to draw conclusions about the efficacy or safety of NPWT for the
treatment of chronic wounds in the home setting due to insufficient evidence.
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 common definitions of outcomes, would be helpful in
providing evidence to inform decisions about the use of NPWT. A very nice
summary of the strength of the body of evidence comparing NPWT with other
wound care treatments is summarized in Table 5. Pre-defined critical outcomes,
those essential for decision making in wound care, were determined to evaluate
the strength of evidence. For each of these five critical outcomes, across all
wound etiologies, the strength of the evidence is insufficient to draw
conclusions on the effectiveness and safety of NPWT compared with other wound
care treatments. There were few studies addressing each outcome for each wound
etiology; for several outcomes, no studies were identified. Most of the
studies were observational studies of poor quality. Only one study was an RCT,
and it was judged to be fair quality. The strength of evidence domain of
directness was downgraded by the reviewer because some studies used
inappropriate control group or used surrogate markers for outcomes. Reviewers
were rarely able to evaluate consistency. There were not enough studies to use
funnel plots to determine if there was reporting bias. Publication bias may be
of concern. Five of the studies reported funding from industry, while Yao et
al. did not report funding source. The RCT had a small sample size, and
therefore, imprecise results. Some of the observational studies reported
limited data on outcomes. Previous systematic reviews on NPWT noted in Table 8
provide a nice summary of systematic reviews on NPWT in various environments.
Given the mixture of wound etiologies, and the lack of details about the
patients in each of the studies, it was difficult to generalize the results to
the overall population. The populations studied all had chronic wounds, and
since the chronic wound treatment modalities can be used across the age
spectrum, the data we found could be applicable to the Medicare population
with moderate generalizability at best. Quality of evidence is low. Strength
of recommendation is weak.

Sullivan, Snyder, Tipton, et al., with ECRI Institute published a revised
"Negative Pressure Wound Therapy Devices: Technology Assessment Report" in
2009. Over 1400 items were submitted by stakeholders and all were reviewed for
relevance. None of the submissions were studies directly comparing different
NPWT devices/systems. Submissions included systematic reviews, comparison
studies, and uncontrolled case series. In 40 comparison studies, it was found
that all of the controlled trials involved the evaluation of one NPWT device,
the V.A.C manufactured by Kinetic Concepts Inc. (KCI). None of the 40
comparison studies met the design and conduct requirements to be considered
high quality, only seven studies could be considered moderate quality, and the
majority of studies (82%) were rated low quality. AHRQ noted conclusions made
in the TA agreed with the systematic reviews examined; the reviews indicated
the majority of evidence on NPWT was of poor quality. The TA indicates the
most commonly reported adverse events associated with NPWT are pain, bleeding,
and infection. 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 and similar complications were reported in 8 (22%) studies. The
TA noted important study features were not typically reported such as
concealment of allocation, reporting of randomization methods and use of power
analysis to ensure adequate study size, blinding patients and especially wound
assessors, and reporting of complete wound healing data to insure the internal
validity of study results. No study included in the TA reported that the
physicians were blinded to treatment assignment, and only 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 randomized controlled trial with failure typically resulting in selection
bias. The TA noted the findings could not be transferred from one wound type
to another so numerous high quality studies of several different wound types
would be necessary in order to determine if any one NPWT system or component
provides a significant therapeutic distinction over another. The TA stated the
strongest evidence of efficacy will come from properly designed and conducted
RCTs that can be replicated by independent research units. The quality of
evidence is low; the strength of recommendation is weak.

In 2013, the _Journal of American Medical Association (JAMA) Dermatology_
published "Frequency of Debridements and Time to Heal; A Retrospective Cohort
Study of 312,744 Wounds" by Wilcox, Carter and Covington. The stated desired
objective in this article was to investigate healing outcomes and debridement
frequency in a large wound data set. This is a retrospective cohort study.
Data was collected from 525 wound care centers from June 1, 2008, through June
31, 2012, using a web-based clinical management system. A referred sample of
154,644 patients with 312,744 wounds of all causes (of an initial data set of
364,534 wounds) participated. A total of 47.1% were male. Median age was 69
years (age range, 19-112 years), with 59.2% having one wound. Eligibility
criteria included age older than 18 years, receiving at least 1 debridement,
and having been discharged from the system. Advanced therapeutic treatment was
ineligible. Because of incomplete, questionable, or ineligible data, 57,190
wounds were not included. Most wounds were diabetic foot ulcers (19.0%),
venous leg ulcers (26.1%), and pressure ulcers (16.2%). Debridement (removal
of necrotic tissue and foreign bodies from the wound) occurred at different
frequencies. Wound healing was defined as complete epithelialization with
dimensions at 000cm. A total of 70.8% of wounds healed. The median number of
debridements was 2 (range, 1-138). Frequent debridement healed more wounds in
a shorter time (P less than .001). In regression analysis, significant
variables included male sex, physician category, wound type, increased patient
age, and increased wound age, area, and depth. The odds ratio varied
considerably for each variable. The authors concluded the more frequent the
debridements, the better the healing, (in spite of noting that the median
number of debridements required is two). Although limited by retrospective
data, this study's strength was the analysis of the largest wound data set to
date. Potential bias is a conflict of interest as the review was obtained from
and conducted by a for-profit wound care company and some authors are employed
by a for-profit wound care company. Limitations of the study include the use
of retrospective data and the statistical analysis. Further analysis will be
necessary to determine the precise effect size due to debridement frequency
because certain causes will have unique factors come into play. They conclude
that the issue remains that there has not yet been an adequately powered
retrospective trial to test the efficacy of debridement of wounds. Quality of
evidence is low. Strength of recommendation is weak.

The 2008 "Principles of best practice: Vacuum assisted closure:
recommendations for use. A Consensus Document" is World Union of Wound Healing
Societies' Initiative. This is a consensus expert opinion drawn from selected
clinical evidence (RCTs, Retrospective match group analysis, Randomized
Controlled Crossover Studies, Randomized Controlled Pilot Studies,
Retrospective Controlled Studies and Data Compilation from publish
literature). It has an unclear risk of bias. VAC therapy must be used as part
of an individualized, comprehensive treatment plan and is indicated for both
acute and chronic wounds. VAC therapy can be considered for deep complex
wounds, for post-surgery wounds and, occasionally, for superficial wounds in
addition to standard treatments. For patients with ischemic wounds, referral
to a vascular surgeon should be considered prior to VAC therapy. Under ideal
conditions (especially in the absence of infection), well perfused wounds will
respond quickly (i.e., within one week) with evidence of granulation tissue
formation. This can be used to test vascularity and suitability of VAC
therapy. VAC therapy can be used in a number of ways to manage the complex
diabetic foot wound, post-surgery diabetic foot wounds and superficial
diabetic foot wounds. It is recognized that compression therapy is regarded as
the first-line treatment for venous leg ulcers. However, there is a role for
VAC therapy in inflammatory or complex therapy-resistant leg ulcers that are
unsuitable for compression. The use of portable VAC systems may also allow
ambulatory patients to be treated at home and can reduce the need for
hospitalization. In patients with inflammatory ulcers, VAC therapy can be used
to enhance wound bed preparation before definitive surgical closure or delayed
secondary healing. VAC therapy is recommended as a first-line treatment for
grade/stage 3 and 4 pressure ulcers in certain situations and should be used
as part of a comprehensive treatment plan. VAC therapy should be considered as
a first-line treatment for dehisced sternal wounds following cardiac surgery.
This can be used as a bridge to definitive surgical closure or to achieve
delayed primary closure or flap reconstruction and closure. The guideline also
recommends VAC therapy is in the treatment of: open abdominal wounds, in the
treatment of complex traumatic wounds. Finally it states that further research
is needed to increase understanding of the therapeutic effects of VAC therapy
to give clinicians stronger arguments to support its use. In particular,
future trials should focus on the generation of level 1 evidence and further
comparative data for specific indications. This will help to clarify the
potential for VAC therapy in different wound types and to enhance clinical
decision making in various population groups. The quality of evidence is low;
the strength of recommendation is moderate.

Wound care must be performed in accordance with accepted standards for medical
and surgical treatment of wounds. The literature on wound care is virtually
without limit; yet, in spite of the volume of research conducted, there exists
a tremendous diversity of opinion in the literature. Clinical trials,
consensus panel reports, and practice patterns reflect considerable
differences among clinicians. The appropriate interval and frequency of
debridement depends on the individual clinical characteristics of the patient
and the extent of the wound. The extent and number of services provided should
be medically necessary and reasonable based on the documented medical
evaluation of the patient's condition, diagnosis, and plan. Given the varied
nature and diversity of options available to the clinician, this LCD does not
impose strictly defined frequency limitations as such on wound care
debridements, palliative care wound treatments, application of negative
pressure wound therapy with the exception of services rendered for low
frequency, non-contact, non-thermal ultrasound (MIST Therapy).  
  
Only when medical necessity continues to be met and there is documented
evidence of clear benefit from the services provided, should services be
continued. When services are performed in excess of anticipated peer norms
based on data analysis, the services may be subject to prepay or post pay
medical review.