subject: vacuum assisted wound closure (vawc)/ negative ... · *please see the grid located in the...

29
Page 1 of 29 PREFACE This Medical Guidance is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the following website: http://www.cms.hhs.gov/center/coverage.asp. FDA INDICATIONS The Food and Drug Administration (FDA) has approved many vacuum assisted wound closure devices to promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids, and infectious materials. *Please see the grid located in the general information section of this document for a list of FDA approved wound closure devices and indications of use applicable at the time of this document revision. On December 20, 2002 the V.A.C. received premarket approval to include the indication of partial-thickness burns. 2 The FDA issued a patient safety warning in November 2005 following the death of patient placed on vacuum assisted wound closure two weeks post leg amputation taking anticoagulants to prevent thromboembolism. 3 The FDA reported special precautions to take to prevent bleeding. Precautions and contraindications to NPWT for the treatment include, but are not limited, to the following 2 : difficult wound hemostasis, active bleeding, nonenteric and unexplored fistula, untreated malnutrition, untreated ostemyelitis near wound, noncompliant patients, exposed vital organs (treatment may proceed after the organ is protected with overlying fascia tissue, or other protective barriers, presence of necrotic tissue with eschar, if debridement is not attempted, malignancy in the wound, as negative pressure leads to cellular proliferation, presence of a fistula to an organ or body cavity near the wound, greater caution must be taken with weakened, irradiated, or sutured blood vessels or organs. On February 24, 2011 the U.S. FDA released an updated Safety Communication, following up on a previous notice regarding major complications related to the use of NPWT systems in 2009. This communication specifically states: NPWT systems are contraindicated for these wound types/conditions: 57 necrotic tissue with eschar present untreated osteomyelitis non-enteric and unexplored fistulas malignancy in the wound Subject: Vacuum Assisted Wound Closure (VAWC)/ Negative Pressure Wound Therapy (NPWT) Original Effective Date: 4/24/07 Guidance Number: MCG-023 Revision Date(s): 7/30/08, 06/29/12 Medical Coverage Guidance Approval Date: 6/29/12

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Page 1: Subject: Vacuum Assisted Wound Closure (VAWC)/ Negative ... · *Please see the grid located in the general information section of this document for a list of FDA approved wound closure

Page 1 of 29

PREFACE

This Medical Guidance is intended to facilitate the Utilization Management process. It expresses Molina's determination as to

whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of

determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not

constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular

member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are

excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's

benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a

discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be

mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members.

CMS's Coverage Database can be found on the following website: http://www.cms.hhs.gov/center/coverage.asp.

FDA INDICATIONS

The Food and Drug Administration (FDA) has approved many vacuum assisted wound closure devices to promote wound

healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids, and infectious materials.

*Please see the grid located in the general information section of this document for a list of FDA approved wound closure

devices and indications of use applicable at the time of this document revision.

On December 20, 2002 the V.A.C. received premarket approval to include the indication of partial-thickness burns.2

The FDA issued a patient safety warning in November 2005 following the death of patient placed on vacuum assisted

wound closure two weeks post leg amputation taking anticoagulants to prevent thromboembolism.3 The FDA reported

special precautions to take to prevent bleeding. Precautions and contraindications to NPWT for the treatment include, but

are not limited, to the following2: difficult wound hemostasis, active bleeding, nonenteric and unexplored fistula,

untreated malnutrition, untreated ostemyelitis near wound, noncompliant patients, exposed vital organs (treatment may

proceed after the organ is protected with overlying fascia tissue, or other protective barriers, presence of necrotic tissue

with eschar, if debridement is not attempted, malignancy in the wound, as negative pressure leads to cellular proliferation,

presence of a fistula to an organ or body cavity near the wound, greater caution must be taken with weakened, irradiated,

or sutured blood vessels or organs.

On February 24, 2011 the U.S. FDA released an updated Safety Communication, following up on a previous notice

regarding major complications related to the use of NPWT systems in 2009. This communication specifically states:

NPWT systems are contraindicated for these wound types/conditions: 57

necrotic tissue with eschar present

untreated osteomyelitis

non-enteric and unexplored fistulas

malignancy in the wound

Subject: Vacuum Assisted Wound Closure (VAWC)/ Negative Pressure Wound

Therapy (NPWT) Original Effective Date: 4/24/07

Guidance Number: MCG-023 Revision Date(s): 7/30/08, 06/29/12

Medical Coverage

Guidance

Approval Date:

6/29/12

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exposed vasculature

exposed nerves

exposed anastomotic site

exposed organs

This update adds further information addressing the use of NPWT systems in the treatment of infants and children. The

communication specifically states: "The safety and effectiveness of NPWT systems in newborns, infants and children has

not been established at this time and currently, there are no NPWT systems cleared for use in these populations. 57

CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS)

The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination

(LCD) will supersede the contents of this Molina medical coverage guidance (MCG) document and provide the directive for all

Medicare members. The directives from this MCG document may be followed if there are no available NCD or LCD documents

available and outlined below.

A National Coverage Determination (NCD) is not currently available for NPWT. Several local coverage determinations

exist for NPWT with coverage for stage III or IV pressure ulcers, neuropathic diabetic ulcers, venous or arterial

insufficiency ulcers, chronic wounds (30 days or longer) of mixed etiology that have proven refractory to conventional

treatments. 4

INITIAL COVERAGE CRITERIA

Molina Healthcare may consider NPWT medically necessary for members who are age 12 and over for the following

indications:

1. Chronic Stage III or IV pressure ulcers when all of the following criteria are present:

Member has been treated by a clinician experienced in appropriate wound care techniques, assessing and

treating the member minimally every two weeks with consideration of complicating factors and

comorbidities (e.g., diabetes, vascular disease, renal disease etc)

Ulcer is large enough to allow foam contact with base and for safe device extraction and is surrounded by

intact tissue of 2cm or more to maintain adequate seal.

Wound has documented poor or inadequate granulation tissue with heavy exudate

Conventional treatment tried and failed for minimally 4 weeks before NPWT is considered:

o Frequent turning and positioning and pressure reducing devices used for off loading weight

o Dressings (e.g., Occlusive, hydrocolloids, collagen dressings, transparent films, alginates, and

enzymatic debriding agents)

o Topical antimicrobials, as appropriate

o Debridement of thick eschar, exudate, slough or necrotic tissue if present

o Nutritional status evaluation and treatment of deficiencies (e.g., albumin 3.5 to 5.5 g/dL or 2.0

to 3.4 g/dL with nutritional supplementation such as high calorie and/or high protein drinks)

o Bowel/bladder incontinence addressed to avoid contamination

Weekly wound assessment including dimensions and characteristics showing no improvement by

appropriate licensed individual

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2. Chronic Diabetic Ulcers (Neuropathic) when all of the following criteria are present:

Member has been treated by a clinician experienced in appropriate wound care techniques, assessing and

treating the member minimally every two weeks with consideration of complicating factors and

comorbidities

Ulcer is large enough to allow foam contact with base and for safe device extraction and is surrounded by

intact tissue of 2 cm or more to maintain adequate seal.

Wound has documented poor or inadequate granulation tissue with heavy exudate

Conventional treatment tried and failed for minimally 4 weeks before NPWT is considered:

o Member is a participant in a comprehensive diabetic management program with adequate blood

sugar control

o Mechanical off-loading weight or non weight bearing, (e.g., removable cast walkers, half shoes,

and total contact casts)

o Appropriate foot care has been implemented (e.g., cleanse the ulcer twice daily, nonadherent dry

dressing, hydrogels)

o Debridement of thick eschar, exudate, slough or necrotic tissue if present

o Nutritional status evaluation and treatment of deficiencies (e.g., albumin 3.5 to 5.5 g/dL or 2.0 to

3.4 g/dL with nutritional supplementation such as high calorie and/or high protein drinks)

Weekly wound assessment including dimensions and characteristics showing no improvement by

appropriate licensed individual

3. Venous or Arterial Insufficiency Ulcers when all of the following criteria are present:

Member has been treated by a clinician experienced in appropriate wound care techniques, assessing and

treating the member minimally every two weeks with consideration of complicating factors and

comorbidities

Ulcer is large enough to allow foam contact with base and for safe device extraction and is surrounded by

intact tissue of 2 cm or more to maintain adequate seal.

Poor or inadequate granulation tissue with heavy exudate

Conventional treatment tried and failed for minimally 3 months before NPWT is considered:

o Leg elevation, 30 minutes three or four times per day

o Compression therapy (e.g., compression stockings, elastic and inelastic compression bandages)

o Dressings (e.g., wet or dry nonadherent, occlusive hydrocolloidal or gel dressings)

o Debridement of thick eschar, exudate, slough or necrotic tissue if present

o Nutritional status evaluation and treatment of deficiencies (e.g., albumin 3.5 to 5.5 g/dL or 2.0

to 3.4 g/dL with nutritional supplementation such as high calorie and/or high protein drinks)

Weekly wound assessment including dimensions and characteristics showing no improvement by

appropriate licensed individual

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4. Postoperative dehiscence, post-sternotomy mediastinitis or other acute/chronic wounds classified as Stage III or

stage IV when one of the following are present:

The wound has failed previous attempt(s) at surgical closure

The wound would generally require surgical closure but the member is not a surgical candidate for

medical reasons

Skin graft over area of excessive motion

Burns requiring extensive skin grafting or flaps (>50%)There is a comorbidity present to significantly

prolong healing with other topical wound treatments (e.g., renal disease, diabetes, coronary artery disease,

collagen vascular disease, immune deficiencies, peripheral arterial disease)

AND ALL of the following criteria are present:

Member has been evaluated and treated by a surgeon and/or clinician experienced in appropriate wound

care techniques, assessing and treating the member minimally every two weeks with consideration of

complicating factors and comorbidities

Ulcer is large enough to allow foam contact with base and for safe device extraction and is surrounded by

intact tissue of 2 cm or more to maintain adequate seal.

Poor or inadequate granulation tissue with heavy exudate

Conventional treatment tried and failed for minimally 4 weeks before NPWT is considered:

o Dressings (e.g., wet or dry nonadherent, occlusive hydrocolloidal or gel dressings etc.)

o Debridement of thick eschar, exudate, slough or necrotic tissue if present

o Nutritional status evaluation and treatment of deficiencies (e.g., albumin 3.5 to 5.5 g/dL or 2.0

to 3.4 g/dL with nutritional supplementation such as high calorie and/or high protein drinks)

Weekly wound assessment including dimensions and characteristics showing no improvement by

appropriate licensed individual

Note: Wound depth must be greater than 0.5 cm to be considered for coverage

5. Authorization Period: NPWT may be approved initially for 2 weeks, continued approval will be based upon

adequate wound healing progression; the wound vacuum should be discontinued if the wound shows no progress

after the initial 2 week wound evaluation.

CONTINUATION OF THERAPY

NPWT may be approved initially for 2 weeks, continued approval will be based upon adequate wound healing

progression; the wound vacuum should be discontinued if the wound shows no progress after the initial 2 week

wound evaluation.

Wound measurements should be performed every two weeks to assess progress in wound healing and submitted

to Molina. A steady decrease in wound volume (length, width and depth) should be noted with each evaluation. If

there is no documented progress, or if there is documented regression, for two successive measurements (4

weeks), the coverage will be discontinued. Measurement of the wound should be in square CM, and if possible

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photographic evidence provided to document progress or lack thereof.

NPWT should be discontinued when either of the following occurs first: The wound is healed as evidenced by a

thin area of “new” epidermis with filling of wound by granulation tissue or when the wound has progressed to be

closed by surgical means. 58

Discontinuation of NPWT should occur with members exhibiting noncompliance with the treatment guidelines. It

is recommended that the wound vacuum remain on for 24 hours the first couple of days and then be utilized for 22

out of 24 hours daily for maximum effectiveness unless otherwise indicated by the wound care clinician.

The average length of treatment is 4 to 6 weeks; continuation beyond 4 months (including inpatient treatment)

would generally not be covered. A review by a Medical Director would be required.

Coverage for Associated Supply Requests:

1. NPWT can be applied to multiple wounds at the same time utilizing one pump. Requests for more than one

wound vacuum per member during the same treatment period would not be covered.

2. Requests for a maximum of 15 dressing kits per month would be considered medically necessary unless the

wound size is documented to require more than one kit for each dressing change.

3. Coverage is provided generally for one canister set (A7000) per week unless the wound volume drainage is in

excess of 90ml drainage per day. Coverage of a maximum of 10 canisters sets per month is considered

appropriate for high volume exudate. Wounds with an excessive amount of drainage must utilize the largest

capacity canister available. Requests for extra canisters due to equipment failure would not be considered a

covered benefit.

COVERAGE EXCLUSIONS

Molina Healthcare does not consider NPWT medically necessary and is excluded for the following indications:

All other applications for the NPWT other than those listed under the ‘Coverage Criteria’ section above

The use of the NPWV/NPWT is contraindicated for patients with the following:

o Malignancy in the wound

o Untreated osteomyelitis within the vicinity of the wound

o Non-enteric and unexplored organ or body cavity fistulas that are in close proximity of the wound

o Necrotic tissue with eschar present (Following debridement of necrotic tissue and complete removal

of eschar the wound vacuum can be considered for use)

Stage I or II pressure ulcers

Wounds less than 1 mm in depth, the sponge cannot be used with this depth.

Wounds with exposed vital organs present

Inadequately debrided wounds

Exposed arteries or veins that would be placed in direct contact with the wound vacuum suction

Members with inadequate nutritional status that prohibit the proper healing of the wound (as evidenced by

members with albumin < 3.5 and not on nutritional supplementation or albumin < 2.0 while taking nutritional

supplements)

Members at high risk for bleeding complications should be evaluated closely for possible exclusion. This

includes members:

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o on anticoagulants or platelet inhibitors

o previous cardiothoracic or vascular surgical procedures

o with brittle, irradiated, sutured or infected blood vessels or organs

o without adequate wound hemostasis (non-sutured hemostatic agents such as bone wax, absorbable

gelatin sponges, or spray wound sealant may increase risk of fatally bleeding if disrupted)

o without appropriate vascularized tissue over vascular structures

o with multiple comorbidities

o Surrounding skin from the wound has less than 2 cm of intact tissue that would not allow for

appropriate adhesive seal to adequately create negative pressure should b in are CM, or lack.

Abdominal wound dehiscence where bowel is present in the wound

Pediatric members including newborns, infants and children from birth to the age of 12. 64

The SNaP (smart negative pressure) Wound Care System (Spiracur Inc.) is considered investigational and not

a covered benefit for any indication as the technology is unproven.

DESCRIPTION OF PROCEDURE/SERVICE/PHARMACEUTICAL

VAWC/NPWT is a device used to treat open wounds through a controlled application of subatmospheric pressure using a

vacuum unit that supplies negative pressure to the surface and margins of a wound.1 The negative pressure was designed

to assist in draining fluid, eliminating the ability of microorganism growth, accelerating granulation tissue formation, and

stimulating and increasing blood flow to the wound. A sterile dressing is applied directly to the wound bed. The wound is

then sealed with an occlusive drape to create a semi-occlusive closed environment that provides moist wound healing. A

number of wound contact layers are available to be used as treatment options with NPWT.59

A vacuum tube is attached

to the dressing and connected to a collection device using a power supply (battery or AC). Negative pressure is set

between a therapeutic range of 50-125mm/Hg to draw fluid drainage into an attached collection device. The pressure can

be adjusted based on wound type, size and the patient’s tolerance to the suction pressure. Generally, during the first 48

hours, (5 days following surgery of a mesh skin graft) the device is used continuously. Once the wound drainage

decreases, the vacuum can be used less often. This device was designed specifically for fostering wound healing and to

promote wound drainage.1

GENERAL INFORMATION

U.S. Food and Drug Administration (FDA)2

*The Food and Drug Administration (FDA) has approved the following vacuum assisted wound closure devices for the

outlined indications of use that include but are not limited to:

PRODUCTS MANUFACTURER INDICATIONS FOR USE

EngenexTM

Advanced

NPWT System

Boehringer Wound

Systems, LLC

To promote wound healing and for the removal of fluids, including

wound exudates, irrigation fluids, body fluids, and infectious

materials.

Genadyne

Biotechnologies Inc.

Genadyne A4 NPWT

Genadyne AS4 XLR8

NPWT

For use in patients who would benefit from negative pressure

wound therapy particularly as the device may promote wound

healing by the removal of excess exudates, infectious material and

tissue debris.

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Innovative Therapies

Inc.

SVED Wound treatment

unit

For the application of suction (negative pressure) to wounds to

promote wound healing and for the removal of fluids, including

wound exudates, irrigation fluids, body fluids and infectious

materials.

Kalypto Medical Inc. NPD 1000 Negative

Pressure Wound Care

system

For the application of suction to remove a small amount of fluid

from the wound bed including wound exudate and infectious

material which may promote wound healing.

V.A.C. ® Instill ®

V.A.C ATS ®

V.A.C ® Freedom®

miniV.A.C. ®

ActiV.A.C.®

Therapy Unit

KCI To promote wound healing for patients with chronic, acute,

traumatic, subacute and dehisced wounds, partial thickness burns,

diabetic ulcers, pressure ulcers, flaps, grafts, and partial thickness

burns.

Invia® Healing

System

Invia Wound

Therapy

Medela To promote wound healing for wounds and thoracic drainage (must

be used only in combination with a chest drainage unit with a built

in flow adjustment valve). The intermittent suction mode is

intended to be used for gastrointestinal suction procedures.

Exusdex® wound

drainage pump

MediTop BV For patients who would benefit from the application of negative

pressure to the area of a wound to promote wound healing by

drainage of fluids and infected materials from the wound and

wound bed.

NeoGen One NeoGen Technologies,

Inc.

Adjunct to standard therapy for patients who would benefit from

vacuum-assisted drainage and removal of infectious material or

other fluids.

Prodigy NPWT Premco Medical Systems For use in patients that would benefit from a suction device

particularly as the device may promote wound healing or for

aspiration and removal of surgical fluids, tissue (including bone),

gases, bodily fluids or infectious material from a patient’s airway or

respiratory support system either during surgery or at the patient’s

bedside.

Prospera Pro I

Negative Pressure

Wound Therapy

Pump

Prospera LLC For use in patients that would benefit from a suction device suction

device particularly as the device may promote wound healing or for

the aspiration and removal of surgical fluids, tissue (including

bone), gases, bodily fluids or infectious materials from a patient’s

airway or respiratory support system either during surgery or at the

patient’s bedside

Prospera Pro-II AC/

DC

Prospera Pro III AC/

DC

Prospera Technologies For use in patients that would benefit from a suction device suction

device particularly as the device may promote wound healing or for

the aspiration and removal of surgical fluids, tissue (including

bone), gases, bodily fluids or infectious materials from a patient’s

airway or respiratory support system either during surgery or at the

patient’s bedside

EZCARE Negative

Pressure Wound

Therapy

Renasys EZ

Renasys Go

V1sta portable

system

Versatile 1 (Blue Sky

Smith & Nephew Patients who would benefit from a suction device for wound

healing or for aspiration and removal of surgical fluids, tissue

(including bone), gases, bodily fluids, or infectious materials from a

patient’s airway or respiratory system either during surgery or at the

patient’s bedside.

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Medical Group,

[Company Purchased

by Smith and

Nephew Inc])

SNaP Wound Care

System, SNaP

Wound Care

Cartridge, SNaP

Wound Care

Dressing, SNaP

Wound Care Strap

Spiracur Inc. Patients who would benefit from a non-powered suction apparatus

device intended for negative pressure wound therapy that is

indicated for wound management via application of negative

pressure to the wound for removal of fluids, including wound

exudates, irrigation fluids, and infectious materials. It is further

indicated for management of wounds, burns, flaps, and grafts.

Venturi compact

Venturi Negative

Pressure wound

therapy

Talley Medical USA

For use for patients with acute or chronic wounds that may be

benefited by the application of negative pressure therapy and the

potential wound healing effects of removal of fluids including

wound exudates, irrigation fluids, body fluids, and infectious

materials. Venturi is intended for use in acute care settings only.

Treatment Recommendations

NPWT may be used for patients with chronic wounds; diabetic foot wounds, dehisced surgical wounds, flaps and grafts,

pressure ulcers. NPWT is best suited for the management of large, Stage III and Stage IV ulcers with inadequate or poor

granulation tissue and heavy exudate.42

NPWT can also be considered in a chronic wound if the wound size decreases by

less than 30% after four weeks following debridement.42

NPWT has shown to be more effective on chronic deep,

complicated nonhealing wounds of mixed etiologies.45

It is recommended that the wound dressing be changed every 48 hours in noninfected wounds. The dressing should be

removed if the negative pressure is turned off for more than 2 hours to prevent adherence and infection to surrounding

tissues.45

According to Kinetic Concepts [KCI] 2006, maximum benefit from NPWT depends upon appropriate wound care and

wound healing strategies including the following:

Accurate diagnosis and treatment of underlying causes (e.g., pressure relief surfaces for pressure ulcers,

adequate nutrition, offloading of lowered extremity wounds, maximizing vascular supply for optimal

perfusion)

Continuous monitoring of patients with a history of noncompliance or inability to adhere with treatment

regime

Therapy compliance is essential. NPWT should be maintained for 22 of 24 hours daily. The dressing should

be removed and replaced with a traditional dressing if therapy is turned off for 2 hours or more.

Osteomyelitis requires treatment (e.g., antibiotics and debridement)

Information Regarding Wounds: National Pressure Ulcer Advisory Panel, 2007

STAGE DESCRIPTION

Stage I Intact skin with non-blanchable redness of a localized area usually over a bony prominence.

Darkly pigmented skin may not have visible blanching; its color may differ from the

surrounding area.

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Stage II

Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound

bed, without slough. May also present as an intact or open/ruptured serum-filled blister.

Stage III

Full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are

not exposed. Slough may be present but does not obscure the depth of tissue loss. May

include undermining and tunneling.

Stage IV Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be

present on some parts of the wound bed. Often include undermining and tunneling.

Unstageable Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan,

gray, green or brown) and/or eschar (tan, brown or black) in the wound bed.

Suspected

Deep Tissue

Injury

Purple or maroon localized area of discolored intact skin or blood-filled blister due to

damage of underlying soft tissue from pressure and/or shear. The area may be preceded by

tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.

Several reference resources from UpToDate, InterQual criteria, and Medicare CMS technology assessments were used to

determine conventional treatment options, initial and continuation of services and documentation requirements.20,23-

25,33,43,51-56 Clinical trial information was also used in criteria development.

Summary of Medical Evidence

There is weak to moderate evidence in peer reviewed medical literature indicating that NPWT is safe and effective in

patients who have failed conventional wound therapy that is comprehensive and includes all reasonable and well-

established alternative medical treatments. NPWT may be used for patients with chronic wounds; diabetic foot wounds,

dehisced surgical wounds, flaps and grafts, pressure ulcers, the evidence currently available does not provide sufficient

conclusions supporting negative pressure wound therapy being a superior treatment to conventional wound care protocol

when used on a routine basis. Conventional wound therapy interventions are still considered the first line of treatment for

wound healing. There is some evidence to support NPWT as an alternative to surgery (secondary closure with or without

myocutaneous flap) or in preparation for surgery for poststernotomy mediastinitis. There is insufficient evidence to

support the routine use of NPWT. Studies have shown benefits to include a decrease in wound volume, decrease in time to

heal or show improvement, higher graft take, and decreased need for surgery. The clinical studies available have many

methodological flaws identified such as small sample sizes, lack of blinding, patient selection and outcome measures

being unclearly defined that compromise the overall quality of evidence.

While scientific evidence does not permit concrete conclusions regarding the efficacy of NPWT on health outcomes, it

has been widely accepted and implemented in the medical community both locally and nationally.

Hayes Directory for Negative Pressure Wound Therapy for Wound Healing1

The Hayes Directory report indicates that there is a moderate amount of evidence from randomized controlled trials

indicating proven benefit that NPWT contributes to healing wounds in patients with subacute, acute or chronic wounds,

with or without skin grafts, that have failed to achieve any improvement from conventional wound therapies. Benefit has

not been established in wounds that have responded to conventional therapies. There are no proven benefits in patients

with contraindications such as untreated osteomyelitis, exposed vital organs, inadequately debrided wounds, active

bleeding, malignancy in the wound, fistulas to body organs or cavities, difficult wound hemostasis, necrotic tissue with

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eschar, or anticoagulant use. The evidence based conclusion evaluated 21 randomized controlled trials, 2 meta-analyses, 1

nonrandomized controlled trial, 2 prospective uncontrolled trials, comparative studies (one multi-center), multiple case

series (one included a control population), 4 retrospective analysis, and 7 retrospective controlled analyses through

February 2011. Annual Hayes literature reviews have been conducted with additional information about safety and

efficacy that did not impact the Hayes ratings. The last Hayes update review performed at the time of this document

revision was February, 2011.

Hayes defines acute, subacute and chronic wound types as follows:

Acute: acute donor sites, deep abrasions, avulsions, gunshot wounds, nonosseous traumatic injury, traumatic

amputation, burns, eviscerations, degloving injuries.

Subacute: Skin graft failures, sternotomy infection following coronary artery bypass grafting, dehiscence,

postfemoral popliteal bypass inguinal wounds, skin graft failures, uninfected and infected open wounds with

exposed orthopedic hardware, and sternotomy infection following coronary artery bypass grafting.

Chronic: Venous stasis ulcers, cystic hidradenitis, pressure ulcers, and trauma and radiation-related wounds.

Hayes Technology Brief for the SNaP Wound Care System (Spiracur Inc.) for Treatment of Lower Extremity Ulcers

The Hayes Technology Brief indicates that the overall quality of the evidence is low in the evaluation of the SNaP

Wound Care system for promoting wound healing in patients with chronic, lower extremity ulcers of varying etiology.

This evidence was based upon three published studies that were supported by the manufacturer. All three studies had

flaws in study design and execution that included small sample sizes, use of historical controls, high attrition rates,

inadequate follow-up times, variation in the definition of wound healing, limited outcome measures, and variation in

treatment protocols. None of the studies evaluated the impact of the SNaP Wound Care System on patient outcomes,

quality of life or the clinical effects of an earlier treatment. The report concluded that in order to further evaluate the safety

and efficacy of the SNaP Wound Care System and establish the device’s optimal role in wound management, large,

independent, long-term comparative studies with clearly defined treatment protocols and diverse outcome measures are

needed. 65-66-67-68

NPWT Evidence Regarding Wound Healing

Several studies have been performed to evaluate wound healing with NPWT. NPWT has shown to promote wound

closure in most patients with some patients failing treatment. Approximately 30% to 100% of patients with various

wound types had successful closure rates. One randomized control trial of patients with diabetic foot amputations

experienced wound closure in 56% of wounds in the NPWT group versus 39% in the control group.7 A randomized

controlled trial showed median time to form granulation tissue to be 42 days in NPWT treated wounds versus 84 days in

moist wound healing patients in acute wounds.7,8

Time to wound closure in these patients were 56 days in the NPWT

patients versus 77 days in the control group. Shorter wound healing times were noted for both acute and chronic wounds

in the NPWT group when compared with the control group7,8

Two controlled studies reviewed wound size changes.9,10

One randomized trial with patients with full thickness wounds

experienced a statistically significant mean wound size reduction of 3.8% per day in the NPWT group versus 1.7% for

patients receiving standard moist gauze dressing.9 Decreased wound size was noted in 100% of the wound vacuum

patients versus 77% in the control group. A randomized trial for pressure ulcers indicated NPWT wound size reduction

was 51.8% versus 42.1%.10

NPWT treatment of pressure ulcers and other chronic wounds treated with NPWT revealed a

statistically significant decrease in depth of 66% versus 20% in those treated with normal saline wet to moist dressings (p

< .0001). Histologically, 81% of ulcers treated with wet to moist dressings revealed inflammation and fibrosis, whereas

NPWT treated ulcers (n = 645) exhibited granulation tissue as the chief characteristic.11

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Wound closure time was similar or superior when compared with standard wound therapy.12,13

The following median

wound healing times were reported in the following randomized control trials:

Combination of various wound types: NPWT 16 days compared with 20 days in the standard treatment control

group12

Poststernotomy mediastinitis: NPWT 21 days compared with 26 days no statistical significance using irrigation

with providine-iodine solution15

Pressure Sores: NPWT 27 days compared with28 days in the control group for 50% wound closure.13

Chronic foot ulcers: NPWT 29 days compared with 45 days in the control group14

Open foot wounds: NPWT 110 days compared with 124 days no statistical significance using wet-to-moist

dressings

Chronic Leg Ulcers

Wound recurrence was evaluated in NPWT used for chronic leg ulcers in a randomized controlled trial.13

Ulcers recurred

in 53% of NPWT patients versus 42% that had conventional wound therapy following a 12 month follow-up. No

statistical significance was noted. A prospective uncontrolled study of NPWT used for treating subacute, acute, and

chronic leg wounds. None of the NPWT treated ulcers recurred out of the 141 patient’s evaluated.16

The duration of treatment was reported to require a median of 57.5 days when combining treatment for various wound

types.17

A retrospective controlled study using MPWT for treating skin graft wounds required a mean of 4.8 days versus

5.2 using a standard bolster dressing and splinting.18

Skin Grafts

Two studies showed statistical significance in graft take or graft loss rates comparing NPWT to standard treatment.35,36

A

randomized, double-blind controlled trial revealed 0% grafts were lost in NPWT compared to 12.8% in the control

group.35

A prospective nonrandomized comparative study after 5 days had a statistically significant greater graft take rate

and shorter healing time, 97.8% at 5.8 days versus 84% at 8.9 days in the control group (p<0.05). Four studies did not

show a significant difference.37-40

The sample sizes may have been too small to achieve significance.

Sternal Wounds

The use of NPWT in postoperative mediastinitis has not been evaluated in randomized control studies. Retrospective case

series have primarily been the means supporting the use of NPWT for this indication.15,27-29

The largest series of 68

patients comparing NPWT treatment for sternal wound infections with open packing as the conventional treatment

resulted in decreased number of patients discharged with an open sternum, decreased hospital length of stay and a

significantly shorter time to bacteriological cure. Methodological flaws were noted in this study that may have impacted

the outcome. Sexton et al (2008) concludes “to fully evaluate this technique, a randomized controlled trial is necessary.

Until that time, VAC appears to be a reasonable option in the management of mediastinitis after surgical

debridement.”23,26

NPWT had higher survival rate in one prospective uncontrolled case series (97.1% versus 74.7%)

cumulative rates were not statistically significant. Survival rates were better or similar for NPWT compared with standard

treatment.1

Abdominal Wounds

The use of NPWT for the treatment of abdominal surgical incisions have not been evaluated through randomized control

trials but several small observational studies have shown positive results.30,31,32

One study evaluated NPWT placement

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outcomes on 27 patients. (e.g., 14 total abdominal hysterectomy with bilateral salpingo-oopherectomy with or without

tumor reductive surgery in 14 patients, vulvectomy with or without inguinal lymph node dissection in five patients, skin

or myocutaneous grafting in three patients, parastomal herniorrhaphy in two patients, retroperitoneal lymph node

dissection in two patients, and incision and drainage of a gluteal abscess after radiation therapy in one patient).30

The

majority of participants had the VAC device placed postoperatively for wound failures (23). Four of the 27 patients had

the VAC device placed at the time of a reoperation. The median number of days of NPWT therapy was 32 days (range: 3-

88 days). There was a 96% reduction (range: 0-100%) in the median size of wound from 330 to 14.0 cm3 with use of the

NPWT device. One patient experienced bleeding, and 26 patients experienced no complications. The mean follow-up was

52 days (range: 0-270 days). Complete wound healing was noted in 26 (96%) of 27 patients at the last time of contact.30

A second observational study evaluated 3 patients with complex wound failures of various chronicity. The authors

reported “in all cases, vacuum-assisted closure therapy was well tolerated and demonstrated

efficacy within 48 hours of

initiation”.31

Additional Procedures Required Following NPWT

A randomized control trial of NPWT for split thickness grafts required regrafting (6.7%) compared with (40%)

improvement in the control group.35

The control group in this study did not receive conventional wound therapy. NPWT

was set up but the negative pressure was not used which may have altered the outcome of the control group result. Foot

amputation was required in 3% of MPWT versus 11% in the control group (p=0.06).7

Systematic Reviews

A systematic review regarding the effectiveness of NPWT in the treatment of diabetic foot ulcers was performed in

2008.19

The authors concluded “The studies included in this review generally report positive findings for NPWT, without

any major adverse events. The findings from the strongest study included in the review suggest that NPWT may be

particularly beneficial in relation to wound healing following partial foot amputation. However, most of the studies were

small, heterogeneous and methodologically weak. There is a need for much larger rigorous studies to be undertaken and

to further investigate the effectiveness of NPWT in treating different types of diabetes-related foot ulcers, both as

monotherapy and in conjunction with other treatments.”19

A systematic review of seven RCT’s and 10 other study types were evaluated.34

The quality of the clinical trials were

considered high quality and a large number of prematurely terminated and unpublished trials were found. Statistically

significant differences in favor of NPWT for time to wound closure and incidence of wound closure were noted in 2 of 5

RCT’s and 2 of the 4 non-randomized trials. A meta-analysis of wound size changes that included 4 randomized trials

and 2 non-randomized trials favored NPWT (standardized mean difference: RCT’s, -0.57; non-randomized, -1.30.). The

authors concluded “although there is some indication that NPWT may improve wound healing, the body of evidence is

insufficient to clearly prove an additional clinical benefit of NPWT.”34

The Cochrane Collaboration conducted two reviews for NPWT. The first review evaluated NPWT in the treatment of

chronic wounds. Only randomized control trials were evaluated, seven in total for chronic wound evaluation.21

The

authors concluded “trials comparing TNP with alternative treatments for chronic wounds have methodological flaws and

data do demonstrate a beneficial effect of TNP on wound healing however, better quality research is needed….In

conclusion, at present there is little high-level evidence to support the use of negative pressure in the treatment of chronic

wounds”21

A review was also performed for evaluation of NPWT for partial thickness burns. One randomized control

study met the criteria.22

The authors concluded “there is lack of evidence about whether topical negative pressure therapy

is effective in treating people with partial thickness burns….there is paucity of high quality RCTs on TNP for partial

thickness burn injury with insufficient sample size and adequate power to detect differences between NPWT and

conventional burn wound therapy dressings.”22

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A systematic review was conducted to evaluate various wound types in all settings using NWPT as treatment. The review

included 15 publications and 13 randomized-control trials where NPWT was used to treat diabetic wounds, skin grafts,

acute wounds, chronic wounds, and pressure ulcers. The authors indicated that in chronic wounds and diabetic wounds,

earlier complete wound healing was not found; a 1 to10 day reduction in time to prepare the wound for secondary closure

surgery was noted. In one trial, 17 percent more wounds healed with NPWT (95% CI), the number needed to treat was 6.

An 11% higher complication rate was also noted in the NPWT patients; the number needed to harm was nine. The

authors concluded “there is little evidence to support the use of NPWT in the treatment of wounds.”49

A quantitative meta-analysis of 10 randomized controlled trials was conducted to compare negative-pressure therapy to

standard wound care for chronic wounds. The authors indicated that time to healing was significantly shorter in the

negative-pressure therapy group in comparison with the standard wound care group and that in the negative-pressure

therapy group, wound size had decreased significantly more than in the standard wound care group The authors concluded

that negative-pressure therapy appears to be an effective treatment for chronic wounds but to fully understand the

advantages of negative-pressure therapy, larger registered randomized controlled trials would be needed. 63

Professional Organizations

The Institute for Clinical Systems Improvement (ICSI) developed a health care protocol for pressure ulcer treatments with

an opinion on the use of NPWT based upon evidence review.20

The opinion states “there have been few randomized

controlled trials regarding the net benefit of NPWT compared to more conventional wound treatments and dressings, and

no trials have included greater than 70 total patients. Results have been conflicting in terms of finding significant

differences in efficacy of NPWT compared to other treatments. Therefore, no definitive conclusions regarding the net

comparative net benefit of NPWT can be drawn. This may be due to small sample sizes, and no study has shown NPWT

to be inferior to any conventional treatment, NPWT may increase patient comfort and decrease nursing staff time due to

the need for fewer dressing changes ( about every 48 hours) as compared to conventional dressings. Therefore, NPWT

may be considered in patients with severe (stage III or IV), non-healing pressure ulcers where optimal conventional

treatments have failed to enhance the healing process.”20

The American College of Foot and Ankle Surgeons43

A clinical practice guideline developed by this organization indicates negative pressure wound therapy has been found

particularly useful if the wound fails to show signs of healing, the patient’s vascularity, nutritional status, infection

control, and wound off-loading should also be re-evaluated. The primary goals for diabetic foot ulcers is to obtain wound

closure as quickly as possible.43

The authors also state “Numerous applications of this modality have proven successful,

including use over exposed bone, tendons, and hardware to generate granulation 44

. It is also frequently used to facilitate

adherence of split thickness skin grafts, rotational flaps, or tissue substitutes to a wound bed.”43,44

The European Tissue Repair Society (ETRS)46

The ETRS Open Focus meeting in November 2000 reviewed the general guidelines as developed by ETRS. The

committee presented that the use of NPWT is considered appropriate for poststernotomy disunions (e.g., generally

infected, sternal bone exposed, and large cavity exposing the anterior mediastinal area), large trauma wounds (e.g.,

exposed tendons, bones, closed joints, vessels),large sacral ulcers, and postoperative disunions of the abdominal wall.46

The European Pressure Ulcer Advisory Panel33

The panel consensus following literature review concluded that the following indications are appropriate uses for NPWT:

Poor or inadequate granulation tissue

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An ulcer large enough to allow foam contact at the base and for safe extraction

Full thickness pressure ulcers (Stage III & IV)

Presence of undermine or tunneling

The following are characteristics opposing the use of NPWT:

Inadequate haemostasis

An ulcer too small to allow foam contact with base

Inadequately debrided or desiccated wound beds

Inadequate perfusion to support healing

The Ontario Ministry of Health conducted a health technology assessment regarding NPWT.47

Seven international health

technology assessments were evaluated with six randomized control trials, five of the six were considered low quality

according to grade criteria. The authors concluded “the clinical effectiveness of NPWT to heal wounds in unclear.

Furthermore saline dressings are not the standard of practice in Ontario, thereby rendering the literature base irrelevant in

an Ontario context. Despite the lack of methodologically sound studies, NPWT has diffused across Ontario.”47

The International Negative Pressure Wound Therapy Expert Panel 58-59-60

The panel published new evidence based recommendations for negative pressure wound therapy in the treatment of soft

tissue trauma, open fractures, burns, flaps, and skin grafts and developed consensus statements on acute, chronic, infected

wounds and open abdominal wounds. The panel concluded that there is a paucity of comparative studies including

randomized clinical trials resulting in weaker than wide spread adoption of NPWT. The strongest recommendations were

for the use of NPWT in chronic wounds as a treatment for diabetic foot ulcers and the weakest recommendations were for

venous leg ulcers.

CODING INFORMATION

CPT Description

97605 Negative pressure wound therapy (e.g., vacuum assisted drainage collection), including topical application(s), wound

assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square

centimeters

97606 Negative pressure wound therapy (e.g., vacuum assisted drainage collection), including topical application(s), wound

assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters

HCPCS Description

E2402 Negative pressure wound therapy electrical pump, stationary or portable

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

G0456 Negative pressure wound therapy, (e.g. vacuum assisted drainage collection) using a mechanically-powered device, not durable

medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions

for ongoing care, per session; total wounds(s) surface area less than or equal to 50 sq cm

G0457 Negative pressure wound therapy, (e.g. vacuum assisted drainage collection) using a mechanically-powered device, not durable

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medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions

for ongoing care, per session; total wounds(s) surface area greater than 50 sq cm

ICD-9 Description

172.x* Malignant melanoma of skin x * -Represents range of codes, coverage depends on the specific diagnosis

173.x* Other malignant neoplasm of skin x * -Represents range of codes, coverage depends on the specific diagnosis

250.6x*. Diabetes with neurological manifestations x * -Represents range of codes, coverage depends on the specific diagnosis

250.7.X* Diabetes with peripheral circulatory disorders x * -Represents range of codes, coverage depends on the specific diagnosis

250.8.X* Diabetes with other specified manifestations

440.23 Atherosclerosis of the extremities with ulceration

454.0 Varicose veins of the lower extremity, with ulcer

459.81 Venous peripheral insufficiency, unspecified

707.0.X* Decubitus Ulcer x * -Represents range of codes, coverage depends on the specific diagnosis

707.1. Ulcer of lower limbs , except decubitus

707.8 Chronic Ulcer of other specified sites

707.9 Chronic Ulcer of Unspecified Site

875.1 Open wound of chest wall complicated

877.1 Open wound of buttock complicated

879.1 Open wound of breast, complicated

879.3 Open wound of abdominal wall, anterior, complicated

879.5 Open wound of abdominal wall, lateral, complicated

879.7 Open wound of other and unspecified parts of trunk, complicated

879.9 Open wound(s) (multiple) of unspecified site(s), complicated

885.X*-

887X*

Traumatic amputation, upper limb

890.1 Open wound of hip and thigh

894.1 Multiple and unspecified open wound of lower limb, complicated

946.X* Burns of multiple specified sites x * -Represents range of codes, coverage depends on the specific diagnosis

998.3X* Disruption of operation of wound, dehiscence x * -Represents range of codes, coverage depends on the specific diagnosis

998.83 Nonhealing surgical wound

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ICD-10 Description E11.621 Type 2 DM w/foot ulcer

E11.622 Type 2 DM w/other skin ulcer

E13.621 Oth spec DM w/foot ulcer

E13.622 Oth spec DM w/oth skin ulcer

E10.621 Type 1 DM w/foot ulcer

E10.622 Type 1 DM w/oth skin ulcer

I70.231 Atherosclerosis native art right leg w/ulceration thigh

I70.232 Atherosclerosis native art right leg w/ulceration calf

I70.233 Atherosclerosis native art right leg w/ulceration ankle

I70.234 Atherosclerosis native art right leg w/ulceration heel & midfoot

I70.235 Atherosclerosis native art right leg w/ulceration oth part foot

I70.238 Atherosclerosis native art right leg w/ulceration oth part lw rt le

I70.239 Atherosclerosis native art right leg w/ulceration

I70.241 Atherosclerosis native art left leg w/ulceration thigh

I70.242 Atherosclerosis native art left leg w/ulceration calf

I70.243 Atherosclerosis native art left leg w/ulceration ankle

I70.244 Atherosclerosis native art left leg w/ulceration heel & midfoot

I70.245 Atherosclerosis native art left leg w/ulceration oth part foot

I70.248 Atherosclerosis native art left leg w/ulceration oth part lw lt le

I70.249 Atherosclerosis native art left leg w/ulcer unspec site

I70.25 Atherosclerosis native art other extremity w/ulceration

I83.001 Varicose vns uns lw extremity w/ulcer thigh

I83.002 Varic vns uns lw extremity w/ulcer calf

I83.003 Varic vns uns lw extremity w/ulcer ankle

I83.004 Varic vns uns lw extremity w/ulcer heel & midfoot

I83.005 Varic vns uns lw extremity w/ulcer oth part foot

I83.008 Varic vns uns lw extremity w/ulcer oth part lower leg

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I83.009 Varic vns uns lw extremity w/ulcer unspec site

I83.011 Varic vns right lw extremity w/ulcer thigh

I83.012 Varic vns right lw extremity w/ulcer calf

I83.013 Varic vns right lw ext w/ulcer ankle

I83.014 Varic vns right lw extremity w/ulcer heel & midfoot

I83.015 Varic vns right lw extremity w/ulcer oth part foot

I83.018 Varic vns right lw extremity w/ulcer oth part lower leg

I83.019 Varic vns right lw extremity w/ulcer unspec site

I83.021 Varic vns left lw extremity w/ulcer thigh

I83.022 Varic vns left lw extremity w/ulcer calf

I83.023 Varic vns left lw ext w/ulcer ankle

I83.024 Varic vns left lw extremity w/ulcer heel & midfoot

I83.025 Varic vns left lw extremity w/ulcer oth part foot

I83.028 Varic vns left lw extremity w/ulcer oth part lower leg

I83.029 Varic vns left lw extremity w/ulcer unspec site

L89.93 Pressure ulcer unspec site stage 3

L89.94 Pressure ulcer unspec site stage 4

I70.25 Atherosclerosis native art other extremity w/ulceration

L89.003 Pressure ulcer unspec elbow stage 3

L89.004 Pressure ulcer unspec elbow stage 4

L89.013 Pressure ulcer right elbow stage 3

L89.014 Pressure ulcer right elbow stage 4

L89.023 Pressure ulcer left elbow stage 3

L89.024 Pressure ulcer left elbow stage 4

L89.103 Pressure ulcer unspec part back stage 3

L89.104 Pressure ulcer unspec part back stage 4

L89.113 Pressure ulcer right upper back stage 3

L89.114 Pressure ulcer right upper back stage 4

L89.123 Pressure ulcer left upper back stage 3

L89.124 Pressure ulcer left upper back stage 4

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L89.133 Pressure ulcer right lower back stage 3

L89.134 Pressure ulcer right lower back stage 4

L89.143 Pressure ulcer left lower back stage 3

L89.144 Pressure ulcer left lower back stage 4

L89.153 Pressure ulcer sacral region stage 3

L89.154 Pressure ulcer sacral region stage 4

L89.43 Prss ulcr contig site back buttock & hip stage 3

L89.44 Prss ulcr contig site back buttock & hip stage 4

L89.203 Pressure ulcer unspec hip stage 3

L89.204 Pressure ulcer unspec hip stage 4

L89.213 Pressure ulcer right hip stage 3

L89.214 Pressure ulcer right hip stage 4

L89.223 Pressure ulcer left hip stage 3

L89.224 Pressure ulcer left hip stage 4

L89.43 Pressure ulcer contig site back buttock & hip stage 3

L89.44 Pressure ulcer contig site back buttock & hip stage 4

L89.303 Pressure ulcer unspec buttock stage 3

L89.304 Pressure ulcer unspec buttock stage 4

L89.313 Pressure ulcer right buttock stage 3

L89.314 Pressure ulcer right buttock stage 4

L89.323 Pressure ulcer left buttock stage 3

L89.324 Pressure ulcer left buttock stage 4

L89.43 Pressure ulcer contig site back, buttock & hip stage 3

L89.44 Pressure ulcer contig site back, buttock & hip stage 4

L89.503 Pressure ulcer unspec ankle stage 3

L89.504 Pressure ulcer unspec ankle stage 4

L89.513 Pressure ulcer right ankle stage 3

L89.514 Pressure ulcer right ankle stage 4

L89.523 Pressure ulcer left ankle stage 3

L89.524 Pressure ulcer left ankle stage 4

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L89.603 Pressure ulcer unspec heel stage 3

L89.604 Pressure ulcer unspec heel stage 4

L89.613 Pressure ulcer right heel stage 3

L89.614 Pressure ulcer right heel stage 4

L89.623 Pressure ulcer left heel stage 3

L89.624 Pressure ulcer left heel stage 4

L89.813 Pressure ulcer head stage 3

L89.814 Pressure ulcer head stage 4

L89.893 Pressure ulcer other site stage 3

L89.894 Pressure ulcer other site stage 4

L97.901 Non-prss chr ulcer uns part uns lw leg brkdwn skin

L97.902 Non-prss chrn ulcr uns part uns lw leg fat exosd

L97.903 Non-prss chrn ulcr uns part uns lw leg necros musc

L97.904 Non-prss chrn ulcr uns part uns lw leg necros bn

L97.909 Non-prss chrn ulcr uns part uns lw leg uns sev

L97.911 Non-prss chr ulcer uns part rt lw leg brkdwn skin

L97.912 Non-prss chrn ulcr uns part rt lw leg fat exosd

L97.913 Non-prss chrn ulcr uns part rt lw leg necros musc

L97.914 Non-prss chrn ulcr uns part rt lw leg necros bn

L97.919 Non-prss chrn ulcr uns part rt lw leg uns sev

L97.921 Non-prss chr ulcer uns part lt lw leg brkdwn skin

L97.922 Non-prss chrn ulcr uns part lt lw leg fat exosd

L97.923 Non-prss chrn ulcr uns part lt lw leg necros musc

L97.924 Non-prss chrn ulcr uns part lt lw leg necros bn

L97.929 Non-prss chrn ulcr uns part lt lw leg uns sev

I70.231 Atheroscler nat art rt leg w/ulcer thigh

I70.241 Atheroscler nat art lt leg w/ulcer thigh

I70.331 Atheroscler uns type bp gft rt leg w/ulcer thigh

I70.341 Atheroscler uns type bp gft lt leg w/ulcer thigh

I70.431 Atheroscler autol vein bp gft rt leg w/ulcer thigh

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I70.441 Athscl autol vein bp gft the lt leg ulcer thigh

I70.531 Atheroscler nonautol bio bp gft rt leg w/ulcer thigh

I70.541 Atheroscler nonautol bio bp gft lt leg w/ulcer thigh

I70.631 Atheroscler nonbiol bp gft rt leg w/ulcer thigh

I70.641 Atheroscler nonbiol bp gft lt leg w/ulcer thigh

I70.731 Atheroscler oth type bp gft rt leg w/ulcer thigh

I70.741 Atheroscler oth type bp gft lt leg w/ulcer thigh

L97.101 Non-prss chrn ulcr uns thigh ltd breakdwn skin

L97.102 Non-prss chrn ulcr uns thigh w/fat lay exposed

L97.103 Non prs chrn ulcr unsp thigh w necrosis muscle

L97.104 Non prs chrn ulcr unsp thigh w necrosis bone

L97.109 Non prs chrn ulcr unsp thigh w unspec severity

L97.111 Non-prss chrn ulcr rt thigh ltd breakdwn skin

L97.112 Non-prss chrn ulcr rt thigh w/fat lay exposed

L97.113 Non prss chrn ulcr rt thigh w/necrosis muscle

L97.114 Non prss chrn ulcr rt thigh w/necrosis bone

L97.119 Non prss chrn ulcr rt thigh w/unspec severity

L97.121 Non-prss chrn ulcr lt thigh ltd breakdwn skin

L97.122 Non-prss chrn ulcr lt thigh w/fat lay exposed

L97.123 Non prss chrn ulcr lt thigh w/necrosis muscle

L97.124 Non prss chrn ulcr lt thigh w/necrosis bone

L97.129 Non prss chrn ulcr lt thigh w/unspec severity

I70.232 Atheroscler nat art rt leg w/ulcer calf

I70.242 Atheroscler nat art lt leg w/ulcer calf

I70.332 Atheroscler unspec type bp gft rt leg w/ulcer calf

I70.342 Atheroscler unspec type bp gft lt leg w/ulcer calf

I70.432 Atheroscler autol vein bp gft rt leg w/ulcer calf

I70.442 Atheroscler autol vein bp gft lt le w/ulcer calf

I70.532 Atheroscler nonautol bio bp gft rt leg ulcer calf

I70.542 Atheroscler nonautol bio bp gft lt leg ulcer calf

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I70.632 Atheroscler nonbiolog bp gft rt leg w/ulcer calf

I70.642 Atheroscler nonbiolog bp gft lt leg w/ulcer calf

I70.732 Atheroscler oth type bp gft rt leg w/ulcer calf

I70.742 Atheroscler oth type bp gft lt leg w/ulcer calf

L97.201 Non-prss chrn ulcr uns calf ltd to breaksown skin

L97.202 Non-prss chron ulcr uns calf w/fat lay exposed

L97.203 Non-prss chron ulcr uns calf w/necrosis muscle

L97.204 Non-prss chron ulcr uns calf w/necrosis bone

L97.209 Non-prss chron ulcr uns calf w/unspec severity

L97.211 Non-prss chrn ulcr rt calf ltd to breakdown skn

L97.212 Non-prss chrn ulcr rt calf w/fat layer exposed

L97.213 Non-prss chrn ulcr rt calf w/necrosis muscle

L97.214 Non-prss chrn ulcr rt calf w/necrosis bone

L97.219 Non-prss chrn ulcr rt calf w/unspec severity

L97.221 Non-prss chrn ulcr lt calf ltd to breakdown skn

L97.222 Non-prss chron ulcr lt calf w/fat lay exposed

L97.223 Non-prss chrn ulcr lt calf w/necrosis muscle

L97.224 Non-prss chrn ulcr lt calf w/necrosis bone

L97.229 Non-prss chrn ulcr lt calf w/unspec severity

I70.233 Atheroscler nat art rt leg w/ulcer ankle

I70.243 Atheroscler nat art lt leg w/ulcer ankle

I70.333 Atheroscler uns type bp gft rt leg w/ulcer ankle

I70.343 Atheroscler uns type bp gft lt leg w/ulcer ankle

I70.433 Atheroscler autol vein bp gft rt leg w/ulcer ankle

I70.443 Atheroscler autol vein bp gft lt leg w/ulcer ankle

I70.533 Atheroscler nonautol bio bp gft rt leg w/ulcer ankle

I70.543 Atheroscler nonautol bio bp gft lt leg w/ulcer ankle

I70.633 Atheroscler nonbiolog bp gft rt leg w/ulcer ankle

I70.643 Atheroscler nonbiolog bp gft lt leg w/ulcer ankle

I70.733 Atheroscler oth type bp gft rt leg w/ulcer ankle

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I70.743 Atheroscler oth type bp gft lt leg w/ulcer ankle

L97.301 Non-prss chron ulcr uns ankle ltd to breakdown skin

L97.302 Non-prss chron ulcr uns ankle w/fat layer exposed

L97.303 Non-prss chron ulcr uns ankle w/necrosis muscle

L97.304 Non-prss chron ulcr uns ankle w/necrosis bone

L97.309 Non-prss chron ulcr uns ankle w/unspec severity

L97.311 Non-prss chron ulcr rt ankle ltd to breakdown skin

L97.312 Non-prss chron ulcr rt ankle w/fat layer exposed

L97.313 Non-prss chron ulcr rt ankle w/necrosis muscle

L97.314 Non-prss chron ulcr rt ankle w/necrosis bone

L97.319 Non-prss chron ulcr rt ankle w/unspec severity

L97.321 Non-prss chron ulcr lt ankle ltd to breakdown skin

L97.322 Non-prss chron ulcr lt ankle w/fat layer exposed

L97.323 Non-prss chron ulcr lt ankle w/necrosis muscle

L97.324 Non-prss chron ulcr lt ankle w/necrosis bone

L97.329 Non-prss chron ulcr lt ankle w/unspec severity

I70.234 Atherscler nat art rt leg w/ulcer heel & midfoot

I70.244 Atherscler nat art lt leg w/ulcer heel & midfoot

I70.334 Atherscler uns type bp gft rt le ulcer heel & midfoot

I70.344 Atherscler uns type bp gft lt le ulcer heel & midfoot

I70.434 Atherscler autol vein bp gft rt leg ulcer heel & midfoot

I70.444 Atherscler autol vein bp gft lt leg ulcer heel & midfoot

I70.534 Atheroscler nonautol bio bp gft rt leg ulcer heel & midfoot

I70.544 Atheroscler nonautol bio bp gft lt leg ulcer heel & midfoot

l70.634 Atheroscler nonbio bp gft rt leg ulcer heel & midfoot

I70.644 Atheroscler nonbio bp gft lt leg ulcer heel & midfoot

I70.734 Atheroscler oth type bp gft rt leg ulcer heel & midfoot

I70.744 Atheroscler oth type bp gft lt leg ulcer heel & midfoot

L97.401 Non-prss chrn ulcr uns heel & midfoot ltd to breakdown skin

L97.402 Non-prss chron ulcr uns heel & midfoot w/fat layer exposed

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L97.403 Non-prss chron ulcr uns heel & midfoot /nec muscle

L97.404 Non-prss chron ulcr uns heel & midfoot /nec bone

L97.409 Non-prss chron ulcr uns heel & midfoot /un severity

L97.411 Non-prss chrn ulcr rt heel & midfoot breakdown skin

L97.412 Non-prss chron ulcr rt heel & midfoot w/fat layer exposed

L97.413 Non-prss chrn ulcr rt heel & midfoot/nec muscle

L97.414 Non-prss chrn ulcr rt heel & midfoot /necrosis bone

L97.419 Non-prss chrn ulcr rt heel & midfoot/unsp severity

L97.421 Non-prss chrn ulcr lt heel & midfoot ltd to breakdown skin

L97.422 Non-prss chron ulcr lt heel & midfoot w/fat layer exposed

L97.423 Non-prss chrn ulcr lt heel & midfoot/nec muscle

L97.424 Non-prss chrn ulcr lt heel & midfoot /necrosis bone

L97.429 Non-prss chrn ulcr lt heel & midfoot/unsp severity

I70.235 Atheroscler nat art rt leg w/ulcer oth part foot

I70.245 Atheroscler nat art lt leg w/ulcer oth part foot

I70.335 Atherscler uns type bp gft rt le ulcer oth prt foot

I70.345 Atherscler uns type bp gft lt le ulcer oth prt foot

I70.435 Atherscler autol vein bp gft rt leg ulcer oth part foot

I70.445 Atherscler autol vein bp gft lt leg ulcer oth part foot

I70.535 Atheroscler nonautol bio bp gft rt leg ulcer other part foot

I70.545 Atheroscler nonautol bio bp gft lt leg ulcer other part foot

I70.635 Atheroscler nonbio bp gft rt leg ulcer other part foot

I70.645 Atheroscler nonbio bp gft lt leg ulcer other part foot

I70.735 Atheroscler oth type bp gft rt leg ulcer other part foot

I70.745 Atheroscler oth type bp gft lt leg ulcer other part foot

L97.501 Non prs chr ulcr oth prt unsp foot/breakdown skin

L97.502 Non-prss chr ulcr other part uns foot w/fat layer ex

L97.503 Non-prss chrn ulcr other part uns foot/ necr muscle

L97.504 Non-prss chron ulcr other part uns foot/necr bone

L97.509 Non-prss chr ulcr other part uns foot/unsp severity

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L97.511 Non-prss chron ulcr other part rt foot brkdwn skin

L97.512 Non-prss chrn ulcr oth part rt foot/fat layer exposd

L97.513 Non-prss chrn ulcr oth part rt foot/necrosis muscle

L97.514 Non-prss chrn ulcr oth part rt foot/necrosis bone

L97.519 Non-prss chrn ulcr oth part rt foot/unspec severity

L97.521 Non-prss chrn ulcr oth part lt foot/brkdwn skin

L97.522 Non-prss chrn ulcr oth part lt foot/fat layer exposd

L97.523 Non-prss chrn ulcr oth part lt foot/necrosis muscle

L97.524 Non-prss chrn ulcr oth part lt foot/necrosis bone

L97.529 Non-prss chrn ulcr oth part lt foot/unspec severity

I70.238 Atherscler nat art rt leg w/ulcer oth part lw rt le

I70.239 Atherscler nat art rt leg w/ulceration

I70.248 Atherscler nat art lt leg w/ulcer oth part lw lt le

I70.249 Atheroscler nat art lt leg w/ulceration

I70.338 Atheroscler uns typ bp gft rt le ulcer oth part lw leg

I70.339 Atheroscler uns type bp gft rt leg w/ulcer

I70.348 Atheroscler uns type bp gft lt le ulc other prt lw leg

I70.349 Atheroscler uns type bp gft lt leg w/ulcer

I70.438 Athscl autol vein bp gft rt le ulcr oth part leg

I70.439 Athscl autol vein bp gft(s) rt le w/ulcr of unspec site

I70.448 Atheroscl auto vein bp gft lt le ulcer oth part lowleg

I70.449 Atherosclr auto vein bp gft lt leg w ulcr unsp site

I70.538 Athscl nonauto bio bp gft rt leg ulcr oth part lowleg

I70.539 Athscl nonauto bio bp gft rt leg w/ulcr unsp site

I70.548 Athscl nonauto bio bp gft lt leg ulcr oth part low leg

I70.549 Athscl nonauto bio bp gft lt leg w/ulcr unspec site

I70.638 Athscl nonbio bp gft rt leg ulcr oth prt low leg

I70.639 Athscl nonbio bp gft rt leg w/ ulcr unspec site

I70.648 Athscl nonbio bp lt le ulcr oth prt lw leg

I70.649 Athscl nonbio bp lt leg w/ ulcer unspec site

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Page 25 of 29

I70.738 Athscl type bp rt leg ulcer oth part low leg

I70.739 Athscl type bp rt leg w/ulcer unspec site

I70.748 Athscl oth type bp lt leg w/ulcer oth part low leg

I70.749 Athscl oth type bp lt leg w/ulcer unspec site

L97.801 Non-prs chr ulcer oth prt unsp low leg /bkdn skin

L97.802 Non-prs chr ulcr oth prt unsp low leg w/fat layer ex

L97.803 Non-prs chr ulcr oth prt unsp low leg w/necr muscl

L97.804 Non-prs chr ulcr oth prt unsp low leg w/necr bone

L97.809 Non-prs chr ulcr oth prt unsp low leg w/unsp sever

L97.811 Non-prs chr ulcer oth prt unsp rt low leg /bkdn skin

L97.812 Non-prs chr ulcr other part rt lw leg w/fat layer ex

L97.813 Non-prs chr ulcr other part rt lw leg w/necrosis musc

L97.814 Non-prs chr ulcr other part rt lw leg w/necrosis bone

L97.819 Non-prs chr ulcr other part rt lw leg w/unsp severity

L97.821 Non-prs chr ulcr oth prt lt lw leg w/brkdwn skin

L97.822 Non-prs chr ulcr oth prt lt lw leg w/fat layer exposd

L97.823 Non-prs chr ulcr oth prt lt lw leg w/necrosis muscle

L97.824 Non-prs chr ulcr oth prt lt lw leg w/necrosis bone

L97.829 Non-prs chr ulcr oth prt lt lw leg w/unspec severity

L98.411 Non-prss chron ulcer buttock w/brkdwn skin

L98.412 Non-prss chron ulcer buttock w/fat layer exposed

L98.413 Non-prss chron ulcer buttock w/necrosis muscle

L98.414 Non-prss chron ulcer buttock w/necrosis bone

L98.419 Non-prss chron ulcer buttock w/unspec severity

L98.421 Non-prss chron ulcer back w/breakdown skin

L98.422 Non-prss chron ulcer back w/fat layer exposed

L98.423 Non-prss chron ulcer back w/necrosis muscle

L98.424 Non-prss chron ulcer back w/necrosis bone

L98.429 Non-prss chron ulcer back w/unspec severity

T30.0 Burn unspec body rgn unspec degree

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Page 26 of 29

T30.4 Corrosion uns body rgn unspec degree

T30.0 Burn unspec body rgn unspec degree

T30.4 Corrosion uns body rgn unspec degree

T30.0 Burn unspec body rgn unspec degree

T30.4 Corrosion uns body rgn unspec degree

T30.0 Burn unspec body rgn unspec degree

T30.4 Corrosion uns body rgn unspec degree

T30.0 Burn unspec body rgn unspec degree

T30.0 Burn unspec body rgn unspec degree

T30.4 Corrosion uns body rgn unspec degree

T81.30xA Disruption wound unspecified init enc

T81.32xA Disrupt internal operation surg wound nec init enc

T81.31xA Disrupt ext operation surg wound nec init enc

T81.33xA Disruption of traumatic injury wound repair init enc

T81.89xA Other complications proc nec init enc

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