Medical Policy

D-1039-002

Policy Id

HHO-DE-MP-1039

Topic

Negative Pressure Wound Therapy in the Outpatient Setting

Section

Archived Policies

Effective Date

Jun 10, 2024

Issued Date

May 10, 2024

Last Revision Date

05/2024

Annual Review

06/2025

Prepared By

K. O'Toole

THIS IS NO LONGER AN ACTIVE POLICY. POLICY WAS ARCHIVED ON 03/18/2025

DISCLAIMER

Highmark medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.

POLICY STATEMENT

This policy provides information regarding the coverage of, as determined by applicable federal and/or state legislation. 

This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.

The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations. 

Policy Position

Prior Authorization

Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool https://www.highmarkhealthoptions.com/providers/prior-auth-lookup

Procedures

Negative Pressure Wound Therapy may be considered medically necessary when the following criteria are met for all wound types:

A.    The patient must be age 12 and older; AND

B.    A complete wound care program has been tried which includes all of the following:

1.     Documentation in the medical record by a licensed medical professional on the current and previous wound care management and wound healing progress; AND

2.     The patient has a complex wound where size, depth, location, complications, exudate amount, etiology and/or other specific factors support non-feasibility of healing with moist topical dressing; AND

3.     Wound care physician notes contain an initial wound measurement followed by measurements at a minimum of once a month. Documentation must show the progress of the healing wound and anticipated duration of vacuum assisted wound therapy (e.g., degree of wound healing required); AND

4.     Controlling of comorbid conditions diabetes, nutritional issues, and pressure relief at wound site (Note: See Contraindications and Precautions Below); AND

5.     Operative note or wound care notes if requests are for treatment in surgical and/or traumatic wounds; AND

6.     If the initiation of NPWT occurred during an inpatient stay, the initial date of service is to be documented.

C.    Use of vacuum assisted wound devices in the outpatient setting are considered medically necessary appropriate for the following conditions:

1.     Chronic Stage III or IV pressure ulcers (>30 days) that have failed to heal despite optimal wound care when:

a.     Standard dressings cannot be maintained due to anatomic factors; AND

b.     The patient’s incontinence and/or moisture issues have been appropriately managed; AND

c.     There has been use of group 2 or 3 support surface for pressure ulcers on the trunk or pelvis; OR

2.     Neuropathic (e.g., diabetic) ulcers

a.     The patient has been actively involved in a comprehensive diabetic management; AND

b.     Pressure on a foot ulcer has been appropriately reduced using medically appropriate modalities; OR

3.     Venous or arterial insufficiency ulcers or chronic ulcers of mixed etiology

a.     Compression bandages OR garments have been applied appropriately; AND

b.     Elevating the affected extremity has been maintained while the patient is sedentary; AND

c.     Ambulation/leg exercises that promote circulation have been encouraged and utilized; AND

d.     For initiation of vacuum assist wound device in the home setting, the ulcer must have been present for at least 30 days; OR

4.     Traumatic or surgical wounds (i.e., preoperative flap or graft, exposed bones, tendons, or vessels) that need accelerated formation of granulation tissue; not achievable by other topical wound treatments (e.g., comorbid conditions of the patient that will hamper appropriate healing with other topical wound treatments) and no contraindications to negative pressure wound therapy. The following traumatic or surgical wound conditions include:

a.     Wounds refractory to standard wound regimens; OR

b.     Burns; OR

c.     Complications of surgically created wounds (i.e., dehiscence, post-sternotomy disunion with exposed sternal bone, post-sternotomy mediastinitis, or post-operative disunion of the abdominal wall) which may include the use of skin grafts to assist in wound closure.

Note: The individual NPWT pump is able to accommodate more than one wound dressing set for multiple wounds on a patient. If more than one NPWT pump is utilized on the patient during the same period, the service will be denied as not medically necessary.

The following supplies are medically necessary for negative pressure wound therapy, including:

A.    Wound care sets will be limited to up to 15 dressing kits per wound, per month. Documentation must be provided to support the medical necessity for requests in excess of limitation.

B.    Canister sets will be limited to 10 per month in most cases. Documentation must be provided showing evidence that a large volume of drainage exists.

Example: Documentation must show an exudate amount greater than 90 ml of exudate per day.

Note: Vacuum assist devices are capable of accommodating more than one wound dressing set for multiple wounds on a patient. Therefore coverage for more than one pump per patient for the same time period will be considered noncovered and not medically necessary.

Continuation of Services

A.    Continuation of the powered vacuum assist wound device is considered medically necessary following an initial two week therapeutic trial or a subsequent period if the treatment has resulted in documented improvements of the wound; AND

B.    Coverage for the medically necessary powered vacuum assist wound device will end when the treating physician reports adequate wound healing has occurred to the degree where the device may be discontinued; AND

C.    There must be documentation by the wound care physician regarding wound healing.    Documentation of wound progress measurements include:

1.     Decrease wound size (length, width, depth, undermining, tunneling); AND

2.     Increased granulation tissue; AND

3.     Increase epithelialization; AND

4.     Decreased wound odor; AND

5.     Decreased wound pain; AND

6.     Decreased volumes of exudate; AND

D.    Continued use of this therapy should be reviewed against outcome criteria at the beginning of therapy, at each dressing change or, at a minimum of every two weeks and reported on a monthly basis

E.    Recent laboratory values do not demonstrate a contraindication exists.

Note: In some circumstances, the use of this treatment modality when initiated in the inpatient setting may not meet the criteria for use in the outpatient setting. A review for medical necessity determination by a Medical Director will be performed.

Contraindications

The wound being treated must be free of the following absolute contraindications for NPWT:

A.    No vacuum assisted wound device has been cleared for use in infant and children. Patient size and weight should be considered when prescribing this device; OR

B.    Exposed anastomotic site; OR

C.    Exposed nerves; OR

D.    Exposed organs; OR

E.    Exposed vasculature; OR

F.    Malignancy in the wound; OR

G.    Necrotic tissue with eschar present; OR

H.    Non-enteric and unexplored fistulas; OR

I.      Untreated osteomyelitis; OR

J.     Severe peripheral arterial disease: Ankle Brachial Pressure Index ≤ 0.5 needs investigation, and if appropriate, revascularization prior to commencement of vacuum assist device; OR

Precautions

A.    The following factors have been identified as risks to wound healing and should be adequately addressed by the ordering provider:

1. Active smoking

 2. Obesity

3.  Poorly managed diabetes

4, Pulmonary disease

5. Uremia

6. Ascites

7. Anemia

8.  Jaundice

9. Steroid Use

B.    Malnourished patients who have not received adequate nutrition/nutritional supplements (e.g., hyperalimentation).

C.    Caution should be used for patients with neuropathic or circulatory compromise.

D.    Caution should be used towards non-concordant or combative patients.

E.    Caution should be used towards patients with infected wounds; they may require more frequent dressing changes.

F.    Patients with burns; the devitalized burned tissue must be debrided prior to application of NPWT.

G.    Patients with wounds in close proximity to blood vessels, delicate fascia, vital organs or exposed tendons (ensure adequate protection with overlying fascia, tissue or other protective barriers).

H.    Bone fragments or sharp edges could puncture protective barriers, vessels, or organs causing injury. Any injury could cause bleeding, which, if uncontrolled results could be fatal.

I.      The dressing must be removed if defibrillation is required in the area of dressing placement. Failure to remove the dressing may inhibit transmission of electrical energy and/or patient resuscitation.

J.     The therapy unit is MRI unsafe and should not be taken in the MRI environment; dressings can typically remain on the patient with minimal risk in an MRI environment.

K.    Hyperbaric Oxygen Therapy (HBOT): the therapy unit is unsafe in the hyperbaric oxygen chamber and is considered a fire hazard. Care must be taken with the dressing to ensure HBO compatible.

L.     Precautions need to be taken in patients receiving long-term anticoagulant therapy, hemophilia and patients with hemoglobinopathies, such as sickle cell.

The NPWT services are not covered and considered not medically necessary when:

A.    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, OR

B.    In the judgment of the treating physician the adequate wound healing has occurred to the degree that NPWT may be discontinued and the wound can be anticipated to heal completely with other wound care treatments; OR

C.    Any measurable degree of wound healing has failed to occur over the prior month. Wound healing is defined as improvement occurring in either surface area (length X width) or depth of the wound; OR

D.    The patient/caregiver is unable/unwilling to follow the plan of care; OR

E.    The wound has developed evidence of a wound complication contraindicating continued use of the device

F.    NPWT that extends beyond four months (this includes NPWT applied in an inpatient setting prior to discharge to the home) is considered not medically necessary and requires Medical Director Review.

Any conditions not listed in criteria above will be considered not medically necessary since the scientific evidence has not been established. Examples of indications not covered include, but are not limited to:

  • Use following cardiac surgery not meeting medical necessity criteria above;
  • Use following surgical excision of pilonidal sinus and/or recurrent pilonidal disease;
  • Use of device as a preventive/prophylactic intervention in patients with surgical wounds, such as a diagnosis of diabetes or obesity as risk factors, ventral hernia repair or post cesarean delivery, post knee arthroplasty or kidney transplantation;
  • Use of chemotherapeutic agents in intermittent instillation with NPWT.

Use of a nonpowered vacuum assist device (e.g., SNaP® system) or a battery operated (A9272), disposable system (e.g., PICO™ system) have not been proven in peer-reviewed literature as medically effective and are not medically necessary for the treatment of acute and/or chronic wounds.

If it is determined during the course of treatment for an initial wound that the NPWT system will be applied to additional wounds, all additional wounds must meet the criteria listed in this policy to determine medical necessity.

DME

The negative pressure wound therapy device (E2402) is classified as a DME rental item and may be subject to prior authorization requirements.

Post-Payment Audit Statement

The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement.

Place of Service

For the purposes of this policy, the place of service for vacuum assisted wound therapy is in the home setting.

Governing Bodies Approval

On December 20, 2002, the VAC device received premarket approval to include the indication of partial-thickness burns.

On November 13, 2009, the U.S. Food and Drug Administration (FDA) released a Medical Device Alert regarding the use of negative pressure wound therapy systems. The alert notified medical practitioners of possible death or serious complications due to the use of the vacuum assisted wound therapy systems. Per the FDA, it had received reports of six deaths and 77 injuries associated with this device over the two years. Major complications reported included bleeding and infection. The alert provided the recommendations to reduce risks with the device:

A.    More careful selection of patients for vacuum assisted wound therapy;

B.    Assure that patient monitoring is performed frequently in an appropriate care setting by a trained practitioner. To determine the frequency of monitoring, the provider must consider the patient’s condition, including wound status, wound location and comorbidities;

C.    Proper training must be obtained prior to prescribing and using the device;

D.    Instructions for proper home use of the vacuum assisted wound therapy device to the patient and/or caregiver must be given. This instruction is to include how to use the device, potential complications and their signs and symptoms, and management of complications.

In addition, the FDA listed the following contraindications for vacuum assisted wound therapy:

A.    Necrotic tissue with eschar present

B.    Untreated osteomyelitis

C.    Non-enteric and unexplored fistulas

D.    Malignancy (within the wound)

E.    Exposed blood vessels, nerves, anastomoses, or organs

 

Rembursement

Participating facilities will be reimbursed per their Highmark Health Options contract.

ELIGIBLE PROCEDURE CODES

 

CPT code

Description

97605

Negative pressure wound therapy (e.g., vacuum assisted drainage collection), utilizing durable medical equipment, 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), utilizing durable medical equipment, including topical application(s), wound assessment, and instruction(s) for ongoing care, per session, total wound(s) surface area greater than 50 square centimeters.

A6550

Wound care set, for negative pressure wound therapy electrical pumps, includes all supplies and accessories.

A7000

Canister, disposable, used with suction pump, each.

A7001

Canister, nondisposable, used with suction pump, each.

E2402

Negative pressure wound therapy electrical pump, stationary or portable.

 

NONCOVERED PROCEDURE CODES

(These procedure codes will not be reimbursed without Medical Director approval)

 

CPT code

Description

A9272

Wound suction, disposable, includes dressing, all accessories and components, any type, each (not covered).

K0743

Suction pump, home model, portable, for use on wounds [for use with NPD 1000).

K0744

Absorptive wound dressing for use with suction pump, home model, portable, pad size 16 square inches.

K0745

Absorptive wound dressing for use with suction pump, home model, portable, pad size more than 16 square inches but less than or equal to 48 square inches.

K0746

Absorptive wound dressing for use with suction pump, home model, portable, pad size greater than 48 square inches.

 

 

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T81.31XA

T81.4XXA

T81.89XA

 

 

 

 

Summary of Literature

Negative pressure wound therapy (NPWT) is a vacuum assisted wound device that has been used in clinical applications for more than five decades. The concept of applying topical negative pressure in the management of wounds emerged in the late 1980s and is increasingly used for a wide variety of wounds. The merits of vacuum assisted wound therapy in the outpatient setting for a variety of wounds such as ulcers related to pressure sores, venous or arterial insufficiency or neuropathy and other wounds have been studied in a number of clinical contexts. NPWT has triggered accelerated wound healing in the outpatient setting which has reduced wound dressing, visits to specialists, and hospitalizations (Lukasz, 2014). An additional positive result of NPWT include significant antibacterial effects by reducing subcutaneous edema (Lukasz, 2014). NPWT devices are classified as either powered (requiring electric power source) or non-powered (mechanical) or battery operated.

It is important to note that these devices are adjunctive therapy and are not intended to replace good basic wound care (i.e., daily wound measurements of dimension and depth, wet dressing applications, necrotic debridement, adequate overall nutrition, and minimization of disease activity of comorbid conditions.

Numerous for NPWT include:

  1. Decubitus (pressure) ulcers
  2. Neuropathic ulcers
  3. Ulcers related to venous or arterial insufficiency
  4. Dehisced wounds or wound with exposed hardware or bone
  5. Post sternotomy wound infection or mediastinitis, or
  6. Complications of a surgically created wound where exhibiting accelerated granulation therapy is necessary and cannot be achieved by other available topical wound treatment.

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

There are concerns surrounding the quantification of exudate levels within clinical research and day-to-day treatment of wounds (Mulder, 1994). The characteristics of wound exudate vary heavily, in regard to factors such as, wound type, underlying patient conditions, wound bed description, and chronic or acute wound. These influencing factors make it difficult to standardize a specific exudate level for vacuum assisted wound therapy or any other wound therapy (Mulder, 1994). Gerit D. Mulder, the CEO of the Wound Healing Institute in Denver, Colorado produced an exudate output classification for chronic wounds, including:

  1. Absent (dry)
  2. Minimal (less than 5cc per 24 hours)
  3. Moderate (5-10 cc per 24 hours)
  4. High (more than 10 cc per 24 hours

According to the Journal of Wound Care (2014), Mulder terminology is familiar in the clinical environment but is not practical in clinical practice due to the numerous factors of wounds. Managing and decreasing exudate production is an important function within NPWT, a licensed clinical professional must assess the fluid quantity and type. A wound vacuum device removes exudate from a wound by applying the negative pressure which can be increased or decreased depending on the needs of the wound.

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

The electric pump applies intermittent or continuous negative pressure to an open cell foam or gauze wound dressing. The dressing evenly distributes pressure to the wound surface. In early stages of healing, fluid is withdrawn by the device, removing inhibitory factors and reducing bacterial counts. In later stages, tensile forces applied to surrounding tissues by the dressing are thought to stimulate cellular proliferation and protein synthesis.

CMS partnered with the AHRQ and commissioned a review of NPWT devices. AHRQ contracted with the ECRI Institute Evidence-based Practice Center to perform the review (AHRQ, 2009). A technology assessment report on NPWT prepared for the AHRQ found that “the systematic reviews of NPWT reveal several important points about this technology. First, all of the systematic reviews noted the lack of high-quality clinical evidence supporting the advantages of NPWT compared to other wound treatments. The lack of high-quality NPWT evidence resulted in many systematic reviewers relying on low-quality retrospective studies to judge the efficacy of this technology. Second, the other systematic reviews found no studies directly comparing different NPWT devices or components have been published. Direct comparison studies are especially important in determining which dressing approach (foam or gauze) may provide the best potential for wound healing. Third, other systematic reviews concluded that NPWT must be evaluated according to wound type. Wound healing varies according to the type of wound being treated and NPWT benefits described for one wound type cannot be transferred to other wound types. Most wound types have insufficient high-quality NPWT evidence to judge if NPWT is better than standard care for specific wounds. Studies comparing foam to gauze are needed for each wound type before decisions can be made about which systems or components offer significant therapeutic distinctions.”

In 2012, the Cochrane Review conducted a systematic review of NPWT to surgical incisions using wound healing as the primary outcome of interest. Unfortunately, assessing the efficacy of NPWT by attempting to determine when a surgical incision is "completely healed" is a difficult endpoint to measure. A more clinically relevant question is how the application of NPWT affects the rate of surgical site complications.

Zhang (2014) conducted a meta-analysis to evaluate the effectiveness and safety of NPWT for diabetic ulcers. Eight qualified studies were identified with a total of 669 patients. Overall, use of the NPWT resulted in a significantly higher proportion of healed diabetic foot ulcers, reduction of ulcer area and shorter time to wound healing. Use of this therapy resulted in fewer major amputations but the rate of minor amputations was not impacted.

NPWT used in a prophylactic role has been reported in primarily observational studies. While there have been a small number of small trials, the use of prophylactic NPWT cannot be supported. Larger randomized trials are needed in order to determine health outcomes and cost effectiveness (Gestring, 2018).

Discontinuation criteria for incisional NPWT have not been clearly defined and may vary according to incision and patient factors. Reported duration of incisional therapy varies between 1 and 5 days in the literature. Reddix et al. (2009) reported discontinuation of incisional NPWT at the point when no edema fluid was evident in the device canister for 12 hours, usually 24 to 72 hours after surgery.

There are a number of non-powered, portable, disposable NPWT systems. The Smart Negative Pressure (SNaP®) Wound Care System, received 510(k) clearance from the FDA in 2009 and is designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute, or subacute wounds and diabetic and pressure ulcers. The device consists of a cartridge that acts as the negative pressure source, a dressing, and a strap and can be worn under clothing. The cartridge utilizes specialized springs that generate continuous negative pressure and is preset at negative 75, 100, or 125 mmHg, weighs less than 3 ounces, and has a 60 cc capacity. The dressing is a hydrocolloid dressing with an antimicrobial gauze wound interface layer. (Powered NPWT systems usually have a foam-based interface layer.)

A single use, disposable NPWT device, the PICO™ system, received 510(k) clearance from the FDA in 2012 and is designed to remove low to moderate amounts of exudate. The system uses batteries instead of electrical power and instead of using a canister, the exudate is absorbed into the dressing. The pump is programmed to stop working after 168 hours (7 days) of use and will not restart after that time, even with new batteries.

According to one manufacturer (Smith-Nephew), optimal wound healing has occurred when:

  • Initial therapy objectives have been met
  • 100% granulation tissue in the wound bed
  • Granulation tissue level with the surrounding skin
  • Patient’s overall condition/wound is improving
  • Wound bed is ready to take a skin graft/flap
  • Exudate levels less than 20-50 mls per day
  • No improvement/reduction in size of wound is seen in the wound bed following two consecutive dressing change

The use of the disposable, single use portable NPWT systems are not supported in scientific literature. Clinical trials fail to provide sufficient evidence to support improvement in net health outcomes compared to alternatives (Armstrong et al., 2012, Gabriel et al., 2013, and Hudson et.al. 2013)

PRESSURE ULCERS

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.

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 includes 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.

 

References

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