Negative Pressure Wound Therapy

POLICY NUMBER

A.1.01.16

DESCRIPTION

Negative pressure wound therapy (NPWT) involves the use of negative pressure or suction devices to aspirate and remove fluids, debris, and infectious materials from the wound bed to promote the formation of granulation tissue and wound healing.

Chronic Wounds

ManagementThe management and treatment of chronic wounds, including decubitus ulcers, is challenging. Furthermore, certain racial and ethnic groups, including African Americans, Hispanics, and Native Americans, experience higher diabetes prevalence, contributing to disparities in the risk for diabetic ulcers; these disparities are exacerbated when inequalities in access to health care result in delayed diagnosis and management.

Most chronic wounds will heal only if the underlying cause (ie, venous stasis, pressure, infection) is addressed. Also, cleaning the wound to remove non-viable tissue, microorganisms, and foreign bodies is essential to create optimal conditions for either re-epithelialization (ie, healing by secondary intention) or preparation for wound closure with skin grafts or flaps (ie, healing by primary intention). Therefore, debridement, irrigation, whirlpool treatments, and wet-to-dry dressings are common components of chronic wound care.

Negative pressure wound therapy (NPWT) involves the use of a negative pressure therapy or suction device to aspirate and remove fluids, debris, and infectious materials from the wound bed to promote the formation of granulation tissue. The devices may also be used as an adjunct to surgical therapy or as an alternative to surgery in a debilitated patient. Although the exact mechanism has not been elucidated, it is hypothesized that negative pressure contributes to wound healing by removing excess interstitial fluid, increasing the vascularity of the wound, reducing edema, and/or creating beneficial mechanical forces thatlead to cell growth and expansion.

A non-powered (mechanical) NPWT system has also been developed; the Smart Negative Pressure Wound Care System is portable and lightweight (3 oz) and can be worn underneath clothing. This system consists of a cartridge, dressing, and strap; the cartridge acts as the negative pressure source. The system is reported to generate negative pressure levels similar to other NPWT systems. This system is fully disposable.

Negative pressure therapy or suction devices cleared by the U.S. Food and Drug Administration (FDA) for treating chronic wounds include, but are not limited to:

• Vacuum-Assisted Closure® Therapy (V.A.C., also known as negative pressurewound therapy; 3M™/KCI);

• Versatile 1™ (V1) Wound Vacuum System (Blue Sky Medical);

• RENASYS™ EZ PLUS (Smith & Nephew);

• Foryou NPWT NP32 Device (Foryou Medical Electronics);

• SVED® (Cardinal Health); and

• PICO Single Use Negative Pressure Wound Therapy System (Smith & Nephew).

Portable systems include the RENASYS™ GO (Smith & Nephew), XLR8 PLUS (Genadyne Biotechnologies), extriCARE® 2400 NPWT System (Devon Medical), the V.A.C. Via™ (KCI), NPWT PRO to GO (Cardinal Health), and the PICO Single Use Negative Pressure Wound Therapy System (Smith & Nephew). The Prevena™ Incision Management System (KCI) is designed specifically for closed surgical incisions.

A non-powered NPWT device, the SNaP® Wound Care System (now SNAP™ Therapy System) (3M™/ previously Spiracur, acquired by Acelity in 2015), was cleared for marketing by the FDA in 2009 through the 510(k) pathway (K081406) and is designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute, or subacute wounds and diabetic and pressure ulcers.

Negative pressure wound therapy devices with instillation include the V.A.C. VERAFLO™ Therapy device (3M™/KCI/Acelity). It was cleared for marketing in 2011 by the FDA through the 510(k) pathway (K103156) and is designed to allow for controlled delivery and drainage of topical antiseptic and antimicrobial wound treatment solutions and suspensions. It is to be used with the V.A.C. Ulta unit, which is commercially marketed for use in the hospital setting. Instillation is also available with Simultaneous Irrigation™ Technology tubing sets (Cardinal Health) for use with Cardinal Health SVED® and PRO NPWT devices, however, its use is not indicated for use in a home care setting (K161418).

No NPWT device has been cleared for use in infants and children.

In November 2009, the FDA issued an alert concerning complications and deaths associated with NPWT systems. An updated alert was issued in February 2011.

POLICY

Prior authorization is required.

1. The services rendered under this policy must be rendered by Blue Cross & Blue Shield of Mississippi Network Providers. Care Management approval is required.

2. The negative pressure wound therapy device may be managed in the Outpatient or Home Health setting.  Please review the Member’s benefits and eligibility for Home Health Care services prior to submitting a prior authorization request for negative pressure wound therapy management in the home setting.

3. The Prior Authorization request for negative pressure wound therapy must be submitted by a Home Health Agency, Discharging Hospital, or Prescribing Provider for consideration using the Home Health & Hospice Authorization Request form. Requests for negative pressure wound therapy from Durable Medical Equipment (DME) Companies will not be accepted.

Initiation of Powered Negative Pressure Wound Therapy (NPWT):

Negative pressure wound therapy is subject to quality of care review.

An initial therapeutic trial of not less than 2 weeks using a powered negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors, such as diabetes, nutrition, relief of pressure, etc., may be considered medically necessary in the following indications:

• Chronic (>90 days) stage III or IV pressure ulcers that have failed to heal despite optimal wound care when there is high-volume drainage that interferes with healing and/or when standard dressings cannot be maintained due to anatomic factors, or

• Traumatic or surgical wounds where there has been a failure of immediate or delayed primary closure, AND there is exposed bone, cartilage, tendon, or foreign material within the wound, or

• Wounds in individuals with underlying clinical conditions that are known to negatively impact wound healing, which are non-healing (at least 30 days), despite optimal wound care. (Examples of underlying conditions include, but are not limited to diabetes, malnutrition, small vessel disease, and morbid obesity. Malnutrition, while a risk factor, must be addressed simultaneously with the negative pressure wound therapy.)

Continuation of Powered NPWT:

Continuation of the powered NPWT system, as part of a comprehensive wound care program, may be considered medically necessary following an initial 2-week therapeutic trial if the treatment trial has resulted in documented objective improvements in the wound, and if there is ongoing objective improvement during subsequent treatment. Objective improvements in the wound should include the development and presence of healthy granulation tissue, progressive wound contracture and decreasing depth, and/or the commencement of epithelial spread from the wound margins.

Continuation of the powered NPWT system is considered investigational when any of the following occurs:

• The therapeutic trial or subsequent treatment period has not resulted in documented objective improvement in the wound, OR

• The wound has developed evidence of wound complications contraindicating continued NPWT, OR

• The wound has healed to the extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments.

Therapeutic trials of powered NPWT systems for the treatment of other acute or chronic wounds except as noted above are considered investigational.

Use of single-use NPWT systems (powered or nonpowered) is considered investigational for the treatment of acute or chronic wounds, including but not limited to diabetic, venous, surgical, and traumatic wounds.

POLICY EXCEPTIONS

State Health Plan (State and School Employees):  Effective 01/01/2021, prior authorization is not required. However, negative pressure wound therapy will be reviewed for medical necessity based on medical policy guidelines.

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Contraindications to the use of negative pressure wound therapy (NPWT) systems include the following conditions as noted in a 2009 U.S. Food and Drug Administration (FDA) alert:

• necrotic tissue with eschar

• untreated osteomyelitis

• nonenteric and unexplored fistulae

• malignancy in the wound

• exposed nerve

• exposed anastomotic site

• exposed organ.

In a 2011 update, the FDA noted additional deaths and injury reports with NPWT since 2009. Although rare, these complications can occur wherever NPWT systems are used, including hospitals, long-term care facilities, and at home. Bleeding was the cause of the most serious adverse events, including deaths. Most reports of wound infection were related to the retention of dressing pieces in the wounds. Recommendations for health care providers include the following: select individuals for NPWT carefully knowing that NPWT systems are contraindicated for certain wound types, and individual risk factors must be thoroughly considered before use; assure that the individual is monitored frequently in an appropriate care setting by a trained practitioner; be aware of complications associated with dressing changes such as infection and bleeding; be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur. The FDA reported that the safety and effectiveness of NPWT systems in newborns, infants, and children had not been established and currently, there are no NPWT systems cleared for use in these populations.

Continuation of healing during use of the NPWT system should be monitored on a frequency not less than every 14 days.

Complete healing of a wound would normally be anticipated if all bone, cartilage, tendons, and foreign material were completely covered, healthy granulation were present to within 5 mm of the surface, and the wound edges were reduced to 2 cm in width or diameter.

Powered negative pressure wound therapy systems should be used as part of a comprehensive wound care program that includes attention to other factors that impact wound healing such as diabetes control, nutritional status, and relief of pressure, etc.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

12/31/2014: Approved by Medical Policy Advisory Committee. This policy replaces the Vacuum-Assisted Closure of Chronic Wounds medical policy. Effective 01/01/2015.

02/11/2015: Policy description updated regarding devices. Policy statement unchanged.

07/31/2015: Code Reference section updated for ICD-10.

03/07/2016: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.

05/26/2016: Policy number A.1.01.16 added.

01/26/2017: Policy description updated regarding devices. Policy statements unchanged.

01/30/2018: Policy description updated. Policy Guidelines updated regarding contraindications for negative pressure wound therapy systems.

02/14/2019: Policy reviewed; no changes.

02/07/2020: Policy reviewed; no changes.

12/09/2020: Policy Exceptions updated to add the following for State Health Plan Participants: Effective 01/01/2021, prior authorization is not required. However, negative pressure wound therapy will be reviewed for medical necessity based on medical policy guidelines.

03/23/2022: Policy description updated regarding devices. Investigational statement updated for clarity, stating: Use of single-use NPWT systems (powered or nonpowered) is considered investigational for the treatment of acute or chronic wounds, including but not limited to diabetic, venous, surgical, and traumatic wounds. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted HCPCS codes G0456 and G0457.

02/13/2023: Policy description updated regarding devices. Policy statements and Policy Guidelines updated to change "patients" to "individuals." "Not medically necessary" policy statements changed to "investigational."

02/09/2024: Policy description updated regarding management of chronic wounds. Policy statements unchanged.

04/30/2024: Policy reviewed; no changes.

02/24/2025: Policy reviewed; no changes.

08/01/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 1.01.16

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes

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