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

NPWT pumps/VAC for nonhealing wounds may be considered medically necessary when the following conditions are met:

Ulcers and Wounds in the Outpatient Setting

• Chronic, nonhealing stage III or IV pressure ulcer, neuropathic (e.g., diabetic) ulcer, venous or arterial insufficiency ulcer, or chronic ulcer of mixed etiology (i.e., present for at least 30 days); and
• Wound therapy program, as described below, (applicable to the type of wound) have been tried or considered and ruled out prior to application of NPWT pumps/VAC.
  • All ulcers or wound types (i.e., surgically created, traumatic), must include ALL of the following therapeutic measures addressed, applied, or considered and ruled out prior to application of NPWT pumps/VAC:
    • Documentation in the patient's medical record of evaluation, care and wound measurements by a licensed medical professional  (i.e., physician, PA, CRNP, RN, LPN, RPT); and
    • Application of dressings to maintain a moist wound environment; and
    • Debridement of necrotic tissue if present; and
    • Evaluation of and provision for adequate nutritional status; or
  • Chronic stage III or IV pressure ulcers:
    • The patient has been on an appropriately turned and positioned schedule; and
    • The patient has used a support surface for pressure ulcers on the trunk or pelvis; and
    • The patient's moisture and incontinence have been appropriately managed; or
  • Neuropathic (e.g., diabetic, ulcers)
    • The patient has been on a comprehensive diabetic management program; and
    • Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities (i.e., saline wet-to-dry dressings; debridement etc.); and
    • Appropriate foot care (i.e., visual inspection, appropriate foot wear, etc.); or
  • Venous or arterial insufficiency ulcers:
    • Compression bandages and/or garments have been consistently applied; and
    • Leg elevation and ambulation have been encouraged; or
  • Surgically created wound or traumatic wound:
    • The wound requires accelerated formation of granulation tissue that cannot be achieved by other available topical wound treatments (e.g., comorbidities that prevent healing); and
    • Results of previous wound treatments are documented.

Ulcers and Wounds Encountered in an Inpatient Setting

• NPWT pumps/VAC may be considered medically necessary when continuation of treatment is ordered beyond discharge to the home setting.
• An ulcer or wound is encountered in the inpatient setting and after wound treatments have been tried or considered and ruled out, NPWT pumps/VAC is initiated because it is considered, in the judgment of the treating physician, the best available treatment option.
• Complications of a surgically created wound (e.g., dehiscence, post-sternotomy disunion with exposed sternal bone, etc.) or traumatic wound, (e.g., preoperative flap or graft, exposed bones), where there is documentation of the medical necessity for accelerated formation of granulation tissue which cannot be achieved by other available topical wound treatments (e.g., other conditions that will not allow for healing times achievable with other topical wound treatments).

If the above criteria are not met for the use of NPWT pumps/VAC systems in either setting, the pump and supplies will be considered not medically necessary.

NPWT pumps/VAC systems and their supplies used in the treatment of children from birth up to and including 12 years of age are considered experimental/investigational and, therefore, non-covered. According to the U.S. Food and Drug Administration (FDA), the safety and effectiveness of NPWT pumps/VAC systems in newborns, infants and children (greater than or equal to 12 years of age) has not been established at this time. Currently there are no NPWT pumps/VAC systems cleared for use in these populations.

Supplies
Supplies for NPWT pumps/VAC are limited to the following. Requests for amounts greater than the stated limits will be denied as not medically necessary.

• Fifteen (15) dressing kits per wound per month - Additional dressing kits per month must be supported by documentation that the wound size requires more than one dressing kit for each dressing change.
• Ten (10) canister sets per month - Additional canister sets per month must be supported by documentation that a large volume of drainage (greater than 90 ml of exudate per day) requires more than one canister set.

The NPWT pumps/VAC must be prescribed by a physician and be capable of accommodating more than one (1) wound dressing set for multiple wounds on a individual. Therefore, more than one (1) pump billed per individual for the same time period will be considered not medically necessary.

The pump and supplies will be considered not medically necessary with ANY of the following, whichever occurs first:

• Adequate wound healing has occurred to the degree that NPWT pumps/VAC may be discontinued, in the judgment of the treating physician; or
• Any measurable degree of wound healing has failed to occur over the prior month as documented in the individual’s records; or
• Four (4) months (including the time NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using an NPWT pumps/VAC device in the treatment of any wound.

Coverage beyond four (4) months will be given individual consideration based upon additional documentation.

This additional documentation must address the initial condition of the wound including measurements, efforts to address all aspects of wound care, subsequent monthly wound measurements, and what changes in wound therapy are being applied to effect wound healing. This information must be updated with each subsequent request for additional months of use of NPWT pumps/VAC.

NPWT pumps/VAC of chronic wounds is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Diagnosis Codes

• Link to References