The purpose of the Negative Pressure Wound Therapy (NPWT) device is to promote wound healing. Wound healing is defined as improvement occurring in either surface area or depth of the wound. Lack of improvement of a wound is defined as a lack of progress in quantitative measurements of wound characteristics including wound length and width (surface area), or depth measured serially and documented over a specified time interval.

NPWT pumps/Vacuum Assisted Closure (VAC) for nonhealing wounds may be considered medically necessary when ANY of 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  individual’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

o    Chronic stage III or IV pressure ulcers:

§  The individual has been on an appropriately turned and positioned schedule; and

§  The individual has used a support surface for pressure ulcers on the trunk or pelvis; and

§  The  individual’s moisture and incontinence have been appropriately managed; or

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

§  The individual 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

o    Venous or arterial insufficiency ulcers:

§  Compression bandages and/or garments have been consistently applied; and

§  Leg elevation and ambulation have been encouraged; or

o    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 are 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, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

All other uses of NPWT pumps/VAC systems for the treatment of chronic wounds are considered not medically necessary.

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

• Fifteen (15) dressing kits 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 an individual. Therefore, more than one (1) pump billed per individual for the same time period is considered not medically necessary.

The pump and supplies are 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.