LCD L37166: Wound Care

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

This LCD does not address specific wound care procedures described by NCD’s and other items such as:

• Hyperbaric Oxygen (HBO) Therapy (See LCD L36504)

• Therapy and Rehabilitation Services (See LCD L33413)

• Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities (See LCD L36377)

• Strapping

• Electrical Stimulation and Electromagnetic Therapy of Specified Wounds (See NCD 270.1)

• Treatment of burns

For the purposes of this LCD, wound care is defined as care of wounds that are refractory to healing or have complicated healing cycles either because of the nature of the wound itself or because of complicating metabolic and/or physiological factors. This definition excludes the following:

• Management of acute wounds, or

• The care of wounds that normally heal by primary intention such as clean, incised traumatic wounds, or

• Surgical wounds that are closed primarily and other postoperative wound care not separately covered during the surgical global period.

Various methods to promote wound healing have been devised over time. A method which is unproven by valid scientific literature would be considered not reasonable and necessary. Wound care involves the evaluation and treatment of a wound, including identifying potential causes of delayed wound healing and the modification of treatment when indicated. Wound evaluations may require a comprehensive medical evaluation, vascular evaluation, orthopedic evaluation, functional evaluation, metabolic/nutritional evaluation, and a plan of care. Reduction of pressure and/or control of infection have been shown to facilitate healing and may reduce the need for repeated debridement services.

Medicare coverage for wound care on a continuing basis for a given wound in a given patient is contingent upon evidence documented in the patient's medical record that the wound is improving in response to the wound care being provided. Evidence of improvement may include measurable changes in the following:

• Drainage

• Inflammation

• Swelling

• Pain and/or tenderness

• Wound dimensions (surface measurements, depth)

• Granulation tissue

• Necrotic tissue/slough

• Tunneling or undermining

Wound care must be performed in accordance with accepted standards for medical and surgical treatment of wounds. The goal of most chronic wound care should be eventual wound closure with or without grafts, skin replacements, or other surgery (such as amputation, wound excision, etc.). Adjunctive measures include but are not limited to appropriate control of complicating factors such as pressure (e.g., off-loading, padding, appropriate footwear), infection, vascular insufficiency, metabolic derangement and/or nutritional deficiency. While complete healing of the wound may be the primary objective, a secondary desired objective is that, with appropriate management, a wound may reach a state at which its care may be performed primarily by the patient and/or the patient’s caregiver with periodic physician assessment and supervision.

In appropriate cases, due to severe underlying debility or other factors such as operability, the goal of wound care provided in outpatient settings may be only to prevent progression of the wound and prevention of prolonged hospitalization.

Active wound care procedures involve selective and non-selective debridement techniques and are performed to remove devitalized tissue and promote healing. The provider is required to have direct (one-on-one) patient contact when performing active wound care management.

The appropriate interval and frequency of debridement depends on the individual clinical characteristics of the patient and the extent of the wound.

It is highly recommended that the treatment plan for a patient who requires frequent repeated debridement be reevaluated to ensure that issues including, but not limited to, pressure reduction, nutritional status, vascular insufficiency, and infection control have been adequately addressed. Overall, evaluation of the wound should be performed at a regular frequency to determine whether the individualized treatment goals are being met for the patient.

Definition of terms for this LCD:

Dressing Changes for Wound Debridement

• Wet dressings: Water and medication may be applied to the skin with dressings (e.g., finely woven cotton or gauze) soaked in solution. Wet compresses, especially with frequent changes, may provide gentle debridement.

• Dry dressings: Used to provide gentle debridement, protect the skin, hold medications against the skin, keep clothing and sheets from rubbing, or keep dirt and air away. Such dressings may also prevent patients from scratching or rubbing the wound.

• Advanced dressings: Used with increasing frequency to provide gentle debridement in the treatment of acute wounds, chronic venous, diabetic and pressure ulcers.

• Dressing changes (removal and subsequent reapplication) alone generally do not require the skills of physicians. They may be performed by physical therapists, occupational therapists, licensed professional nurses, or wound care nurses.

Covered Indications

1. Medicare would expect that wound care may be necessary for the following types of wounds:

• Surgical wounds that must be left open to heal by secondary intention.

• Infected open wounds induced by trauma or surgery.

• Wounds with biofilm.

• Wounds associated with complicating autoimmune, metabolic, and vascular or pressure factors.

• Open or closed wounds complicated by necrotic tissue and/or eschar.

2. Active Wound Care Management

Debridement may be indicated whenever necrotic tissue as well as cellular or proteinaceous debris is present on an open wound in order to keep the wound in an active state of healing. Debridement may also be indicated in cases of abnormal wound healing or repair. The routine application of a topical or local anesthetic does not elevate active wound care management to surgical debridement. Debridement may be categorized as selective or non-selective.

Wound Care Selective Debridement includes:

Removal of specific, targeted areas of devitalized or necrotic tissue from a wound along the margin of viable tissue by sharp dissection utilizing scissors, scalpel, curettes, and/or tweezers/forceps. This procedure typically requires no anesthesia and generally has no or minimal associated bleeding.

Wound Care Non-Selective Debridement may include:

Mechanical Debridement: This type of debridement is the removal of necrotic tissue by cleansing or application of a wet-to-dry or dry-to-dry dressing technique. Wet-to-dry dressings should be used judiciously as maceration of surrounding tissue may hinder healing. Generally, dressing changes are not considered a skilled service.

Enzymatic Debridement: Debridement with topical enzymes is used when the necrotic substances to be removed from a wound are protein, fiber, and collagen. The manufacturer’s product insert contains indications, contraindications, precautions, dosage and administration guidelines; it is the clinician’s responsibility to comply with those guidelines.

Autolytic Debridement: This type of debridement is indicated where manageable amounts of necrotic tissue are present, and there is no infection. Autolytic debridement occurs when the enzymes that are naturally found in wound fluids are sequestered under synthetic dressings.

Maggot/larvae therapy: debridement with medical-grade maggots in wounds.

3. Wound Care Surgical Debridement

• Conditions that may require surgical debridement of large amounts of skin may include but are not limited to: rapidly spreading necrotizing process (sometimes seen with aggressive streptococcal infections), severe eczema, extensive skin trauma (including large abraded areas with ground-in dirt), or autoimmune skin diseases.

• Surgical debridement occurs only if material has been excised and is typically reported for the treatment of a wound to clear and maintain the site free of devitalized tissue including but not limited to necrosis, eschar, slough, infected tissue, biofilm, abnormal granulation tissue, etc., and should be accomplished to the margins of viable tissue.

• These procedures can be very effective but represent extensive debridement. They may be complex in nature and may on occasion require the use of anesthesia.

4. Use of Evaluation and Management (E/M) Codes in Conjunction with Surgical Debridement

• Patients who have chronic wounds may frequently have underlying medical problems that require concomitant management in order to bring about wound closure. In addition, patients may require education, other services, and coordination of care both in the preoperative and postoperative phases of the debridement procedure. An E/M service provided and documented on the same day as a debridement service may be covered by Medicare only when the documentation clearly establishes the service as a "separately identifiable service" that was reasonable and necessary, as well as distinct, from the debridement service(s) provided.

5. Negative Pressure Wound Care (NPWT)

• Negative pressure wound therapy (NPWT), utilizing either durable or disposable medical equipment, is a method of wound care to manage wound exudates and promote wound closure. The vacuum-assisted drainage collection (i.e., NPWT) may be applied in an effort to cleanse the wound by removing fluids and stimulate the wound bed in order to reduce localized edema and improve local oxygen supply.

• NPWT involves the application of controlled or intermittent negative pressure to a properly dressed wound cavity. Suction (negative pressure) is applied under airtight wound dressings to promote the healing of open wounds resistant to prior treatments.

• NPWT for non-healing wounds is medically necessary when at least one of the following conditions is met:

• There are complications of a surgically created wound (e.g., dehiscence, post sternotomy disunion with exposed sternal bone, post sternotomy mediastinitis, or postoperative disunion of the abdominal wall).

• There is a traumatic wound (e.g., preoperative flap or graft, exposed bones, tendons, or vessels) and a need for accelerated formation of granulation tissue not achievable by other topical wound treatments (e.g., the individual has comorbidities that will not allow for healing times usually achievable with other available topical wound treatments).

• There is a chronic, non-healing ulcer with lack of improvement despite standard wound therapy, including the application of dressings, debridement of necrotic tissue (if present), maintenance of an adequate nutritional status, and weekly evaluations with documentation of wound measurements (i.e., length, width, and depth) in ONE of the following clinical situations:

• Acute wounds

• Subacute and dehisced wounds

• Traumatic wounds

• Ulcers (such as diabetic or pressure)

• Chronic Stage III or Stage IV pressure ulcer

• Chronic diabetic neuropathic ulcer

• Chronic venous ulcer

• Flaps and grafts

6. Low-Frequency, Non-Contact, Non-Thermal Ultrasound (MIST Therapy)

• Low frequency, non-contact, non-thermal ultrasound describes a system that uses continuous low-frequency ultrasonic energy to produce and propel a mist of liquid and deliver continuous low-frequency ultrasound to the wound bed. This modality is often referred to as “MIST Therapy.”

• Low-frequency, non-contact, non-thermal ultrasound (MIST Therapy) is considered reasonable and necessary wound therapy and therefore eligible for coverage by Medicare when provided for any of the following clinical conditions:

• Wounds and ulcers which are too painful for sharp or excisional debridement and have failed conventional debridement with documentation supporting the same.

• Wounds and ulcers meeting Medicare coverage for debridement but with documented contraindications to sharp or excisional debridement.

• Wounds and ulcers meeting Medicare coverage for debridement but with documented evidence of no signs of improvement after 30 days of standard wound care.

• Low-frequency, non-contact, non-thermal ultrasound (MIST Therapy) may be provided two to three times per week to be considered reasonable and necessary. The length of individual treatments will vary per wound size.

• Observable, documented improvements in the wound(s) should be evident after six treatments. Improvements include documented reduction in pain, necrotic tissue, or wound size, or improved granulation tissue.

7. Application of Paste Boot (Unna Boot) or Application of Multi-Layer Compression System may be useful adjuncts to wound care management.

Limitations

1. Wound care should employ comprehensive wound management including appropriate control of complicating factors such as unrelieved pressure, infection, vascular and/or uncontrolled metabolic derangement, and/or nutritional deficiency in addition to appropriate debridement. Medicare coverage for professional wound care procedures requires that all applicable adjunctive measures are also employed as part of comprehensive wound management. Wound care in the absence of such measures, when they are indicated, is not considered to be medically reasonable and necessary.

2. Debridement will be considered not reasonable and necessary for a wound that is clean and free of necrotic tissue/slough.

3. Debridements are considered selective or non-selective unless the medical record supports that a surgical excisional debridement was performed.

4. Debridements are best provided under an individualized plan of care.

5. Wound care may be of a palliative nature. Optimally, the overall goal of care is healing, and it would be neither reasonable nor medically necessary to continue a given type of wound care if evidence of wound improvement leading to healing of the wound as outlined in this LCD cannot be shown. However, if it is determined that the goal of care is not wound healing, which would lead ultimately to wound closure, the patient should be managed following appropriate palliative care standards. Wounds of some Medicare beneficiaries residing in Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs) may not close, heal, or be amenable to self-care in spite of optimal therapy. In those patients where wound closure, healing, or self-care is not a likely outcome, the goals of wound care may include prevention of hospitalization and improvement in quality of life. As such, due to severe underlying debility or other factors, the goal of wound care provided in these settings may be only to prevent progression of the wound by stabilizing the wound by:

• minimizing the risk of infection and further progression of the wound;

• managing the multiple issues that cause patient and family suffering; and

• optimizing the patient’s function and quality of life.

An article was published in Wound Repair and Regeneration on “Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: A multicenter randomized controlled trial” in January 2012 by DG Armstrong, WA Marston, AM Reyzelman, and RS Kirsner. This was a 17-center prospective, randomized controlled clinical trial designed to evaluate the relative impact on wound closure using the “mechanically powered” Smart Negative Pressure (SNaP) Wound Care System (Spiracur, Inc.) vs. the “electrically powered” Vacuum-Assisted Closure (VAC) Therapy System (KCI, San Antonio, TX). One hundred thirty-two (132) patients were enrolled with non-infected, non-ischemic, non-plantar lower extremity diabetic and venous wounds. Eighty-three patients (n = 41 SNaP, n = 42 VAC) completed the study with either healing or 16 weeks of therapy. The study provides evidence that treatment of wounds using a disposable NPWT device (SNaP System) compared to a traditional NPWT device (VAC System) have similar results but have less impact on the patient’s quality of life. Potential conflict of interest is that this study was sponsored by Spiracur Inc. and two of the authors received research funding from both Spiracur (SNaP device) and KCI (VAC device). The quality of evidence is low; the strength of recommendation is weak.

“Comparison of high-frequency and MIST ultrasound therapy for the healing of venous leg ulcers” by Beheshti A, Shafigh Y, Parsa H, and Zangivand AA was published in the 2014 Advances in Clinical and Experimental Medicine . The aim of the year-long randomized controlled study of 90 patients was to analyze the effect of standard ulcer care alone (compression bandages) with high-frequency ultrasound (HFU) and MIST ultrasound therapy (US) on venous leg ulcers (VLUs). The patients were chosen from patients with VLUs who had received wound care at the hospital outpatient vascular clinic of Shahid Rajaii Hospital. Patients were instructed to contact the clinic monthly and recurrence of VLUs was recorded for six months after complete wound healing. Study results showed no significant differences in recurrence between groups during a six-month follow-up after complete wound healing. All VLUs in the study healed within one year. Recurrence was observed in four cases in the standard group (13.3%); two cases in the HFU group and two cases in the MIST US group (6.6%). The authors stated their results were lower than similar studies but state the 6-month follow-up is very short to truly decide about the potential of prevention of recurrence in patients treated with US therapy. Mean age was 58.5 years (SD 11.6 years).The authors concluded the study showed significant effectiveness of ultrasound therapy, especially MIST therapy, in wound healing as an adjuvant therapy. They noted differences between the two ultrasound therapy groups were not statistically significant. Exclusion criteria were listed. The design of this study presents limitations including selection bias. The report states the patients were randomized but suggests the study may not have been blinded. Other limitations to this study were a small sample size and inconsistency across studies when comparisons were made. The authors compare the results of their study to other studies of different sample size, different ages, unknown co-morbidities and different wound types. The authors remark that additional work on cost-effectiveness outcomes and planning are greatly needed for the future studies. Note: This study was conducted outside the U.S. and does not largely represent the Medicare population. The quality of evidence is low; the strength of recommendation is weak.

The 2007 Journal of Palliative Medicine article by Ferris, Al Khateib, and Fromantin, “Palliative wound care: managing chronic wounds across life’s continuum: a consensus statement from the International Palliative Wound Care Initiative,” is a consensus statement which recognizes that while most chronic wounds will eventually heal if managed appropriately, some will not. In patients with non-healable wounds, therapies that aim to heal the wound may not be in anyone’s best interest. The Initiative recognizes that the expertise and skills in palliative wound care can improve the quality of life of all individuals living with or affected by healing and non-healing chronic wounds and is guided by the philosophy that the opportunity exists to negotiate personalized goals of care to optimize quality of life through an interdisciplinary approach to care. Quality of evidence is low. Strength of recommendation is weak.

The 2015 “Debridement for venous leg ulcers (Review)” by Gethin, Cowman, and Kolbach is a Cochrane Database Systematic Review done through search of a wide range of electronic data bases for randomized controlled trials (RCTs), either published or unpublished, which compared methods of debridement or compared debridement with no debridement. Ten RCTs were identified involving a total of 715 participants. These studies were selected independently by two review authors who completed all study selection, data extraction and assessment of trial quality; resolution of disagreements was completed by a third review author. Eight RCTs evaluated autolytic debridement and included the following agents or dressings: biocellulose wound dressing (BWD), non-adherent dressing, honey gel, hydrogel (gel formula), hydrofibre dressing, hydrocolloid dressings, dextranomer beads, Edinburgh University Solution of Lime (EUSOL) and paraffin gauze. Two RCTs reported enzymatic preparations and one evaluated biosurgical debridement. No RCTs evaluated surgical, sharp or mechanical methods of debridement, or debridement versus no debridement. The systematic review had the following weaknesses: study results were presented in a narrative form, small populations, heterogeneity of outcomes, and lack of comparability across trials, inconsistent methodology across trials and there was a high risk of bias since most of the RCTs had high risk of bias. The authors conclude there is limited evidence to suggest that actively debriding a venous leg ulcer has a clinically significant impact on healing. The overall small number of participants, low number of studies and lack of meta-analysis in this review precludes any strong conclusions of benefit. Comparisons of different autolytic agents (hydrogel versus paraffin gauze; Dextranomer beads versus EUSOL and BWD versus non adherent dressings) and Larvae versus hydrogel all showed statistically significant results for numbers of wounds debrided. Larger trials with follow up to healing are required. The quality of evidence is low; the strength of recommendation is weak.