LCD L38902: Wound and Ulcer Care

Compliance with the provisions in this policy 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 NCD 20.29)

• Initial physical therapy or occupational therapy evaluations

• Skin Substitutes for Wound Care

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

• Treatment of burns

• Services covered under the DME benefit

For the purposes of this LCD, wound care is defined as care of wounds and ulcers 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, progressing through normal phases of the healing cycle, or

• The care of wounds that normally heal by primary intention such as clean, incised traumatic wounds that have approximated edges.

• 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 should lead to a plan of care, to include a comprehensive medical evaluation, vascular assessment , and a metabolic/nutritional evaluation. Functional evaluations by different specialties, and integration of physical therapy may also be of value. Reduction of pressure and/or control of infection have been shown to facilitate healing and may reduce the need for repeated debridement services.

The general discipline of wound care may involve almost any part of the integumentary system. Elements of a previously retired policy particularly focusing on lower extremity care have been incorporated here. Ulcers may develop because of a combination of ischemia, infection, abscess, trauma, prolonged pressure, repetitive stress, venous and arterial insufficiency, edema, and loss of sensation. The management of ulcers includes:

• Overall medical and surgical treatment of the cause and

• Meticulous care of the ulcerated skin and other associated soft tissue with application of medications and dressings, and

• When reasonable and necessary, debridement of the necrotic and devitalized tissue and

• Offloading of the external pressure source(s).

The management of a symptomatic hyperkeratosis may involve medical treatment, paring or cutting, shaving, excision, or destruction. This policy addresses only the paring or cutting approach. These services are coverable and not inclusive of Routine Foot Care when the medical record details the symptoms leading to the need for treatment.

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 healing is being maintained in response to the wound care being provided.

Consistent measurement of a wound is essential for the documentation of wound healing and fundamental to good patient care decision making. Wound measurements are consistently reported in terms of length, depth and width, attention to wound volume should be added, when possible. Undermining, tunneling, and the severely contracted patient are acknowledged to compromise both wound measurement and wound healing and should be described in the medical record.

• Undermining and tunneling are reported by location according to numbers on a clock, oriented so that the patient’s head is at 12 o’clock and feet are at 6 o’clock.

• Undermining is measured by inserting a cotton swab under intact skin at the wound’s edge at the point of longest extension under the skin.

• Tunneling is measured by inserting a swab into the deepest channel.

• Infection is reported by describing wound exudate – amount, turbidity, color, and odor – and signs of infection (cellulitis) in the tissue surrounding the wound.

• Necrosis is the ultimate loss of tissue vitality. The presence of devitalized tissue impedes healing.

Ongoing wound care may include debridement to promote healing. The patient’s clinical status and the characteristics of the wound will determine the appropriate method of debridement, its frequency, and the interval between treatments.

Please see “Covered Indications” for more information on debridement methods.

Wound care must be performed in accordance with accepted standards for medical and surgical treatment of wounds. The goal of most acute wound or chronic ulcer care should be eventual wound closure with or without grafts, cellular or tissue products, or other surgery (such as amputation, wound excision, etc.). Standard wound care measures include, but are not limited to, appropriate control of complicating factors such as pressure (e.g., off-loading, padding, and 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. Frequent debridement suggests a need to reassess and reexamine the treatment plan to ensure that clinicians are addressing all facets of care.

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 policy:

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 in the treatment of acute wounds, chronic venous, diabetic and pressure ulcers. May be used to provide gentle debridement, moisture control, prevent bacterial overgrowth, for thermal insulation and for physical protection.

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

Covered Indications

• 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.

• Wounds complicated by necrotic tissue and/or eschar.

• 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, curette, 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 appropriate use of dressings. Removal of debris and dressing changes are not considered a skilled or separate 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.

• Wound Care Surgical Debridements

• 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 require the use of anesthesia.

• Use of Evaluation and Management (E/M) Codes in Conjunction with Surgical Debridements

• 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.

• Negative Pressure Wound Therapy (NPWT)

• See coverage provisions of the Noridian Durable Medical Equipment (DME) LCD L33821

• Low-Frequency, Non-Contact, Non-Thermal Ultrasound

• 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.

• Low-Frequency, Non-Contact, Non-Thermal Ultrasound 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 where the normal process of healing has not progressed as expected at 30 days.

• Low-frequency, non-contact, non-thermal ultrasound is considered reasonable and necessary when provided two to three times per week. 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.

• Application of Paste Boot (Unna Boot) may be of value, as is the use of Total Contact Casting. Application of a Multi-Layer Compression System may be a useful component of wound care management, particularly with venous ulcerations of the lower extremity.

Limitations

• 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.

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

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

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

• 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.

• Complicating circumstances that support additional wound care services as reasonable and necessary must be supported by adequate medical record documentation.

• Autolytic debridement is contraindicated for infected wounds.

• Debridement of extensive eczematous or infected skin is not appropriate for debridement of a localized amount of tissue normally associated with a circumscribed lesion. Examples of this are ulcers, furuncles, and localized skin infections.

• Surgical debridement will be considered not reasonable and necessary when documentation indicates the wound is without devitalized, fibrotic, nonviable tissue, infection, necrosis, foreign matter, or if the wound has pink to red granulated tissue. When utilized, it is expected that the frequency of debridement will decrease over time.

A chronic wound is defined as a wound that has failed to progress through normal healing in a timely manner; they generally occur in patients with comorbid conditions, such as diabetes or vascular disease.

Older adults are more likely to have chronic ulcers, and to have quality of life affected by such ulcers.

Chronic ulcers are more challenging to treat and are associated with higher treatment costs, especially in the Medicare population. Chronic ulcers include, but are not limited to, diabetic ulcers, vascular ulcers, and pressure ulcers. 1-3

Evidence-based clinical guidelines and other published evidence support the following for chronic wound care: 4-15