LCD L37228: Wound Care

This Local Coverage Determination (LCD) offers coverage indications and guidelines for wound care involving debridement, electrical stimulation and electromagnetic therapy, negative pressure wound therapy, low frequency non-contact non-thermal ultrasound (MIST Therapy), and topical oxygen therapy (TOT).

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.

Active wound care procedures are performed to remove necrotic tissue and/or devitalized tissue to promote healing. Providers are responsible to determine medical necessity and use the appropriate current CPT/HCPCS code for service provided. Please consult the current AMA CPT book for the complete code description of the procedures being performed to submit claims.

This LCD supplements but does not replace, modify, or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for additional wound care. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify, or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations, and rules for Medicare payment for additional wound care sessions and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies are provided in CMS National Coverage Policy section.

This policy does not address metabolically active human skin equivalent/substitute dressings, burns, skin cancer or hyperbaric oxygen therapy.

Debridement

Debridement is defined as the removal of foreign material and/or devitalized or contaminated tissue from or adjacent to a traumatic or infected wound until surrounding healthy tissue is exposed. This LCD applies to debridement of localized areas such as wounds and ulcers. The mere removal of secretions, cleansing of a wound, does not represent a debridement service.

At least 1 of the following conditions must be present and documented:

• Pressure Injury, Stage II, III or IV,

• Venous insufficiency ulcers,

• Arterial insufficiency ulcers including diabetic lower extremity ulcers,

• Dehiscenced wounds,

• Wounds with exposed hardware or bone,

• Neuropathic ulcers,

• Neuroischaemic ulcers,

• Diabetic Foot Ulcer(s)

• Complications of surgically created or traumatic wound where accelerated granulation therapy is necessary which cannot be achieved by other available topical wound treatment.

Should deep tissue pressure injury or Stage II injury progress to Unstageable, Stage III or Stage IV requiring debridement then documentation supporting this must be included in the medical record

Goals of Debridement:

Remove devitalized tissue

Decrease risk of infection

Promote wound healing

Prevent further complications

Debridement may be categorized as selective or non-selective:

Selective debridement refers to the removal of specific, targeted areas of devitalized or necrotic tissue from a wound along the margin of viable tissue. Occasional bleeding and pain may occur. The routine application of a topical or local anesthetic does not elevate active wound care management to surgical debridement. Selective debridement includes selective removal of necrotic tissue by sharp dissection including scissors, scalpel, and forceps; and selective removal of necrotic tissue by high-pressure water jet. Selective debridement should only be done under the specific order of a physician.

Wound Care Non-Selective Debridement includes:

• Surgical debridement is excision or wide resection of all necrotic or devitalized tissue, possibly including excision of the viable wound margin. This is usually carried out in the operating room by a surgeon. Anesthesia is usually required. It is frequently used for deep tissue infection, drainage of abscess or involved tendon sheath, or debridement of bone.

• Sharp debridement is the removal of necrotic or foreign material just above the level of viable tissue and is performed in an office setting or at the patient’s bedside with or without the use of local anesthesia. Sharp debridement is less aggressive than surgical debridement but has the advantage of rapidly improving the healing conditions in the ulcer. These typically are the services of recurrent, superficial, or repeated wound care.

• Enzymatic Debridement is debridement with topical enzymes used when the necrotic substances to be removed from a wound are protein, fiber, and collagen. The manufacturers’ product insert contains indications, contraindications, precautions, dosage, and administration guidelines.

• Wet to moist dressing: This type of dressing is used to keep the wound moist. This type of dressing is used to remove drainage and necrotic tissue from wounds.

Debridement of the wound(s), if indicated, must be performed judiciously and at appropriate intervals. Medicare expects that with appropriate care and no extenuating medical or surgical complications or setbacks, wound volume or surface dimensions should decrease over time or wounds optimally will demonstrate granulation tissue. Wounds that fail to demonstrate measurable reduction in size at 2 to 4 weeks despite appropriate therapy are unlikely to heal. There is also literature to support that a reduction of less than 40% for venous and less than 50% diabetic ulcers at 4 weeks is an overall predictor of negative outcome for healing.

Medicare expects the wound care treatment plan to be modified in the event that appropriate healing is not achieved. Debridement should be performed by a health care professional acting within the scope of his/her legal authority.

Evidence of improvement includes measurable changes (decreases) of some of the following:

Drainage (color, amount, consistency)

Inflammation

Swelling

Pain

Wound dimensions (diameter, depth, tunneling)

Necrotic tissue/slough

Use of Evaluation and Management (E/M) Codes in Conjunction with Debridement(s)

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.

Biophysical Agents

Biophysical agents or modalities such as electrical stimulation; induced electrical stimulation;

negative pressure wound therapy; hyperbaric oxygen; and non-contact, non-thermal ultrasound all add some form of energy to the wound bed to help drive the healing process forward, especially in the compromised tissues of patients who tend to get pressure ulcers.

Electrical Stimulation and Electromagnetic Therapy

Please refer to: CMS Publication 100-03, Medicare National Coverage Determination (NCD) Manual , Chapter 1-Part 4, § 270.1 Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds.

Negative Pressure Wound Therapy

Negative Pressure Wound Therapy (NPWT), utilizing either durable or disposable medical equipment, 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 . Coverage of traditional NPWT (tNPWT) device/unit/type, or supplies is under DME and providers should consult their DME LCD for specific coverage, parameters, and guidelines.

Low Frequency, Non-contact, Non-thermal Ultrasound (MIST Therapy)

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

There should be documented improvements in the wound(s) evident after 6 MIST treatments.

Improvements include documented reduction in pain, necrotic tissue, or wound size or improved granulation tissue. Continuing MIST treatments for wounds demonstrating no improvement after 6 treatments is considered not reasonable and necessary. No more than 18 services of low frequency, non-contact, non-thermal ultrasound (MIST Therapy) within a 6-week period will be considered reasonable and necessary. Also, Low Frequency, Non-Contact, Non-Thermal Ultrasound treatments would be separately billable if other active wound management and/or wound debridement is not performed.

Topical Oxygen Therapy

Refer to Change Request (CR) 10220, Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Application of Oxygen .

Despite many recent advances in wound care, the challenge of managing chronic wounds remains

complicated by the lack of agreement on clearly defined comprehensive wound care principles and consistently accepted analytical scientific methods to evaluate outcomes.

Negative Pressure Wound Therapy (NPWT)

There is moderate evidence in the peer-reviewed published literature to indicate that NPWT using a powered device approved by the U.S. Food and Drug Administration (FDA) is effective for a specific subgroup of patients who have failed a comprehensive, conventional wound therapy program that includes all reasonable, well-established alternative medical treatments. There is also moderate evidence to support the use of this therapy as an alternative to surgery. There is insufficient evidence to support the routine use of NPWT.