LCD L34032

Coverage Guidance

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications:

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 16:

120 Cosmetic Surgery

Indications and Limitations of Coverage

Abstract:

Debridement is the removal of infected, contaminated, damaged, devitalized, necrotic, or foreign tissue from a wound. The codes in this local coverage determination (LCD) cover debridement of skin, subcutaneous tissue, fascia, muscle, bone and removal of foreign material. Debridement promotes wound healing by reducing sources of infection and other mechanical impediments to healing. Its goal is to cleanse the wound, reduce bacterial contamination and provide an optimal environment for wound healing or possible surgical intervention. The usual end point of debridement is removal of pathological tissue and/or foreign material until healthy tissue is exposed. Debridement techniques include, among others, sharp and blunt dissection, curettement, scrubbing, and forceful irrigation. Surgical instruments may include a scrub brush, irrigation device, electrocautery, laser, sharp curette, forceps, scissors, burr or scalpel. Prior to debridement, determination of the extent of an ulcer/wound may be aided by the use of blunt probes to determine wound/ulcer depth and to disclose abscess and sinus tracts.

This LCD does not apply to debridement of burned surfaces. For debridement of burned surfaces CPT codes 16000-16036 apply. Regulations concerning the use of these codes are not addressed in this LCD. This LCD does not apply to debridement of nails and the provider is referred to CGS LCD Routine Foot Care and Debridement of Nails (L34246). This LCD does not apply to debridement services performed by physical or occupational therapists. For debridement services performed by physical or occupational therapists, please use CPT codes 97597, 97598 and 97602. Providers should refer to CGS LCD for Outpatient Physical and Occupational Services (L34049).

Indications:

Debridement is indicated for any wound requiring removal of deep seated foreign material, devitalized or nonviable tissue at the level of skin, subcutaneous tissue, fascia, muscle or bone, to promote optimal wound healing or to prepare the site of appropriate surgical intervention.

CPT codes 11000 and 11001 describe removal of extensive eczematous or infected skin. A key word is extensive. Conditions that may require debridement of large amounts of skin include: rapidly spreading necrotizing process (sometimes seen with aggressive streptococcal infections), severe eczema, bullous skin diseases, extensive skin trauma (including large abraded areas with ground-in dirt), or autoimmune skin diseases (such as pemphigus).

CPT codes 11040 and 11041 have been deleted and providers (including physicians and non-physician practitioners) are instructed to use CPT codes 97597 and 97598 for selective debridement of non-viable tissue in wounds/ulcers. These CPT codes are contained in CGS LCD for Outpatient Physical Therapy and Occupational Services (L34049). Please refer to that LCD for additional information on use of these CPT codes and services.

CPT codes 11042-11047 should be used for debridement of relatively localized areas depending upon the involvement of contiguous underlying structures. These codes are appropriate for treatment of skin ulcers, circumscribed dermal infections, conditions affecting contiguous deeper structures, and debridement of deep-seated debris from any number of injury types.

The number of debridement services required is variable and depends on numerous intrinsic and extrinsic factors. Debridement services are covered provided all significant relevant comorbid conditions are addressed that could interfere with optimal wound healing.

Debridements of the wound(s) if indicated must be performed judiciously and at appropriate intervals. It is expected that, with appropriate care, and no extenuating medical or surgical complications or setbacks, wound volume or surface dimension should decrease over time. It is also expected the wound care treatment plan is modified in the event that appropriate healing is not achieved. It is expected that co-morbid conditions that may interfere with normal wound healing have been addressed; the etiology of the wound has been determined and addressed as well as addressing patient compliance issues. This may include, for example, evaluation of pulses, ABI and/or possible consultation with a vascular surgeon.

Limitations:

If there is no necrotic, devitalized, fibrotic, or other tissue or foreign matter present that would interfere with wound healing, the debridement service is not medically necessary. The presence or absence of such tissue or foreign matter must be documented in the medical record.

The following procedures are considered part of active wound care management, and are not considered as debridement and are not included in this LCD: Removal of devitalized tissue from wound(s), non - selective debridement, without anesthesia (e.g., wet-to-moist dressings, enzymatic, abrasion), including topical application(s), wound assessment, and instruction(s) for ongoing care.

CPT codes 11000 and 11001 are 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.

CPT code 11001 is limited to those practitioners who are licensed to perform surgery above the ankle, since the amount of skin required by the code is more than that contained on both feet.

Skin breakdown under a dorsal corn is not considered an ulcer and generally does not require debridement. These lesions typically heal without significant surgical intervention beyond removal of the corn and shoe modification.

Removing a collar of callus (hyperkeratotic tissue) around an ulcer is not debridement of skin or necrotic tissue and should not be billed as such. The service should be billed under CPT code 11055 or 11056. Please refer to CGS LCD Routine Foot Care and Debridement of Nails (L34246) for information regarding these CPT codes. This LCD does not apply to debridement services performed by physical or occupational therapists. For debridement services performed by physical or occupational therapists, please use CPT codes 97597, 97598 and 97602. Providers should refer to CGS LCD for Outpatient Physical and Occupational Services (L34049).

Debridement for osteomyelitis is covered for chronic osteomyelitis and osteomyelitis associated with an open wound.

Local infiltration, metacarpal/digital block or topical anesthesia are included in the reimbursement for debridement services and are not separately payable. Anesthesia administered by or incident to the provider performing the debridement procedure is not separately payable.

Other Comments:

For claims submitted to the Part A MAC: this coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators, LLC. to process their claims.

Bill type codes only apply to providers who bill these services to the Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.

For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.

Limitation of liability and refund requirements apply when denials are anticipated, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.

Summary of Evidence

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Analysis of Evidence

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Associated Information

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

The medical record should include the following information:

•An operative note or procedure note for the debridement service. This note should describe the anatomical location treated, the instruments used, anesthesia used if required, the type of tissue removed from the wound, the depth and area of the wound and the immediate post procedure care and follow-up instructions.

•Identification of the wound location, size, depth and stage either by description and/or a drawing or photograph.

•A description of the type(s) of tissue involvement, the severity of tissue destruction, undermining or tunneling, necrosis, infection or evidence of reduced circulation. If infection has developed, the patient's response to this infection should be described.

•The patient's comorbid medical and mental condition, and all health factors that may influence the patient's ability to heal tissue, such as, but not limited to the following: mental status, mobility, infection, tissue oxygenation, chronic pressure, arterial insufficiency/small vessel ischemia, venous stasis, edema, type of dressing, chronic illness such as diabetes mellitus, uremia, COPD, malnutrition, CHF, anemia, iron deficiency, and immune deficiency disorders.

•A determination of the initial treatment plan to include the expected frequency and duration of the skilled treatment and the potential to heal. Continuation of treatment plan with ongoing evidence of the effectiveness of that plan, including diminishing area and depth of the ulceration, resolution of surrounding erythema and /or wound exudates, decreasing symptomatology, and overall assessment of wound status (such as stable, improved, worsening, etc). Appropriate changes in the ongoing treatment plan to reflect the clinical presentation must be present in the record.

The documentation must include that if indicated, ongoing pressure relief has been prescribed, for example, shoe inserts, modifications, padding, frequent position changes, etc. and monitoring is occurring.

In cases of excessive frequency or prolonged duration of treatment, documentation should include an evaluation for possible infection (e.g. culture and sensitivity), osteomyelitis (e.g. x-ray), and treatment of any infection by antibiotics. Any other conditions that may significantly affect wound healing should also be appropriately addressed in the medical record.

Photographic documentation of wounds either immediately before or immediately after debridement is recommended for prolonged or repetitive debridement services (especially those that exceed five extensive debridements per wound (CPT code 11043 and/or 11044)). If the provider is unable to use photographs for documentation purposes, the medical record should contain sufficient detail to determine the extent of the wound and the result of the treatment.

Medical records must be made available to Medicare upon request.

Cornerstones of chronic foot ulcer management include relief of pressure, control of infection and appropriate debridement. While there is some consensus that repeated debridement may promote more rapid healing of diabetic foot ulcers, the appropriate interval and frequency of debridement depends on the individual clinical characteristics of patients and ulcers. Reduction of pressure and/or control of infection will facilitate healing and may reduce the need for repeated debridement services. The treatment plan for a patient who requires frequent repeated debridement should be reevaluated, to ensure that pressure reduction and infection control have been adequately addressed. Frequent repeated debridement is not considered reasonable and necessary; pressure reduction and infection control are insufficient to allow for healing of the ulcer. In the presence of documented significant ischemic disease with necrotic ulceration, extensive and definitive debridement may be required.

When the patient has required more debridement services per wound than defined below, the medical record must include documentation reflecting neuropathic, vascular, metabolic, or other comorbid conditions.

Debridement of diabetic foot ulcers more frequently than once every seven (7) days, for a period longer than three (3) months may not be reasonable and necessary. Services exceeding this intensity and duration of treatment will be considered not medically necessary.

Debridement services are now defined by body surface area of the debrided tissue and not by individual ulcers or wounds. For example, debridement of two ulcers on the foot to the level of subcutaneous tissue, total area of 6 sq cm should be billed as CPT code 11042 with unit of service of “1”.

For patients with chronic wounds being treated in an outpatient setting, services beyond the fifth surgical debridement, CPT code 11043, 11046 and/or 11044, 11047, per patient, per year, per wound may require a medical review of records demonstrating the medical reasonableness and necessity. Providers are reminded that the CPT code used to report the debridement must represent the level of debridement and not the depth of the ulcer.

Bibliography

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