Highmark Medicare Services

12102, 12202, 12302

MAC Part A & B

L27547

Wound Care

L27547

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1862(a)(7).  This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Maryland, District of Columbia, Delaware

Central Office

For services performed on or after 07/11/2008

N/A

For services performed on or after N/A

N/A

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

This policy addresses the care of wounds, including, but not limited to ulcers, pressure ulcers, open surgical sites, fistulas, tube sites and tumor erosion sites when the skills of a licensed therapist, qualified wound care nurse, nurse or physician/physician extender are required to safely and effectively provide the care necessary for their treatment.

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

• Hyperbaric oxygen therapy
• Electrical stimulation and electromagnetic therapy
• Noncontact normothermic wound therapy
• Treatment of burns
• Initial physical therapy or occupational therapy evaluations

Wound healing involves several factors and is influenced by the severity of the injury. Partial thickness wounds penetrate the epidermis and involve the dermis. A full thickness wound involves the epidermis and dermis and may include subcutaneous tissue, muscle, tendon, and bone.

Indications

Wound care involves evaluation and treatment of a wound. Wound care thus involves identifying potential causes of delayed wound healing and modification of treatment as directed by the certifying physician. Determining the agent of delayed wound healing such as vascular disease, infection, diabetes or other metabolic disorders, immunosuppression, unrelieved pressure, radiation injury and malnutrition will help determine the course of treatment. Evaluations could include comprehensive medical evaluation, vascular evaluation, orthopedic evaluation and metabolic/nutritional evaluation leading to a plan of care. The plan may include metabolic corrections including dietary supplementation, specialized wound care, pressure relief, use of compression to manage edema, debridement and reconstruction, rehabilitation therapy, possible general, vascular and/or orthopedic surgery, and antimicrobial agents.

In order to be covered under Medicare, a service must be reasonable and necessary. Among the requirements for a reasonable and necessary service are that the service be safe and effective, furnished in the appropriate setting, and ordered and/or furnished by qualified personnel.

Evaluation of wounds

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. Evaluations may require a comprehensive medical evaluation, vascular evaluation, orthopedic evaluation, metabolic/nutritional evaluation, and a plan of care.

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 record that the wound is improving in response to the wound care being provided. It is neither reasonable nor medically necessary to continue a given type of wound care if evidence of wound improvement cannot be shown. Evidence of improvement includes measurable changes in at least some of the following:

• Drainage
• Inflammation
• Swelling
• Pain and/or tenderness
• Wound dimensions (surface measurements, depth)
• Granulation tissue
• Necrotic tissue/slough

Such evidence must be documented each time the patient is seen. A wound that shows no improvement after 30 days requires a new approach, which may include a physician reassessment of underlying infection, metabolic, nutritional, or vascular problems inhibiting wound healing, or a new treatment approach.

In rare instances, the goal of wound care provided in outpatient settings may be only to prevent progression of the wound, which, due to severe underlying debility or other factors such as inoperability, is not expected to improve. In this case the focus of the care should be to transition the patient for self care or to the patient’s care giver for continued care of the wound.

Dressings

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

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

Advanced dressings: Used with increasing frequency in the treatment of acute wounds, chronic venous, diabetic and pressure ulcers. A variety of dressings are available including transparents films, foams, hydrocolloids, and hydrogels.

Dressing changes (removal and subsequent reapplication) alone usually do not require the skills of physicians, podiatrists, physical therapists, occupational therapists or wound care nurses and in fact are usually performed by non-physician providers. More significantly, dressing changes are not part of the therapy benefit but must be provided incident to the physician’s service. Dressing changes are therefore not billed independently but must be incorporated with another service. Documentation must support the need for the skilled intervention and the provision of the dressing change incident to the physician service.

Active Wound Care Management

Active wound care procedures are performed to remove devitalized tissue and promote healing, and involve selective and non-selective debridement techniques.

1. Wound Care Selective - HCPCS 97597, 97598

Debridement is usually indicated whenever necrotic tissue is present on an open wound. Debridement may also be indicated in cases of abnormal wound healing or repair. Debridement techniques usually progress from non-selective to selective but can be combined. Debridement will not be considered a reasonable and necessary procedure for a wound that is clean and free of necrotic tissue. Selective debridement should only be done under the specific order of a physician.

Note – Currently, code 97602 is a status B (bundled) code on the MFSDB; therefore, separate payment is not allowed for this service.

a. Conservative sharp debridement: Conservative sharp debridement is the classical method of selective wound debridement. Conservative sharp debridement is a minor procedure that typically requires no anesthesia. Scalpel, curettes, scissors and tweezers/forceps may be used and only clearly identified devitalized tissue is removed. Generally, there is no bleeding associated with this procedure.

b. High Pressure Water Jet: Whirlpool provides a means where a wound can be submerged in water and, if appropriate, an additive agent is used for cleansing. Whirlpool may be covered if medically necessary for the healing of the wound. Generally, whirlpool treatments do not require the skills of a therapist to perform. The skills of a physical therapist may be required to perform an accurate assessment of the patient and the wound to assure the medical necessity of the whirlpool for the specific wound type. The skills, knowledge and judgment of a qualified physical therapist might be required when the patient's condition is complicated by circulatory deficiency, areas of desensitization, complex open wounds, and fractures. Immersion in the whirlpool to facilitate removal of a dressing would not be considered a skilled treatment modality.

c. Lavage (non-immersion hydrotherapy) involves the use of an irrigation device, with or without pulsation, to provide a water jet to administer a shearing effect to loosen debris within a wound. Some electric pulsatile irrigation devices include suction to remove debris from the wound after it is irrigated.

2. Wound Care Non-Selective - HCPCS 97602

a. Blunt Debridement: Blunt debridement is the removal of necrotic tissue by cleansing, scraping, chemical application or wet to dry dressing technique. It may also involve the cleaning and dressing of small or superficial lesions. Generally this is not a skilled service and does not require the skills of a physician, podiatrist, therapist, or wound care nurse.

b. Enzymatic Debridement: Debridement with topical enzymes is 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; it is the clinician’s responsibility to comply with those guidelines.

c. AutolyticDebridement: 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; it is contraindicated for infected wounds.

d. Mechanical Debridement: Wet-to-dry dressings may be used with wounds that have a high percentage of necrotic tissue. Wet-to-dry dressings should be used cautiously as maceration of surrounding tissue may hinder healing.

e. Jet Hydrotherapy and Wound Irrigation: Mechanical debridement is used to remove necrotic tissue. They also should be used cautiously as maceration of surrounding tissue may hinder healing. Documentation must support the use of skilled personnel in order to be a covered service.

3. Negative Pressure Wound Care – HCPCS 97605, 97606

Negative wound pressure therapy is a procedure that manages wound exudates and promotes wound closure. The vacuum cleanses the wound and stimulates the wound bed, reduces localized edema and improves local oxygen supply.

Active Wound Care Management – HCPCS 97597, 97598, 97602, 97605, and 97606

HCPCS 97597, 97598, 97602, 97605 and 97606 fall under the CPT code section Physical Medicine and Rehabilitation. These services may be performed by non-therapists when permitted by the scope of practice requirements of each state. These services when performed by a physical therapist must be furnished under a plan of treatment that has been written and developed by the physician caring for the patient. The plan must be established prior to the initiation of treatment, must be signed by the physician, and must be incorporated into the physician's permanent record for the patient. The services provided must relate directly to the written treatment regimen. The plan may include metabolic corrections including dietary supplementation, specialized wound care, debridement and reconstruction, rehabilitation therapy, possible general, vascular, plastic and/or orthopedic surgery, and antimicrobial agents.

1. The plan of care must contain the following information:
   • Patient’s significant past history
   • Patient's diagnoses that require physical therapy
   • Related physician orders
   • Therapy goals and potential for achievement
   • Any contraindications
   • Patient’s awareness and understanding of diagnosis, prognosis, treatment and goals
   • When appropriate, the summary of treatment provided and results achieved during previous periods of physical therapy services.
     
     
2. The plan of care indicates anticipated goals and specifies therapy type, amount, frequency and duration. The amount, frequency, and duration of the physical therapy services must be reasonable and necessary.
   
   
3. The plan of care and results of treatment are reviewed every 30 days. When services are continued for more than 30 days, the physician must re-certify the plan of treatment every 30 days. Any change in treatment plan must be noted in writing in the patient record, per CMS physical therapy regulations.

Wound assessment to evaluate progress should be done weekly. A wound that shows no improvement after 30 days may require a new approach, which should include a physician reassessment of underlying infection, metabolic, nutritional, or vascular problems inhibiting wound healing, or a new treatment approach.

In rare instances, the goal of wound care provided in an outpatient setting may be only to prevent progression of the wound, which, due to severe underlying debility or other factors such as inoperability, is not expected to improve.

Standard wound care includes assessment of a patient's vascular status and correction of any vascular problems in the affected area, controlling infection, optimization of nutritional status (including glucose control), and debridement by appropriate means to remove devitalized tissue. Patients with wounds that are associated with ischemia that has not been evaluated and treated, abscess formation, active infection, exposed tendons or bones, wet or dry gangrene, and or otherwise cannot be treated with local care should have general, vascular and/or orthopedic surgery consultations in their documentation.

Surgical Debridements - HCPCS 11000-11001 and 11040-11044

The HCPCS for the 11000-11044 series of codes may be billed by physicians as defined by Medicare and when within the scope of practice according to State law, by other health care providers. Additionally, these codes represent extensive debridement procedures. The documentation for these procedures should include the indications for the procedure, the type of anesthesia if and when used, and the narrative of the procedure that describes the wounds and the details of the debridement procedure itself. The debridement code submitted should reflect the type and amount of tissue removed during the procedure and not the depth, size, or other characteristics of the wound. For example, if a wound involves exposed bone but the debridement procedure did not remove bone, CPT code 11044 cannot be billed.

Use of E/M Codes in Conjunction with Surgical Debridements

Patients who have chronic wounds almost always 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. This care is considered part of the preoperative/postoperative management that is included with the debridement procedure. Therefore, E/M codes are not usually billed in conjunction with a debridement procedure. However, on rare occasions there may be unusual circumstances that may require the use of an E/M code in conjunction with a debridement. In order for the E/M code to be considered in addition to the debridement the patient must receive either:

• An unexpected or unrelated service or procedure
• Care that is over and beyond the usual preoperative and postoperative care

If and when this situation occurs, the documentation must clearly state why this is so.

Application of Unna Boots (HCPCS 29580) and Surgical Debridements

Unna boot is a type of compression dressing used to promote return of blood from the peripheral veins back into the central circulation. When both a debridement is done and an Unna boot is applied only the debridement will be reimbursed. If only an Unna boot is applied and the wound is not debrided, then the Unna boot application is eligible for reimbursement.

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.
• Debridement of the wound(s), if indicated, must be done judiciously and at appropriate intervals. If there is no necrotic, devitalized, fibrotic, or other tissue or foreign matter present that would interfere with wound healing, debridement is not medically necessary. The presence or absence of such tissue or foreign matter must be documented in the medical record. If required, it is expected that the frequency of debridement will decrease over time.
• With appropriate management, it is expected that, in most cases, a wound will reach a state at which its care should be performed primarily by the patient and/or the patient's caregiver with periodic physician assessment and supervision. Wound care that can be performed by the patient or the patient's caregiver will be considered to be maintenance care. Reassessment of a wound maintained by the patient or patient's caregiver is covered as a physician evaluation and management service.
• Various methods to promote wound healing have been devised over time. Physicians and health care providers must understand that many of these methods are expensive and unproven by valid scientific literature, and would be considered investigational. Investigational treatments are noncovered by Medicare as not medically necessary. The patient can be requested to pay for investigational treatment under waiver of liability provisions of Medicare law, but an Advance Beneficiary Notice must be obtained for the beneficiary to be liable for such payment.
• This policy excludes the management of acute wounds, the care of wounds that normally heal by primary intention, such as clean, incised traumatic wounds, surgical wounds which are closed primarily, and other postoperative wound care not separately payable during the surgical global period.
• Procedures performed for cosmetic reasons or to prepare tissues for cosmetic procedures are statutorily excluded from coverage by Medicare.
• Local infiltration, metacarpal/metatarsal/digital block or topical anesthesia are included in the reimbursement for wound care services and are not separately payable.
• The following procedures are considered part of an evaluation and management (E&M) service or wound care management services, and are not separately covered: 1) removal of necrotic tissue by cleansing and dressing, including wet-to-dry dressing changes; 2) cleaning and dressing small or superficial lesions; and 3) removal of coagulated serum from normal skin surrounding an ulcer.

Ambulatory Surgical Centers, Doctor Office Visits, Non-Physician Health Care Provider Services, Outpatient Hospital Services, Physical Occupational, and Speech Therapy, Skilled Nursing Facility Care, Surgical Services

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A

All those not listed under the “ICD-9 Codes that Support Medical Necessity” section of this policy.

Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.

1. All documentation must be maintained in the patient’s medical record and available to the contractor upon request.
   
   
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
   
   
3. The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.
   
   
4. The most accurate and specific diagnosis code(s) must be submitted on the claim. The patient's medical record should indicate the specific signs/symptoms, and other clinical data supporting the diagnosis code(s) used. It is expected that the physician will document the status of the wound in the patient's medical record and the patient's response to the treatment.
   
   
5. When providing Active Wound Care Management (97597, 97598, 97602, 97605 and 97606), it is necessary to document all aspects of the patient's care. More specifically, it is expected that the documentation will include:
   • Physician order
   • Signed and dated certification by physician if services being performed by a therapist
   • Date of evaluation
   • Start of care date
   • Medical diagnosis with onset date
   • Treatment diagnosis
   • Treatment plan with long and short term goals
   • Wound characteristics such as diameter, depth, color, presence of exudates or necrotic tissue
   • Wound stage
   • Previous therapy administered to include date, diagnosis for treatment, and modalities administered.
   • Progress notes from each wound evaluation to include current status of the wound, wound measurement and the treatment provided.
   • In patients with grade 3 to 5 (modified Wagner Cianci) wounds, documentation of appropriate vascular and/or orthopedic evaluations.
     
     
6. When reporting codes 11000-11001 and 11040-11044 it is expected that the documentation will include the following:
   • Medical diagnosis
   • Indication(s) for the debridement
   • Type of anesthesia used, if and when used
   • Level/depth of tissue debrided
   • Wound characteristics such as diameter, color, presence of exudates or necrotic tissue
   • Vascular status
   • Narrative of the operative procedure
   • Patient specific goals and/or response to treatment
     
     
7. When reporting code(s) 11000 and 11001, the percentage of body surface area being debrided must be clearly documented in the medical record.
   
   
8. When reporting codes 11040-11044, the documentation in the medical record must clearly reflect the depth/thickness of the tissue being removed and not the depth of the wound itself.
   
   
9. Wound progress must be documented noting an improvement in the wound characteristics (i.e., surface dimensions, depth, amount of necrotic tissue, amount of exudate, etc.).

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Agency for Healthcare Research and Quality.  Usual care in the Management of Chronic Wounds:  A review of the Recent Literature.  March 8, 2005 Technology Assessment.  Available at:  http://www.cms.hhs.gov/mcd/viewtechassess.asp?where=index&tid=37.  Accessed on May 14, 2007.

Agency for Healthcare Research and Quality.  Wound-Healing Technologies:  Low-Level Laser and Vacuum-Assisted Closures.  Evidence Report/Technology Assessment: Number 111.  Available at:  http://www.ahrq.gov/clinic/epcsums/woundsum.htm

Sheffield, P.J., et al. Wound Care Practice.  Flagstaff, AZ:  Best Publishing Co., 2004.

Other Contractors' Policies

Highmark Medicare Services Contractor Medical Directors

This policy does not reflect the sole opinion of the contractor or Contractor Medical Directors. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the appropriate specialty (ies).

CAC/IAC Distribution:  04/01/2008

05/15/2008

05/23/2008

L27547

05/22/2008

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