DISCLAIMER

Highmark Health Options medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.

POLICY STATEMENT

Highmark Health Options may provide coverage under medical surgical benefits of the Company’s Medicaid products for medically necessary. Refer to the Noncovered Services policy for more information.

This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.

The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the West Virginia Department of Health and Human Resources (DHHR) and all applicable state and federal regulations.

Purpose 

This medical policy outlines Highmark Health Options services for Bioengineered Skin and Skin Replacement Therapy ­­­­­­­­in the Outpatient Setting.

Definitions

Acellular Products – Skin products that contain a matrix or scaffold composed of materials such as collagen, hyaluronic acid, and fibronectin.

 

Allograft – Skin or tissue harvested from another human being (e.g., cadaver) used as a temporary skin replacement and must be replaced by either an autograft or the ingrowth of the patient’s own skin.

 

Ankle-Brachial Index (ABI) –This is a numeric value of the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium) by Doppler ultrasound. Compared to the arm, lower blood pressure in the leg is an indication of blocked arteries

 

Autograft – A sample of the patient’s own healthy skin, as pinch or mesh grafts, is harvested and placed in the ulcer in split- or full-thickness grafts; alternatively, the patient’s cells may be grown in a laboratory to form a thin film (cultured keratinocyte autograft, or cultured epidermal autograft), which can take 3 to 4 weeks.

 

Autologous/Autografts Skin Grafts – Permanent skin coverings that use skin from other parts of the patient’s body.

 

Bio-engineered Skin – Soft tissue substitutes may be derived from human tissue (autologous or allogeneic), nonhuman tissue (xenographic), synthetic materials, or a composite of these materials. Bio-engineered skin and soft tissue substitutes are utilized in the treatment for breast reconstruction, healing of lower extremity ulcers and severe burns. Acellular dermal matrix (ADM) products are utilized in the repair of a variety of soft tissues.

 

Cellular Products – Skin products that contain living cells such as fibroblasts and keratinocytes with a matrix.

 

Chronic Wound – A wound that does not respond to standard wound treatment for at least a 30-day period during organized comprehensive therapy.

 

Failed Response – An ulcer or skin deficit that has failed to respond to documented appropriate wound care measures, has increased in size or depth, or has not changed in baseline size or depth, and has no indication that improvement is likely.

 

Highmark Health Options (HHO)- Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services WV Mountain Health Trust (MHT) and West Virginia Health Bridge (WVHB) including an expansion plan (WVHB ABP Alternative Benefit Plan) and WVCHIP members.

Lower Extremity – Anatomically defined as the hip, thigh, leg, ankle, and foot.

 

Standard Treatment of Chronic Lower Extremity Ulcers – Therapies that primarily include infection and edema control, mechanical off-loading, mechanical compression or limb elevation, debridement of necrotic or infected tissue, and management of concomitant medical issues (e.g., blood glucose control, tobacco use).

 

Xenograft – Skin or tissue is harvested from an animal with similar skin structure (usually pigs or cows)

Prior Authorization

Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool

https://wv.highmarkhealthoptions.com/providers/prior-authorization-code-lookup.html

Procedures

This medical policy addresses the use of skin replacement products for the treatment of chronic non-healing wounds. The goal of this treatment is to provide temporary wound coverage, complete wound closure, reduced time to heal, lessen pain, minimize post-operative contracture, and improve overall quality of health.

The following general information is required for all covered indications:

·       The ordering provider must be a physician licensed by the state with full scope of practice for the treatment of the systemic disease process that is responsible for causing the chronic non-healing wound; AND

·       In the situation when the performing provider is NOT the physician caring for the systemic disease, the performing provider must document in the medical record that he/she is aware of the systemic condition and notates the identity of the physician who is responsible for care related to the condition; AND

·       The patient’s wound has a failure of response (an ulcer or skin deficit that has failed to respond to clearly documented appropriate wound care, has a wound that has increased in size or depth, or has not changed in baseline size or depth, and there is no indication that improvement is expected); AND

·       There must be evidence of adequate arterial blood supply (e.g., ankle-brachial index of 0.65 or greater in the affected limb; AND

·       There must be an evaluation and provision for adequate nutritional status, including pre-albumin and albumin levels.

 

Covered Services

The following products are covered for wound care based on the criteria indicated below:

 

A. Apligraf (graftskin)

 

1. Standard diabetic foot ulcer for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration that have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule, or

bone exposure OR

 

2. In conjunction with standard therapy to promote effective wound healing of chronic, noninfected, and full-thickness venous stasis ulcers that have failed conservative measures of greater than one month duration using regular dressing changes and standard therapeutic compression.

 

3. All other indications are not covered.

 

B. Dermagraft

 

1. In the treatment of full-thickness diabetic foot ulcers greater than six-week duration that extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure and in the treatment of wounds related to dystrophic epidermolysis bullosa.

 

2. All other indications are not covered.

 

C. OrCel or Surgimend Collagen Matrix

 

1. For healing donor site wounds in burn victims

 

2. For use in persons with dystrophic epidermolysis bullosa undergoing hand reconstruction surgery to close and heal wounds created by the surgery, including those at donor sites.

 

3. All other indications are not covered.

 

D. Integra Dermal Regeneration Template and Integra Bilayer Wound Matrix

 

1. Treatment of individuals with severe burns where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created.

 

2. All other indications are not covered.

 

E. AlloDerm and AlloDerm-RTU

 

1. For breast reconstructive surgery.

 

2. All other indications are not covered.

 

F. Oasis Wound Matrix

 

1. Treatment of difficult-to-heal chronic venous or diabetic partial and full-thickness ulcers of the lower extremity that have failed standard wound therapy of at least four-week duration.

 

2. All other indications are not covered.

 

G. Graftjacket Regenerative Tissue Matrix

 

1. Treatment of full-thickness diabetic foot ulcers greater than three-week duration that extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.

 

2. All other indications are not covered.

 

H. TheraSkin

 

1. Treatment of diabetic foot ulcers, venous leg ulcers, pressure ulcers, dehisced surgical wounds, necrotizing fasciitis, traumatic burns, and radiation burns.

 

2. Can be used over exposed tendon, muscle, joint capsule, and bone.

 

3. All other indications are not covered.

 

I. Hyperbaric Oxygen Therapy (HBOT).

 

Chronic Non‐Healing Wounds

 

In addition to the general information above, the following wound-specific medical necessity criteria must be met:

A. Diabetic Foot Ulcers (DFU)

               Indication(s):

1) Presence of a neuropathic diabetic foot ulcer of greater than four weeks which has failed to respond to documented conservative wound care measures such as surgical debridement, complete off‐loading, and standard dressing changes; AND

2) There must be documentation of patient compliance with all conservative wound care measures; AND

3) The foot ulcer must extend through the dermis but without tendon, muscle, joint capsule, or bone exposure; AND

4) The diabetes is well managed, and the HbA1C is within an acceptable range; AND

5) The diabetic foot ulcer is free of infection; AND

6) Wound must have adequate circulation and presence of acceptable peripheral pulses or as evidenced by ankle-brachial index (ABI) of 0.65 or greater in the limb being treated. An index of greater than 0.45 is needed to heal.

 

Venous Leg Ulcers (VLU)

 

       Indication(s):

1) The presence of a venous stasis ulcer which has not responded to documented appropriate therapy for greater than four weeks. These therapies would include the use of compression therapy using multilayer dressings or compression stockings with greater than 20 mmHG pressure or pneumatic compression; AND

2) There must be documentation that the patient has been compliant with wound care measures.

 

Documentation requirements for all wound types

 

A. Medical record documentation includes measurements of the initial ulcer, measurements at the completion of at least four weeks of appropriate wound care, and measurements immediately prior to skin replacement product and with each subsequent placement of skin products;

B. Medical record documentation that specifically states the reason that the wound has failed to heal with standard wound care;

C. Medical record documentation that demonstrates that the medical policy criteria have been met, along with appropriate diagnoses and response to treatment(s);

D. Medical record has clear descriptions of the wound(s) relative to the location, stage, size duration, and presence or lack of infection. There must be a wound description pre‐ and post‐treatment with each skin replacement application.

E. Documentation of the amount of skin replacement product used and amount wasted.

F. Timing, frequency, and number of reapplications of bioengineered skin substitutes should be appropriate for the material used and clinical condition of the patient.

In a course of treatment, repeat application of skin substitutes/replacements are not indicated when prior application was unsuccessful.

 

Contraindications

 

Presence of any of the following:

 

A. Edema, venous hypertension, or lymphedema

B. Active cellulitis, osteomyelitis, foreign body, or malignant process

C. Tunneling and tracts, eschar, and necrotic material

 

 

 

Length of Coverage

A single application of skin replacement products is usually all that is necessary in order to effect wound healing in wounds that are likely to be improved by this therapy. The use of more than two applications for the same ulcer within six months is considered not medically necessary. Requests for additional skin replacement applications will be reviewed on a case-by-case basis with supporting medical record documentation.

 

Retreatment within one year following successful initial treatment (up to two applications) is not considered medically necessary.

 

 

When services are not covered

 

A. For conditions other than those listed above, scientific evidence has not been established.

B. Services are not covered for the use of a skin replacement product for indications not approved by the FDA or in accordance with the manufacturer’s package guidelines.

C. Services are not covered for the use of Autologous Platelet Rich Plasma (PRP) and are considered experimental/investigation and therefore considered not medically necessary.

D. Simultaneous use of more than one product for the episode of the wound is not covered.

 

 

Post-payment Audit Statement

The medical record must include documentation that reflects the medical necessity criteria and issubject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement.

Place of Service:

Outpatient

REIMBURSEMENT

Participating facilities will be reimbursed per their Highmark Health Options contract.

Summary of Literature

Chronic wounds of the lower extremity are known to be a condition associated with high prevalence, high cost, and poor clinical outcome. Wounds become chronic when they are unresponsive to initial therapy or persistent in the face of appropriate care. The most common types of chronic wounds of the lower extremity are described by their etiology:

 

·                     Vascular (e.g., arterial, venous, or mixed ulcers)

·                     Pressure ulcers

·                     Neuropathic (e.g., diabetic ulcers)

 

Skin grafting has evolved from the initial autograft and allograft preparations to biosynthetic and tissue engineered human skin equivalents. There are a large number of potential applications for these products, and one large category is non-healing wounds. Non-healing wounds encompass diabetic neuropathic ulcers, vascular insufficiency ulcers, and pressure ulcers. These types of wounds are known to heal inadequately with standard wound care, leading to prolonged morbidity and increased risk of mortality.

 

Numerous clinical trials have been published for many commercially available skin replacement products for several medical conditions including non-healing wounds, pressure ulcer, inflammatory ulcers, and burns. In addition, there are ongoing and unpublished trials.

 

In 2015, the United Kingdom’s National Institute for Health and Care Excellence (NICE) published clinical guidelines on the prevention and management of diabetic foot problems. NICE recommends that clinicians consider dermal or skin substitutes as an adjunct to standard care when treating diabetic foot ulcers, only when healing has not progressed and on the advice of the multidisciplinary foot care service.

 

Autologous platelet-derived growth factors are referred to as platelet rich plasma (PRP), autologous platelet gel, or platelet releasate, and several PRP preparations available today that are FDA approved. There are PRP preparations intended to be used to mix with bone graft materials to enhance bone grafting properties in orthopedic practices. There are two preparations that can be prepared at the bedside for immediate application (i.e., AutoGel and SafeBlood), specifically for wound healing. Proc uren® (Cytomedix, Inc.) was another product used for chronic wound healing, however, it is no longer manufactured or commercially available.

 

Platelet-derived growth factor has been suggested for adjunctive use in the management of chronic non-healing wounds. It is not clearly understood how PRP works, but some practitioners speculate that if the acute healing pathways can be activated, the body can be induced to repair damage. Therefore, an injection into the injury site is thought to stimulate an acute injury and may possibly induce an acute healing process.

 

Several agencies have concluded that the effectiveness of growth factors for this condition have not been adequately established to warrant recommendation for use (AHRQ, 2011) (CMS, 2013). The available studies have mixed results with some trials reporting improvement with PRP and other trials reporting improvement. Additional studies are needed to truly resolve these issues.

 

In 2012, a Cochrane analysis was completed to address autologous PRP used for healing chronic wounds. There were nine eligible random controlled trials (RCT) with a total of 325 participants, and 44% were women. Four RCTs recruited patients with mixed chronic wounds, three RCTs recruited patients for venous leg ulcers and two trials used patients with diabetic foot ulcers. The median length of treatment was 12 weeks. The authors reported that there were no statistically significant differences in groups treated with PRP compared to the groups that were not treated with PRP. In conclusion, there is no evidence to suggest that autologous PRP is of value for treating chronic wounds, and well-designed, adequately powered clinical trials are needed.