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ImpaDescription/Scope
Tissue-engineered skin is a significant advance in the field of wound healing and was developed due to limitations associated with the use of autografts. Blood-derived growth factors are also being investigated as aid in wound healing. This policy addresses the use of skin substitutes and growth factors in wound healing.
- Alloderm®:
Investigational/Not Medically Necessary:
Alloderm® is considered investigational/not medically necessary for any use, including, but not limited to the following indications:
- Treatment of burns, either to treat the burn site or to treat autograft donor site; and
- Repair of lower lid retraction in patients with Graves’ disease; and
- Prevention or treatment of post-parotidectomy gustatory sweating (Frey’s Syndrome).
- Apligraf® (graftskin):
Medically Necessary:
Apligraf® (graftskin) is considered medically necessary when used for either of the following indications:
- In conjunction with standard therapeutic compression for the treatment of chronic, non-infected, partial and/or full-thickness skin ulcers due to venous insufficiency of greater than one month duration and which have not adequately responded following a one month period of conventional ulcer therapy (such as standard dressing changes, and standard therapeutic compression); OR
- In conjunction with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded following at least a three week period of conventional ulcer therapy (such as surgical debridement, complete off-loading and standard dressing changes) and which extend through the dermis but without tendon, muscle, joint capsule, or bone exposure.
Investigational/Not Medically Necessary:
Apligraf® (graftskin) is considered investigational/not medically necessary when used beyond five applications.
Apligraf® (graftskin) is contraindicated and considered investigational/not medically necessary for (a) use on clinically infected wounds, (b) in patients with known allergies to bovine collagen, and (c) in patients with a known hypersensitivity to the components of the Apligraf® agarose shipping medium.
Apligraf® is considered investigational/not medically necessary for all other applications not listed above as medically necessary
- Dermagraft®:
Medically Necessary:
Dermagraft®, an interactive wound dressing, is considered medically necessary when used for either of the following indications:
- The treatment of full-thickness diabetic foot ulcers of greater than six weeks duration that extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure; OR
- When used on the wounds with dystrophic epidermolysis bullosa.
Investigational/Not Medically Necessary:
Dermagraft® is contraindicated and considered investigational/not medically necessary for infected ulcers and ulcers with sinus tracts.
Dermagraft® is considered investigational/not medically necessary for all other applications not listed above as medically necessary.
- GraftJacket™:
Investigational/Not Medically Necessary:
GraftJacket™ is considered investigational/not medically necessary for any use, including, but not limited to the treatment of chronic diabetic skin ulcers.
- Integra™:
Medically Necessary:
Integra™, an artificial skin substitute, is considered medically necessary in the post-excisional treatment of full- thickness or deep partial-thickness burns when autografting is not feasible due to the individual's weakened physiological condition or a lack of suitable healthy tissue.
Investigational/Not Medically Necessary:
Integra™ is considered investigational/not medically necessary for all other applications not listed above as medically necessary.
- OrCel™:
Medically Necessary:
OrCel™, a composite skin substitute, is considered medically necessary in children with recessive dystrophic epidermolysis bullosa who are undergoing reconstructive hand surgery.
Investigational/Not Medically Necessary:
OrCel™ is considered investigational/not medically necessary for all other applications not listed above as medically necessary.
- Recombinant platelet-derived growth factor [i.e., becaplermin (Regranex®)]:
Medically Necessary:
Recombinant platelet-derived growth factor [i.e., becaplermin (Regranex®)] is considered medically necessary when it is used as an adjunct to standard wound management for either of the indications (1 or 2) below:
1. When used according to the U.S. Food and Drug Administration (FDA) labeled indication for patients with neuropathic diabetic ulcers extending into the subcutaneous tissue or beyond. In addition, candidates for becaplermin gel for treatment of neuropathic ulcers should meet ALL of the following criteria:
- Adequate tissue oxygenation, as measured by a transcutaneous partial pressure of oxygen of 30 mm Hg or greater on the foot dorsum or at the margin of the ulcer; and
- Full-thickness ulcer (i.e., Stage III or IV), extending through dermis into subcutaneous tissues; and
- Participation in a wound management program, which includes sharp debridement, pressure relief (i.e., non-weight-bearing), and infection control.
OR
2. As a treatment of pressure ulcers extending into the subcutaneous tissue. In addition, candidates for becaplermin gel for treatment of pressure ulcers should meet ALL of the following criteria:
- Full-thickness ulcer (i.e., Stage III or IV), extending through dermis into subcutaneous tissues; and
- Ulcer in an anatomic location that can be offloaded for the duration of treatment; and
- Albumin concentration > 2.5 dL; and
- Total lymphocyte count > 1,000; and
- Normal values of vitamins A and C.
Note: Patients are typically treated once daily for up to 20 weeks or until complete healing occurs with becaplermin.
Investigational/Not Medically Necessary:
Recombinant platelet-derived growth factor becaplermin/Regranex®) is considered investigational/not medically necessary for all other applications not listed above as medically necessary, including, but not limited to, the following:
- Ischemic ulcers;
- Venous stasis ulcers;
- Ulcers that do not extend through the dermis into subcutaneous tissue
- TransCyte™ :
Medically Necessary:
TransCyte™, a biosynthetic skin substitute, is considered medically necessary as a temporary wound covering to treat second and third degree burns.
Investigational/Not Medically Necessary:
TransCyte™ is considered investigational/not medically necessary for all other applications not listed above as medically necessary.
- Surgisis®:
Investigational/Not Medically Necessary:
Surgisis®, including Surgisis AFP™ Anal Fistula Plug, is considered investigational/not medically necessary for the treatment of chronic or surgical wounds including, but not limited to anal fistula.
- Other:
Investigational/Not Medically Necessary:
Acticoat, therapy and dressings, are considered investigational/not medically necessary for all applications.
Autologous blood-derived wound factors Autologel™ and SafeBlood™ are considered investigational/not medically necessary.
Biological wound dressings, Oasis™, E-Z Derm™ and Biobrane® are considered investigational/not medically necessary for all applications.
Platelet-derived healing formula (e.g., Procuren®) is considered investigational/not medically necessary for all applications, including, but not limited to, the management of chronic, non-healing wounds. Note: Procuren is no longer marketed.
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