REVIEW REQUEST FOR
Allogeneic, Xenographic, Synthetic and
Composite Products for Wound Healing and
Soft Tissue Grafting
Provider Data Collection Tool Based on Medical Policy SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
05/11/2015
Provider Tool Effective Date:
Individual’s Name:
Date of Birth:
Insurance Identification Number:
Individual’s Phone Number:
Ordering Provider Name & Specialty:
Provider ID Number:
05/11/2015
Office Address:
Office Phone Number:
Office Fax Number:
Rendering Provider Name & Specialty:
Provider ID Number:
Office Address:
Office Phone Number:
Office Fax Number:
Facility Name:
Facility ID Number:
Facility Address:
Date/Date Range of Service:
Place of Service:
Service Requested (CPT if known):
Outpatient
Home
Inpatient
Other:
Diagnosis Code(s) (if known):
This data collection tool is provider request for medical necessity review for the use of soft tissue (for
example, skin, ligament, cartilage, etc.) substitutes in wound healing and surgical procedures. This
document is not for requests for use of the following:
 fresh, unfrozen, unprocessed allogeneic cadaver-derived skin grafts OR
 meshes or patches of non-biologic origin when used for standard hernia repair procedures.
Please complete check all information that applies to the individual under the specific product category
below.
ALLODERM®
Request is for Alloderm® Regenerative Tissue Matrix, also known as Alloderm® RTM soft tissue substitute
Request is for Alloderm® RTM Ready To Use soft tissue substitute
Request is for identified product use : (Check the following a appropriate to the individual)
In surgical repair of complex abdominal wall wounds (for example, due to infection, fascial defect, etc.)
In breast reconstruction surgery
An indication other than those listed above (Please describe):
Page 1 of 5
REVIEW REQUEST FOR
Allogeneic, Xenographic, Synthetic and
Composite Products for Wound Healing and
Soft Tissue Grafting
Provider Data Collection Tool Based on Medical Policy SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
05/11/2015
Provider Tool Effective Date:
05/11/2015
APLIGRAF
Request is for initial application of Apligraf® soft tissue substitute
Request for continued use of Apligraf® soft tissue substitute. (If checked, complete the following)
Please list the number of treatments the individual has already received:
Request for Apligraf® is for the treatment of : (check the following that apply to the individual)
Venous insufficiency skin ulcers with the following characteristics:
(check all of the following that apply)
Chronic, non-infected, partial or full thickness ulcers due to venous insufficiency
Standard therapeutic compression also in use
At least 1 month of conventional ulcer therapy (such as standard dressing changes, and standard
therapeutic compression) has been ineffective
Diabetic foot ulcers (DFU) with the following characteristics:
(check all of the following that apply)
Full-thickness neuropathic diabetic foot ulcers
Extends through the dermis but without tendon, muscle, joint capsule, or bone exposure
At least 3weeks of conventional ulcer therapy (such as surgical debridement, complete off-loading
and standard dressing changes) has been ineffective
An indication other than those listed above: (Please describe)
DERMAGRAFT®
Request is for use of Dermagraft® soft tissue substitute.
Request is for Dermagraft® in the treatment of: (check the following that apply to the individual)
Full-thickness diabetic foot ulcers of greater than six (6) weeks duration that extend through the dermis,
but without tendon, muscle, joint capsule, or bone exposure
Wounds with dystrophic epidermolysis bullosa
An indication other than those listed above (Please describe):
Page 2 of 5
REVIEW REQUEST FOR
Allogeneic, Xenographic, Synthetic and
Composite Products for Wound Healing and
Soft Tissue Grafting
Provider Data Collection Tool Based on Medical Policy SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
05/11/2015
Provider Tool Effective Date:
05/11/2015
AlloSkin™* and TheraSkin®
Request is for use of fresh frozen unprocessed allograft skin product for the treatment of
full-thickness or deep partial-thickness burns (If checked, mark all of the following that apply)
Fresh, unfrozen allograft is not readily available
The treating provider has determined that use of fresh, unfrozen allograft poses significant risk of disease
transmission,
*Note: “AlloSkin” and “AlloSkin RT” are different products. AlloSkin is a fresh-frozen product and AlloSkin RT
is a fresh irradiated product (not frozen).
INTEGRA™ BILAYER MATRIX WOUND DRESSING
Request is for Integra™ Bilayer Matrix Wound Dressing, an artificial skin substitute.
Integra™ Bilayer Matrix Wound Dressing will be used in the treatment of:
Post-excisional 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
An indication other than that listed above (Please describe):
EpiFix™
Request is for application of sheet or membrane form of EpiFix™.
EpiFix™ will be used in the treatment of: (check the following that apply to the individual)
A non-healing diabetic foot ulcer. (If checked, answer all of the following that apply to the individual)
Individual has failed standard conservative therapy (such as surgical debridement, complete
off-loading, and standard dressing changes) for at least 1 month but not greater than 52 weeks,
Individual is 18 years of age or older with Type 1 or 2 diabetes AND hemoglobin A1C (HbA1C)
less than 12%
The wound extends through the full thickness of the skin, but not down to the muscle,
tendon, or bone
The wound is a minimum of 1 cm2 and a maximum of 25 cm2
Infection or cancer is NOT present or suspected at the wound site
Sufficient extremity oxygenation of the limb has been established
(If checked, identify how the limb’s oxygenation status was established by checking any of
the following that apply)
Dorsum transcutaneous oxygen test (TcPO2) greater than or equal to 30 mmHg
Ankle-brachial index (ABI) between 0.7 and 1.2
Triphasic or biphasic Doppler arterial waveforms at the ankle of the affected leg
The individual has not been diagnosed with an autoimmune connective tissue disease
The individual is not receiving radiation, chemotherapy or Cox-2 inhibitors
Page 3 of 5
REVIEW REQUEST FOR
Allogeneic, Xenographic, Synthetic and
Composite Products for Wound Healing and
Soft Tissue Grafting
Provider Data Collection Tool Based on Medical Policy SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
05/11/2015
Provider Tool Effective Date:
05/11/2015
A Chronic venous stasis ulcers (VLU).
(If checked, answer all of the following that apply to the
individual)
Individual is18 years of age or older
Individual has a venous leg ulcer (VLU) wound which has been present for at least 1 month
Individual has been unsuccessfully treated with compression therapy for at least 14 days
Individual’s wound extends through the full thickness of the skin, but does not extend into
the muscle, tendon, or bone
Ankle-Brachial Index (ABI) is greater than 0.75
The wound is a minimum of 2 cm2 and a maximum of 20 cm2
The wound has a clean, granulating base with minimal adherent slough
No infection, cancer, or history of radiation is suspected or present at the wound site
If the individual has diabetes, HbA1c is less than or equal to 10%;
The wound is not on the dorsum of the foot or more than 50% of the ulcer below the malleolus.
An indication not specified above. (Please describe):
OrCel™
Request is for OrCel™, a composite skin substitute.
OrCel™ will be used in the treatment of a child with recessive dystrophic epidermolysis bullosa
who is undergoing reconstructive hand surgery
An indication other than that specified above (Please describe):
TransCyte™
Request is for TransCyte™, a biosynthetic skin substitute.
TransCyte™ will be used as a temporary wound covering in the treatment of a second and/or third degree burn
An indication not specified above. (Please describe):
OTHER
Request is for another product for wound healing or soft tissue grafting not listed above:
Please specify the product and indication:
Page 4 of 5
REVIEW REQUEST FOR
Allogeneic, Xenographic, Synthetic and
Composite Products for Wound Healing and
Soft Tissue Grafting
Provider Data Collection Tool Based on Medical Policy SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
05/11/2015
Provider Tool Effective Date:
05/11/2015
This request is being submitted:
Pre-Claim
Post– Claim. If checked, please attach the claim or indicate the claim number
I attest the information provided is true and accurate to the best of my knowledge. I understand that the health plan or its
designees may perform a routine audit and request the medical documentation to verify the accuracy of the information
reported on this form.
_____________________________________________________________
Name and Title of Provider or Provider Representative Completing Form and Attestation (Please Print)*
Date
*The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted
Anthem UM Services, Inc., a separate company, is the licensed utilization review agent that performs utilization
management services on behalf of your health benefit plan or the administrator of your health benefit plan.
Page 5 of 5