REVIEW REQUEST FOR
Allogeneic, Xenographic, Synthetic and
Composite Products for Wound Healing and
Soft Tissue Grafting
Provider Data Collection Tool Based on Coverage Guideline SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
07/01/2015
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 for medical necessity review for the use of soft tissue (e.g., skin, ligament,
cartilage, etc.) substitutes in wound healing and surgical procedures
Please 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
Other: __________________
(If checked, mark all of the following that apply to the individual)
Product will be used in the surgical repair of complex abdominal wall wounds (for example, due to
infection, fascial defect, etc.)
Product will be used 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 Coverage Guideline SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
07/01/2015
Provider Tool Effective Date:
05/11/2015
APLIGRAF
Request is for Apligraf® for a total of five (5) applications
(If checked, mark all of the following that apply to the individual)
Product will be used in the treatment of a venous insufficiency skin ulcer
(If checked, mark all of the following that apply to the individual)
The ulcer is chronic, non-infected, partial thickness
The ulcer is chronic, non-infected, full thickness
Standard therapeutic compression is in use
At least 1 month of conventional ulcer therapy (for example, standard dressing changes, standard
compression) has been ineffective
Individual has a diabetic foot ulcer (DFU)
(If checked, mark all of the following that apply to the individual)
The ulcer is a full-thickness neuropathic ulcer
The ulcer extends through the dermis
There is no tendon, muscle, joint capsule, or bone exposure
At least 3weeks of conventional ulcer therapy (for example, surgical debridement, complete offloading, standard dressing changes) has been ineffective
An indication other than those listed above: (Please describe)
DERMAGRAFT®
Request is for use of Dermagraft®.
(If checked, mark all of the following that apply to the individual)
Product will be used in the treatment of a full-thickness diabetic foot ulcer that extend through the dermis
There is no tendon, muscle, joint capsule, or bone exposure
The ulcer has been present for more than 6 weeks
Product will be used in the treatment of a wound with dystrophic epidermolysis bullosa
An indication other than those listed above (Please describe):
AlloSkin™* and TheraSkin®
Request is for use of fresh frozen unprocessed allograft skin product (AlloSkin™, TheraSkin®)
(If checked, mark the following that apply to the individual)
Product will be used in the treatment of a full-thickness or deep partial-thickness burn
Fresh, unfrozen allograft is not readily available
In the opinion of the treating provider, the 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).
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 Coverage Guideline SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
07/01/2015
Provider Tool Effective Date:
05/11/2015
INTEGRA™ BILAYER MATRIX WOUND DRESSING
Request is for Integra™ Bilayer Matrix Wound Dressing.
(If checked, mark the following that apply to the individual)
Product will be used in the post-excisional treatment of a full- thickness or deep partial-thickness burn
Product will be used in the post-excisional treatment of a full- thickness or deep partial-thickness burn
Autografting is not feasible due to the individual's weakened physiological condition
Autografting is not feasible due to the 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™.
(If checked, mark the following that apply to the individual)
Product will be used in the treatment of a non-healing diabetic foot ulcer.
(If checked, answer all of the following that apply to the individual)
The ulcer has not healed with standard conservative therapy (for example surgical debridement,
complete off-loading, standard dressing changes)
Conservative therapy has been attempted for at least 1 month
Conservative therapy has been attempted for not greater than 52 weeks
Individual is 18 years of age or older
Individual has Type 1 or 2 diabetes
Individual has a hemoglobin A1C (HbA1C) less than 12%
The wound extends through the full thickness of the skin
The wound does not extend to the muscle, tendon, or bone
The wound size is within the range between 1 cm2 to 25 cm2
No infection is suspected or present at the wound site
No cancer is suspected or present at the wound site
Sufficient extremity oxygenation of the limb has been established
(If checked, mark the indicator of sufficient oxygenation status below)
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
The individual is not receiving chemotherapy
The individual is not receiving Cox-2 inhibitors
Product will be used in the treatment of chronic venous stasis ulcers (VLU).
(If checked, answer all of the following that apply to the individual)
Venous leg ulcer (VLU) has been present for at least 1 month
Ulcer has been unsuccessfully treated with compression therapy for at least 14 days
The wound extends through the full thickness of the skin
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 Coverage Guideline SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
07/01/2015
Provider Tool Effective Date:
05/11/2015
The wound does not extend to the muscle , tendon, or bone
Individual is 18 years of age or older
Ankle-Brachial Index (ABI) is greater than 0.75
The wound is size is within the range between 2 cm2 to 20 cm2
The wound has a clean, granulating base with minimal adherent slough
No infection is suspected or present at the wound site
No cancer is suspected or present at the wound site
No 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
Not more than 50% of the ulcer is positioned below the malleolus.
An indication not specified above. (Please describe):
OrCel™
Request is for OrCel™ in 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™ as a temporary wound covering to treat second degree burns.
Request is for TransCyte™ as a temporary wound covering to treat third degree burns
An indication not specified above. (Please describe):
OTHER
Request is for an allogeneic, xenographic, synthetic, and composite product not listed above for wound healing
Please specify the product and indication:
Request is for an allogeneic, xenographic, synthetic, and composite product not listed above for soft tissue
grafting
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 Coverage Guideline SURG.00011
Policy Last Review Date:
05/07/2015
Policy Effective Date:
07/01/2015
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