REVIEW REQUEST FOR Autologous, 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: 05/19/2011 Policy Effective Date: 07/01/2011 Provider Tool Effective Date: 07/01/2011 Individual’s Name: Date of Birth: Insurance Identification Number: Individual’s Phone Number: Ordering Provider Name & Specialty: Provider ID Number: 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 (ICD-9) if known): Please check all that apply to the individual: SYNTHETIC PRODUCTS Becaplermin gel (Regranex®) for Neuropathic Diabetic Ulcers: Request is for becaplermin gel (Regranex®) recombinant human platelet-derived growth factor for neuropathic diabetic ulcers extending into subcutaneous tissue or beyond There is 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 The individual has a full-thickness ulcer (i.e., Stage III or IV), extending through dermis into subcutaneous tissues There is documentation of participation in a wound management program, which includes sharp debridement, pressure relief (i.e., non-weight-bearing), and infection control Other: (please list) Becaplermin gel (Regranex®) for Pressure Ulcers: Request is for becaplermin gel (Regranex®) recombinant human platelet-derived growth factor for pressure ulcers The individual has a full-thickness ulcer (i.e., Stage III or IV), extending through dermis into subcutaneous tissues The ulcer is in an anatomic location that can be offloaded for the duration of treatment There is recent documentation that the serum albumin concentration is greater than 2.5 dL There is recent documentation that the serum total lymphocyte count is greater than 1,000 There are recent documented normal values of vitamins A and C. Other: (please list) Page 1 of 4 REVIEW REQUEST FOR Autologous, 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: 05/19/2011 Policy Effective Date: 07/01/2011 Provider Tool Effective Date: 07/01/2011 Becaplermin gel (Regranex®) for Other Uses: Request is for becaplermin gel (Regranex®) recombinant human platelet-derived growth factor for the treatment of ischemic ulcers Request is for becaplermin gel (Regranex®) recombinant human platelet-derived growth factor for the treatment of venous stasis ulcers Request is for becaplermin gel (Regranex®) recombinant human platelet-derived growth factor for the treatment of ulcers which do not extend through the dermis into the subcutaneous tissue Other: (please list) Other synthetic products: Request is for antimicrobial silver wound dressings, (e.g., Acticoat, Actisorb ™ , and Silversorb® ) therapy and dressings Request is for synthetic Silicone/Nylon Membrane wound dressing (e.g., Biobrane®) Request is for synthetic fistula plugs (e.g. GORE BIO-A Fistula Plug) Request is for synthetic soft-tissue grafting materials (e.g. SportMesh™) Request is for a synthetic product or use not described in the synthetic product section: (please specify): AUTOLOGOUS PRODUCTS Request is for (check all that apply): Blood derived wound products, (e.g., Autologel™ , SafeBlood™ , Vitagel® ) Platelet rich plasma (PRP) for the treatment of cutaneous wounds, soft tissue injuries (including epicondylitis and sinus surgery), or bone injuries (including surgically created wounds and non-unions) Request is for an autologous product or use not described in the autologous product section: (please specify) ALLOGENEIC PRODUCTS (Alloderm®, Apligraf®, Dermagraft®, OrCel™, TransCyte™, Cymetra® , GraftJacket™, and Neoform Dermis™) Request is for Alloderm® for breast reconstruction surgery Request is for Alloderm® for surgical repair of complex abdominal wall wounds (e.g., due to infection, fascial defect, etc.) Request is for Alloderm® for other use (please list): This is initial request for Apligraf® This is request for continued use of Apligraf® . Please list how many treatments the individual has received: Request is for Apligraf® in conjunction with standard therapeutic compression for the treatment of chronic, non-infected, partial 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) Request is for Apligraf® 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 Request is for Apligraf® use on clinically infected wounds Request is for Apligraf® in individuals with known allergies to bovine collagen Request is for Apligraf®in individuals with a known hypersensitivity to the components of the Apligraf® agarose shipping medium Request is for Apligraf® for other use (please list): Page 2 of 4 REVIEW REQUEST FOR Autologous, 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: 05/19/2011 Policy Effective Date: 07/01/2011 Provider Tool Effective Date: 07/01/2011 Request is for Dermagraft® for 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 Request is for Dermagraft® for wounds with dystrophic epidermolysis bullosa Request is for Dermagraft® for infected ulcers and ulcers with sinus tracts Request is for Dermagraft® for other use (please list): Request is for OrCel™ for children with recessive dystrophic epidermolysis bullosa who are undergoing reconstructive hand surgery Request is for OrCel™ for other use (please list): Request is for TransCyte™ as a temporary wound covering to treat second and third degree burns Request is for TransCyte™ for other use (please list): Request is for Cymetra® Request is for GraftJacket™ Request is for Neoform Dermis™ Request is for C-QUR™ biosynthetic mesh Request is for cryopreserved allogeneic human skin ( e.g., TheraSkin® ) Request is for a use or product not specificed above (please list): XENOGRAPHIC & XENOGRAPHIC-RELATED OR DERIVED PRODUCTS Request is for: Integra™ Bilayer Matrix Wound Dressing, 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 Request is for one of the following xenographic products (please check appropriate product) Avaulta Plus™ CellerateRX® Collamend CorMatrix® CRXa™ Cuffpatch™ ENDURAgen™ E-Z Derm™ Integra™ Matrix Wound Dressing Matristem® Mediskin® Menaflex™ Collagen Meniscus Implant Oasis™ OrthADAPT™ Pelvicol® Pelvisoft® Permacol™ PriMatrix Strattice™ SurgiMend® Surgisis® (including Surgisis AFP™ Anal Fistula Plug TenoGlide™ Unite™ Page 3 of 4 REVIEW REQUEST FOR Autologous, 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: 05/19/2011 Policy Effective Date: 07/01/2011 Provider Tool Effective Date: 07/01/2011 Veritas® Collagen Matrix Request is for xenographic-related or derived products (e.g. MediHoney®) Request is for a xenographic product not listed above other (please list): COMPOSITE AUTOLOGOUS / ALLOGENEIC / XENOGRAPHIC PRODUCTS Request is for a product made from a combination of human autologous and xenographic cellular materials (e.g. Epicel®) Request is for a product made from a combination of human allogeneic and xenographic cellular materials Other: (please list) 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 4 of 4