Reimbursement Guide - Osiris Therapeutics

1 Reimbursement Guide 5. Grafix Reimbursement Hotline: 1-855-947-2349. (855-9 GRAFIX). FAX: 1-855-850-3005. Osiris Therapeutics , Inc. Customer Support: 866-352-4540. 2015 Reimbursement Guide Grafix is a cryopreserved placental allograft tissue for acute and chronic wounds. Grafix is regulated as a human cells, tissue, or a cellular or tissue-based product (HCT/P) under 21 CFR part 1271 and section 361 of the Public Health Service (PHS) Act. Osiris Therapeutics , Inc. is registered with the FDA as a tissue establish- ment and accredited by the American Association of Tissue Banks (AATB). Description Three-dimensional matrix designed for application directly to acute and chronic wounds, including but not limited to: diabetic foot ulcers, venous leg ulcers, pressure ulcers, and burns.

2 Cryopreserved placental membranes have been shown to be beneficial in supporting natural wound repair in the following ways1: Serves as a barrier from the environment and thus protects the tissue from infection Reduces inflammation Reduces scarring by supporting wound closure without excessive fibrosis Grafix is an alternative to autologous skin grafting that eliminates the pain, co-morbidities, and procedure time associated with obtaining autologous grafts. Clinical Data Grafix has been studied in a multi-center (n=20), randomized, controlled clinical trial, Protocol 302, which demonstrated overwhelming efficacy of Grafix compared to the control (standard of care included surgical debridement, off-loading, and non-adherent dressings) in the closure of diabetic foot ulcers over 12 weeks (62% vs.)

3 , p= , n=97).2. A retrospective study of the use of Grafix in chronic refractory wounds included diabetic foot ulcers, venous leg ulcers, and pressure ulcers. This study included a total of 66 patients with 67 wounds. Average time to closure in these wounds was weeks. More than 75% of wounds were closed after 12 weeks of care after previously being treated unsuccessfully for an average of 38 weeks. Additionally, 75% of these patients had failed other wound therapies prior to Grafix and 50% had failed two previous wound References: 1. Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian A. Properties of the amniotic membrane for potential use in tissue engineering.

4 Eur Cell Mater. 2008;15:88-99. 2. Lavery LA, Fulmer J, Shebetka KA, Regulski M, Vayser D, Fried D, et al. The efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. 2014;11(5):554-560. Published online July 21, 2014. 3. Regulski M, Jacobstein DA, Petranto RD, Migliori VJ, Nair G, Pfeiffer D. A retrospective analysis of a human cellular repair matrix for the treatment of chronic wounds. Ostomy Wound Manage. 2013;59(12):38-43. The information provided in this manual is not a guarantee of coverage or payment. Documentation should always reflect the actual services completed.

5 Please refer to the patient's insurance plan and/or the local Medicare Administrative Contractor for Local Coverage Determinations (LCDs) and for additional information and guidance on coding, coverage, and payment. Grafix Product HCPCS Codes Product Code Billable Units Grafix PRIME Q4133 2. 14 mm Disc Grafix PRIME Q4133 3. x 2 cm Grafix PRIME Q4133 6. 2 x 3 cm Grafix PRIME Q4133 12. 3 x 4 cm Grafix PRIME Q4133 16. 4 x 4 cm Grafix PRIME Q4133 25. 5 x 5 cm Grafix CORE Q4132 3. x 2 cm Grafix CORE Q4132 6. 2 x 3 cm Grafix CORE Q4132 12. 3 x 4 cm Grafix CORE Q4132 16. 4 x 4 cm Grafix CORE Q4132 25. 5 x 5 cm HCPCS stands for Healthcare Common Procedure Coding System (HCPCS).

6 For Medicare and other health insurance programs to ensure health care claims are processed in an orderly and consistent manner, standardized coding systems are essential. The HCPCS Level II code set is one of the standard code sets used by medical coders and billers for this purpose. The other, HCPCS Level I coding set, is comprised of CPT (Current Procedural Terminology), copyrighted by the American Medical Association (AMA). The HCPCS codes are supplied for informational purposes only and do not represent a statement, promise, or guarantee by Osiris that these codes will be appropriate or that Reimbursement will be made. Coding practice will vary by site of care, patient condition, range of service provided, local payer instructions, and other factors.

7 The decision as to how to complete a Reimbursement form, including amount to bill, is exclusively the responsibility of the provider. The provider is ultimately responsible for verifying coverage with the patient's payer source. 2015 Reimbursement Guide ICD-9 Diagnosis Codes*. Please check with your local payers or Medicare Administrative Contractor for specific coding and billing requirements. The following represents ICD-9-CM codes that can be utilized with skin substitutes. The following ICD-9-CM codes must be used in pairs, , one primary diagnosis and one secondary diagnosis. ICD-9-CM Description Unspecified ulcer of lower limb Ulcer of thigh Ulcer of calf Ulcer of ankle Ulcer of the heel and midfoot Ulcer of other part of foot Ulcer of other part of lower limb ICD-9-CM Description Secondary diabetes mellitus with neurological manifestations, not stated as uncontrolled, or unspecified Secondary diabetes mellitus with neurological manifestations, uncontrolled Secondary diabetes mellitus with peripheral circulatory disorders, not stated as uncontrolled, or unspecified Secondary diabetes mellitus with peripheral circulatory disorders.

8 Uncontrolled Secondary diabetes mellitus with other specified manifestations, not stated as uncontrolled, or unspecified Secondary diabetes mellitus with other specified manifestations, uncontrolled Diabetes with neurological manifestations, type II or unspecified type, not stated as uncontrolled Diabetes with neurological manifestations, type I (Juvenile type), not stated as uncontrolled Diabetes with neurological manifestations, Type II or unspecified type, uncontrolled Diabetes with neurological manifestations, Type I [Juvenile type], uncontrolled Diabetes with peripheral circulatory disorders, Type II or unspecified type, not stated as uncontrolled Diabetes with peripheral circulatory disorders, Type I (Juvenile type)

9 , not stated as uncontrolled Diabetes with peripheral circulatory disorders, Type II or unspecified type, uncontrolled Diabetes with peripheral circulatory disorders, Type I (Juvenile type], uncontrolled Diabetes with other specified manifestations, Type II or unspecified type, not stated as uncontrolled Diabetes with other specified manifestations, Type I (Juvenile type], not stated as uncontrolled Diabetes with other specified manifestations, Type II or unspecified type, uncontrolled Diabetes with other specified manifestations, Type I (Juvenile type], uncontrolled ICD-9-Diagnosis Codes*. Venous Ulcer Codes Please check with your local payers or Medicare Administrative Contractor for specific coding and billing requirements.)))

10 The following represents ICD-9-CM codes that can be utilized with skin substitutes. The following ICD-9-CM codes must be used in pairs, , one primary diagnosis and one secondary diagnosis. ICD-9-CM Description Unspecified ulcer of lower limb Ulcer of thigh Ulcer of calf Ulcer of ankle Ulcer of heel and midfoot Ulcer of other part of foot Ulcer of other part of lower limb ICD-9-CM Description Varicose veins of lower extremities with ulcer Varicose veins of lower extremities with ulcer and inflammation Postphlebetic syndrome with ulcer Ulcer of ankle Chronic venous hypertension with ulcer Chronic venous hypertension with ulcer and inflammation Venous (peripheral) insufficiency, unspecified *.