Apligraf A Reimbursement Case Study Antonio S. Montecalvo, CPA Director of Customer Support Services ISCT San Diego - May 5th, 2009

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1 Apligraf A Reimbursement Case Study Antonio S. Montecalvo, CPA Director of Customer Support Services ISCT San Diego - May 5th, 2009

2 Key Points Current Business Reimbursement Landscape FDA Approval Hospital Outpatient Payment History of Apligraf ASP Data Coding History for Apligraf Learning: Reimbursement to do list

3 Current Business Mission To bring regenerative medicine to patients and standardize its use in every day medical care Approach / Technology We use human allogeneic cells and biological matrices to induce soft tissue regeneration Competitive Advantage We have built unique skill sets to take living technology from R&D through scale-up to full commercialization Primary Focus Bio-active wound healing Oral tissue regeneration

4 Platform Technology Living Cells Platform Focus Areas Brands Bio-active Wound Healing Oral Regeneration 4

5 Apligraf Market Opportunity Venous Leg Ulcers & Diabetic Foot Ulcers Source: Cavorsi, JP Evidence-Based Wound Care Standards in the Clinical Setting: Applying the Knowledge to Real World Practice, Supplement to Wounds,

6 Apligraf Our Flagship Product

7 FDA Competitors Reimbursement Landscape RUC CMS National AMA Congress SOCIETIES CAC LCD Local Local Physicians

8 FDA Approval FDA regulates Apligraf as a Class III medical device. Approved for the treatment of both venous leg and diabetic foot ulcers. Required Pre-market Approval 1. Requires the demonstration of clinical safety and efficacy. Prior to receiving approval to market Apligraf 2. Submitted two pivotal studies to FDA One for diabetic foot ulcers and another for venous leg ulcers. Each pivotal study involved more than 200 subjects and occurred at multiple clinical sites throughout the United States.

9 Hospital Outpatient Payment History of Apligraf Reimbursed by Medicare as a biologic since 2001 Transmittal states Apligraf met statutory requirement as a biologic C1305 assigned to Apligraf for Hospital Outpatient coding Reimbursed under Pass Through as biologic In 2001 and 2002 reimbursed as a biologic under the pass through list Apligraf reimbursed as a sole source biologic under MMA 88% of AWP in % of AWP in 2005 GAO Report June 30,2005 Apligraf designated as Specified Covered Outpatient Drug and is listed as number 38 in Table 1 with Associated ASP data Lists $7m in hospital outpatient spending for Apligraf

10 Apligraf is Paid as a Biologic Apligraf has been recognized as a biologic and will be paid at 95% of it s average wholesale price (AWP) effective January 1, 2001.

11 ASP Data for Apligraf Organogenesis has submitted ASP data since 2004 according to the CMS defined criteria Organogenesis continues to submit ASP data quarterly to CMS under the NDC # The ASP data is inclusive of ALL sales for Apligraf irrespective of the site of care: Hospital OPPS and Part B Physician Office Payment CMS proposes that future ASP data submissions include product name. This will help crosswalk Hospital OPPS and Part B Physician Office Payment for drugs and biologics

12 ASP Filing - June 2005

13 Coding History for Apligraf Apligraf has two separate HCPCS C Hospital OPPS Descriptor: Apligraf, per 44 square centimeters Program Transmittal B assigned HCPCS C1305 to Apligraf Apligraf is reimbursed with APC 1305 J Part B Physician Office Payment Descriptor: Dermal and epidermal tissue of human origin, with or without bioengineered or process elements, with metabolically active elements, per square elements Apligraf was assigned temporary code Q0185 Program Transmittal B Apligraf was assigned permanent code J7340 Program Transmittal B

14 Learning: Reimbursement to do list Incorporate reimbursement early in Product Design Path thru FDA 510K vs. PMA Education: Physician and Hospitals Place of Service DRG - included in payment for in patient stay APC outpatient payment Physician payment system Product and application Product name Coding New codes vs. existing code

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