BME416-Reimbursement

BME416-Reimbursement - University of Southern California...

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Reimbursement 101: Coverage, Codes, and Payment University of Southern California USC Regulatory Science Program "Development & Regulation of Medical Products" BME416 April 2009 Judy Rosenbloom President, JR Associates
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Reimbursement takes time. Reimbursement Adage #7
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Reimbursement must be integrated into the product development and marketing plan. Reimbursement Adage # 6
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Reimbursement is a moving target. Reimbursement Adage # 5
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Reimbursement requires clarity: Goals Product Market Reimbursement Adage # 4
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Reimbursement requires different skills and experience: Strategy development Health care policy New code development Coding and billing rules Payer coverage Advocacy Product/clinical knowledge Health Economics Legislation and Regulation Law Project management Reimbursement Adage # 3
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Reimbursement requires a budget for strategy, planning, execution, monitoring, and ongoing education for various stakeholders. Reimbursement Adage # 2
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Reimbursement Adage # 1 “Get used to disappointment….” The Princess Bride, 1987
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Device Company Goals COVERAGE from as many payers as possible Adequate PAYMENT A reporting mechanism (CODING) Show economic and clinical VALUE
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What Guides Reimbursement ? Three primary elements are needed: Legislative, regulatory, and billing rules drive the process of getting paid. Establishing the value of a technology has been added to the mix. Coverage Codes Payment + + Services for which an insurer will pay What is considered reasonable and necessary Clinical value Describes procedures and services Describes clinical dx, symptoms, and conditions $ amount an insurer will pay Applicable to various sites of service
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When is Reimbursement Likely to be a Challenge for New Technologies? Coverage Code Payment If the technology is non covered If there is coverage with limitations If payers do not pay separately If payment is inadequate If a code is not available If a code is available but the payment is inadequate
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Reimbursement “Easy Wins” Technology is a significantly improved “me too” product Technology sells for less than competitors Technology saves costs for providers especially for those sites that receive DRG or case rate (lump sum) reimbursement
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Reimbursement “Probable Successes” Technology has comparative studies illustrating benefits of outcomes and costs against “gold standard” Technology price is equivalent to or slightly higher than competitors’ Technology saves time for physicians and improves efficiencies for hospitals
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Reimbursement “Nightmares” Technology is a modestly improved “me too” product Technology sells for more than the “gold standard” Technology allows for a shift to a lower- cost setting of care, e.g. MD office, but there’s no predicate reimbursement for it No data specifying outcome improvements
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Know Your Target: The Healthcare System
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The Sheer Number of Payers has Yielded Multiple
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