Research and Markets: A Guide to Achieving Reimbursement for Medical Devices, Diagnostics, and Pharmaceuticals in the United States.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c8677) has announced the addition of A Guide to Achieving Reimbursement for Medical Devices, Diagnostics, and Pharmaceuticals in the United States to their offering Reimbursement plays a key role in the success and valuation of a product- making it crucial for product development decision-makers to have a sophisticated knowledge of this complex matter. Reimbursement regulation is a constantly moving target set into motion by the continuous evolution of legislation (impacting Medicare and Medicaid Medicare and Medicaid U.S. government programs in effect since 1966. Medicare covers most people 65 or older and those with long-term disabilities. Part A, a hospital insurance plan, also pays for home health visits and hospice care. ) and the private insurance sectors. In addition, changes within the payer environment have drawn attention to the accessibility of new technologies to patients. Companies need to focus on achieving milestones during the reimbursement process to aid in effectively positioning themselves for optimal market launch, and for clearly defining and providing management with a more realistic and credible idea of the value of their technology. Reimbursement planning should be conducted concurrently with FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval and clinical trials to ensure the data captured not only addresses the demands of the FDA but also the requirements of the major insurance carriers to enable a favorable coverage decision. This Guide to Achieving Reimbursement explores the basics and lays a foundation for reimbursement that will assist companies in navigating through this complex process. In addition, the Guide highlights recent amendments to legislation that have significantly impacted the industry. Questions Answered in this guide: - Learn how to incorporate reimbursement activities into company's product development cycle and strategic & development plans. - Identify and achieve key milestones during the reimbursement process. - Recognize the processes for achieving coverage, coding, and payment and access the impact of these achievements on the financial forecast and adoption rates. - Assess the benefit of using health economics modeling to establish value and price. - Implement tactics to ensure market adoption is optimized and health providers receive payment from both private and government payment systems. - Detect the roadways to gaining both public (Medicare and Medicaid) and private insurance coverage for new medical technologies. - Understand the impact of health policy legislation and politics on devices, drugs, durable medical equipment Durable medical equipment is a term of art used to describe certain Medicare benefits, that is, whether Medicare may pay for the item. The item is defined by Title XVIII the Social Security Act: DME - Distributed Management Environment ), and how patients access new technologies. This Guide will prove beneficial to: Executives and senior managers at medical device, diagnostic, biotechnology, and pharmaceutical companies who are seeking to license, market, and commercialize a product within the United States healthcare system. In addition, this Guide will prove invaluable to commercial reference laboratories, reagent suppliers, equipment manufacturers, venture capitalists, investment bankers, research analysts, and other healthcare service professionals wanting an understanding of the issues within reimbursement and how they will impact their own, or their portfolio companies. Valuable Case Studies: Learn the in's and out's of reimbursement from case studies of three companies. -Medical Device -In Vitro Diagnostic -Drug/Biologic 1. Introduction: The Role of Reimbursement in the U.S. Healthcare System 1.1 Overview 1.2 Public Sector 1.3 Private Sector 1.4 Worker's Compensation 1.5 Self-insured Employer Groups 1.6 Supplemental Insurance 2. Understanding the Basics 2.1 Site of Care and Reimbursement 2.2 Coverage 2.3 Coding Systems 2.4 Payment Systems 3. Health Economics and Reimbursement 3.1. Economic Modeling and Analysis and Clinical Trial Integration 3.2. Formulary formulary /for·mu·lary/ (for´mu-lar?e) a collection of recipes, formulas, and prescriptions. National Formulary see under N. for·mu·lar·y n. Review/Positioning 4. Timeline of Events 5. Reimbursement and Adoption: Tactics 5.1. Hotlines 5.2. Coding and Reimbursement Guides 5.3. Sales Force 6. The Government: Impact on Reimbursement 6.1. Role of Congress 6.2. Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and (CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. ) 6.3. The Food and Drug Administration (FDA) 7. Reimbursement's Impact on Business Strategy 7.1. Strategic Planning 7.2. Clinical Development 7.3. Reimbursement and Valuation 8. Case Studies 8.1. Medical Device 8.2. In Vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. Diagnostic 8.3. Drug/Biologic 9. Coding Application Examples 9.1. Current Procedural Terminology Current Procedural Terminology See CPT. (CPT CPT See: Carriage Paid To ) 9.2. Healthcare Common Procedure Coding System The Healthcare Common Procedure Coding System (HCPCS) is a set of health care procedure codes based on the American Medical Association's Current Procedural Terminology (CPT). Commonly pronounced Hick-Picks. (HCPCS HCPCS Healthcare Common Procedure Coding System ) 10. Technology Assessment 11. Appendix-Acronyms and Glossary 11.1. Reimbursement Acronyms 11.2. Reimbursement Glossary For more information visit http://www.researchandmarkets.com/reports/c8677 |
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