Contents:

Chapter 1 The 2006 Reimbursement Guide - Reimbursement—The Key to New Medical Technology Commercialization Success - Why an Update? - Style and Organizational Changes Chapter 2 Overview of Basic Reimbursement Concepts - Reimbursement Stakeholders - Mixed Payer System—Public and Private - Coverage Benefit Category and Site of Care Public versus Private Decision Processes Medicare1 National Coverage Determination Local Coverage Decisions MMA Change: Medicare Contractor Reform Private Insurance Prior Authorization (PA) and Pre-Certification Processes The Difference Between PA and Pre-Certification Patient Selection Criteria Technology Assessment - Coding Systems Healthcare Common Procedure Coding System (HCPCS) Level I—Current Procedural Terminology (CPT) Level II—HCPCS National Codes International Classification of Diseases (ICD-9) National Drug Codes (NDC) Revenue Codes - Payment Systems Medicare Payment Systems Inpatient Prospective Payment System (IPPS) Diagnosis Related Groups (DRGs) Outpatient Prospective Payment System (OPPS) Ambulatory Procedure Classifications (APCs) Other Medicare Payment Systems Ambulatory Surgical Centers (ASC) Long-Term Care Facilities and Skilled Nursing Facilities Home Healthcare Agencies (HHAs) Durable Medical Equipment, Prosthetics/Orthotics, and Supplies Clinical Laboratories Private Payment Methodologies Fee-for-Service (FFS) Capitated/Contracted Payments Carve-Outs - References Chapter 3: The Impact of Political and Regulatory Processes on Reimbursement Role of Congress Role of Agencies References Chapter 4: HHS Agencies With The Greatest Impact on Reimbursement - The Food and Drug Administration (FDA) Medical Devices Premarket Notification 510(k) Premarket Approval (PMA) Impact of Regulatory Process on Reimbursement for Devices In Vitro Diagnostics General Purpose Reagents (GPR) Analyte Specific Reagent (ASR) Impact of Regulatory Process on Reimbursement for IVDs Pharmaceuticals Impact of Regulatory Process on Reimbursement for Drugs Biologics Impact of Regulatory Process on Reimbursement for Biologics Combination Products Impact of Regulatory Process on Reimbursement for Combination Products Fast-Track Review - The Centers for Medicare and Medicaid Services (CMS) - References Chapter 5: Public Sector Payers & Programs - Medicare Medicare Part A—Hospital Insurance Medicare Part B—Supplemental Insurance Drugs Covered Under Traditional (Original) Medicare Medigap Policies (Medicare Supplement Insurance) Medicare Part C—Medicare Advantage Medicare Part D—Prescription Drug Program - Medicaid Medicaid Managed Care Dual Eligibles National Medicaid Rebates, Best Price PDLs, Supplemental Rebates, Supplemental Drug Programs Recent court battles have cleared the way for PDLs and supplemental rebates: The Veterans Health Administration (VHA) Department of Defense (DoD) Bureau of Indian Affairs: Indian Health Services (IHS) Community Health Centers (CHCs) - References Chapter 6: Private Sector Payers - Role of Employers - Plan Types Health Maintenance Organization (HMO) Preferred Provider Organization (PPO) Point of Service (POS) Consumer-Driven Health Care Medical Savings Plans (MSAs) / Health Savings Accounts (HSAs) - Reimbursement Mechanisms and Types Fee-for-Service (FFS) Discounted Fee-for-Service (DFFS) Per Diem & Episode of Care Capitation - Workers' Compensation - Self-insured Employer Groups - References Chapter 7: Health Economics and Reimbursement - Economic Modeling and Analysis Cost Minimization Analysis Cost Effectiveness Analysis Cost Utility Analysis - References Chapter 8: Tactical Reimbursement Support Tools - Hotlines Health Insurance Portability and Accountability Act (HIPAA) of 1996 - Coding and Reimbursement Guides - Sales Force Reimbursement Training - References Chapter 9: The Timing of Reimbursement Actions and The Impact on Business Strategy - Strategic Planning and Portfolio Management - Product Lifecycle Timeline - Cyclical CMS Timelines Appendix A: Coding Application Examples - CPT Code Application Process Current Procedural Terminology (CPT) Instructions for Code Proposal Submission Application for consideration of a CPT Category I Code - Healthcare Common Procedure Coding System (HCPCS) HCPCS Application Process HCPCS Update to New Process - New/Revised ICD-9 Procedure Codes Process for Requesting New/Revised ICD-9 Procedure Codes - Transitional Pass-Through Payment Process for New Technology Services Transitional Pass-Through Payment Process - Medicare's New Technology Ambulatory Payment Classification (APC) Process for New Technology Ambulatory Payment Classification (APC) Designation under the Prospective Hospital Outpatient Payment System (OPPS) Appendix B: Glossary and Key Terms Reference List Appendix C: Acronyms and Abbreviations TABLE OF EXHIBITS Exhibit 2.1 Reimbursement Stakeholders Exhibit 2.2 The US's Health Dollar in 2003 Exhibit 2.3 Health Benefits and Site of Care Exhibit 2.4 National Coverage Determination Process Exhibit 2.5 Common Coding Systems Exhibit 2.6 CPT Application Review Process Exhibit 2.7 HCPCS Level II Code Categories Exhibit 2.8 HCPCS Application Review Process Exhibit 2.9 One Fee Covers All Services in Course of Treatment Exhibit 3.1 Comparison of Roles of Statutes and Regulations Exhibit 3.2 Executive Branch Departments Exhibit 3.3 HHS Agencies Exhibit 4.1 CMS Organizational Structure Exhibit 5.1 Medicare Part A Service Guidelines Exhibit 5.2 Medicare Part B Service Guidelines Exhibit 5.3 Medicare Part D Beneficiary Cost-Sharing Responsibilities . Exhibit 5.4 Model Formulary for Medicare Prescription Drug Plans Exhibit 5.5 Percent Medicaid Expenditures for Dual Eligibles 2002 Exhibit 5.6 2005 Medicaid Preferred Drug List Status Exhibit 5.7 2005 Medicaid Supplemental Rebate Programs Exhibit 5.8 Veterans Integrated Service Networks (VISN) Exhibit 5.9 Comparison of Patient-Related Revenue to Overall CHC Revenue Exhibit 9.1 Timeline of Events Exhibit 9.2 Schedule of the CMS Reimbursement Activities Exhibit A.1 Coding Change Request Form Exhibit A.2 Dates for Pass-through Status Implementation Exhibit A.3 Dates for New Technology Status Implementation