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A Guide To US Reimbursement For Drugs, Medical Devices, and Diagnostics
Drug and Market Development Publishing, March 2006, Pages: 140
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
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