Global Trends in Reimbursement of Medical Technology

Table of Contents

ABBREVIATIONS

CHAPTER 1 GAINING REIMBURSEMENT IN THE US

• 1.1 The US health environment: a medical device perspective
• 1.2 Payers
  • 1.2.1 Public healthcare
    • 1.2.1.1 The Medicare programme
    • 1.2.1.2 The Medicaid programme
    • 1.2.1.3 Veterans Administration (VA)
  • 1.2.2 Private healthcare
    • 1.2.2.1 Self-pay and uninsured
• 1.3 The influencers and advocates
  • 1.3.1 Congress
  • 1.3.2 MedPAC
  • 1.3.3 State government departments of health and human services
  • 1.3.4 Other influencers
    • 1.3.4.1 Physician specialty and patient advocacy groups
    • 1.3.4.2 Trade associations
    • 1.3.4.3 Group purchasing organisations
  • 1.3.5 Outside US activities
  • 1.3.6 Competition
• 1.4 Providers
• 1.5 Reimbursement
• 1.6 Coverage
  • 1.6.1 Health plan benefits
  • 1.6.2 Reasonable and necessary services
  • 1.6.3 Clinical evidence and coverage
  • 1.6.4 Cost and coverage
  • 1.6.5 Overview of Medicare coverage
  • 1.6.6 Medicare national coverage
  • 1.6.7 Medicare Condition of Evidence Development (CED)
    • 1.6.7.1 Coverage with Appropriateness Determination (CAD) 25
    • 1.6.7.2 Coverage with Study Participation (CSP)
  • 1.6.8 Registries
  • 1.6.9 Medicare Evidence Development & Coverage Advisory Committee (MedCAC)
  • 1.6.10 Coverage for clinical trials
  • 1.6.11 Medicare local coverage
  • 1.6.12 Overview of private payers coverage
• 1.7 Codes
  • 1.7.1 CPT/HCPCS Level I: Physician and outpatient services
    • 1.7.1.1 CPT category codes
  • 1.7.2 HCPCS Level II: supplies and other services
  • 1.7.3 International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM): Diagnosis codes and inpatient procedure codes
  • 1.7.4 ICD-9-CM procedure codes
  • 1.7.5 ICD-10
• 1.8 Payment: Systems under pressure
  • 1.8.1 Prospective payment systems
    • 1.8.1.1 Inpatient prospective payment system (IPPS)
    • 1.8.1.2 Special payments for innovation
    • 1.8.1.3 Other hospital prospective payment systems
    • 1.8.1.4 Private payers
    • 1.8.1.5 Outpatient prospective payment system
    • 1.8.1.6 New device category for pass-through payment and new technology APCs
    • 1.8.1.7 Ambulatory Surgery Centers (ASCs): Moving to prospective payment
  • 1.8.2 Fee schedules
    • 1.8.2.1 Physician fee schedule
    • 1.8.2.2 Durable medical equipment (DME)
    • 1.8.2.3 Clinical laboratory fee schedule
• 1.9 Integrating reimbursement activities into a business plan

CHAPTER 2 GAINING REIMBURSEMENT IN EUROPE

• 2.1 Introduction
• 2.2 The European medical devices market
• 2.3 Commonalities to some reimbursement systems
  • 2.3.1 Public tendering
  • 2.3.2 Diagnosis related groups
  • 2.3.3 Health technology assessment
  • 2.3.4 Other commonalities
• 2.4 Reimbursement strategies
• 2.5 Gaining reimbursement in France
  • 2.5.1 The French market
  • 2.5.2 Reimbursement system
    • 2.5.2.1 Coding
    • 2.5.2.2 Reimbursement process
  • 2.5.3 Key contacts
• 2.6 Gaining reimbursement in Germany
  • 2.6.1 Introduction
  • 2.6.2 Healthcare spending and finance in Germany
  • 2.6.3 Current developments
    • 2.6.3.1 Germany' s DRG system
  • 2.6.4 Health care reform - the GKV-WSG
  • 2.6.5 Outlook
    • 2.6.5.1 The hospital sector
    • 2.6.5.2 Private practice
• 2.7 Gaining reimbursement in Italy
  • 2.7.1 The Italian market
  • 2.7.2 Reimbursement system
    • 2.7.2.1 Coding
    • 2.7.2.2 Health technology assessment
    • 2.7.2.3 Other issues
  • 2.7.3 Key contacts
• 2.8 Gaining reimbursement in Spain
  • 2.8.1 The Spanish market
  • 2.8.2 Reimbursement
    • 2.8.2.1 Health technology assessment
  • 2.8.3 Key contacts
• 2.9 Gaining reimbursement in the UK
  • 2.9.1 The UK market
  • 2.9.2 Reimbursement system
    • 2.9.2.1 Coding
    • 2.9.2.2 Purchasing
    • 2.9.2.3 Health technology assessment
  • 2.9.3 Key contacts

CHAPTER 3 GAINING REIMBURSEMENT IN JAPAN

• 3.1 Introduction - the Japanese healthcare system
• 3.2 Healthcare funding in Japan
• 3.3 Characteristics of the Japanese market - market size and demographics
• 3.4 Overview of the Japanese regulatory environment
  • 3.4.1 Reform of the Pharmaceutical Affairs Law
  • 3.4.2 The Market Authorization Holder system
  • 3.4.3 Medical device approval
    • 3.4.3.1 The Pharmaceutical and Medical Devices Agency (PMDA)
    • 3.4.3.2 PMDA consultations
  • 3.4.4 Medical device regulatory classification
  • 3.4.5 Revised clinical trial requirements
  • 3.4.6 Further implications of the revised Pharmaceutical Affairs Law
    • 3.4.6.1 New labeling requirements for medical devices
    • 3.4.6.2 Quality assurance
• 3.5 The pricing and reimbursement system in Japan
  • 3.5.1 General overview
  • 3.5.2 Key decision-makers on pricing and reimbursement issues
    • 3.5.2.1 The Central Social Insurance Medical Council (Chuikyo)
    • 3.5.2.2 Health Insurance Bureau (HIB)
    • 3.5.2.3 Health Policy Bureau (HPB)
  • 3.5.3 Medical facility reimbursement
  • 3.5.4 New product pricing - reimbursement classification for medical devices
    • 3.5.4.1 Class A1 products
    • 3.5.4.2 Class A2 products
    • 3.5.4.3 Class B products
    • 3.5.4.4 Class C1 products
    • 3.5.4.5 Class C2 products
    • 3.5.4.6 Class F reimbursement
• 3.6 Postscript
  • 3.6.1 Medical device and pharmaceutical pricing reform and related issues

CHAPTER 4 GAINING REIMBURSEMENT IN CHINA

• 4.1 Introduction
• 4.2 The health insurance system
  • 4.2.1 Rural health insurance
  • 4.2.2 Urban health insurance
• 4.3 Chinese market demographics and market size
  • 4.3.1 The customer base
    • 4.3.1.1 The private hospital network
    • 4.3.1.2 The Ministry of Health network.
    • 4.3.1.3 The military hospital network
    • 4.3.1.4 The industrial hospital sector
• 4.4 Pricing and reimbursement of medical devices
  • 4.4.1 Need for value for money
• 4.5 Major healthcare reform
• 4.6 The Chinese medical device market
  • 4.6.1 The regulatory environment
  • 4.6.2 The Ministry Of Health
  • 4.6.3 The import marketplace
    • 4.6.3.1 Barriers to access
• 4.7 Key contacts in China

LIST OF TABLES

• Table 1.1 Sites of service categories
• Table 1.2 Reimbursement analysis for new medical devices
• Table 1.3 Codes application timeline
• Table 2.1 Patient grouping systems of selected countries
• Table 2.2 Regional DRG reimbursement in Italy 2004
• Table 2.3 Products in Annex I or Annex II of Royal Decree 9/1996
• Table 3.1 Japanese medical device classification system and regulatory clearance requirements
• Table 3.2 Japanese terminologies for regulated devices
• Table 3.3 List of medical devices subject to regulation
• Table 3.4 Premium price criteria

LIST OF FIGURES

• Figure 1.1 Payer mix US: Personal healthcare expenditures by source of funds: selected years 1960-2004
• Figure 1.2 US National Coverage Determination Process
• Figure 1.3 Guidelines for new technology payments
• Figure 2.1 EU procurement process under the restricted award procedure
• Figure 2.2 Submission of reimbursement application
• Figure 2.3 Healthcare expenditures 1995-2005
• Figure 2.4 Annual rate of change of expenditures in different markets
• Figure 2.5 Sources of healthcare finance - 2005 (€ bn)
• Figure 2.6 Changes in Italy' s funding structure
• Figure 3.1 Percentage of Japanese population over 65 years
• Figure 3.2 Reform of Japanese medical device regulatory approval system
• Figure 4.1 Medical device market size - the big four in Asia
• Figure 4.2 The SFDA organisation
• Figure 4.3 Organisation chart of the Department of Medical Devices