全球醫療技術償付動向

Abstract

Overview

MAKE SURE YOU UNDERSTAND GLOBAL REIMBURSEMENT MECHANISMS AND MAXIMISE THE MARKET POTENTIAL FOR YOUR PRODUCTS

Reimbursement mechanisms for medical technology are complex, with different systems applicable to private and public healthcare, different product categories and even different regions of the same country also, countries are reforming and restructuring their healthcare provision. Often reimbursement is used politically as a means of price curbing and slowing access to the latest technology, which leads to frequent overhauls of the systems in an attempt at achieving the best value for money.

These factors mean that for a medical technology company to be successful, it must devote significant time and resources to keeping abreast of the latest developments and devising strategies to best address the requirement

This report will help you

• Analyse the role of clinical and economic data in obtaining reimbursement
• Understand the importance of technology assessment, allowing you to maximise the chances of overcoming reimbursement hurdles and prepare a successful market entry strategy
• Plan your reimbursement strategy for all the main markets for your product
• Save time and money by avoiding the pitfalls of each reimbursement system
• Stay ahead of your competitors by understanding the likely effect of recent and upcoming legislation
• Learn from the experiences of experts who have many years' experience in reimbursement

In-depth country analysis

Provides in-depth country profiles for the US, Japan, China, Germany, France, the UK, Italy and Spain, for each country analysed, the report will focus on:

• Overview of the healthcare system
• Reimbursement and pricing system
• Medical device registration requirements
• Timing of reimbursement actions
• Procurement practices and types of tenders
• Case studies
• Postmarket and surveillance requirements
• Key contacts

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