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Medical Device Pricing & Reimbursement 2014

  • March 2014
  • -
  • Espicom Business Intelligence
  • -
  • 77 pages

Provides insight into medical device pricing and reimbursement systems and latest regulations across 17 key countries!
This guide provides everything you could need to know about medical device pricing and reimbursement in 17 established and emerging economies. It examines the increasing role that health technology assessment plays in the reimbursement decision-making process and procurement strategies - both of which have a direct impact on device pricing.

Countries covered in this report:

Asia/Pacific: Australia, China, Japan and South Korea
European Union: Belgium, France, Germany, Italy, The Netherlands, Spain and United Kingdom
Latin America: Brazil, Chile, Colombia, Mexico and Peru
USA

Health Technology Assessment (HTA) plays a key role in the increasing trend of value-based care.
Whether through direct or indirect measures, the prices of medical devices are being squeezed in order to provide healthcare systems with the best quality of care for the lowest cost. The key trend is value-based healthcare. Value is defined in terms of clinical efficacy as well as cost-effectiveness. HTA is increasingly being employed as part of the reimbursement decision-making process. While the majority of markets do not yet directly link the outcome of HTA to reimbursement, in some countries, notably France and Australia, a positive HTA is required prior to listing for reimbursement. Particularly in advanced healthcare markets where costs are constrained and growth is slow, demonstrating value to HTA agencies has never been more important for medical device manufacturers. In emerging markets, formal HTA policies are in their infancy. However, HTA is becoming more important around the world, with countries such as Brazil, South Korea, Chile and Colombia all having introduced HTA policies over the last few years.

Key questions answered in this report

Which countries use reference pricing for medical devices?
What strategies are being employed to indirectly regulate prices?
Which countries have positive lists for reimbursement?
What have diagnosis related groups got to do with medical device reimbursement?
Is there a national standard for HTA in the USA?

Table Of Contents

Medical Device Pricing and Reimbursement 2014
FOREWORD 1
EXECUTIVE SUMMARY 3
MEDICAL DEVICES PRICING AND REIMBURSEMENT 4
Medical Devices Pricing 4
Free Pricing and Indirect Control 4
Reference Pricing 4
Medical Devices Reimbursement 5
The Role of Health Technology Assessment 5
Procurement Strategies 6
USA 8
Medical Device Regulation 8
Medical Device User Fees 8
Pre-Marketing Requirements 8
Post-Marketing Requirements 9
Unique Device Identifier 10
Pricing and Reimbursement 11
Medicare 11
Health Maintenance Organisation Plans 11
Inpatient prospective payment system 11
Medicaid and the Children's Health Insurance Program 12
Medical Device Excise Tax 12
Managed Care 13
Health Technology Assessment and Procurement 13
Agency for Healthcare Research and Quality 13
Blue Cross and Blue Shield Association 14
ECRI Institute 14
Hayes 14
DMEPOS Competitive Bidding 15
EUROPEAN UNION 16
EU Procurement Regulation 16
Official Journal of the European Union (OJEU) 16
EU Medical Device Regulation 16
Belgium 18
Medical Device Regulation 18
Federal Drugs and Healthcare Products Agency 18
Notified Bodies 18
Regulatory Developments 18
Identification And Traceability 18
Controls 19
Materio-vigilance 19
Pricing and Reimbursement 19
Implantable Devices 19
Qermid Pacemaker Register 20
Health Technology Assessment 21
France 22
Medical Device Regulation 22
Agence nationale de securite du medicament et des produits de sante (ANSM) 22
Notified Body 22
Pricing and Reimbursement 22
Health Technology Assessment 23
Reimbursement under the DRG 23
Medical devices included on the LPPR 23
Procurement 24
Germany 25
Medical Device Regulation 25
Bundesinstitut für Arzneimittel und Medizinprodukte 25
Notified Bodies 25
Pricing and Reimbursement 26
Inpatient sector 26
Outpatient sector 27
Health Technology Assessment 27
Procurement 27
Italy 28
Medical Device Regulation 28
Direzione Generale Dei Dispositivi Medici, Del Servizio Farmaceutico E Della Sicurezza Delle Cure 28
Notified Bodies 29
Commissioni Regionali Sui Dispositivi Medici 29
Pricing and Reimbursement 29
Commissione Unica Sui Dispositivi Medici 30
Agenzia Nazionale Per I Servizi Sanitari Regionali 30
Agenzie Sanitarie Regionali 31
Commissione Prontuario Terapeutico Ospedaliero 31
Health Technology Assessment 31
Horizon Scanning 31
Netherlands 32
Medical Device Regulation 32
CIBG-Farmatec 32
Notified Body 32
Pricing and Reimbursement 32
Hospital Sector 32
Ambulatory Sector 33
Health Technology Assessment 33
Procurement 34
Spain 35
Medical Device Regulation 35
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) 35
Pricing and Reimbursement 35
Orthopaedics and prosthetics used in ambulatory care 35
Taxation 36
Health Technology Assessment 37
Procurement 37
Centralised Purchases 37
United Kingdom 39
Medical Device Regulation 39
Medicines and Healthcare Products Regulatory Agency (MHRA) 39
Notified Bodies 39
Pricing and Reimbursement 40
Health Technology Assessment 41
Procurement 41
NHS Supply Chain 42
Tenders Direct 42
NHS Trusts 42
ASIA/PACIFIC 43
Australia 43
Medical Device Regulation 43
Therapeutic Goods Administration 43
Pricing and Reimbursement 43
Health Technology Assessment 44
China 45
Medical Device Regulation 45
China Food and Drug Administration 45
Medical Device Classification 45
New System For Monitoring Medical Device Adverse Events 46
Compulsory Product Certification 46
High-Risk Devices Subject To Clinical Trial Pre-approval 46
Innovative Devices Special Approval Process 47
Pricing and Reimbursement 47
Procurement 47
Standards for Large Medical Equipment 48
Japan 49
Medical Device Regulation 49
Pharmaceuticals and Medical Devices Agency (PMDA) 49
Pricing and Reimbursement 50
South Korea 51
Medical Device Regulation 51
Ministry of Food and Drug Safety 51
Class I Notification 51
Class II, III and IV Approval 52
Pricing and Reimbursement 52
Reference Pricing 53
Health Technology Assessment 54
LATIN AMERICA 55
Brazil 55
Medical Device Regulation 55
ANVISA 55
Registration 56
Pricing and Reimbursement 56
Health Technology Assessment 57
Chile 58
Medical Device Regulation 58
ANAMED 58
Pricing and Reimbursement 59
Health Technology Assessment 59
Colombia 60
Medical Device Regulation 60
Pricing and Reimbursement 60
Health Technology Assessment 60
Mexico 62
Medical Device Regulation 62
Pricing and Reimbursement 62
Basic Formulary and Catalogue of Medical Equipment and Supplies 63
Peru 64
Medical Device Regulation 64
Pricing and Reimbursement 65
Public Tenders 65
SOURCES 66

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