Coronary imaging and diagnostic procedures

Series
Coronary interventions
Status
Published
Date
Number of report
020

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The report presents a summary of reimbursement situation for a number of coronary imaging methods. Procedures, covered in the report include:

  • Intravascular ultrasound (IVUS)
  • Coronary fractional flow reserve measurement (FFR)
  • Instantaneous wave-free ratio (iFR)
  • Cardiac computed tomography
  • Optical coherence tomography (OCT)

An analysis is provided for three indications: stable angina, unstable angina, and acute myocardial infarction.

Reimbursement analysis is provided only for admitted care settings for stand-alone imaging procedures and for imaging procedures performed in adjunction to percutaneous coronary intervention with and without stenting.

The report includes essential information about reimbursement and national funding, including:

  • Brief overview of reimbursement system for medical devices
  • Procedure coding for technology
  • Diagnosis coding
  • Payment mechanism for technology
  • Reimbursement tariffs for technology
  • Restrictions in indications or scenarios for use of technology
  • Policy considerations by payers and policy-makers about technology

Reimbursement information is provided for the following geographies:

  • Austria
  • Belgium
  • Denmark
  • England (UK)
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Sweden
  • Switzerland

Manufacturers of devices for coronary imaging system include:

1.  Abbott (OPTIS™)
2.  Acist (RXi Rapid Exchange FFR)
3.  Arineta 
4.  Asahi Intecc
5.  Avinger (WildCat)
6.  Axsun Technologies
7.  Boston Scientific (OPTICROSS™, iLab™, Ultra ICE™, Polaris, COMET™)
8.  Canon (Aquilion)
9.  CathWorks
10. FUJIFILM (Speedia)
11. GE (Innova®, Revolution FrontierTM, Discovery™)
12. Hitachi (SCENARIA)
13. InfraReDx (LipiScan IVUS, Makoto™ Intravascular Imaging System)
14. Opsens Inc. (OptoWire and OptoMonitor FFR)
15. Philips/ Volcano (Eagle Eye Platinum, Verrata)
16. Samsung/NeuroLogica (BodyTom®)
17. Shimadzu (NeuViz)
18. Siemens (IVUSmap)
19. Silicon Valley Medical Instruments (HD IVUS)
20. SinoVision Technologies (Insitum)
21. St. Jude Medical (PRESSUREWIRE™ X GUIDEWIRE)
22. Terumo (Lunawave)

 

1.    Introduction and summary
2.    Executive summary table
3.    Contents
4.    Methodology
5.    Reimbursement analysis in Austria

5.1.    Overview of the reimbursement system
5.2.    Reimbursement for coronary imaging and diagnostic procedures
5.2.1.    Procedure coding
5.2.2.    Diagnosis coding
5.2.3.    Payment mechanism and reimbursement tariffs
5.2.4.    Health technology assessments by LBI-HTA
6.    Reimbursement analysis in Belgium
6.1.    Overview of the reimbursement system
6.2.    Reimbursement for coronary imaging and diagnostic procedures
6.2.1.    Procedure coding
6.2.2.    Diagnosis coding
6.2.3.    Payment mechanism and reimbursement tariffs
6.2.4.    Policy considerations by the INAMI/RIZIV
6.2.5.    Health technology assessments by KCE
7.    Reimbursement analysis in Denmark
7.1.    Overview of the reimbursement system
7.2.    Reimbursement for coronary imaging and diagnostic procedures
7.2.1.    Procedure coding 
7.2.2.    Diagnosis coding
7.2.3.    Payment mechanism and reimbursement tariffs
7.2.4.    Policy considerations
8.    Reimbursement analysis in England
8.1.    Overview of the reimbursement system
8.2.    Reimbursement for coronary imaging and diagnostic procedures
8.2.1.    Procedure coding 
8.2.2.    Diagnosis coding
8.2.3.    Payment mechanism and reimbursement tariffs
8.2.4.    Policy considerations 
8.2.4.1.    Specifics of commissioning of the procedure
8.2.4.2.    Health technology assessments by NICE
9.    Reimbursement analysis in France
9.1.    Overview of the reimbursement system
9.2.    Reimbursement for coronary imaging and diagnostic procedures
9.2.1.    Procedure coding 
9.2.2.    Diagnosis coding
9.2.3.    Payment mechanism and reimbursement tariffs
9.2.4.    Policy considerations by HAS
10.    Reimbursement analysis in Germany
10.1.    Overview of the reimbursement system
10.2.    Reimbursement for coronary imaging and diagnostic procedures
10.2.1.    Procedure coding 
10.2.2.    Diagnosis coding
10.2.3.    Payment mechanism and reimbursement tariffs
10.2.4.    Policy considerations by G-BA
11.    Reimbursement analysis in Italy
11.1.    Overview of the reimbursement system
11.2.    Reimbursement for coronary imaging and diagnostic procedures
11.2.1.    Procedure coding at national level
11.2.2.    Procedure coding at regional level (Emilia-Romagna, Lombardy, Veneto regions)
11.2.3.    Diagnosis coding
11.2.4.    Payment mechanism and reimbursement tariffs at national level
11.2.5.    Payment mechanism and reimbursement tariffs at regional level
11.2.6.    Policy considerations
12.    Reimbursement analysis in the Netherlands
12.1.    Overview of the reimbursement system
12.2.    Reimbursement for coronary imaging and diagnostic procedures
12.2.1.    Procedure coding 
12.2.2.    Diagnosis coding
12.2.3.    Payment mechanism and reimbursement tariffs
13.    Reimbursement analysis in Norway
13.1.    Overview of the reimbursement system
13.2.    Reimbursement for coronary imaging and diagnostic procedures
13.2.1.    Procedure coding 
13.2.2.    Diagnosis coding
13.2.3.    Payment mechanism and reimbursement tariffs
13.2.4.    Policy considerations 
14.    Reimbursement analysis in Sweden
14.1.    Overview of the reimbursement system
14.2.    Reimbursement for coronary imaging and diagnostic procedures
14.2.1.    Procedure coding 
14.2.2.    Diagnosis coding
14.2.3.    Payment mechanism and reimbursement tariffs
14.2.4.    Policy considerations
15.    Reimbursement analysis in Switzerland
15.1.    Overview of the reimbursement system
15.2.    Reimbursement for coronary imaging and diagnostic procedures
15.2.1.    Procedure coding 
15.2.2.    Diagnosis coding
15.2.3.    Payment mechanism and reimbursement tariffs
15.2.4.    Policy considerations
16.    Disclaimer

02

Jan 2018

A 150-page reimbursement report covers angiography, intravascular ultrasound (IVUS), fractional flow reserve (FFR), cardiac computer tomography (CCT), optical coherence tomography (OCT) for angina and myocardial infarction in hospital settings. Stand-alone application of imaging / diagnostic methods and use in conjunction with percutaneous coronary intervention procedure was considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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30

Nov 2017

A 155-page reimbursement report covers coronary angioplasty (using a plain and drug-coated balloon, bare metal, drug-eluting and bioresorbable stents), mechanical thrombectomy and atherectomy in hospital settings. The analysis covers procedure coding, payment mechanism, reimbursement tariff and policy restrictions. The report provides an overview of reimbursement situation in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden, and Switzerland.

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20

Nov 2017

Annual report from the Italian Society of Interventional Cardiology (GISE) shows increasing trends in procedural volume of percutaneous coronary interventions (PCI), transcatheter aortic valve implantations (TAVI), mitral clip implantations, closure of left atrial appendage (LAA) and patent foramen ovale (PFO).

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13

Nov 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for nitrogen washout test for lung capacity and fractional flow reserve CT measurement.

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17

Oct 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September 2017. They include knee and hip prostheses, therapeutic shoes, coronary stents, heart valves, peripheral stents, and balloons.

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03

Oct 2017

New procedure codes will be created for stem cell procedures, extracorporeal techniques (including hemodialysis and CO2 removal), surgical interventions, including growth-controlling spinal correction, transposition of peripheral nerve, interventions on veins, and percutaneous image-guided procedures (including code for pressure measurement in coronary arteries and additional code for drug-eluting balloon). Classification will be enabled from January 1, 2018.

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06

Sep 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2017. They include different types of stents and stent-grafts for multiple indications (coronary, peripheral vascular), mechanical thrombectomy devices for stroke, medical devices applied for treatment of ulcer of venous origin, remote monitoring for Implantable Cardioverter Defibrillator Systems (ICDS).

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30

Aug 2017

There is an ongoing process to establish add-on reimbursement for FFR guidewires. Earlier in 2017 two guidewires (Verrata & Verrata More, Philips Volcano; Pressurewire (Certus - Aeris – X), Abbott) received a positive assessment by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) with moderate improvement vs. standard of care. In June 2017, COMET device also received a positive recommendation from CNEDiMTS (no improvement vs. already recommended devices) only on the basis of data about technical equivalency. This is unusual for brand-specific applications and may be an interesting precedent for further applications.

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16

Aug 2017

In the second two weeks of July, the National Institute for Health and Care Excellence published one new (FebriDx for C-reactive protein and Myxovirus resistance protein A testing in primary care) and 3 updated Medtech Innovation Briefings, new Diagnostics Guidance for quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care and three new Interventional Procedures Guidance for laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease, transcatheter aortic valve implantation for aortic stenosis and hysteroscopic sterilisation by insertion of intrafallopian implants.

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26

Jul 2017

In the first two weeks of July, National Institute for Health and Care Excellence published four Medtech Innovation Briefings (Nasal Alar SpO2 sensor for monitoring oxygen saturation by pulse oximetry, Arctic Sun 5000 for therapeutic hypothermia after cardiac arrest, L-Dex U400 for lymphoedema after breast cancer treatment, FreeStyle Libre for glucose monitoring), new clinical guideline for Parkinson’s disease in adults, and updated diagnostic guidance for a new generation cardiac CT scanners.

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03

Jul 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 8 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). They include coronary stents, portable oxygen concentrators, Urolift device, spinal ganglion stimulator and insulin pumps.

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09

May 2017

National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) positively appraised Verrata and Verrate Plus guidewires for add-on reimbursement via LPPR title V. Level of added clinical value was considered moderate (ASA III) in comparison with management strategy, based solely on angiography data. This decision complements decision early this year in relation to St. Jude Medical’s (now Abbott) PressureWire FFR wires.

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