2020 Meeting of Representatives
Report of the Reimbursement Subcommittee
1. Medical material
2. Diagnosis and treatment
December 10, 2020
European Business Council (EBC) Medical Devices and IVD Committee
Meeting of Representatives
UnrestrictedMember• Tadashi Idei*, Vice-Chairperson(Japan Lifeline)• Ryoichi Tanaka**, Subcommittee
Chairperson (Siemens)[Diagnosis and Treatment WG]• Shigeyasu Mori*, Assistant Subcommittee Chairperson (U&I)• Katsuhiko Koyama** (Phillips)• Hiroyuki Akimoto* (Integral)• Tomohiko Matsukawa** (Phillips)[Medical Material WG]• Sumako Naito*, Assistant Subcommittee Chairperson (Coloplast)• Akiko Tsubota**, Hitoshi Iwasaki** (Japan Lifeline) (LivaNova)• Mitsunori Nomura * (Japan Lifeline),• Shuichi Harayama** (B. Braun), Madoka Makishima* (B. Braun),• Kenichi Sato** (NBXI), Tomohiko Matsukawa** (Phillips)
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Reimbursement of Medical fee are thelifeline of companies• About the relationship between basic relevant laws and the system– Work-style reform and appropriate placement of medical equipment –Medical fees
Evaluation and income frommedical practices
Evaluation of safety management
and consistency of requirements

Medical law
Basic precepts in the provision of medical care
Maintenance, inspections, medical safety

Evaluation of technology
by function
Ensuring quality
Evidence baseWork-style reform
Systematization of medicaldevices and establishment
facility requirements
Various guidelines

PMD Act (Pharmaceuticals and Medical Devices Act)
Ensuring quality, efficacy, and safety
Sales, repairs, medical devices requiring special maintenance, and package inserts

Cited from materials of JFMDA and JIRA Committee on Medical Fees
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Research, development,salesRelationship to law – Where to approach!!
Not printed

Constitution
lawmaker-drafted
legislation• PMD Act, Medical Low

Law

National StrategicSpecial Zones Law(Passed by Diet and promulgated by the Emperor)• Cabinet Order for Enforcementof the Medical Care Act
CabinetGovernment
ordinance• Ordinance for Enforcement ofthe Medical Care Act Ministerof State

Ministerialordinance(ordinance regarding administrative matters under supervision of each ministryand agency)• Notifications by directors, etc.

Notification

Directors-General, Section Directors, and OfficeDirectors(an order established by the Cabinet to enforce the law)

Announcement•Page 4Officecommunication

Guidelines for the interpretation and enforcement of laws and regulations to be observed by various organizations (prefectures, etc.) and employees under
the jurisdiction of ministries and agencies

Table of Contents• Activity Report for 2020
• Medical fees revision• Government-Industry Dialogue, the Council for
Cardiovascular Preventive Measures, and Medical
department - industry regular meetings• 2021 Action Plan

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Reimbursement Subcommittee’s 2020

Activities and Results

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Reimbursement Subcommittee’s 2020
Activities and Results
Basic Principles of the EBC Compensation Subcommittee⚫

Continuation of Tripartite Joint Proposals → Cooperation between academic societies and the government⚫

Expansion of further subdivision of functional categories for medical materials and appeal for innovation
evaluation (C1, C2), and safety management⚫

Response to new trends such as annual revisions, consumption taxes, cost-effectiveness, and SUD<Creating a new system design to maintain the universal health insurance system - toward 2022>(1) Foreign price adjustment measures(2) Continued promotion of further subdivision of functional categories and evaluation of innovativedevices(3) HTA: Continued monitoring of the Cost-Effectiveness Assessment System(4) Reimbursement price of R-SUD (R-Single Use device)(5) Appropriate evaluation of innovative technologies (new systems for new technologies:
telemedicine, AI diagnosis, etc.)(6) Development of medical infrastructure using ICT - cooperation with academic societies, etc.
(7) Responses to community medical care planning policies (follow-up for exposure control)• We would like to participate in the government's Insurance Policy Council andplan to hold study meetings
Page 7Ongoing

Certain degree of effectPage 8Subcommittee on Medical Technology
Evaluation

Schedule for future consideration of next medical fee revision
January2012

ReportExamination of specific items

Medical fees revisionDecemberInsured Medical Materials
Subcommittee

Revisedrate

NovemberExpert Subcommittee on Drug Prices

Discussion on basic policy

Presentation ofbasic policy(4) Draft Basic Policy(3) Specific viewpoints
and directions

October

DPC Evaluation Subcommittee(Bulletin)

Verification of results of 2011 revision

Social Security and Tax Reform Bill

Opinion statement(2) Overview ofviewpoints and directions

SeptemberMedical Economy Fact-finding Survey(Decision of the Government and Ruling Party Headquarters for Review of Social Security Reform)

Regular meeting

AugustVerification of results of 2010 revision

Comprehensive Evaluation Subcommittee
on Chronic Inpatient CareJuly(1) Schedule, etc.

June

Report on visits to disaster areas

Medical technology
evaluation

FebruaryMay

Dental care

Psychiatric care

DecemberNovember

October

SeptemberMarch April

Cost Research Subcommittee

Regular meeting

Public-private dialogue

Medical fees revision

CabinetJanuary
2011

Reducing the burden on
healthcare professionals

Visiting nurses

Discharge coordination

Rehabilitation

Cooperation
between medicalcare and nursing
Home medical care
care

Dental, pharmaceuticals

Basic fees
Foreign price survey

Priority matters for discussion
No. 1 side and No. 2 side

Report on FY 2010 revisions

Ancillary opinion

General meeting

Medical Insurance
Subcommittee

Medical Care
Subcommittee

February
2010

Various reports

Subcommittees, organizations
and small committees

Central Social Insurance Medical Council

The years in between medical fee revisions
are years of preparation
Chuikyo General

February March April8Specific insured medical materials

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Summary points of the revision being
considered by the Economic Affairs Division
Excerpted from the EBC Medical Fees Committee Briefing Session, March 2020, EBC Study Group

Summary of FY 2020 revisions (specified insured medical material)➢ Foreign price reference systemReduction in comparison level at time of new listing (1.3→1.25)
Review of margin of reduction in recalculation (change in lower limit of re-calculated price from75/100 to 50/100)
Comparison level (1.3) would be maintained but it is a matter for future consideration➢ New introduction of recalculation for market expansion

To be implemented starting with FY 2022 revision
Consistency with the functional classification system and operational issues should be sortedout and discussed as soon as possible
Consideration of the need for early subdivision of potential categories➢ Review of functional categoriesIn the FY 2020 revision, only 1 item was subject to streamlining
Also, the category of items that were discussed before the revision but left unresolved for thenext revision
It is necessary to continue appealing for acceleration of the review process.
When making unprofitable requests, prepare supporting data, etc.

➢ Consideration of proposals such as evaluation of innovation, etc., and theoretical backing on
a fixed price range of 4% for the actual market price
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Specific Material WG of theReimbursement Subcommittee
Appropriate evaluation of innovation V4.2
July 21, 2020, Economic Affairs Division (3 groups at MTJ)
December 2, 2020: Economic Affairs Division
European Business Council (EBC)
Medical Devices and IVD Committee
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Table of Contents[Appropriate evaluation of innovation] → ReviewI.

(1)Price calculation for R-SUD (Reprocessed - Single Use Device): systematized in 2018(2)[HTA]: Cost-Effectiveness Assessment System*[C2 challenge for inclusion of specific materials in technical fee] Response to inclusion of medical materials
in technical fee (Proposed July 2019) → Proposal from EBC was postponed because of the lack ofapplicable devices and the inability to take specific measures: Deleted*Corrective premiums of 1 to 20% (premiums for function, innovation, etc.) are too low to recoup development
costs and cannot be introduced (concrete example) → Process transparency → Unnecessary because there
is a guidebook on insurance coverage of medical devices (March 2017: standard booklet).

[Foreign price reference system] (1) [rate of reduction in recalculation] 75/100 → 50/100(2) [price differential between Japan and overseas] 1.3 → 1.25

II.

III. [Review of functional categories] (1) Clarify the process

IV. [Stable supply] (1) Support in emergencies
V.

[Recalculation for market expansion] (1) Grace period for recalculation for market
expansion by streamlining functional categories

VI. [Other] (1) Medical fee listing for digitization of tracking form entry
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Diagnostic and therapeutic equipment

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Summary points of the revision being
considered by the Economic Affairs Division
Summary of FY 2020 revisions (technical fee)
➢ New introduction of recalculation for market expansion
 Newly introduced in and after fiscal 2020 for some medical devices that areevaluated as part of the technical fee
 Deliberation including standards to be reviewed at the time of review by Insured
Materials Expert Committee
 Need to make proposals on the ideal form for the system while looking at examplesof application➢ How best to rethink the evaluation of technical fees The current situation is as follows: proposal by the secretariat, evaluation by theSubcommittee on Medical Technology Evaluation, advanced medical care
 What do we consider the most appropriate way of evaluating devices, taking into
account the industry's vision and future innovation?
 Need to consider proposals made in public-private dialogue, etc.
➢ C2 Challenge The C2 challenge has continued to be the subject of debate It is necessary for the industry to propose system designs with reference to thescheme for recalculation for market expansion
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Today's Proposals
1. Evaluation of innovation in medical devices (medical technology)(1) Evaluation based on actual use: C2 challenge application(2) Improving predictability of C2 applications (new functions and new technologies)(3) Evaluation of medical devices included in technical fee by Needs Review Committee

2. To promote safety assurance(1) Promoting joint use of high-performance medical devices(2) Promotion of infection prevention measures in cooperation with medical institutions(3) Promotion of radiation exposure control in cooperation with medical institutions(4) Assessment of monitor accuracy management

3. Improving the quality and productivity of medical care through the use of digitaltechnology(1) Evaluation of the use of AI to contribute to reform of the way doctors work

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Proposals on medical devices (medical technology)
Data from the 41st Regular Meeting of the Ministry of Health,Labour and Welfare and the Medical Device Industry

EBC Draft V4.5 for "Diagnostic andtherapeutic device related"
March 25, 2020, 3 groups, by JFMDA
November 13, 2020, 3 groups, by MHLW
December 2, 2020, EBC, by MHLW

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European Business Council (EBC)
Medical Devices and IVD Committee

Draft

20200325 . Submitted by the Economic Affairs Division (20201030 Tripartite Conference)2020 EBC appeal regarding medical devices(medical technology)
1. Evaluation of innovation in medical devices (medical technology)(1) C2 Challenge application (2019 Regular Meetings/Chuikyo) → (3-region integration
based on EBC proposal)(2) Preventive Medicine: Low-dose CT screening for lung cancer → Creation of a New
Insurance System(3) Examination of mechanism of medical technology evaluation (C2 Challenge/burden
on patient, etc.) → Creation of new insurance system including establishment of"Expert Committee on Insurance Digitization"
2. In order to promote stable supply and safety assurance for medical devices(1) Proper evaluation of medical devices → need to reconsider joint use and create
new insurance system(2) Improving the rate of maintenance and inspection of medical devices → Written
clarification(3) Promotion of radiation exposure control in cooperation with medical institutions →3. (1) Use of cloud

3. Infrastructure development for medical technology using AI and ICT(1) Linking device information and medical images with PHR - promoting use of cloud(2) Appropriate evaluation of new value of AI utilization → 1 (3) integration
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• 2021 Activity Plan54

Reimbursement Subcommittee’s 2021 Action Plan⚫
⚫
⚫

Basic Principles of the EBC Compensation Subcommittee
Continuation of Tripartite Joint Proposals → Cooperation between academic societies and the government
Expansion of further subdivision of functional categories for medical materials and appeal for innovation
evaluation (C1, C2), and safety management
Response to new trends such as annual revisions, consumption taxes, cost-effectiveness, and SUD<Creating a new system design to maintain the universal health insurance system - toward 2022>(1) Appropriate evaluation of innovative technology
1) Connection of medical information to PHR 2) Premium for improvement with time limit
3) Promotion and review of reevaluation 4) Online/remote robots
5) Evaluation of artificial intelligence 6) New insurance system(2) Foreign price adjustment measures(3) Ongoing promotion of subdivision and streamlining of functional categories(4) HTA: Continued monitoring of the Cost-Effectiveness Assessment System(5) Development of medical infrastructure using ICT - Response to cooperation with academic
societies, etc. (1)(6) Responses to movement in community medical care planning policies (establishment ofrequirements for maintenance management and radiation exposure control)

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Reimbursement Subcommittee’s 2021 Action Plan
〇 New proposals will be made with new members throughout the year.
〇 The WG will be led by the vice chairpersons of the Diagnostic and Therapeutic
Device WG and Specific Materials WG, and reports will be presented at monthly
meetings.
[Internal study meeting] held on the Web〇 Themes are linked to regular meetings for further study[EBC-Government Study Meeting] Can this be held in a hybrid form?
〇 Study Group for C Application in consideration of HTA, GDPR, CE Marking,〇 Study Group on AI (Hajime Takeda, Bureau Director) and PHR (KDDI, government)[Proposal]
Improvement of meetings for policy proposals → appropriate evaluation of medical
technologies using "ICT” and AI"⇒"Achieving practical benefits at regular meetings"
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