FY2021 Representative Meeting
Reimbursement Subcommittee
1. Diagnostic and therapeutic devices
2. Special treatment materials

Dec. 2021
European Business Council (EBC) Medical Devices and IVD Committee
Reimbursement Subcommittee
Page 1

Medical Service Fee (NHI Price Listing): A Lifeline for Companies••

With the reform of the primary care and health sectors and the adoption of digital technologies toward 2040, it
is inevitable that there will be changes in the medical service fee system.
Let's review our approach with an emphasis on the NHI price listing as a practical benefit.

Localcomprehensive care

Adoption of digitaltechnologies

Primary care
Medical service fee
Evaluation of and revenue from medical practiceEvaluation of safety control and consistency with requirements

Medical Care Act
Basic requirements for the provision of medical care
Maintenance and inspection/medical safety

PMD Act (Pharmaceutical and Medical Device Act)
Assuring quality, effectiveness, and safety
Sales, repair, specially-designated medical devices requiring maintenance,
package inserts

https://www.mhlw.go.jp/content/12401000/000517328.pdf

Page 2

Evaluation of technology byfunction
Assuring quality
Evidence-basedWork style reform
Systematization of medical
devices and establishmentof requirements for facilities
Guidelines

Research, development,sales•Page 3Reimbursement Subcommittee Activity Report for FY2021

Events the Reimbursement Subcommittee Has Participated in and Activity-Related Events[1] Regular meeting/Statement of opinions Overall flow

[2] Cost-effectiveness assessment** Overall flow

FY2020 (41st) Regular meeting 2/18 (Mori, Idei, Tanaka)

7/13

Exchange of opinions with the Medical Affairs Division

Medical Technology Evaluation Proposal Hearing EBC 6/10

8/4

Expert committee/Statement of opinions

FY2021 (42nd) Regular meeting 7/30 Face-to-face (Idei, Tanaka)

9/15

Expert committee meeting (1st)Opinions of expert committee on revision of treatment materials 8/4

10/5

Exchange of opinions with the Medical Affairs Division

Central Social Insurance Medical Council (CSIMC) expert
committee/Statement of opinions 8/25

10/15

Expert committee meeting (2nd)Survey on foreign prices LEK (participants: 3 companies from EBC)
9/17

10/27

Exchange of opinions with the Economic Affairs Division

CSIMC expert committee Review ( 1st) 9/22

11/2

Deadline for statement of opinions

CSIMC expert committee Review (2nd) 10/1511/12

Expert committee meeting (3rd)/Statement of opinions

CSIMC expert committee Statement of opinions by industry 11/12(Idei)
Exchange of opinions with the Economic Affairs Division 10/26,* 11/10,*
12/7,* & 11/16**

12/1

Expert committee meeting (4th)/Outline (draft)

CSIMC expert committee Statement of opinions 11/26 (Idei, Tanaka)
Expert committee Outline (draft) 12/22*Diagnosis and treatment, **Special treatment materials, Dates without asterisk indicate both.

Page 4

Reimbursement Subcommittee Activity Policyand Results for FY2021• Basic Principles of the EBC Reimbursement Subcommittee
1.
2.

Continuation of Japan/EU/US joint proposals (Cooperation with academic societies and the government)
Promotion of stable supply, fair evaluation for innovation, and safety(expansion and subdivision of functional
categories, reevaluation of C1 and C2, safety management, etc.)3.

Response to new trends (annual revision, consumption tax, cost effectiveness, SUD, etc.)< Creation of a New System Design for Sustainable Universal Insurance System - Toward 2022 >[1] Fair evaluation of innovative technologies
1) Linking of medical information with PHR2) Time-limited premium for improvement
3) Promotion and review of C2 reevaluation
4) Online/remote robots
5) Recognition of the value of artificial intelligence
6) New insurance system[2] Measures for adjustment based on foreign prices[3] Continuous promotion of responses to subdivision and streamlining of functional categories[4] HTA: Continuous monitoring of the cost-effectiveness assessment system[5] Development of medical infrastructure utilizing ICT - Cooperation with academic societies, etc.In linewith [1][6] Responses in line with trends such as regional medical care planning policies (establishment ofrequirements for maintenance management and radiation exposure control)
Page 5

Ongoing

A certain level of results

1. Diagnostic and Therapeutic Devices

Page 6

For Revision of Medical Service Fees in 2022 - Major Individual Discussions
on Topics Relevant to EBC•

Software as a Medical Device (SaMD) artificial intelligence management
Requires appropriate management and support for operation in clinical practice•Radiation exposure reduction network
Recognition of the value of utilization of protocol management and exposure management through proper
management of a large-scale imaging information database network•Management of orphan disease image interpretation
The interests of patients are protected by consulting a specialist for diagnostic interpretation ofpediatric diseases.

•Page 7

Radionuclide therapy
Since beta rays and gamma rays are generated each time treatment is performed, it requires
radiation protection and radiation control for healthcare professionals and hospitalized patients andother members of the public.

Documents for Statement of Opinions for Central Social Insurance Medical Council Expert
Committee on Special Treatment Materials Nov. 28, 2021
Medical Devices and Medical Technologies

Dissemination of Opinions of EBC as Statement of Opinions
1. Recognition of the value of medical technologies and innovations: C2 challenge application
Usefulness of the C2 challenge

2. Evaluation of Software as a Medical Device (SaMD) for reimbursement
Evaluation and verification of outcomes
Aim for a certain opinion/clarification
Suggestion of a possible direction toward treatment by patient choice (special or specified medical care coverage)

Discussions of special treatment materials in the framework of special
treatment materials and medical devices in the framework of technicalfees•••Page 8Emphasis on evidence (additional points)
Work style reform (facility standard, etc.)
Considerations for special or specified medical care coverage(other than approved products)

2. Special Treatment Materials

9Page 9

For Revision of Medical Service Fees in 2022

2021/7 Medical Affairs Division Regular meeting
1. Actions to assure a stable supply(1) Actions for medical devices with demand for a stable supply andunprofitable high-risk products(2) Review of the system of adjustment/repricing based on foreign
prices(3) Review of calculation rules for establishing a new functional category(4) Streamlining

2021/11 Central Social Insurance Medical Council(CSIMC) Statement of opinions
1.
Stable supply of medical devices
2.

Evaluation of innovations
Response to pioneering medical devices andspecific use medical devices

3.

Acceleration of listing in the NHI price list

4.

Correction of domestic and foreign prices
Requests regarding adjustment and repricing
based on foreign prices

2. Review of evaluation of innovations(1) Fair evaluation of innovative medical devices and medical
devices for orphan diseases and pediatrics(2) Simplification of B2 and A3 procedures(3) Utilization of the B3 category(4) Challenge application(5) Recognition of values such as improving the efficiency of medicalcare, reducing the burden on healthcare professionals, etc.
(6) Expansion of special exceptions for functional categories and thecontinuation of premiums for outpatient rapid sample testing
3. Fixed range
4. Other(1) Correction of coefficients for the cost accounting system(2) Clarification of operational rules of repricing for market expansion(3) Holding of organizations specializing in treatment materials, etc. inthe year of revision(4) Fair evaluation of innovations at time of revision(5) Realization of value-based healthcare (AMDD)
Page 10•Page 11

Reimbursement Subcommittee Activity Policy for FY2022

Reimbursement Subcommittee Activity Policy for FY2022[1] Fair evaluation of innovative technologies
1) Recognition of the value of artificial intelligence2) Online/remote robots

3) Linking of medical information with PHR (development of ICT infrastructure)4) Fair evaluation of radiation therapy, radionuclide diagnosis and therapy5) Recognition of values such as improving the efficiency of medical care, reducing the burden on
healthcare professionals, etc.*

Proposal of new evaluation criteria* + Proposal of a new insurance system(*Time-limited premium for improvement)[2] Measures for adjustment based on foreign prices[3] Continuous promotion of responses to subdivision and streamlining of functional categories[4] Relaxation of rules on the withdrawal of unprofitable products of eliminated categories (confirmationrequired)[5] HTA: Continuous monitoring of the cost-effectiveness assessment system (follow-up on draft outline)[6] Responses in line with trends such as regional medical care planning policies (establishment ofrequirements for maintenance management and radiation exposure control)
Page 12FY2022 Reimbursement Subcommittee Activity Policy[Working Group Activities] At the EBC, both special treatment materials and diagnostic andtherapeutic devices are discussed in the Reimbursement Subcommittee. This allows sharing ofstudies and information. The vice chairman and the chairman of the committee are responsible
for special treatment materials as well as diagnostic and therapeutic devices.

•Meanwhile, in order to accelerate individual discussions, working groups were establishedin FY2021 and have been operating on a trial basis since. We will continue to hold WG
meetings to discuss individual topics under the monthly meetings of the Reimbursement
Subcommittee.

[Subcommittee/EBC - Workshops with the Government]•On trends such as CE marking, studies in cooperation with DTF, cost effectiveness, etc.
(Workshop on the revision of medical service fees)[Presentation of Issues and Recommendations]•••Page 13Developing an organization capable of presenting and consolidating issues and making
recommendations at WGs, monthly meetings, etc.
Specifically, promotion of the fair evaluation of medical technologies such as AI Cooperation with DTF and JFMDA
Continue activities for practical benefit!!