Insurance reimbursement for SaMD

The insurance coverage routes for Software as a Medical Device (SaMD) are effectively limited to Category A1 or Category C1/2. Category A1 is included in the medical service fees and is not evaluated separately. On the other hand, very few SaMDs have been approved under Category C1/2 in the past, making insurance reimbursement for SaMD a challenging prospect. Additionally, the evaluation criteria for SaMD were clarified during the Reiwa 6 (2024) medical fee revision.


Categories from which SaMD is (or will likely be) Excluded
It is not possible to request the following categories in an application for insurance coverage.

• Category A2 and Category B1
  • A notice from the Ministry of Health, Labour and Welfare clearly states that requests for insurance coverage under categories A2 and B1 are "limited to medical devices other than program medical devices". Insurance Coverage for Medical Devices and In Vitro Diagnostics | Ministry of Health, Labour and Welfare
• Category A3 (Existing Technology, with modifications)
  This category presupposes that the product falls under "A1 or A2". Since SaMD is not eligible for A2, this route is not very realistic.
• Category B3 (Limited-term Improvement Surcharge)
  This category requires that the product "falls under the existing function category (B1)". Since SaMD is not eligible for B1, applying under its derivative, B3, would also be difficult.

SaMD Insurance Coverage - Categories and Product Examples
Here are the main insurance coverage routes that SaMD aims for, along with product examples.
1. A1 (Comprehensive) Category
This is a category where the evaluation of SaMD is included (bundled) within the existing technical fees for physicians' diagnoses and treatments. No new points are added for the SaMD itself.

• Product Example: EIRL Colon Polyp, medical image analysis software by LPIXEL Inc.
  "EIRL Colon Polyp" detects colorectal polyp candidates and supports colonoscopy examinations. Initially, it was calculated under the "A1 (Comprehensive) Category," where it received a comprehensive evaluation within an existing medical fee item and no individual insurance points were added. Later, due to the Reiwa 6 (2024) medical fee revision, an additional 60 insurance points were granted as a Lesion Detection Support Program Surcharge when an endoscopic colorectal polypectomy/mucosal resection is performed using this product (Category A2). (This is because the medical fee revision specified a "Lesion Detection Support Program Surcharge" in "Note 3" of "K721 Endoscopic Colorectal Polypectomy/Mucosal Resection" for cases where a lesion detection support program is used.)

2. C1 (New Function) Category
This is for products used within the scope of existing technical fees but for which a new functional category is established.

• Product Example: CureApp HT, a therapeutic app for hypertension
  • Applicable Insurance Items
    • The Program Medical Device, etc. Guidance and Management Fee (including an initial phase surcharge for the first month only) and the Specified Insurance Medical Material [Hypertension Therapeutic Support App] fee are calculated (from June 2024 onwards).
    • Program Medical Device, etc. Guidance and Management Fee: 90 points
      • Calculated once a month only when the Specified Insurance Medical Material [Hypertension Therapeutic Support App] is calculated.
    • Program Medical Device, etc. Guidance and Management Fee, Initial Phase Surcharge: 50 points
      • Calculated only for the first time.
    • Specified Insurance Medical Material [Hypertension Therapeutic Support App]: ¥7,010
      • Calculated once a month, including the first time, for a maximum of six months from the month of the first use.
  • Initially, a new technical fee was established under Category C2. However, with the Reiwa 6 medical fee revision, a new functional category called "Hypertension Therapeutic Support App" was created under Category C1 as a specified insurance medical material, and a material price of ¥7,010 was set.
  •  https://cureapp.co.jp/productsite/ht/

3. C2 (New Function/New Technology) Category
When there are no existing technical fees or functional categories, a new technical fee (medical service points) and a new functional category are established.

• Product Example: nodoca
  An endoscopic system that assists in diagnosing influenza virus infections by having an AI analyze images of the pharynx (throat). It was the first AI medical device in Japan to receive insurance coverage under the C2 category, and a new technical fee (305 points) was established. (Initially, in Reiwa 4, D296-2 Nasopharyngeal Endoscopy was applied mutatis mutandis; later, in Reiwa 6, a new technical fee "Pharyngeal Image Analysis Using an Endoscopic Telescope" was established with the same point value).
  • https://prtimes.jp/main/html/rd/p/000000021.000035813.html

Clarification of SaMD Evaluation Criteria in Reiwa 6 (2024)
The evaluation criteria for SaMD were also clarified during the Reiwa 6 (2024) medical fee revision.
001251540.pdf  Slides 14-17
Overview

• Evaluation of Support-type Program Medical Devices
  • This covers programs that support examinations, treatment planning, surgery, etc.
  • If the effectiveness of existing technology is clearly improved, a surcharge evaluation is given.
  • There is a possibility that physician staffing requirements may be relaxed (if the effectiveness is equivalent).
• Evaluation of Implementation-type Program Medical Devices
  • This covers programs that conduct the examination or treatment themselves.
  • They are evaluated as a standard C2 (New Function/New Technology) category.
• Evaluation of Control-type Program Medical Devices
  • This covers programs that control other medical devices.
  • If the effectiveness is clearly improved, they are evaluated with a surcharge or as a specified insurance medical material.
• Evaluation of Self-management-type Program Medical Devices
  • This covers programs used by patients outside of medical institutions.
  • If the effectiveness of medical management is improved, they are evaluated as a specified insurance medical material.

This is in line with the basic policy of evaluating innovation through insurance points as well. However, looking at the minutes of the Central Social Insurance Medical Council (Chuikyo), one gets the impression that not a few committee members are hesitant to easily assign high points to SaMD.
Regarding the Insurance Coverage of "CureApp HT Hypertension Therapeutic Support App" | Chuikyo News
Revisions may occur again in the short term, so please watch for the latest information and respond accordingly.