If ICU Acquired “Before” Effective Date of FY2026 Revision, It Will Be Deemed to Meet ICU Acquisition Requirement of Optimal Use Promotion GL for Kymriah, etc. – MHLW

News Highlights

The Ministry of Health, Labour and Welfare (MHLW) has indicated that if an ICU (Intensive Care Unit) was acquired before the effective date of the FY2026 medical fee revision, it will be considered to meet the ICU acquisition requirement in the Optimal Use Promotion Guidelines for CAR-T cell therapy such as Kymriah. This measure alleviates the impact on medical institutions that planned to acquire or expand ICUs after the revision’s effective date, as they might have otherwise been unable to meet the requirements.

M&A Medical Editorial Department’s Perspective

This notification from the MHLW can be considered an important “grace period” for medical institutions providing advanced treatments like CAR-T cell therapy, in adapting to the medical fee revisions. For facilities that were concerned about losing the opportunity to bill for advanced treatments like Kymriah due to the ICU acquisition requirement in the FY2026 revision, the continuation of their existing ICU operations is a significant relief from a business continuity perspective. On the other hand, this measure has a clear cutoff point of “before the revision effective date,” meaning medical institutions considering ICU expansion or acquisition from now on will be pressed to meet the requirements by the revision’s effective date. In M&A, the timing of the target medical institution’s ICU acquisition and any future plans for ICU expansion will be crucial decision-making factors directly linked to their CAR-T treatment provision capabilities and, consequently, their corporate valuation.

Points Highlighted by This News

• It has been clarified that acquiring an ICU before the effective date of the FY2026 revision meets the requirements of the Optimal Use Promotion GL for Kymriah, etc.
• This is a transitional measure that ensures the continuity of billing for advanced medical treatments, impacting the business continuity of relevant medical institutions.
• For medical institutions considering ICU acquisition or expansion after the revision’s effective date, acquiring it by the revision date becomes urgent.
• In selecting target medical institutions for M&A, the timing of ICU acquisition and future expansion plans hold the key to valuation.

Practical Questions Arising from This News

• What specific condition constitutes “acquisition” of an ICU before the effective date of the revision (April 1, 2026)?
• If an ICU expansion is planned but cannot be completed by the revision date, what alternative measures can be considered?
• Does this relaxation of the ICU acquisition requirement apply to advanced medical treatments other than Kymriah?

If You Feel “Should I Consult Too?”

If your institution acquired and operated an ICU before the effective date of the FY2026 medical fee revision (April 1, 2026), concerns regarding the continuity of billing for advanced treatments like Kymriah will be alleviated. However, if you are considering expanding or newly acquiring an ICU, meeting the requirements by the revision date becomes urgent. Those considering business succession through M&A or strengthening their advanced medical treatment provision system should consult with experts on how these changes in ICU requirements will affect your future strategy and M&A strategy.

M&A Medical (CentralMedience Inc.) supports the business succession of medical corporations, hospitals, and clinics on a full success fee basis as an M&A support institution certified by the Small and Medium Enterprise Agency. We handle consultations with strict confidentiality. Free consultation here