Epiminder Limited (ASX:EPI) has disclosed that the Centers for Medicare & Medicaid Services (CMS) has finalised the CY2027 Hospital Outpatient Prospective Payment System rule, assigning the Minder System implant procedure a national Medicare payment rate of US$31,265, compared to US$27,700 in 2026, with the payment taking effect on January 1, 2027.

Key Points

  • CMS has assigned the Minder System implant procedure to Ambulatory Payment Classification (APC) 5117 with a national Medicare payment rate of US$31,265 for CY2027.
  • The CY2027 rate of US$31,265 compares to the CY2026 rate of US$27,700, representing a 13% increase as stated in the filing.
  • The Medicare payment rate takes effect January 1, 2027, covering hospital costs for the procedure including the implanted device in the outpatient setting.
  • The company expects to reach 125 participants in its DETECT study by December 2026, following enrolment of the 100th participant announced in mid-October 2026.

CY2027 Medicare Payment Rate and APC Assignment

CMS has finalised the CY2027 Hospital Outpatient Prospective Payment System (OPPS) rule, assigning the Minder System implant procedure to APC 5117. The national Medicare payment rate of US$31,265 covers the hospital's costs for the procedure, including the implanted device. The national rate is adjusted for local wage levels at each hospital. Because the Minder System is implanted through a minimally invasive subscalp procedure, the hospital outpatient department is described in the filing as a natural setting of care, making this payment rate central to how US hospitals will evaluate and adopt the technology.

Minder System Background and FDA Authorisation

The Minder System is a minimally invasive implantable continuous EEG Monitoring (iCEM) device that provides clinicians and patients with long-term, objective data on brain electrical activity. The system continuously records bilateral subscalp EEG and transmits data via an external wearable and smartphone application to a secure cloud platform. The Minder System was authorised by the US Food and Drug Administration via the de novo pathway and is currently being used in the DETECT post-market study as a marketed device. The filing also references an expanded paediatric clearance issued by the FDA the prior week.

DETECT Study Enrolment and Company Expectations

Epiminder disclosed that the 100th participant enrolled in the DETECT study was announced in mid-October 2026. The company expects to reach 125 participants in DETECT by December 2026, according to the filing. The Medicare 2027 payment determination is described in the filing alongside the FDA paediatric clearance expansion and DETECT enrolment progress. The filing also references the UMPIRE first-in-human multicentre trial, published in Epilepsia in 2025, which the filing states demonstrated the Minder System's safety and high-quality signal acquisition across extended monitoring periods.