Bioretec

Bioretec's RemeOs™ Screw LAG Solid confirmed for Medicare transitional pass-through payment in CMS's Calendar Year 2027 OPPS final rule

Källa: Cision
Positiv

Sammanfattning

Bioretec meddelar att deras produkt RemeOs™ Screw LAG Solid har fått bekräftat övergångsstatus för betalning (transitional pass-through payment) av CMS för kalenderåret 2027. Detta ger separat ersättning för nya medicintekniska produkter utöver standardproceduren.

Analys

Beskedet bekräftar att RemeOs™ Screw LAG Solid kommer att erhålla separat betalning från Medicare fram till september 2028. Detta är en viktig regulatorisk milstolpe som underlättar bredare tillgång till produkten för Medicare-patienter i USA. Statusen är en bekräftelse på tidigare information och ger finansiell klarhet för sjukhus och kirurgiska centra.

Nyckeltal

Pass-through status giltig från
1 oktober 2025
Pass-through status giltig till
30 september 2028
Antal godkända ansökningar av 13
9

Insikter

  • • Detta är en bekräftelse av tidigare kommunicerad information gällande betalningsstatus.
  • • Statusen är tidsbegränsad till maximalt tre år, vilket är standard för denna typ av betalning.
  • • Godkännandet underlättar bredare tillgång till bioresorberbar fixation för Medicare-patienter.
Fundamental påverkan
Positiv

Denna bekräftelse av betalningsstatus för RemeOs™ Screw LAG Solid i USA ger ökad finansiell förutsägbarhet och underlättar bredare marknadsacceptans och försäljning av produkten.

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Bioretec Ltd Press release 9 November 2026 at 12:30 p.m. EET

Bioretec Ltd announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) has finalized transitional pass-through payment status for the RemeOs™ Screw LAG Solid in the Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center final rule, published in the Federal Register on November 6, 2026.

The device is covered by HCPCS code C1741. Pass-through status took effect on October 1, 2025 and runs through September 30, 2028, the maximum three-year period the law allows. In January 2026, CMS revised the code's descriptor to “Anchor/screw for bone fixation, absorbable, metallic (implantable).”

The RemeOs™ Screw LAG Solid was approved under CMS’s alternative pathway for devices with FDA Breakthrough Device designation. Of 13 complete device applications CMS reviewed in the CY 2027 rulemaking cycle, nine were approved.

Transitional pass-through payment gives hospitals and ambulatory surgery centers separate payment for qualifying new devices on top of the standard procedure payment. CMS designed it to ensure that Medicare beneficiaries can access new technologies, focusing on devices whose cost could otherwise limit patient access.

“This final confirmation from CMS gives U.S. healthcare facilities clarity on reimbursement for RemeOs™ through September 2028 and supports broader access to bioresorbable fixation for Medicare patients,” says Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec.

 

Further enquiries

Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with bioabsorbable implant technologies. The company offers two product families, Activa and RemeOs™, both based on advanced bioabsorbable materials. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.

Bioretec’s Activa product family features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA both CE marked and FDA cleared for a wide range of indications.

The company’s latest innovation, the RemeOs™ product family, is based on a high-performance magnesium alloy and hybrid composite. The first RemeOs™ product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. To date, the RemeOs™ product line has received three FDA Breakthrough Device Designations.

To learn more about Bioretec, visit www.bioretec.com