REYKJAVIK, Iceland and COPENHAGEN, Denmark, July 18, 2024 /PRNewswire/ -- Embla Medical (Nasdaq Copenhagen: EMBLA), a leading global provider of innovative mobility solutions, today announced that the Centers for Medicare & Medicaid Services has finalized a proposal that will expand patients access to high activity K3 knees in the United States. The proposal enables a large patient group of active K2¹ functional level amputees to gain access to bionic knee technology. Previously, Medicare had restricted access to these knees to only high-active amputees classified as functional level K3 and K4.

The decision follows a process initiated at the beginning of the year by the U.S. Durable Medicare Equipment Medicare Administrative Contractors (DME MACs). The DME MACs relied upon a substantial body of research spanning more than a decade establishing that more advanced prosthetic devices lead to significant clinical benefits for active K2 amputees, including reduced fall rates, improved mobility, and increased patient confidence while walking. These benefits, in turn, have the potential to positively reduce healthcare expenditures while simultaneously improving quality of life.

The finalized policy, which will take effect on 1 September 2024, does not automatically create access for every person currently classified as a K2 amputee. Treating healthcare professionals will have to establish through medical documentation that a bionic knee (MPK or microprocessor-controlled knee) or other K3 knee would improve the patient's functional health outcomes, help them accomplish activities of daily living, and that lower-level knee options have been considered and ruled out. In addition, to provide a K2 patient with an MPK, clinicians must use knees with integrated stumble recovery.

In addition, the extended coverage may also grant these active K2 functional level amputees access to a compatible high active K3 foot solution as a complement to the bionic knee when certain coverage criteria are met.

Sveinn Sölvason, President and CEO, comments

"The decision by U.S. Medicare to allow for extended coverage creates a pathway for K2 transfemoral amputees to utilize more functional knee and foot solutions than they have historically had access to. This is great news for active K2 lower-limb amputees as they account for a large part of the overall amputee population. We welcome this decision, which we believe will hugely improve these individuals' lives, helping them become more active and able to perform critical activities of daily living more independently.