Embla Medical hf: The Centers for Medicare & Medicaid Services (CMS) grants extended coverage in the U.S. for lower-limb active K2 amputee patients to access bionic prosthetic solutions

USA - English

• USA - English

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.

We are also pleased that the MPK's sold by Embla Medical companies include integrated stumble recovery. This means that they are appropriate for certain K2 users and consistent with the final coverage standards published by Medicare.

As a leading global provider of innovative mobility solutions, we at Embla Medical believe we can be part of the solution needed to address this patient population suffering from chronic mobility challenges, helping them live a Life Without Limitations."

Link to news from US Medicare https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39777

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About Embla Medical

Embla Medical (Nasdaq Copenhagen: EMBLA) is a leading global provider of innovative mobility solutions that help people live a Life Without Limitations®. Home to several leading brands, Embla Medical is dedicated to improving people`s mobility by providing prosthetics, neuro orthotics, bracing & supports and patient care through a global network of orthotic & prosthetic facilities. Embla Medical is committed to sustainable business practices renowned for positively impacting people`s health and well-being.

^[1] K2 amputees: K-levels are a rating system used by Medicare to indicate a person's rehabilitation potential. The system is a rating from 0 through 4 and it indicates a person's potential to use a prosthetic device if they had a device that worked well for them and they completed rehabilitation to use the device properly. K2 describes a "limited community ambulator" who has the ability (or potential) to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, while K3 and K4 amputees are unlimited community ambulators who can walk at different speeds and perhaps even engage in athletic activities(K4).

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