Medicare Considers Policy Amendments for K2 Amputees
Medicare is studying policy changes to offer microprocessor knees (MPKs) coverage to K2-level amputees. The reason behind this policy reform is the substantial amount of research conducted over the last decade, revealing that active K2 amputees can significantly benefit from MPKs, which improve their gait stability, balance, fall prevention, and overall quality of life.
It has been reported that Ottobock submitted a request for reconsideration in March 2022. However, the company has been working towards this policy change request since 2005, when the first MPK study was initiated in K2 patients.
Over the years, Ottobock has commissioned and supported 11 clinical studies, resulting in 13 peer-reviewed publications and two peer-reviewed systematic reviews, including one meta-analysis of the study results of 704 patients, proving the benefits of MPK technology for K2 patients.
Patients classified as K2 level include many healthy and active senior amputees. Because most do not engage in intensive activities, like running marathons, Medicare has determined that patients classified as level K2 and below cannot fully benefit from advanced prostheses, such as MPKs.
However, recent studies have revealed that MPKs can help K2 ambulators function at a K3 level and become more active than they would otherwise be. By improving the health and quality of life of many K2-level amputees, giving them access to MPKs can reduce their healthcare needs and health expenditures.
Understanding the proposed changes
The draft policy, introduced in late January 2024, doesn’t automatically cover everyone classified as K2 level. Interested applicants need to establish that an MPK would reduce falls, improve overall health, and help them accomplish activities of daily living.
Below is a detailed list of requirements for specific prostheses:
Fluid, pneumatic, and microprocessor-controlled knees
Until now, fluid, pneumatic, and microprocessor-controlled knees have only been available for K3 users. The draft proposal suggests that K2 users could have access to them if they meet the following:
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Undergo a comprehensive clinical evaluation
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Submit supporting medical documentation that includes the rationale for this specific knee
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Undergo a thorough consideration of other knee systems
Microprocessor-Controlled Knees (MPKs)
The draft policy outlines additional criteria for would-be beneficiaries of MPKs. These criteria include:
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The device must be indicated for functional level K2
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The device must be integrated with stumble recovery technology
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The user must be able to charge the device daily
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The user must be able to respond to any alerts or alarms that the device may generate
Revised criteria for foot prosthetics
Some prosthetic feet previously available only to K3 above-knee amputees might now be available to K2 users. The applicant needs to meet the K2 level criteria above and submit medical documentation that proves a higher-level prosthetic foot is necessary to effectively use the prescribed knee system.
What’s next?
These proposed changes would undoubtedly improve the quality of life of many K2-level amputees. These changes will also address the criticisms that have long been associated with the K-level classification system. The system sometimes limits patients' access to the most appropriate prosthetic technologies and services.
If you’re interested, you can participate in a national virtual meeting, which will be hosted by the Centers for Medicare and Medicaid Services (CMS) on February 22, 2024. To register, you can head over to this link before February 21.
In addition, you can submit your public comments on the draft policy until March 2, 2024. To do so, you can review the draft policy and submit your public comment at this link.
