Public comments on proposed MCIT rule

Ensuring that the implantable artificial kidney will be reimbursed by Medicare and private insurers is a critical issue for The Kidney Project. Many venture capital investors have been reluctant to provide funding to advance our technology because they perceive a lengthy and uncertain timeline to obtaining coverage for reimbursement. A federal policy that provides automatic Medicare coverage for lifesaving new devices like the implantable artificial kidney would make it easier to attract the investment needed to complete our development and get it to patients.

Medicare is now considering the development of policy guidelines – a Medicare Coverage of Innovative Technology (MCIT) pathway – that would provide automatic coverage for Breakthrough Devices like the implantable artificial kidney. The ability to receive simultaneous FDA and Medicare approval could shave time and money needed to bring the artificial kidney to patients.


Please consider submitting a public comment in support of the proposed MCIT rule. Medicare encourages comments that are based in personal experience, include examples, and are backed up by sound reasoning and evidence. Here are a few points to consider mentioning:

• Identify yourself as a patient stakeholder and describe your experience relying on current dialysis equipment. If you are a Medicare patient, mention this.
• Speak to the importance of receiving access to innovative new technologies like the implantable artificial kidney as soon as possible.
• Convey that funding has limited our progress and with the MCIT pathway, it is likely to catalyze investors to support the development of the implantable artificial kidney.

To submit a comment online, copy and paste the link below into your browser.
https://beta.regulations.gov/commenton/CMS-2020-0098-0002
Comments are due by 5pm EDT on November 2, 2020.

You can read the full text of the proposal here: https://www.federalregister.gov/…/medicare-program-medicare…

Thank you for using your voice to advocate for The Kidney Project!

 

[Source: Federal Register]