Ms. Chiquita Brooks-LaSure
Administrator, Centers for Medicare & Medicaid Services (CMS)
Department of Health and Human Services (HHS)
Attention: CMS-3372-P2
P.O. Box 8013, Baltimore, MD 21244-8013
Dear Administrator Brooks-LaSure,
Thank you for everything you are doing to encourage health equity and promote access to innovative technologies and treatments for all Americans. Alio appreciates the opportunity to provide feedback and comments on proposed revisions and updates to the Medicare Coverage of Innovative Technologies (MCIT).
As you may know, Alio has developed a SmartPatch for dialysis patients that allows clinicians to not only remotely track vitals like temperature, blood pressure, oxygen saturation—but also receive clinically actionable metrics regarding AV fistula function and stenosis to reduce hospitalizations and unneeded interventions. This February, we were honored to be named by the Kidney Innovation Accelerator (KidneyX) — a public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) to accelerate treatment, prevention, and diagnosis of kidney disease –as one of their winners for using remote patient monitoring to reduce COVID-19 risk for hemodialysis patients. As noted in the announcement, our “end-to-end remote patient monitoring enables proactive, noninvasive monitoring of hemodialysis patients. Alio’s platform identifies early warning signs of COVID-19 and reduces the need for contact between dialysis patients and staff by monitoring, basic vitals, fluid status, electrolyte levels and vascular access health.” We stand committed to continuing to work with the Biden Administration, HHS, CMS, FDA and KidneyX to use our technology to help patients.
According to research from the National Kidney Foundation, African Americans constitute more than 35% of all patients in the U.S. receiving dialysis for kidney failure, but only represent 13.2% of the overall U.S. population. We stand committed to working with you and your Administration to make sure the African American community is aware of these risks. If they end up on dialysis, we believe our intentionally designed easy-to-use remote patient monitoring technology can help improve care in the community and improve health equity.
I understand that you and the senior leadership at CMS appreciated the intent and nature of the MCIT/R&N rule regarding breakthrough devices that was finalized in January 2021, but ultimately decided the rule in its current state was not in the best interest of Medicare beneficiaries. We sincerely appreciate your belief that there are other ways to achieve the goal of expediting coverage while protecting the health and well-being of beneficiaries. In particular, you cited how the FDA relies on scientific and medical evidence that does not necessarily include Medicare beneficiaries in all their clinical trials. We are happy to share that nearly all the data and domestic studies we at Alio are conducting are in fact with Medicare beneficiaries.
Although we conceptually supported the direction CMS was heading in the original proposed rule, we understand you had legitimate concerns and we look forward to working with you to find ways to improve care for dialysis patients. As you know, kidney failure is an extraordinary cost not only for the individuals and their families but also for Medicare, as it accounts for nearly 7% of the entire Medicare budget. We would greatly appreciate the opportunity to discuss how we can partner with you to help Medicare beneficiaries, please visit our website https://alioai.wpengine.com/.
Best,
David J. Kuraguntla
CEO/Founder of Alio
