1. What is the decision or change (e.g., clinical topic, practice guideline, system design, delivery of care) you are facing or struggling with where a summary of the evidence would be helpful?
End-stage kidney disease (also called kidney failure) affects over 800,000 patients in the United States (US), kills 50% of patients in 5 years, and costs over $50 billion per year in Medicare costs. The Federal government, recognizing that home dialysis could improve patient outcomes and lower costs for patients with ESKD, announced the Advancing American Kidney Health Initiative in 2020 which seeks to improve home dialysis use towards 80% of patients by 2025. Unfortunately, fewer than 15% of patients receive home dialysis in the US, in part due to regulatory issues and lack of infrastructure that limit innovation in home dialysis care delivery. Would staff-assisted home dialysis—a technique where trained nurses, patient care technicians, or other trained staff visit a patient’s home to assist with dialysis—improve patient-centered outcomes and lower costs to Medicare, compared to the more expensive therapy of in-center hemodialysis? Further, would reimbursement for caregiver-assisted home dialysis—where family members, friends, or other trusted partners—improve uptake and retention of patients on home dialysis?
2. Why are you struggling with this issue?
International studies suggest that assisted home dialysis is safe and effective (for example, in France, Canada, Australia, and New Zealand). Yet, comprehensive reviews of the topic with a lens towards implementation in the US are lacking. Medicare 1) does not reimburse for assisted home dialysis and 2) limits the ability for personnel to provide assistance due to narrowly defined scopes of practice in the Medicare conditions for covera ge. Without reimbursement and a broader scope of practice for staff/caregiver assistance, it is operationally difficult to provide assistance for home dialysis. With growing federal and national interest in home dialysis, the Centers for Medicare and Medicaid Services (CMS) requested public commentary in 2021 on whether CMS should institute guidelines for assisted home dialysis (https://public-inspection.federalregister.gov/2021-26146.pdf). Unfortunately, CMS has yet to introduce guidelines for assisted home dialysis, in part due to the limited US evidence for assisted home dialysis. As more studies have been published using US data (including a feasibility study in 2022: https://pubmed.ncbi.nlm.nih.gov/35383044/), we believe that a systematic review of the evidence would help inform CMS’ decision on whether or not to produce guidelines for assisted home dialysis.
3. What do you want to see changed? How will you know that your issue is improving or has been addressed?
We would like to see a summary of US and international evidence on the success and failures of assisted home dialysis, written with the intention to help inform CMS’ and kidney professional societies’ decision-making on feasibility, implementation, and outcomes to be monitored when introducing assisted home dialysis in the US. We will know if this issue has been addressed based on 1) whether the body of evidence produced by AHRQ informs CMS’ decision-making in subsequent rulemaking, 2) how kidney professional societies, such as the American Society of Nephrology, the National Kidney Foundation, and the American Nephrology Nurses Association incorporate AHRQ’s recommendations in future public comments to CMS, and 3) whether assisted home dialysis is implemented by private agencies across the US.
4. When do you need the evidence report?
Friday, 11/01/2024
5. What will you do with the evidence report?
We will incorporate the evidence report into our public commentary to CMS to help them develop new guidelines for assisted home dialysis (i.e., whether to incorporate assisted home dialysis in the US, how to incorporate assisted home dialysis [for example, temporary or permanent assistance], and how long to pay for assisted home dialysis [e.g., 3 months of assistance]). We will also use the evidence report to guide future studies needed to optimize assisted home dialysis in the US. If the report could be produced by November 2024, it would still give the US at least one year to implement assisted home dialysis before the Advancing American Kidney Health initiative target of 2025.
Optional Information About You
What is your role or perspective? Physician, researcher, health policy advocate (on behalf of a professional society).
If you are you making a suggestion on behalf of an organization, please state the name of the organization
American Society of Nephrology Quality Committee
May we contact you if we have questions about your nomination? Yes
