ASN Policy Q&A on the Advancing American Kidney Health initiative: Part 1

AAKHI_0.PNGThe American Society of Nephrology (ASN) Department of Policy and Public Affairs team has received numerous questions from interested members and from the broader kidney community on the recent Executive Order on Advancing American Kidney Health and the accompanying Department of Health and Human Services report highlighting specific initiatives. In order to engage with our members, we will be running a series in Kidney News Online that addresses these questions. This is the first piece in that series.

If you have additional questions that you would like to see answered in the next article, please contact the ASN Department of Policy and Public Affairs team at .

1. What is ASN’s stance on the Executive Order (EO) and Advancing American Kidney Health (AAKH) initiative?

The EO and the AAKH initiative feature ASN policy priorities centered around discovery, innovation, and comprehensive kidney care that the society has advocated for over many years. The ASN and its leadership are excited that many of these priorities including KidneyX, a public-private partnership between ASN and the Department of Health and Human Services, have made it into the EO and the initiative.

2. I’m interested in providing feedback on the AAKH initiative, particularly the models proposed by the Centers for Medicare & Medicaid Innovation (CMMI), how do I do so?

ASN has multiple standing committees to handle various topics. In this case, the ASN Quality Committee is reviewing everything that has been proposed by CMMI. The Quality Committee is assiduously working on drafting the society’s comment letter on the proposed End-Stage Renal Disease (ESRD) Treatment Choices Model (ETC Model) and will also evaluate the four voluntary models once they are released. While ASN supports the transformational direction the EO has laid out, the Quality Committee is considering recommendations for refinement to several components of the proposed model. The Quality Committee's comment letter will be reviewed and approved by ASN Council before its submission on September 16.

The ASN Quality Committee also welcomes feedback from ASN members during this process. You can share your insights through a variety of methods including ASN Communities (ASN’s online membership forum) and by emailing the ASN Department of Policy and Public Affairs team at . You are also welcomed to provide your own personal comments directly to CMS through the Federal Register.

3. I’m pleased to see the Trump Administration is placing a large emphasis on prevention and delay of progression, what are the primary new strategies the administration is hoping to utilize to achieve these goals?

ASN is excited that the administration is emphasizing more upstream kidney care by focusing on diagnosis, prevention, and delaying kidney failure. The administration seeks to prevent or delay the progression to kidney failure in multiple ways including, but not limited to:

  • Calling for an awareness initiative on kidney and related diseases to be announced within 120 days of its signing in section III of the EO. This campaign will increase public awareness and visibility of kidney diseases among patients and physicians and support programs that promote kidney disease awareness.
  • Directing CMMI to develop new payment models, particularly Kidney Care First, to incentivize upstream kidney care to slow the progression of the disease and provide education for the patient to choose the therapy best for them.
  • Supporting new studies funded by the National Institutes of Health, including the Preventing Early Renal Loss in Diabetes (PERL) Study which addresses the topic of delaying progression through medication

We would encourage you to read the entire Advancing American Kidney Health report and Executive Order for more examples.

4. Could you please address the level of funding that is committed at this point and for what period to help ensure the success of the AAKH initiative?

The AAKH initiative through the EO does not include levels of funding as the EO is solely an action taken by the Executive branch. The legislative branch, or Congress, controls the funding levels for federal programs through its appropriation process. We expect that when the Office of Management and Budget drafts the President’s proposed budget for Fiscal Year 2021 next spring, which Congress considers during the appropriations process, it will ask for increased funding to achieve these goals.

5. KidneyX’s Redesign Dialysis Phase II competition will award three awards, each of $500,000 each. Will KidneyX receive more funding in order to provide more awards?

KidneyX is envisioned to run as a series of prize competitions. Redesign Dialysis Phase I, II, and III is just one prize competition focused on accelerating the development and commercialization of next-generation dialysis products. KidneyX will expand into other prizes and other topics areas, including drugs and moving more upstream to include prevention and detection.

ASN has committed the first $25 million to KidneyX and is actively looking for other external private partners to contribute. As a public-private partnership, KidneyX envisions matching funding will come from the public sector. HHS contributed to the Redesign Dialysis Phase I awards; however, Congress must take action and provide $25 million to match what the private sector has already committed.

Congress controls what is amount of funding is appropriated to federal programs. The House Committee on Appropriations appropriated $10 million to KidneyX this spring. The Senate's appropriations process is still ongoing and ASN is actively advocating for KidneyX in the Senate. Once the Senate finalizes its appropriations both the House and Senate will need to conference and reconcile any differences in their appropriations. We do expect KidneyX to be viewed favorably in the Senate appropriations process and are expecting new funding from the government for KidneyX next year.

6. How can I support ASN’s advocacy efforts to secure more funding for KidneyX?

If you would like to help ASN advocate for Congress to fund KidneyX, please share your story about why we need to accelerate the development of new therapies for people living with kidney diseases by clicking here .

Your valuable perspective will be shared with Congressional offices on why breakthroughs are needed across the spectrum of kidney care and how KidneyX can catalyze innovation.