Last Wednesday, Director of Government Affairs Alexis Denny attended the signing of an executive order titled Advancing American Kidney Health. This order and its accompanying policies mark one of few times a sitting president has brought chronic kidney disease — and the obstacles this community faces — to the forefront. We encourage our community to read the order and other articles about it:

• Politico Article: Trump Aims to Shake Up Kidney Care
• NPR All Things Considered: Trump Administration Announces Plans To Shake Up The Kidney Care Industry
• NPR Weekend Edition Story: Overhauling Kidney Care
• Visual representation of the executive order

Read on for Alexis’s take on how the PKD Foundation views the program, how it will impact PKD patients in the U.S., and what the next steps for our community are.

PKD Foundation staff in D.C.

The PKD Foundation had strong representation at the event. I was joined by our CEO Andy Betts, board members Ashley Brown and Bill Brazell, and patient advocates Mary Ann Brazell, Meg Munits, and her son Dov Munits. “It was an exciting day for PKD and all kidney patients in the U.S., and it was great to have such a passionate group of PKD advocates in attendance. We look forward to the changes the new plan will bring, and we will be there every step of the way to ensure the PKD patient voice and experience are part of the conversation,” said Andy Betts.

See a slideshow of photos from the event on our Facebook page.

What does the executive order address?

In summary, the executive order (EO) addresses issues in kidney care from three main areas:

1. Prevention and Dialysis
2. Transplant and Living Donation
3. Innovation in Treatment

Prevention and Dialysis

Current policy  Does not support or incentivize early detection and prevention of chronic kidney disease (CKD). Instead, it is built to wait until kidney failure, and then send the vast majority of patients to a center for dialysis. Physicians are not well-trained to educate and support patients for do at-home dialysis, and often individuals do not even know they are in kidney failure until dialysis is required.

Executive order  Calls for an awareness campaign to educate patients about kidney disease in the hopes of driving earlier diagnosis and prevention efforts, and for a new payment model to increase incentives for home dialysis and transplants with a goal of 80% of end-stage renal disease (ESRD) patients receiving either home dialysis or transplantation by 2025.

PKD impact  Most people with PKD are aware of the disease long before they are in late stage kidney failure (if this was not your experience, please tell us your story in the comments). While we don’t know exactly how many PKD patients who are dialyzing are doing so at home, my experience based on conversations with a variety of patients and providers is that it is at a similar or possibly slightly higher rate than the general CKD population. Unfortunately, hard data to back this up are not available. Incentives for better patient education and increased patient choice are always welcome, but implementation details need to be spelled out. While home dialysis may be beneficial, there are larger issues to consider when pushing this option. Home dialysis will have unique issues; fortunately, we can look to the many other countries that use this in the majority of their dialysis cases to identify potential pitfalls and plan for them.

My initial questions include:

• What about individuals who do not live in a home large enough to house the equipment needed for home dialysis?
• What about those who live alone (home dialysis requires someone be trained to administer to the patient) or who live with someone not able to manage the dialysis machinery or manage unexpected issues?

Ensuring the incentives for patient choice are in place so that each person can make an informed and educated decision about the modality and location of dialysis that is right for them will be critical to the success of this new plan.

Transplant and Living Donation

Current policy  We know that the waiting time for a kidney transplant is long; for years, the shortage of available kidneys at any given time has been around 100,000. This is due, in part, to inefficiency in Organ Procurement Organizations (OPOs). Additionally, living donors often pay expenses out of pocket to donate, have to take time off work for recovery, and may face future issues securing life, disability, or long-term care insurance.

Executive order  Calls for testing of a new payment model based on cost and quality outcomes and focuses on delaying or preventing the onset of kidney failure, preventing unnecessary hospitalizations, and increasing rate of transplants. The order also calls for regulation of the OPOs to establish rules and evaluation metrics to increase transparency and efficiency, with intent to increase the number of kidneys (and other organs) available for transplant. Finally, it calls for new regulation to lower barriers to living donation. This regulation will increase a donor’s income limit eligible for reimbursement of expenses and expand allowable reimbursements to living donors to include lost wages and child and elder care. These expenses are reimbursed to eligible donors through the National Living Donor Assistance Center (NLDAC).

PKD Impact  This portion of the order may be the most beneficial to PKD patients. Increased efficiency in OPOs in recovering more organs for transplants means more transplants, some of which will go to individuals with PKD. PKD patients tend to do better with transplants than general CKD patients, making it the desired option for our community.

Living donor support is exciting because many members of our community track their kidney function closely and know for months or even years they will eventually need a transplant. This means that PKD patients are well-situated to find living donors. Reducing barriers to living donation will increase the potential pool of donors and improve the odds of finding a donor.

Innovation in Treatment

Current policy  Innovation in kidney care is something we don’t often hear about. The approaches to kidney failure have remained the same for much of the last 30+ years. Dialysis has been essentially the same since the 1970s and drug development has been largely focused on dialysis and transplant medications. Tolvaptan, the first approved drug to treat ADPKD in the US, was approved in April 2018 and is one of few medications ever approved to treat the cause of kidney disease.

Executive order  Calls for investment in development of a wearable or implantable artificial kidney as well as investment in the Kidney Innovation Accelerator (KidneyX), a public-private partnership between the Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN).

PKD Impact  I admit to having conflicting feelings about this section. Development of a wearable or artificial kidney is long overdue and I applaud the Administration’s effort to drive that innovation. However, I am disappointed that nothing in the EO dedicates resources to therapy development efforts to prevent kidney failure from occurring in the first place. Singularly focusing on improving renal replacement therapy and transplant efficiency somewhat misses the mark for the PKD community (and other genetic kidney disease communities) by providing no pathway to increased funding of basic and clinical research to develop more and better therapies to stop the disease before it destroys the kidney. The PKD Foundation will continue to advocate for NIH funding to support basic and clinical science.

Final thoughts

As with most things in life (and government), the details will make or break this new plan. It is one thing to talk about big, sweeping changes to decades-old policy and to offer high-level ideals about ways to improve kidney care in the United States; it is another thing entirely to put those ideals into action, adjust when things don’t go as planned, and stay focused on the overall purpose: to improve the lives of everyone impacted by chronic kidney disease. The implementation details are not clear right now, and only time will tell us if these new policies will result in the intended outcomes.

This is the beginning, not the end, of the conversation. We have gained traction with this Administration, but we must also hold it accountable for the promises it has made. In his speech on Wednesday, the president stated that he will protect patients with preexisting conditions, and that his party agrees to do this as well. Signing this executive order is a step in the right direction, but we must also step back and not lose sight of the bigger picture. One that ensures patients have affordable access to the current and future therapies for PKD; that no one ever loses a kidney transplant because they cannot afford their immunosuppressive medications; that all patients have access to quality, affordable medical care; and that money for basic and medical research is increased year-over-year.

The PKD Foundation has your back — we will continue to fight for all of these things and hold the Administration accountable to make good on the promises it has made. We will continue to work closely with other kidney organizations to push as a community to truly and finally improve care for all PKD and kidney patients.

What do you think about the executive order? Tell us in the comments below!

Want to get involved?

1. Check out the advocacy portion of our website.
2. Sign up for Advocacy Alerts.
3. Follow us on Twitter: @adennyPKD and @PKDFoundation
4. Use our tools to tell Congress that you expect action!