COMMENTARY

Advancing American Kidney Health: The Ultimate Randomized Controlled Trial?

Executive Order Puts Nephrology Center Stage

Tejas P. Desai, MD

Disclosures

July 19, 2019

On July 10, 2019, President Donald Trump signed the Executive Order Advancing American Kidney Health to improve the lives of kidney patients. It is one of the first significant changes to the current, and perhaps "entrenched," kidney care system in the United States.[1] The order has many parts that are designed to improve the lives of kidney patients and their families. The most intricate and detailed portion changes the way clinicians and dialysis organizations are reimbursed for the care they deliver. Before I delve into those intricacies, let's discuss the other components first.

Promoting Kidney Transplant and the Artificial Kidney

Two components of the order focus on kidney transplantation, namely organ procurement and living donors. Organ procurement organizations often operate with a different set of policies in how they accept organs These differences result in a large number of unused or discarded organs. The new order authorizes the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) to develop a national standard on how organs are procured, with the hope that this will increase the number of available organs (not just kidneys) for transplant.

The initiative aims to decrease the burden placed on living donors, who often sacrifice personal funds to care for children and/or miss work while hospitalized. The income eligibility threshold for the Living Organ Donation program will be expanded, and there will be a pilot program to see if covering lost wages and family expenses (up to $5000) results in more donors.

The third and perhaps least detailed of the five components of the order discusses the artificial kidney. The Executive Order calls for further investment by the federal government into the development of the artificial kidney through KidneyX, but it does not detail the amount or all funding sources. The Kidney Health Initiative, led by the American Society of Nephrology, has developed a roadmap on how an investment strategy can be constructed, and I presume that this framework will be the foundation upon which HHS and CMS will devise their strategy.

https://twitter.com/ASNKidney/statuses/1149051436321390593

Changes to Payment Structure

The last two components deal with the care of end-stage renal disease (ESRD) patients and the incentives for physicians. The Secretary of HHS, Alex Azar, has set a target for 80% of incident ESRD patients to start home dialysis therapy (most likely peritoneal dialysis) or undergo kidney transplant by 2025, although some worry that this is overly ambitious.

https://twitter.com/GlassockJ/status/1149308218599829504

Physicians and dialysis organizations will be incentivized to help reach this target through one of five models that are designed in ways similar to randomized clinical trials.

The first model will randomly assign nearly 50% of kidney disease clinicians or dialysis organizations in the United States to one of two arms: the ESRD Treatment Choices (ETC) model or conventional treatment.

In the ETC arm, clinicians and organizations will receive financial incentives to transition patients with stage 4 or 5 chronic kidney disease (CKD) to home dialysis. The Home Dialysis Payment Adjustment will be paid out from January 2020 to December 2022 (See Figure). Because enrollment into the ETC is both randomized and mandatory, this is the "ultimate intention-to-treat" trial.

Additionally, those in the ETC arm will be subject to a new Performance Pay Adjustment (PPA) model that incentivizes home dialysis therapy, kidney or kidney-pancreas transplantation, and preemptive transplantation (pre-dialysis). Using data collected through Medicare claims and the Scientific Registry of Transplant Recipients, clinicians/organizations will be rewarded or penalized on the basis of their rates of home therapy enrollment or transplantation versus the national averages. Quality measures will also be factored into the PPA using both the Standard Mortality and Hospitalization Ratios. Finally, those in the ETC arm will be relieved of some Medicare program rules to allow for implementation of these incentives and penalties. Those randomly assigned to the conventional arm will see no changes in the 3-year study period.

KCF and CKCC Models

The next four models are optional for both clinicians and dialysis organizations. In the Kidney Care First (KCF) model, clinicians will receive a capitated payment for the care of patients with ESRD or stage 4/5 CKD.

They can keep any savings earned over the year and there is also a Kidney Transplant Bonus for transplanted patients who maintain their allograft for 3 years. Details about the bonus payment or how a 3-year "successful kidney transplant" will be defined have not been released.

The final three models, collectively known as Comprehensive Kidney Care Contracting, similarly will allocate capitated payments for clinicians and facilities treating patients with ESRD or stage 4/5 CKD, but enrollees can also participate in a risk-reward scheme in which greater earnings are possible for taking on greater clinical risk. The details of these models are sparse as of this writing.

What Next?

I hope this helps you better understand the Executive Order and spurs discussion in the medical community. At its core, the action is an exquisitely unique "randomized trial" in nephrology. Nearly every nephrologist and kidney organization in the United States will be included in this trial. Mandatory participation in the ETC model means that this experiment is the ultimate intention-to-treat study.

Unlike the vast majority of randomized trials, Advancing American Kidney Health is not a public-private partnership but rather a wholly managed/funded trial by the federal government. Finally, the subjects of this trial are the deliverers of kidney care themselves. Advancing American Kidney Health separates nephrology from any other specialty with its creativity, reach, and broad implications for patients and nephrologists.

Government agencies including HHS, CMS, and the Center for Medicare & Medicaid Innovation (CMMi) are soliciting comments from the nephrology community until early September 2019. Use the included infographic to better understand the ETC and spur discussion among your partners in practice. If you have suggestions or concerns, email them to ETC-CMMI@cms.hhs.gov. You can also voice your comments on Twitter by using the hashtag #AdvancingKidneyHealth. I'll be collating these comments to send to CMMi.

Follow Tejas P. Desai, MD, on Twitter: @nephondemand

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