A year later, pandemic-delayed Advancing American Kidney Health faces tough test
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The executive order signed by President Donald J. Trump on July 10, 2019, launched Advancing American Kidney Health.
It was greeted by most stakeholders in the kidney care community – patients and their caregivers, nephrologists, other provider professionals, societies and dialysis organizations – as a landmark federal policy effort to raise awareness of chronic kidney disease as a public health menace and to provide a blueprint for improving the health of the vulnerable population of patients with CKD.
Long- and short-term goals
The long-term goals of AAKH are to promote disruptive advances in research, especially in precision medicine, artificial wearable dialysis devices and artificial implantable organs. This will be achieved through transformation catalysts including the Kidney Precision Medicine Project, the Kidney Health Initiative, KidneyX and the Center for Dialysis Innovation. These efforts, just beginning to ramp up, have been overshadowed by the COVID-19 pandemic which appropriately diverted some of the resources to addressing issues affecting patients with kidney disease.
The short-term goals of the AAKH are to provide earlier upstream prevention and intervention for CKD, more access to transplantation and greater availability of transplantable organs, and greater use of home dialysis.
One goal that has received a great deal of attention is to have 80% of new patients with ESKD receiving home dialysis or have a functioning kidney transplant by 2025.
This goal has been viewed by many,including this author, as highly unrealistic given current resources and barriers.
Increase kidney transplants
No one disputes the superiority of this option over chronic dialysis in terms of outcomes, quality of life and costs. The major barriers to kidney transplantation are inadequate availability of transplantable organs (as evidenced by the more than 100,000 patients on kidney transplant wait lists in the United States), medical contraindications to transplant in some patients and patient choice to forego transplantation. AAKH attempts to address the first barrier through greater accountability of organ procurement agencies for unused harvested organs, but it is unlikely this alone will increase deceased donor organs by more than twofold.
A greater issue with regard to inadequate organ availability is how donors provide consent in the first place. In the United States, organ donation is designated through an affirmative symbol on the driver’s license or a statement in a living will. In most states, these choices are nonbinding and serve only to inform the next of kin of the deceased’s preferences; it is ultimately up to the next of kin to provide consent for organ harvesting. This opt-in system is highly inefficient and fails to capture the intentions of many potential organ donors.
In a number of Western European countries, there is an opt-out organ donation system in which the deceased is presumed to provide consent for organ donation unless there is written evidence to the contrary. Such a system in the United States, although it may meet political resistance, is clearly preferable to the status quo because it favors living patients who can use the organs over deceased patients who cannot. It is a shortcoming of AAKH not to address this root cause of low organ availability.
The 3-year limitation of Medicare eligibility with coverage for immunosuppressive agents for kidney transplant recipients younger than 65 years has been an issue for many patients without other health care insurance. Legislation is moving through Congress this year to extend Medicare coverage for the life of the transplanted organ in this population, which would overcome this barrier to the AAKH transplant goal.
Increase home dialysis
Informed patient choice should be the cornerstone of policy with regard to dialysis modality selection. The AAKH, however, appears somewhat disingenuous in this regard by setting arbitrary goals for home dialysis which are not evidence-based. The following are some facts about home therapy:
- Survival of patients receiving peritoneal dialysis (PD) is equal to that of those receiving in-center hemodialysis (HD), although PD is less expensive than in-center PD.
- Survival of patients receiving home HD is superior to that of those receiving in-center HD, but home HD is more expensive than in-center HD.
Unfortunately, under the current payment system, Medicare Administrative Contractors only cover three to four weekly treatments for short daily home HD so inadequate reimbursement may continue to be a barrier to its expansion. This needs to be addressed by CMS if the agency wants home HD to expand. A recently published meta-analysis1 showed physical health-related quality of life to be marginally better for home dialysis vs. in-center HD patients, but the quality of design of the included studies was poor, so promises of improved HRQoL to our patients who choose home dialysis are not evidence based.
Most home dialysis champions estimate that no more than 40% of patients with ESKD are suitable for home modalities, and dropout rates for PD are substantial even in the best programs. Home dialysis requires highly skilled nursing support and the infrastructure for this has yet to be developed due to shortages of qualified personnel willing to provide the needed 24/7 coverage.
A payment model for these visiting assistants should be developed and incorporated into an assisted PD bundle once the cost-effectiveness has been established.
Since the introduction of AAKH a year ago, most dialysis providers have intensified their efforts to increase home dialysis referral and it is likely the growth rate for home dialysis will accelerate. In 2019, 12.2% of patients on dialysis received home dialysis, an increase from 11.5% in 2018.2
However, the major barrier to home dialysis is patient fear, which is not addressed in AAKH. Experience in other countries where home dialysis utilization is significantly higher has shown that assisted PD, staffed by a mixture of nurses and community health care workers, is highly successful in decreasing patient fear, increasing patient choice of PD and decreasing dropouts.
There are several home HD machines coming to market with increasingly user-friendly interfaces. In the End-Stage Renal Disease Prospective Payment System (PPS) Calendar Year 2021 Proposed Rule, CMS will pay 65% of the cost of home dialysis machines representing an advance that substantially improves, relative to dialysis services previously available, the treatment of Medicare beneficiaries. This payment is made outside the PPS bundle for 2 years.3
The shortage of continuous renal replacement therapy solutions for patients with AKI secondary to COVID-19 has raised concerns whether such shortages could occur with PD and home HD solutions, especially because many of these solutions are not produced domestically.
COVID-19 and home dialysis
The COVID-19 pandemic has provided an unexpected new rationale to promote home dialysis, which limits patient exposure to infectious agents, including this virus, by minimizing interactions with health care staff, other patients, transportation personnel and people sharing public transportation. Surprisingly, CMS will not pay for home PD for patients with unsolved AKI from COVID-19 who received PD while hospitalized and are discharged from the hospital. Such patients must switch to in-center HD until their AKI resolves or they are declared to have ESKD, at which time they can choose a home modality. This seems inconsistent with the goals of AAKH which should encourage continued use of PD and not subject the patient to placement of a tunneled HD catheter and interruption of a home modality which the patient has gotten used to. Without such an interruption, PD would be more likely to be chosen if the patient does not recover from AKI.
The ESRD Treatment Choices (ETC) Model, which is to be implemented in randomized fashion based on geographic region vs. a conventional payment model, rewards a higher percentage of patients receiving home therapy. Rather than valuing patient choice and being process based (ie, Was the patient offered the appropriate education and then chose the modality best suited to their preferences and situation?), this model is outcome based. That can lead to inappropriate incentives and unintended consequences.
Slow CKD progression
Enhanced upstream care of patients with CKD before they reach end-stage provides the greatest opportunity for improving outcomes in this vulnerable population (see this month’s Cover Story). AAKH recognizes this opportunity with optional payment models based on capitated payments and shared savings, depending on the model. A bonus payment is provided for patients who undergo renal transplantation. These payment models begin in 2021, so there are no positive results yet to report. However, there are increased challenges.
The major barriers to enhancing the care of patients with CKD who are nondialysis dependent are access, referral and denial. Thirty-five percent of patients “crash land” on dialysis with no prior nephrology care and, in a significant percentage of patients, no recent health care at all.4 CKD disproportionately affects socioeconomically disadvantaged populations with inadequate or no health care insurance. Access to health care by these populations has been further compromised by rollbacks in the Affordable Care Act, decreasing Medicaid benefits in many states, and increased unemployment from the COVID-19 pandemic which has caused 5.4 million Americans to lose health care coverage between February and May 2020.4 Recently, access to federal health care benefits by the LGBTQ population has been threatened.
Telehealth
The COVD-19 pandemic has recognized the value of telehealth and Medicare has compensated it appropriately, bringing health care to populations, including those with CKD, whose access was previously limited by geography or transportation. However, the benefits of AAKH only apply to the “haves” with health insurance; the disproportionate population of CKD “have not” patients without health insurance are still at risk for poorer outcomes and generating higher health care costs once they reach ESKD and qualify for Medicare.
Consider the improved outcomes and cost savings that could be achieved if these vulnerable under- or non-insured patients with stages 4 and 5 CKD received health care benefits so they could receive preemptive transplants and the education/preparation needed to choose a home dialysis modality. Cost-effectiveness studies of this approach need to be undertaken.
The second barrier to enhanced upstream care of patients with CKD is timely referral to nephrologists. That means on-time and not too early. All patients with CKD stage 4 should be referred (and stage 5 if they were not referred at stage 4). Patients with heavy proteinuria, rapidly declining kidney function, poorly controlled hypertension, primary glomerular disease, immunologic disorders such as lupus, and unusual acid-base or electrolyte disorders should be referred before stage 4. As there is a limited number of nephrologists, patients with stable stage 3 CKD and/or mild proteinuria should not be referred so nephrologists can focus their attention on the patients most likely to benefit. There are a number of promising new treatments for primary glomerular disease and lupus nephritis that have recently been approved or are in phase 3 studies. More effective use of agents which inhibit the renin-angiotensin-aldosterone system, SGLT-2 inhibitors and GLP-1 agonists have been shown to further slow the progression of diabetic nephropathy.
Patient-centered culture
Patient denial is the third most common barrier to enhanced upstream care of patients with CKD. As CKD is usually asymptomatic until its most advanced stages, patients often fail to follow up on nephrologist referrals and, as ESKD approaches, they fail to follow up on referrals for modality education and transplant evaluation, and often do not read the educational material that is provided in the nephrologist’s office.
In the patient-centered culture we are trying to achieve, it is tempting to accept these inactions as patient choice, but these are not informed inactions. Upstream ESKD education programs need to be more accessible and patient friendly. They need to be more patient-centric and account for cultural nuances. How this is developed and operationalized remains to be seen, but AAKH cannot ignore this vital component of its mission.
Conclusion
Attention to COVID-19 has obscured efforts to advance kidney health during the past year, and we have had some hits and misses.
Hits. Funding for strategic goals such as wearable dialysis devices and implantable artificial kidneys has been implemented. The COVID-19 epidemic led to the acceleration and appropriate reimbursement for telehealth to increase access of patients with CKD to health care providers; it also provided a boost to home dialysis as a patient safety strategy. Payment for new qualifying home dialysis machines outside the PPS bundle for 2 years and promising new therapies for primary glomerular diseases and diabetic nephropathy have been positive stories. Long-needed reform of performance standards for organ procurement organizations that will hopefully lead to more organs for transplant, and strong indications that legislation implementing lifetime coverage for immunosuppressive drugs, a financial burden for many kidney transplant patients, will be passed in this Congressional session are steps in the right direction.
Misses. The over-valuation of PD as a strategy to improve patients’ outcomes and HRQoL, and the use of home dialysis (which is predominately PD in the United States) utilization as a metric to drive provider reimbursement, which devalues patient choice and may lead to inappropriate incentives and unintended consequences, is the wrong approach. The decision by CMS not to pay for home PD in patients with AKI from COVID-19 who were initiated on PD while in the hospital is a major miss and a setback for the AAKH enterprise.
Suboptimal care for patients with nondialysis CKD will worsen as health care benefits for vulnerable populations are eroded by current policies and increased unemployment, and this will ultimately be the greatest factor undermining the well-intentioned goals of AAKH.
- References:
- Bonenkamp AA, et al. Kidney Med. 2020;doi:10.1016/j.xkme.2019.11.005.
- www.healio.com/news/nephrology/20190723/large-providers-continue-strong-growth-in-home-dialysis
- www.usrds.org/2018/view/v2_01.aspx
- www.familiesusa.org/resources/the-covid-19-pandemic-and-resulting-economic-crash-have-caused-the-greatest-health-insurance-losses-in-american-history
- For more information:
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Jay B. Wish, MD,
is professor of clinical medicine at Indiana University School of Medicine and chief medical officer for dialysis at Indiana University Health in Indianapolis. He is also co-chair of the Nephrology News & IssuesEditorial Advisory Board.
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