key: cord-0062302-6tfv0ano authors: Crews, Deidra C.; McCowan, Precious; Saffer, Tonya title: Bringing Kidney Care Home: Lessons from Covid-19 date: 2021-04-09 journal: NEJM Catal Innov Care Deliv DOI: 10.1056/cat.20.0695 sha: 661159b842d3caadc72b87964b1d0d2de8607cce doc_id: 62302 cord_uid: 6tfv0ano Care for end-stage kidney disease, which disproportionately affects people of color, has been predominantly delivered in dialysis centers, even when home dialysis would offer the same benefits with less cost and more convenience for the patients. The Covid-19 pandemic made the expansion of home care essential for many diseases. The authors explore how to preserve and expand home care for dialysis patients with regulatory changes and better coordination among programs. The Centers for Disease Control and Prevention (CDC) CKD Surveillance Team indicates that 15% of the U.S. adult population has chronic kidney disease (CKD), including 16% of non-Hispanic Black adults, 14% of Hispanic adults, 13% of non-Hispanic Asian adults, and 13% of non-Hispanic white adults. 3 Prevalence is higher among individuals with lower educational attainment and income.4 Many people with CKD eventually develop end-stage kidney disease (ESKD). In 2018, compared with white people, the prevalence of ESKD was about 3.4 times greater in Black Americans, 1.8 times greater in American Indians/Alaska Natives, and 1.3 times greater in Asian Americans.5 The proportion of new ESKD patients who reside in high poverty areas (those with 20% or more of households living below the federal poverty line) has increased in recent years to 34%,6 reflecting that people living with kidney failure in this country are often some of the most socially vulnerable Americans. Medicare is the universal health insurance provider for Americans with ESKD. Data from the Centers for Medicare & Medicaid Services (CMS) shows that during the first peak of the Covid-19 pandemic, ESKD beneficiaries were hospitalized 7.5 times more7 than older adult or disabled Medicare beneficiaries, and mortality increased by 40% for dialysis patients and 60% for transplant recipients, prior to their pre-pandemic mortality rates.5 Acute kidney injury has also been documented in the setting of Covid-19 infection, with Black individuals being at greater risk for acute kidney injury than white individuals.8 Most dialysis -the predominant form of treatment for ESKD -is delivered in dialysis centers, many of which experienced significant Covid-19 outbreaks among staff and patients. While home dialysis substantially reduces that risk, people of color are well documented to be less likely to initiate dialysis with a home therapy than are white people,9 , 10 underscoring amplified risk of poor outcomes for people of color with ESKD during the pandemic. Medicare spends $114 billion on kidney disease, with $35 billion onthe care of individuals with ESKD, who represent 1% of Medicare beneficiaries but 7% of its total budget." Covid-19 has reduced access to non-emergent surgeries and other procedures, and this reduction has had a major deleterious impact on the timely provision of surgical procedures such as vascular access surgery that are required to optimize dialysis care, particularly in geographic regions experiencing high rates of Covid-19 infection. There were already disparities in the receipt of these surgical procedures prior to Covid-19.5 , 11 The pandemic has likely made them worse. " Similarly, in the early months of the Covid-19 pandemic, more than 75% of kidney transplantation programs were either suspended or operating under restrictions, and the return to full capacity has been slow in many areas.12 This impact on transplantation is likely to be felt most profoundly among socially disadvantaged patient populations, who, again, had reduced access to transplantation even prior to All ESKD patients in the U.S. receive their care through Medicare. Coverage of ESKD was signed into law in 1972.14 Medicare spends $114 billion on kidney disease, with $35 billion on the care of individuals with ESKD, who represent 1% of Medicare beneficiaries but 7% of its total budget. The majority of ESKD costs are spent on patients who receive hemodialysis in outpatient clinics 3 times per week for 3 to 4 hours per treatment. Each dialysis patient is admitted to the hospital 1.58 times per year with an average length of stay of 9.4 days per year.5 Sixty percent of patients start dialysis while hospitalized and have a central venous catheter placed to access their blood for hemodialysis.15 Receiving a kidney transplant is the best modality for treating ESKD; however, locating a compatible kidney can take years, which ESKD patients must spend undergoing dialysis. These years take a toll: depressive symptoms occur in approximately one-third of dialysis patients. 16 These and other mental challenges make it difficult for ESKD patients to manage their health effectively. Restrictive, outdated federal and state regulations require all providers receiving Medicare reimbursement to become certified dialysis facilities and meet lengthy prescriptive requirements, many of which duplicate existing patient safety regulations that already govern health care providers. The burden of these extra regulations is one reason that the rest of the health care system has tended to cede the provision of dialysis to freestanding for-profit dialysis centers that make regulatory compliance a central feature of their business model. Two Fortune 500 companies, DaVita Kidney Care and Fresenius Medical Care, provide dialysis to more than 73% of U.S. ESKD patients.17 These companies' profitability depends on keeping their centers as close to capacity as possible. Restrictive, outdated federal and state regulations require all providers receiving Medicare reimbursement to become certified dialysis facilities and meet lengthy prescriptive requirements, many of which duplicate existing patient safety regulations that already govern health care providers." " But should dialysis center profits come at the expense of the best interests of patients? Though it is often feasible to receive dialysis at home, only about 12.5% of patients use home dialysis today, with 10.5% undergoing peritoneal dialysis [which uses the lining of the abdomen (peritoneum) as a filter and removes waste products from the blood] and less than 2% undergoing home hemodialysis. 5 Nephrologists themselves realize that dialysis centers are not optimal care: a majority would choose home hemodialysis for themselves or a family member if they had kidney failure and required dialysis, followed by peritoneal dialysis.18 Home dialysis is less expensive: Medicare spends $93,191 on mostly in-center hemodialysis patients and $78,741 on mostly home peritoneal dialysis patients.5 Yet patients often report not being provided a choice or being judged to be unfit for home dialysis, despite few absolute contraindications to home dialysis. Conflicts of interest pose one obstacle to changing this pattern of care. Many nephrologists have joint ventures and medical directorships with dialysis facilities. Those arrangements often require nephrologists to sign non-compete contracts that can be multiyear prohibitions on working with competitors in a certain geographic area. The extent of these agreements and the impact they have on patient care is not well studied and data is difficult to obtain.17 Simple changes to the regulations could allow for dialysis to more easily be provided within existing health care settings, and reduce requirements placed on home dialysis training and support programs. Such changes could broaden the options for better coordinated kidney care and patientcentered dialysis. There are compelling reasons to expedite this shift. When transplant is not an immediate option, home dialysis can help patients stay activated in their care, which may lead to improved outcomes. We believe that ESKD care needs the following critical reforms: • Easier to use home dialysis technology • Provider education on the benefits of home dialysis, to reduce the existing bias in favor of center-based care • Patient education to empower home dialysis • Support for patients to maintain treatment on a home modality In addition, financial conflicts of interest, reimbursement, and regulations must be reformed to address the entrenched interests of delivering in-center dialysis. At its November 2020 meeting, the Medicare Payment Advisory Committee (MedPAC) noted the challenges and high costs associated with consolidation of the dialysis market and its impact on potentially limiting patients' options to minimize out-of-pocket expenses through Medicare Advantage plans.19 To move toward the home-based model for dialysis that we describe above, and propagate other evidence-based improvements in kidney care, we believe the executive and legislative branches of the federal government must address a larger issue with the development of kidney care policies and programs. ESKD, widely and correctly recognized as a public health issue, has inspired multiple federal efforts staffed by committed, passionate civil servants quietly doing their part to drive forward improvement in kidney care. However, these programs often receive little attention, funding, and coordination. Attempts at coordination have stalled and sometimes fallen short in the absence of support from political leadership. Table 1 and Table 2 provide an overview of current initiatives across the Department of Health and Human Services (HHS) aimed at improving outcomes for people with CKD. Though it is often feasible to receive dialysis at home, only about 12.5% of patients use home dialysis today." The Medicare ESRD program represents the first example of bipartisan support for a single-payer system in the United States. To ensure its sustainability and extend its benefits to improving kidney health generally, a public health approach to CKD will require coordination across all of the agencies and departments within HHS. For this reason, we recommend a division of Kidney Health • EmPower: a mapping tool to identify dialysis dependent ESKD patients in emergencies and ensure continuity of their treatment; collaborates with CMS • Federal contracts to private companies to assist with delivering dialysis treatment in emergencies Centers for Disease Control and Prevention (CDC) • CKD Surveillance System: monitors the burden and trends of CKD and its risk factors over time, and monitors and evaluates trends in achieving Healthy People 2020 objectives • Dialysis Safety: develops and disseminates education, tools, protocols, and resources to prevent hemodialysis bloodstream infections Center for Medicare & Medicaid Services (CMS) (see Table 2 for more detail) • ESKD and organ payment system rules; quality metric development and implementation; quality public reporting; quality improvement initiatives; kidney community emergency response; dialysis facility and organ procurement regulation; survey and certification of dialysis facilities; and innovation demonstrations Hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019 -COVID-NET, 14 states The color of coronavirus: COVID-19 deaths by race and ethnicity in the Chronic Kidney Disease Initiative. Chronic Kidney Disease in the United States National trends in the prevalence of chronic kidney disease among racial/ethnic and socioeconomic status groups USRDS annual data report: Epidemiology of kidney disease in the United States. Bethesda, MD: National Institutes of Health: National Institute of Diabetes and Digestive and Kidney Diseases Time trends in the association of ESRD incidence with area-level poverty in the US population Preliminary Medicare COVID-19 Data Snapshot Acute kidney injury in patients hospitalized with COVID-19 Racial and ethnic disparities in use of and outcomes with home dialysis in the United States Home dialysis utilization among racial and ethnic minorities in the United States at the National, Regional, and State Level Racial disparities in the arteriovenous fistula care continuum in hemodialysis patients Evolving impact of COVID-19 on transplant center practices and policies in the United States Association of race and ethnicity with live donor kidney transplantation in the United States from 1995 to Public Law 92-603, section 299I. Social Security Amendment of Inpatient hemodialysis initiation: reasons, risk factors and outcomes Prevalence of depression in chronic kidney disease: systematic review and meta-analysis of observational studies Dialysis-facility joint-venture ownership -hidden conflicts of interest Perceptions about renal replacement therapy among nephrology professionals Medicare Payment Advisory Commission. Public Meeting Coordination be established within HHS under the office of the Assistant Secretary of Health to