ASN Executive Vice President's Update: Five Big Hairy Audacious Goals for US Nephrology

Improving care by developing a national clearinghouse to help match patients with transplant programs.

People with kidney diseases and their nephrologists struggle to navigate the current system to find a transplant program, creating barriers to access transplant care. This challenge is especially acute for transplant candidates living in rural areas with already limited access to transplant facilities. Also, transplant candidates who might be deemed higher risk—a designation that often overlaps with populations who are socioeconomically disadvantaged or who face systemic racism in access to other areas of care—struggle to navigate the current system.

A centralized, national online clearinghouse would help match patients with transplant programs by uploading information from electronic health records (EHRs) for prospective patients and urging transplant center decision-makers to input their baseline criteria for accepting patients. The patient's information would be compared with the program's criteria and suggest likely matches. This clearinghouse would:

• Create a pathway to transplant for many patients for whom one does not presently exist.

• Decrease redundancy, administrative burdens, and paperwork (such as nephrology care teams or patients having one-off interfaces sharing the same information with multiple transplant centers to attempt to identify a good fit).

• Reduce transplant coordinator effort (such as fielding many one-off interactions regarding patients who may or may not be a good fit).

• Increase transplant center transparency to better understand—and improve—patients’ access to transplant nationwide.

Pioneering research funded by the Agency for Healthcare Research and Quality (AHRQ) aims to help empower patients with more of this type of information, but this effort is in its infancy (3). Eventually, this AHRQ proof-of-concept platform could be expanded into a nationwide matching clearinghouse to help patients identify the transplant center(s) that are the optimal fit, including integration with EHRs at dialysis facilities, nephrology clinics, and transplant centers nationwide.

Advancing research by forming the NIH National Center for Kidney Health and Transplantation.

With 27 institutes and centers, NIH is the world's leading research agency, seeking “fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability” (4). In fiscal year 2021, NIH spent an estimated $700 million (1.6%) on kidney research and $201 million (0.47%) on organ transplantation research of its $42.94 billion total budget (5, 6).

Most of the funding for kidney research comes from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), whereas organ transplantation research is funded across 18 different institutes and centers. By spending an estimated $18.13 for each American with kidney diseases—compared with an estimated $305.57 for each American with cancer—NIH significantly underfunds kidney research (7).

In the early 1970s, the federal government made two decisions that helped determine the future of both oncology and nephrology. As part of the “war on cancer,” the government in 1971 declared that “the amount spent on cancer is grossly inadequate” and directed broad authority to the National Cancer Institute (NCI)—established in 1937—to pursue “new scientific leads” (8). From 1971 to 1979, the overall budget for NIH increased by more than 160%, with the budgets for NCI and NIDDK increasing by more than 300% and 50%, respectively (9).

By establishing the Medicare End-Stage Renal Disease (ESRD) Program in 1972, the government ensured that every American had access to lifesaving dialysis. In making this remarkable commitment, however, the government focused on treating people with kidney failure rather than finding cures to kidney diseases, reimagining dialysis, improving kidney transplants, or aligning incentives to promote kidney health and care. The National Center for Kidney Health and Transplantation is an important step toward embracing transplant as the optimal therapy for kidney failure, investing holistically across the entire research continuum, and improving access to and outcomes in kidney transplantation and research.

Strengthening education by embracing an ACGME-accredited fellowship in transplant nephrology.

The federal government pays more than $16 billion annually for medical education, including fellowship training, through the Medicare program (10). This federal funding, however, is only available to ACGME-accredited residency and fellowship programs. ACGME currently accredits fellowships in transplant hepatology (since 2007), advanced heart failure and transplant cardiology (2013), and interventional pulmonology (2024) but not transplant nephrology (11). The American Society of Transplantation (AST) accredits nearly 70 transplant nephrology fellowship programs in the United States and Canada (12). Therefore, Medicare helps fund additional training in transplant hepatology, transplant cardiology, and interventional pulmonology but provides no support for transplant nephrology.

ACGME accreditation would raise the profile of kidney transplantation and nephrology among residents, faculty, and institutions that sponsor medical education; provide a pathway for federal funding of transplant nephrology fellows; emphasize the bond between kidney transplantation and nephrology; and help implement the final recommendations from the ASN Task Force on the Future of Nephrology (13). Starting July 1, 2023, ACGME will become responsible for overseeing J-1 visa holders in non-accredited fellowship programs (such as transplant nephrology). This policy change means that the directors of these programs will need to navigate two accreditation processes (ACGME and AST).

Increasing awareness, surveillance, and prevention by creating the CDC Division of Kidney Health and Transplantation.

To accomplish its vision of “equitably protecting health, safety, and security,” the CDC relies on 10 centers and institutes, including the National Center for Chronic Disease Prevention and Health Promotion (14). In turn, this center includes eight divisions focused on cancer, diabetes, heart disease, nutrition (and physical activity and obesity), oral health, population health, reproductive health, and smoking.

The Division of Diabetes Translation includes the CDC's Chronic Kidney Disease Surveillance System (15). While kidney diseases are housed within the CDC Division of Diabetes Translation, the agency's efforts related to transplantation are organized within the CDC's National Center for Emerging and Zoonotic Infectious Diseases’ Division of Healthcare Quality Promotion (16). Given the magnitude of kidney diseases as a public health issue, the inequities and disparities in kidney health, the distinct approaches to prevention and care management, the bond between nephrology and transplantation, and the amount the federal government pays through Medicare to treat Americans with kidney failure, the CDC should equate kidney health and transplantation with cancer, diabetes, and heart disease.

In addition to raising the profile of kidney diseases, kidney failure, and kidney transplantation—which would help increase awareness in the public and private sectors, likely leading to more prevention—a freestanding CDC Division of Kidney Health and Transplantation in the National Center for Chronic Disease Prevention and Health Promotion would help coordinate the agency's many efforts related to improving kidney health and increasing transplantation. This focused approach could also lead to new efforts, such as establishing a national registry for people with kidney diseases. The absence of such a real-time database was a major challenge in the CDC's response to the COVID-19 pandemic.

This division would also help the CDC prepare for the next pandemic. During the early months of COVID-19, a sharp increase in acute kidney injury cases occurred, resulting in mortality rates never seen before—often in otherwise healthy people (17). Moreover, a Division of Kidney Health and Transplantation would help the CDC ensure that people receiving dialysis and people with a transplant are prioritized during the first rounds of future vaccines and therapeutics, as was the case during the pandemic for residents of long-term care facilities (18).

Helping to coordinate these efforts by establishing the HHS Office of Kidney Health and Transplantation.

Nearly 50 years after declaring war on cancer and providing “Medicare for all” for every US citizen with kidney failure, the federal government focused on Advancing American Kidney Health (19). Through three priorities, this initiative shifted the emphasis from treating kidney failure to promoting kidney health. First, the initiative prioritized preventing kidney failure via better diagnosis, treatment, and incentives for preventive care. Second, the initiative focused on increasing patient choice, which includes encouraging higher value-based care, educating patients about treatment alternatives, and advancing the development of artificial kidneys. And third, the initiative is committed to enhancing access to kidney transplants.

Unfortunately, the oversight, administration, and delivery of care for the more than 37 million Americans with kidney diseases, kidney failure, and kidney transplants are spread across the federal government, particularly at HHS and the Department of Veterans Affairs (VA). The government recognized this problem in 1987 and created the Kidney Interagency Coordinating Committee (KICC) “to encourage communication and collaboration to shape a more coordinated federal response to CKD [chronic kidney disease]” (20).

Despite KICC's efforts, this decentralized approach—especially at HHS—impedes the government's ability to accomplish Advancing American Kidney Health's three priorities. For example, the Centers for Medicare & Medicaid Services (CMS) retired the use of a 1-year outcome metric for transplant centers in 2019, acknowledging that it resulted in “unintended consequences” and impeded patients’ access to transplant. The Health Resources and Services Administration (HRSA), however, continues to use a 1-year outcome metric to grade the very same transplant centers. These types of misaligned, duplicative policies detract from the ability of nephrologists and other kidney health professionals to focus on doing what is best for patients.

With an annual budget of $2.4 trillion (21), HHS's massive department influences kidney policy through nearly every component of the agency, including the Immediate Office of the Secretary as well as the following entities (in alphabetical order):

• Administration for Strategic Preparedness and Response

• AHRQ

• Agency for Toxic Substances and Disease Registry

• CDC

• CMS and the Center for Medicare & Medicaid Innovation

• Food and Drug Administration (FDA)

• HRSA

• Indian Health Service

• NIH

The HHS Office of Kidney Health and Transplantation would help ensure that each of these components works synergistically toward the shared goals of improving access and care; advancing research; strengthening education; and increasing awareness, surveillance, and prevention. Besides improving coordination within HHS, the Office of Kidney Health and Transplantation would offer an ideal home for the Kidney Innovation Accelerator (KidneyX), the public-private partnership between ASN and HHS launched in 2018 to “accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases.”

KidneyX is building on the success of the Kidney Health Initiative (KHI), a partnership started in 2012 among ASN, the FDA, and approximately 100 member organizations “to catalyze innovation and the development of safe and effective patient-centered therapies for people living with kidney diseases.” Through its Patient and Family Partnership Council (PFPC), KHI has also helped ensure that “the patient's voice, experience, and involvement is meaningful and effective” in helping bring new drugs, devices, biologics, and food products to market.

The HHS Office of Kidney Health and Transplantation would amplify the patient voice even further than the KHI PFPC. It would offer people with kidney diseases, kidney failure, and kidney transplants a centralized opportunity to share their experiences to drive access, accelerate innovation, and benefit from scientific advancements.

Eventually, the success of these five BHAGs—particularly the HHS Office of Kidney Health and Transplantation—could lead to a larger national effort like the bipartisan National Nanotechnology Initiative (NNI), which focuses on research, development, commercialization, and awareness as well as expanding the workforce. In addition to HHS, the kidney version of NNI would include other federal government agencies and departments that already fund kidney research, such as VA, the Department of Defense, and the National Science Foundation.

For the record, none of these five BHAGs is originally my idea. They have evolved in discussions with ASN leaders, members, and staff as well as other stakeholders during my 16 years with the society. The time is now to think big, aim high, and galvanize the kidney and transplant communities in the United States to speak boldly with one voice as never before.