Policy Update: ASN Advocacy Makes Early Progress in United States and Abroad

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ASN advocacy delivered early progress on an ambitious policy agenda as 2024 began. Building upon a year of historic accomplishments, including the first significant steps to reform the US transplant system since its establishment over 40 years ago, ASN's 2024 policy priorities (1) set a course to build on this progress and achieve kidney health for the more than 850 million people living with kidney diseases internationally, including 37 million people in the United States.

Massive funding increase for transplant modernization

On March 23rd, President Joe Biden signed into law the fiscal year 2024 (FY24) Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations bill, which included funding for several ASN priorities, particularly a large $23 million funding increase to continue transplant modernization.

The LHHS appropriations bill includes the majority of health programs funded by the federal government, including the entirety of the US Department of Health and Human Services (HHS). HHS had been operating under a series of temporary funding agreements or continuing resolutions since the start of the federal FY24 on October 1, 2023, hampering the ability of HHS to enact important policy reforms such as the Securing the US Organ Procurement and Transplantation Network (OPTN) Act and the Health Resources and Services Administration (HRSA) OPTN Modernization Initiative—twin policy initiatives supported by ASN in 2023 to transform the US transplant system (2).

The final FY24 LHHS funding bill signed by Biden included a total of $59 million to implement the reforms called for in the Securing the US OPTN Act and proposed as part of the HRSA OPTN Modernization Initiative, a $23 million increase over the prior FY, and the largest increase ever in the program's history. HRSA has requested increases in funding to establish an independent OPTN board, invest in core systems, as well as build out information technology systems that use modern technology and are more capable of meeting the needs of patients and health professionals.

ASN advocates had repeatedly stressed the importance of funding these generational improvements to the transplant system in the lead-up to passage of the legislation. In 2023, 27,000 kidney transplants were performed in the United States, far short of the nearly 100,000 person-long kidney transplant waitlist. Despite this need, more than one in four kidneys are wasted, even though data suggest that many of these unused organs would benefit patients. ASN representatives noted the urgency of increasing transparency and navigability of the transplant system for patients and physicians, particularly through modernizing information technology systems, among other key reforms.

ASN leaders are already encouraging continued investment in the US transplant system in FY25 to continue building on this historic progress. Members of the ASN Council, Policy and Advocacy Committee, Quality Committee, and Transplant Workgroup met with their congressional delegations on April 18th to call for an $8 million increase to continue implementing the Securing the US OPTN Act and the HRSA OPTN Modernization Initiative to help ensure that Congress keeps transplant transformation a priority for FY25 and beyond.

Shaping the HRSA OPTN Modernization Initiative

In addition to advocating for funding, ASN has been engaging extensively with the Biden administration as it designs and implements the HRSA OPTN Modernization Initiative to ensure that it addresses the society's transplant-related policy priorities. The broad strokes of the reform efforts—increased transparency, strengthened transplant system accountability, and an emphasis on equity to improve system performance and allow more patients access to kidney transplant—share a great deal of resemblance to what ASN has advanced. Moreover, the specific policy changes that have come into focus also reflect ASN advocacy efforts. For example, HRSA will soon initiate data collection regarding the period between when a patient is referred for transplant and when a waiting list decision is made, including reporting on referrals to transplant centers and time to patient evaluation—key ASN requests in recent years. These data will help ASN identify and resolve unnecessary barriers to waiting lists that affect patients who would benefit from a transplant.

Complementing this effort, the Centers for Medicare & Medicaid Services (CMS) also recently announced similar transplant-related changes to the 2728 form for which ASN had advocated, including the addition of data points such as when and to which transplant centers patients are referred. Together, the CMS and HRSA changes will allow ASN to gain a holistic understanding of the referral and evaluation process. This advancement is crucial, as more than half of people with kidney failure under 40 years old with no other major comorbidities are not waitlisted, even though many would likely be excellent candidates. By collecting this information, ASN, through policy changes, can design a system that better serves them.

Other changes that ASN is advancing and aiming to see addressed through the HRSA OPTN Modernization Initiative include greater transparency for patients regarding details like program acceptance criteria and facilitating shared decision-making, such as retrospective information about organs offered and declined on their behalf. ASN is also urging HRSA and CMS to align metrics for transplant centers across the two agencies as well as to share crucial CMS patient data (particularly graft survival and mortality data) with HRSA and the Scientific Registry of Transplant Recipients.

In line with the changes made possible by the Securing the US OPTN Act, HRSA will be allowing multiple vendors to support the many functions of the OPTN for the first time in its nearly 40-year history, ushering in competition and ensuring that patients are served by the best-in-class expertise in every aspect of the transplant system. HRSA is expected to issue these Requests for Proposal in the second quarter of 2024.

Reaffirming commitment to diversity, equity, and inclusion in medical education

On March 26th, the American Medical Association and the Council of Medical Specialty Societies—to which ASN belongs—and other health care organizations issued a statement (3) on improving health through diversity, equity, and inclusion, noting: “Excellence in patient care cannot exist until we have a physician workforce capable of caring for our patients and their needs holistically, and until the profession of medicine is accessible to all qualified individuals.” ASN will continue to advocate for achieving diversity, equity, and inclusion in the kidney health workforce, for funding medical education, and for nonintervention in the patient–physician relationship.

On April 12th, ASN joined members of the American College of Physicians in support of actions to achieve diversity, equity, and inclusion in medical education. Responding to recent proposals to ban federal funding for medical education that includes reference to such a commitment, ASN and 24 other health professional organizations highlighted research showing the importance of achieving diversity, equity, and inclusion to improve patient outcomes and to strengthen the health workforce—commitments risked by eliminating federal funding for medical education.

New milestones in kidney innovation

On March 27th, the Advanced Research Projects Agency for Health (ARPA-H)—a newly established agency to invest in breakthrough health care technology—announced a program to develop artificial kidneys and other organs using biotechnology and regenerative medicine (4). Building off the success of KidneyX (Kidney Innovation Accelerator) in de-risking the development of an artificial kidney, this announcement marks the first time ARPA-H has invested in kidney innovation.

The announcement follows a March 20th House Ways and Means Committee hearing in which Representative Suzan DelBene (D-WA), cochair of the Congressional Kidney Caucus, pressed HHS Secretary Xavier Becerra on several ASN priorities, including the importance of funding the US transplant system, supporting living donors, and ensuring that people with kidney failure have access to innovation. During the exchange, DelBene secured Becerra's commitment to continued support for cutting-edge innovation in kidney health, including through ARPA-H (5).

Continued provision of oral-only medications by pharmacies

On March 20th, the full House Energy and Commerce Committee reported out—on a 36-to-10 bipartisan vote—an amended Kidney PATIENT Act (6). As passed by the committee, this legislation would extend current policy to keep oral-only medications in Medicare Part D (and distributed by pharmacies) for 2 more years and require HHS to report on outstanding questions surrounding the implementation of this policy. Initially proposed as a 10-year exclusion that faced opposition, the 2-year compromise solution was brokered by DelBene after speaking with members of the kidney community and was passed out of the House Ways and Means Committee earlier in March. The legislation now awaits action on the House floor and in the Senate before becoming law.

Ensuring success of voluntary kidney payment models

On March 29th, ASN and the Renal Physicians Association (RPA) sent joint organization letters to leaders in Congress and HHS requesting a commitment to addressing increased financial risk facing participants in the Comprehensive Kidney Care Contracting (CKCC) model that is jeopardizing their continued participation. Due to a decision by CMS to apply a retrospective trend adjustment to participation years 2022 and 2023, nephrologists and nephrology practices are facing an unexpected increase in financial risk for prior years and may decide to drop out entirely by the April 30th deadline.

Previously, ASN called for risk corridors within the voluntary models to be capped, one of several solutions offered in the joint ASN and RPA letters to stabilize risk and avoid a drop in participation. The CKCC model incentivizes care coordination, delayed progression of kidney diseases, and increased rates of transplantation—goals shared by ASN to improve the health of people with kidney diseases. ASN will continue to promote improvements to the model to ensure continued participation by nephrologists.

Developing international goals for kidney health

On April 3rd, Nature Reviews Nephrology published a landmark international consensus statement by ASN, the European Renal Association (ERA), and the International Society of Nephrology (ISN) titled, “Chronic Kidney Disease and the Global Public Health Agenda: An International Consensus” (7). The three societies emphasized that, despite the growing global problem of kidney diseases—including their disproportionate impact on populations with limited resources, vulnerabilities, and marginalization and being a major contributor to premature death and disability—they are not explicitly included in the major noncommunicable diseases identified by the World Health Organization (WHO). ASN, ERA, and ISN noted that kidney diseases, the third fastest-growing cause of death, have not received adequate attention beyond WHO from governments, multilateral organizations, the media, or health systems.

The consensus statement explains that the increasing rise of kidney diseases is the result of a confluence of factors including but not limited to environmental, social, and medical drivers of the disease. The growth in prevalence around the world can be explained in part by the impact of population growth, aging, diabetes, heart disease, hypertension, and environmental factors such as climate change, toxins, and air pollution, all coupled with a general lack of early detection and awareness among those living with kidney diseases.

The statement featured the following key recommendations:

  1. Improved access to care: Enhancing the availability of affordable and accessible health care services is paramount to addressing the diagnostic, treatment, and preventive needs of individuals with chronic kidney disease (CKD) and acute kidney injury, especially in resource-constrained settings.

  2. Better prevention strategies: Effective strategies for preventing CKD and acute kidney injury must be developed through multidisciplinary research and community engagement, with a focus on understanding risk factors and tailoring interventions to local contexts.

  3. Development and scaling of care models: Implementing balanced, scalable, and sustainable models of care requires collaborative efforts with stakeholder communities and innovative approaches such as task-sharing, digital technologies, and online platforms for training and supervision.

  4. Greater awareness and education: Awareness campaigns are essential to educate both individuals and primary care practitioners about the importance of early diagnosis and management of CKD, thereby reducing its progression and associated complications.

  5. Addressing social determinants of kidney health: Recognizing and addressing social determinants of health, such as poverty and lack of access to basic amenities, are crucial steps in mitigating the burden of kidney diseases, particularly among communities that are marginalized.

  6. Increased funding for research and development: Adequate funding is needed to support research initiatives aimed at developing new treatments, improving understanding of kidney diseases, and addressing global disparities in health care access and outcomes.

  7. International cooperation and coordination: Collaborative efforts at the international level are vital for promoting effective policies, programs, and knowledge-sharing to prevent, detect, and manage kidney diseases worldwide.

  8. Greater engagement with patient communities: Meaningful involvement of patient communities is essential for designing patient-centric policies, programs, and services that address the diverse needs and priorities of individuals living with kidney diseases.

The kidney community must continue to advocate that WHO prioritizes global kidney health by listing kidney diseases on its list of major noncommunicable diseases.

In the meantime, ASN will continue to call for improved access to and the novel models of care, better prevention and increased awareness strategies, more funding for research, and greater engagement with patient communities to effectively combat the burden of kidney diseases. A forthcoming article in JASN will review ongoing initiatives that ASN has already undertaken to address the causes of kidney diseases in an effort to reduce disease burden and ultimately save lives.