Policy Update: President's Budget: Status Quo for Kidney Health

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In April 2022, the Office of Management and Budget released the annual President's Budget for fiscal year (FY) 2023. The President's Budget is a non-binding request to Congress that describes the priorities of the current administration. In the words of President Biden, “Don't tell me what you value. Show me your budget, and I will tell you what you value.”

The priorities of the current administration are clear. For the Department of Health and Human Services, the budget prioritizes “tackling the COVID-19 pandemic, expanding access to care, addressing health disparities, strengthening behavioral health, and promoting the well-being of children, families, and seniors.” The focus on these priorities can be seen throughout the budget, at times even at the expense of existing programs. Below are several line items and issues that affect kidney health professionals.

COVID-19

The FY 2023 budget includes an effort totaling $81.7 billion in mandatory funding to fight COVID-19 and to respond to future pandemics. Available over 5 years, this funding is budgeted across the Office of the Assistant Secretary for Preparedness and Response, Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Food and Drug Administration. This funding is in addition to a now-stalled $10 billion in COVID-19 funding currently under consideration by Congress that would be used to purchase and develop COVID-19 tests, vaccines, and therapeutics.

Kidney Innovation Accelerator (KidneyX)

KidneyX is slated to receive $5 million in FY 2023, the same total that it received in FY 2022 congressional appropriations. ASN and congressional allies are calling on the Biden administration to support a full $25 million for KidneyX. This funding is essential to continue accelerating innovation in kidney health by supporting additional innovators through the Artificial Kidney Prize, which seeks to promote the integration and advancement of prototype artificial kidneys, and provide prizes in other essential areas, such as the diagnosis and prevention of kidney diseases. Recent advancements in regenerative medicine and xenotransplantation demonstrate the promise and importance of fostering responsible innovation in kidney health.

NIH

The FY 2023 budget includes $63 billion for the NIH, a $16 billion (34%) increase in new and mandatory funding over FY 2022 funding levels. This budget includes more than $12 billion of new COVID-19 funding (referenced above) that would support NIH research and development of vaccines, diagnostics, and therapeutics against high-priority viral families; support biosafety and biosecurity; and expand laboratory capacity and clinical trial infrastructure.

The budget also calls for the proposed Advanced Research Projects Agency for Health (ARPA-H). Modeled after the groundbreaking Defense Advanced Research Projects Agency, which supported the development of products ranging from the internet to mRNA vaccines, ARPA-H holds promise to revolutionize health care research and development and may serve as a viable new vehicle to advance the state of kidney care.

The FY 2023 budget calls for ARPA-H to be housed within the NIH to promote medical and scientific innovation. Many policymakers and stakeholders in the scientific community have raised concerns of housing ARPA-H within the NIH, claiming that its location will limit the new program's independence and ability to take calculated risks that push the envelope and help fund generational advances versus the incremental, basic science approach that has been perfected by the NIH.

In addition, the $5 billion in funding proposed for ARPA-H would—combined with the new COVID-19 funding—total $2 billion more than the total increase proposed for the NIH, meaning funding for the project would need to come out of the budgets of the 17 investigative centers at the NIH. This proposal has deeply worried advocates for medical research, and ASN has joined the call for ARPA-H to be supported by funding in addition to the regular increases for the NIH.

This ARPA-H budget adjustment will be felt by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). NIDDK is budgeted to receive a total of only $2.34 billion, a $2 million or .09% increase over FY 2022 funding levels. ASN and the entire kidney community remain united in advocating that the final appropriations for NIDDK are higher than what the FY 2023 budget presents. During Kidney Health Advocacy Day, ASN members advocated for a $632 million increase for NIDDK to keep pace with medical inflation and provide dedicated COVID-19 funding. To date, NIDDK has not received any dedicated funding to study COVID-19; thus, this research may come at the expense of other critical kidney health research projects.

Finally, the FY 2023 budget also provides an increase of $350 million to enhance health disparities and inequities research, including a $210 million increase for the National Institute on Minority Health and Health Disparities.

Agency for Healthcare Research and Quality (AHRQ)

The FY 2023 budget outlines $376 million for the AHRQ, with $34 million specifically for research on health costs, quality, and outcomes. This is a $38 million increase over FY 2022 funding levels.

AHRQ provides scientific and administrative support for the U.S. Preventive Services Task Force (USPSTF), which is budgeted for $12 million in FY 2023. This is the same total that USPSTF received in FY 2022 congressional appropriations, and the budget commits that the funding will be used to conduct evidence reviews and develop approximately 8−12 screening recommendations in FY 2023. At the urging of ASN and other organizations within the kidney community, USPSTF has added Screening for Chronic Kidney Disease to the list of preventive services topics under active consideration for one of the 8−12 recommendations made in 2023.

Centers for Medicare & Medicaid Services (CMS)

The FY 2023 budget estimates $1.4 trillion in mandatory and discretionary spending for the CMS. This is a $53 billion increase over FY 2022 funding levels. Specifically, the FY 2023 budget invests $35 million in a new initiative to systematically identify and resolve barriers to equity in each CMS program through research, data collection and analysis, stakeholder engagement, building upon rural health-equity efforts, and technical assistance.

The FY 2023 budget also outlines several legislative proposals for consideration by Congress, including:

  • beginning Physician Fee Schedule Conversion Factor updates in calendar year 2025 instead of 2026 as planned,

  • providing Medicare coverage and reimbursement to community health workers acting under Medicare's Physician Fee Schedule for select care management services, effective in calendar year 2024, and

  • allowing CMS to certify new entities as Organ Procurement Organizations (OPOs) while weakening oversight of OPOs by allowing CMS to recertify certain OPOs that do not meet the criteria—recently put in place at the urging of ASN and other stakeholders—for recertification based on outcome measure performance.

Congress has been increasing oversight of OPOs, including establishing objective and verifiable methods to measure their performance. Concerns still remain about how OPOs serve their communities, especially Americans of Black race, and it is essential that Congress and the administration have the tools to continue to ensure accountability in this important part of the transplant system and not weaken oversight by allowing failing OPOs to be recertified.

The FY 2023 budget reiterates the administration's support for the End-Stage Renal Disease Treatment Choices (ETC) model, which runs from January 2021 to June 2027. The budget highlights the October 2021 changes to the ETC model that aim to encourage dialysis facilities and health care providers to decrease disparities in the rates of home dialysis and kidney transplantation among patients with lower socioeconomic status. Fittingly, the budget notes that the ETC model was the first payment model to address health equity.

CDC

The CDC's Chronic Disease Prevention and Health Promotion program is budgeted for $1.6 billion in FY 2023. This is a $274 million increase over FY 2022-enacted levels. This program helps people and communities prevent chronic diseases, including kidney diseases, and promotes health and wellness for all. ASN will continue to advocate with kidney stakeholder organizations that no less than $15 million of this line item is used to promote kidney disease awareness, surveillance, and disease prevention.

Health Resources and Services Administration (HRSA)

The HRSA includes several programs that support kidney health, including programs to support the health workforce, telehealth, and transplantation. Funding for these programs is mixed in the FY 2023 budget. All HRSA workforce programs are slated to receive $2.1 billion, an increase of $324 million, and the budget provides $133 million, an increase of $15 million, to expand the diversity of the health professions workforce, although the specific allocation that may be used to support kidney health professionals is unstated. In addition, the budget includes $44 million for a new Office for the Advancement of Telehealth, an essential program, as Congress determines which expanded telehealth flexibilities, as part of the COVID-19 Public Health Emergency, to retain.

However, the budget also proposes decreasing the funding for organ transplantation efforts, proposing a $1 million decrease for a total of $29 million. Facing a nearly 100,000-person waitlist for a transplant, people with kidney failure must have increased access to transplantation. Unified federal oversight of the transplant system, as proposed by many stakeholders in the kidney health community, would help ensure this important therapy is prioritized across the federal government, including in future budgets.

Although the Biden administration's attention to health equity and COVID-19 throughout the FY 2023 budget is commendable, the budget maintains the status quo of kidney health programs and does not substantially propose increasing investment on behalf of this critical population. Ultimately, Congress, with input from advocacy organizations such as ASN, will decide how closely to follow this budget. ASN will continue to fight for increased investment in the health of the 37 million Americans living with kidney diseases and to create a world without kidney diseases.

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