HHS acknowledges that regulatory overreach has throttled competition, and the plan it proposes does not significantly reduce the government’s dominant control over the market.
The kidney-care sector in the United States has long been mired in bureaucracy, miring a large portion of American healthcare in red tape. The Trump administration asserts it intends to alter that landscape. On Tuesday, Health and Human Services Secretary Robert F. Kennedy Jr. unveiled the department’s Kidney Care National Plan, a framework that pledges to foster greater competition, cut regulatory obstacles, broaden patient options, and overhaul the country’s kidney-transplant system.
The core of the plan centers on barriers to entry within dialysis services, which currently serve roughly 558,000 Americans. While home-based dialysis is possible, the majority of patients undergo treatment at specialized clinics that must meet federal certification standards governing equipment, staffing, water quality, and patient safety to participate in Medicare.
Kennedy contends that regulatory hurdles have dampened competition and stifled innovation, leaving patients with limited dialysis choices. “Dialysis technology is an extraordinary achievement,” Kennedy stated during the press conference, but “because of monopolies in the system and the barriers to new entrants, we have not seen any real improvements in that technology.”
Of course, the existence of large or even monopolistic firms in a market does not automatically prove a problem; however, government regulation can often entrench those players’ positions. “I appreciate that they’re recognizing that many regulatory barriers contribute to the problem, and that’s a refreshing acknowledgment,” said Jeffrey Singer, a practicing general surgeon and senior fellow at the Reason Foundation, a nonprofit that publishes Reason. Singer argues that removing impediments to entry would not only expand patient choice but could also drive prices down.
HHS notes that two companies, DaVita and Fresenius Medical Care, together control about 74 percent of the U.S. dialysis market. As of 2019, roughly one in three Americans lived in areas where the only dialysis provider available was one of those two firms, according to the agency. The administration claims that government regulation has helped entrench this dominance by hindering new entrants from entering the market.
To tackle this issue, the Kidney Care National Plan proposes several reforms, including simplifying certification requirements. The plan also contemplates examining whether dominant dialysis providers have leveraged payment arrangements and legal strategies to secure higher reimbursements without delivering improved care.
The 17-page report calls for a review of existing requirements but does not specify which regulations would be repealed, nor does it set a concrete timetable for such changes. It likewise does not advocate a substantial reduction in the government’s role in financing the distorted market. Rather, the plan aims to make existing publicly financed systems, such as Medicare, more competitive and efficient.
Kennedy has rightly identified the need for reform in kidney donation. At any given moment, nearly 90,000 people in the United States are waiting for a kidney transplant, and about 11 individuals die each day while waiting. The transplantation process is currently overseen by Organ Procurement Organizations (OPOs), which are federally certified nonprofit bodies responsible for recovering organs from donors and coordinating their transfer. There are presently 55 federally designated OPOs operating in the United States, and HHS contends that they function as “regional monopolies.” With no new OPOs approved in the past year, the Kidney Care National Plan suggests expediting certification processes.
The plan also seeks to lower the financial barriers to living kidney donation. Following the February enactment of the Honor Our Living Donors Act, HHS revised federal reimbursement rules so that a donor’s eligibility for financial assistance is no longer determined by the transplant recipient’s income. Eligible donors can receive up to $6,000 to cover expenses such as travel, lost wages, and childcare.
However, the reforms stop short of allowing donors to receive direct compensation for the kidneys themselves, which remains prohibited under federal law. “I can sell my blood. Why can’t I sell my kidney?” asks Singer.
Peter Jaworski, director of the Georgetown Blood and Plasma Research Group, shares a similar view, arguing that financial incentives are available to nearly everyone involved in kidney transplantation except the donors themselves. “Under this plan, it’s acceptable to use incentives to encourage them to be more productive, to actually do a better job,” Jaworski told Reason, referring to transplant surgeons, hospitals, and organ procurement organizations. “The only exception, once again, is the donor who is offering a kidney.”
Jaworski points to the End Kidney Deaths Act as a better path forward. The bill, introduced last year by Representative Nicole Malliotakis (R–N.Y.), would grant living kidney donors a $50,000 refundable tax credit, paid over five years. “We have those systems in place to ensure we can treat patients. That’s the purpose of blood donation, that’s the purpose of plasma donation, and that’s the purpose of kidney donation as well.”
The American plasma market offers a clear illustration of how financial incentives can boost donation. Unlike many other countries, the U.S. allows compensation for plasma donors, and despite representing just over 4 percent of the world’s population, it supplies around 68 percent of the plasma collected globally for manufacturing medicines.
“Why do you think America does it? Is it because Americans are more altruistic than those in France or Italy or Belgium? No — it’s because in the United States you can be paid to donate plasma,” Jaworski maintains.
The Trump administration appears to recognize that government overreach has throttled competition and constrained patient choice. It also acknowledges that living adults donating kidneys will be part of the solution to the long, deadly waiting lists. Yet, its plan leaves the government’s outsized role in kidney care mostly unchanged. For patients facing years on dialysis or waiting for a life-saving transplant, simply acknowledging the problem is not sufficient.
