Home / The Issues / A SID&T Update: If the Final Rule Stands, Can For-Profit Donation and Transplantation Be Averted?

A SID&T Update: If the Final Rule Stands, Can For-Profit Donation and Transplantation Be Averted?

Profit Motive Special Interests Co-Opt CMS Organ Procurement

For years, warnings that for-profit interests were lurking around the U.S. organ donation system, looking for opportunities to gain control, were dismissed as paranoid.

We were all told that the Centers for Medicare and Medicaid Services (CMS)’s Final Rule was designed only to force underperforming Organ Procurement Organizations (OPOs) to recover more organs through “competition.” CMS, which oversees the donation and transplantation system, approved a metric, originally conceived by profit driven special interests to rank OPO performance, eliminating some non-profit OPOs while requiring others to compete to keep their donation service areas.

Under the flawed Final Rule tier system as currently written, as many as 42 of the nation's 55 OPOs could face decertification and competition beginning in 2027. To promote its metric, the team of advocates led by Organize and funded by Arnold Ventures LLC showed their for profit colors while spending lavishly on a misinformation campaign.

But according to 22 independent, peer-reviewed scientific studies of the Final Rule, the metric itself is faulty. It eliminates CMS' long-standing reliance on demographic and community risk adjustments and improperly imputes transplant-center decisions to OPO performance.

In short, neither those awaiting transplants, nor selfless donors and donor families, or even CMS itself has an accurate evaluation of the system.

The Final Rule effectively targets the largest OPOs—those serving the greatest numbers of donors, transplant centers and patients needing transplants—for elimination. Worse, CMS left unanswered the question of how dozens of decertified OPOs would be replaced.

The resulting disruption could destabilize organ recovery and transplantation at a scale never experienced in the United States. Whether intentional or not, such instability would make unacceptable policies appear increasingly acceptable as policymakers scramble to prevent a system-wide breakdown.

The Cure For A Manufactured Crisis: Profits?

The taboo to be broken is profiting from organ donation, an option that would have dismayed the founders of organ transplantation in America who won passage of the National Organ Transplant Act (NOTA) in 1984. NOTA and its bipartisan supporters in the scientific, medical and health policy communities agreed that live-saving organs must be treated as gifts, not commodities.

As leading medical professionals stress, virtually no moment in their experience can match the intimacy involved in the sensitive interaction of specially trained non-profit representatives speaking with grieving donor families to confirm the donor’s gift of life to an awaiting patient. All involved have a profound right to know there are altruistic motives underpinning that conversation.

What will happen after widespread OPO decertification in 2026 produces the chaos critics anticipate? Just as we’ve seen happen in other parts of the US healthcare system, a market-based restructuring of the nation's organ procurement system is likely to be presented not as a radical departure, but as an all-American solution to the crisis.

An indication that the prohibition against for-profit participation in organ procurement may be eroding came earlier this year when TransMedics, a publicly traded medical technology company, formally urged CMS to expand the Final Rule by allowing for-profit entities to compete for organ procurement contracts. This latest is a continuation of their monetization efforts. Previously, TransMedics drafted privatization legislation for then Congressman Ed Markey.

Calling For Profits: The Transmedics Letter And Dr. Lynch’s Testimony

In a March 31, 2026, letter to CMS Administrator Dr. Mehmet Oz, TransMedics President and CEO Waleed Hassanein urged the agency to remove the requirement that OPOs be nonprofits. Arguing that nonprofits are "simply a tax status," Hassanein wrote that any organization with the necessary capabilities should be permitted to win contracts. Existing law already allows CMS to certify for-profit entities, he claimed, arguing that the nonprofit requirement created a "closed market" that suppresses competition and innovation.

For supporters of the nonprofit model and altruistic principles established under the National Organ Transplant Act in 1984, TransMedics’ letter represented an explicit challenge to the organizing ethos of American transplantation law: that organs donated by the public should be recovered and managed by nonprofit institutions rather than market competitors. Today, TransMedics operates inside the nonprofit system as a contractor providing organ recovery, preservation, and transportation services. Its proposal would allow companies occupying that role to compete directly for the authority currently reserved for nonprofit OPOs.

In his letter, Hassanein asserted "CMS has recognized" his concerns about nonprofit OPOs. Although he did not identify CMS officials who were aligned with his views, public statements by senior federal transplantation leaders indicate privatization has supporters inside the federal bureaucracy.

In 2023 testimony before a Senate Finance Committee health subcommittee, Dr. Raymond Lynch, Chief of the Organ Transplant Branch at HRSA pushed back against legislators’ concerns about for-profit participation in organ donation.

"For-profit is a part of American healthcare," Dr. Lynch said. "And I can tell you that our not-for-profit entity doesn't work. And there are for-profit hospitals and for-profit transplant centers that do work. So, patients don't need to be afraid of that. They do need to be afraid of the status quo." Before being appointed to his HRSA position, Dr. Lynch was a participant in the Arnold Ventures coalition, along with ORGANIZE, The Bridgespan Group, and the Federation of American Scientists (FAS), that had pressured CMS to decertify OPOs using the Final Rule’s metric.

Altruism Should Prevail Not Profiteers

The recommendation by TransMedics – one of the most influential private companies operating in the organ transplantation sector – marks a turning point: From the mission-driven, altruistic vision behind NOTA to a market-driven focus. TransMedics’ plan would treat OPOs as businesses that like any other for profit concern are responsible for generating a return on owners’ investments. A for-profit OPO would face pressures unfamiliar to nonprofit organizations: generating returns for investors, growing market share, and maximizing revenue from procurement-related services.

Iran is currently the only country that permits compensation for kidney donors, and critics argue it has created a market in which financially desperate people disproportionately bear the risks of donation while wealthier recipients benefit from increased access to transplants. Is that what organ donors and organ transplant patients want for America?

Organ Donation Based On Altruism Is Worth Keeping: Pause The Rule

The U.S. transplant system remains a global leader in total transplants, a leader in per-capita performance and one of the fastest-growing systems in the world. Its success depends on public trust—the belief that donation is altruistic, not transactional. Injecting a profit motive into the donation system would change incentives, behavior and public perception. Once commercial incentives begin shaping the donation system, restoring the public's original understanding of organ donations as a gift – not a commercial enterprise – may prove extraordinarily difficult.

Enough damage has already been done to the system by the calculated misinformation campaign by Organize, Arnold Ventures, and Dr. Ray Lynch that has resulted in a decline in donor registries.

The nation's supply of transplantable organs does not begin in a boardroom or an operating room. It begins with a family's willingness to transform private loss into a public gift. Any reform that weakens that understanding risks weakening the very foundation on which the entire transplant system depends.