The federal government has finished rewriting the rules for the nonprofits that run the nation’s organ donation system. For a West Ashley nonprofit with 157 staff members, the decision that matters most is still to come.

On Oct. 30, the Centers for Medicare & Medicaid Services issued a final rule revising its conditions for coverage for organ procurement organizations. These nonprofits work with hospitals and grieving families to recover organs from deceased donors and get them to transplant centers. The rule was published in the Federal Register on Nov. 3 and takes effect Jan. 4.

It keeps the three-tier grading system CMS adopted in 2020. An organization whose service areas all fall in the bottom tier will be decertified and cannot compete for other open territories, according to a CMS fact sheet. Organizations in the middle tier can be recertified but must compete to keep their territories. Middle-tier status alone is not grounds for decertification, CMS said.

“CMS remains committed to holding all OPOs accountable for their performance and will be moving to decertify tier 3 OPOs as indicated in the 2020 final rule,” the fact sheet said.

Where Sharing Hope stands

We Are Sharing Hope SC is the federally designated organ procurement organization for every South Carolina county except Aiken and Edgefield, according to its website. It works with more than 80 hospitals from its headquarters on Henry Tecklenburg Drive.

In CMS’s most recent public performance report, released in 2025, Sharing Hope was in the bottom tier for 2023 and for each of the three years before that. It was one of 10 organizations, out of 56 at the time, in the bottom tier for 2023.

CMS grades each organization on two measures. The donation rate counts donors with at least one organ transplanted against the potential donors in its area. In 2023, Sharing Hope’s was about 9.1 donors per 100 potential donors, below the median cutoff of about 12.5. CMS calculated that it would have needed 46 more donors to reach that cutoff.

Its age-adjusted transplant rate was about 25.1 organs per 100 potential donors, against a median cutoff of about 38.6. By CMS’s calculation, it would have needed 255 more transplanted organs.

The grades that decide this cycle come from one more year of data. For the 2026 certification cycle, the final assessment uses 2024 data, according to a CMS user guide. CMS’s public reporting site lists tier results only through the 2025 report.

CMS has not said which organizations’ contracts will be renewed, Stateline reported Oct. 26. The current agreements end Jan. 31, 2027, according to the final rule, and CMS may extend them to finish appeals and competitions for open territories.

A business at stake

Sharing Hope reported $52.3 million in revenue and $49.6 million in expenses for 2025, according to its federal tax filing, as compiled by ProPublica.

Some of that business is already in question. In March, CMS published requests from 12 Prisma Health hospitals in the Upstate, the Midlands and Sumter to leave Sharing Hope for LifeShare Carolinas, based in Charlotte. The comment period closed May 8. CMS said it would notify the hospitals and both organizations of its decisions. None has been announced publicly.

“Ultimately, it’s a business decision,” Tim Brookshire, CEO of Prisma’s Greenville Memorial Hospital, told the SC Daily Gazette in March. He said Prisma had no specific problems with Sharing Hope but that LifeShare received more donations, transplanted more organs and charged less.

Sharing Hope charges an average of $62,500 for each kidney and liver, compared with about $57,000 at LifeShare, according to data in the waiver request, the Gazette reported. Sharing Hope President David DeStefano told the Gazette that losing the Prisma hospitals would cost the nonprofit nearly a third of its business, and he argued that Sharing Hope remained the best choice for the state. “I think we’re a clear choice to continue that work,” he said.

Sharing Hope’s case

DeStefano argues the measures penalize a state with poor health and limited access to care. In a June 29 commentary in the Gazette, he wrote that the metrics do not adequately account for factors outside an organization’s control.

“For states like South Carolina, which faces significant challenges in population health and access to care, these omissions can produce misleading comparisons and distort actual performance,” DeStefano wrote.

In the same commentary, he wrote that Sharing Hope had reported a 44% increase in organ donors in South Carolina since 2022. Sharing Hope’s website lists 332 organ donors and 772 organs transplanted in 2025.

He also wrote that, by Prisma’s own account, its decision to seek the switch “was not prompted by dissatisfaction with Sharing Hope or the care and service we provide,” but was a response to federal metrics still under legal and regulatory review.

Challenges to the rule

Sharing Hope and other organ procurement organizations sued in federal court in Washington to overturn the 2020 rule. On Oct. 29, U.S. District Judge Sparkle L. Sooknanan ruled for the government, finding that the rule is lawful. “The agency acted well within its statutory authority in promulgating the rule by exercising discretion conferred by Congress,” she wrote, according to court records.

In another case, brought by organizations serving California, Florida and five other states and territories, a federal court in Florida upheld the rule, and the organizations appealed, Stateline reported.

CMS received 129 timely pieces of correspondence on the proposed version of the rule, which it released in January. Several commenters warned that CMS would decertify an unreasonable number of organizations and disrupt the transplant system, according to the final rule. The Association of Organ Procurement Organizations has said nearly 42% of the nation’s 55 organizations could land in the bottom tier, Stateline reported.

The federal government has shut down at least two organizations in the past two years, citing questionable practices, Stateline reported.