Analysis | U.S. to tighten organ donation rules

U.S. to tighten rules on donated transplant organs

The U.S. government is moving to tighten a regulation for the collection of human pancreases for research after a Senate committee and others complained the rule was being exploited by groups that also procure kidneys, hearts, livers and other organs for transplant. 

A rule issued in 2020 requires the nation’s 56 nonprofit organ procurement organizations (OPOs) to meet certain collection benchmarks to retain government certification to operate. Pancreases, which contain “islet cells” that produce insulin and are most often valuable for diabetes research, count toward the total needed to reach those thresholds.

Some of the groups began collecting large numbers of pancreases after the regulation was issued, eliciting “concern” from the Centers for Medicare and Medicare Services in a Jan. 18 memo that the spike in procurements may not reflect “a meaningful increase in pancreata being actually used for islet cell research.”

Officials with several OPOs have said the increased collection of pancreases reflects a rising demand for them by researchers. One noted that pancreases are not collected from every deceased donor, which the official maintains would be a clear indication of an attempt to inflate total organ procurement statistics.

But in March 2023, the Senate Finance Committee, which has been investigating the troubled U.S. transplant system for years, issued a blunt warning to some of the 56 organizations. In a letter to 10 groups that reported sharp increases in pancreas collection, it questioned whether they were “flagrantly gaming” the system to “falsely inflate their performance.”

• The committee’s letter also cited an email it said was sent by one organ procurement employee to another. “Savvy (or cynical?) OPOs ought to start a pancreas for research program immediately,” the message said.

In its memo, CMS warned the procurement organizations that the organs can be counted only if they are used for legitimate purposes. The agency said it would update regulations regarding islet cell research and planned to develop approaches to “validate” organ procurement organization reports of how pancreases were used. 

Each organ procurement organization holds a government-guaranteed monopoly over a swath of territory where it collects organs, mainly kidneys, from deceased donors. The groups arrange the transfer of organs to hospitals for implantation into patients and to centers that conduct research on organs unsuitable for therapeutic use.

Some have long done a poor job of collecting enough organs, according to academic research, a House subcommittee and other outside reviews of the U.S. transplant system. Though the number of transplants is rising, more than 100,000 people remain on the national waiting list for organs — most seeking kidneys — and some die every day.

But CMS has never revoked any organ procurement group’s right to operate.

Under rules that took effect in 2021 to weed out poor performers, the procurement groups must meet certain benchmarks for organ collection or risk losing their contracts. Pancreases for research count toward the total.

In September, researchers who have been critical of the groups’ performance published peer-reviewed data in JAMA Network Open showing that the number of pancreases collected for research rose from 1,258 in 2018 to 4,563 in 2022. They said it is impossible to determine where the organs went or how they were used.

• The article also showed that six of the procurement organizations were among a group most likely to lose their government contracts in 2026, when CMS conducts its first review of their performance under the new rule. Seven more were vulnerable to loss of their contracts.

Micah Davis, chief operations officer of Lifebanc, which collects organs in northeast Ohio, said in an interview that well over 90 percent of the pancreases his organization collected in 2023 were used in research, while a few were used in training. The organization retrieved 169 pancreases in 2023, according to Davis, up from just two in 2021.

• Davis said there was no shortage of legitimate medical researchers who have accepted the organs. “It was easy to find them,” he said. “They were enthusiastic to participate.”

But Sen. Ron Wyden (D-Ore.), chairman of the Senate Finance Committee, said in a statement in January that “I’ve been investigating this issue with my colleagues and have seen the evidence of inflated metrics firsthand.”

You can read Lenny’s full report here. 

Georgia sues to extend timeline for narrow Medicaid expansion

Georgia is suing CMS in a bid to recover “stolen implementation time” from its new health program for low-income adults, which is set to expire next year under the current agreement, Jill Nolin reports for the Georgia Recorder. 

The state filed a federal complaint on Friday asking the court to move the end date for Georgia Pathways to Sept. 30, 2028, citing the Biden administration’s unsuccessful attempt to challenge the program’s work requirement. 

A closer look: Republican Gov. Brian Kemp’s plan to partially extend Medicaid first received sign-off from the Trump administration three weeks before the 2020 election. But Democrats have fiercely opposed work rules, and the Biden administration revoked Georgia’s approval for such a mandate in 2021. 

The move led to a legal showdown, where a district judge ultimately sided with the state. The program officially launched in July, two years after its original start date. As of mid-December, about 2,300 people had enrolled. About 345,000 are thought to be eligible for the Medicaid program, according to the state’s estimate. 

Senators take aim at 340B reform

A bipartisan group of senators has drafted proposals aimed at resolving controversial disputes in the federal government’s drug discount program, according to documents obtained by Stat’s Rachel Cohrs. 

Among other 340B targets, the new framework would: 

• Allow providers, including community health centers and hospitals, to contract with external pharmacies to deliver discounted medications to patients. 
• Establish clear criteria for which subsidiaries can qualify for discounts through the program. 
• Require providers to report more information about how they use their savings and how many patients received discounted drugs. 

The draft legislation comes from Senate Minority Whip John Thune (S.D.) and fellow Republican Sens. Jerry Moran (Kan.) and Shelley Moore Capito (W.Va.). Across the aisle, they are joined by Democratic Sens. Debbie Stabenow (Mich.), Tammy Baldwin (Wis.) and Ben Cardin (Md.).  

• A federal judge approved McKinsey & Co.’s proposal to pay $230 million to settle claims that the company’s consulting work fueled an opioid crisis that led municipal governments to divert public resources toward emergency responses, Joyce E. Cutler reports for Bloomberg Law. 
• Juul launched an aggressive campaign in 2018 aimed at securing the public support of civil rights organizations and Black leaders for its e-cigarettes, as the company sought to bolster its beleaguered public image, Stat’s Nicholas Florko reports, citing documents made public last week. 
• Independent advisers to the Food and Drug Administration called for greater diversity in pulse oximeter clinical trials on Friday, saying the agency’s proposal to increase the minimum number of participants probably wouldn’t be enough to ensure the devices produce accurate results for all skin tones, CNN’s Jacqueline Howard reports. 
• Congress may make insulin pumps and other medical devices more accessible to the blind, Stat’s Lizzy Lawrence reports. 

📅 Welcome back! The House and Senate are both in session this week. Here’s what we’re watching:

On tap today: The House Rules Committee will meet to consider legislation that would ban the use of quality-adjusted life years in all federal health insurance programs. 

On Tuesday: The House Budget Committee will mark up a bill that would change how the Congressional Budget Office evaluates the costs and savings of preventive health-care policies. The House Ways and Means Committee will examine chronic drug shortages in the United States. A House Energy and Commerce subcommittee will scrutinize the FDA’s foreign drug inspection program. 

Meanwhile, at the agencies, independent advisers to the FDA will discuss and make recommendations on medical device supply chain resiliency and shortage issues. 

On Thursday: The CEOs of Merck, Johnson & Johnson and Bristol Myers Squibb will testify before the Senate Health, Education, Labor and Pensions Committee on prescription drug prices. The Senate Finance Committee will examine artificial intelligence in health care. 

And at The Post, Dan Diamond will speak with New York City Health Commissioner Ashwin Vasan about winter respiratory viruses, lessons from the pandemic and youth mental health. 

Texas Medical Board under pressure to define emergency exception to abortion ban (By Olivia Goldhill | Stat)

Providence officials approve overdose prevention center (By Anna Betts | The New York Times)

Ozempic, Wegovy strain state budgets in battle against obesity (By Celine Castronuovo | Bloomberg Law)

Thanks for reading! See you tomorrow.