News : Organ transplant reform draws Hill scrutiny

Friday, May 24, 2024

Organ transplant reform draws Hill scrutiny

May 24, 2024

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Programming note: We’ll be off this Monday for Memorial Day. We’ll be back in your inboxes on Tuesday.

Sen. Chuck Grassley speaks with reporters as he heads to a vote on Capitol Hill on Sept. 6, 2023.

Sen. Chuck Grassley and others on the Hill are keeping a close eye on the overhaul of the U.S. organ-transplantation system. | Alex Brandon/AP

CONGRESS SIDE-EYES ORGAN OVERHAUL — The federal push to solicit contracts as part of an effort to overhaul the U.S. organ-transplantation system is drawing the skeptical eyes of some in Congress.

The Health Resources and Services Administration seeks to secure the contracts to help staff a new board of directors and help transform a system created 40 years ago. But Sens. Chuck Grassley (R-Iowa) and Jerry Moran (R-Kan.) told Pulse that HRSA, which has received millions from Congress for the modernization effort, must do more to ensure the program is free of influence from the group tasked with running it for the last four decades.

“There’s strong bipartisan resolve to prevent HRSA from backsliding into the failed 40-year norm Congress fought to knock down. I intend to keep holding HRSA’s feet to the fire throughout the implementation process,” Grassley told Pulse. Moran’s office said “improvements have been made” by HRSA, but he expects the agency to “be transparent regarding funding utilization.”

How we got here: Last September, Congress ordered the administration to revamp the system, which has been run by the United Network for Organ Sharing since it was created. In that time, the transplant waiting list has ballooned to more than 100,000 people, and congressional inquiries, including by the Senate Finance Committee on which Grassley sits, uncovered mismanagement and failures by UNOS.

The scrutiny coincides with an oversight investigation by bipartisan members of the House Energy and Commerce Committee, who warned in March that “errors and inefficiencies in [the Organ Procurement and Transplantation Network] management can have deadly consequences” and discouraged HRSA from putting potential contractors other than UNOS “at a disadvantage.”

UNOS, in response to congressional scrutiny, has said there’s room for improvement, including working to increase organ acceptance rates and having a more transparent waiting list.

Grassley’s office said he remains concerned HRSA could still award UNOS, whose contract with HRSA is set to end in December with the option to be extended, one of the contracts to assist with the transition. Grassley and Moran also joined Sens. Ron Wyden (D-Ore.), Elizabeth Warren (D-Mass.) and Todd Young (R-Ind.) earlier this month to urge HRSA to ensure the board of directors remains independent from HHS or UNOS.

A UNOS spokesperson said it would not bid for the board of directors support contract, but CEO Maureen McBride said the group feels it “has the experience and expertise to remain an integral part of the U.S. organ donation and transplant system.”

HRSA responds: A HRSA spokesperson said contract solicitations are open to all — public and private companies — and that it has been “exceptionally transparent about our modernization efforts.”

“We received a great deal of feedback during the draft solicitation comment period and expect robust competition for these contracts,” the spokesperson said.

According to HRSA, 6,000 patients awaiting transplants die each year, a figure policymakers have said highlights the urgency for reform.

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The size of the 340B drug pricing program has ballooned in recent years, but patients aren’t seeing the benefit. Instead, hospital systems, chain pharmacies and PBMs are exploiting the program to generate massive profits. Let’s fix 340B so it better helps patients.

Mental Health

Nora Volkow testifies during a hearing.

Nora Volkow, director of the National Institute on Drug Abuse, warned against putting too much stock in psychedelic medicine as a mental health treatment. | Jacquelyn Martin/AP

DON’T BELIEVE THE HYPE — A top NIH official warned against putting too much stock in psychedelic medicine as a mental health treatment on Thursday, POLITICO’s Erin Schumaker reports.

"Because the data is starting to translate into evidence that it could be beneficial, what has happened is that clinicians are ahead of actually where the data is," Nora Volkow, director of the National Institute on Drug Abuse, told a Senate Appropriations subcommittee considering fiscal 2025 funding for the National Institutes of Health, the NIDA’s parent agency.

"It's being offered to a wide variety of patients without sufficient evidence,” she said.

At the same time, Volkow offered psychedelics researchers some support. She said their work was “very promising, but we need to do much more research."

Why it matters: The Food and Drug Administration is considering a drug application from Lykos Therapeutics for MDMA, also known as ecstasy, combined with talk therapy as a post-traumatic stress disorder treatment.

What's next: A different expert advisory panel assisting the FDA will review the Lykos application on June 4. The FDA will then review the findings before deciding whether to approve Lykos’ application.

DISPARITIES IN MENTAL HEALTH CARE — White adults who say they have poor or fair mental health are more likely to say they’ve received mental health services in the past three years, compared with Black and Hispanic adults, according to a KFF analysis.

The analysis — which uses 2023 nationally representative survey results from over 6,000 adults — found 39 percent of Black adults and 36 percent of Hispanic adults who reported fair or poor mental health were able to access services in the past three years, compared with 50 percent of white adults.

Why it matters: 90 percent of Americans say there’s a mental health crisis in the U.S. following the pandemic, according to KFF — including among youth.

Among adults who received care: 55 percent of Asian adults and 46 percent of Black adults say they had difficulty finding a provider who could understand their background compared with 38 percent of white adults.

Additionally, awareness of the 988 mental health hotline remains low. As of summer 2023, 1 in 5 adults say they’ve heard some or a lot about the hotline. Black, Hispanic and Asian adults were less likely than white adults to say they’ve heard it — even though 1 in 5 adults overall say they or a family member has had a serious mental health crisis resulting in homelessness, hospitalization, self-harm or suicide.

A message from PhRMA:

Congress

INCREASING DOC SLOTS — Bipartisan legislation to increase the number of government-funded physician residency slots could be coming soon, according to three people familiar with the plan, POLITICO’s Daniel Payne reports.

The bill is being worked out by senators who want to increase the number of doctors entering a health system plagued by workforce shortages. The plan is to boost the number of physicians training in rural areas, serving minority communities and specializing in primary care and psychiatry.

Under the proposal, 25 percent of the new slots would go to doctors specializing in primary care and 15 percent would go to psychiatrists in training. Hospitals would be required to maintain those slots for a decade.

The senators want to prioritize hospitals that serve rural or minority populations. They would task HHS with creating a database to track where government-funded residents train and where they end up practicing.

Why it matters: Lawmakers and administration officials agree that a physician shortage is making it difficult for patients to get timely appointments.

What’s next: The senators haven’t decided how many Medicare Graduate Medical Education slots to add and are considering budget offsets.

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Public Health

NURSES ON BOARD — Members of a provider union group that has opposed new infection control guidance proposed by CDC advisers are joining the committee writing the guidance.

National Nurses United, a union of registered nurses, said this week that Jane Thomason, its lead industrial hygienist, and Lisa Baum, lead occupational safety and health representative of the union’s New York affiliate, were invited to join the Healthcare Infection Control Practices Advisory Committee.

“This is a major win for nurses and other health care workers,” NNU President Nancy Hagans said in a statement.

Why it matters: The committee advises the CDC on steps providers in health care facilities should take to prevent the spread of infectious disease. Last year, the committee proposed updates to 16-year-old infection control guidance, recommending a tiered system to some infection control approaches, like wearing a face mask.

The guidance drew outcry from some providers — and most prominently NNU — who say masks should be worn as a minimum level of protection against respiratory infections. The CDC sent the guidance back to its advisers in January, asking them to reconsider some of the proposals.

What’s next: According to the committee’s website, new members have been approved by HHS and the next meeting will be in August.

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WHAT WE'RE READING

POLITICO’s Rachel Bluth reports on a California law allowing Arizona doctors to perform abortions in the state.

POLITICO’s Megan Messerly reports on a Louisiana bill headed to the governor’s desk criminalizing having abortion pills without a prescription.

The New York Times reports that fallout from the Ascension cyberattack continues to impact hospitals.

A message from PhRMA:

A recent report from the Berkeley Research Group shows the 340B program is the second largest federal drug program for another year in a row. Despite its massive size, 340B has zero reporting requirements and zero patient protections to ensure the program is working as it should. Let’s fix 340B so it better helps patients.