Friday, August 2, 2024

Reforming organ transplant system? Not so easy.

Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
Aug 02, 2024 View in browser
 
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By Chelsea Cirruzzo and Ben Leonard

With Erin Schumaker 

Driving The Day

Pictured is a styrofoam box used for transporting human organs

The Biden administration’s efforts to overhaul the U.S. organ transplant system are threatened by disagreement over the system’s board structure. | Sean Gallup/Getty Images

INSIDE THE TURMOIL OVER ORGAN REFORM — A new organ transplant system is on the horizon — but conflict over how the new system’s board will be run has shaken up the reform.

Since last year, members of Congress, the Health Resources and Services Administration and several providers have shared concerns over the reform, including who will be tasked with leading the system into the future, Chelsea reports.

How we got here: Since the Organ Procurement and Transplantation Network, which is responsible for policy around organ allocation, was created 40 years ago, a single nonprofit contractor has run operations. The same board of directors that oversees that nonprofit, the United Network for Organ Sharing, has also overseen the OPTN. UNOS separated its own board from the OPTN in March.

Last September, President Joe Biden signed a law splitting up the system and allowing different entities to oversee certain functions. HRSA recently finalized a policy that no member of the OPTN board can also sit on an OPTN vendor’s board.

The latest conflict centers on who the new board answers to. While HRSA said the board will be independent from vendors, the agency will also retain some oversight. Some current OPTN board members — which include transplant surgeons and organ procurement leaders — want complete independence from HRSA.

And that’s raised alarms among Congress members who pushed for reforms.

“There’s a real chance for a power grab here if things are not done correctly,” said a Senate aide involved in the modernization initiative and granted anonymity to speak candidly about the reform.

Some current OPTN board members say HRSA “backpedaled” on its original promises for the board.

They want the agency to create a stronger role for the OPTN board of directors, saying in a letter to HRSA that its updated solicitation structure will make the board’s role “extremely restricted, with only limited authority on a narrow set of issues.”

They want to see the network and the board itself divorced from the government.

HRSA’s take: In an interview with POLITICO, HRSA Administrator Carole Johnson pushed back on the characterization that the agency reversed course.

“The statute is clear that we, in HRSA, have an oversight and accountability responsibility here, and so we need to ensure that that is a part of this process,” she said.

Senate Finance Committee leaders have agreed with HRSA.

What’s next? Both HRSA and the concerned OPTN board members say conversations are ongoing.

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DIGITAL HEALTH

A logo sign outside of the headquarters of the Epic Systems Corporation in Verona, Wisconsin.

Epic is expanding its electronic health record system by making it accessible to patients. | Kristoffer Tripplaar/Sipa via AP

EPIC LAUNCHES PATIENT RECORD ACCESS — Electronic health record giant Epic told Pulse on Thursday that it will allow individuals to access and share their health records with health apps through the data-sharing framework known as TEFCA under HHS’ purview, Ben reports.

The company says the move will let patients share their data with apps for health and fitness, among others.

“We’re excited to get to this next frontier of individual access,” said Rob Klootwyk, director of interoperability at Epic. “I’m excited to see what innovative ideas are out there that help people do whatever they want to do with their health data.”

Klootwyk said the company aims to have all of its customers signed up for individual access services by year’s end with plans to go live in 2025, noting that apps in TEFCA voluntarily agree to comply with HIPAA rules, which includes cybersecurity protocols, even though they aren’t required to.

The bigger picture: It’s a significant step for Epic and the nationwide data-sharing network it’s a part of, the Trusted Exchange Framework and Common Agreement. HHS and its nonprofit partner, the Sequoia Project, have made the case that TEFCA can help solve longstanding data-sharing issues in health care that the private sector can’t tackle without government help.

TEFCA has a number of other use cases for data-sharing, including those for treatment, payment, public health and operations.

AROUND THE AGENCIES

FY 2025 HOSPITAL PAYMENT BUMP — CMS finalized a rule that gives a $3.2 billion boost to inpatient hospital payment rates starting October 1, POLITICO’s Robert King reports.

The agency released a final rule Thursday that increased the fiscal 2025 payment rate by 2.9 percent compared with fiscal 2024, which ends in September. The rule will also pay smaller hospitals more money to keep certain vital medicines in stock to mitigate shortages.

The rule is likely to draw pushback from hospital groups that complained it wasn’t enough to offset rising costs when CMS first proposed the increase earlier this year.

Additionally, CMS will give smaller and independent hospitals a separate payment if they keep a buffer stock of essential medicines.

“These hospitals are particularly vulnerable to supply disruptions during shortages because they lack the resources of hospitals that are larger and/or are part of a chain organization,” according to a CMS fact sheet on the rule.

CMS hinted the program could expand to other hospitals.

NIH LOSES COURT BATTLE The National Institutes of Health violated animal rights activists’ right to free speech, the U.S. Court of Appeals for the District of Columbia ruled this week, Erin reports.

PETA, and two other activist groups, successfully argued that the NIH violated the First Amendment when the agency put keyword filters on online forums, blocking comments containing words like “animal,” “testing” and “cruel.”

NIH didn’t make a reasonable case for excluding those terms, the court found, writing that the government “must be able to articulate some sensible basis for distinguishing what may come in from what must stay out.”

The court also warned: “The government should tread carefully when enforcing any speech restriction to ensure it is not viewpoint discriminatory and does not inappropriately censor criticism or exposure of governmental actions.”

Big picture: Other health agencies have been taken to task over their social media strategies this year. In March, the FDA settled a lawsuit over a cheeky tweet it posted about the drug ivermectin during the pandemic’s height, which read: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

What's next: NIH would not comment on pending litigation.

DIGITAL HEALTH COMMITTEE NAMED — The FDA named the members of its new Digital Health Advisory Committee on Thursday.

The committee is responsible for advising the FDA on the use of digital health technologies as medical products or parts of medical products.

The committee, set to meet in November, will be chaired by Ami B. Bhatt, chief innovation officer at the American College of Cardiology, with James Swink as designated federal officer.

Members are Dr. Ray Dorsey, professor of neurology at the University of Rochester; Dr. Yaniv Kerem, ER physician at Kaiser Permanente Redwood City Medical Center; Joyce Ho, associate professor of computer science at Emory University; Jessica Jackson, founder and CEO of Therapy Is For Everyone; Dr. Thomas Maddox, professor of medicine at the Washington University School of Medicine; and Dr. Chevon Rariy, chief health officer and SVP digital health at Oncology Care Partners.

 

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Names in the News

Brian Carey and Erik Schulwolf have joined law firm Hogan Lovells’ health practice in Boston. Both were previously Foley Hoag partners.

WHAT WE'RE READING

The New York Times speaks with experts on why birth rates are dropping amid comments by Republican vice presidential nominee JD Vance.

Chelsea reports on the Senate HHS fiscal 2025 budget.

 

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