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National health coordinator wants to certify how data moves

National health coordinator wants to certify how data moves

Politico6 days ago
WASHINGTON WATCH
On the same day last week that the Centers for Medicare and Medicaid Services rolled out plans to ease the flow of health information, the Office of the National Coordinator for Health IT made two fairly significant announcements at an event in the Eisenhower building.
'The first was that we were going to continue our work on certification, and that this was going to include certification of APIs to improve interoperability,' Tom Keane told Ruth. 'The other thing I talked about is how we were going to enforce the information blocking.'
Keane did not specify a timeline for when the agency would start certifying what are known as APIs, which are the means by which information is sent and received between applications. He also didn't provide information about when or how that the ONC would start enforcing information blocking, the practice of preventing payers, patients, and providers from accessing electronic health information. The agency hasn't yet penalized companies that unreasonably limit access to health data.
Ryan Howells, a partner at health care policy consulting firm Leavitt Partners, says that these changes could unclog data congestion and pave the way for better use of technology in health care.
'It will unleash more health care technology innovation than we've ever seen both inside and outside the EHR,' said Howells, a partner at health care policy consulting firm Leavitt Partners, who published a paper earlier this year proposing that the ONC start certifying the way data transfers instead of focusing on EHR features.
He said this will incentivize EHR companies to make it easier to move health data out of the silos it sits in.
ONC also dropped new rules. The finalized rules were a subset of those proposed last year, under former President Joe Biden, that support President Donald Trump's desire to make prior authorization less arduous.
In June, Trump secured commitments from the largest health insurers in the country that they would improve the process of obtaining prior authorization.
Here's what's in ONC's HTI-4 final rule:
— Adds new certification criteria enabling prescribers to check patients' benefit information in real time
— Updates its baseline standard for e-prescribing, for the first time in a decade and requires that prescriber systems support functionality for electronic prior authorization of prescriptions
— Requires electronic health record companies to follow ONC guidelines to help standardize electronic prior authorization
What does all this mean? One big takeaway is that CMS is driving the agenda for how data flows between entities in health care and ONC is playing a supporting role.
Also, despite Trump's overall deregulatory approach, it does seem that the administration is willing to push forward some rules.
Brendan Keeler, interoperability policy lead at tech consultancy HTD Health, told POLITICO he wouldn't discount the industry pledges that Trump has sought as a mere stunt.
'This isn't a pledge, this is a competition,' Keeler said of the Trump executive order unveiled last week. 'If they don't get what they want, it can turn very punitive very quick.'
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AROUND THE AGENCIES
The Federal Trade Commission is mapping the future of competition in the drug market. It will host a third and final listening session this afternoon on how the agency can use its authority to help lower drug prices in the U.S.
In April, President Donald Trump signed an executive order urging federal agencies to ensure 'federal health care programs, intellectual property protections, and safety regulations are optimized to provide access to prescription drugs at lower costs to American patients and taxpayers.'
Part of that order gave the FTC 180 days to conduct listening sessions on reducing anticompetitive behavior from drug manufacturers and write a final report.
In its sessions, the FTC has looked at claims that drugmakers stifle generic or biosimilar competition and preserve market dominance through price-fixing, rebates and fraudulent entries in the so-called Orange Book, which lists Food and Drug Administration-approved drugs. The FTC is also reviewing the role of pharmacy benefit managers, which negotiate drug costs for insurers and employers, in drug pricing.
'To promote competitive pharmaceutical markets, we need to identify and eliminate all forms of rent-seeking activity that allow companies to reap financial rewards that are entirely out of proportion to their contribution to genuine innovation in pharmaceuticals,' FTC Chair Andrew Ferguson said during the agency's July 24 session.
He has already initiated antitrust enforcement: In May, the FTC sent letters to Amphastar Pharmaceuticals, Covis Pharma, Mylan Specialty, Novartis and three Teva entities, disputing more than 200 patent listings in the Orange Book.
This third session, titled 'Turning Insights into Action to Reduce Drug Prices,' is expected to include discussions about how the FTC could use its authority to increase market competition and determine what new laws would be needed to support that effort.
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Claiming to fight waste, Trump administration slashes potentially cost-saving research
Claiming to fight waste, Trump administration slashes potentially cost-saving research

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  • Boston Globe

Claiming to fight waste, Trump administration slashes potentially cost-saving research

Harvard researchers had spent five years and some $3.8 million from the National Institutes of Health trying to answer this question when Mueller heard that the study might never yield results. In May, amid a feud with the university, the Trump administration abruptly terminated the grant that was funding it with one year and some $734,000 still to go. Without that time and money, pulmonologist Mary Berlik Rice and her team couldn't collect the final bits of data or analyze what they'd found. The clinical trial needed outcomes from a minimum number of participants to be able to conclude anything with any statistical significance. Advertisement 'It's a waste,' said Mueller — of taxpayer money, of everyone's time, of blood and tissue samples. N. Mueller sat beside the air purifier he was loaned as part of the study, which may or may not be functional. Lucy Lu for STAT That alone might seem to conflict with President Trump's stated goal of fighting 'waste, fraud, and abuse.' But scientists and participants like Mueller see another irony. The entire premise of this sort of study is that it might curb future waste. Advertisement It's a pillar of public health: Healthier people cost less. Figure out what could keep them well, and the government money spent on the discovery may well be dwarfed by the amount saved in hospitalizations and prescriptions averted. One of the most famous examples involves central venous catheters, thin tubes that intensive care doctors put into a patient's neck, chest, or groin to give fluids and medications or to draw blood. Those lines allow access to the bloodstream — but also pose an infection risk, creating a conduit that bacteria can take from the outside world into the veins. Such complications were both scary and common. In the early 2000s, they killed some 28,000 American ICU patients and cost $2.3 billion dollars every year. But then in 2006, a paper came out showing that the infections were avoidable. Led by intensive care specialist Peter Pronovost, a team of researchers tried out a simple solution in Michigan hospitals, instituting a checklist of risk-reducing hacks. These included clinicians washing their hands before inserting central lines; cleaning the patient's skin with a disinfectant called chlorhexidine; wearing sterile hair-coverings, masks, gowns, and gloves; using blood vessels in the neck or chest rather than the groin; and taking out catheters when they were no longer needed. Duh, you might say. But the infection rate fell dramatically. Within 18 months, it was near zero, and the intervention was estimated to have saved $100 million and 1,500 lives. 'I don't know how to describe how jaw-dropping this was,' said Leora Horwitz, a hospitalist in New York who studies how health care can be improved. 'This was like a shockwave of a paper.' Advertisement Pronovost says none of that could have happened without a grant of $500,000 a year for two years from a federal bureau called the Agency for Healthcare Research and Quality, which is dedicated to improving the delivery of medical care to patients and represents about 0.04 percent of the government's spending on health care. 'AHRQ pays for itself over and over again with studies like that,' said Horwitz. But the agency hasn't been spared in the Trump administration's slashing of federal research funding and the employees who administer it. Over a third of its employees were laid off in April, and the administration said it would be merged with another office within the Department of Health and Human Services. The effects of such cutbacks have been felt in the last few weeks. 'As a result of recent reduction in force at HHS, AHRQ's grants management staff were separated from Federal service on July 14, 2025,' one of the agency's directors wrote in an email to recipients of a grant for training new researchers, 'We are currently unable to process grant awards.' Signage for the Department of Health and Human Services headquarters was seen on April 2 in Washington, D.C. Anna Moneymaker/Getty Pronovost, now the chief quality and clinical transformation officer for the University Hospitals Cleveland, worries about the agency's decimation. His landmark 2006 paper can seem almost dull. It was partially about handwashing reminders and antiseptic usage. It was neither rocket science, nor a blockbuster drug. Nor, for that matter, does it sound like the 'edge science.' But it worked. When Pronovost sees package-delivery companies providing nearly flawless services, he knows that doesn't happen by accident; it happens through a management system. 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TruBridge Second Quarter 2025 Earnings: EPS Beats Expectations, Revenues Lag
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RFK Jr.'s vaccine pullback stokes fears of lost medical breakthroughs
RFK Jr.'s vaccine pullback stokes fears of lost medical breakthroughs

Axios

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RFK Jr.'s vaccine pullback stokes fears of lost medical breakthroughs

Health Secretary Robert F. Kennedy Jr.'s decision to cut federal funding for mRNA vaccine research is the latest in a series of moves that have the potential to crush future medical breakthroughs and accelerate a brain drain. Why it matters: America has historically led the world in scientific innovation — driving economic growth, strengthening national security, and attracting global talent. But scientists, including some who served in Trump's first administration, warn that lead is slipping away. The mRNA divestment "risks stalling progress in some of the most promising areas of modern medicine," Jerome Adams, surgeon general during the first Trump administration and now a professor at Purdue University, told Axios. "Walking away from this technology now would be like pulling funding from antibiotics after penicillin or from computers after the microchip. It's short-sighted and puts us at a disadvantage globally." State of play: Kennedy said last week that HHS's Biomedical Advanced Research and Development Authority would pull nearly $500 million worth of contracts with universities, drug companies and other labs working on new mRNA vaccines. No new mRNA-based projects will be launched as the administration shifts to "safer, broader vaccine platforms," he added. Scientists refute the implication that mRNA vaccines are unsafe. The technology that brought mRNA COVID vaccines in Trump's first term has been in development for decades. Large scientific trials and real-world data have shown that the vaccines are safe and effective — and capable of training the body's immune system to create antibodies to fight a host of afflictions. HHS, when asked for the research on which Kennedy based this decision, sent Axios a link to a citation collection put together by anti-COVID vaccine advocates, including Steven Hatfill, who promoted the use of the antimalarial drug hydroxychloroquine to treat the virus before vaccines were available despite reports of safety issues. Friction point: mRNA technology is what allowed the most common COVID vaccines to be deployed so quickly, and it's essential to responding to new viral pandemic threats, said Cynthia Leifer, a professor of immunology at Cornell University's College of Veterinary Medicine. "When we have a pandemic, we need to act quickly. We don't have time to wait several years or decades to do testing of older platforms the way they were normally done in years past," she said. "The newer technology could allow us to move so much faster to develop and have these vaccines rolled out to protect people when a pandemic is ongoing," Leifer added. Researchers are also studying how mRNA technology could treat or prevent cancer, HIV, and other chronic diseases — and the science so far is promising. Now, they're worried that progress could be lost. "If we stop now, we could delay or even miss the next generation of cures entirely," said Adams, the former surgeon general. Zoom out: Scientists say some of Kennedy's other changes are stifling innovation, too. Kennedy is working to implement massive staff cuts at HHS, reduce funding for research labs' overhead costs and end National Institutes of Health grants for a wide swath of projects. The cuts, along with the broader Trump administration's immigration restrictions, has already started to steer promising international scientific talent away from the country. Kennedy also is reportedly considering overhauling the U.S. Preventive Services Task Force, whose independent experts establish care and coverage guidelines to account for advances in medical treatments and new disease trends. Its past work included recommending beginning mammograms at 40, which has been credited with saving thousands of lives. The other side: HHS denies that its changes will stymie medical advances. "Those concerns are unfounded and not supported with facts," HHS Communications Director Andrew Nixon told Axios. Kennedy's decision to cut BARDA funding for mRNA work won't affect other government uses involving the technology, HHS said. The Centers for Disease Control and Prevention has endorsed mRNA COVID vaccines for most adults. Between the lines: An independent and bipartisan commission warned Congress in April that China has already pulled ahead of the U.S. in key life sciences areas. The U.S. can stay dominant, but it only has a few years to strengthen its position — and it needs to put significant resources into biotechnology resources, the commission's report said. Reality check: It's impossible to know whether breakthroughs actually won't happen as a result of these policy changes, or which advances we could miss out on. "That is a long-term impact that is hard to measure. What cure wasn't found? What question wasn't asked and investigated?" Richard Besser, CEO of the Robert Wood Johnson Foundation, said. mRNA therapy start-ups are also still raising private investment, which could keep research moving.

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