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Kennedy's Next Target: the Federal Vaccine Court
Kennedy's Next Target: the Federal Vaccine Court

New York Times

timea day ago

  • Health
  • New York Times

Kennedy's Next Target: the Federal Vaccine Court

For nearly 40 years, a special federal court system has compensated Americans who prove they were harmed by vaccines while also protecting the manufacturers from litigation. Even the staunchest defenders of the Vaccine Injury Compensation Program agree it needs reform. It is slow, understaffed and can feel adversarial to families legitimately in need. Now Health Secretary Robert F. Kennedy Jr. plans to overhaul the program, saying he will make it more efficient and speedier for Americans seeking payment. He said in a social media post last month that the vaccine court had 'devolved into a morass of inefficiency, favoritism and outright corruption.' Parents who believe their children were injured by vaccines are 'facing the monumental power and bottomless pockets of the U.S. government,' he said. Mr. Kennedy has also claimed, falsely, that the compensation program prevents families from suing vaccine makers in traditional courts. And he has claimed that the vaccine court punishes and intimidates expert witnesses and petitioners' attorneys. Experts fear that some of the changes Mr. Kennedy has hinted at could lead to an onslaught of lawsuits, jeopardizing the manufacture of vaccines and undermining their use. 'Kennedy can fix this system without burning it down,' said Tony Yang, a health policy expert at George Washington University. But Mr. Kennedy sounds 'more like a frustrated lawyer who lost cases than an eager secretary trying to fix things.' Indeed, allies of the secretary have fared poorly in the vaccine court. Their litigation in traditional courts — including a 2022 lawsuit in which Mr. Kennedy delivered closing arguments — also has fallen short. The Department of Health and Human Services did not respond to repeated requests for comment. Public health officials in the United States have been tracking vaccine safety for decades and have long said that shots routinely given to children are safe. But all vaccines have at least occasional side effects, and there are rare instances of serious injury. Congress set up the vaccine court in 1986 after a spate of lawsuits began to drive vaccine makers out of the market. So-called special masters judge claims of injuries from vaccines, weighing the available evidence. The program covers most routine immunizations given to children and pregnant women, and is funded by a small tax on each shot. The vaccine court has paid $5.4 billion in claims since its inception, awarding compensation in about 42 percent of the roughly 28,000 claims filed. But in accordance with a great body of scientific evidence, the court's special masters have denied thousands of claims that childhood vaccines are linked to autism. Mr. Kennedy, a prominent vaccine skeptic, believes that there is such a link and has long accused government officials of hiding the risks. Some reforms widely seen as necessary would require Congress to intervene. Among them: more of the special masters who preside as judges over cases. The legislation establishing the program allowed for three; five more were added later. But at least double that number are needed to adjudicate the roughly 1,200 applications each year, according to some experts. The program also needs more staff to review medical records, and an online system for families to track the status of their claims. The compensation fund has a $4 billion surplus, some of which could be applied to remedy these problems. Mr. Kennedy said in an interview last month that he wanted to ensure families seeking compensation 'get it very quickly, and they get it without the kind of adversarial impediments that have now been erected over the past 40 years.' A new fast-track system for rare injuries that studies have definitively linked to certain vaccines could speed up the process. In the current system, government lawyers sometimes fight families over settled links, said Altom Maglio, an attorney who has represented people in the vaccine court for 25 years. 'Fighting tooth and nail is just not appropriate, and doesn't meet the goals,' he said. At the same time, special masters sometimes make awards even when the connection between a side effect and vaccine is tenuous, said Dr. Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health. 'There are a lot of things that are being compensated where there's inadequate evidence,' Dr. Salmon said. 'We need more science.' Mr. Kennedy has also suggested that injury claims regarding Covid-19 shots should be moved to the vaccine court. At present, those claims are piling up in a parallel federal system called the Countermeasures Injury Compensation Program. Of more than 14,000 injury claims filed regarding Covid vaccines, only 69 have been paid out. More than 9,400 are pending, and about 4,800 have been dismissed. Congress would need to act to move those claims to the Vaccine Injury Compensation Program. But adding the large Covid backlog to the vaccine court's own poses huge challenges, Dr. Yang said: 'You're complaining about your kitchen sink, it's clogged, and then you try to wash your bike in it.' There are some aspects of the program that Mr. Kennedy can change without Congress. That includes altering the official table detailing the injuries presumed to be linked to certain vaccines. Changing the table to say that certain vaccines cause autism or asthma, months or years after shots, for example, could hobble the system, opening the doors to tens of thousands of new claims that would previously have been dismissed. 'He's talking about opening a can of worms that could result in Americans losing access to some vaccines and huge expenditures in court fees,' said Dr. Thomas R. Frieden, a former director of the Centers for Disease Control and Prevention. Mr. Kennedy has said, falsely, that the vaccine court is the 'exclusive remedy' for families seeking compensation. In fact, claimants can sue vaccine makers in traditional courts if the government does not respond to them within 240 days, or if they are dissatisfied with its offer of compensation. But the traditional courts have not been any more generous to Americans who believe they were injured, said Renee Gentry, director of the Vaccine Injury Litigation Clinic at George Washington University. 'The idea that going to straight to civil litigation means you're going to win is absurd,' Ms. Gentry said. 'These are incredibly difficult cases.' She believes her clients are better off in the vaccine court. Mr. Kennedy has been deeply involved in litigation over vaccines for years. For example, he worked on lawsuits against Merck over claims related to the Gardasil vaccine, which protects against the human papilloma virus. As health secretary, Mr. Kennedy initially planned to keep his financial stake in the litigation. But he relinquished those earnings to an adult son following controversy at his confirmation hearing. Senator Elizabeth Warren, Democrat of Massachusetts, also pressed him to pledge to refrain from suing pharmaceutical companies after he leaves government. 'I'm not going to agree to that,' Mr. Kennedy said. His harsh criticism of the program — and claims that it is corrupt — appear tied to his steadfast support to people who have lost in the court with unproven claims that vaccines cause autism, said Dorit Reiss, a law professor at the University of California, San Francisco, who has followed the cases. Rolf Hazlehurst, who was until recently a lawyer with Children's Health Defense, the anti-vaccine group Mr. Kennedy founded, has litigated his son's case for 22 years, claiming that the measles vaccine and thimerosal, a preservative, caused his son's autism. The case has failed in forum after forum. Mr. Kennedy became involved in 2022, when claims were brought in a Tennessee court against the pediatrician who in 2001 inoculated Mr. Hazlehurst's child. Mr. Kennedy delivered the closing argument. The jury sided with the doctor. Mr. Kennedy has also recently hired at H.H.S. — and has defended — David Geier, who has for years pushed the discredited theory that thimerosal caused autism. Mr. Geier's attempts to bill the vaccine court for his expertise regarding vaccine injuries were often challenged. One judge determined in 2016 that Mr. Geier's report was 'neither useful nor relevant, because he is not qualified as an expert concerning the matters he discusses.' Mr. Kennedy also has hired another Children's Health Defense alumna, Lyn Redwood, who presented inaccurate data that thimerosal caused autism at recent meeting of scientific advisers to the C.D.C. The panelists, newly appointed by Mr. Kennedy, voted to withdraw endorsements of the few flu vaccines in which thimerosal is an ingredient. Some experts are concerned that Mr. Kennedy may open the door to at least one proposal already pending in Congress — to abolish the Vaccine Injury Compensation Program altogether. 'I think he's been really clear,' said Richard Hughes IV, a lawyer who represents vaccine makers. 'He would be fine with the total collapse of the program.'

The Big Beautiful Bill's Healthcare Opportunity
The Big Beautiful Bill's Healthcare Opportunity

Wall Street Journal

time31-07-2025

  • Health
  • Wall Street Journal

The Big Beautiful Bill's Healthcare Opportunity

Health-insurance companies have long dictated which doctors Americans can consult, trapping patients in narrow networks and bureaucratic red tape. The One Big Beautiful Bill Act breaks that monopoly. By loosening the grip of insurers and empowering families with greater choice and flexibility, this bold reform restores control to patients. Most Americans pay for medical care through traditional health insurance provided by their employer or through the individual market. This system puts insurers in charge of determining which physicians and facilities families can visit, often through network restrictions and prior-authorization barriers. It also forces healthcare providers to spend large sums of money on billing departments to request and negotiate payments from health insurers. One 2009 study estimates that physician practices spent 13% of their revenue on administrative overhead for insurance billing and reimbursement. Every dollar that healthcare providers spend on their billing departments shows up in higher prices.

Greater Price Transparency Will Improve Affordability
Greater Price Transparency Will Improve Affordability

Forbes

time22-07-2025

  • Health
  • Forbes

Greater Price Transparency Will Improve Affordability

Price Transparency Inefficiencies plague our current healthcare system. Politicians are quick to blame these problems on the market and subsequently advocate for ever greater government control. But government programs, which are already major players in the healthcare market, provide lousy insurance for patients and undermine the viability of doctors and hospitals. Expanding the government's role will only worsen these problems. Rather than expand the government's role, reforms need to address the price opacity problem that is obstructing the ability of healthcare professionals to deliver higher quality care to patients at lower costs. The price transparency problem afflicting hospitals exemplifies the problem. As the Center for Medicine in the Public Interest (CMPI) documents, hospitals account for nearly one-third of the nation's total healthcare expenditures. While attention is often placed on pharmaceutical companies and insurance providers, hospital systems, especially nonprofit institutions, are the primary driver of healthcare cost inflation and systemic inefficiency. To substantiate this claim, CMPI documents that hospital prices have increased by more than 250% over the last 25 years, which was double the rate of overall medical care inflation. Clearly, if hospital costs are one-third of spending and those costs are rising faster than the overall healthcare sector, then hospital costs are driving healthcare inflation. But it gets even worse. Hospital costs are also growing twice as fast as the median household's income. Consequently, hospital services are becoming increasingly less affordable for the average family. And while insurers and government payers are supposed to cover these costs, a larger share is being shifted to payments through large deductibles and coinsurance obligations. Addressing the problem of price opacity will help control the growth in expenditures at hospitals because 'a significant portion of this spending arises from redundant services, excessive administrative overhead, and inefficiencies embedded in payment models.' Establishing a competitive market with clear and transparent prices would impose discipline on hospital prices, make it difficult to inflate overhead costs, and rein in expenditure growth. It is important to recognize that it matters how transparency reforms are implemented. Previous efforts to mandate transparency have fallen short due to lack of follow-through. In its Seventh Semi-Annual Hospital Transparency Report, estimated 'that only 21.1% of the 2,000 hospitals are in compliance with all of the price transparency rule requirements.' Consequently, patients and insurers still cannot easily compare prices and the ability of competition to improve quality and reduce costs is still hampered. The Trump Administration should address this problem by enforcing the existing regulations and ensuring that patients and payers have access to clear and upfront pricing data. Greater price transparency would also help mitigate the cost pressures created by the rampant abuse of the 340B program by many hospitals. The 340B program was created to subsidize hospitals and clinics serving low-income populations to help these institutions provide more care for vulnerable populations at lower cost. To achieve this goal, 340B allows qualified hospitals to buy steeply discounted drugs and then resell these medicines to Medicare or privately insured patients at full price and pocket the difference. While the program offers hospitals large profit opportunities, the costs have become a burden that inflates costs for other patients and insurers. As a New York Times investigation noted, prescription drug spending for state employees [in North Carolina] jumped almost 50 percent from 2018 to 2022. A report in May from the state treasurer's office found that 340B was partly to blame: Hospitals that participated in the program billed the state health plan far more than hospitals that did not — almost 85 percent more for certain cancer drugs. In one example, hospitals bought a drug commonly used to treat melanoma for an average of $8,000 but billed the state $21,512. Due to the extreme profitability of the program, the program has experienced rapid growth. In 2009, the discounted value of 340B purchases was $4 billion. By 2023, these purchases grew to $66 billion – a sixteen fold increase! Yet, as I document in JAMA Network, abuse of this well intentioned program has turned it into a profit center for large health systems that do not pass the savings on to patients and tend to provide less charity care than the average hospital. Worsening the impact from the program, it has grown so large that the prices for other patients are increasing to help cover 340B's costs. With over one-half of nonprofit hospitals participating in the program, not to mention major pharmacy chains, the program's adverse impacts are materially harming the broader healthcare system. Coupling price transparency reforms with policies that address the abuses by contract pharmacies and ensure that 340B hospitals serve their intended purpose can rein in the 340B program materially improve drug affordability. Markets only work when transparent prices reflect the desires of consumers and the costs of producers. While the third-party payer system creates complications, this principle holds for healthcare markets. Regulatory reforms that promote widespread price transparency offers Congress and the Trump Administration an opportunity to meaningfully bend the healthcare cost curve and improve the quality-of-care patients receive.

‘Taking over the city, letting our voices be heard, being visible - that's the real power of today'
‘Taking over the city, letting our voices be heard, being visible - that's the real power of today'

Irish Times

time12-07-2025

  • Health
  • Irish Times

‘Taking over the city, letting our voices be heard, being visible - that's the real power of today'

Thousands attended the annual Trans and Intersex Pride march through Dublin city centre on Saturday in what was the event's largest ever turnout. A parade of sound and colour made its way from City Hall to Leinster House as spectators watched the demonstrators chant, sing and wave flags and banners as part of their combined protest and celebration. Outgoing Trinity College Students' Union president Jenny Maguire, who is co-organiser of the event, said they were 'trying to show that a united movement is the way forward in pushing for a better Ireland for everyone. 'We want the Government to implement an informed consent, GP-led healthcare model. The current reform that they're trying to do will still hurt trans people. We need it led by the community. We need intersex people to be recognised and de-medicalised. READ MORE 'A review is happening at the moment but it's by the people who currently run the system and that system goes against the World Health Organisation guidelines.' Ms Maguire said the last programme for government contained a trans inclusive model for healthcare and but it was removed from the current programme. 'The Government is afraid of the far right but we are showing that the support is here for trans people,' she said. On the march numerous chants were sung: 'Trans rights, women's rights – same struggle, same fight,' was one call and response. 'Trans healthcare is our right – this is why we have to fight', was another. Marchers at the Trans and Intersex Pride event in Dublin. Photograph: Chris Maddaloni 'Not the church, not the State, we alone decide our fate,' the demonstrators chanted as well as 'one struggle, one fight, Palestine, trans rights'. The trans blue, pink and white flag was hoisted by many while others carried Palestinian, Amnesty International and political party flags and banners including the Socialist Party, Social Democrats, People Before Profit and Labour. One speaker at the event, Sexy Tadhg, who addressed and sang for the crowd said 'taking over the city and taking up space and letting our voices be heard' and being visible 'is the best thing we can achieve today'. 'We're reminding Dublin, and Ireland and the world that trans people are here that trans Ireland people exist, intersex Irish people exist and we are so beautiful and we are so gorgeous and we're letting our voices be heard. That's the real power of today.' An Indian member of the Queer Asian Pride Ireland who addressed the crowd but did not wish to be identified, spoke of 'how every single day for trans people it's so, so difficult to live our daily lives whether in university, at workplaces, in hospital, wherever it is. 'We have been spat at, yelled at. I have been egged. I have been mocked so many times, just walking on the street. I am visibly queer and visibly trans and you see the colour of my skin and I can't tell where the hate is coming from whether it is transphobia, homophobia or whether it is racism.' Ollie Bell, an LGBTQ+ activist, leads the annual Trans and Intersex Pride march towards the Dáil from Dame Street. Photograph: Chris Maddaloni Labour TD Duncan Smith said the party is showing 'full solidarity with the trans community'. He said the parade is getting bigger each year 'because I think there's a realisation that the trans community need proper allegiance, proper support'. Labour will put a motion on the order paper this coming week on trans healthcare, 'the first motion on trans healthcare ever in the Dáil', he said. 'The National Transgender Service isn't fit for purpose for trans people and our health service needs to recognise that,' he said. The motion calls for 'what every citizen in this country should have….. healthcare in the community, GP-led healthcare, informed consult-led healthcare.' Logan Ferrante is a student from Georgia, US is visiting Ireland as part of a three-week study abroad programme. 'I thought it really important to come here today to fight not only for Irish transgender rights but for the rights of all transgender people globally.' Ciarán O'Donnell was one of a number of people wearing a T-shirt with the message 'Protect the Dolls'. He said it was introduced in May 'as a fashion statement to show your support and solidarity for trans people'.

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