States take the reins on insurance reform
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Driving The Day
STATE CRACKDOWN — Congressional lawmakers have tried and failed several times to push through a bipartisan, health-industry-backed bill that would speed up health insurers' prior authorization processes for certain prescription drugs and medical services. Congress will launch another attempt this year, but a growing number of blue and red states have taken the matter into their own hands.
In 2024, at least 10 states passed laws to reform the prior authorization process, according to a report from the American Medical Association. Insurers use prior authorization to control costs.
The state action continues to increase in 2025. Within the past few months, states including California, Connecticut, Hawaii, Iowa, New Jersey, North Carolina and North Dakota have either proposed or enacted reforms aimed at simplifying and streamlining prior authorization. And other states, including Illinois, Georgia, Texas, Rhode Island, Minnesota and Florida, have proposed cracking down on the use of artificial intelligence in prior authorization decisions.
Why it matters: The uptick in state prior authorization reforms comes as health insurers have come under intense public and congressional scrutiny over how often they deny care, especially in the wake of the fatal shooting of UnitedHealthcare CEO Brian Thompson in December. The use of AI to deny care has also put insurers in the hot seat, with UnitedHealth Group facing a lawsuit over allegations that it used AI to wrongfully deny care to Medicare Advantage patients.
The state reforms also come amid a lack of congressional action on the issue, despite widespread bipartisan and industry support for reforming the prior authorization process, which can sometimes be slow and administratively burdensome — impeding patients' access to necessary medical care.
Even so: State power to regulate prior authorization is limited. While states have considerable authority over insurance companies operating within their markets, the federal government has jurisdiction over self-insured employer health plans and Medicare Advantage plans.
'State action is important, but it's not complete without federal action in some ways, because it's a federal requirement for employers, for self-insured and for Medicare Advantage plans, that state activity is not going to touch them,' said Kaye Pestaina, director of KFF's Program on Patient and Consumer Protections.
Background: Last week, bipartisan lawmakers in the House and the Senate reintroduced the Improving Seniors' Timely Access to Care Act — a bill that would streamline prior authorization for older adults enrolled in Medicare Advantage. Despite widespread support from lawmakers, providers, doctors and insurers — and estimated to cost $0 by the last Congress — the repeatedly introduced bill has yet to pass.
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At the Agencies
A THREAT TO MEDICAL JOURNALS — HHS Secretary Robert F. Kennedy Jr. is escalating his war on institutions he says are influenced by pharmaceutical companies, Chelsea reports.
On Tuesday, Kennedy, speaking on the 'Ultimate Human' podcast — a show hosted by a longevity expert that focuses on optimizing health — threatened to stop government scientists from publishing their work in major medical journals, including The New England Journal of Medicine, JAMA and The Lancet. He said the influential medical journals are 'corrupt' and publish studies that pharmaceutical companies fund and approve.
'Unless those journals change dramatically, we are going to stop NIH scientists from publishing in them, and we're going to create our own journals in-house,' he said. NIH is the world's largest funder of health research.
Key context: Kennedy's comments come days after his Make America Healthy Again Commission released a report saying overprescribed medications could be driving a rise in chronic disease in children, suggesting the pharmaceutical industry has an outsize influence on doctors and scientists. It also comes after both JAMA and NEJM received letters from the Department of Justice probing them for partisanship.
A JAMA spokesperson said the journal had nothing to add when asked about Kennedy's remarks, while NEJM and The Lancet did not respond to requests for comment. HHS also did not respond to requests for comment.
Even so: Kennedy's stance conflicts with that of his NIH director, Dr. Jay Bhattacharya, who recently told a reporter with POLITICO sister publication WELT that he supports academic freedom, which 'means I can send my paper out even if my bosses disagree with me.'
UPPING STATE OVERSIGHT — The Centers for Medicare and Medicaid Services is warning states against using federal dollars to pay for the health care of undocumented immigrants.
In a Tuesday letter, the agency notified states it's ramping up financial oversight of state Medicaid expenditures to comply with President Donald Trump's executive order on 'Ending Taxpayer Subsidization of Open Borders.' The increased oversight includes 'focused reviews' of certain state spending reports and in-depth reviews of state financial management systems. The agency will also review eligibility rules in federal regulations and 'be proposing revisions as may be necessary.'
'Medicaid is not, and cannot be, a backdoor pathway to subsidize open borders,' said CMS Administrator Mehmet Oz in a news release. 'States have a duty to uphold the law and protect taxpayer funds. We are putting them on notice — CMS will not allow federal dollars to be diverted to cover those who are not lawfully eligible.'
Key context: Undocumented immigrants are generally not eligible for Medicaid, though some states have used state-only funds to expand coverage to noncitizens.
The increased oversight from CMS comes as Republicans' 'big, beautiful bill,' which passed the House, includes a provision that would penalize states that have expanded Medicaid coverage to undocumented immigrants by reducing the federal matching rate for the Medicaid expansion population for those states.
Vaccines
CDC'S COVID VAX CHANGE — The CDC no longer recommends that 'healthy' children and pregnant women receive the Covid-19 vaccine, a controversial change that's perplexed some public health experts, POLITICO's Sophie Gardner and David Lim report.
On Tuesday, HHS Secretary Robert F. Kennedy Jr. announced the guidance change in a post on social media platform X, saying 'it's common sense and it's good science.'
'We're now one step closer to realizing President Trump's promise to make America healthy again,' Kennedy said in a video, standing beside FDA Commissioner Marty Makary and NIH Director Jay Bhattacharya. Kennedy cited 'a lack of any clinical data to support the repeat booster strategy in children.'
Background: The CDC had recommended the vaccine for everyone at least 6 months old. Kennedy has long maintained that Covid vaccines aren't safe, despite the medical consensus that they are.
Most Americans have stopped getting Covid vaccines. The most recent CDC data says about 1 in 8 children under 18 have received the latest shot, while fewer than 1 in 4 adults ages 18 and older have.
Key context: The change bucks the CDC's precedent for updating vaccine recommendations, which typically takes place after a panel of experts votes on proposed changes.
'I'm disturbed for a couple reasons,' said Dr. Georges Benjamin, executive director of the American Public Health Association, which represents public health workers. 'I don't believe that they followed the normal process whereby you bring the advisory committees into this decision.'
Other experts raised concerns about the public health implications of the decision.
'I'm perplexed by this decision,' said Mark Turrentine, an OB-GYN and professor at Baylor College of Medicine in Houston. 'A lot of pregnant people died of Covid, especially during the Delta wave. And we know Covid still hasn't gone away. And we know pregnant people are a high-risk group. And we have a lot of data that the vaccine provides strong protection for both the mother and the baby.'
WHAT WE'RE READING
POLITICO's Victor Goury-Laffont reports on France advancing an assisted-dying bill in a historic vote.
STAT's Jason Mast reports on what one child's success story means for the CRISPR gene-editing industry.
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By GlobeNewswire Published on June 23, 2025, 00:35 IST New FRONTIER5 data show that a direct switch to investigational Mim8 (denecimig) prophylaxis treatment from emicizumab, without the need for a washout period, was well-tolerated with no safety concerns in adults and adolescents with haemophilia A, with or without inhibitors 1 . . Switching to Mim8 led to a sustained increase in thrombin generation into the normal range, but without causing thrombin levels that might pose a thrombotic risk 1 . . FRONTIER5 Patient-Reported Outcomes (PROs) assessment found the Mim8 pen-injector easy to use, with strong user preference over their emicizumab injection system 2 . . These results add to the overall safety profile of Mim8 based on the FRONTIER clinical trial programme3. Bagsværd, Denmark, 22 June 2025 – Novo Nordisk today presented results from the phase 3b FRONTIER5 trial showing that a direct switch to investigational Mim8 (denecimig) prophylaxis from emicizumab treatment, without a washout period or Mim8 loading dose, was well-tolerated with no safety concerns in adults and adolescents living with haemophilia A, with or without inhibitors1. Additionally, a FRONTIER5 Patient-Reported Outcomes (PROs) assessment found the Mim8 pen-injector easy to use, with an overall strong user preference for the pen-injector compared to the previous emicizumab injection system2,3. The results were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C. In the study, the first Mim8 maintenance dose was administered on the next planned emicizumab dosing day. Patients were given the option of switching to once-monthly, once every two weeks or once-weekly dosing frequencies of Mim8, regardless of their prior dosing frequency1,3. Steady-state Mim8 concentration was achieved by Week 16, and emicizumab elimination was completed by Week 261. Switching to Mim8 led to a sustained increase in thrombin peak levels without an exaggerated thrombin response1. 'Continuous prophylactic coverage is critical to avoiding breakthrough bleeds in people living with haemophilia; with new non-factor therapeutic options, many people could have hesitations about switching treatment options. These data demonstrate that switching to Mim8 from emicizumab can be done without requiring a washout period,' said Allison P. Wheeler, MD, Washington Center for Bleeding Disorders, Seattle, WA. 'This is critical in ensuring that individuals maintain continuous protection against bleeding events as we seek to help address the ongoing needs of people living with this complex disease.' The open-label phase 3b FRONTIER5 study consisted of 61 adults and adolescents, aged 12 years and older, with haemophilia A. Mim8 was well-tolerated with no safety concerns. No thromboembolic events, hypersensitivity reactions, or treatment-emergent adverse events (TEAEs) leading to discontinuation were observed, and there was no clinical evidence of neutralising anti-Mim8 antibodies1. The PROs data from FRONTIER5 indicated a strong overall preference for the Mim8 pen-injector, with 97% (n=57/59) of patients reporting a 'very strong' or 'fairly strong' preference in comparison to their previous emicizumab injection system2. Of the participants who completed the Haemophilia Device Handling and Preference Assessment (HDHPA) questionnaire at week 26, 98% (n=58/59) found the Mim8 pen-injector 'very easy' or 'easy' to use, and 95% (n=56/59) found it 'much easier' or 'easier' compared with their previous administration method. All participants (100%) were 'extremely confident' or 'very confident' in using the pen-injector correctly, and most participants (83%; n=49/59) found it 'very easy' to inject the dose2. 'The FRONTIER5 safety and patient-reported outcomes data support Mim8 as a potential future treatment option for people living with haemophilia A and demonstrate our continued commitment to developing innovative treatment options for this community', said Stephanie Seremetis, chief medical officer and CVP for Haemophilia at Novo Nordisk. 'These results give valuable insights into haemophilia A management, highlight the feasibility of directly switching to Mim8 from emicizumab, and reveal a strong patient preference for the Mim8 pen-injector device.' Novo Nordisk expects to submit Mim8 for regulatory review during 2025. Data from the ongoing phase 3 FRONTIER programme will be disclosed at upcoming congresses and in publications in 2025 and 2026. About haemophilia Haemophilia is a rare inherited bleeding disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding4. It is estimated to affect approximately 1,125,000 people worldwide5. There are different types of haemophilia, which are characterised by the type of clotting factor protein that is defective or missing4. Haemophilia A is caused by a missing or defective clotting Factor VIII (FVIII), and haemophilia B is caused by a missing or defective clotting Factor IX4. 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About the FRONTIER5 trial FRONTIER5 is a single-arm, open-label, 26-week, phase 3b trial evaluating the safety of switching from previous emicizumab prophylaxis treatment directly to Mim8 prophylaxis treatment using the Mim8 pen-injector in adults and adolescents with haemophilia A, with or without inhibitors3. The FRONTIER clinical programme investigates Mim8 as a prophylaxis treatment for people with haemophilia A, with or without inhibitors. This programme includes FRONTIER1, FRONTIER2, FRONTIER3, FRONTIER4 and FRONTIER53,12-15. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information _______________________ References Oldenberg J, Benson G, Chowdaryet P, et al. FRONTIER5 direct switch study: Safety of initiating Mim8 prophylaxis without washout of emicizumab. Oral presentation presented at the Congress of the International Society on Thrombosis and Haemostasis 2025; June 21-25 2025; Walter E. Washington Convention Center, Washington D.C., US. Session code 13686. Mahlangu J, Ahuja S, Cockrell E, et al. FRONTIER5 device handling and patient-reported outcomes. Oral presentation presented at the Congress of the International Society on Thrombosis and Haemostasis 2025; June 21–25 2025; Walter E. Washington Convention Center, Washington D.C., US. Session code 13786. A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER5). Available at: Last accessed: June 2025. MedlinePlus. Hemophilia. Available at: Last accessed: June 2025. Iorio A, Stonebraker JS, Chambost H, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach Using National Registries. Ann Intern Med. 2019;171:540–546. doi: 10.7326/M19-1208. Kim JY, You CW. The prevalence and risk factors of inhibitor development of FVIII in previously treated patients with hemophilia A. Blood Res. 2019;54:204-209. doi: 10.5045/br.2019.54.3.204. Ostergaard H, Lund J, Greisen PJ, et al. A factor VIIIa-mimetic bispecific antibody, Mim8, ameliorates bleeding upon severe vascular challenge in hemophilia A mice. Blood. 2021;138:1258-1268. doi: 10.1182/blood.2020010331. Mancuso EM, et al. Efficacy and safety of Mim8 prophylaxis in adults and adolescents with hemophilia A with or without inhibitors: Phase 3, open-label, randomized, controlled FRONTIER2 study. Abstract presented at the International Society on Thrombosis and Haemostasis (ISTH) 2024 Congress. Kenet G, et al. Patient- and caregiver-reported outcomes with subcutaneous Mim8 prophylaxis in paediatric patients with haemophilia A with or without factor VIII inhibitors: phase 3 FRONTIER3 study. Abstract presented at the European Association for Haemophilia and Allied Disorders (EAHAD) 2025 Annual Congress. Session 6. Chowdary P, Banchev AM, Kavakli K, et al. Safety and Efficacy of Mim8 Prophylaxis Administered Once Every Two Weeks for Patients with Hemophilia A with or without Inhibitors: Interim Analysis of the FRONTIER4 Open-Label Extension Study. Abstract presented at the American Society of Hematology (ASH) 2024 Annual Congress. Session: 322. U.S. National Library of Medicine. F8 gene. MedlinePlus Genetics. Available at Last accessed: June 2025. A Research Study Investigating Mim8 in People With Haemophilia A (FRONTIER1). Available at: Last accessed: June 2025. A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors. Available at: Last accessed: June 2025. A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors. Available at: Last accessed: June 2025. A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER4). Available at: Last accessed: June 2025. Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
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