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 <title>HHS Gov News: Secretary Kennedy and Chef André Rush Give Fast-Food Favorite a MAHA Makeover for the Fourth Episode of The Real Food Show</title>
 <link>https://www.hhs.gov/press-room/secretary-kennedy-chef-andre-rush-real-food-show-crunch-wrap.html</link>
 <description>HHS Secretary Kennedy released the fourth episode of the Real Food Show with celebrity chef Andre Rush.</description>
 <pubDate>Fri, 18 Sep 2026 16:22:00 -0400</pubDate>
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 <title>HHS Gov News: HHS Awards More Than $42 Million to States and Territories to Advance ‘Treatment First’ Model in Support of President Trump’s Executive Order</title>
 <link>https://www.hhs.gov/press-room/hhs-awards-42-million-treatment-first-homelessness-addiction-recovery.html</link>
 <description>SAMAHSA announced it awarded $42.3 million in new funding through two federal block grants to advance a “Treatment First” model.</description>
 <pubDate>Fri, 18 Sep 2026 14:02:41 -0400</pubDate>
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 <title>HHS Gov News: HHS Launches First Ever Department-Wide PPE Demand Forecast to Strengthen American Manufacturing</title>
 <link>https://www.hhs.gov/press-room/hhs-launches-ppe-demand-forecast-strengthen-american-manufacturing.html</link>
 <description>HHS announced a new Department-wide policy establishing the HHS Personal Protective Equipment (PPE) Forecast.</description>
 <pubDate>Fri, 18 Sep 2026 10:25:34 -0400</pubDate>
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 <title>Kaiser Health News:Medicaid: Cost-Saving Medicaid Meal Deliveries Threatened by Cuts, Policy Uncertainty</title>
 <link>https://kffhealthnews.org/medicaid/medicaid-meal-deliveries-food-nutrition-waivers-trump-massachusetts-north-carolina/</link>
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&lt;p&gt;On a weekday morning in a quiet Boston neighborhood, a kitchen bustled with activity. Volunteers sliced chicken breasts, stuffed bell peppers, filled trays, and carefully labeled each item. It was part of an experiment to offer nutritious and medically tailored meals to Medicaid patients who are unable to shop for groceries and cook for themselves.&lt;/p&gt;



&lt;p&gt;&amp;#8220;Once I started to eat these meals that were geared toward my illness, I built up my muscle mass again, built up my strength, built up my confidence in myself,&amp;#8221; said Vanessa Georges, who is in remission from throat cancer and said she would struggle to consume enough calories without the deliveries. &amp;#8220;These meals have given me a second chance.&amp;#8221;&lt;/p&gt;



&lt;p&gt;Georges said she noticed another benefit from the meals: She spends less time at the doctor&amp;#8217;s office.&lt;/p&gt;



&lt;p&gt;Researchers have found evidence backing her observation. About 1,900 Massachusetts residents who, like Georges, received medically tailored meals for at least three months needed less medical care, according to &lt;a href=&quot;https://www.nature.com/articles/s41591-026-04407-5&quot;&gt;a study&lt;/a&gt; published in the journal Nature Medicine. They had 20% fewer emergency department visits and 31% fewer hospitalizations than similar patients who did not receive meals.&lt;/p&gt;



&lt;p&gt;&amp;#8220;It actually saves the healthcare system money,&amp;#8221; said &lt;a href=&quot;https://nutrition.tufts.edu/academics/faculty/dariush-mozaffarian&quot;&gt;Dariush Mozaffarian&lt;/a&gt;, a cardiologist and professor at Tufts University who led the study. &amp;#8220;That&amp;#8217;s a really big deal, because most things in healthcare don&amp;#8217;t.&amp;#8221;&lt;/p&gt;



&lt;p&gt;The research from Massachusetts &lt;a href=&quot;https://jamanetwork.com/journals/jama/fullarticle/2830892&quot;&gt;adds to evidence&lt;/a&gt; that medically tailored meals could save states money — in addition to improving health. Yet such programs could land on the chopping block as states look to tighten spending under Trump administration budget cuts, even as federal officials argue that food is a critical component of health.&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;Medicaid Budget Cuts Loom&lt;/strong&gt;&lt;/p&gt;



&lt;p&gt;The 2025 law known as the One Big Beautiful Bill Act slashed projected Medicaid funding by more than $900 billion. Many Republicans who backed the bill believe federal health spending is too high and riddled with fraud. Sen. John Kennedy, a Louisiana Republican, for example, has accused California of &lt;a href=&quot;https://kffhealthnews.org/medicaid/medicaid-social-services-gavin-newsom-california-republican-criticism/&quot;&gt;&amp;#8220;outrageous fraud&amp;#8221;&lt;/a&gt; for using Medicaid dollars to fund housing and nutrition programs.&lt;/p&gt;



&lt;p&gt;&lt;a href=&quot;https://www.kff.org/person/amaya-diana/&quot;&gt;Amaya Diana&lt;/a&gt;, a policy analyst at KFF, said states will have to make tough choices in the next few years as they figure out how to fill funding gaps. &amp;#8220;If states are not able to offset the loss of federal funds with new taxes or reductions in other state spending, they may have to make program cuts,&amp;#8221; she said. (KFF is a health information nonprofit that includes KFF Health News.)&lt;/p&gt;



&lt;p&gt;Thirteen states have received federal waivers to use Medicaid dollars to pay for meals — part of an approach known as &amp;#8220;food is medicine.&amp;#8221; Three other programs are awaiting federal approval.&lt;/p&gt;



&lt;p&gt;President Donald Trump&amp;#8217;s support for social services has wavered. While the first Trump administration &lt;a href=&quot;https://kffhealthnews.org/medicaid/medicaid-medi-cal-social-determinants-health-california-guidance-trump-cms/&quot;&gt;allowed states&lt;/a&gt; to pursue medically tailored meals and other social supports, the second Trump administration &lt;a href=&quot;https://www.medicaid.gov/federal-policy-guidance/downloads/cib03042025.pdf&quot;&gt;rescinded Biden-era guidance&lt;/a&gt; for Medicaid initiatives that address social needs. It hasn&amp;#8217;t detailed a new policy. Administration officials have warned that they will be more focused on the &lt;a href=&quot;https://kffhealthnews.org/medicaid/trump-cms-medicaid-expansion-1115-waivers-budget-neutrality-arkansas/&quot; data-type=&quot;link&quot; data-id=&quot;https://kffhealthnews.org/medicaid/trump-cms-medicaid-expansion-1115-waivers-budget-neutrality-arkansas/&quot;&gt;budget impacts&lt;/a&gt; of such initiatives.&lt;/p&gt;



&lt;p&gt;&amp;#8220;They signaled they&amp;#8217;re going to be a lot more skeptical,&amp;#8221; said &lt;a href=&quot;https://profiles.umassmed.edu/display/33591707&quot;&gt;Kurt Hager&lt;/a&gt;, an assistant professor at the University of Massachusetts Chan Medical School who studies nutrition programs and helped lead the Massachusetts study. &amp;#8220;Instead of using a broad-based approach nationwide, they&amp;#8217;re going to make decisions on a state-by-state basis.&amp;#8221;&lt;/p&gt;



&lt;p&gt;At the same time, health leaders in Trump&amp;#8217;s administration have made nutrition a major focus, including by promoting &lt;a href=&quot;https://realfood.gov/&quot;&gt;less-processed foods&lt;/a&gt;. Robert F. Kennedy Jr., who leads the Department of Health and Human Services, and Mehmet Oz, administrator of the Centers for Medicare &amp;amp; Medicaid Services, have &lt;a href=&quot;https://www.hhs.gov/press-room/secretary-kennedy-administrator-oz-launch-make-hospital-food-healthier-pledge.html&quot;&gt;pushed hospitals&lt;/a&gt; to serve healthier foods to boost patient outcomes.&lt;/p&gt;



&lt;figure&gt;&lt;img decoding=&quot;async&quot; src=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/CommunityServings_02.jpg&quot; alt=&quot;Trays of meals &quot; /&gt;&lt;figcaption&gt;Trays of stuffed peppers and carrots from Community Servings are ready to be sealed and delivered to Boston-area residents who receive medically tailored meals.  (Robin Lubbock/WBUR)&lt;/figcaption&gt;&lt;/figure&gt;



&lt;p&gt;The healthcare system is often willing to pay for surgeries, Oz said in a social media video in June, &amp;#8220;but not always willing to pay for the nutrition that might help prevent those outcomes in the first place. That&amp;#8217;s bothered me my whole career.&amp;#8221; He added that the agency is &lt;a href=&quot;https://www.instagram.com/reels/DaDOT8KyCq9/&quot;&gt;evaluating several strategies&lt;/a&gt;, including medically tailored meals, to prevent illness and hospitalization. CMS officials did not respond to several emailed requests for comment for this article.&lt;/p&gt;



&lt;p&gt;&lt;a href=&quot;https://chlpi.org/about-us/staff/katie-garfield/&quot;&gt;Katie Garfield&lt;/a&gt;, who studies social determinants of health at Harvard Law School&amp;#8217;s Center for Health Law and Policy Innovation, said the lack of federal guidance is stirring uncertainty for states that want to pursue nutrition programs in Medicaid. &amp;#8220;We&amp;#8217;re still waiting to see that big step forward around ‘food is medicine&amp;#8217; interventions,&amp;#8221; she said. &amp;#8220;We need to see that step forward to resolve some of the uncertainty.&amp;#8221;&lt;/p&gt;



&lt;p&gt;Lawmakers have had a hard time engaging administration officials on medically tailored meals, said U.S. Rep. Jim McGovern, a Massachusetts Democrat who sponsored a bill that would pilot meal deliveries for some &lt;a href=&quot;https://mcgovern.house.gov/news/documentsingle.aspx?DocumentID=400249&quot;&gt;chronically ill seniors on Medicare&lt;/a&gt;. The legislation has yet to come up for a vote.&lt;/p&gt;



&lt;p&gt;&amp;#8220;I had thought, based on some of his rhetoric before he entered the Trump administration, that RFK Jr. would be a natural ally on this,&amp;#8221; McGovern said. &amp;#8220;But we can&amp;#8217;t seem to get his attention.&amp;#8221;&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;The Costs of Poor Nutrition&lt;/strong&gt;&lt;/p&gt;



&lt;p&gt;Some companies have been accused of &lt;a href=&quot;https://www.statnews.com/2024/07/11/medicaid-food-is-medicine-medically-tailored-meals-quality-questioned/&quot;&gt;billing Medicaid&lt;/a&gt; for meals that were neither healthy nor nutritious, raising concerns about lax regulation of these programs.&lt;/p&gt;



&lt;p&gt;But at &lt;a href=&quot;https://www.servings.org/&quot;&gt;Community Servings&lt;/a&gt; in Boston, the food is prepared with specific attention to sugar, salt, fat, vitamins, and minerals and is based on a person&amp;#8217;s health needs, said &lt;a href=&quot;https://www.servings.org/about-us/staff/&quot;&gt;David Waters&lt;/a&gt;, chief executive of the nonprofit. Many recipients require food that is mild or low in fiber, for example.&lt;/p&gt;



&lt;p&gt;&amp;#8220;What we&amp;#8217;re able to do is to work with your healthcare provider to understand your health realities — what your diagnoses are, what your medications are, side effects, food allergies, cultural norms — and then prescribe a diet for you that is scratch-made,&amp;#8221; Waters said.&lt;/p&gt;



&lt;p&gt;The Massachusetts researchers found that the meals — at a cost of $125 per person per week — essentially paid for themselves. Patients with heart disease used about $10,000 less in healthcare services over six months, and patients with kidney disease used $12,000 less in healthcare. There were also savings for people with diabetes, depression, and anxiety.&lt;/p&gt;



&lt;p&gt;&amp;#8220;Those are pretty big numbers when you think of how expensive those diseases can be and the prevalence in the population,&amp;#8221; Waters said.&lt;/p&gt;



&lt;p&gt;Nationally, &lt;a href=&quot;https://www.healthaffairs.org/doi/10.1377/hlthaff.2024.01307&quot;&gt;researchers estimate&lt;/a&gt;, 10 million Americans would benefit from medically tailored meals, though only a small fraction are enrolled.&lt;/p&gt;



&lt;p&gt;&amp;#8220;Poor nutrition is the top cause of poor health in this country. It&amp;#8217;s the top cause of preventable healthcare spending,&amp;#8221; said Mozaffarian, director of the Food is Medicine Institute at Tufts. He has estimated that medically tailored meals could help patients avoid 1.6 million hospitalizations and &lt;a href=&quot;https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2797397&quot;&gt;save the U.S. $13.6 billion&lt;/a&gt; in healthcare costs each year.&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;A Weekly Delivery That Makes a Difference&lt;/strong&gt;&lt;/p&gt;



&lt;p&gt;Steve Honyotski receives 10 meals at his Boston home each week, cooked fresh and delivered cold or flash-frozen. They&amp;#8217;re ready to eat after just a couple of minutes in the microwave.&lt;/p&gt;



&lt;p&gt;&amp;#8220;The carrot ginger soup is my favorite,&amp;#8221; Honyotski said.&lt;/p&gt;



&lt;p&gt;Honyotski, 71, lives with several chronic conditions, including diabetes, obesity, and high blood pressure. He said he&amp;#8217;s noticed improvements in his health since he started eating medically tailored meals. He needs less insulin to control his diabetes, and he&amp;#8217;s lost enough weight to delay a knee replacement surgery.&lt;/p&gt;



&lt;figure&gt;&lt;img decoding=&quot;async&quot; src=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/CommunityServings_04.jpg&quot; alt=&quot;The exterior of a building &quot; /&gt;&lt;figcaption&gt;Community Servings is a nonprofit that provides medically tailored meals in the Jamaica Plain neighborhood of Boston.  (Robin Lubbock/WBUR)&lt;/figcaption&gt;&lt;/figure&gt;



&lt;p&gt;For now, those meals will keep coming. And Massachusetts&amp;#8217; Medicaid director, Ryan Schwarz, said the state will seek federal approval to continue medically tailored meals in the coming years. &amp;#8220;We feel very strongly committed to continuing these services,&amp;#8221; he said.&lt;/p&gt;



&lt;p&gt;In North Carolina, researchers found that food and housing supports lowered Medicaid spending over time. Yet even with federal approval for medically tailored meals, and evidence that the meals — along with housing and transportation support — were helping people, North Carolina state lawmakers suspended the services in 2025 over budget worries. After budget deliberations this summer, state legislators changed course and decided to &lt;a href=&quot;https://www.northcarolinahealthnews.org/2026/07/01/nc-full-budget-reflects-transformed-health-landscape/&quot;&gt;partially fund&lt;/a&gt; the program.&lt;/p&gt;



&lt;p&gt;&amp;#8220;To me, that&amp;#8217;s a signal of what might occur in other states as these Medicaid cuts hit,&amp;#8221; said Hager, the UMass researcher. &amp;#8220;Even though they have the authority to run these programs, it might be a lot harder for the states to actually implement them.&amp;#8221;&lt;/p&gt;



&lt;p&gt;&lt;em&gt;This article is from a partnership that includes&amp;nbsp;&lt;em&gt;&lt;a href=&quot;https://www.wbur.org/&quot;&gt;WBUR&lt;/a&gt;&lt;/em&gt;,&amp;nbsp;&lt;a href=&quot;https://www.npr.org/&quot;&gt;NPR&lt;/a&gt;, and KFF Health News.&lt;/em&gt;&lt;/p&gt;






&lt;em&gt;&lt;a href=&quot;https://kffhealthnews.org/about-us&quot;&gt;KFF Health News&lt;/a&gt; is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about &lt;a href=&quot;https://www.kff.org/about-us&quot;&gt;KFF&lt;/a&gt;.&lt;/em&gt;&lt;p&gt;This &lt;a target=&quot;_blank&quot; href=&quot;https://kffhealthnews.org/medicaid/medicaid-meal-deliveries-food-nutrition-waivers-trump-massachusetts-north-carolina/&quot;&gt;article&lt;/a&gt; first appeared on &lt;a target=&quot;_blank&quot; href=&quot;https://kffhealthnews.org&quot;&gt;KFF Health News&lt;/a&gt; and is republished here under a &lt;a target=&quot;_blank&quot; href=&quot;https://creativecommons.org/licenses/by-nc-nd/4.0/&quot;&gt;Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License&lt;/a&gt;.&lt;/p&gt;
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 <pubDate>Fri, 18 Sep 2026 05:00:00 -0400</pubDate>
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 <title>Kaiser Health News:Health Industry: The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done.</title>
 <link>https://kffhealthnews.org/health-industry/fda-approval-drugs-medical-devices-postmarket-studies-safety-delays-amgen-tavneos/</link>
 <description>&lt;p&gt;When the FDA was deciding whether to approve the drug Tavneos several years ago to treat a set of &lt;a href=&quot;https://my.clevelandclinic.org/health/diseases/anca-vasculitis&quot;&gt;rare autoimmune diseases&lt;/a&gt;, agency experts argued that would be a mistake, according to &lt;a href=&quot;https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214487Orig1s000MultidisciplineR.pdf#page=215&quot;&gt;FDA records&lt;/a&gt;.&lt;/p&gt;



&lt;p&gt;One problem cited: The manufacturer had provided only &lt;a href=&quot;https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214487Orig1s000MultidisciplineR.pdf#page=170&quot;&gt;&amp;#8220;limited safety data.&amp;#8221;&lt;/a&gt;&lt;/p&gt;



&lt;p&gt;As it often does, the FDA in 2021 approved the drug with a proviso: It required the manufacturer to conduct an additional years-long safety study once the drug was on the market.&lt;/p&gt;



&lt;p&gt;Today, like many similar &amp;#8220;postmarket&amp;#8221; studies mandated by the FDA, that additional study &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/Tavneos-Study-Listed-as-Delayed-8-18-2026.pdf&quot;&gt;is delayed&lt;/a&gt;, according to a &lt;a href=&quot;https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm&quot;&gt;federal database&lt;/a&gt;. As of last fall, only 21 of the planned 300 patients had been enrolled, the FDA said in an &lt;a href=&quot;https://www.fda.gov/media/192160/download?attachment#page=13&quot;&gt;April letter&lt;/a&gt; and &lt;a href=&quot;https://www.federalregister.gov/d/2026-08455/p-70&quot;&gt;regulatory posting&lt;/a&gt;.&lt;/p&gt;



&lt;p&gt;Meanwhile, the FDA has &lt;a href=&quot;https://www.fda.gov/drugs/drug-safety-communications/fda-identifies-cases-serious-liver-injury-patients-taking-tavneos-avacopan-severe-active-anti&quot;&gt;identified&lt;/a&gt; dozens of cases of &lt;a href=&quot;https://www.federalregister.gov/documents/2026/04/30/2026-08455/chemocentryx-inc-proposal-to-withdraw-approval-of-new-drug-application-for-tavneos-avacopan-capsule#p-100&quot;&gt;liver damage&lt;/a&gt; &amp;#8220;possibly&amp;#8221; or &amp;#8220;probably causally associated&amp;#8221; with the drug. That was one of the potential side effects the postmarket study was meant to evaluate.&lt;/p&gt;



&lt;p&gt;Tavneos illustrates the perils of the FDA&amp;#8217;s approach to many drugs and medical devices — and the frequent lapses in follow-through.&lt;/p&gt;



&lt;p&gt;A KFF Health News analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the work was delayed by more than a decade or the manufacturer was still developing a plan for the study.&lt;/p&gt;



&lt;p&gt;As a result of delays, patients, doctors, and others could be left in a fog about the risks and benefits of the drugs or devices, even as they stake their money, their health, or their lives on the products.&lt;/p&gt;



&lt;p&gt;Postmarket study requirements &amp;#8220;have often proven toothless,&amp;#8221; said cardiologist &lt;a href=&quot;https://profiles.ucsf.edu/sanket.dhruva&quot;&gt;Sanket Dhruva&lt;/a&gt;, an associate professor of medicine at the University of California-San Francisco who has published &lt;a href=&quot;https://pmc.ncbi.nlm.nih.gov/articles/PMC5967364/&quot;&gt;related research&lt;/a&gt;.&lt;/p&gt;



&lt;p&gt;The FDA&amp;#8217;s reliance on postmarket studies reflects a balancing act.&lt;/p&gt;



&lt;p&gt;Making new treatments available faster can save or improve lives, especially when patients with grim prognoses and no good options have little to lose. The full risks and benefits may be revealed only over the long term, and when therapies are used by far more people than even large clinical trials enroll.&lt;/p&gt;



&lt;p&gt;But relying on post-approval studies to resolve questions risks exposing patients to products that do more harm than good. Whoever is paying the bills — patients, insurance companies, employers, or government health programs such as Medicare and Medicaid — can end up wasting money and rewarding manufacturers for useless or risky products.&lt;/p&gt;



&lt;p&gt;&amp;#8220;Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it&amp;#8217;s going to lead to a lot of uncertainty,&amp;#8221; Dhruva said.&lt;/p&gt;



&lt;p&gt;Trump administration policy changes designed to hasten drugs through FDA review could leave more riding on postmarket studies, medical researchers say.&lt;/p&gt;



&lt;p&gt;For example, in February, &lt;a href=&quot;https://www.nejm.org/doi/full/10.1056/NEJMsb2517623&quot;&gt;FDA leaders announced&lt;/a&gt; that &amp;#8220;the default requirement&amp;#8221; for agency approvals will be one clinical trial instead of two.&lt;/p&gt;



&lt;p&gt;Reducing pre-approval testing &amp;#8220;will inevitably put a lot of pressure on the post-approval system,&amp;#8221; said &lt;a href=&quot;https://portalresearch.org/team/aaron-kesselheim/&quot;&gt;Aaron Kesselheim&lt;/a&gt;, a professor at Harvard Medical School who &lt;a href=&quot;https://www.nejm.org/doi/full/10.1056/NEJMp2400699?logout=true&quot;&gt;has analyzed&lt;/a&gt; postmarket studies.&lt;/p&gt;



&lt;p&gt;FDA officials said the new policy would &amp;#8220;substantially reduce costs&amp;#8221; for manufacturers and &amp;#8220;speed drugs to market.&amp;#8221; Writing in The New England Journal of Medicine, they denied the change would compromise safety or efficacy, saying that &amp;#8220;erroneous conclusions may be reached even with two, three, or four studies.&amp;#8221;&lt;/p&gt;



&lt;p&gt;In response to questions for this article, a spokesperson for the Department of Health and Human Services, which includes the FDA, said postmarket studies can experience delays for legitimate reasons. &amp;#8220;Assessing the significance of any delay requires a case-specific review,&amp;#8221; said the spokesperson, Emily Hilliard.&lt;/p&gt;



&lt;p&gt;The fact that a study is delayed &amp;#8220;should not be treated as evidence that a product has an unresolved safety or effectiveness issue,&amp;#8221; Hilliard said.&lt;/p&gt;



&lt;p&gt;Amgen, the company that makes Tavneos, is still working on the postmarket research the FDA mandated, company spokesperson Alison Chartan said, adding, &amp;#8220;We remain committed to completing this important study.&amp;#8221;&lt;/p&gt;



&lt;figure&gt;&lt;img decoding=&quot;async&quot; src=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/GettyImages-1491079744-resize.jpg&quot; alt=&quot;An aerial photo shows a large company headquarters with various buildings.&quot; /&gt;&lt;figcaption&gt;Amgen&amp;#8217;s headquarters in Thousand Oaks, California, in May 2023. (Mario Tama/Getty Images)&lt;/figcaption&gt;&lt;/figure&gt;



&lt;p&gt;&lt;strong&gt;Behind Schedule&lt;/strong&gt;&lt;/p&gt;



&lt;p&gt;An FDA database downloaded by KFF Health News in August tracks the progress of postmarket studies that makers of &lt;a href=&quot;https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm&quot;&gt;drugs or biologics&lt;/a&gt; — such as vaccines and gene therapies — were required to perform or promised to perform.&lt;/p&gt;



&lt;p&gt;The database showed almost 600 were running behind schedule.&lt;/p&gt;



&lt;p&gt;Of those, more than 250 originally had final reports due before July 31, 2026 — the date that, according to an FDA webpage, the database last had been updated.&lt;/p&gt;



&lt;p&gt;About a third of ongoing studies were listed as delayed.&lt;/p&gt;



&lt;p&gt;In some cases, the FDA has granted extensions. In others, it has denied them. And in rare instances, the products were discontinued before the studies ran their course.&lt;/p&gt;



&lt;p&gt;Postmarket studies can involve clinical trials or other analyses of patient data. They can look at safety or efficacy. A product can be the subject of more than one postmarket study.&lt;/p&gt;



&lt;p&gt;The nearly 600 delayed studies involved almost 350 products, KFF Health News found.&lt;/p&gt;



&lt;p&gt;The FDA has defined delayed as &lt;a href=&quot;https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-status-and-fulfillment-categories&quot;&gt;behind the original schedule&lt;/a&gt;. That can mean off track or overdue.&lt;/p&gt;



&lt;p&gt;As of August, other FDA databases tracking &lt;a href=&quot;https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm&quot;&gt;medical&lt;/a&gt; &lt;a href=&quot;https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pss.cfm&quot;&gt;devices&lt;/a&gt; listed dozens of postmarket studies as behind schedule.&lt;/p&gt;



&lt;p&gt;Products included:&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;The CustomFlex Artificial Iris,&lt;/strong&gt; a prosthesis implanted in the eye in place of damaged, defective, or congenitally missing irises. The protocol for a study in children was accepted in 2019, the database said. The study was meant to follow patients for five years. According to an FDA page downloaded in August, &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/CustomFlex-Artificial-Iris-Study-Listed-as-Delayed-8-18-2026.pdf&quot;&gt;zero patients&lt;/a&gt; were enrolled.&lt;/p&gt;



&lt;p&gt;Barbara Fant of Clinical Research Consultants, to whom the FDA&amp;#8217;s 2018 &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/CustomFlex-Artificial-Iris-Approval-Letter.pdf&quot;&gt;letter approving the product&lt;/a&gt; was addressed, said the rarity of an eye disease called aniridia poses challenges for post-approval studies. The German manufacturer, the U.S. distributor, and Clinical Research Consultants are working with the FDA to identify alternative ways to fulfill the postmarket requirements, Fant said.&lt;/p&gt;



&lt;p&gt;&amp;#8220;Confirming the long-term safety of the device remains a top priority for both the study team and FDA,&amp;#8221; Fant said.&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;Paxlovid,&lt;/strong&gt; a treatment for covid. A study to assess its &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/Paxlovid-Study-Listed-as-Delayed-8-18-2026.pdf&quot;&gt;safety in pregnant women&lt;/a&gt; was originally to be completed by the end of 2024, the FDA database said. &amp;#8220;The trial completion and final report milestones were missed,&amp;#8221; the database said.&lt;/p&gt;



&lt;p&gt;Pfizer, the manufacturer, is working with the FDA and remains committed to &amp;#8220;submitting results as soon as practicable,&amp;#8221; Pfizer spokesperson Jerica Pitts said.&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;The Scandinavian Total Ankle Replacement system.&lt;/strong&gt; The device and the original protocol for the clinical trial were approved in 2009. The study was meant to include a minimum of 500 subjects, the database said, but the actual number enrolled was 142. Almost half those patients had one or more &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/Scandinavian-Total-Ankle-Replacement-System-Study-Listed-as-Delayed-8-18-2026.pdf&quot;&gt;adverse events&lt;/a&gt;, with dozens of &amp;#8220;reoperations,&amp;#8221; &amp;#8220;revisions,&amp;#8221; or &amp;#8220;removals,&amp;#8221; the database said.&lt;/p&gt;



&lt;p&gt;Rachel Colloff and Cristina Pasquino — spokespeople for Enovis, which markets STAR Ankle — did not respond to multiple inquiries. Jenny Braga, a spokesperson for Stryker, which previously sold the product, did not answer questions about the postmarket study.&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;Oxaydo (originally named Oxecta),&lt;/strong&gt; a form of the potentially addictive opioid painkiller oxycodone &lt;a href=&quot;https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_acura_announce_fda_approval_of_oxectatm_oxycodone_hcl_usp_cii&quot;&gt;touted as designed to deter abuse&lt;/a&gt;. When the FDA approved it in 2011, &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/Oxaydo-Approval-Letter.pdf#page=3&quot;&gt;it required&lt;/a&gt; the manufacturer, &lt;a href=&quot;https://www.pfizer.com/news/press-release/press-release-detail/pfizer_completes_acquisition_of_king_pharmaceuticals_inc&quot;&gt;part of Pfizer&lt;/a&gt;, to conduct a postmarket study to assess whether it reduces &amp;#8220;misuse and abuse, and their consequences: overdose, death and addiction.&amp;#8221; The final report was originally scheduled to be submitted in 2016.&lt;/p&gt;



&lt;p&gt;The FDA database &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/Oxaydo-Study-Listed-as-Delayed-8-18-2026.pdf&quot;&gt;listing the study as delayed&lt;/a&gt; said the agency &amp;#8220;issued a failure to respond letter&amp;#8221; in 2022.&lt;/p&gt;



&lt;p&gt;Today the issue may be all but moot. &amp;nbsp;&lt;/p&gt;



&lt;p&gt;Control of the product passed from company to company over the years until 2023, when Acura Pharmaceuticals said in a &lt;a href=&quot;https://investors.acurapharm.com/static-files/09fc17ed-9482-47a5-bcd0-e319fa873ddb&quot;&gt;Securities and Exchange Commission filing&lt;/a&gt; that patents on Oxaydo would begin expiring that year and it didn&amp;#8217;t intend to continue marketing the drug.&lt;/p&gt;



&lt;p&gt;According to another FDA database, Oxaydo &lt;a href=&quot;https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&amp;amp;Appl_No=202080#18474&quot;&gt;has been discontinued&lt;/a&gt;.&lt;/p&gt;



&lt;p&gt;The FDA has enforcement powers and uses them &amp;#8220;where appropriate,&amp;#8221; HHS&amp;#8217; Hilliard said. She did not provide requested details, and she did not answer questions about the studies listed above.&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;Delay Can Pay&lt;/strong&gt;&lt;/p&gt;



&lt;p&gt;For manufacturers, delay can pay, Harvard&amp;#8217;s Kesselheim said. While postmarket studies are ongoing, companies can continue to sell the products.&lt;/p&gt;



&lt;p&gt;&amp;#8220;Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for accelerated approval drugs with incomplete confirmatory trials past their original planned completion dates,&amp;#8221; the HHS Office of Inspector General &lt;a href=&quot;https://oig.hhs.gov/documents/evaluation/2622/OEI-01-21-00401-Complete%20Report.pdf&quot;&gt;estimated in 2022&lt;/a&gt;.&lt;/p&gt;



&lt;p&gt;The FDA can demand postmarket studies for a variety of reasons, including to address concerns that arise after a product has been approved. Some look at uses not covered by the original approval, and some are meant to shed light on &lt;a href=&quot;https://www.fda.gov/media/192138/download?attachment#page=1&quot;&gt;serious risks&lt;/a&gt; that are already known.&lt;/p&gt;



&lt;p&gt;In April, when it approved Foundayo, a weight loss drug made by Eli Lilly, the FDA required the company to conduct &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/Foundayo-Approval-Letter.pdf#page=4&quot;&gt;additional research&lt;/a&gt; to assess a variety of concerns, including &amp;#8220;retained gastric contents,&amp;#8221; &amp;#8220;major adverse cardiovascular events,&amp;#8221; and &amp;#8220;drug-induced liver injury,&amp;#8221; as well as effects of exposure during pregnancy, such as &amp;#8220;major congenital malformations,&amp;#8221; &amp;#8220;spontaneous abortions,&amp;#8221; and &amp;#8220;stillbirths.&amp;#8221;&lt;/p&gt;



&lt;p&gt;The FDA said it approved the drug under the new Commissioner&amp;#8217;s National Priority Voucher program, intended for products that &amp;#8220;&lt;a href=&quot;https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program&quot;&gt;address critical national health priorities&lt;/a&gt;.&amp;#8221; The program strives for an &amp;#8220;&lt;a href=&quot;https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program&quot;&gt;ultra-fast&lt;/a&gt;&amp;#8221; review, the FDA has said — one to two months, instead of six months or more with other expedited pathways.&lt;/p&gt;



&lt;p&gt;&amp;#8220;Postmarketing requirements and enhanced safety monitoring are a routine part of the FDA&amp;#8217;s approach to evaluating newly approved medicines,&amp;#8221; Eli Lilly spokesperson Kristiane Silva Bello said, &amp;#8220;including ongoing monitoring in areas identified during clinical development.&amp;#8221;&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;‘False Hope&amp;#8217;&lt;/strong&gt;&lt;/p&gt;



&lt;p&gt;The FDA waded into a world of uncertainty in 2016 when it granted accelerated approval to a drug for Duchenne muscular dystrophy, a degenerative disease that primarily affects boys, disabling them at a young age and ultimately killing them.&lt;/p&gt;



&lt;p&gt;Agency scientists had found that the drug, Exondys 51, was unproven and argued against greenlighting it.&lt;/p&gt;



&lt;p&gt;Ellis Unger, then a senior drug evaluation official at the FDA, &lt;a href=&quot;https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_summary%20review_Redacted.pdf#page=62&quot;&gt;wrote in an internal memo&lt;/a&gt; that &amp;#8220;thousands of patients and their families would be given false hope in exchange for hardship and risk.&amp;#8221;&lt;/p&gt;



&lt;p&gt;The manufacturer, Sarepta Therapeutics, &lt;a href=&quot;https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-fda-accelerated-approval-exondys#:~:text=%E2%80%9CToday&quot;s%20accelerated%20approval%20of%20EXONDYS,of%20the%20dystrophin%20protein%2C%E2%80%9D%20said&quot;&gt;conceded the uncertainty&lt;/a&gt;. &amp;#8220;A clinical benefit of EXONDYS 51 has not been established,&amp;#8221; it said when the drug, also known by the generic name eteplirsen, was approved.&lt;/p&gt;



&lt;p&gt;The drug, the first FDA-approved treatment for Duchenne muscular dystrophy, targeted a subset of patients with the disease.&lt;/p&gt;



&lt;p&gt;The FDA required Sarepta to conduct further studies and &lt;a href=&quot;https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488Orig1s000Approv.pdf#page=6&quot;&gt;warned that&lt;/a&gt; it could withdraw approval if postmarket trials failed to verify a clinical benefit or were &amp;#8220;not conducted with due diligence.&amp;#8221;&lt;/p&gt;



&lt;p&gt;Unger issued a warning of his own: &amp;#8220;FDA has not succeeded in withdrawing the marketing of a single drug for lack of verification of clinical benefit following accelerated approval. The reality is that if eteplirsen is given accelerated approval, it is highly likely to remain on the market indefinitely, irrespective of whether or not efficacy is verified.&amp;#8221;&lt;/p&gt;



&lt;p&gt;Sarepta was originally required to submit a final report on a postmarket study by a May 2021 deadline, according to an FDA database and a 2016 &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/Exondys-51-Approval-Letter.pdf#page=6&quot;&gt;FDA letter to the company&lt;/a&gt;.&lt;/p&gt;



&lt;p&gt;Almost a decade after the drug was approved, and more than five years after that deadline, the study was listed in an FDA database &lt;a href=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/Exondys-51-Study-Listed-as-Delayed-8-18-2026.pdf&quot;&gt;as delayed&lt;/a&gt;.&lt;/p&gt;



&lt;p&gt;&amp;#8220;The final report milestone was missed, because the sponsor requested milestone extensions due to study delays,&amp;#8221;&amp;nbsp; the database said.&lt;/p&gt;



&lt;p&gt;Meanwhile, in 2022 the website &lt;a href=&quot;https://www.pharmaceutical-technology.com/features/most-expensive-drugs-us/&quot;&gt;Pharmaceutical Technology&lt;/a&gt; ranked Exondys 51 as the second-most expensive drug in the U.S., at an annual cost of $750,000 to $1.5 million.&lt;/p&gt;



&lt;p&gt;Last year, the drug generated &lt;a href=&quot;https://investorrelations.sarepta.com/static-files/c10ec226-e90e-4f62-a722-ed73fa1dc486&quot;&gt;$538 million in sales&lt;/a&gt; for Sarepta, according to a company presentation to investors.&lt;/p&gt;



&lt;p&gt;Sarepta found it difficult to recruit patients for the postmarket clinical trial, company spokesperson Tracy Sorrentino said. The target population is small, patients were hesitant to enroll, and Sarepta was competing with other clinical trials for participants, Sorrentino said.&lt;/p&gt;



&lt;p&gt;The study has been fully enrolled since 2023, Sorrentino said, and the company plans to provide an initial look at the data late this year.&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;‘Manipulated&amp;#8217;&lt;/strong&gt;&lt;/p&gt;



&lt;figure&gt;&lt;img decoding=&quot;async&quot; src=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/08/GettyImages-2285340858-resized.jpg&quot; alt=&quot;A pair of hands holds a bottle of Amgen&#039;s drug Tavneos.&quot; /&gt;&lt;figcaption&gt;Amgen is the maker of the drug Tavneos. (Hannah Yoon/Bloomberg via Getty Images)&lt;/figcaption&gt;&lt;/figure&gt;



&lt;p&gt;Amgen has cited similar challenges, even as Tavneos generated $459 million in global sales last year.&lt;/p&gt;



&lt;p&gt;When an approved treatment is available, patients may be reluctant to enroll in a study in which they could be given a placebo, Amgen&amp;#8217;s Chartan said.&lt;/p&gt;



&lt;p&gt;The clinical trial &lt;a href=&quot;https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214487Orig1s000ltr.pdf#page=3&quot;&gt;was originally&lt;/a&gt; supposed to be done &lt;a href=&quot;https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214487Orig1s000MultidisciplineR.pdf#page=233&quot;&gt;by the end of 2030&lt;/a&gt;. As of July 24, just 49 patients had been enrolled, Chartan said.&lt;/p&gt;



&lt;p&gt;The FDA has said the study was to include &lt;a href=&quot;https://www.federalregister.gov/documents/2026/04/30/2026-08455/chemocentryx-inc-proposal-to-withdraw-approval-of-new-drug-application-for-tavneos-avacopan-capsule#p-70&quot;&gt;300 patients&lt;/a&gt;, and each patient enrolled must be followed for five years, said Hilliard, the HHS spokesperson.&lt;/p&gt;



&lt;p&gt;Tavneos was approved to treat severe cases of a group of diseases — known by the shorthand ANCA-associated vasculitis — in which, as the &lt;a href=&quot;https://my.clevelandclinic.org/health/diseases/anca-vasculitis&quot;&gt;Cleveland Clinic&lt;/a&gt; explains, the immune system inflicts potentially fatal damage on blood vessels and organs.&amp;nbsp;&lt;/p&gt;



&lt;p&gt;&amp;#8220;As of January 2026, estimated real-world exposure&amp;#8221; to Tavneos &amp;#8220;exceeds 25,000 patient-years globally, consisting of over 6,500 in the United States and 19,000 abroad,&amp;#8221; Amgen has said. (For context, one patient taking a drug for five years would amount to five &amp;#8220;patient-years.&amp;#8221;)&lt;/p&gt;



&lt;p&gt;A clinical trial sponsored by ChemoCentryx to secure approval of Tavneos failed to prove it was effective, the FDA now alleges. Instead of disclosing that outcome to the FDA, company personnel &amp;#8220;&lt;a href=&quot;https://www.fda.gov/media/192160/download?attachment#page=8&quot;&gt;manipulated&lt;/a&gt;&amp;#8221; the &lt;a href=&quot;https://www.federalregister.gov/d/2026-08455/p-51&quot;&gt;results&lt;/a&gt;, the FDA alleged in an &lt;a href=&quot;https://www.fda.gov/media/192160/download?attachment&quot;&gt;April letter&lt;/a&gt; to Amgen.&lt;/p&gt;



&lt;p&gt;Amgen, the parent company of ChemoCentryx, has denied the results were manipulated and has said the data &amp;#8220;&lt;a href=&quot;https://wwwext.amgen.com/newsroom/company-statements/-/media/Themes/CorporateAffairs/amgen-com/amgen-com/downloads/newsroom/AmgenResponse,-d-,7,-d-,23,-d-,2026_REDACTED.pdf?_gl=1*e6mjq3*_up*MQ..*_ga*MzIwNjQ5OTk3LjE3ODQ4OTQ0Njg.*_ga_CBMSV0J9VL*czE3ODQ4OTQ0NjckbzEkZzEkdDE3ODQ4OTQ1MDEkajI2JGwwJGgw#page=13&quot;&gt;remain valid&lt;/a&gt;.&amp;#8221;&lt;/p&gt;



&lt;p&gt;Nonetheless, the &lt;a href=&quot;https://www.ema.europa.eu/en/medicines/human/referrals/tavneos#key-facts&quot;&gt;European Union&lt;/a&gt; recently &lt;a href=&quot;https://newsroom.csl.com/2026-08-06-European-Commission-EC-adopts-decision-to-revoke-marketing-authorisation-for-TAVNEOS-R-avacopan-in-the-European-Union-and-European-Economic-Area-countries&quot;&gt;revoked its approval&lt;/a&gt; of Tavneos.&lt;/p&gt;



&lt;p&gt;The FDA is trying to &lt;a href=&quot;https://www.fda.gov/drugs/drug-alerts-and-statements/cder-proposes-withdraw-approval-tavneos&quot;&gt;pull Tavneos from the market&lt;/a&gt;, and Amgen is fighting that effort.&lt;/p&gt;



&lt;p&gt;The company has a lot riding on the outcome. Tavneos can cost more than $220,000 per year, according to the &lt;a href=&quot;https://www.goodrx.com/tavneos?pharmacyId=3&quot;&gt;drug discount website GoodRx&lt;/a&gt;, and when Amgen &lt;a href=&quot;https://www.amgen.com/newsroom/press-releases/2022/10/amgen-successfully-completes-acquisition-of-chemocentryx&quot;&gt;acquired ChemoCentryx&lt;/a&gt; in 2022 for $3.7 billion, Tavneos was the only drug ChemoCentryx had brought to market.&lt;/p&gt;



&lt;p&gt;In a June &lt;a href=&quot;https://www.regulations.gov/comment/FDA-2026-N-1321-0056&quot;&gt;letter to the FDA&lt;/a&gt;, Amgen said the benefits of Tavneos outweigh the risks.&lt;/p&gt;



&lt;p&gt;The FDA disagrees.&lt;/p&gt;



&lt;p&gt;The FDA &amp;#8220;can no longer conclude that there is, or has ever been, a valid demonstration of substantial evidence of effectiveness for TAVNEOS,&amp;#8221; &lt;a href=&quot;https://www.federalregister.gov/d/2026-08455/p-98&quot;&gt;the agency wrote&lt;/a&gt;.&lt;/p&gt;



&lt;p&gt;Citing 76 cases of DILI — &lt;a href=&quot;https://www.fda.gov/media/191708/download?attachment&quot;&gt;drug-induced liver injury&lt;/a&gt; — the agency said it was &amp;#8220;increasingly concerned about the safety profile of TAVNEOS.&amp;#8221; Without proof of effectiveness, at least for its approved use, &amp;#8220;the drug&amp;#8217;s benefits &lt;a href=&quot;https://www.federalregister.gov/d/2026-08455/p-100&quot;&gt;cannot outweigh&lt;/a&gt; its known risks,&amp;#8221; the FDA wrote.&lt;/p&gt;



&lt;p&gt;&lt;em&gt;Data reporter Maia Rosenfeld contributed to this report.&lt;/em&gt;&lt;/p&gt;






&lt;em&gt;&lt;a href=&quot;https://kffhealthnews.org/about-us&quot;&gt;KFF Health News&lt;/a&gt; is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about &lt;a href=&quot;https://www.kff.org/about-us&quot;&gt;KFF&lt;/a&gt;.&lt;/em&gt;&lt;p&gt;This &lt;a target=&quot;_blank&quot; href=&quot;https://kffhealthnews.org/health-industry/fda-approval-drugs-medical-devices-postmarket-studies-safety-delays-amgen-tavneos/&quot;&gt;article&lt;/a&gt; first appeared on &lt;a target=&quot;_blank&quot; href=&quot;https://kffhealthnews.org&quot;&gt;KFF Health News&lt;/a&gt; and is republished here under a &lt;a target=&quot;_blank&quot; href=&quot;https://creativecommons.org/licenses/by-nc-nd/4.0/&quot;&gt;Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License&lt;/a&gt;.&lt;/p&gt;
&lt;img decoding=&quot;async&quot; id=&quot;republication-tracker-tool-source&quot; src=&quot;https://kffhealthnews.org/?republication-pixel=true&amp;amp;post=2275664&amp;amp;ga4=G-J74WWTKFM0&quot;&gt;</description>
 <pubDate>Fri, 18 Sep 2026 05:00:00 -0400</pubDate>
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 <title>HHS Gov News: HHS’ Office for Civil Rights Settles HIPAA Investigation of Ambry Genetics Phishing Attack Affecting 225,000 Individuals</title>
 <link>https://www.hhs.gov/press-room/hhs-office-civil-rights-settles-hipaa-investigation-ambry-genetics-phishing-attack-affecting-225000-individuals.html</link>
 <description>The U.S. Department of Health and Human Services (HHS), Oﬃce for Civil Rights (OCR) today announced a settlement with Ambry Genetics Corporation (Ambry).</description>
 <pubDate>Thu, 17 Sep 2026 16:00:00 -0400</pubDate>
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 <title>Kaiser Health News:Health Industry: The Health Risks of AI</title>
 <link>https://kffhealthnews.org/podcast/what-the-health-463-ai-dangers-trump-obamacare-aca-refunds-september-17-2026/</link>
 <description>&lt;h3&gt;
		The Host	&lt;/h3&gt;
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			&lt;img decoding=&quot;async&quot; src=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2024/07/Rovner-Julie2021_1100sq.jpg&quot; alt=&quot;Julie Rovner photo&quot; /&gt;
		
	
	
					&lt;div&gt;Julie Rovner
		
					KFF Health News
		
					
				&lt;a href=&quot;https://twitter.com/jrovner&quot; title=&quot;@jrovner&quot;&gt;
					@jrovner				&lt;/a&gt;
			
		
					
				&lt;a href=&quot;https://bsky.app/profile/julierovner.bsky.social&quot; title=&quot;@julierovner.bsky.social&quot;&gt;
					@julierovner.bsky.social				&lt;/a&gt;
			
		
		
					
				&lt;a href=&quot;https://kffhealthnews.org/news/author/julie-rovner/&quot;&gt; 
					Read Julie&amp;#039;s stories.				&lt;/a&gt;
			
		
					
				Julie Rovner is chief Washington correspondent and host of KFF Health News&amp;#8217; weekly health policy news podcast, &amp;quot;What the Health?&amp;quot; A noted expert on health policy issues, Julie is the author of the critically praised reference book &amp;quot;Health Care Politics and Policy A to Z,&amp;quot; now in its third edition.			
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&lt;p&gt;Reports from a top artificial intelligence company that it stopped several attempted uses of its product that could assist in manufacturing a bioweapon caught the attention of lawmakers in Washington this week. But it is still unclear whether or when Congress will act to regulate the fast-moving industry — and the House has left town until after Election Day.&lt;/p&gt;



&lt;p&gt;Meanwhile, with many voters expressing anger over the rising cost of healthcare, President Donald Trump is proposing to send $500 checks to some people enrolled in Affordable Care Act insurance plans before the election. But even if those checks materialize, in most cases they will be smaller than the increases many policyholders have already seen.&lt;/p&gt;



&lt;p&gt;This week&amp;#8217;s panelists are Julie Rovner of KFF Health News, Anna Edney of Bloomberg News, Tami Luhby of CNN, and Alice Miranda Ollstein of Politico.&lt;/p&gt;




		&lt;h3&gt;
		Panelists	&lt;/h3&gt;
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			&lt;img decoding=&quot;async&quot; src=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2023/01/Edney.jpg&quot; alt=&quot;Anna Edney photo&quot; /&gt;
		
	
	
					&lt;div&gt;Anna Edney
		
					Bloomberg News
		
					
				&lt;a href=&quot;https://twitter.com/annaedney&quot; title=&quot;@annaedney&quot;&gt;
					@annaedney				&lt;/a&gt;
			
		
					
				&lt;a href=&quot;https://bsky.app/profile/annaedney.bsky.social&quot; title=&quot;@annaedney.bsky.social&quot;&gt;
					@annaedney.bsky.social				&lt;/a&gt;
			
		
		
					
				&lt;a href=&quot;https://www.bloomberg.com/authors/AP519FMOg7w/anna-edney&quot;&gt; 
					Read Anna&amp;#039;s stories.				&lt;/a&gt;
			
		
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			&lt;img decoding=&quot;async&quot; src=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2023/01/Luhby_667sq.jpg&quot; alt=&quot;Tami Luhby photo&quot; /&gt;
		
	
	
					&lt;div&gt;Tami Luhby
		
					CNN
		
					
				&lt;a href=&quot;https://twitter.com/Luhby&quot; title=&quot;@Luhby&quot;&gt;
					@Luhby				&lt;/a&gt;
			
		
		
		
					
				&lt;a href=&quot;https://www.cnn.com/profiles/tami-luhby&quot;&gt; 
					Read Tami&amp;#039;s stories.				&lt;/a&gt;
			
		
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			&lt;img decoding=&quot;async&quot; src=&quot;https://kffhealthnews.org/wp-content/uploads/sites/8/2026/05/Alice_Ollstein_square.jpg&quot; alt=&quot;Alice Miranda Ollstein photo&quot; /&gt;
		
	
	
					&lt;div&gt;Alice Miranda Ollstein
		
					Politico
		
					
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					Read Alice&amp;#039;s stories.				&lt;/a&gt;
			
		
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&lt;/div&gt;

	&lt;/div&gt;
&lt;/div&gt;



&lt;p&gt;Among the takeaways from this week&amp;#8217;s episode:&lt;/p&gt;



&lt;ul&gt;
&lt;li&gt;Anxieties about AI reached a fever pitch this week, with a few leading developers calling to slow the pace of innovation amid troubling reports about AI&amp;#8217;s progress and use, including reported attempts to misuse AI for biological warfare. Meanwhile, the Trump administration is pressing to incorporate AI into healthcare.&lt;/li&gt;



&lt;li&gt;Federal lawmakers are exploring changes to the independent arbitration system created by the No Surprises Act, which took effect in 2022. While the law has cut down on patient exposure to surprise out-of-network medical bills in emergencies, the system has resulted in far larger paydays than anticipated for many doctors — which, in turn, has prompted a sizable increase in coverage costs, including for employers.&lt;/li&gt;



&lt;li&gt;Some cities and states are suing to block implementation of the latest public charge rules from the Trump administration, arguing they could have a chilling effect for some who are entitled to public benefits, such as the eligible children of immigrants. They allege that could leave cities and states on the hook and harm local economies.&lt;/li&gt;



&lt;li&gt;Abortion opponents are claiming victory as the Environmental Protection Agency moves to test water for remnants of abortion pills, among other chemicals and drugs. California&amp;#8217;s attorney general is wrapping up a lawsuit against two nonprofits offering what they describe as abortion pill reversals, despite a lack of evidence the method works or is safe. And the family of a Texas woman who died after being denied an abortion is suing her doctors and the state&amp;#8217;s attorney general, Ken Paxton.&lt;/li&gt;
&lt;/ul&gt;



&lt;p&gt;Also this week, Rovner interviews Sabrina Corlette of the Georgetown University Center for Health Insurance Reforms, discussing some potential short-term fixes to the nation&amp;#8217;s health system.&lt;/p&gt;





&lt;p&gt;Plus, for &amp;#8220;extra credit&amp;#8221; the panelists suggest health policy stories they read this week that they think you should read, too:&amp;nbsp;&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;Julie Rovner:&lt;/strong&gt; KJZZ Phoenix&amp;#8217;s &amp;#8220;&lt;a href=&quot;https://www.kjzz.org/politics/2026-09-11/data-shows-des-failed-to-complete-most-snap-eligibility-interviews-resulting-in-massive-cuts&quot;&gt;Data Shows DES Failed To Complete Most SNAP Eligibility Interviews, Resulting in Massive Cuts&lt;/a&gt;,&amp;#8221; by Camryn Sanchez.&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;Tami Luhby:&lt;/strong&gt; The Washington Post&amp;#8217;s &amp;#8220;&lt;a href=&quot;https://www.washingtonpost.com/wellness/2026/09/15/what-ferritin-face-means-how-tell-if-you-may-be-iron-deficient/&quot;&gt;What ‘Ferritin Face&amp;#8217; Means — And How To Tell If You May Be Iron-Deficient&lt;/a&gt;,&amp;#8221; by Erica Sloan.&amp;nbsp;&amp;nbsp;&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;Anna Edney:&lt;/strong&gt; Bloomberg News&amp;#8217; &amp;#8220;&lt;a href=&quot;https://www.bloomberg.com/news/features/2026-09-14/about-half-of-health-insurance-denials-get-reversed-analysis-finds?accessToken=eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJzb3VyY2UiOiJTdWJzY3JpYmVyR2lmdGVkQXJ0aWNsZSIsImlhdCI6MTc4OTQwNDcwNiwiZXhwIjoxNzkwMDA5NTA2LCJhcnRpY2xlSWQiOiJUTENRTTJLR0lGUVgwMCIsImJjb25uZWN0SWQiOiI2MkUxRTdCQjIyNzA0Mzk5QTBGNzRBRThCQ0I2QkZGMCJ9.binFsUnPwEURPwmRXs3QMTOr9yePzJhXWThYuG3x-RY&quot;&gt;Patients Who Fight Health Insurance Denials Often Win&lt;/a&gt;,&amp;#8221; by John Tozzi, Tanaz Meghjani, and Ike Swetlitz.&lt;/p&gt;



&lt;p&gt;&lt;strong&gt;Alice Miranda Ollstein:&lt;/strong&gt; KFF Health News&amp;#8217; &amp;#8220;&lt;a href=&quot;https://kffhealthnews.org/medicaid/native-hawaiians-not-exempt-medicaid-work-requirements-indigenous-groups/&quot;&gt;Indigenous Groups Are Exempt From Medicaid Work Rules, but Native Hawaiians Aren&amp;#8217;t&lt;/a&gt;,&amp;#8221; by Ashley Mizuo.&lt;/p&gt;



&lt;p&gt;Also mentioned in this week&amp;#8217;s podcast:&lt;/p&gt;



&lt;ul&gt;
&lt;li&gt;Science&amp;#8217;s &amp;#8220;&lt;a href=&quot;https://www.science.org/content/article/chilling-warning-or-overreaction-ai-bioweapons-report-divides-experts&quot;&gt;‘Chilling&amp;#8217; Warning or Overreaction? AI Bioweapons Report Divides Experts&lt;/a&gt;,&amp;#8221; by Jocelyn Kaiser.&lt;/li&gt;



&lt;li&gt;The New York Times&amp;#8217; &amp;#8220;&lt;a href=&quot;https://www.nytimes.com/2026/09/14/health/ai-doctors-medicare-fda.html&quot;&gt;U.S. Health Officials Move Quickly To Deploy Medical A.I. Despite Concerns&lt;/a&gt;,&amp;#8221; by Christina Jewett.&lt;/li&gt;



&lt;li&gt;Roll Call&amp;#8217;s &amp;#8220;&lt;a href=&quot;https://rollcall.com/2026/09/14/surprise-billing-dispute-process-in-crisis-groups-say/&quot;&gt;Surprise Billing Dispute Process In ‘Crisis,&amp;#8217; Groups Say&lt;/a&gt;,&amp;#8221; by Ariel Cohen.&lt;/li&gt;



&lt;li&gt;KFF Health News&amp;#8217; &amp;#8220;&lt;a href=&quot;https://kffhealthnews.org/race-and-health/trump-ice-immigration-immigrant-families-kids-parents-separation-health-trauma/&quot;&gt;A Generation of Kids Suffer as Trump Destabilizes Immigrant Families&lt;/a&gt;,&amp;#8221; by Claudia Boyd-Barrett.&lt;/li&gt;



&lt;li&gt;Politico&amp;#8217;s &amp;#8220;&lt;a href=&quot;https://subscriber.politicopro.com/article/2026/09/abortion-opponents-claim-tremendous-victory-as-epa-tests-water-for-abortion-pills-01073232&quot;&gt;Abortion Opponents Claim ‘Tremendous Victory&amp;#8217; as EPA Tests Water for Abortion Pills&lt;/a&gt;,&amp;#8221; by Miranda Willson, Alice Miranda Ollstein, Ariel Wittenberg.&lt;/li&gt;



&lt;li&gt;Politico&amp;#8217;s &amp;#8220;&lt;a href=&quot;https://www.politico.com/news/2026/09/15/abortion-pill-reversal-court-01075907?utm_source=dlvr.it&amp;amp;utm_medium=twitter&quot;&gt;Free Speech or False Advertising? California Judge To Rule on ‘Abortion Pill Reversal&amp;#8217; Claims&lt;/a&gt;,&amp;#8221; by Rachel Bluth and Alice Miranda Ollstein.&lt;/li&gt;
&lt;/ul&gt;




		&lt;h3&gt;
		Credits	&lt;/h3&gt;
		&lt;div&gt;
	

&lt;div&gt;
	
	&lt;div&gt;
					&lt;div&gt;Francis Ying
		
					Audio producer
		
		
		
		
		
			&lt;/div&gt;
&lt;/div&gt;




	
	&lt;div&gt;
					&lt;div&gt;Emmarie Huetteman
		
					Editor
		
		
		
		
		
			&lt;/div&gt;
&lt;/div&gt;

	&lt;/div&gt;
&lt;/div&gt;



&lt;hr /&gt;



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&lt;p&gt;&lt;em&gt;And subscribe to &amp;#8220;What the Health? From KFF Health News&amp;#8221; on &lt;a href=&quot;https://podcasts.apple.com/us/podcast/what-the-health/id1253607372?mt=2&quot;&gt;&lt;u&gt;Apple Podcasts&lt;/u&gt;&lt;/a&gt;, &lt;a href=&quot;https://open.spotify.com/show/32EdsB662C3oyIrqLMmBXI?si=TQhRjzzLTgWtK3crfbOFtA&quot;&gt;&lt;u&gt;Spotify&lt;/u&gt;&lt;/a&gt;, &lt;a href=&quot;https://app.npr.org/aggregation/fis-1269164038&quot;&gt;&lt;u&gt;the NPR app&lt;/u&gt;&lt;/a&gt;, &lt;a href=&quot;https://www.youtube.com/playlist?list=PL5Qew-7pSXbAucCUQnyRx6qpLglzrxzFb&quot; target=&quot;_blank&quot; rel=&quot;noopener&quot;&gt;YouTube&lt;/a&gt;, &lt;a href=&quot;https://play.pocketcasts.com/web/podcasts/a379e280-3f57-0135-9028-63f4b61a9224&quot;&gt;&lt;u&gt;Pocket Casts&lt;/u&gt;&lt;/a&gt;, or wherever you listen to podcasts.&lt;/em&gt;&lt;/p&gt;
&lt;em&gt;&lt;a href=&quot;https://kffhealthnews.org/about-us&quot;&gt;KFF Health News&lt;/a&gt; is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about &lt;a href=&quot;https://www.kff.org/about-us&quot;&gt;KFF&lt;/a&gt;.&lt;/em&gt;&lt;p&gt;This &lt;a target=&quot;_blank&quot; href=&quot;https://kffhealthnews.org/podcast/what-the-health-463-ai-dangers-trump-obamacare-aca-refunds-september-17-2026/&quot;&gt;article&lt;/a&gt; first appeared on &lt;a target=&quot;_blank&quot; href=&quot;https://kffhealthnews.org&quot;&gt;KFF Health News&lt;/a&gt; and is republished here under a &lt;a target=&quot;_blank&quot; href=&quot;https://creativecommons.org/licenses/by-nc-nd/4.0/&quot;&gt;Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License&lt;/a&gt;.&lt;/p&gt;
&lt;img decoding=&quot;async&quot; id=&quot;republication-tracker-tool-source&quot; src=&quot;https://kffhealthnews.org/?republication-pixel=true&amp;amp;post=2284843&amp;amp;ga4=G-J74WWTKFM0&quot;&gt;</description>
 <pubDate>Thu, 17 Sep 2026 14:45:00 -0400</pubDate>
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 <title>HHS Gov News: HHS Seeks Public Input on Electromagnetic Fields and Wireless Radiation</title>
 <link>https://www.hhs.gov/press-room/hhs-seeks-public-input-electromagnetic-fields-wireless-radiation.html</link>
 <description>HHS issued an RFI seeking evidence and information from the public and experts on the potential health effects of electromagnetic fields.</description>
 <pubDate>Thu, 17 Sep 2026 13:30:00 -0400</pubDate>
</item>
<item>
 <title>HHS Gov News: ARPA-H Launches SPECTRA to Transform Autism Diagnosis and Precision Care</title>
 <link>https://www.hhs.gov/press-room/arpa-h-launches-spectra-transform-autism-diagnosis-precision-care.html</link>
 <description>HHS launched the new Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program.</description>
 <pubDate>Thu, 17 Sep 2026 12:26:56 -0400</pubDate>
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<item>
 <title>HHS Gov News: Secretary Kennedy Announces New Appointments to U.S. Preventive Services Task Force</title>
 <link>https://www.hhs.gov/press-room/secretary-kennedy-announces-new-us-preventive-services-task-force-members.html</link>
 <description>HHS Secretary Robert F. Kennedy, Jr., announced the addition of eight new members to the U.S. Preventive Services Task Force.</description>
 <pubDate>Thu, 17 Sep 2026 10:30:00 -0400</pubDate>
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