Drugs Archives - Ñî¹óåú´«Ã½Ò•îl Health News /tag/drugs/ Ñî¹óåú´«Ã½Ò•îl Health News produces in-depth journalism on health issues and is a core operating program of KFF. Fri, 18 Sep 2026 09:20:50 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.9 /wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=32 Drugs Archives - Ñî¹óåú´«Ã½Ò•îl Health News /tag/drugs/ 32 32 257378068 The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done. /health-industry/fda-approval-drugs-medical-devices-postmarket-studies-safety-delays-amgen-tavneos/ Fri, 18 Sep 2026 09:00:00 +0000 /?p=2275664 When the FDA was deciding whether to approve the drug Tavneos several years ago to treat a set of , agency experts argued that would be a mistake, according to .

One problem cited: The manufacturer had provided only

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.

Today, like many similar “postmarket” studies mandated by the FDA, that additional study is delayed, according to a . As of last fall, only 21 of the planned 300 patients had been enrolled, the FDA said in an and .

Meanwhile, the FDA has dozens of cases of “possibly” or “probably causally associated” with the drug. That was one of the potential side effects the postmarket study was meant to evaluate.

Tavneos illustrates the perils of the FDA’s approach to many drugs and medical devices — and the frequent lapses in follow-through.

A Ñî¹óåú´«Ã½Ò•îl 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.

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.

Postmarket study requirements “have often proven toothless,” said cardiologist , an associate professor of medicine at the University of California-San Francisco who has published .

The FDA’s reliance on postmarket studies reflects a balancing act.

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.

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.

“Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it’s going to lead to a lot of uncertainty,” Dhruva said.

Trump administration policy changes designed to hasten drugs through FDA review could leave more riding on postmarket studies, medical researchers say.

For example, in February, that “the default requirement” for agency approvals will be one clinical trial instead of two.

Reducing pre-approval testing “will inevitably put a lot of pressure on the post-approval system,” said , a professor at Harvard Medical School who postmarket studies.

FDA officials said the new policy would “substantially reduce costs” for manufacturers and “speed drugs to market.” Writing in The New England Journal of Medicine, they denied the change would compromise safety or efficacy, saying that “erroneous conclusions may be reached even with two, three, or four studies.”

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. “Assessing the significance of any delay requires a case-specific review,” said the spokesperson, Emily Hilliard.

The fact that a study is delayed “should not be treated as evidence that a product has an unresolved safety or effectiveness issue,” Hilliard said.

Amgen, the company that makes Tavneos, is still working on the postmarket research the FDA mandated, company spokesperson Alison Chartan said, adding, “We remain committed to completing this important study.”

An aerial photo shows a large company headquarters with various buildings.
Amgen’s headquarters in Thousand Oaks, California, in May 2023. (Mario Tama/Getty Images)

Behind Schedule

An FDA database downloaded by Ñî¹óåú´«Ã½Ò•îl Health News in August tracks the progress of postmarket studies that makers of — such as vaccines and gene therapies — were required to perform or promised to perform.

The database showed almost 600 were running behind schedule.

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.

About a third of ongoing studies were listed as delayed.

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.

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.

The nearly 600 delayed studies involved almost 350 products, Ñî¹óåú´«Ã½Ò•îl Health News found.

The FDA has defined delayed as . That can mean off track or overdue.

As of August, other FDA databases tracking listed dozens of postmarket studies as behind schedule.

Products included:

The CustomFlex Artificial Iris, 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, zero patients were enrolled.

Barbara Fant of Clinical Research Consultants, to whom the FDA’s 2018 letter approving the product 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.

“Confirming the long-term safety of the device remains a top priority for both the study team and FDA,” Fant said.

Paxlovid, a treatment for covid. A study to assess its safety in pregnant women was originally to be completed by the end of 2024, the FDA database said. “The trial completion and final report milestones were missed,” the database said.

Pfizer, the manufacturer, is working with the FDA and remains committed to “submitting results as soon as practicable,” Pfizer spokesperson Jerica Pitts said.

The Scandinavian Total Ankle Replacement system. 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 adverse events, with dozens of “reoperations,” “revisions,” or “removals,” the database said.

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.

Oxaydo (originally named Oxecta), a form of the potentially addictive opioid painkiller oxycodone . When the FDA approved it in 2011, it required the manufacturer, , to conduct a postmarket study to assess whether it reduces “misuse and abuse, and their consequences: overdose, death and addiction.” The final report was originally scheduled to be submitted in 2016.

The FDA database listing the study as delayed said the agency “issued a failure to respond letter” in 2022.

Today the issue may be all but moot.  

Control of the product passed from company to company over the years until 2023, when Acura Pharmaceuticals said in a that patents on Oxaydo would begin expiring that year and it didn’t intend to continue marketing the drug.

According to another FDA database, Oxaydo .

The FDA has enforcement powers and uses them “where appropriate,” HHS’ Hilliard said. She did not provide requested details, and she did not answer questions about the studies listed above.

Delay Can Pay

For manufacturers, delay can pay, Harvard’s Kesselheim said. While postmarket studies are ongoing, companies can continue to sell the products.

“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,” the HHS Office of Inspector General .

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 that are already known.

In April, when it approved Foundayo, a weight loss drug made by Eli Lilly, the FDA required the company to conduct additional research to assess a variety of concerns, including “retained gastric contents,” “major adverse cardiovascular events,” and “drug-induced liver injury,” as well as effects of exposure during pregnancy, such as “major congenital malformations,” “spontaneous abortions,” and “stillbirths.”

The FDA said it approved the drug under the new Commissioner’s National Priority Voucher program, intended for products that “.” The program strives for an “” review, the FDA has said — one to two months, instead of six months or more with other expedited pathways.

“Postmarketing requirements and enhanced safety monitoring are a routine part of the FDA’s approach to evaluating newly approved medicines,” Eli Lilly spokesperson Kristiane Silva Bello said, “including ongoing monitoring in areas identified during clinical development.”

‘False Hope’

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.

Agency scientists had found that the drug, Exondys 51, was unproven and argued against greenlighting it.

Ellis Unger, then a senior drug evaluation official at the FDA, that “thousands of patients and their families would be given false hope in exchange for hardship and risk.”

The manufacturer, Sarepta Therapeutics, . “A clinical benefit of EXONDYS 51 has not been established,” it said when the drug, also known by the generic name eteplirsen, was approved.

The drug, the first FDA-approved treatment for Duchenne muscular dystrophy, targeted a subset of patients with the disease.

The FDA required Sarepta to conduct further studies and it could withdraw approval if postmarket trials failed to verify a clinical benefit or were “not conducted with due diligence.”

Unger issued a warning of his own: “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.”

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 FDA letter to the company.

Almost a decade after the drug was approved, and more than five years after that deadline, the study was listed in an FDA database as delayed.

“The final report milestone was missed, because the sponsor requested milestone extensions due to study delays,”  the database said.

Meanwhile, in 2022 the website ranked Exondys 51 as the second-most expensive drug in the U.S., at an annual cost of $750,000 to $1.5 million.

Last year, the drug generated for Sarepta, according to a company presentation to investors.

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.

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.

‘M²¹²Ô¾±±è³Ü±ô²¹³Ù±ð»å’

A pair of hands holds a bottle of Amgen's drug Tavneos.
Amgen is the maker of the drug Tavneos. (Hannah Yoon/Bloomberg via Getty Images)

Amgen has cited similar challenges, even as Tavneos generated $459 million in global sales last year.

When an approved treatment is available, patients may be reluctant to enroll in a study in which they could be given a placebo, Amgen’s Chartan said.

The clinical trial supposed to be done . As of July 24, just 49 patients had been enrolled, Chartan said.

The FDA has said the study was to include , and each patient enrolled must be followed for five years, said Hilliard, the HHS spokesperson.

Tavneos was approved to treat severe cases of a group of diseases — known by the shorthand ANCA-associated vasculitis — in which, as the explains, the immune system inflicts potentially fatal damage on blood vessels and organs. 

“As of January 2026, estimated real-world exposure” to Tavneos “exceeds 25,000 patient-years globally, consisting of over 6,500 in the United States and 19,000 abroad,” Amgen has said. (For context, one patient taking a drug for five years would amount to five “patient-years.”)

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 “” the , the FDA alleged in an to Amgen.

Amgen, the parent company of ChemoCentryx, has denied the results were manipulated and has said the data “.”

Nonetheless, the recently of Tavneos.

The FDA is trying to , and Amgen is fighting that effort.

The company has a lot riding on the outcome. Tavneos can cost more than $220,000 per year, according to the , and when Amgen in 2022 for $3.7 billion, Tavneos was the only drug ChemoCentryx had brought to market.

In a June , Amgen said the benefits of Tavneos outweigh the risks.

The FDA disagrees.

The FDA “can no longer conclude that there is, or has ever been, a valid demonstration of substantial evidence of effectiveness for TAVNEOS,” .

Citing 76 cases of DILI — — the agency said it was “increasingly concerned about the safety profile of TAVNEOS.” Without proof of effectiveness, at least for its approved use, “the drug’s benefits its known risks,” the FDA wrote.

Data reporter Maia Rosenfeld contributed to this report.

Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

]]> 2275664 3 Common Drugs Older Adults Might Be Overusing /aging/3-common-drugs-older-adults-might-overuse-new-old-age-column/ Thu, 17 Sep 2026 09:00:00 +0000 /?p=2282208 The scenario often unfolds like this: Medical researchers investigate a frequently used drug and report that it’s less effective for older patients than previously thought, or that its risks outweigh its benefits in older adults. More studies follow, confirming those findings.

After a few years, medical associations revise their guidelines, warning that the drug in question should be avoided or at least prescribed more selectively. It might be added to the Beers Criteria, an influential list of potentially inappropriate medications for older patients, published by the American Geriatrics Society.

If the drug’s role is preventive, the U.S. Preventive Services Task Force, an independent expert panel, may weigh in with cautions. The FDA may issue “black box” warnings about concerning side effects.

After a few more years, researchers look at broad national data to see whether use of this drug declined. Often, the answer is: Yes, but not enough. Sometimes, though, use didn’t decline much at all or actually increased.

“Medications are like barnacles,” said Michael Steinman, a geriatrician at the University of California-San Francisco and co-director of the . “They’re easy to start, but they can be hard to stop.”

This medical inertia partly reflects the time lag involved in disseminating findings. “Clinicians have a million things they need to know and attend to, and information may take a while to get to them,” Steinman said.

But it also reflects the way “clinicians and patients get used to treating conditions in certain ways,” he said. “They become ingrained habits.” Finding alternative approaches is challenging, so “it’s easy to go with what you know.”

Recent studies of three medications or classes of drugs widely used among older Americans illustrate the problem.

The Drawbacks of Benzodiazepines

Scientists began about benzodiazepines more than 20 years ago. Prescribed for insomnia and anxiety, “they offer prompt relief,” said Mark Olfson, a psychiatrist and epidemiologist at Columbia University.

? Benzodiazepines (including Valium, Xanax, and Ativan) and the related “Z” drugs (Ambien, Lunesta) “may impair balance, coordination, and cognition that can translate into falls and fractures and motor vehicle accidents,” Olfson said. In patients also taking opioids for pain, benzodiazepines can cause overdoses.

Moreover, “once you’ve taken them for a period of time, you develop a dependence,” Olfson added. “When you come off them, you may develop withdrawal symptoms.”

So what’s happened to , who are more sensitive to these effects? In a , published in the Annals of Internal Medicine, Olfson and his team reported progress. Among people 65 and older, the rate of patients filling prescriptions for benzos dropped to 11.5% in 2024, from about 14% in 2015.

But that decline has stalled since 2020, perhaps related to the covid-19 pandemic. Moreover, prescribed use actually rose among those over 75, from 12% in 2020 to about 13% four years later. Dispensing through pharmacies in long-term care facilities more than doubled. And about a third of users were taking the drug for longer than six months, increasing the likelihood of dependence. “It’s worrisome,” Olfson said.

But he cautioned that patients shouldn’t stop benzodiazepines suddenly or on their own, which can provoke withdrawal. “It requires supervised tapering” with a medical professional, he said. “It takes many weeks.”

Overprescribing Antibiotics

For years, the standard treatment for diverticulitis, the inflammation or infection of small pouches that form in the colon, was antibiotics, primarily fluoroquinolones (like Cipro and Levaquin) or amoxicillin-clavulanate (Augmentin).

“It was unquestioned,” said Jesse Sutton, a pharmacist and researcher at the Minneapolis Veterans Affairs healthcare system. “Antibiotics are safe and effective, great, lifesaving drugs, so the mindset was: When in doubt, use them.”

But in 2015, the against routinely prescribing antibiotics for “uncomplicated” diverticulitis, which represents a great majority of cases. Other .

Clinical trials had shown that, for this condition, antibiotics on mortality, the need for surgery, complications, or recurrences. “They hadn’t improved anything,” Sutton said.

And as with any drug, “, unintended consequences,” he said. “Side effects from antibiotics account for a ” for symptoms like nausea, vomiting, and diarrhea. Antibiotics heighten the risk of the virulent C. difficile infection, too.

Plus, “the more you use antibiotics, the less they work in the future,” Sutton said. The World Health Organization has “a major global health threat.”

So Sutton and his colleagues, studying treatment in 70,000 visits to 120 VA facilities, expected to see antibiotic use for uncomplicated diverticulitis decline over 10 years.

Instead, they in the Annals of Internal Medicine that antibiotic prescriptions remained nearly universal at 97% of visits, guidelines or no guidelines. The patients would most likely have done as well with a few days of Tylenol and a clear liquid diet.

for other conditions of later life, too, including the kind of that cause no troublesome symptoms and upper respiratory infections that are typically viral, not bacterial.

In such cases, when a doctor prescribes an antibiotic, “I’d encourage patients to say, ‘Please explain the rationale for doing this,’” Sutton said. “If they don’t, it’s OK to press pause.”

When Aspirin Isn’t the Answer

Aspirin is different. Because it’s cheap and sold over the counter, anybody can start taking it on their own — and , thinking it will help prevent cardiac problems.

For people who’ve already had a heart attack, stroke, or cardiac intervention like a stent or bypass surgery, daily low-dose aspirin for “secondary prevention” does lower the odds of another event, studies have demonstrated.

But for “primary prevention” in people who haven’t had one, the guidelines changed in 2019, when the American College of Cardiology and the American Heart Association for this purpose in those 70 or older. The , warning against aspirin for primary prevention starting at age 60.

Large clinical trials had shown scant benefit for aspirin as a primary prevention measure, but there were harms, notably gastrointestinal bleeding. “As we age, the risks of bleeding go up,” said Timothy Anderson, an internist at the University of Pittsburgh who co-directs its Prescribing Wisely Lab. More rarely, but more seriously, aspirin can cause bleeding in the brain.

In a published last year, Anderson and his co-author found the message was getting through: Aspirin use for primary prevention, as reported in the National Health and Nutrition Examination Survey, had dropped substantially from 2011 to 2023. But more than a third of those 70 or older were still taking it.

Some caveats: A subgroup of older adults with high risk factors for cardiovascular disease may benefit from aspirin for primary prevention. And, confusingly, some evidence suggests that older patients already taking aspirin face a higher risk of cardiovascular disease .

“Step 1 is a conversation with your primary care physician” about aspirin, Anderson said. “‘Is this still right for me as I get older?’”

Older patients taking aspirin, , “are interested in reducing their risk of heart attack and stroke,” he said. “They’re trying to be proactive and healthy.” But with blood pressure medications and statins for cholesterol, “we have better strategies than aspirin for that.”

The New Old Age is produced through a partnership with .

Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

]]> 2282208 Watch: Mark Cuban Says You Can’t Fix Healthcare Until Every Price Is Known /health-care-costs/interview-mark-cuban-fix-healthcare-full-price-transparency/ Fri, 21 Aug 2026 09:00:00 +0000 /?p=2277194&preview=true&preview_id=2277194 The ongoing debate over the U.S. health system shouldn’t be based on whether the government or the private sector is the dominant player, billionaire entrepreneur Mark Cuban said this week. The bigger issue, he said, is whether the system’s participants are transparent about what they charge and what they pay.

“I’m not opposed to single-payer or universal healthcare at all,” Cuban said Aug. 18 in an interview with Ñî¹óåú´«Ã½Ò•îl Health News. But “when you don’t know all the costs, when there’s no transparency, it’s impossible to determine if it’s a better solution or not,” he said.

Cuban’s remarks came on the heels of primary election victories by progressive supporters of “Medicare for All” — most notably Abdul El-Sayed, who recently clinched the Democratic Senate nomination in Michigan.

The former majority owner of the Dallas Mavericks and a former investor on the hit TV show Shark Tank, Cuban changed the way generic prescription drugs are sold in 2022 by co-founding Mark Cuban Cost Plus Drugs. The website, which posts all its costs and takes a blanket 15% markup, sells thousands of medications, often at deep discounts compared with buying through private insurance plans or self-pay pharmacies.

“We took the transparent path for an industry where there was zero transparency,” Cuban said. “Everybody else prices to the market; we price to what we thought was fair.”

Cuban said that, in thinking about the broader problems facing the U.S. healthcare system, the key is to rebuild trust. “Trust really is a formula,” he said. “Trust equals transparency divided by self-interest.”

One way to build trust, he said, is to give consumers incentives to find the best price for nonemergency health services. Cuban said that means every medical purchase should count toward health insurance deductibles and out-of-pocket maximums, which is not currently the case.

He also advocates breaking up some of the vertically integrated health companies that have grown so large — owning insurers, care providers, and the companies that serve them — that they can dictate their prices. “If you break up these big, huge conglomerates, everything changes. The price of everything drops like a rock,” he said.

But so far, only a few lawmakers have been brave enough to push that goal, Cuban said, citing the co-sponsored by senators Josh Hawley of Missouri, a Republican, and Elizabeth Warren of Massachusetts, a Democrat.

In the end, Cuban said, what matters is not who is running the system but whether all the cards are on the table — in particular, whether the terms of healthcare contracts are public. Whether it’s the government or private businesses doing the negotiating, “if you don’t know how the deals are structured, it’s impossible to negotiate better ones.”

The interview was part of the “How Would You Fix It?” series featuring Julie Rovner, Ñî¹óåú´«Ã½Ò•îl Health News’ chief Washington correspondent and host of the What the Health? podcast.

An abbreviated version of this interview aired Aug. 20 in Episode 460 of What the Health? From Ñî¹óåú´«Ã½Ò•îl Health News: “Headless FDA Gets a New Nominee.”

Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

]]> 2277194 How Much of a Cancer Drug Is Too Much? Patients, Researchers Challenge FDA-Approved Dosages /health-industry/cancer-drug-immunotherapy-fda-approved-dosages-challenged-keytruda-opdivo/ Thu, 20 Aug 2026 09:00:00 +0000 /?p=2273114 Northwestern University economist Chuck Manski studies decision-making amid uncertainty. That prepared him better than many other cancer patients to decide whether to stay on an immunotherapy treatment that was making him very ill.

For six months in 2022, Manski received monthly infusions of nivolumab to fight advanced melanoma. The drug ruined his thyroid gland, he said, requiring him to go on a special medication for the rest of his life, and caused severe dryness in his eyes, lips, and mouth. The FDA’s protocol for the drug called for an entire year of treatment, but Manski said his oncologist couldn’t explain why. It’s FDA-approved, “so that’s what we use,” she said.

By that point, Manski showed no cancer signs or symptoms, and after reading a lot of medical journal articles, he concluded that the intense side effects probably meant the treatment had done about all it could do.

“She couldn’t tell me a year was the optimal dose. Nobody could,” he said in a June interview from Spain, where he received an award for his economics work. “So I made my own diagnosis. I took myself off.”

Manski’s decision was in line with what doctors in , , were already doing: giving lower doses of nivolumab, sold under the brand name Opdivo, and of a similar drug, pembrolizumab (Keytruda), or giving them for shorter periods or over longer intervals than the FDA recommended. In India, oncologists found that of nivolumab had a powerful impact on several cancers.

“There is incredible uncertainty in drug dosing,” Manski said.

His experience impelled him to join an informal yet determined community of researchers, doctors, and patients pushing for extra studies to help patients and doctors find the right dosage for an array of cancer drugs. They point to evidence suggesting that taking smaller doses of some cancer drugs, or remaining on them for shorter periods, could save billions of dollars and prevent some of the worst side effects.

In a , 43% of U.S. adults said they had skipped their medication in the past year because of cost. A Vanderbilt University study of Medicare enrollees released in 2022 found that went unfilled at the pharmacy.

But dose-optimization studies rarely occur after the early stages of a drug’s development, or once it’s on the market. By then, few parties in the U.S. healthcare system — beyond patients — have a stake in learning that a lower dosage could work as well while causing less harm.

Pharmaceutical companies have shown little interest in dialing back recommended dosages. Once they set the price for a drug, the more sales, the more profit. One study that examined 29 expensive cancer drugs estimated that if minimum necessary dosages had been used in 2024, the U.S. healthcare system could have saved roughly $31 billion.

“Decisions aren’t always made with the best needs of the patients in mind. The bottom line is another reason,” said Matthew Goetz, a breast cancer researcher at the Mayo Clinic Comprehensive Cancer Center.

A photo of two IV bags as someone receives immunotherapy medication for melanoma treatment. The leftmost IV bag has "nivolumab" written on it.
Doctors in other countries have been giving patients lower doses of nivolumab or giving them for shorter periods or over longer intervals than the FDA recommends. (George Frey/Bloomberg via Getty Images)

Merck last year sold nearly $32 billion worth of pembrolizumab, a drug that’s FDA-approved for more than 40 cancer conditions. It accounted for almost half of Merck’s drug sales. Bristol Myers Squibb, meanwhile, brought in $10 billion from nivolumab, which works similarly to pembrolizumab in tweaking the immune system. Three important but often toxic breast cancer drugs — Ibrance, Verzenio, and Kisqali — at Pfizer, Eli Lilly, and Novartis by $4.1 billion, $5.7 billion, and $4.8 billion, respectively.

Pembrolizumab is usually prescribed at a fixed dosage; nivolumab is sometimes prescribed at a fixed dosage, sometimes based on the patient’s weight. If the patient is dosed less than what’s on the label, drugmakers generally get less money. And they aren’t the only ones who lose out.

Through a federal program known as 340B, created in 1992 to subsidize the treatment of low-income patients, hospitals that treat a certain percentage of low-income patients can buy drugs at a steep discount, while charging insurers or patients more. For Medicare patients, doctors are paid an additional for each infusion.

From 2010 to 2024, cancer drug revenue to doctors and hospitals increased from about $9 billion to nearly $36 billion, according to research by . About half those profits came from immunotherapy drugs like pembrolizumab and nivolumab.

“Pembrolizumab is ,” said Mark Ratain, a professor of medicine and chief hospital pharmacologist at University of Chicago Medicine. “That’s why you don’t see hospitals in this country running to do trials that test lower doses.”

A man stands in a garden area outside of his home. Foliage is seen blurred in the foreground.
Mark Ratain, a University of Chicago oncologist and clinical pharmacologist, battles what he sees as unnecessarily high dosages of high-cost cancer drugs such as Keytruda and Opdivo. (Taylor Glascock for Ñî¹óåú´«Ã½Ò•îl Health News)

Merck spokesperson Julie Cunningham said the drug’s dosage recommendations were based on extensive testing. “In a life-threatening and challenging disease such as cancer, it is critical that the dosing for a cancer therapy is established through well-designed clinical trials,” she said. “Changes in dose or duration that have not been similarly studied may potentially compromise the therapeutic effect.”

Still, some oncologists start their patients off slowly on any of a variety of cancer drugs, although there may be concerns about lawsuits by a patient or their survivors over a prescription of lower-than-labeled dosages.

Kathy Miller, a professor of oncology at the Indiana University School of Medicine, routinely starts metastatic breast cancer patients with 400 milligrams of Kisqali daily for three weeks (with one week off), rather than the 600 milligrams recommended on the label. Sometimes patients ask for the standard dosage.

“I have to tell them, ‘I don’t want to kill you,’” she said.

Insurers routinely challenge her lower-dosage prescriptions, Miller said, presumably because price rebates from the drug company are set to the standard dosage. To avoid endless phone battles with insurers, she prescribes 600 milligrams but tells her patients to take only two of the 200-mg pills and save the third for the next cycle.

Follow the Cures — And the Money

On May 31, at the annual meeting of the American Society of Clinical Oncology, or ASCO, at Chicago’s McCormick Place convention center, most of the audience of 8,000 rose in a prolonged standing ovation for the experimental drug daraxonrasib. Patients with pancreatic cancer who took the drug, presented that day, lived nearly twice as long — a median of 13 months — as those receiving chemotherapy.

The next day, in a slightly smaller hall, Amol Patel, a medical oncologist from New Delhi, discussed studies in various cancers in which 20- or 40-mg doses of nivolumab biweekly — one-sixth or one-twelfth the recommended dosage — gave Indian patients several months to a year longer survival than patients who underwent chemotherapy, and with fewer side effects.

Fewer than 100 people attended Patel’s talk.

The ingenious development of daraxonrasib was big news, since pancreatic cancer has been a death sentence until now. But from a global perspective, the news out of India might be just as important.

At the ASCO meeting, “the focus is always on the shiny new drug,” said Daniel Goldstein, an oncologist and drug policy researcher at the Rabin Medical Center in Israel who has fought for a decade, with some success, to lower pembrolizumab dosages in hospitals there and in other countries. “It can be quite lonely to be us,” he said, adding that he’s seen increasing appreciation of his work.

The data from India offered a glimpse of what could be. However, the studies Patel referred to compared ultralow-dosage immunotherapy to older chemo drugs; none compared ultralow doses against standard nivolumab or pembrolizumab treatments. In India, this would be a sterile exercise, because full-dose treatments are beyond the reach of any but the very wealthy, said Vanita Noronha, an oncologist at Tata Memorial Hospital in Mumbai.

Bristol Myers Squibb, or BMS, to make its drugs available in lower-income countries. But the company hasn’t been involved in the lower-dose nivolumab trials and, in a statement to Ñî¹óåú´«Ã½Ò•îl Health News, said the evidence suggested that or shorter duration harmed patients.

While not all U.S. oncologists agree with BMS’ assertion, the Indian data is, to most, a mere curiosity. “Can we really give 20 milligrams as opposed to 240?” asked Jessica Bauman of the Fox Chase Cancer Center in Philadelphia. “The only way we know for sure is a randomized study between the low dose and the highest.”

And such trials are unlikely to occur. That means only poorer countries are going to host “this groundbreaking research,” said Ratain, who is also a cancer doctor at the University of Chicago Medical Center. “The Indians may have better immunotherapy than we do.”

Clinicians in Europe, where maximizing healthcare dollars has long been a priority, have taken a middle course, studying lower, but not ultralow, doses of immunotherapy.

Pulmonologist Michel van den Heuvel at Utrecht University is comparing the standard nivolumab dosage for lung cancer patients with one that is as much as 50% lower. He also considered giving the low doses half as frequently, but that would have raised ethical concerns and led to a more cumbersome research protocol, van den Heuvel said.

In the United States, researchers led by a group at the Dana-Farber Cancer Institute are taking another tack: who’ve done well on 27 weeks of pembrolizumab can stop taking it, rather than doing the additional six months per FDA protocol.

At the Veterans Health Administration, which has more leeway in testing money-saving medical procedures, doctors saved $1.5 million, about 10% of the previous pembrolizumab cost, over two years at three Veterans Affairs hospitals where they implemented a pilot program to dose patients less frequently, said Garth Strohbehn, a University of Michigan oncologist who also works at the VA.

It saves money and requires fewer visits for veterans who often live hours from the hospital, he said. “It also helps other patients because it opens more slots for infusion.”

Julie Gralow, ASCO’s executive vice president and chief medical officer, has made testing dosage a priority. She’s working with scientists in India on an ambitious clinical trial to compare standard nivolumab with four lower dosage levels.

She’s also leading an , supported by the federally funded Patient-Centered Outcomes Research Institute, to see whether breast cancer patients can be effectively started on lower doses of the drugs Kisqali and Ibrance, which, along with Verzenio, are in a class of key breast cancer drugs known as CDK4/6 inhibitors.

“We want to maintain efficacy. But we also want patients to have excellent quality of life,” she said. Especially for patients with advanced cancers, where absolute cure is unlikely, “it’s our job to make sure we’re not compromising quality of life with higher doses that are unnecessary.”

In 2021, at Ratain’s urging, Richard Pazdur, who led the FDA’s cancer drug division for many years, launched , intended to get companies to conduct dosing studies that are more precise before launching the large clinical trials they use to obtain FDA approval for new drugs.

An exterior shot of the Food and Drug Administration headquarters.
The FDA usually can’t compel a drugmaker to conduct dose-ranging studies after a drug is approved, and by law the agency does not influence drug pricing, says Emily Hilliard, a Department of Health and Human Services spokesperson. (Valerie Plesch/Bloomberg via Getty Images)

The agency issued for dosing studies in 2024 and has incorporated Project Optimus principles into the approval process for new cancer drugs, said Health and Human Services spokesperson Emily Hilliard. For example, two dosing regimens were evaluated for each of four lung cancer drugs (fam-trastuzumab deruxtecan, tarlatamab, zongertinib, sunvozertinib), and the lower dose with fewer toxicities was approved in each case, she said.

The FDA usually can’t compel a drugmaker to conduct dose-ranging studies after a drug’s approval, Hilliard noted. And by law the agency does not influence drug pricing, she said.

Future drugs should have better dosage information, Bauman said, but “newer drugs will probably be just as expensive at lower doses.”

Financial Toxicity

Verzenio’s side effects made Allegra Warfield feel so sick, tired, and bewildered, she said, that she considered suicide. She switched to Kisqali, which was tolerable until last September, when coverage of the drug stopped despite her monthly premium payment of $6,000. The cash price for Kisqali was at least $16,000 a month.

After fighting her insurer for three months, Warfield, 42, sold her house and belongings in Palm Desert, California, and moved with her fiancé to Durham, North Carolina, where they’d found what they considered a reasonable insurance plan.

The cancer, the side effects, and the unpayable bills were bad enough. The lack of good answers for her treatment made everything worse, she said.

“I was left to research these medications on Facebook and Reddit. The only people talking about the daily reality of these drugs were other patients,” she said. “But I wanted the studies. I wanted practical guidance.”

Stories like these launched a new life mission for Kelly Shanahan, who was an OB-GYN in South Lake Tahoe, California, until side effects from a breast cancer drug caused her to lose sensation in her hands. Unable to practice medicine, Shanahan became a patient advocate who works with a group called the Patient-Centered Dosing Initiative. In 2021, Shanahan developed profound fatigue (“worse than caring for a newborn baby while being on call in my solo practice”) within a few weeks of going on Ibrance. Lowering the dosage caused her worst symptoms to lift, she said.

After gathering countless anecdotes, her group has approached drug companies seeking data — so far with little success — that might indicate what percentage of patients have needed dosage reductions, and how they fare on lower doses.

“If going down two dose levels cuts effectiveness by 50%, patients need to know that while making decisions. If it doesn’t, they need to know that,” Shanahan said — even if it means “the companies won’t make as much money.”

Shanahan suggested the data could be found in clinical trials and postmarket studies. But if drug companies won’t provide the necessary studies, Manski said, governments should.

“The knowledge to be gained is a common good,” he said.

A photo of Chuck Mansku standing in his home.
Manski’s research, focused on how people deal with conditions of uncertainty, helped him decide whether to stay on a melanoma treatment after it caused severe side effects. (Taylor Glascock for Ñî¹óåú´«Ã½Ò•îl Health News)

Has an insurance company or pharmacy benefit manager refused to cover a drug an oncologist recommended or prescribed for you or a loved one because the cancer is unusual or rare and lacks clear guidelines? Click here to contact Ñî¹óåú´«Ã½Ò•îl Health News’ reporting team.

Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

]]> 2273114 Newsom Promotes Affordable Insulin, but California’s Generic Label Off to a Slow Start /health-care-costs/gavin-newsom-calrx-state-branded-insulin-generic-biosimilar-drugs-rollout/ Mon, 17 Aug 2026 09:00:00 +0000 /?p=2270444 SAN FRANCISCO — At a Walgreens in this city’s bustling Japantown neighborhood, pharmacist Margaret On stocks two boxes of long-acting insulin pens from California’s new prescription drug label, , emblazoned with the state’s iconic grizzly bear.

Although she hasn’t dispensed any, On plans to keep them on hand. “It’s good to have if a patient comes in and doesn’t have health insurance,” she said. “Or just in case of emergencies.”

Seven months after the launch of its own low-cost insulin brand, state health officials said California has distributed more than 120,000 five-pen packs of insulin glargine priced at $55 each, significantly less than the $89 to $411 that the state says most popular brand names charge before any retail markups or consumer discounts.

While it represents a tiny amount of the state’s insulin pipeline, it marks the first time a state is competing against the insulin drugmakers — Eli Lilly, Sanofi, and Novo Nordisk — under its own prescription drug label. CalRx, Gov. Gavin Newsom’s experimental initiative, has dual aims: to act as an emergency supplier for people who are uninsured or can’t afford their prescriptions, and to disrupt the nation’s deep-pocketed pharmaceutical industry, which cost the U.S. in 2024, the federal government reported in June.

Newsom, a Democrat considering a presidential run in 2028, is expected to make healthcare a central pillar of his national platform as he concludes his second and final term as governor. To create the state brand of generic drugs, California inked a $50 million contract with , a Utah-based nonprofit drugmaker, to develop the CalRx insulin, known as a biosimilar. Though major distributors make the drug available in pharmacies around the state, uptake has been limited.

Newsom’s goal is to saturate the insulin market and offer generic versions of drugs either high in cost or low in supply, or that can improve public health. The state is also distributing free naloxone, used in a nasal spray to reverse opioid overdoses, and trying to bring albuterol inhalers to public schools for students with asthma emergencies. In the next two years, the state plans to launch epinephrine injectables, commonly known by the brand name EpiPen, which are used to treat severe allergic reactions, as well as a state-branded medication to treat tuberculosis.

Before he leaves office in January, Newsom said, he wants to add generic GLP-1 medications to compete with brand-name drugs such as Ozempic and Wegovy. The drugs have , but employers have about their cost.

Taking on drug costs is a winning political issue for both Democrats and Republicans, who have for years tried to rein in as Americans feel the pinch of high prices at pharmacy counters, in doctors’ offices, and from health insurance premiums. The U.S. spends roughly on prescription drugs as other industrialized countries. Six in 10 adults in the U.S. say they’re worried about being able to afford their prescription drug costs, according to a , and 4 in 10 say they’ve tried to save money such as by skipping doses and not filling prescriptions.

, President Donald Trump launched to potentially lower out-of-pocket costs for consumers. But TrumpRx doesn’t produce drugs; rather, it directs consumers to find more affordable medications with coupons or on drugmakers’ websites. Newsom, in contrast, is trying to drive down the underlying price of medicines by increasing the manufacturing and availability of generic drugs.

While some people with diabetes may benefit from CalRx insulin, California’s generic drug effort is largely symbolic at this time, said Geoffrey Joyce, director of health policy at the Schaeffer Center at the University of Southern California. “There is some value, but it’s for a very limited number of drugs for just a fraction of the population,” Joyce said.

And TrumpRx isn’t helping at a large scale either, Joyce added, because many medications it advertises have cheaper generic versions available elsewhere. It would be better, he said, to develop large-scale initiatives that tackle key drivers of the high cost of drugs, for rare cancers for instance, and produce safer and higher-quality medicines.

“What you really need is a national effort that focuses on vulnerabilities like supply shortages and increasing the supply of generic products for higher-priced drugs,” Joyce said.

Market Disruptor

CalRx aims to make insulin more affordable and accessible for the California adults diagnosed with diabetes. Newsom last year singled out the three major drugmakers that control more than 90% of the global insulin market, while also targeting intermediaries known as pharmacy benefit managers for promoting higher-priced drugs over cheaper generic alternatives.

Patients with health insurance often receive discounts at the pharmacy counter and do not pay sticker prices, yet those discount programs can be hard to navigate and patients can face restrictions. While drugmakers and pharmacy benefit managers said they’ve already initiated on out-of-pocket costs and pass price discounts on to consumers, Newsom argues that consumers still struggle to afford their medications.

He has criticized pharmaceutical companies for gouging Californians and contended that the industry’s discounting schemes don’t adequately address inflated prescription drug spending, which in the U.S. rose 7.9% in the most recent reporting year.

In his announcement last year that CalRx insulin would go on sale in January 2026, Newsom said the industry had been using discounts to distract consumers from solutions that could bring overall prices own. “One of the things that all of us should be increasingly concerned about is announcements around caps, announcements around discounts,” he said.

In January, California joined in setting . It also passed attempting to ban by pharmacy benefit managers.

Representatives for drug companies and pharmacy benefit managers said insulin is largely an affordable medicine in the U.S., arguing that consumers have benefited from discounts.

“While insulin prices, set solely by pharma companies, may be high in some instances, the amount patients are paying out of pocket has declined significantly,” said Christine Rex, senior director of state public affairs for the Pharmaceutical Care Management Association, which represents pharmacy benefit managers.

Reid Porter, a spokesperson for Pharmaceutical Research and Manufacturers of America, which represents brand-name drugmakers, said PBMs have driven up costs for consumers by excluding lower-cost medicines from their lists of covered drugs. “Too often, patients face a system in which insurers and PBMs exclude coverage of those medicines on formularies because of supply-chain incentives,” he said.

Where To Find CalRx Insulin

CalRx insulin has been slow to reach pharmacies around the state, and in interviews, patient advocates said many people with diabetes aren’t aware it’s an option.

In Sacramento, pharmacist Sharon Ngo, who works at a Safeway pharmacy, was surprised to learn that California had a long-acting insulin product on the market. She didn’t know that CalRx insulin was interchangeable with Lantus, which was on back order for roughly two weeks.

“I had no idea this was available,” she said as she took notes on a pad of paper. “We’re going to give this a try.”

CalRx insulin has a suggested retail price of $55 a pack and is available with or without insurance. California has inked deals with four health insurers to cover CalRx insulin on their health plan formularies, potentially making it cheaper, depending on copays. They include Anthem Blue Cross, Blue Shield of California, the Valley Health Plan for Santa Clara County employees, and the Federal Employees Health Benefits Program, according to the state Department of Health Care Access and Information.

A box of CalRx insulin.
Pharmacist Margaret On keeps two boxes of California’s new generic insulin product under the CalRx brand on hand in case of emergencies. (Angela Hart/Ñî¹óåú´«Ã½Ò•îl Health News)

Elizabeth Landsberg, the department’s director, said the state is working to get more insurers to cover CalRx insulin and to provide it at more pharmacies. The state doesn’t know how many boxes have been dispensed. However, Landsberg said it was more meaningful that the state had reached agreements with to distribute its product in California. Currently, CalRx insulin is available on Amazon and at Costco, as well as at some retail and grocery store pharmacies including CVS, Walgreens, and Walmart.

“What we’re really trying to do is change market behavior and offer both affordable and transparent pricing,” Landsberg said. “The rebates and discounts are hard for consumers to understand and can change at any time, so we are trying to be straightforward and say, ‘Let’s not play this shell game anymore.’”

Allan Coukell, chief government affairs and public policy officer at Civica, said the company first partnered with the state on long-acting insulin that helps patients keep blood sugar steady for 24 hours or more. Next, it plans to help California develop rapid-acting insulin, which is used to pull elevated glucose down within minutes, to compete with brand names such as Humalog and NovoLog.

Health insurance companies welcomed the state’s efforts, in part because they could help save money they pay out on prescriptions.

“Making this drug available is really about helping people improve their health,” said Paul Markovich, CEO of Blue Shield of California’s parent company. “And the more supply we can get on the market, the more we can get rid of the profit motives in the pharmaceutical industry.”

One July afternoon in the Southern California city of Corona, Chris Noble went to a CVS pharmacy to get a box of CalRx insulin. The pharmacist didn’t have any on hand, but Noble, a healthcare organizer with Type 1 diabetes, was told he could get a prescription filled in 24 hours.

“I have insurance, but I see myself using this if I’m traveling and something happens like my insulin pump malfunctions,” he said. “Now I know I can go to a CVS and get insulin within a day.”

Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

]]> 2270444 Watch: Why Abortions Are on the Rise Since ‘Roe’ Was Overturned /courts/video-five-things-abortions-increase-since-roe-overturned/ Fri, 07 Aug 2026 09:00:00 +0000 /?p=2264199 Say you live in deep-red Louisiana, a state that has effectively banned abortion. It may be easier for you to get abortion pills now than before the Supreme Court overturned Roe v. Wade. Here’s why — and what it means for future battles over abortion access.

And as a federal court mulls a case that could result in significant restrictions on a pill used in most abortions, healthcare providers say they have alternatives to preserve access even in states with bans in place. Read more here.

Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

]]> 2264199 Watch: GOP Senator Says Trump’s Tariffs Could Mean Safer Drugs — For a Price /health-industry/bill-cassidy-interview-senate-trump-tariffs-drug-prices-rfk-promises/ Fri, 24 Jul 2026 09:00:00 +0000 /?p=2263419&preview=true&preview_id=2263419 President Donald Trump’s proposed tariffs on imported generic drugs could raise some prices for patients, a key GOP lawmaker on health issues said this week. But he said that’s a potentially worthwhile trade-off to protect the nation’s drug supply.

“The national security might be something worth paying for,” Sen. Bill Cassidy of Louisiana, chairman of the Senate Health, Education, Labor, and Pensions Committee, said July 22 in an exclusive interview with Ñî¹óåú´«Ã½Ò•îl Health News.

The U.S., which has grappled with drug shortages in recent years, relies primarily on China to produce the active ingredients in many antibiotics, according to in JAMA Health Forum. Domestic facilities have closed or shifted to producing other drugs.

“Do we want China to have that sort of leverage for these drugs to be produced principally, maybe 99%, over there, and we don’t have access to them if tension rises between the two countries?” said Cassidy, who is a physician.

On July 21, Trump said in a that he would give generic drug companies two years to move production back to the U.S., after which he would impose 100% tariffs on imported products, rising to 200% the following year. Generic drugs make up an estimated 90% of all prescriptions filled in the U.S.

Cassidy, who has served in Congress , lost his bid for reelection in May after Trump endorsed a Republican primary challenger, Rep. Julia Letlow.

Last month, more than 16 months after his vote to confirm Robert F. Kennedy Jr. as head of the Department of Health and Human Services, on CBS News’ Face the Nation that the secretary broke promises he made to the senator, including that he would not change the federal recommendations for childhood vaccines.

Asked whether he would summon Kennedy again to discuss those promises, Cassidy said he had asked for him to appear before his committee but had not heard back about whether he would do so. Kennedy in April to discuss the Trump administration’s fiscal 2027 budget request for HHS.

Cassidy told Ñî¹óåú´«Ã½Ò•îl Health News that when he agreed to vote to advance Kennedy’s nomination, he trusted that Kennedy would keep his word about not disparaging vaccines.

“If they agree to guardrails and disregard those guardrails, you can judge me,” Cassidy said. “You may decide my judgment wasn’t very good, but I don’t think you can say I acted in bad faith.”

Regardless, Cassidy added, Kennedy was going to exert influence in the administration, and he thought it would be better for Kennedy to be in an official post, where his work would be subject to oversight.

“I’m pretty sure that RFK was going to have the president’s ear whether he was in office or not,” he said.

While Kennedy’s efforts to roll back federal vaccine recommendations are being blocked by courts, this week reported that the number of measles cases confirmed in the U.S. so far in 2026 has exceeded the total for 2025 — making it the highest number of cases in 35 years.

Cassidy, a principal author of the 2020 No Surprises Act targeting surprise medical bills, also said he doesn’t think Congress needs to make modifications to the law in the wake of reports that doctors and other healthcare providers are winning huge payouts under the arbitration system the law created. The No Surprises Act was intended to shield patients from receiving big bills for receiving medical care they didn’t know was outside their health plan’s network.

An analysis by this week found that providers were awarded nearly $15 billion in disputed claims in 2025, more than triple the 2024 figure of $4.08 billion.

“The initial step to make sure that people are getting their best deal is price transparency,” Cassidy said.

The HELP Committee on July 22 overwhelmingly approved advancing the Patients Deserve Price Tags Act, a bipartisan bill that would further expand the requirements that hospitals, insurers, and other healthcare providers make prices public and available to patients and employers. A House committee advanced a similar bill this week, also with bipartisan support, but it remains unclear whether either measure will be approved by the full House and Senate.

The interview — in which Cassidy also discussed his — was part of the “How Would You Fix It?” series featuring Julie Rovner, Ñî¹óåú´«Ã½Ò•îl Health News’ chief Washington correspondent and host of the What the Health? podcast.

An abbreviated version of this interview aired July 23 in Episode 456 of What the Health? From Ñî¹óåú´«Ã½Ò•îl Health News: “A Shrinking Safety Net.”

Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

]]> 2263419 Readers Share Personal Insights on Deadly Denials and Pregnancy Centers /letter-to-the-editor/reader-response-deadly-denials-pregnancy-centers-glp1-july-2026/ Thu, 16 Jul 2026 09:00:00 +0000 /?p=2259597&preview=true&preview_id=2259597 Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

A Tragic, Deadly Denial

I read your article in The Washington Post about the woman whose Humana policy required prior authorization for a drug she’d been taking (Bill of the Month: “She Struggled To Get a Lifesaving Drug Even After Insurers Vowed To Help,” June 29).

My husband, Kenney, had chronic obstructive pulmonary disease. On June 7, he fatally shot himself after a COPD exacerbation event.

His pulmonologist had prescribed two new nebulizer prescriptions on June 2. One was a specialty medication that would come directly from the drug company. A couple of days later, we called Walgreens to see why the other one hadn’t been filled. Turns out it required prior authorization.

Why the doctor who prescribed it needed to tell his health insurer that he really did think his patient needed it, I will never understand. The pharmacist said she would send the request to the doctor. And why she hadn’t already done that, again, I do not understand. By June 7, of course, it still wasn’t filled.

That day, a Sunday, Kenney experienced the flare-up when I was out mowing the yard. How terrifying it must have been for him to be unable to breathe and me not being there at least to hold his hand. That night he killed himself, leaving a note saying that he hated to leave me but that he couldn’t keep living like that — with the constant anxiety of not knowing when he wouldn’t be able to draw a breath.

Not long ago, a “welcome” packet came in the mail about the other nebulizer treatment — 25 days after it had been prescribed.

Admittedly, my husband’s health was not great. He did have COPD, but we still went out to eat once in a while, and he didn’t have to take his oxygen on those trips. He rarely used it just walking around the house.

He did make a serious suicide attempt six years ago (our daughter and granddaughter had died), but after seeing what it did to me and our son, he promised he’d never do it again. It was only when these exacerbation/flare-up events started this year that he indicated life was getting bad.

Perhaps, just perhaps, if he had received both medications in a timely manner, he would be here today, and we would have had many more years together. We met when we were 16 and had been together ever since. He was 78 when he died.

— Cindy Clements Blewett; Kyle, Texas

Navigating GLP-1 Coverage

Sydney Lupkin’s thoughtful article about the obstacles in obtaining weight loss drugs was interesting (Healthcare Helpline: “Trouble Getting Weight Loss Drugs Covered by Insurance? Here’s What To Know,” June 26). It would have been more helpful had it included a discussion of Medicare’s decision to cover these drugs as of July 1, 2026, and how to navigate the rocky shores of obtaining a prescription that won’t be denied.

— Sharie Hartman; Manteca, California

Beyond the Veil of Pregnancy Centers

I would like to address the article about a pregnancy resource center providing prenatal care in Sandpoint, Idaho (“Religious Anti-Abortion Center Finds Opportunity in Town Without OB-GYNs,” May 20). It is unfortunate that many still do not understand what pregnancy resource centers do, nor the high-quality care they provide. While there are some “crisis pregnancy centers” that provide limited offerings, most centers are aligned with a national organization like the National Institute of Family and Life Advocates, the Heartbeat Pregnancy Center, or Care Net. All these organizations require centers to have a medical director (a licensed healthcare practitioner) and require that the nurses who perform the ultrasounds have appropriate training. While I am not affiliated with 7B Care Clinic, I am concerned that the article may not have accurately reflected what is provided in such clinics. I offer my experiences to bring further clarity.

I work at a life-affirming women’s clinic. I am a board-certified family physician. I have delivered approximately 1,000 babies in my career. I have been performing ultrasounds for my patients for over a decade, and fought for this ability under the scrutiny of maternal-fetal medicine specialists, spending time alongside their registered diagnostic medical sonographer technicians, and having my scans reviewed by maternal-fetal medicine physicians. I have practiced medicine in three states over three decades.

Second, while I am life-affirming, I am not “anti-abortion.” I happen to believe that there are better choices, and I know that some women will still choose abortion, even after hearing all their options. I will gladly see those women for follow-up to answer questions and evaluate for complications — something that the abortion clinics in my area apparently will not do. I say this because that is what the women I see tell me. The clinic that performed the procedure or gave them the pills will not see a patient after the abortion for any follow-up. I have always willingly seen patients for any reason, whether I was working at a private clinic or hospital-owned clinic. That is no different now that I work for a life-affirming women’s clinic.

We provide a variety of services — free of charge. We are also stepping up to provide prenatal care up to 20 weeks because there is a shortage of obstetrical clinicians in our county. We encourage women to see a clinic where they can be followed throughout the entire pregnancy, if possible, and we are in no way marketing ourselves as competition. We are stepping in to fill the large gap that exists.

Just because the clinic in Sandpoint chooses to respect life does not make it a fake clinic. This clinic seeks to bring in physicians to provide prenatal care. They are bringing in OB-GYNs from Washington state, which has no restrictions on abortion. With this information taken into consideration, I ask you to reconsider any concerns about a clinic bringing board-certified OB-GYNs into an area where there is a shortage.

— James Heid, Vancouver, Washington

The Root of All Good

The article Claudia Boyd-Barrett wrote about how immigrant parents’ arrests are creating a mental health crisis for children was moving and brought awareness to the mental health challenges faced by them (Growing Up Scared: “Arrests of Immigrant Parents Create Mental Health Crisis for Children,” June 18). It was important to note how every story was different but focused on how much children missed and yearned for their parents to come back home. You also wrote about how it affected them by not having a parental figure in the home. That really touched me. Specifically, Jacob’s story and when he listed all the things he missed about his mom but especially being close to her.

I am currently a master’s student in social work working to become a better ally to the Hispanic immigrant community. I’ve seen how being afraid and sad over the immigration policies has affected my friends in this community. Losing a close parent and not being able to have that security with them anymore is hard to go through, and trauma affects children as they grow.

In this article, you have recognized the worth of a person, which is a core principle in social work. These children are worthy and have the right to feel taken care of and secure.

I would love to see more mental health services accessible to immigrant communities and their families. This would benefit children as they learn to cope with their feelings and how to make sense of a new world.

— Stacy Xiong, Athens, Georgia

Bagging a Bargain

Author Susan Jaffe mentioned GoodRx in the article “Thousands of Medicare Beneficiaries Thought Their Drug Plan Was Free. Then They Lost It” (July 7), but she failed to mention a much better discount drug site, Mark Cuban’s costplusdrugs.com, where a 90-day supply of 2.5 milligrams of rivaroxaban, a generic for Xarelto, is available for under $50. This could help the thousands of people who lost coverage through unpaid premiums from Wellcare Value Script obtain their medications. The problem of yearly increasing penalties for losing Part D coverage is something that has to be addressed by the Centers for Medicare & Medicaid Services.

Thanks to Ñî¹óåú´«Ã½Ò•îl Health News for the relevant coverage.

— Jackie Button; Miami

Fleshing Out the Details

Your report identifying alpha-gal syndrome as a red meat allergy is accurate in that respect but inadequate in its breadth (“Would Hunters Take a Lyme Disease Vaccine? We Asked,” June 30). Alpha-gal is an allergic reaction to virtually all mammalian products. If you explore that, you’ll find an interesting story, as mammalian products are everywhere, including in pharmaceuticals, cosmetics, and other non-meat products. Alpha-gal is growing rapidly, and too many people, including doctors, do not realize that AGS is far worse than just a red meat allergy.

I suggest you help build understanding of the threat by describing the allergy in the future as an allergy to mammalian products. If you do not think your audience will understand that term, perhaps you can explain that it includes pork and anything derived from animals with hooves. As a former and now retired reporter, I encourage you to cover this allergy because its implications are surprising and scary.

— John Varner, Surry, Virginia

Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

]]> 2259597 Copay Assistance Is Meant To Defray Patient Drug Costs. Some Insurers Keep It Instead. /health-care-costs/copay-accumulator-adjustment-programs-patient-assistance-insurance-pharma-drugs/ Tue, 07 Jul 2026 09:00:00 +0000 /?p=2250564 For 16 years, Larry Gruber, a fitness coach from Wilton Manors, Florida, received a coupon card to help him pay for a psoriatic arthritis medication he needs that costs more than $7,700 a month.

Each year, Amgen, which makes the drug, called , sent the coupon card worth thousands of dollars, and that counted toward Gruber’s health insurance deductible and out-of-pocket maximum.

Using the card, Gruber usually met that maximum by February, leaving his health insurance to fully cover his in-network medical costs and reducing his cost for the drug to $0 for the rest of the year.

But this year, his new health insurer, , pocketed the coupon card and required Gruber to pay for the drug until he satisfied the cost-sharing requirements on his own.

If Oscar Health had applied Amgen’s coupon toward Gruber’s cost sharing, he would have been on the hook for about $3,000 in covered services. Without it, he had to use his savings to meet the plan’s $10,600 out-of-pocket maximum.

“The real insult here is that they’re taking the money that’s intended to help you,” said Gruber, who had planned to buy a home next year with his savings. “I feel desperate, pressed against the wall, and squeezed.”

Oscar Health is one of many commercial health insurers that use what are often called copay accumulator programs to keep funds that are meant to defray patients’ out-of-pocket costs for expensive specialty drugs. Over the past decade, more insurers have to reduce their prescription drug costs, according to Avalere Health, a consulting company.

Patients who rely on copay assistance from drugmakers are typically heavy users of healthcare for whom delays in treatment or worsening conditions can lead to higher costs, according to patient advocates.

, Florida market president for Oscar Health, did not comment on the specifics of Gruber’s case. He said the company uses copay accumulators to manage rising medical and prescription costs and “to keep monthly premiums as low as possible.”

Drugmakers argue that insurers and pharmacy benefit managers use copay accumulators and other strategies to delay or deny care and steer patients toward medicines that insurers prefer instead. Insurers counter that coupon cards and other patient financial assistance from drug manufacturers drive up premiums and encourage patients to use higher-priced, brand-name drugs instead of less-expensive generics.

Meanwhile, patient advocates say it’s difficult for consumers to find out if their plan uses a copay accumulator or to understand how they work. Not only do the programs make medications unaffordable for consumers, critics argue, but they allow insurers to double-dip.

“They’re collecting the money twice and they’re hurting patients,” said , executive director of the HIV+Hepatitis Policy Institute, a patient advocacy group.

“Why does it make a difference to Oscar if they get the money from a drug company or, you know, his mother or him?” he said of Gruber’s experience. “They’re still getting the money.”

Larry Gruber stands in front of a mirror at a gym, his arms extended on both sides, stretching. Blurred arms in the foreground show students copying his move.
Gruber teaches a fitness class. (Scott McIntyre for Ñî¹óåú´«Ã½Ò•îl Health News)

Controlling Costs or Harming Patients?

Not all insurance types use copay accumulators. Medicare and Medicaid prohibit copay assistance because federal anti-kickback laws forbid drug manufacturers from offering financial incentives to influence patients’ choices. And the Internal Revenue Service prohibits such help for high-deductible plans with health savings accounts. But individual and commercial group plans can use them.

Regulation of copay accumulator programs has fallen largely to states, which oversee individual and small-group plans sold on the Affordable Care Act marketplace.

For 2026, of ACA marketplace plans have such a program, according to a review from The AIDS Institute, a nonprofit group that opposes the programs. Of the 16 insurers that sell plans on the marketplace in Florida, 10 use copay accumulator programs, the review found.

Patients who take brand-name specialty drugs for conditions such as autoimmune disorders, multiple sclerosis, diabetes, HIV, and cancer are most likely to encounter these programs. Health insurers say that making patients share the costs for specialty drugs encourages them to choose value over brand.

But Gruber doesn’t have a choice because there is no medically equivalent generic for Enbrel. Gruber’s livelihood as a trainer depends on his athleticism. The weekly injections, which he has to take for the rest of his life, prevent his joints from getting stiff. When he was diagnosed in 2010, Gruber said, he couldn’t shake hands or lift his knee to get into bed. Without treatment, he said, “I ache from my neck down to my toes.”

A close-up shot of Larry Gruber's hand holding up an injector for Enbrel.
Gruber’s new health insurer won’t apply a coupon card for Enbrel, making him spend $10,600 to meet the cost-sharing requirement. (Scott McIntyre for Ñî¹óåú´«Ã½Ò•îl Health News)

If manufacturers priced their drugs affordably, patients like Gruber wouldn’t need financial assistance, said , a senior vice president for AHIP, a trade association representing insurers.

“Drugmakers offer short-term ‘discounts’ to justify overcharging Americans in the long term, driving up healthcare costs for everyone,” he said in a statement. “Research shows limiting copay coupons can reduce premiums and lower consumers’ out-of-pocket costs.”

Sarah Ryan, a spokesperson for Pharmaceutical Research and Manufacturers of America, a trade association for the pharmaceutical industry, said copay assistance helps patients access medications free of charge or at reduced cost.

“Health insurance is supposed to protect patients,” Ryan said, adding that insurers and pharmacy benefit managers that refuse to count copay assistance toward cost sharing are “leaving patients facing unexpected costs and disrupting their care.”

Insurance companies already have tools to control costs without keeping financial assistance intended for patients, said , deputy executive director for The AIDS Institute.

Insurers choose what drugs to cover, whether they are medically necessary, and if a patient must try a cheaper alternative first.

“They are the ones making the decisions,” Klein said. “Now the individual is left trying to figure out how they’re going to pay for it.”

Consumers Stuck in the Middle

Larry Gruber stretches both arms upward, hands clasped together. A blurred figure in the foreground does the same stretch, framing his face.
Weekly injections of Enbrel prevent Larry Gruber’s joints from getting stiff, which is vital for his work as a fitness coach. The drug costs more than $7,700 a month, and he has to take it for the rest of his life. (Scott McIntyre for Ñî¹óåú´«Ã½Ò•îl Health News)

Before moving to Florida in 2024, Gruber said, he had bought coverage on the ACA marketplaces in Illinois and Louisiana, which prohibit copay accumulators. Gruber said he hadn’t encountered one until his experience with Oscar Health.

He complained to the office of Florida’s insurance consumer advocate, which informed him that the practice is legal in the state and that Oscar Health had disclosed its use of a copay accumulator program. Page 127 of his 168-page evidence of coverage states, “Third party assistance will not count towards your out-of-pocket maximum or deductible.”

Gruber said he selected his coverage using a tool on that listed all the Florida ACA plans that cover Enbrel. “I always choose the one with the highest deductible to get the lowest premium,” he said, “because I know I’m going to meet it.” His monthly premium is about $315 after subsidies.

Adding to Gruber’s confusion, he said, was that his patient portal with Oscar Health was counting his coupon card at first. He said he met his out-of-pocket maximum in February, and in March Oscar covered all the cost for the medication.

But when he ordered his refill for April, the pharmacy told him that Oscar would cover only $1,000 of the medication’s cost for that month. He would have to pay the remaining $6,700.

Gruber then received a letter from Oscar Health, telling him that an incorrect amount had been applied to his deductible.

An extract from a letter that reads, "March 13, 2026. Important information from your health insurance plan. Hi Lawrence. We are reaching out to let you know that we noticed an incorrect amount applied to your deductible for your Oscar health insurance plan. This issue has been corrected."

“They sent me a letter that basically stated they made a mistake,” he said. “The fact that they’re allowed to sort of change things midstream is also, I think, a little galling.”

He began rationing the injections, taking them every other week instead of weekly. By May, he had dipped into his savings to pay for the drug.

States Step Up While Federal Oversight Stalls

The first state laws banning copay accumulators were adopted in 2019, and since then more states have moved to regulate the programs, said , public policy director for the Alliance for Patient Access, an advocacy group.

“The goal is to build upon that progress at the federal level and to continue to drive this momentum forward,” he said.

Twenty-six states, Washington, D.C., and Puerto Rico have adopted laws banning copay accumulators or prohibiting them for drugs that do not have a generic equivalent. Colorado also prohibits copay accumulators for drugs without a biosimilar. In states that have not banned or restricted the programs, insurance companies decide whether to use them.

Half of States Restrict Insurers From Pocketing Copay Assistance (Choropleth map)

Half of States Restrict Insurers From Pocketing Copay Assistance

Some health insurers use copay accumulator programs to keep funds that are meant to defray patients’ out-of-pocket costs for expensive specialty drugs, such as those that treat chronic conditions. These programs are restricted for individual and small-group health plans in 26 states and Washington, D.C.

Sources: <a href=”; target=”_blank”>The AIDS Institute</a>; <a href=”; target=”_blank”>America’s Health Rankings</a>; <a href=”; target=”_blank”>KFF</a>

But federal regulation of the programs, which would apply to all states, remains at a standstill.

A federal court in 2023 struck down a policy enacted during President Donald Trump’s first term that had permitted insurers to use copay accumulator programs. As a result, the Department of Health and Human Services reverted to that restricts their use to brand-name drugs with a medically appropriate generic equivalent.

After the court ruling, the Biden administration pledged to address copay accumulators in future rulemaking. But HHS has yet to do so, said Schmid, whose group, the HIV+Hepatitis Policy Institute, led a coalition of patient advocacy groups that sued to overturn the rule.

“The Trump administration can stop this once and for all at the national level,” Schmid said. “If they really care about patient affordability, this is something they can do.”

Bipartisan legislation in Congress called the would require financial assistance to count toward deductibles and other out-of-pocket costs on plans regulated by the federal government, including much employer-sponsored coverage.

Schmid said the bill has not gotten “enough traction on the Hill yet.”

Other ways to obtain medication don’t help patients facing copay accumulators either. The president’s , an online platform through which consumers can buy prescription drugs at a discount, requires patients to pay out-of-pocket, and the cost does not count toward their plan’s cost-sharing requirements.

Christopher Krepich, a Centers for Medicare & Medicaid Services spokesperson, said that HHS, along with the departments of Labor and the Treasury, intend to address the issue of whether copay assistance must apply toward health plan cost sharing.

Until then, he wrote, “the Departments do not intend to take any enforcement action against health insurance issuers or group health plans based on their treatment of such manufacturer assistance.”

Outside of government regulation, consumers have few protections or alternatives.

Patients who rely on expensive medications — and who have a choice in their health insurance plan — should research their coverage options and choose wisely so they’re not caught by surprise, Clingham said.

That may mean reading plan benefit explanation packages, contacting their state’s insurance regulator, or calling an insurance company to ask if their plans use copay accumulator programs.

For Gruber, the extra expense means he won’t take a vacation this year. He’s also concerned that the money he was saving for a home will now go to his medication costs instead.

“It’s the first thing I think of when I wake up in the morning,” he said. “If this happens every year, it would be financially devastating.”

Larry Gruber stands outside.
(Scott McIntyre for Ñî¹óåú´«Ã½Ò•îl Health News)

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Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

]]> 2250564 Thousands of Medicare Beneficiaries Thought Their Drug Plan Was Free. Then They Lost It. /medicare/medicare-drug-plans-part-d-small-premium-increases-disenrollments-wellcare/ Tue, 07 Jul 2026 09:00:00 +0000 /?p=2253783 Jude Pare and his partner, Diane Tix, live in rural Minnesota until temperatures dip below freezing, when they take refuge in Arizona for the winter. While away, their mail is forwarded. But Pare, 77, said he didn’t receive any warning from his Medicare prescription drug plan that his $0 monthly premium was about to increase.

So he didn’t know he had a bill to pay. After he and Tix returned home to Minnesota in April, they got a letter from Wellcare, the insurer that provided his drug plan, saying his coverage had been terminated after three months of unpaid premiums totaling $28.80. Under Medicare’s rules, he can’t enroll in a plan again until the fall, for coverage beginning in 2027.

Pare takes Xarelto, a blood thinner that reduces his risk of strokes, blood clots, and pulmonary embolism. “He could bleed to death without it,” Tix said. A 90-day supply of the drug costs about $1,800 using a coupon from GoodRx, a discount drug website, she said.

Pare is among tens of thousands of Medicare beneficiaries who were on Wellcare’s Value Script drug plan who will likely go without prescription drug coverage for the rest of the year because they didn’t pay premiums for three months.

Next year, thousands more people in 32 states and Washington, D.C., who are enrolled in zero-premium drug plans from Wellcare and other insurance companies may find themselves in the same situation if their premiums go up and they don’t realize it, according to a Ñî¹óåú´«Ã½Ò•îl Health News analysis of drug plan data. Premiums and other changes for 2027 will be unveiled in September.

Going without medication can be life-threatening, especially for Medicare beneficiaries. take one or more prescription drugs, according to the Centers for Disease Control and Prevention. Almost half live with four or more chronic health conditions that can cause functional or cognitive impairments.

By the time Jude Pare and his partner, Diane Tix, found out he owed $28.80 for three months of drug plan premiums, his coverage had been canceled. He is among tens of thousands of Medicare beneficiaries who will likely go without prescription drug coverage for the rest of the year after their drug plans were canceled. (Diane Tix)

Congress added prescription drug coverage to Medicare in 2003. But the coverage is administered by commercial insurance companies, which compete fiercely with one another for the business of about enrolled in drug plans.

Zero-dollar or very low monthly premiums have helped make Wellcare’s Value Script the bestselling stand-alone prescription drug plan in Medicare, with nearly 6 million customers across the U.S., according to government data. But in 26 states and Washington, D.C., some Value Script members who didn’t have to pay a premium last year were caught off guard by increases in 2026.

After a two-month grace period — which Wellcare extended to three — Medicare drug plans can drop customers who don’t pay their premiums, no matter how small the amount. Some members who lost their coverage in Nevada, for example, owed as little as $8.10 for three months, according to a Ñî¹óåú´«Ã½Ò•îl Health News analysis of Medicare drug plan data.

Wellcare terminated coverage for about 140,000 Value Script beneficiaries in April, according to a person with knowledge of the matter who was not authorized to speak publicly about it and feared reprisals at work for doing so. About 40,000 of the people who were dropped may be able to enroll in new coverage immediately because they have low incomes and receive financial assistance through a program Medicare calls “.”

Multiple state officials said they had heard the same disenrollment figures, including Nevada’s insurance commissioner, Ned Gaines, who chairs the National Association of Insurance Commissioners’ senior issues task force; Rebecca Gouty, director of the State Health Insurance Assistance Program in West Virginia; and Tim Smolen, director of Washington state’s Statewide Health Insurance Benefits Advisors. The West Virginia and Washington initiatives are part of the federally funded , or SHIP, which provides free, unbiased help navigating Medicare.

Surprise Bills

The Centers for Medicare & Medicaid Services, which oversees Medicare drug plans, declined to provide the number of Value Script members who lost coverage due to unpaid premiums. “The agency does not publicly provide plan-specific disenrollment figures or state-level breakdowns related to the non-payment of premiums,” Christopher Krepich, a spokesperson, said in a written statement to Ñî¹óåú´«Ã½Ò•îl Health News.

Centene Corp., Wellcare’s parent company, also declined to provide disenrollment numbers.

“We recognize how disruptive a loss of coverage can be and are committed to helping members understand their options,” said Sarah Baiocchi, senior vice president for specialty and prescription drug plans at Centene. She acknowledged that “some members in our Value Script plan experienced a premium for the first time, or for the first time in several years.”

Baiocchi said all Value Script members received a CMS-required annual notice of changes in September, before the premium increases took effect.

A sent to members in two states and Washington, D.C., is 21 pages long. The new premium is mentioned on pages 3 and 8, along with changes to out-of-pocket costs and how to find updates on covered drugs and network pharmacies.

The company also informed members about 2026 premium changes through phone calls, text messages, regular mail, or email, Baiocchi said.

People who are dropped are not able to reenroll or join another drug plan until the start of the open enrollment period this fall for coverage beginning Jan. 1, unless they qualify for an exception, Krepich said. And because they will have gone without coverage for at least 63 days, they could be hit with a permanent that increases every year for the rest of their lives.

“Medicare should be doing something about this so that we can go ahead and get coverage now,” said Wayne Bennett, 74, who lives in Durham, North Carolina.

In May, he found out that Wellcare had canceled his Value Script plan because he hadn’t paid his $3.60 monthly premiums. He takes nine prescription drugs to treat his blood pressure, glaucoma, chronic obstructive pulmonary disease, and other health problems. He filled most of his prescriptions — including several at no cost — before he lost coverage. He doesn’t know what he’ll have to pay when his supply runs out.

Gouty, the West Virginia program head, said many Medicare beneficiaries arrange for their monthly drug plan premium to be automatically deducted from their Social Security benefits, and that many likely thought that choice remained in place until they changed it.

“They didn’t realize that when the plan was a zero premium in 2025, that stopped the Social Security premium deduction and they would have had to reelect it for 2026,” Gouty said.

In other words, even if they mistakenly thought the premium was still zero, Medicare beneficiaries would have needed to somehow allow Social Security to make deductions — something the agency doesn’t do — or set up a payment plan through their bank or credit card in case payment was necessary.

“That sounds goofy,” Tix said.

Centene’s Baiocchi blamed the Social Security Administration for the problem: “We believe this was a key driver of non-payment disenrollments and subsequent complaints.”

Spokespeople for the agency referred questions about the matter to CMS.

Krepich said legal requirements for drug plan enrollment and disenrollment limit what CMS can do to help beneficiaries who lose coverage for not paying their premiums.

‘Pretty Upset’

Now that Pare has no prescription drug coverage, his doctor replaced his blood thinner medication with a much less expensive drug that should be just as effective. Pare paid $111 for four other medications that used to be free under his Value Script plan. He hasn’t had to refill four more prescriptions yet and doesn’t know what they will cost, Tix said.

If Wellcare members knew about the premium increases, they could have set up direct billing or an automatic payment plan early this year before the payment grace period ended April 1. But they would have been able to fill prescriptions during the grace period, so if they didn’t see Wellcare’s notices, they likely assumed there was no problem with their coverage.

Bennett, the North Carolina man, said Wellcare used to send him text messages with health tips and reminders when it was time to pick up a prescription. He didn’t know his premium had increased from $0 to $3.60 until it was too late.

An older man with white hair stands with his arms crossed.
Wayne Bennett lost his Medicare drug coverage because he didn’t pay the premium, which was free last year but — without his knowing — went up this year. “Medicare should be doing something about this so that we can go ahead and get coverage now,” he says. (Wayne Bennett)

“I was pretty upset,” he said, when he called the company. “The premium wasn’t that much, and I was ready to pay it right off the bat. I had my credit card out ready to make the payment.”

The customer service representative wouldn’t let him pay because his coverage had been canceled, Bennett said.

Hoping to restore it, Bennett called , a Durham nonprofit that advises Medicare beneficiaries and is one of more than 2,200 SHIP sites across the country. He was told he must wait until January to restart his drug coverage, said the group’s executive director, Gina Upchurch.

He doesn’t qualify for the “Extra Help” low-income subsidy or meet other CMS criteria for a , which would allow him to change drug plans during the year. CMS typically allows midyear switches for beneficiaries who, for example, move out of their plan’s service area, experience a natural disaster, or get help paying for drugs from a .

Senior PharmAssist was able to help one of its participants join another drug plan after she lost Value Script coverage because she is in North Carolina’s pharmacy assistance program for people with HIV/AIDS and has limited income, Upchurch said.

A further exception allows any Medicare beneficiary to enroll at any time in a drug plan that has earned five stars, the top grade in Medicare’s performance ratings. However, there are no five-star Medicare drug plans available to the general public. Only two insurers offer five-star plans, and only for retirees from certain employers. Their combined enrollment is about 8,700 as of June 1, according to the insurers.

But Upchurch, with more than two decades of Medicare expertise, doesn’t blame beneficiaries for not paying attention or for assuming Wellcare’s messages were bogus. Older adults are particularly vulnerable to identity theft and other scams and are often advised to ignore junk mail and calls from telemarketers.

Since Value Script members such as Bennett continued to get their prescriptions filled during the payment grace period, “why wouldn’t they think this was a scam?” Upchurch asked. “They are constantly bombarded by people selling them something that’s illegitimate or trying to scam them.”

Ñî¹óåú´«Ã½Ò•îl Health News 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 .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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