Drugs Archives - ºÚÁϳԹÏÍø News /tag/drugs/ ºÚÁϳԹÏÍø News produces in-depth journalism on health issues and is a core operating program of KFF. Wed, 03 Jun 2026 17:39:32 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.5 /wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=32 Drugs Archives - ºÚÁϳԹÏÍø News /tag/drugs/ 32 32 161476233 At a Tennessee Hospital, a Nurse Stole Fentanyl and AI Missed It, State Records Say /health-industry/ai-drug-diversion-theft-artificial-intelligence-hospitals-sentri7-software-tennessee/ Wed, 03 Jun 2026 09:00:00 +0000 /?p=2242533 About a year ago at Erlanger Baroness, the largest hospital in Chattanooga, anesthesia staff noticed that a nurse was slurring his words and struggling to stay awake while on duty in the surgery center, according to a .

In the days that followed, the nurse failed a drug test and was fired, the order states. The nurse later admitted that for months he had pilfered and abused fentanyl left over after surgeries, sometimes daily, according to the order.

Under most circumstances, this would be a routine case of what is known as “drug diversion,” the unlawful taking of controlled substances from healthcare facilities — believed to be so widespread that it occurs at just about every U.S. hospital.

But the Erlanger case stands out because a high-tech watchdog was supposed to be on guard.

The hospital uses the newest line of defense against drug diversion: Sentri7, powered by artificial intelligence and designed to detect missing drugs faster than any human can. But for months at Erlanger, Sentri7 failed to raise alarms, overlooking missing drugs and other “inconsistencies” that “should have been flagged,” the nursing board’s order states.

The Erlanger case, which has not been previously reported, offers a rare glimpse at an apparent failure of AI drug diversion software used in hundreds of U.S. hospitals with little transparency or oversight. Healthcare facilities are not required to disclose their implementation of this kind of software or report malfunctions to anyone, so there is no full account of how widely these programs are used or how often they fail.

Erlanger Baroness, also referred to as Erlanger Medical Center, declined to comment on its use of Sentri7 or on the diverted drugs. André Rebelo, a spokesperson for the health division at Wolters Kluwer, the Dutch technology company behind Sentri7, declined to answer questions about what happened at Erlanger but said the company remained “confident in our software.”

Little Transparency

David Rastall, a Johns Hopkins Medicine neurologist and AI researcher, said that because AI technology is heavily proprietary and hospital officials often don’t understand how it works, this lack of transparency allows for errors to be buried rather than fixed. That means errors could be repeated at other hospitals, he said.

“The ideal for patients, caregivers, and hospital systems would be,” Rastall said, “when an AI is found to be making some type of error, that becomes very transparent and public.”

The Drug Enforcement Administration mandates that hospitals confidentially report lost or stolen drugs. Hospitals can also report stolen drugs to state health agencies, which license medical professionals and investigate wrongdoing.

But these reports are not required to include details about any AI software involved, according to interviews with three drug diversion prevention experts. In interviews, all said they had never seen an AI failure publicly documented like the apparent one at Erlanger.

“I’ve never myself seen these technologies be called out in that specific way,” Jacob Smith, a pharmacist in charge of drug security at Johns Hopkins Medicine, said of the apparent Sentri7 failure. “It doesn’t make sense to me how you could miss it.”

Smith and other experts said the Erlanger case also raises questions because the theft of leftover drugs is one of the most well-known methods of diversion. And fentanyl, a painkiller that can be 50 times as strong as heroin, is one of the most common targets.

Terri Vidals, the founder of , questioned whether the Erlanger case was the result of user error instead of malfunction.

“This is the most basics of basics for this software,” Vidals said. “I find it interesting that they’re saying it wasn’t flagged by the software. I think there’s maybe more to that story.”

The apparent Sentri7 failure at Erlanger was revealed by the Tennessee Department of Health in a routine release of in December. Among those records was the Board of Nursing order, which summarizes a state investigation into nurse anesthetist John Stevenson, who settled the case against him by signing the document in November.

Stevenson declined to comment through his attorney. He has not been charged with any crime related to the Erlanger case. The nursing board put his license on probation while he went to drug counseling.

Bill Christian, a spokesperson for the Department of Health and Board of Nursing, declined to comment on the Erlanger case or Sentri7. In response to public records requests, the Department of Health and the Tennessee Health Facilities Commission each said it possessed no other documents about the apparent Sentri7 failure at Erlanger.

Erlanger spokesperson Charlie Milburn said earlier this year that the hospital had prepared a written statement about its use of Sentri7 in response to questions from ºÚÁϳԹÏÍø News.

That statement was never released.

“Our legal team is debating whether this is something we want to talk about at all,” Milburn said in a March email, before later declining to answer any questions.

Kristy Drollinger, a Wolters Kluwer executive who spoke generally about Sentri7 to ºÚÁϳԹÏÍø News in March, said the software is in high demand because so many hospitals have struggled to secure their drugs.

Sentri7 monitors about 60 “attributions of risk” that identify red flags for further investigation by hospital employees, Drollinger said.

“It’s pretty scary,” Drollinger said of widespread drug theft. “Every health system, every health facility, has had diversion at some point — and probably has it now.”

‘The Way of the Future’

Drug diversion is a widespread challenge in U.S. medical facilities. It can lead to patients not receiving medication or getting drugs that are contaminated with blood-borne diseases. It’s estimated as many as 15% of all healthcare workers divert drugs at least once, according to the nonprofit .

Diversion has been linked to at least — causing more than 200 infections, mostly of hepatitis C — since 1985, according to the Centers for Disease Control and Prevention.

To prevent this, hospitals attempt to track each pill or vial from the moment it is dispensed to the moment it is given to a patient, by comparing data from electronic medication cabinets and patients’ health records.

Hospital staff once performed this painstaking process manually, but in the past decade the task has become largely automated by anti-diversion software. After years of mergers and buyouts, two programs now dominate the industry: Wolters Kluwer’s Sentri7 and Bluesight’s ControlCheck. Both incorporate AI.

“It’s definitely the way of the future,” said Luke Overmire, owner of .

More than 1,500 hospitals use ControlCheck, according to Bluesight. An additional 700 use Sentri7 Clinical Surveillance programs, which can include its drug diversion software, according to Wolters Kluwer.

Neither company publishes the price of its software. Smith, the drug safety official from Johns Hopkins, said hospitals purchase these “expensive technologies” because a disastrous diversion case could result in a multimillion-dollar fine from the DEA.

“They don’t promise a return on investment,” Smith said. “They promise cost avoidance.”

In 2022, a funded by the National Institutes of Health found that Sentri7, then known as Flowlytics, could uncover drug diversion faster than existing methods. The study’s primary author worked for Invistics, the company that previously owned Sentri7.

According to that study, researchers tested the software by having it comb through medication data spanning two years and 10 hospitals in search of 22 nurses who were already known to have diverted drugs.

The program not only found them all, the study states, but found them faster than humans by as little as a week and as much as a year and a half.

At Erlanger, the humans spotted the signs of trouble first.

According to the Board of Nursing order, co-workers reported that Stevenson appeared impaired “while on duty in the surgery center” on or around June 30, 2025.

Stevenson “had slurred speech, appeared extremely tired, was seen standing with his eyes closed and swaying, exhibited head nodding while standing upright and appeared to have difficulty keeping his eyes open,” according to the order.

When questioned by state investigators, Stevenson admitted that he began diverting “unused fentanyl that would otherwise have been wasted after surgical procedures” in March 2025, according to the order. Stevenson said he used the fentanyl waste once or twice a week at first, then “increasing to daily use” by June of that year, the order states.

Erlanger audited Stevenson’s dispensing record over those four months. It found approximately five instances when Sentri7 didn’t flag missing drugs, according to the order.

It adds that the hospital found “additional inconsistencies between drug dispensing and waste documentation that should have been flagged by the automated monitoring system.”

One possible explanation is provided by the Board of Nursing, which said in the order that Sentri7 was in its “initial learning phase” at Erlanger, though the board provided no details.

In an interview, without discussing Erlanger specifically, Drollinger said Sentri7 has no “learning phase,” because it is trained on nine to 12 months of historical data when implemented at a new hospital.

Smith, of Johns Hopkins, had another theory.

In an interview, Smith said his experience with AI drug diversion software had led him to believe that it is effective at monitoring emergency rooms and intensive care units but less so in operating rooms, where drugs are dispensed and charted differently.

These areas can be harder for AI to track, Smith said, and therefore require humans to keep a closer watch.

“We’ve got people whose entire job is to work with this software,” Smith said. “The software is a piece of it, but if you rely on the software to give you all your signals, you’ll miss stuff. It’s just not 100%.”

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/health-industry/ai-drug-diversion-theft-artificial-intelligence-hospitals-sentri7-software-tennessee/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2242533&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2242533
Telehealth Booms as Demand for GLP-1s Surges and Questions Mount About Safety, Oversight /health-industry/glp1-weight-loss-drugs-telehealth-oversight-regulation-compounded-semaglutide/ Mon, 01 Jun 2026 09:00:00 +0000 /?p=2236393 Within 24 hours of injecting the first dose of a weight loss medication she received following a visit with a telehealth doctor, Karleigh McClain was admitted to the hospital, she said.

The 31-year-old compliance consultant from Hendersonville, Tennessee, said she couldn’t stop vomiting.

“Sunday morning, it all hits,” McClain recalled, as she described what happened that weekend in January. “I can’t keep anything down.”

McClain said she thought the dosage the telehealth company had prescribed seemed too high. She tried to contact her doctor, but when she didn’t get an immediate response, she said she called the company and a “care team” representative confirmed the instructions — which said to inject 2.21 milligrams of the semaglutide medication once a week — were correct.

It turned out, however, that was nearly nine times the amount patients are typically told to take for their first dose.

Nearly a month after she was diagnosed with an overdose, McClain said she was “still dealing with the residual side effects,” including an elevated heart rate and vision problems she felt were tied to the medication.

Most patients who have taken a GLP-1 received their prescription through a primary care doctor or a specialist, shows. But as the uptake of telehealth has grown substantially since the start of the covid pandemic, McClain is one of millions of Americans who have used online companies to meet a variety of their medical needs.

Many of the companies have started offering GLP-1 medications for weight loss as demand for these drugs has exploded. But certain medication errors tied to GLP-1s have exploded too, according to a ºÚÁϳԹÏÍø News review of Food and Drug Administration data, and physicians and telemedicine researchers worry that adverse experiences tied to telehealth companies are becoming more common.

Bad outcomes aren’t unique to telehealth providers or to the compounded weight loss drugs many of them offer. In fact, product liability lawsuits alleging patient injuries have been filed overwhelmingly against pharmaceutical giants Eli Lilly and Novo Nordisk, which manufacture name-brand weight loss drugs, court data shows. The drugmakers have defended their products.

However, some critics are also concerned that getting a weight loss prescription online is usually much easier than getting one through an in-person appointment. Not only do many telehealth companies write quick prescriptions for GLP-1s, but they often sell the medications, too, allowing patients to bypass in-person pharmacy visits. This one-stop shopping isn’t necessarily a good thing, according to critics who say some telehealth providers are writing prescriptions for people who should not be taking GLP-1s and then providing little or no follow-up care.

“It gives a black eye to telemedicine,” said Elizabeth Krupinski, an experimental psychologist at Emory University who has conducted research on the effectiveness of telehealth.

Telemedicine stands to benefit “so many people,” Krupinski said, particularly when the technology is integrated within a larger healthcare system. That way, patients benefit from the convenience of telehealth while maintaining a connection with their in-person providers.

But some telehealth companies are marketing GLP-1s as an easy way to lose weight — sometimes with the help of paid celebrity endorsements — without emphasizing the importance of healthy eating and exercise, she said.

They may be following the letter of the law, Krupinski said. But writing prescriptions while skimping on care “is not in the Hippocratic oath.”

A woman's hand holds a small vial of liquid GLP-1 medication on a table.
McClain says she overdosed on an injectable weight loss medication in January after following dosing instructions from a telehealth provider. (Arielle Weenonia Gray for ºÚÁϳԹÏÍø News)

The Perfect Storm

Starting around 2020, many states loosened restrictions on telehealth, which allowed online companies to proliferate. This helped accommodate patients who could not, or chose not to, be seen in person at the height of covid transmission.

Expanded telehealth access was also intended to lower barriers in rural communities, as well as mitigate doctor and nurse shortages. In many places, telehealth doctors and nurses are legally allowed to treat patients across state lines. But the way telemedicine is practiced , and state laws largely dictate rules that telehealth providers must follow.

Some companies, such as Mochi Health, require patients to meet virtually with a provider, such as a doctor, nurse practitioner, or physician assistant, before they can get a GLP-1 prescription.

But others, including Ro, sometimes require nothing more of patients than an “asynchronous” evaluation, which does not include a live conversation with a healthcare provider. During this type of evaluation, customers are typically asked to fill out an intake form and answer a medical history questionnaire before they are evaluated for a prescription. Ro requires a conversation in real time when required by state law, or when requested by a patient or clinician, said Nicholas Samonas, a spokesperson for the company.

“Every patient is counseled by their provider on the potential benefits and risks of treatment based on their individual medical history,” Samonas said. Ro’s clinicians can order lab work when necessary and, when appropriate, may recommend patients seek in-person care, he said.

But some medical experts are concerned that virtual care may be insufficient for prescribing weight loss drugs.

Patients with a history of pancreatitis, for example, should be counseled about potential complications, medical studies show. The same goes for people with a condition called gastroparesis, which affects stomach nerves and muscles, and those susceptible to medullary thyroid cancer.

Some patients may also benefit from blood work or muscle mass screening before starting a GLP-1.

But not all telehealth companies are adequately evaluating patients before writing prescriptions, said Marc-Andre Cornier, an endocrinologist at the Medical University of South Carolina and the immediate past president of The Obesity Society.

When it comes to parsing the good from the bad, “whose job is it to police that?” he asked. The problem, he said, is there aren’t criteria written by a government agency or a medical society to determine which providers are treating patients appropriately and which aren’t.

While the first GLP-1 was approved by the FDA more than 20 years ago, to treat Type 2 diabetes, the use of these drugs took off in 2021 when Novo Nordisk received approval for a semaglutide drug to treat obesity, with the brand name Wegovy. In a 2025 KFF poll, said they had taken a GLP-1.

In a in The New England Journal of Medicine, physician Amanda Banks noted that the proportion of GLP-1 prescriptions written for people who were not diabetic, obese, or overweight increased from 4.5% in 2018 to 17% in 2023.

In the paper, Banks called it “troubling” how easy it is to obtain a prescription for weight loss drugs and worried they might exacerbate existing eating disorders or cause new cases, including of anorexia.

Cornier, who has received compensation from Novo Nordisk for serving as a consultant, echoed some of Banks’ concerns. “It’s not just filling out a form online and then having some random healthcare provider sign off on it,” he said. “There are concerns with some of these online programs that there’s not a proper evaluation, there’s not a baseline, and there’s not proper supervision.”

The American Telemedicine Association, which advocates for the expansion of “digitally enabled care,” has not addressed how telehealth providers prescribe GLP-1s, spokesperson Gina Cella said.

“This is a bit out of our scope,” Cella said, when asked if the association had addressed the topic of telehealth providers and GLP-1 prescriptions.

The lack of clarity makes choosing a company potentially confusing for patients, and the medical profession is partly to blame, said Jamy Ard, an obesity doctor and researcher at Wake Forest University School of Medicine in Winston-Salem, North Carolina.

Doctors have historically done a bad job counseling patients about weight loss, and many people aren’t comfortable talking to their primary care doctor about it, Ard said. Patients think, “Why would I go to my doctor and have them say, ‘Eat less and move more,’ when I have heard that a million times and I don’t want to have that lecture again?” Ard said.

This problem, combined with past shortages of name-brand versions of GLP-1s, such as Ozempic, Mounjaro, and Trulicity, has created a “perfect storm” for telehealth companies to flourish, said Ard, who has received support from pharmaceutical and telehealth companies.

While some telehealth companies prescribe only name-brand weight loss drugs, many also offer cheaper, compounded versions. They act as intermediaries between customers and mail-order compounding pharmacies, which create GLP-1s by mixing active ingredients, such as semaglutide, with additives. The ingredients for compounded drugs are commonly sourced from overseas suppliers, and the formulations are not reviewed by the FDA for safety.

The environment is “very much uncontrolled and poorly, if at all, regulated,” Ard said. “There is just no standard of care.”

Emily Hilliard, a spokesperson for the Department of Health and Human Services, told ºÚÁϳԹÏÍø News that compounded drugs “should only be used in patients whose medical needs cannot be met by an FDA-approved drug.”

Hilliard said the agency urges “consumers to be vigilant and know the source of their medicine.”

Understanding the Risks

While weight loss drugs have helped millions of people lose weight, they’re not without risk, the data shows.

A ºÚÁϳԹÏÍø News data analysis of the FDA’s Adverse Event Monitoring System found that medication errors made by providers or patients with popular weight loss drugs exploded from just over 2,000 reports in 2020 to over 25,000 in 2025. Those self-reported events involved semaglutide, tirzepatide, dulaglutide, and liraglutide, the generic names for leading GLP-1s.

Among frequent issues cited in the adverse event reports were administration of an extra or incorrect dose, issues with communication about a product, and prescribing errors.

Reports of GLP-1 Errors Explode (Column Chart)

Since 2019, the National Poison Data System has fielded a related to overdoses or side effects from injectable weight loss drugs. The data does not distinguish between overdoses tied to a telehealth prescription and those stemming from an in-person medical appointment, but it is a reflection of how prevalent these drugs have become.

Yet data on potential medication errors and adverse reactions to GLP-1 medications is incomplete, because many issues are never reported to federal officials.

For example, in a , the FDA accused drugmaker Novo Nordisk, the maker of Wegovy and Ozempic, of failing to report some adverse events to the federal government, including suicidal ideation and death.

Nobody knows how often adverse events occur, said Kristen Nixon, a Johns Hopkins University researcher who has studied posts about weight loss drugs on Reddit, a popular online forum.

Her team analyzed hundreds of Reddit posts from 2020 through last August and identified frequent mentions of drug reactions and user errors, such as patients’ not knowing how to correctly dose and inject the medication.

But another finding also stood out to her.

“Wow, there are a lot of people talking about telehealth,” Nixon recalled thinking. Reddit commenters said they got GLP-1 prescriptions from scores of telehealth platforms, Nixon found. Commenters also mentioned several dozen compounding pharmacies — often in the same posts about telehealth.

Pharmacies are typically required to counsel patients on medications they receive. But Nixon’s research found that telehealth companies often mail the medications directly, meaning patients do not need to go to a pharmacy.

“Anecdotally, it seems like the telehealth companies are really facilitating access to compounded medications,” Nixon said.

A collage of 6 advertisements for online GLP-1 medication.
A collage of weight loss drug advertisements on social media from telehealth companies. In recent months, the Trump administration has sent warning letters to online companies for false or misleading claims related to compounded versions of GLP-1 medications. (Collage by ºÚÁϳԹÏÍø News)

Leslie Gammon, 54, an office manager from Wendell, North Carolina, said she turned to a telehealth company called Amble Health for a weight loss drug prescription. She was given a GLP-1 after filling out an online form, she said.

Like McClain, when she received her mail-order compounded medication in late October, she thought the dosage that accompanied it seemed too high. She’d received a box of semaglutide earlier in the month with a much lower dose. But the refill she received was a stronger formulation, and the instructions told Gammon to inject three times the volume she had been taking in previous weeks.

Even though she injected slightly less than that recommended amount before bed on a Sunday evening, she woke up in the middle of the night “throwing up every 20 to 25 minutes,” she said. And it didn’t stop until Tuesday. She was eventually admitted to a hospital in Raleigh and now owes the hospital over $9,000, a medical bill shows.

Amble Health did not respond to questions for this article.

The delivery system for injectable versions of weight loss drugs is more complicated than for a pill. In its National Poison Data System alert, America’s Poison Centers noted that some people reported “accidentally taking 10-times the recommended dose due to confusing measurement units while using a syringe.”

And people who are eager to lose extra weight — before a wedding or a vacation, for example — may choose to self-administer a higher-than-recommended dose, said Arthur Caplan, a bioethics professor at New York University’s Grossman School of Medicine.

Some telehealth companies aren’t doing enough, he said, to make sure patients understand the risks or the complex delivery system associated with the injectable drugs.

“The consent is not adequate,” Caplan said. “There’s no probing to see if you understood anything.”

Cella, with the American Telemedicine Association, said the group has not addressed the difficulty of educating patients about the risks of injecting weight loss drugs. But she pointed to the association’s “,” which states that telehealth business models “must put the patient first.”

Proceed With Caution

Pharmaceutical companies must list potentially harmful side effects when they advertise the name-brand versions of their FDA-approved medications. Potential include nausea, vomiting, changes in vision, low blood sugar, and, in rare cases, thyroid cancer. Meanwhile, telehealth companies have not historically followed the same rules that drugmakers have in disclosing medication risks in advertisements. But the FDA has started cracking down on misleading drug ads.

A national shortage of weight loss medications in 2022 opened the door for compounding pharmacies to manufacture these drugs. But since the FDA declared the shortage over last year, companies that offer compounded drugs are increasingly facing legal and regulatory challenges related to their marketing tactics.

Mounjaro manufacturer Eli Lilly and other drugmakers are suing multiple telehealth companies for promoting compounded versions of their drugs. In one legal complaint, Eli Lilly alleged Mochi Health had engaged in “deceptive” business tactics. In a motion to dismiss the lawsuit last year, lawyers for Mochi Health called the complaint part of a “nationwide campaign to bolster Lilly’s profits by dictating patient care through the elimination of compounded drugs as a treatment option for weight management.” The lawsuit is ongoing.

Eli Lilly spokesperson Michael Jamison said in a written comment that telehealth companies sued by the drug manufacturer threaten “patient safety by falsely promoting supposedly ‘personalized’ compounded tirzepatide” and mislead “consumers about the safety, clinical testing, and effectiveness of their compounded knockoffs.”

Meanwhile, Novo Nordisk has filed 130 lawsuits against “entities engaged in unlawful marketing and sale of knockoff semaglutide drugs,” said Liz Skrbkova, a spokesperson for the drugmaker.

She said the company is committed to “protecting patients from unapproved knockoff drugs made with foreign, inauthentic active pharmaceutical ingredients that pose significant safety and efficacy risks.”

The Trump administration sent a in September and February to online companies such as , , , and . The FDA said these and other companies had made false or misleading claims related to compounded versions of weight loss drugs.

“Your claims imply that your products are the same as an FDA-approved product when they are not,” the agency’s Center for Drug Evaluation and Research on Sept. 9. HHS later referred the company to the Department of Justice after it announced the launch of a $49 version of Novo Nordisk’s Wegovy pill.

When asked about the FDA warning, Abby Reisinger-Moley, a spokesperson for Hims & Hers, pointed to a announcing a shift away from compounded weight loss drugs. The company said in the press release that it had entered into an agreement with Novo Nordisk to sell name-brand versions.

Alex Smith, CEO of Join Josie, an online platform that helps women in menopause lose weight by prescribing GLP-1s, said his company also made changes in response to an FDA letter, to include removing Join Josie’s name from medication vials. “Which I agree with,” Smith said, “because you don’t want patients thinking you’re the compounding pharmacy.”

SkinnyRx and Genesis Health International did not respond to requests for comment.

But these warnings aren’t the first time the federal government has stepped in to ensure that telemedicine is being used appropriately, said Mei Wa Kwong, executive director of the Center for Connected Health Policy.

Prior cases involved attention-deficit/hyperactivity disorder medications and other controlled substances prescribed by telehealth providers, she said. While those drugs pose more risk to patients than GLP-1s, the companies were also accused of improperly screening potential customers.

The onus still falls on consumers to research companies before signing up for their services, Kwong said.

“Always approach anything on the internet with a hint of skepticism,” Kwong said.

A woman stands beside her kitchen counter and dining table and faces the camera.
McClain was admitted to the hospital after injecting nearly nine times the amount of semaglutide that patients typically take as a first dose of the popular weight loss drug. That’s what her prescription from a telehealth provider had dictated. (Arielle Weenonia Gray for ºÚÁϳԹÏÍø News)

‘Keeps Getting Worse’

McClain, the Tennessee woman hospitalized this year after a GLP-1 overdose, said she lost 50 pounds a few years ago by taking a name-brand GLP-1 prescribed by her doctor.

At the time, the medication was covered by her health insurance. This year, when she was ready to take a GLP-1 again following a pregnancy, the drug was no longer covered for weight loss.

To save money by obtaining a cheaper, compounded GLP-1, McClain signed up for Mochi Health after doing her own research. “That was just the most affordable option,” she said.

But within hours of her first dose, she said, she found herself on the phone with poison control.

After her overdose, McClain said, she spoke to a clinical director at Mochi Health, once by phone but mostly via email, about her lingering symptoms before communication paused.

David Pilip, a spokesperson for Mochi Health, said in a statement that the company would not discuss individual patients due to privacy obligations. But he said adverse events are “immediately flagged” and “investigated with extreme precision.”

“Mochi Health takes patient safety extremely seriously,” Pilip wrote in an email. “We promptly initiated a review and have been in direct and ongoing communication with the patient to reach a resolution. We remain committed to doing so.”

McClain anticipates her healthcare bills related to the hospital stay will total at least $900. She said that to get the $159 refund for her three-month membership and reimbursement for the hospital expenses, she has been asked to sign a document saying she won’t take legal action against the company. Her experience, she said, “just keeps getting worse.”

NBC News producer Jessica Herzberg and ºÚÁϳԹÏÍø News senior correspondent Fred Schulte contributed to this report.

Do you have an experience using an online company for healthcare services or medicinal products that you think others should know about? Click here to contact our reporting team.

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/health-industry/glp1-weight-loss-drugs-telehealth-oversight-regulation-compounded-semaglutide/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2236393&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2236393
Trump Bought Stock in Eli Lilly as His Policies Gave the Drugmaker a Big Boost, Documents Show /health-industry/the-week-in-brief-trump-eli-lilly-stock-pharmaceuticals/ Fri, 22 May 2026 18:30:00 +0000 /?p=2241506&preview=true&preview_id=2241506 President Donald Trump has long bantered about GLP-1s, the breakthrough medicines that have changed care for diabetes and obesity. Sometimes he calls them “the fat drug.” In an interview with the in January, he mused that “I probably should” take them.

A few days before the Times published that story, Trump invested in Eli Lilly, the nearly $1 trillion drugmaker whose fortunes are closely tied to its blockbuster GLP-1s, Zepbound and Foundayo — and to government reimbursement for the medicines.

This week we reported on several Lilly stock purchases made by Trump or his brokers from January to March, totaling as much as $680,000, according to a disclosure signed by the president. He also purchased stock worth $250,000 to $500,000 in West Pharmaceutical Services, a company that manufactures devices for injectable drugs. It, too, is benefiting from the GLP-1 surge. 

As the purchases occurred, the Trump administration was undertaking an agenda that boosted the GLP-1 market, including advancing Medicare reimbursement for the drugs to treat obesity, a long-held goal for Lilly. The deadline for drug manufacturers to get involved in a reimbursement project was Jan. 8. 

The administration also intensified a crackdown on “compounded” GLP-1s — cheaper, copycat medications made by pharmacies that critics (and brand-name drugmakers) claim are unsafe. That knocked out competitors to Lilly’s products. Trump’s FDA also rapidly approved Lilly’s GLP-1 pill, Foundayo. 

The timing of the Lilly purchases — among more than 3,600 trades Trump or his representatives made in the first quarter of the year — troubled government ethics experts. 

“A president who buys or sells the stock of a company whose value is affected by his administration’s actions undermines the public’s trust in two ways,” said Kathleen Clark, a legal ethicist at Washington University in St. Louis.

First, she said, the public should believe government actions are motivated by common good, not personal enrichment. Second, the public should believe that those within government aren’t benefiting from inside information.

The disclosures have also intensified criticism from Trump opponents who say he’s trying to profit from the presidency.

Congressional Democrats are calling for legislative action. “Trump is the ultimate con man — rig the game, manipulate the rules, and reap the benefits,” Sen. Andy Kim (D-N.J.) , highlighting our report. “It’s long past time we ban presidents from owning and trading stocks.”  

Democrats might have their shot at a bill in 2027. Public opinion is increasingly swinging in their direction, and taking both chambers of Congress is a possibility. (Of course, even if Democrats claimed those majorities and passed a bill, it would have to be signed by Trump.) If they were determined to pursue anti-corruption measures relating to health issues, they would have targets beyond Trump’s stock trading. Democrats have also questioned corporate contributors’ influence on changes in FDA tobacco regulation, for example. 

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/health-industry/the-week-in-brief-trump-eli-lilly-stock-pharmaceuticals/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2241506&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2241506
Efforts To Understand the Nation’s Drugged Driving Problem Stall Under Trump /public-health/drugged-driving-impairment-research-stalled-trump-policies/ Tue, 19 May 2026 09:00:00 +0000 /?p=2235912 GRAND JUNCTION, Colo. — Two state transportation workers were replacing a sign on the shoulder of U.S. Highway 6 in western Colorado one morning when a Jeep Grand Cherokee swerved off the road and struck them.

The workers, Nathan Jones and Trent Umberger, died in the September 2024 crash, as did a passenger in the Jeep. Tests found that the driver, Patrick Sneddon, then 59, had oxycodone and six times Colorado’s presumed impairment threshold for THC — the psychoactive compound in cannabis — in his blood. He pleaded guilty and is serving on three counts of vehicular homicide and other charges.

“Our four children are completely crushed without their Dad,” wrote Kristine Umberger, the wife of Trent, in a victim impact statement for the local district attorney. “We have lost our ability to live life like we used to.”

Federal highway safety officials have long tracked the role of alcohol in fatal crashes, but they don’t track deaths that involve a driver under the influence of drugs or a combination of drugs and alcohol.

That discrepancy is partly due to the challenges of proving impairment, since some drugs remain detectable for weeks after use. Sneddon’s attorney, Jennifer Gregory, said a driver can be presumed impaired under Colorado law if their blood contains 5 nanograms of THC or higher per liter. But that “permissible inference” threshold is different from a legal limit — such as the 0.08% blood alcohol content limit — and the level set by Colorado is not supported by published scientific studies, Gregory said.

Such information could prove useful as the nation struggles with , the on marijuana, and more than 40 states have legalized or decriminalized some forms of cannabis and .

“Impaired driving is a top public safety issue that extends beyond alcohol,” said Sean Rushton, a spokesperson for the federal highway safety agency, which is tackling the issue collaboratively, with resources to ensure a “comprehensive and coordinated approach.”

But President Donald Trump’s cuts to the federal workforce since he returned to office in 2025, along with dwindling federal investments, mean that efforts to expand and improve the tracking of impaired-driving deaths nationwide have slowed.

The gap in data can be significant. In Mesa County, Colorado, where Jones and Umberger were killed, the coroner’s office tracks various forms of impaired-driving fatalities. From 2017 through 2024, a third of traffic deaths involved alcohol alone, according to data from the county coroner’s office.

When drugs are factored in, nearly half of Mesa County’s traffic deaths over the same period involved a driver intoxicated with alcohol, drugs, or a combination, according to the coroner’s reports.

“If you want to solve a problem, you need to understand the problem,” National Transportation Safety Board researcher Jana Price said. “If you only know that alcohol is present, then it limits your ability to fully understand what might have been impairing a person or a population of people. It trickles into the countermeasures that we use as a society to address the problem.”

Identifying a Hidden Issue

NTSB researchers that, across four geographical samples of roughly 26,000 drivers, about half of those arrested for impaired driving and more than a quarter of drivers killed in crashes tested positive for more than one substance, such as cocaine, sedatives, and antidepressants. The analysis also found that only four states and the District of Columbia drug-tested more than 60% of fatally injured drivers in 2020.

Those findings led the NTSB, an independent federal agency that investigates major incidents, to make a series of recommendations to the and states to establish a comprehensive, nationwide dataset on impaired driving.

But hurdles remain to creating such a system. Fatality and injury reports submitted to the NHTSA database often feature missing or erroneous data, according to a .

Varying state laws around testing arrestees and decedents for drugs make getting uniform data difficult, according to , a former employee of NHTSA’s impaired-driving division, as does a lack of proven metrics like blood alcohol content to measure drug impairment, not just the presence of a drug.

“It’s a slow process, which is incredibly difficult when you know that each day that passes is risking a lack of safety for however many people facing the potential of a drug-impaired-driving crash,” Cash said. “But some progress is better than no progress.”

Acknowledging how long those efforts will take, the NTSB also recommended that NHTSA build an interim surveillance system that would use data from trauma centers to create a national sample of crash-involved impaired drivers.

The agency made some headway, reporting in 2023 that it was conducting its own study with the help of 11 trauma centers and medical examiner offices. It also helped California establish a 19-month statewide surveillance system, which NHTSA will use to evaluate the feasibility of a nationally representative system.

Such programs are useful for public awareness and for improving the ability of police to understand drugged driving patterns that can help them tailor enforcement, said , a University of California-Davis associate professor who researches toxicology and was involved in the California program. But some trauma centers, especially in rural areas, often lack the research infrastructure necessary for round-the-clock drug testing and participation.

Still, it’s possible, and he said the benefit is apparent in the findings from California’s surveillance system.

“If you go out there and tell people that 44% of drivers who ended up in the ER from a car accident had at least one potentially impairing substance in their blood at the time of the accident, that gets people’s attention,” Chenoweth said.

Shrinking Research Teams

Since NHTSA’s update to the NTSB three years ago, however, the agency has yet to follow up on the recommendation. Staff cuts and departures at NHTSA last year paint a poor outlook for change.

From 2021 to 2024, the agency . At the end of Trump’s first year in office, NHTSA had dropped to about 550 people due to government-wide cuts and people leaving on their own.

Cash, who now works for the nonprofit Governors Highway Safety Association, was one of five employees who left NHTSA’s last year. That leaves just two staff members in the division, she said.

Ian O’Dowd, a former employee in NHTSA’s , said he was part of a team of 16 people who studied, in part, impaired driving. Only three or four team members are still with the agency, he said.

“At some point, it becomes unwieldy for a handful of people to be managing all of the research work going on,” O’Dowd said.

NHTSA communications director Sean Rushton said the agency has “both the financial and personnel resources necessary to support its programs with multiple offices carrying out this work collaboratively, ensuring a comprehensive and coordinated approach.”

The 2021 infrastructure law, passed under the Biden administration, increased funding for NHTSA’s state highway safety program from about $667 million in 2021 to nearly $953 million this year.

The law included $750 million to modernize crash-data programs, but as of January over $475 million was unused. The funds expired in September unless they were obligated through a signed agreement.

A report by the U.S. Government Accountability Office found that nearly a quarter of entities awarded grants in 2022 had not received a signed agreement when surveyed between December 2024 and March 2025. It also found that over 1 in 5 grantees reported that obtaining timely replies from Department of Transportation staff was moderately or very challenging.

With the Biden-era infrastructure law expiring later this year, Congress could extend the unused crash-data fund or implement a new approach to impaired driving.

In mid-April, House Transportation and Infrastructure Committee Chairman Sam Graves (R-Mo.) said proposed legislation — less than half of the current bill’s $1.2 trillion — with a more “traditional” focus on roads and bridges.

The bill has amid negotiations for more funding, leaving future support uncertain.

“Certainly, we are always hoping that there will be an increase in the amount of money available to do this work,” Cash said. “Whether or not that will happen this year, I don’t know.”

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/public-health/drugged-driving-impairment-research-stalled-trump-policies/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2235912&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2235912
Trump Bought Stock in Drugmaker as His Government Boosted Its Obesity Drugs /health-industry/trump-stock-trades-eli-lilly-glp-1-weight-loss-drugs-invest-ethics-disclosures/ Mon, 18 May 2026 09:00:00 +0000 /?p=2238742 President Donald Trump earlier this year bought as much as $680,000 in stock of Eli Lilly, the maker of blockbuster obesity drugs, as the agencies he oversees undertook an agenda that largely benefited the company.

On May 14, the federal government released ethics disclosures revealing a list of and trades made on Trump’s behalf from January to March of this year. They included extensive trades across the economy, including investments in tech giants such as Microsoft and Nvidia, aerospace firms such as Boeing, and household-name companies such as Target and Chipotle.

In healthcare, however, the trades for Lilly — a company valued by the stock market at just under $1 trillion — stand out. That’s because the timing of Trump’s purchases coincides with several favorable government decisions benefiting the drugmaker’s GLP-1 business, including progress toward a long-held goal: qualifying the drugs for reimbursement from Medicare, the government health insurance program primarily serving seniors, when they are prescribed for weight loss.

The disclosure forms — which bear Trump’s distinct signature — give ranges rather than exact dollar amounts for the trades. They show seven purchases of Lilly stock made on the president’s behalf through the end of March, the first of which occurred on Jan. 6.

During that period, and just afterward, several Trump administration initiatives ultimately benefited Lilly. Perhaps the biggest was an initiative from the Centers for Medicare & Medicaid Services, which was proposing a pilot program — a temporary “bridge,” potentially followed by permanent reimbursement — through which Medicare patients would pay $50 a month for GLP-1 drugs.

The deadline for drug manufacturers to submit applications indicating their interest in participating was Jan. 8. Lilly has since been named as a participating manufacturer in the program, a “significant milestone.”

Another purchase on Feb. 10, of West Pharmaceutical Services stock valued between $250,000 and $500,000, was similarly a bet on the GLP-1 market. The company, which manufactures injectable devices for drugs, with driving increased revenue in its most recent quarter.

Lilly declined to comment. West Pharmaceutical Services did not immediately respond to a request for comment.

A spokesperson at the Department of Health and Human Services declined to comment, referring ºÚÁϳԹÏÍø News to the White House. A White House spokesperson referred questions to the Trump Organization — the holding company for most of the president’s businesses — which did not immediately respond to a request for comment.

In response to other outlets’ questions about Trump’s stock trades, the Trump Organization has said the investments are controlled by independent brokers.

It is unclear from the disclosures whether Trump directed any of the trades himself. Four of the Lilly stock purchases are marked “unsolicited,” though the Office for Government Ethics did not immediately respond to a request for clarification on the use of that term.

Trump’s assets are in a trust held by his children, and  have said in the past that neither the president nor his children play a role in “selecting, directing, or approving” specific investments.

Eric Trump, the president’s son and a Trump Organization executive, : “To suggest that individual stocks are being bought or sold, at the discretion of any member of the Trump family, would be a lie and blatantly false.”

He claimed the purchases of index funds account for the investments. The disclosures record purchases of funds and individual stocks.

Lilly had a strong 2025, finishing with $65 billion in revenue, up $20 billion from the year before. GLP-1 drugs accounted for a substantial portion of that total.

At the beginning of 2026, the drugmaker said it expected another surge in revenue this year, above $80 billion. It was a “stunning” projection, analysts at the bank Citi said.

Analysts for the financial services firm TD Cowen said the Medicare and Medicaid market would be critical to making it happen. “Guidance anticipates favorable impact from Medicare coverage of obesity medications by 7/1/26,” the analysts noted.

Historically, Medicare hasn’t covered obesity drugs. In a May 2025 , noting unfavorable reimbursement decisions across government and private-run insurance, Lilly said: “This isn’t about just one medicine, formulary, or insurance plan. It’s about a system that limits patients’ and health care providers’ ability to choose an obesity management treatment plan that is best for them.”

Key to that market was the pilot program rolled out by CMS, called , aimed at helping Medicare and Medicaid beneficiaries improve their health. Last fall, 12% of U.S. adults reported currently using GLP-1s, according to a , and 56% of those who had used GLP-1s found the medications — prescribed to treat diabetes and aid weight loss — hard to afford.

The appearance of a potential conflict of interest is enough to trouble ethics experts.

“A president who buys or sells the stock of a company whose value is affected by his administration’s actions undermines the public’s trust in two ways,” said Kathleen Clark, a legal ethicist at Washington University in St. Louis.

First, she said, the public should believe government actions are motivated by common good, not personal enrichment. And second, the public should believe that those within government aren’t benefiting from inside information.

A ban on stock trading by the president would require an act of Congress, though some lawmakers have resisted such legislation. Members of Congress are also permitted to buy and sell stocks.

Trump’s White House and HHS boosted GLP-1s throughout the first few months of the year. In February, the government unveiled TrumpRx, a web portal directing patients to lower-price versions of some drugs, with some terms and conditions.

The website offers Zepbound for as low as $299 a month and points patients to LillyDirect, the drug company’s telemedicine service prescribing the drug. Company executives haven’t commented on TrumpRx specifically, but they have touted the telemedicine service. Lilly’s 2025 to the Securities and Exchange Commission said LillyDirect was a “growing portion of our business.”

Also, in February the FDA intensified a broad crackdown on “compounded” GLP-1s — drugs manufactured by pharmacies that are cheaper and, critics charge, often unsafe alternatives to Lilly’s branded products.

The agency made another favorable decision for Lilly in April, approving its Foundayo weight loss pill under its Commissioner’s National Priority Voucher program. The program was launched by FDA Commissioner Marty Makary, who had promised to approve high-priority drugs in record time. Foundayo was approved in 50 days after filing.

“This approval demonstrates what the FDA can achieve when we eliminate delays and prioritize fast and thorough work from the agency and industry partners,” Makary, who stepped down last week, said in .

Not all agency decisions were favorable. The to provide additional safety data regarding liver toxicity in Foundayo, though analysts don’t appear particularly troubled. The company news outlets that no negative safety signals have been observed.

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/health-industry/trump-stock-trades-eli-lilly-glp-1-weight-loss-drugs-invest-ethics-disclosures/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2238742&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2238742
Journalists Unpack Latest on Vaccines, Vaping, and TrumpRx /on-air/on-air-may-16-2026-vaccines-vaping-mifepristone-trumprx/ Sat, 16 May 2026 09:00:00 +0000 /?p=2238301&preview=true&preview_id=2238301

ºÚÁϳԹÏÍø News chief Washington correspondent Julie Rovner discussed federal policy on vaccine research, vaping, and drug access on Science Friday on May 8. Rovner also discussed the Supreme Court decision on the abortion pill mifepristone on NPR’s Morning Edition on May 5.

  • .
  • .

Céline Gounder, ºÚÁϳԹÏÍø News’ editor-at-large for public health, discussed the rising cost of drug prices, despite hopes about TrumpRx, on CBS News’ The Daily Report on May 7.

  • .

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/on-air/on-air-may-16-2026-vaccines-vaping-mifepristone-trumprx/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2238301&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2238301
FDA Blocked Melanoma Drug as Confusion Reigned Under Makary /health-industry/fda-blocked-melanoma-drug-marty-makary-confusion-reigned/ Fri, 15 May 2026 09:00:00 +0000 /?p=2238195 The FDA’s to withhold approval of a new skin cancer treatment fell like a hammer on doctors who treat melanoma and patients who saw that the drug had prolonged the lives of a third of the participants in a clinical trial.

“It was devastating news,” said Trisha Wise-Draper, a dermatologist at the University of Cincinnati who had patients enrolled in the trial.

“This is life or death for maybe 2,000 patients,” added Eric Whitman, medical director of the Atlantic Health System’s oncology service. A assailed the ruling, noting that it “will have a chilling effect on drug development.”

Despite the benefit to some patients, oncologists and pharmaceutical industry analysts say there were legitimate concerns about the treatment, called RP1, that may have led the FDA to reject it in any event. The company, they noted, had ignored repeated FDA suggestions that it change the design of the trial used to seek approval for the medication.

The FDA’s decision would have raised few eyebrows before the current administration took power. But Marty Makary, who took charge as commissioner 13 months ago, altered the agency’s culture and damaged the trust it had built over decades while regulating 20% of U.S. consumer spending, said Steven Grossman, a regulatory consultant and former Health and Human Services official.

“People have to speculate about the standards and processes by which the agency makes decisions,” he said. “And that uncertainty is bad for everybody — patients and sponsors and investors.”

Under Makary — who resigned this week — senior officials have or some at the behest of President Donald Trump or HHS Secretary Robert F. Kennedy Jr., ignoring the advice of agency professionals. In defending his actions, Makary often eschewed the agency’s traditionally measured language about its decisions.

In response to criticism for rejecting the melanoma treatment, for example, Makary accused its manufacturer, Replimune, of “corruption,” saying it was “engaging in corporate spin” to make the FDA look bad.

“I don’t work for Replimune. I work for the American people,” Makary said in a May 5 interview on CNBC. Kennedy backed him up during a congressional budget hearing in which Kennedy mistakenly claimed that patients in Replimune’s clinical trial had also received chemotherapy.

Makary did not respond to requests for comment.

“All the norms have been thrown out the window, so we don’t know what underlines an agency decision,” said , a former FDA staffer and Senate aide to Sen. Edward Kennedy who’s now a pharmaceutical industry consultant in Boston. “Even when there are legitimate scientific and regulatory reasons why a drug will not be approved, we’re left guessing whether it’s legitimate grounds or just a political play.”

A Doomed Cancer Drug

Melanoma is the fifth most commonly diagnosed cancer in the United States, with about 112,000 new cases each year. The American Cancer Society projects that from melanoma this year in the U.S. If Replimune’s treatment, RP1, worked as well as it did in the clinical trial, Whitman said, as many as 2,500 of those patients could be saved.

RP1 is a genetically engineered virus designed to destroy tumor cells and alert the immune system to swing into action against them. Replimune sought accelerated approval — a sort of shortcut that allows a product to enter the market while a larger confirmatory trial takes place — by presenting data that showed a third of 140 people in the trial had their tumors shrink or disappear. But the agency had warned Replimune in July that it risked denial unless it changed its development plans. In particular, the FDA noted that the trial had no control arm to compare RP1 to an approved melanoma treatment. Instead, all patients were given RP1 along with Opdivo, a type of immunotherapy.

Replimune’s scientists don’t entirely understand how the drug works, but research indicates that, in addition to destroying cancer cells, it releases chemicals that revive Opdivo’s capacity to stimulate the immune system. The company argued it would be unethical to give Opdivo alone as a control arm, because all the patients entered in the trial had already stopped getting better while taking only Opdivo or other drugs in its class.

“Having a control arm would have been unethical,” Wise-Draper said. Some of her patients responded extremely well to RP1 and no longer have evidence of melanoma, she said.

Replimune currently has a larger trial that includes a control arm, but “the bigger question is whether the company will survive,” Whitman said. The FDA-accelerated approval would have persuaded investors to provide enough cash to finish the larger trial, he said.

Replimune did not respond to repeated requests for comment. But it is firing more than half its staff and closing some operations in the wake of the FDA ruling.

RP1 wouldn’t have been the first melanoma drug approved based on a single-arm trial. Keytruda, the best-selling Merck cancer drug, was approved to treat melanoma some 12 years ago based on such a trial design. But in its denial statement, the FDA said it wasn’t convinced that the positive effects of the combination regimen were all due to RP1 and not partly to Opdivo.

Replimune arguably could have found an ethical way to set up a control arm for its treatment, Kim said. On the other hand, the FDA could have “given them a provisional yes” with accelerated approval, he said. The whole point of the three-decade-old accelerated approval program is to “take a gamble,” Kim said. The agency’s statement, stressing the company’s methodology over the result, “is a recalibration of how confident sponsors can be with similar studies,” he said.

Vinay Prasad’s Final Days at FDA

Much of the criticism of the FDA under Trump has focused on Vinay Prasad, who was fired then rehired last summer and held various leadership roles at the agency. Prasad, an oncologist known for critiquing the statistical bases of studies, repeatedly intervened in approval processes for drugs and vaccines normally decided by lower-ranking FDA professionals.

Prasad, who did not respond to requests for comment, resigned for good May 1, three weeks after the Replimune decision. “There’s this lingering question of whether this was Vinay’s last stand, or an objective decision made by careful scientists,” Kim said.

Makary ran afoul of Trump administration officials over various decisions, the last being his reluctance to approve flavored vapes for smoking cessation. Trump’s anti-abortion supporters wanted him ousted for allowing a generic form of mifepristone on the market, and for failing to speed up studies they hoped would lead to the abortion drug’s withdrawal from the market.

But in the industries regulated by the FDA, ranging from gene therapy to vaccines and cancer, officials are frustrated by the agency’s uncertain direction. In past administrations, the agency generally swung on a narrow arc between loosening and tightening requirements for drug approvals. Under Makary, “it’s been swinging in every conceivable direction,” Grossman said.

“It’s very inconsistent; it’s all over the place,” Whitman said. “The inconsistency is part of the concern.”

During his tenure, Makary made a series of categorical statements that either claim credit for progress made during earlier administrations or exaggerate the agency’s ability to move forward on goals.

For example, he set a goal of , which is considered impractical at the moment, Kim said, and moved to artificial intelligence at the FDA — prematurely, critics say. Makary and Prasad also promised to reduce the from two to one. FDA statutes require two well-controlled clinical trials for drug approvals, but exceptions to that rule are already frequent.

“The FDA is sending signals that it wants to even further reduce the evidence needed to support drug approval,” said Aaron Kesselheim, a Harvard Medical School professor and an expert on the drug industry. “Of course, if we’re talking about vaccines, the total opposite is the case. FDA has been taking real steps to make it harder to get vaccines approved.”

The FDA fired about 4,000 staffers at the start of the Trump administration. Makary promised to hire thousands back, but considering the upheavals at HHS and the FDA, these positions may be hard to fill. “What magic trick will get that done?” Grossman asked.

“The unfortunate thing is that there has been so much chaos at FDA that this Replimune decision, which may have needed to happen, has gotten mired in the controversy,” said Evan Seigerman, leader of healthcare research at BMO Capital Markets.

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/health-industry/fda-blocked-melanoma-drug-marty-makary-confusion-reigned/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2238195&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2238195
That Discount at the Pharmacy Counter May Pack Hidden Costs /health-care-costs/pharmacy-discount-coupons-hidden-costs/ Thu, 07 May 2026 09:00:00 +0000 /?p=2230769 Next time you go to the pharmacy, you might be offered a coupon on your prescription drugs. While it may sound like a great deal — with the prospect of saving hundreds of dollars — the decision to accept it is complicated, especially for people with insurance.

Even as prescription drug costs rise, patients with commercial insurance have slowed their use of manufacturer-sponsored drug coupons in recent years, according to April 6 by the Journal of the American Medical Association.

Manufacturers are offering just as many of them, “but still, we see a lot of affordability issues among this commercially insured population,” said So-Yeon Kang, the study’s main author, who is an assistant professor of health management and policy at Georgetown University.

“Patients are at the intersection and battle place between these payers and manufacturers,” she said.

Drug manufacturers distribute copay coupon cards to consumers online or in person at the pharmacy counter. These manufacturer-sponsored coupons are not the same as discount card services from companies like GoodRx, which negotiate lower bulk pricing for prescription drugs, then pass those savings along to the consumer.

Manufacturers issue the coupons to keep their drugs competitive by offering patients short-term savings. Consumers pay less out-of-pocket, often for brand-name drugs. This encourages patients to use the brand-name version of the drug, even when a cheaper, generic version might be available.

Some insurers say this unfairly puts them on the hook for pricier drugs. They say monthly premiums are higher as a result, punishing consumers and patients, not the manufacturers.

So, should you use manufacturer-sponsored prescription drug coupons when they are offered?

The short answer: It depends.

Here are five things to consider:

1. What if you do not have insurance?

If you are uninsured, using a coupon can be a great way to save money, especially if there is no generic version of the drug.

TrumpRx is a new federally funded initiative that acts as a prescription drug coupon dashboard for patients. Some of the coupons come from manufacturers, while others do not. Not every drug has a coupon offer, but the portal will save consumers money on drugs for those that do, especially in the short term.

Michelle Long, a senior policy manager at KFF who studies patient and consumer protections, said people without insurance can save money by using TrumpRx or manufacturer coupons. (KFF is the health policy research, polling, and news organization that includes ºÚÁϳԹÏÍø News.)

“I wouldn’t brush it off entirely because it’s got Trump’s name on it,” Long said. “For a lot of people who take certain medications, there really could be some real savings.”

Still, Long said, TrumpRx lists only about 85 drugs, among thousands approved by the FDA. It is important to note that drug coupons have limitations and guidelines. They do not last forever. When they are exhausted, uninsured consumers may have to pay full price for the drug.

2. What if you have commercial health insurance?

For people with insurance, the answer is a little more complicated.

If the drug isn’t covered by your insurance plan or if you intend to pay cash, then the coupon may be the way to go. If not, be wary.

Insurance coverage varies for certain kinds of drugs, such as GLP-1 obesity drugs. Kang’s study found that coupon use by commercial insurance holders on obesity drugs dropped from 54.6% of prescriptions in 2017 to only 2.5% in 2024, even though use of the drugs has been rising in the United States.

She said this reflects the growing number of patients paying cash for the drugs as prices decline, along with insurers’ reluctance to cover them and manufacturers’ shifting focus from coupon distribution to marketing campaigns.

3. What should you do if you expect high medical costs this year?

If you have insurance and anticipate meeting your deductible for the year through health care visits and treatments, consider using the coupons.

Coupons let you pay less out-of-pocket when you visit the pharmacy, but your insurer likely won’t count the value of the coupon toward your deductible. Only use a coupon if there is no generic option available and if you know you’d otherwise hit your deductible.

4. What if you have insurance but low overall medical costs?

The answer will almost always be: Don’t use the coupon.

Unless the drug you are looking for is not covered by your insurance plan, using coupons will put you at risk for higher indirect costs. It’s also often more advantageous to spend toward your deductible.

Watch out for copay adjustment programs that insurers use to discourage the use of drug coupons. They come in two common forms, Long said.

“” allow the use of drug coupons up to their full value, but the amount of the coupon won’t count toward patients’ deductibles or out-of-pocket maximums. That makes it harder for them to reach the threshold at which insurers will pitch in on prescriptions and other medical care. It can also mean a patient will eventually start paying the full cost of the drug because they haven’t yet met their annual deductible.

“Copay maximizers” use a similar technique that also prevents the coupon value from counting toward deductibles. Maximizer programs use a third party to over the course of a year to match the amount of the manufacturers’ coupons.

Insurers sometimes offer the programs to consumers under euphemistic names like “Employee Savings Program” that sound good in theory, but, in reality, take away some of the value of the coupons, Long said.

Initially, consumers will see savings at the pharmacy counter, but they may end up paying more in the long run.

5. What if you’re on Medicaid or Medicare?

Medicare and Medicaid beneficiaries are prohibited from using manufacturer-sponsored coupons.

A federal anti-kickback law makes it illegal to give someone anything of value to influence their decision to purchase something that will ultimately be paid for by a federal health care program. The law also prevents remuneration, which includes waiving copays and charging less than fair-market value for a product.

Manufacturer drug coupons categories.

Some states, notably California and Massachusetts, prohibit or limit the use of manufacturer drug coupons when a generic version of the drug is available — highlighting the tension among manufacturers, health plans, and the government.

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/health-care-costs/pharmacy-discount-coupons-hidden-costs/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2230769&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2230769
Trump Promised Cheaper Drugs. Some Prices Dropped. Many Others Shot Up. /health-care-costs/trumprx-reality-check-drugs-not-always-cheaper/ Thu, 07 May 2026 09:00:00 +0000 /?p=2233819 Since his second term started, President Donald Trump has announced, negotiated, or floated a flurry of initiatives aimed at taming the excesses of the pharmaceutical industry.

No surprise. About are “worried about being able to afford prescription drug costs for themselves or their families,” a recent KFF nationwide poll showed. More than 80% consider the price of prescription drugs “unreasonable,” and most support increased regulation to lower costs. Americans pay about three times as much as people in other countries for the same prescription drugs.

Last July, Trump sent letters to 17 drugmakers, demanding they voluntarily lower drug prices. Then the president said he’d negotiated one by one at the White House. In December, that he had compelled them to agree to on Medicaid, the government coverage for low-income Americans.

Then came the , a site where cash-paying patients could find discounted medicines, and a promise to speed biosimilar products — generic versions of certain high-priced specialty drugs — by cutting through FDA red tape.

The scope of these grand gestures remains uncertain. But it’s certainly less than what the announcement promised, partly because many details of the negotiations, even which drugs are covered, are hazy.

White House spokesperson Kush Desai did not answer queries about TrumpRx.

Medicaid already buys drugs at deep discounts. And other patients may well have better options through commercial drug discount programs, which offer far more products, or through their insurance and associated drug company copayment cards.

So, for all Trump’s showmanship, the share of Americans likely to benefit from these options remains slim, even if some people do come out ahead.

“If it makes a difference to any patient, it’s a win,” said Mark Cuban, a billionaire investor on his own mission to bring down drug prices. He pointed to discounted pricing on TrumpRx for branded fertility drugs and GLP-1 weight loss drugs for people without insurance or whose plans don’t include coverage. Cuban launched the Mark Cuban Cost Plus Drug Co., known as Cost Plus Drugs, in 2022 to sell drugs cheaply by eliminating middlemen — buying from factories and selling directly to consumers. Most of the drugs he sells are generics.

Aaron Kesselheim, a professor of medicine at Harvard Medical School whose research focuses on drug prices, said the Trump announcements are “one-off agreements made for publicity purposes. They don’t change anything about the way drugs are priced.”

He added: “The agreements are opaque and unenforceable.”

It was unclear, for example, which drugs would be sold at “most favored nation” prices or how exactly that was defined. But, clearly, not all were.

Doing the Math

46brooklyn, a consulting firm and data project that tracks brand-name drug prices, found that close to 1,000 brand drugs went up in price in January 2026. What’s more, 2025 had the highest number of list price increases ever. “This is not a material change, it’s business as usual,” said Antonio Ciaccia, the company’s co-founder.

In the first week of 2026, Pfizer raised the list prices of 71 drugs by an average of 5% and lowered the price of only one, by 9.8%, the data project found.

The biggest win for patients has likely been the Trump administration’s quiet continuation of a Biden administration program: Medicare drug price negotiation for expensive drugs. The negotiated discounts on the — from blood thinners to insulins to medicines for inflammatory disorders — went into effect Jan. 1. With reductions in price of on some products, the estimated $6 billion in annual savings allowed the program to cap Medicare patients’ out-of-pocket spending on Part D prescription drugs at $2,000 for 2025 and beyond.

What Patients Will Find in the Mix-and-Match World of American Pricing (Table)

An additional 15 high-priced drugs — including popular weight loss and cancer drugs — were subject to negotiation in 2025, with discounted Medicare prices taking effect next year. And 15 more high-priced drugs are . All told, the 40 negotiated drug prices are expected to save Medicare well over $20 billion a year.

Even as these discounts take effect, drug industry lobbyists have been working to limit the impact, with some success. For example, the One Big Beautiful Bill Act from negotiations.

Still, “this is historic because it’s the first time the United States has negotiated prices, like every other developed country,” Kesselheim said. “And guess what? Innovation didn’t stop.”

Of course, these discounts benefit only Medicare enrollees. The newer Trump administration initiatives help some other patients, but they are limited and require knowledge of how to access the discounts.

What Patients Will Find in the Mix-and-Match World of American Pricing (Table)

Trump’s One-on-Ones

The president’s televised appearances with the heads of major drug companies resulted in deals, but few, if any, will mean much to patients. For example, after Trump met with Albert Bourla, CEO of Pfizer, the company announced discounts on 30-plus drugs. Bourla “a win for American patients, a win for American leadership, and a win for Pfizer.”

The discounts are offered via TrumpRx, which, in turn, offer coupons co-branded on GoodRx.com, which already offers discount coupons for many hundreds of medicines.

Pfizer made hay of the deal, announcing it was part of Pfizer’s broader, landmark with the U.S. government, enabling patients to pay lower prices for their prescription medicines “while strengthening America’s role as the global leader in biopharmaceutical innovation.”

Pfizer spokesperson Steven Danehy cited a press release from September noting that the TrumpRx site offers patients savings that “range as high as 85%.”

Most of the list features brand-name drugs, competing with far cheaper generic versions from other manufacturers, such as the cholesterol-lowering drug Colestid, which TrumpRx lists for “50% off” at $127.91. Generic versions cost about $17 on the Cost Plus site.

This means the branded companies aren’t making a sacrifice by offering them at lower costs as reflected on Trump’s portal, said Sean Tu, a patent law expert at the University of Alabama. “That’s a sale they would not have made if not for TrumpRx.”

Others are very old drugs, such as Cortef, or hydrocortisone, whose 5-milligram branded Pfizer version is listed at $45 on TrumpRx, half its list price of $91.80. It sells for far less on Cuban’s Cost Plus site. Still others, such as the $607.20 HIV treatment Viracept, are useful only in combination with other drugs that are not discounted.

Last week, TrumpRx added AbbVie’s Humira, for years the world’s best-selling drug, at $950 a dose, down from a list price of nearly $7,000. But Humira lost its patent protection in 2023, and biosimilars — essentially generic equivalents — have since come to market. More to the point, two of those biosimilars are listed on TrumpRx for as little as $207.60 a dose.

Since most of the TrumpRx products are available only to customers without insurance who pay cash, the arthritis drug Xeljanz’s drop from $2,277 to $1,518 a month would still leave it unaffordable.

A Few Notable Deals

The much-touted TrumpRx site, launched Feb. 6, consists largely of Pfizer’s 30 drugs (30 of roughly 85) with a smattering of discounts likely to generate headlines.

These include three fertility drugs from EMD Serono, a subsidiary of the pharmaceutical giant Merck KGaA, the most expensive of which, Gonal-F, has a list price of $966 but is only $168 per IVF cycle using a TrumpRx coupon.

They will save women thousands of dollars — although the overall cost of fertility treatment will continue to put them beyond the reach of many, since drugs represent only a portion of the payment.

The TrumpRx discounts could reduce the $15,000-to-$25,000 cost of a single fertility treatment cycle — women typically need two or three cycles to become pregnant — by about 10%, said Sean Tipton, spokesperson for the American Society for Reproductive Medicine. In some European countries, each cycle costs about $3,000.

In exchange for lowering those prices, EMD Serono got tariffs lifted on its mostly overseas-produced medications. It also won the right to a sped-up FDA approval process for a fertility drug it’s been marketing heavily in Europe.

Another newsworthy offering on the site resulted from a deal with Novo Nordisk for Wegovy, its GLP-1 drug for weight loss and diabetes, with the price reduced to as little as $199 a month for the pen. (Many insurers cover such drugs only for diabetes, leaving those who are interested in losing weight paying out-of-pocket. Zepbound, Wegovy’s Lilly & Co. competitor, is also on the list, at $299.)

Pressure has been building on Novo and Lilly to lower the U.S. price of their GLP-1 drugs. The compounds have lost patent protection in India, and pressure from customers buying overseas will likely increase when generic Wegovy goes on sale in Canada, for as low as $73 a month, possibly this year.

In the United States, meanwhile, dozens of patents should keep Wegovy generics off the market until 2039, said professor Robin Feldman, a patent expert at the University of California Law-San Francisco. A from the research group I-Mak delved into several ways patent manipulation keeps generics off the U.S. market long after they are available in European countries and Canada.

And while the Trump administration has vowed to approve biosimilars more rapidly to ensure more competition and lower prices, that may not have much impact. The big hurdle in getting generics and biosimilars to market is often not FDA approval, but the time it takes to override the thickets of patents that U.S. law allows manufacturers to deploy to protect their intellectual property.

For example, in 2021, the FDA approved a generic of Otezla, a popular drug for psoriatic arthritis, but it will not hit the market until 2028. Its entry would to Medicare if they charged the program more than other developed countries for “single source” drugs and biologics. That would essentially allow the Medicare program to piggyback on other countries that negotiate the prices of some of the most expensive medicines. Those programs are still going through the rulemaking process and, again, would benefit only those covered by the Medicare program and only indirectly.

The average patient-consumer, if willing to pay cash, may find some bargains. But getting the best deal could take a lot of mixing and matching, forcing patients to become choosy shoppers, eyeing deals for essential medicines as they would for a carton of milk or eggs.

Data reporter Maia Rosenfeld contributed to this article.

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/health-care-costs/trumprx-reality-check-drugs-not-always-cheaper/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2233819&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2233819
A New Medicare Option for Weight Loss Drugs: What Older Americans Should Know /medicare/cheaper-glp-1-weight-loss-medicare-bridge-wegovy-zepbound-foundayo/ Wed, 06 May 2026 09:00:00 +0000 /?p=2232451 Starting in July, Medicare beneficiaries may be able to get a GLP-1 prescription for weight loss for $50 a month. It’s a notable shift for Medicare, which has long been barred from covering weight loss treatments.

The drugs, such as Wegovy and Zepbound, are effective but can be expensive without insurance coverage. They’re available in injection or pill form. Even with discounts, current cash prices typically range from $149 to $699 per month.

About half of GLP-1 users say these drugs were difficult for them to afford, according to . A quarter said they were “very difficult” to afford.

But the new Medicare benefit comes with caveats, particularly around clinical guidelines and what happens when the short-term program ends.

What Is This Program?

The initiative, announced by the , is a short-term pilot program known as the Medicare GLP-1 Bridge. It will run from July 1, 2026, through Dec. 31, 2027. It’s meant to “bridge” the gap before a longer-term program that might — or might not — begin in 2028.

The pilot program will offer coverage for the following GLP-1 medications approved for weight loss: the pill and injectable formulations of Wegovy, the KwikPen formulation of Zepbound, and the Foundayo pill.

Who Can Participate?

To get access to these weight loss medications, you must be enrolled in a Medicare Part D plan, which covers prescription drugs. After that, eligibility is based mainly on body weight and health status. People will qualify if they have a of 27 or higher and have a condition such as heart disease or prediabetes, among others. People with BMIs of 35 or higher automatically qualify. About are clinically obese, with a BMI of 30 or higher, according to the Centers for Disease Control and Prevention.

How the Program Works (It’s a Bit Unusual)

This is not your typical Medicare benefit. Even though Part D enrollment is required, the Bridge program itself works differently.

Instead of going through your regular Part D plan, you will need prior authorization. Your doctor will send the prescription to a central system run by CMS contractor Humana, using a system already in place for another Medicare drug program. Doctors don’t need to be enrolled as Medicare providers to write a prescription or submit a prior authorization request under this program. Once they get approval, patients will pay the flat $50 copayment at the pharmacy when they pick up the prescription.

What Are the Benefits?

The cost savings could make these drugs accessible to patients who simply couldn’t afford them before. Even with discounts, the prices can be daunting without insurance coverage. TrumpRx, a new government website, provides links to direct-to-consumer prescription drug discounts for patients not using their health insurance. On that site, Wegovy injectables range in price from $199 for a lower dosage for the first two months to $399 for a higher dosage. The KwikPen formulation of Zepbound costs up to $699 per month. At the highest dosages, the daily Wegovy pill costs up to $299 while Foundayo tops out at $349.

Most people who use these drugs will need a higher dose to maintain weight loss. The Bridge program is unique in that it offers a predictable $50 copayment that does not go up as dosages increase.

What Are the Downsides?

Like many pilot programs, there are trade-offs. The $50 copay will not count toward the Part D deductible, nor does it count toward the $2,100 annual out-of-pocket cap on prescription drug costs. The pilot program will also end in December 2027. Most that many people who stop using the GLP-1 drugs regain weight they lost while taking them.

Still Obstacles for Those With Low Incomes

If you receive the low-income subsidy, also known as the Medicare program, you cannot use that assistance for the drugs covered by the GLP-1 Bridge program. For beneficiaries accustomed to paying a $5 or $10 copay for their pharmaceuticals, a $50 copay could still be a big financial barrier.

“Fifty dollars a month sounds like a great deal compared to paying the discounted prices through TrumpRx and these other direct-to-consumer options, but it’s a lot of money for somebody who’s living on a $750-a-month Social Security check,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF, a health information nonprofit that includes ºÚÁϳԹÏÍø News.

The $50 Copay Is Only for Weight Loss

If you’re already taking one of these medications for a qualifying condition such as Type 2 diabetes, cardiovascular disease risk reduction, or sleep apnea, you’ll continue to get it through your regular Part D plan. That means you’ll pay your plan’s price, which may be higher than the $50 Bridge copay, meaning the same drug could cost different amounts depending on the reason it is prescribed.

If you’re already on a GLP-1 for weight loss, you may qualify for the Bridge program. Your prescriber will need to attest that you met the clinical criteria when you first started the medication. For example, if you started a GLP-1 in September 2024 with a BMI of 37 but in July 2026 you’ve lost weight and now have a BMI of 34, the prescriber should attest in the prior authorization request that you met the BMI criteria of 35 or over when the GLP-1 therapy started.

What Happens After 2027?

The Trump administration had proposed a two-step approach to expand coverage of GLP-1s for obesity in Medicare. The Bridge program was initially planned to last six months — after that, the idea was to launch a longer-term program that would shift the cost of the drugs from the government to insurers. A found the long-term program would have cost insurance companies billions of dollars in the first year. Not enough insurers signed on for the voluntary plan by the April deadline, so CMS instead announced it would extend the Bridge program to 18 months, with a new end date of December 2027.

The move will give insurance companies more data on how many people with Medicare get GLP-1 drugs during the Bridge program and more time to negotiate with the Trump administration.

But extending the Bridge program will be “really expensive” for Medicare, Cubanski said, because the program heavily subsidizes the cost of the drugs.

“There’s no sense right now of the cost of the Bridge model, but it is likely to be billions of dollars a year in additional spending for Medicare,” Cubanski said.

The cost to Medicare will depend largely on how many people use the Bridge program. CMS has not provided any projections publicly, but a estimated that in 2020 close to 14 million Medicare beneficiaries were overweight or obese.

“This will just cost additional money, and we don’t know how much, because they haven’t disclosed it,” Cubanski said.

Are you on Medicare and interested in getting a GLP-1 for weight loss? Is a $50 copay manageable? Click here to contact ºÚÁϳԹÏÍø News’ reporting team.

ºÚÁϳԹÏÍø 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 <a target="_blank" href="/medicare/cheaper-glp-1-weight-loss-medicare-bridge-wegovy-zepbound-foundayo/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2232451&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]>
2232451