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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A Tragic, Deadly Denial

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

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

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

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

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

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

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

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

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

— Cindy Clements Blewett; Kyle, Texas

Navigating GLP-1 Coverage

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

— Sharie Hartman; Manteca, California

Beyond the Veil of Pregnancy Centers

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

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

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

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

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

— James Heid, Vancouver, Washington

The Root of All Good

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

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

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

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

— Stacy Xiong, Athens, Georgia

Bagging a Bargain

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

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

— Jackie Button; Miami

Fleshing Out the Details

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

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

— John Varner, Surry, Virginia

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

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

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

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

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

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

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

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

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

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

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

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

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

Controlling Costs or Harming Patients?

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

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

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

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

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

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

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

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

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

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

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

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

Consumers Stuck in the Middle

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

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

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

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

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

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

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

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

States Step Up While Federal Oversight Stalls

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Are you struggling to afford your health insurance? Have you decided to forgo coverage? Click here to contact Ñî¹óåú´«Ã½Ò•îl Health News and share your story.

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

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

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

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

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

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

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

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

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

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

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

Surprise Bills

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

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

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

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

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

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

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

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

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

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

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

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

“That sounds goofy,” Tix said.

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

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

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

‘Pretty Upset’

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

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

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

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

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

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

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

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

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

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

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

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

By the end of the month, she was in a hospital bed.

Hvatum, a part-time computer science professor, has a weakened immune system due to a rare condition known as primary immunodeficiency, which makes it difficult for her body to fight infections. Prior to her 2005 diagnosis, she had four bouts of shingles, a painful rash caused by a virus.

For more than a decade she relied on an expensive medicine to treat her chronic condition — and relied on her insurance to pay for it.

Then the denial letters came.

The Medical Service

To give her weakened immune system a boost, she relies on Hizentra, which is made up of antibodies collected from donated blood plasma.

At her home, near St. Louis, Hvatum can administer the complex medicine herself. She uses a large syringe to draw the medicine from a vial and loads the syringe into a plastic apparatus that looks like a toy Nerf gun. She cranks a blue plastic dial that triggers a steady drip of the medicine, and it snakes through plastic tubing until it enters her leg through a needle.

The Bill

$8,141.94: The full charges for a 28-day supply of Hizentra without insurance coverage.

After her Medicare Advantage plan through Humana denied payment for the drug in January, she missed several weekly doses.

The Billing Problem: Prior Authorization

Hvatum got tangled up in the controversial process known as prior authorization, which often requires patients or their medical team to get an insurance company’s approval before obtaining medicines or treatment. 

At the start of the year, after Hvatum switched Medicare Advantage plans, she received a letter saying that Humana, her new carrier, had denied her “prior authorization prescription request” for Hizentra. The authorization from her previous insurer didn’t carry over. 

Without the medicine, Hvatum developed a urinary tract infection that sent her to the emergency room on Jan. 30. Though it is a common infection, her doctor advised her to go there because people with her condition can get sick and deteriorate quickly, she said. 

That ER visit turned into an overnight hospital stay. That turned into hospital charges of more than $18,000, and again her insurance denied payment, saying this time that she wasn’t sick enough to require hospital care.

Hvatum’s experience with prior authorization is not unique.

Medicare Advantage plans reviewed nearly 53 million prior authorization requests in 2024, . That’s equivalent to nearly two reviews for every person enrolled in the program.

It’s common for Medicare Advantage plans to deny payment for care — which helps them make a profit, said Carrie Graham, director of the Medicare Policy Initiative at Georgetown University’s Center on Health Insurance Reforms.

The government pays a monthly sum to Medicare Advantage insurers to cover care for each member. “They make a profit if the care that person receives in that year is less than the amount they receive,” Graham said.

More than half of eligible Medicare beneficiaries choose Medicare Advantage insurance coverage. In 2026, roughly 35 million selected one of these private policies offered by insurance companies.

Humana is a dominant player in the space. Nearly half of all Medicare Advantage enrollees nationwide are covered by UnitedHealth Group or Humana, according to KFF.

The killing of UnitedHealthcare CEO Brian Thompson prompted renewed scrutiny of prior authorization. Last summer, months after his death, the nation’s largest insurers, including Humana, signed a pledge that outlined a handful of commitments to ease the burden on patients.

For example, insurers vowed to reduce the number of services that would require prior authorization approval. They also promised to reduce delays by honoring existing prior authorizations for a 90-day period when patients switched plans.

That’s not what happened in Hvatum’s case.

Humana said this pledge to honor existing approvals comes with limitations. “These commitments are for medical services only and do not apply to prescription medications,” spokesperson Mark Taylor said.  

Humana declined to comment on the specifics of Hvatum’s case, even though she agreed to waive her privacy rights, giving the insurer permission to comment.

While acknowledging that the prior authorization process can be deeply frustrating for patients, Humana said it “builds important checks and balances into the healthcare system by verifying that treatments and care delivery are in the best interest of patient safety and quality of care, while safeguarding taxpayer dollars.”

In July 2025, it would remove one-third of prior authorization requirements for outpatient services.

“We are committed to making the process faster and more seamless for patients and providers,” Humana said in a statement Taylor provided to Ñî¹óåú´«Ã½Ò•îl Health News.

The Resolution

Hvatum appealed, and Humana in late January reversed its initial payment denial for Hizentra, enabling her to afford her medicine again.

But the approval came with a catch: It expires at the end of the year, after which she would need to obtain approval all over again.

Hvatum has since switched to a different drug — and she might not stick around for any more medical-bill fights like this one. She and her husband are considering a move to Norway, a place with universal healthcare. He is a citizen there, which could give her a path to public health coverage.

The industry’s promises to change are too little, too late for Hvatum. 

By her account, she has done her part. Running is her outlet, maybe an obsession, and it keeps her healthy. Scores of medals and trophies are tucked about her home. Some sit on a white wicker end table, next to family photos, candles, and framed St. Louis Cardinals memorabilia. Above a large bay window in the kitchen, medals hang from ribbons of all colors, made to look almost like custom window drapery.

“I have done everything I possibly can to be healthy,” Hvatum said, sitting at her dining room table in her running gear. Her printed T-shirt read, “If found on ground, please drag across the finish line.”

The Takeaway

Data shows patients should appeal prior authorizations, because those who do often get their denials reversed, Graham said. In fact, 81% of Medicare Advantage appeals were partially or fully overturned in 2024, according to KFF.

Relatively few people appeal, because “it’s an exhausting process,” Graham said. It puts the onus on patients — and doctors get frustrated, too.

It’s not just Medicare Advantage plans that subject enrollees to prior authorization approvals. It’s prevalent in other types of coverage, and it has prompted blowback from the public. Graham believes the public outcry instigated the industry’s pledge to change.

Hvatum is well versed in filing appeals. She submitted another appeal to Humana after the insurer denied payment for her January hospital stay. Humana again reversed its denial of payment in her case.

Hvatum blames Humana for her January trip to the hospital. Had Humana approved her Hizentra, she said, she could have avoided hospital care altogether.

In March, she had a stroke. Humana denied coverage of that hospital stay, too.

Humana determined that it was not reasonable for the physician who admitted Hvatum to think she would need to stay at least two nights, the threshold for approval. “You had a small stroke,” Humana’s denial letter stated.

Hvatum noted the letter was dated March 25, two days after she was hospitalized. Humana reversed its denial two weeks after Hvatum appealed.

“They love to send you the denials fast,” Hvatum said. “Approvals take longer.”

Bill of the Month is a crowdsourced investigation by and that dissects and explains medical bills. Since 2018, this series has helped many patients and readers get their medical bills reduced, and it has been cited in statehouses, at the U.S. Capitol, and at the White House. Do you have a confusing or outrageous medical bill you want to share? !

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The drug is now marketed and sold across the state in roadside shops and small-town strip malls with little oversight from health authorities. Highway billboards advertise ivermectin as “Available Without a Prescription in Tennessee!” while dozens of pharmacies offer highly concentrated pills, sometimes at 10 or 20 times the potency of a standard tablet.

Ivermectin is a approved by the FDA for treating , which can generally be done with a single dose of three or four prescription-strength tablets. It is also used as a dewormer for horses and other livestock.

Its popularity surged during the pandemic as fringe doctors and anti-vaccine activists promoted it as a treatment for covid. have shown that ivermectin is against covid.

Nonetheless, it has since become a symbol of resistance against the medical establishment among conservatives and followers of the Make America Healthy Again movement, championed by Health and Human Services Secretary Robert F. Kennedy Jr.

Timothy Caulfield, a professor at the University of Alberta who studies health misinformation, said ivermectin became an “ideological flag” during the covid pandemic, opening the door for influencers to push the drug for other ailments to a “captured audience” even without proof it works for those conditions.

“This is really about profit. This is about political identity. This is about creating distrust in the existing biomedical community. This is about money,” Caulfield said in an interview with ABC News, which partnered with Ñî¹óåú´«Ã½Ò•îl Health News to report on ivermectin.

After a hantavirus outbreak on a cruise ship earlier this year, unproven claims that ivermectin is effective against the virus have been spread by some popular social media accounts and right-wing figures, including former congresswoman . The World Health Organization says it has seen that shows ivermectin is an effective hantavirus treatment.

Tennessee’s ivermectin bill was shepherded by a Republican supermajority in 2022. Its passage blindsided state medical officials and handed a victory to medical groups that spread covid misinformation.

Some pharmacy websites now offer the drug as a treatment for covid, “long haul vax symptoms,” diabetes, or cancer — despite no evidence of its effectiveness for those purposes — while the largely gives pharmacists immunity from lawsuits or professional sanctions related to ivermectin.

The law was also a harbinger of legislation to come: More than two dozen states have since considered look-alike bills that would make the politicized medication available without a requiring a doctor visit. 

John Mafi, a UCLA internal medicine physician who has studied the rise of ivermectin among cancer patients, worries it will lure people away from proven treatments. He co-authored a new study in prescribing rates for ivermectin and another antiparasitic drug, particularly in the South. The rise followed a January 2025 episode of the Joe Rogan Experience podcast in which actor Mel Gibson claimed ivermectin and other drugs cured three friends with stage 4 cancer.

“It’s going back to 19th-century quack science,” Mafi said about off-label use of ivermectin. “It is alarming that I’m seeing this really unproven therapy being touted to so many potentially vulnerable Americans.”

The FDA says ivermectin can be . Tennessee has seen a small but concerning rise in signs of overuse. The Tennessee Poison Center, which fields calls from people exposed to drugs or toxic substances, received more than 60 calls for possible ivermectin poisoning in 2025, the most since 2021. They included reports of vomiting, blurred vision, neurological problems, and difficulty walking.

“People are taking this because they just feel unwell. It’s almost like a panacea now,” said Rebecca Bruccoleri, the poison center’s medical director. “I’ve heard rumblings on the internet of using ivermectin for an alternative cancer treatment, and we’re seeing it definitely in here.”

Pharmacist Paul Hughey has dispensed ivermectin under the new law at two Tennessee pharmacies: Mt. Juliet Pharmacy and Compound Rx. He estimated that “up to 20 people in a week” are buying ivermectin but that peak demand was double or triple that amount.

For years, Hughey said in an interview, customers have relayed emotional “testimonies” about the drug healing the sick, “especially with the cancer patients.”

“I’ll get a doctor call in and they say: ‘Guess what. So-and-so is cured.’ And it’s just amazing to hear that. So anybody who doubts that,” Hughey said, “I don’t really know that they’re practicing medicine. I think they’re just following the narrative.”

‘I’ve Taken Bucketloads of This Stuff’

The linchpin of Tennessee’s ivermectin market is , a conservative doctor to the creation of the 2022 ivermectin law. She has with pharmacies across the state empowering them to sell the drug.

Tennessee’s law to dispense ivermectin without a specific prescription for each patient, through a “collaborative pharmacy practice agreement” with a doctor who provides what is functionally a pre-written, nonspecific prescription for all potential customers.

In podcast interviews, Sibley has said she has made as many as 40 of these agreements with Tennessee pharmacies, which she said forward her the paperwork on each ivermectin customer. Before selling the drug, pharmacies are required to ask customers questions about medical conditions and medications that could cause complications if taken with ivermectin. Afterward, the collaborating physician also is expected to receive a record for each person who purchases ivermectin.

“We literally have folks coming from all over the world to get our ivermectin,” Sibley said on in February 2025. “As the collaborator for these pharmacies, I get every person’s sheet.”

“They’re from every state,” she said. “They’re from Canada. They’re from Europe.”

Sibley did not respond to requests for comment.

Ñî¹óåú´«Ã½Ò•îl Health News has independently confirmed that Sibley signed agreements with at least 10 pharmacies. The agreements say pharmacists shall dispense ivermectin only in Tennessee, where Sibley is licensed, although one of those pharmacies said friends and family in Tennessee can “.”

Hughey, the Tennessee pharmacist, said Sibley had prescribing agreements ready to go when the law was enacted. He credited her with advancing ivermectin sales throughout the state.

“Had Dr. Sibley not stepped in and really pushed forward, there’s no telling how hard it would have been,” Hughey said. “It would have been a lot less widespread.”

Sibley also works with Children’s Health Defense, the Kennedy-founded group that has become one of the nation’s most influential anti-vaccine organizations. In podcasts, Sibley has referred to the covid vaccine as a “” and “ that’s ever been produced.”

Separately, before Tennessee legislators in 2024 about an alleged plot to change the weather and block sunlight. The New York Times then included her .

Sibley has said in podcast interviews that she was told by God to treat covid patients. She said she has advocated for ivermectin ever since.

“God agrees with what I’m doing,” Sibley said in 2023 on the podcast , which is recorded in Nashville. “I wake up every day and I say: ‘Yes, sir. I’m reporting to duty.’”

In legislative and government hearings throughout 2022, Sibley testified that she had treated around 4,400 people with ivermectin, including some Tennessee lawmakers, all without taking payment. Sibley described ivermectin as “a wonder drug” and said making it more available “.”

“I’ve taken bucketloads of this stuff myself,” Sibley said . “I feel like I’ve been a good test subject.”

Sibley has said she dispenses ivermectin using treatment guidelines developed by Paul Marik, who in 2020 co-founded the Independent Medical Alliance, a medical group that has promoted ivermectin as an effective treatment for , , , and .

Some Tennessee pharmacies now follow those protocols, too. The protocols recommend patients take 1.5 to five times as much ivermectin as is normally prescribed to treat parasites, with the dose taken for days or weeks instead of just once.

Marik and other ivermectin proponents sued the FDA in 2022 after it discouraged the use of the drug for covid by tweeting: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The agency settled the lawsuit with no admission of wrongdoing and deleted the viral tweet in 2024.

The American Board of Internal Medicine has revoked Sibley’s and Marik’s board certifications but declined to explain why. Sibley still holds a Tennessee medical license; Marik is based in Virginia and is not licensed. Sibley and Marik the internal medicine board’s actions.

In response to questions from Ñî¹óåú´«Ã½Ò•îl Health News, Marik, through an Independent Medical Alliance spokesperson, said medical science benefits from “open discussion of ideas and treatments.”

“Many independent doctors have reported that treatments like Ivermectin, in conjunction with traditional treatments, are showing promise. These ideas should be explored,” alliance spokesperson Lynne Kristensen said in an emailed statement.

Marik testified in favor of Tennessee’s ivermectin legislation in 2022, telling lawmakers that it is necessary because people would otherwise buy animal-grade ivermectin in stronger dosages meant for livestock.

“They’re buying ivermectin from farm stores. We don’t know the quality,” Marik said at a March 2022 legislative hearing on the Tennessee bill. “So this would prevent that from happening.”

Tennessee Does Not Track Its Ivermectin Market

Arkansas, Idaho, Louisiana, and Texas enacted similar laws in 2025, and legislation that makes ivermectin available without the need for a doctor visit has been introduced or debated in at least 24 other states, according to a Ñî¹óåú´«Ã½Ò•îl Health News analysis. That means half the country could be following Tennessee down an unlit path, because no one knows the full scope of its ivermectin market.

Tennessee does not effectively track which pharmacies offer ivermectin this way, and the state government has been unable to produce some foundational documents that pharmacies are legally required to file before they sell the drug, according to a Ñî¹óåú´«Ã½Ò•îl Health News investigation.

Doctors and pharmacies are the Tennessee Department of Health when they sign agreements that allow ivermectin to be dispensed without patient-specific prescriptions, although it is not clear whether this consistently occurs.

In response to a Ñî¹óåú´«Ã½Ò•îl Health News public records request for those ivermectin notifications filed by pharmacies, the agency over three months produced records from only 12 pharmacies, half of which have agreements with Sibley. The agency said it did not locate records related to at least 13 others that Ñî¹óåú´«Ã½Ò•îl Health News has identified as selling ivermectin without requiring individual prescriptions.

Department of Health spokesperson Dean Flener said the agency would not answer questions about whether or how it regulates ivermectin or the pharmacies that distribute it.

Tennessee has said it does not track how much of the drug is sold in the state, and the amount is not well captured by federal or insurance data sources. That’s because the drug is often sold at compounding pharmacies, which make customized medications that are not FDA-approved and rarely covered by insurance. Drugmakers and wholesalers did not respond to questions about how much ivermectin they supply to pharmacies in the state.

Even the Independent Medical Alliance, one of ivermectin’s , says it doesn’t know how much is flowing through Tennessee.

States are getting pressure from clinicians ”who have had success with the use of ivermectin,” said IMA President Joseph Varon, a physician based in Houston. “That’s what happened in Texas, and that’s what happened in Tennessee.”

‘An Unproven, Potentially Unsafe Drug’

Once signed by Tennessee Gov. Bill Lee, the state’s ivermectin law took effect immediately — even before the state’s physician and pharmacy licensing boards created rules to guide the process, which Tennessee law also requires. 

Some board members were shocked.

“We’re talking about an unproven, potentially unsafe drug,” Shant Garabedian, a doctor on the state’s Board of Osteopathic Examination, said of off-label ivermectin use during a . “It’s already law. Somehow it passes without our sort of input.”

In meetings that followed, at least five members of Tennessee’s medical boards voiced concerns about the law beyond safety and efficacy. Some said pharmacists could overcharge for a drug that normally costs pennies per pill. Some worried that a loosely regulated, cash-based ivermectin market might attract shady characters, especially because the law also shields prescribers from ivermectin-related civil lawsuits.

“This involves no clinical engagement,” Melanie Blake, then-president of the Board of Medical Examiners, said during a . “If they’re exempt from liability as well, I hate to think of things that individuals could do just to make money, but this would be one.” 

The boards eventually enacted regulations affirming that ivermectin could be dispensed without any diagnosis. Board members said the law left them no choice.

“This is more of a situation where, legally, the legislature has decided for us,” John McGraw, another board member, said in a . “This has sort of tied our hands in a lot of ways.”

The first known sale under the new law occurred in Sibley’s home of Johnson City, a city of about 74,000 people in northeastern Tennessee. According to a , Sibley entered into a collaborative agreement with pharmacist Josh Harrison at The Compounding Lab, which dispenses drugs for people and animals. 

The first customer was Bernadette Pajer, an anti-vaccine activist who has worked with Children’s Health Defense. In a of the Nashville podcast Rebunked With Scott Armstrong, Pajer said Sibley was a medical adviser for the group and described the first ivermectin sale.

“On that day, she was the doctor, he was the pharmacist making the sale, and I was the first customer,” Pajer said. “So that was pretty cool.”

Ivermectin pharmacies have spread across the state. In the suburbs of Nashville, Roman Pharmacy advertises ivermectin on at least four billboards along Interstate 65, and is mostly focused on the drug. Outside Knoxville, allows customers to order ivermectin for multiple sclerosis and Parkinson’s disease, or “to use it to detoxify.”

Roman Pharmacy did not respond to interview requests. Fresh Pharmacy declined an interview.

In Chattanooga, the Medicine Counter pharmacy says on its website that ivermectin should be taken “only as prescribed by your healthcare provider.” And yet the pharmacy sells some of Tennessee’s available without a prescription from a doctor — up to 21 times as strong as a standard tablet, for nearly $19 per pill — according to the Ñî¹óåú´«Ã½Ò•îl Health News analysis.

Himanshu Patel, Medicine Counter’s head pharmacist, declined to be interviewed. He said in an email that the pharmacy operates in a “very competitive market” and that its strongest pills were below the maximum dose for humans evaluated by the FDA for safety purposes.

And then there is Compound Rx, which, in addition to selling ivermectin in its store, has built a website in preparation to ship nationwide. The site, which is in “test mode,” cannot currently make any sales. It also asks customers how they heard about the pharmacy, with a dropdown menu of answers that features right-wing figures such as Donald Trump Jr., Steve Bannon, Laura Ingraham, and Kevin Sorbo.

Who is not listed as an option? Your doctor.

Hughey, the Compound Rx pharmacist, said he wasn’t involved with the website, which he said may never launch.

The highly concentrated pills are a concern for Tennessee state Sen. Richard Briggs, who worries lawmakers have created a “dangerous” ivermectin market rife with “misleading advertising” about what the drug can actually do.

Briggs, who is a surgeon and the only Republican who voted against the ivermectin bill in 2022, said he planned to introduce legislation to rein in the sale of ivermectin when lawmakers reconvene in 2027.

“But it may be a hard sell, because with the anti-vaxxers and some of these other folks,” Briggs said. “We don’t base a lot of things that we do on science, data, or facts. To a lot of folks in the legislature, the facts are just an inconvenience.”

‘Enough Trouble With Ivermectin’

Lawmakers in at least seven states have considered ivermectin legislation this year, including Alabama, Florida, Oklahoma, and South Carolina. If enacted, these bills would allow people to obtain ivermectin without an individual prescription, like in Tennessee, or make it available over the counter.

Kennedy praised such legislation at an event in Texas last August.

“I think it’s a really good bill,” he said of Texas’ ivermectin legislation, according to . “I think Americans should have the choice.”

But proponents have hit roadblocks. A Utah bill failed to advance out of the state House this year. In Oklahoma, some lawmakers have put up a fight.

“I’m a scientific person. I need to see some research and some data that shows what we’re treating,” Oklahoma state Rep. Cynthia Roe, a Republican and nurse practitioner who opposes the state’s ivermectin bill, said in an interview. “And God forbid somebody start giving it to their kid.”

Back in Tennessee, one of the medical boards that was alarmed when the law was enacted in 2022 started to distance itself from ivermectin altogether.

In January, the Board of Medical Examiners grappled with how to punish Ricky Lee Jackson, a doctor who was licensed in Tennessee and had been sanctioned and fined by Washington state’s medical commission. The Tennessee board normally mirrors punishments from other states without hesitation. But the Washington case centered on Jackson prescribing ivermectin for covid, which in Tennessee no longer required a patient to see a doctor.

After a debate, the board voted to reprimand Jackson — but told its staff to ensure the public record made .

“This board has been in enough trouble with ivermectin,” member Keith Anderson said, according to a . “Maybe we ought to just leave that out.”

journalist Blake Farmer and reporter Adam Friedman contributed to this report.

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

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 Ñî¹óåú´«Ã½Ò•îl Health 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.”

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 Ñî¹óåú´«Ã½Ò•îl Health 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 Ñî¹óåú´«Ã½Ò•îl Health 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.

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.

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.

‘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 Ñî¹óåú´«Ã½Ò•îl Health 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.

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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 Ñî¹óåú´«Ã½Ò•îl Health 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.

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“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.

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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 Ñî¹óåú´«Ã½Ò•îl Health 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.

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