An executive at Teva Pharmaceuticals flagged Publix Super Markets in October 2015 after detecting what he called in an email "serious red flags" with the grocery chain's orders of powerful opioids.
The share of high-strength oxycodone orders was well above normal for a chain of grocery store pharmacies, and the total number of pills sent to Publix stores was "significantly above their peers," Teva's head of federal compliance wrote in the email to his supervisors, according to court records in a federal lawsuit pending in Ohio against Publix and other companies.
"This is high-strength oxycodone ultimately going to Florida, a well-established hot spot for oxycodone abuse in the U.S.," wrote the compliance officer, Joseph Tomkiewicz, in the email explaining why he halted Teva-manufactured prescription opioids to Florida's Publix pharmacies.
The volume of prescription opioids dispensed in Florida fell 56% from 2011 to 2019 as the pharmaceutical industry was hit by lawsuits for its role in the national opioid crisis, according to a Tampa Bay Times analysis of Drug Enforcement Administration data recently released by a federal court. But while national pharmacy chains like CVS and Walgreens were dispensing fewer of the highly addictive drugs, Publix's sales were soaring.
The Lakeland-based grocer's sales of oxycodone climbed from 26 million pills per year in 2011 to 43.5 million in 2019, the data shows. The increase in sales, which far outpaced the chain's addition of stores in Florida, saw its market share rise to 14%, enough to overtake CVS to become Florida's second-largest dispenser of all opioid medications, behind only Walgreens, which dispensed 28% of opioids in the state in 2019. The analysis excludes drugs like methadone prescribed for addiction treatment. Opioid sales at Publix dipped slightly in 2018 and 2019, the last two years of available data.
Even as its market share grew, however, Publix was not among the 15 national manufacturers, distributors, and pharmacies that Florida sued in 2018. That lawsuit claimed other pharmacies had flooded America with painkillers such as OxyContin, fueling debilitating addictions that strained communities' first responders and medical providers.
The state's lawsuit was a boon for Florida. While admitting to no wrongdoing, the companies agreed to settlement payments to the state, including $177 million from Teva, $440 million from CVS, and $620 million from Walgreens. The state didn't sue Walmart but in 2022 negotiated a $215 million settlement from the retail giant, which also denied any wrongdoing.
However, there is no mention of Publix's role on a state webpage touting the 10 opioid settlements reached during Ashley Moody's tenure as attorney general.
That's despite Publix being the third-biggest dispenser of opioids in the state, selling nearly twice the amount of the drugs as Walmart from 2006 to 2012, according to earlier DEA data made public in July 2019, more than two years before Florida prosecutors reached settlements with other pharmacy chains.
Moody, a Republican, took over as the state's top legal official in January 2019. Her office declined to specifically address why Florida has not included Publix in any of its legal actions over opioids.
"We are proud of the more than $3 billion recovered through the historic opioid litigation, and since the filing of the amended complaint, the Department of Legal Affairs has and will continue to take action when merited by the evidence — as we did in the more recent actions with Walmart and McKinsey," said Moody's communications director, Kylie Mason, in an email.
The grocery chain made $10.6 million in political donations in Florida from 2016 to 2022 when the state was preparing and pursuing its litigation, state election data shows. Most of the donations were for Republican committees and candidates, including $125,000 donated to the Friends of Ashley Moody political action committee.
In Florida, Walgreens made $637,000 in political donations, including $8,000 to Moody, over the same period. CVS made $208,500 in donations, none of which went to Moody.
Other local communities in Florida and beyond did sue Publix. The federal suit naming Publix that prompted the release of the federal data was filed by Georgia's Cobb County. It has been earmarked as a test case for dozens of other lawsuits brought by cities and counties in the Southeast. Those include more than 20 Florida communities, among them St. Petersburg and Pinellas and Pasco counties.
While Walgreens and other national companies paid billions to settle their lawsuits and agreed to stricter drug controls, Publix is still contesting the cases.
Those communities claim that the grocery chain failed to operate an "effective suspicious ordering monitoring program" and that when Publix did limit orders to its own pharmacies, those pharmacies could bypass the check by going to a third-party distributor such as AmerisourceBergen.
Publix also should have known that its pharmacies in Georgia, Florida, Alabama, Tennessee, and South Carolina, were filling multiple prescriptions written for the same patient by the same doctor or by multiple doctors, the federal lawsuit alleges. As part of the national opioid settlement, other pharmacy chains were required to be more compliant with laws regulating opioids, including checks on suspicious orders and prescriptions from "blocked and potentially problematic" doctors.
"It's a heck of a lot cheaper to distribute and dispense controlled substances without all these checks," said Jayne Conroy, an attorney with New York law firm Simmons Hanly Conroy who is representing the Florida communities and has served as co-lead counsel in the national opioid litigation that has secured more than $50 billion in settlements and verdicts.
Publix did not respond to three emails and three phone calls to its communications office seeking comment.
In its responses to the lawsuits, it has repeatedly denied allegations of wrongdoing.
In seeking to get the Ohio case dismissed, Publix attorneys argued that it can't be considered "a public nuisance" to legally distribute and dispense opioids. The judge in the case denied the company's motion and another legal brief that sought to prevent the release of the more recent DEA data.
In November 2022, Publix sued more than a dozen of its insurers in federal court in Tampa, claiming they had not honored policies that would protect it from opioid litigation claims.
It also countersued Cobb County in 2023, saying the Georgia community's lawsuit was "motivated by promises of a windfall." The case is still pending.
"Publix takes great pride in its relationship with its valued customers and the communities it serves," that lawsuit states. "These novel and unprecedented claims are baseless, false, and belied by Publix's decades of service."
DEA officials declined to comment on Publix's opioid record. No enforcement actions against Publix are listed in the federal registry.
A Growing Player
Since its 1930 start as a food store in Winter Haven, Florida, Publix has grown into a massive company with more than 250,000 employees and nearly 900 stores in Florida alone. Revered for its free cookies for kids, chicken tender subs, fresh produce, birthday cakes, and BOGO deals, the grocery chain has become one-stop shopping for customers.
And, increasingly, "Where Shopping Is a Pleasure" — Publix's slogan since 1954 — includes powerful prescription drugs.
Publix was a smaller player in Florida's opioid market before 2011, responsible for fewer than 5% of all opioid medications distributed to pharmacies across the state, according to the Times analysis of federal opioid data.
That year marked a turning point for opioid sales in Florida. As the scale of the opioid epidemic came to public attention, and litigation followed, most chain pharmacies began to back off their orders for pills, the data shows.
Many companies ultimately agreed to pay billions of dollars to settle lawsuits filed across the country by state and local governments. That included a $683 million settlement between Florida and Walgreens in May stating the pharmacy, which denied any wrongdoing, must pay for community treatment, education, and prevention programs, plus litigation costs.
In addition to hefty payouts, some settlement agreements required companies to adopt stricter controls to bring operations into fuller compliance with the Controlled Substances Act, a federal law that governs the manufacture, distribution, and use of drugs considered to have a high risk of being abused.
Distributors were required to adopt automated software that would flag suspicious orders from pharmacies such as quantities well above a store's average. Pharmacy companies were required to conduct checks on doctors to ensure the prescribers are registered with the Drug Enforcement Administration.
Those measures and others put the brakes on opioid distribution nationwide. Meanwhile, the distribution in Florida's Publix stores went in the opposite direction: From 2011 to 2019, the grocery chain increased its dispensing of all opioid medication by 35%, according to the Times' analysis of the data.
That growth far exceeded any increase in sales that would correspond to the grocer's net addition of 146 pharmacies from 2011 to 2019.
As Publix's distribution increased, so too did the number of orders that should have been flagged as suspicious, according to plaintiffs in multiple lawsuits. Drug distributor McKesson instructed its employees to investigate any pharmacy ordering more than 8,000 oxycodone pills in a single month as part of the company's "Lifestyle Drug Monitoring Program," according to 2018 congressional testimony.
Publix pharmacies' orders surpassed that threshold almost 1,500 times in 2019, the Times analysis found, more than triple the number in 2011. The benchmark has been repeatedly used in opioid litigation as evidence of inadequate monitoring of drug distribution.
'Red Flags' Missed
As Tomkiewicz faced pressure from Teva management to fulfill Publix's orders, he mined the data to back up his concerns, court records show. During a heated phone call, one Teva executive stressed that Publix was an increasingly important player in the opioid distribution market, Tomkiewicz said at his deposition, and an important client for the world's largest generic drug manufacturer.
Tomkiewicz requested data from Publix's 10 largest pharmacies by opioid sales, all located in Florida.
By law, Publix was required to keep tabs on the physicians whose prescriptions it filled. But it took Tomkiewicz just one day of searching the internet to find problems, according to time stamps on emails submitted in the court records.
Among the top prescribers at two Publix locations in Melbourne was Thomas Velleff, according to Tomkiewicz's email. Public records and a newspaper report showed "significant anecdotal evidence of pill mill activity," Tomkiewicz wrote. He said he found a 2010 article in the Treasure Coast Palm, in which a city employee claimed Velleff's prior pain clinic in Palm City attracted "carloads" of patients, often with out-of-state license plates.
Complaints filed with the state Department of Health dating to 2010 allege that Velleff overprescribed opioids and failed to monitor his patients' usage for signs of abuse. One 2017 complaint alleges that Velleff pressured one patient into loaning him money. The state Board of Medicine revoked Velleff's medical license in December 2020. Velleff did not appear at his medical board hearing, according to the final order revoking his license. He did not respond to emails seeking comment.
A top prescriber at one Ocala store had been disciplined in 2011 for injecting herself with a sedative while leaving an anesthetized patient unsupervised. Other pharmacies repeatedly filled prescriptions from "cash-only" pain clinics or written by physicians located hundreds of miles away with no license to practice in Florida, Tomkiewicz wrote in the email. It is legal to do so, but drug diversion experts consider out-of-state prescriptions a red flag that should prompt additional checks for possible drug abuse.
Tomkiewicz had amassed a list of nine doctors among Publix's top prescribers who made him wonder: "Why the hell do they still have a license and are still registered with the DEA?" according to his deposition.
Tomkiewicz also said in his deposition he was troubled by not just the volume of opioids Publix was selling, but that they were handing out a disproportionate share of 30-milligram instant-release oxycodone pills — another red flag for abuse. In an email to Teva's director of compliance, he compared that with the Moffitt Cancer Center in Tampa, where cancer patients were mostly being prescribed 5 mg instant-release pills, court records show.
As the strongest dose on the market, the 30 mg pills have limited use in retail pharmacies and are highly sought-after among abusers, Tomkiewicz wrote in the email. Stronger doses of oxycodone are available, but only in long-release capsules such as OxyContin, according to the U.S. National Institutes of Health.
Publix sold 4.8 million of the highly addictive high-dose pills in 2019 — roughly 1 in 10 of all oxycodone pills dispensed by the pharmacy chain that year, according to the Times analysis of the federal data.
Eventually, Tomkiewicz relented, he said in his deposition. As long as Publix promised not to send Teva products to nine locations that he'd picked out, he would let the shipment go ahead. Teva did not notify federal authorities, according to his deposition.
A Times review of court documents found no written record indicating that Publix responded to Tomkiewicz's concerns at the time. An expert report submitted in the lawsuit came to the same conclusion.
Tampa Bay Times staff writer Ian Hodgson previously worked for a research company, Cornerstone Research, that had a client relationship with Teva Pharmaceuticals. This article was produced in partnership with the Tampa Bay Times.
Methodology
For comparison and dosing purposes, it is standard practice to convert opioid medications to an equivalent dose of morphine. Every shipment of opioids in the federal database is reported as both the number of pills and its morphine milligram equivalent, or "MME." This story uses that standard to calculate increases in the number of pills dispensed and compare the volume of pills prescribed by different pharmacy chains.
New York City pledged this week to pay down $2 billion worth of residents' medical debt. In doing so, it has come around to an innovation, started in the Midwest, that's ridding millions of Americans of healthcare debt.
The idea of local government erasing debt emerged a couple of years ago in Cook County, Illinois, home to Chicago. Toni Preckwinkle, president of the county board of commissioners, says two staffers came to her with a bold proposal: The county could spend a portion of its federal pandemic rescue funds to ease a serious burden on its residents.
In 2022, Cook County became the first local government to partner with RIP Medical Debt, a nonprofit group that uses private donor funds to buy up and forgive patient debt.
RIP's model turns debt collection on its head. Normally, debt collectors buy unpaid bills and then try to collect the money owed. RIP identifies unpaid hospital bills owed by people making up to four times the federal poverty level, then buys that debt on secondary markets or directly from hospitals at a small fraction of the original value. Instead of trying to collect, RIP forgives it — so it simply disappears for the patients.
In the Chicago area, as across the country, medical debt is an ongoing problem, causing mental and financial strain that can follow patients for years. An estimated 100 million people in the U.S. carry some form of healthcare debt, KFF Health News and NPR reported in 2022.
Preckwinkle said the RIP model dovetailed nicely with Cook County's healthcare mission. For nearly two centuries, the county has funded its own hospital and health system, Cook County Health, in part to provide care to all residents, regardless of income.
"We have a legacy commitment to delivering quality healthcare to people without regard to their ability to pay," Preckwinkle said.
She said that healthcare mission eats up nearly half of the county's $9.3 billion annual budget. It is now in the process of spending $12 million — a tiny portion of its budget — to retire $1 billion worth of hospital bills for residents.
Since Cook County announced its program, seven other local governments have followed suit, including Ohio cities Akron, Cleveland, and Toledo; New Orleans; Wayne County, Michigan; Washington, D.C.; and now New York City, which announced its commitment Jan. 22.
During his announcement, New York Mayor Eric Adams noted that medical debt disproportionately affects Black and Hispanic people, who are more likely to be uninsured or underinsured. For the city's low-income residents, he said, "taking on medical debt isn't a choice."
"Working-class families often have to choose between paying their medical bills or some of the basic essentials that they need to go through life," he said.
RIP is in talks with 30 other municipalities and states, including Connecticut, New Jersey, and Michigan.
Typically, RIP can retire at least $100 worth of debt for every $1 of government funds, so the local initiatives could end up wiping out several billion dollars in medical debt. The software selects eligible patients who remain anonymous, so it's hard to know what the impact of eliminating that debt might be across a community, or for the families that benefit.
Allison Sesso, CEO of RIP Medical Debt, acknowledged that debt is one of many factors contributing to unequal access to healthcare, and as hospital costs continue to rise, new debts are also piling up perhaps faster than her group can retire it. She said RIP hopes to retire $2.5 billion worth of unpaid medical bills through various government initiatives this year, but that's a drop in the bucket of the $195 billion estimated medical debt held by Americans.
"I'm under no illusions," Sesso said. "I don't think what I'm doing is the solution to getting rid of medical debt, writ large."
An Unusual Move for Local Government
Amber Clapsaddle said having the city of Toledo eliminate a $1,500 medical bill of hers from three years ago has given her hope.
In the past, Clapsaddle said, she looked down on those who didn't pay their bills. "I was like, ‘I'll never do that,' and I judged people really hard," she said.
Then, several years ago, her entire family of five each got sick one after another, requiring numerous surgeries, ultrasounds, and diagnostic tests. She had insurance, but she and her husband, a warehouse worker, couldn't meet the $6,000 deductible. Clapsaddle, a social worker, realized why medical debt is such a prevalent problem: "It just takes one bill, one bad insurance plan, just one extra diagnosis to have it all fall apart."
When Toledo's program with RIP forgave some of her family's debt two months ago, she cried with joy and relief. She said that motivated her to negotiate with doctors' offices and her insurance company to try to prevent herself from getting into debt again. "It's the spark that lights the fire of getting out of medical debt," she said.
Debt forgiveness is an unusual solution for local governments. More are taking it on, aided by access to federal pandemic rescue funds through the American Rescue Plan Act of 2021, and RIP Medical Debt offered a quick and easy fix to distribute those funds to those most burdened by medical expenses.
Nationally, medical debt is shown to disproportionately affect people of color and people who earn less. It also contributes to a vicious health cycle, discouraging patients from seeking preventive or follow-up care, leading to worse and more expensive outcomes.
Cook County's Preckwinkle said the pandemic only deepened racial and income gaps that affect people's access to healthcare.
"I always talk about the fact that medical debt is the leading cause of bankruptcy in the United States," she said.
Getting Down to the Root Causes of Debt
Medical debt is being created at high rates, Sesso said, and stronger policies — such as protecting consumers and strengthening insurance coverage — are needed to stop it at its source.
Often that boils down to high prices charged by hospitals and providers.
As Adams, the New York City mayor, put it: "You know, not only do you hold your breath when you go into a hospital or a doctor's office and wait for a diagnosis, you continue to hold your breath when you see the bill and what it costs, particularly for low-income New Yorkers."
The idea of forgiving medical debt has broad political support, said Sesso, perhaps because the issue affects people of all political stripes. A recent RIP survey, she said, showed that "84% of people agreed that it is the responsibility of government to ensure healthcare is affordable, and that position is held by people on the left and the right."
The enduring benefit of the recent local government initiatives is that they have helped draw more attention to the problem, raising its profile in useful ways, she said. "I think the issue of medical debt is becoming a priority, local governments are talking about it," and that is leading to other conversations about what else they can do to get more eligible families insured through Medicaid, or through the Affordable Care Act insurance marketplace, for example.
It is also inspiring programs like one recently adopted by Milwaukee County, in which it's urging more hospitals and health systems to use credit reports to screen and automatically enroll eligible patients in financial assistance programs. These programs already exist to help reduce medical expenses for patients making up to three times the poverty level, but often patients are unaware or not told to apply for them.
By automating the process, as many as 50% more patients may receive free or reduced-cost care, so they have a better chance of avoiding incurring medical debt in the first place, said Shawn Rolland, a member of Milwaukee County's board of supervisors.
"Why make it more difficult than necessary to get enrolled?" he said. "Because ultimately this will make it more likely that they'll come back for preventative care."
About This Project
"Diagnosis: Debt" is a reporting partnership between KFF Health News and NPR exploring the scale, impact, and causes of medical debt in America.
The series draws on original polling by KFF, court records, federal data on hospital finances, contracts obtained through public records requests, data on international health systems, and a yearlong investigation into the financial assistance and collection policies of more than 500 hospitals across the country.
Additional research was conducted by the Urban Institute, which analyzed credit bureau and other demographic data on poverty, race, and health status for KFF Health News to explore where medical debt is concentrated in the U.S. and what factors are associated with high debt levels.
The JPMorgan Chase Institute analyzed records from a sampling of Chase credit card holders to look at how customers' balances may be affected by major medical expenses. And the CED Project, a Denver nonprofit, worked with KFF Health News on a survey of its clients to explore links between medical debt and housing instability.
KFF Health News journalists worked with KFF public opinion researchers to design and analyze the "KFF healthcare Debt Survey." The survey was conducted Feb. 25 through March 20, 2022, online and via telephone, in English and Spanish, among a nationally representative sample of 2,375 U.S. adults, including 1,292 adults with current healthcare debt and 382 adults who had healthcare debt in the past five years. The margin of sampling error is plus or minus 3 percentage points for the full sample and 3 percentage points for those with current debt. For results based on subgroups, the margin of sampling error may be higher.
Reporters from KFF Health News and NPR also conducted hundreds of interviews with patients across the country; spoke with physicians, health industry leaders, consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.
SAN FRANCISCO — Every year, thousands of bankers, venture capitalists, private equity investors, and other moneybags flock to San Francisco's Union Square to pursue deals. Scores of security guards keep the homeless, the snoops, and the patent-stealers at bay, while the dealmakers pack into the cramped Westin St. Francis hotel and its surrounds to meet with cash-hungry executives from biotech and other healthcare companies. After a few years of pandemic slack, the 2024 J.P. Morgan Healthcare Conference regained its full vigor, drawing 8,304 attendees in early January to talk science, medicine, and, especially, money.
1. Artificial Intelligence: Revolutionary or Not?
Of the 624 companies that pitched at the four-day conference, the biggest overflow crowd may have belonged to Nvidia, which unlike the others isn't a healthcare company. Nvidia makes the silicon chips whose computing power, when paired with ginormous catalogs of genes, proteins, chemical sequences, and other data, will "revolutionize" drug-making, according to Kimberly Powell, the company's vice president of healthcare. Soon, she said, computers will customize drugs as "healthcare becomes a technology industry." One might think that such advances could save money, but Powell's emphasis was on their potential for wealth creation. "The world's first trillion-dollar drug company is out there somewhere," she dreamily opined.
Some healthcare systems are also hyping AI. The Mayo Clinic, for example, highlighted AI's capacity to improve the accuracy of patient diagnoses. The nonprofit hospital system presented an electrocardiogram algorithm that can predict atrial fibrillation three months before an official diagnosis; another Mayo AI model can detect pancreatic cancer on scans earlier than a provider could, said Matthew Callstrom, chair of radiology at the Mayo Clinic in Rochester, Minnesota.
No one really knows how far — or where — AI will take healthcare, but Nvidia's recently announced $100 million deal with Amgen, which has access to 500 million human genomes, made some conference attendees uneasy. If Big Pharma can discover its own drugs, "biotech will disappear," said Sherif Hanala of Seqens, a contract drug manufacturing company, during a lunch-table chat with KFF Health News and others. Others shrugged off that notion. The first AI algorithms beat clinicians at analyzing radiological scans in 2014. But since that year, "I haven't seen a single AI company partner with pharma and complete a phase I human clinical trial," said Alex Zhavoronkov, founder and CEO of Insilico Medicine — one of the companies using AI to do drug development. "Biology is hard."
2. Weight Loss Pill Profits and Doubts
With predictions of a $100 billion annual market for GLP-1 agonists, the new class of weight loss drugs, many investors were asking their favorite biotech entrepreneurs whether they had a new Ozempic or Mounjaro in the wings this year, Zhavoronkov noted. In response, he opened his parlays with investors by saying, "I have a very cool product that helps you lose weight and gain muscle." Then he would hand the person a pair of Insilico Medicine-embossed bicycle racing gloves.
More conventional discussions about the GLP-1s focused on how insurance will cover the current $13,000 annual cost for the estimated 40% of Americans who are obese and might want to go on the drugs. Sarah Emond, president of the Institute for Clinical and Economic Review, which calculates the cost and effectiveness of medical treatments, said that in the United Kingdom the National Health Service began paying in 2022 for obese patients to receive two years of semaglutide — something neither Medicare nor many insurers are covering in the U.S. even now.
But studies show people who go off the drugs typically regain two-thirds of what they lose, said Diana Thiara, medical director for the University of California-San Francisco weight management program. Recent research shows that the use of these drugs for three years reduces the risk of death, heart attack, and stroke in non-diabetic overweight patients. To do right by them, the U.S. healthcare system will have to reckon with the need for long-term use, she said. "I've never heard an insurer say, ‘After two years of treating this diabetes, I hope you're finished,'" she said. "Is there a bias against those with obesity?"
3. Spotlight on Tax-Exempt Hospitals
Nonprofit hospitals showed off their investment appeal at the conference. Fifteen health systems representing major players across the country touted their value and the audience was intrigued: When headliners like the Mayo Clinic and the Cleveland Clinic took the stage, chairs were filled, and late arrivals crowded in the back of the room.
These hospitals, which are supposed to provide community benefits in exchange for not paying taxes, were eager to demonstrate financial stability and showcase money-making mechanisms besides patient care — they call it "revenue diversification." PowerPoints skimmed through recent operating losses and lingered on the hospital systems' vast cash reserves, expansion plans, and for-profit partnerships to commercialize research discoveries.
At Mass General Brigham, such research has led to the development of 36 drugs currently in clinical trials, according to the hospital's presentation. The Boston-based health system, which has $4 billion in committed research funding, said its findings have led to the formation of more than 300 companies in the past decade.
Hospital executives thanked existing bondholders and welcomed new investors.
"For those of you who hold our debt, taxable and tax-exempt, thank you," John Mordach, chief financial officer of Jefferson Health, a health system in Pennsylvania and New Jersey. "For those who don't, I think we're a great, undervalued investment, and we get a great return."
Other nonprofit hospitals talked up institutes to draw new patients and expand into lucrative territories. Sutter Health, based in California, said it plans to add 30 facilities in attractive markets across Northern California in the next three years. It expanded to the Central Coast in October after acquiring the Sansum Clinic.
4. Money From New — And Old — Treatments for Autoimmune Disease
Autoimmunity drugs, which earn the industry $200 billion globally each year, were another hot theme, with various companies talking up development programs aimed at using current cancer drug platforms to create remedies for conditions like lupus and rheumatoid arthritis. AbbVie, which has led the sector with its $200 billion Humira, the world's best-selling drug, had pride of place at the conference with a presentation in the hotel's 10,000-square-foot Grand Ballroom.
President Robert Michael crowed about the company's newer autoimmune drugs, Skyrizi and Rinvoq, and bragged that sales of two-decades-old Humira were going "better than anticipated." Although nine biosimilar — essentially, generic — versions of the drug, adalimumab, entered the market last year, AbbVie expects to earn more than $7 billion on Humira this year since the "vast majority" of patients will remain on the market leader.
In its own presentation, biosimilar-maker Coherus BioSciences conceded that sales of Yusimry, its Humira knockoff listed at one-seventh the price of the original, would be flat until 2025, when Medicare changes take effect that could push health plans toward using cheaper drugs.
Biosimilars could save the U.S. healthcare system $100 billion a year, said Stefan Glombitza, CEO of Munich-based Formycon, another biosimilar-maker, but there are challenges since each biosimilar costs $150 million to $250 million to develop. Seeing nine companies enter the market to challenge Humira "was shocking," he said. "I don't think this will happen again."
McALESTER, Okla. — It took little more than an hour for Deborah Hackler to dispense with the tall stack of debt collection lawsuits that McAlester Regional Medical Center recently brought to small-claims court in this Oklahoma farm community.
Hackler, a lawyer who sues patients on behalf of the hospital, buzzed through 51 cases, all but a handful uncontested, as is often the case. She bantered with the judge as she secured nearly $40,000 in judgments, plus 10% in fees for herself, according to court records.
It's a payday the hospital and Hackler have shared frequently over the past three decades, records show. The records indicate McAlester Regional Medical Center and an affiliated clinic have filed close to 5,000 debt collection cases since the early 1990s, most often represented by the father-daughter law firm of Hackler & Hackler.
Some of McAlester's 18,000 residents have been taken to court multiple times. A deputy at the county jail and her adult son were each sued recently, court records show. New mothers said they compare stories of their legal run-ins with the medical center.
"There's a lot that's not right," Sherry McKee, a dorm monitor at a tribal boarding school outside McAlester, said on the courthouse steps after the hearing. The hospital has sued her three times, most recently over a $3,375 bill for what she said turned out to be vertigo.
In recent years, major health systems in Virginia, North Carolina, and elsewhere have stopped suing patients following news reports about lawsuits. And several states, such as Maryland and New York, have restricted the legal actions hospitals can take against patients.
But with some 100 million people in the U.S. burdened by health care debt, medical collection cases still clog courtrooms across the country, researchers have found. In places like McAlester, a hospital's debt collection machine can hum away quietly for years, helped along by powerful people in town. An effort to limit hospital lawsuits failed in the Oklahoma Legislature in 2021.
In McAlester, the lawsuits have provided business for some, such as the Adjustment Bureau, a local collection agency run out of a squat concrete building down the street from the courthouse, and for Hackler, a former president of the McAlester Area Chamber of Commerce. But for many patients and their families, the lawsuits can take a devastating toll, sapping wages, emptying retirement accounts, and upending lives.
McKee said she wasn't sure how long it would take to pay off the recent judgment. Her $3,375 debt exceeds her monthly salary, she said.
"This affects a large number of people in a small community," said Janet Roloff, an attorney who has spent years assisting low-income clients with legal issues such as evictions in and around McAlester. "The impact is great."
Settled more than a century ago by fortune seekers who secured land from the Choctaw Nation to mine coal in the nearby hills, McAlester was once a boom town. Vestiges of that era remain, including a mammoth, 140-foot-tall Masonic temple that looms over the city.
Recent times have been tougher for McAlester, now home by one count to 12 marijuana dispensaries and the state's death row. The downtown is pockmarked by empty storefronts, including the OKLA theater, which has been dark for decades. Nearly 1 in 5 residents in McAlester and the surrounding county live below the federal poverty line.
The hospital, operated by a public trust under the city's authority, faces its own struggles. Paint is peeling off the front portico, and weeds poke up through the parking lots. The hospital has operated in the red for years, according to independent audit reports available on the state auditor's website.
"I'm trying to find ways to get the entire community better care and more care," said Shawn Howard, the hospital's chief executive. Howard grew up in McAlester and proudly noted he started his career as a receptionist in the hospital's physical therapy department. "This is my hometown," he said. "I am not trying to keep people out of getting care."
The hospital operates a clinic for low-income patients, whose webpage notes it has "limited appointments" at no cost for patients who are approved for aid. But data from the audits shows the hospital offers very little financial assistance, despite its purported mission to serve the community.
In the 2022 fiscal year, it provided just $114,000 in charity care, out of a total operating budget of more than $100 million, hospital records show. Charity care totaling $2 million or $3 million out of a $100 million budget would be more in line with other U.S. hospitals.
While audits show few McAlester patients get financial aid, many get taken to court.
Renee Montgomery, the city treasurer in an adjoining town and mother of a local police officer, said she dipped into savings she'd reserved for her children and grandchildren after the hospital sued her last year for more than $5,500. She'd gone to the emergency room for chest pain.
Dusty Powell, a truck driver, said he lost his pickup and motorcycle when his wages were garnished after the hospital sued him for almost $9,000. He'd gone to the emergency department for what turned out to be gastritis and didn't have insurance, he said.
"Everyone in this town probably has a story about McAlester Regional," said another former patient who spoke on the condition she not be named, fearful to publicly criticize the hospital in such a small city. "It's not even a secret."
The woman, who works at an Army munitions plant outside town, was sued twice over bills she incurred giving birth. Her sister-in-law has been sued as well.
"It's a good-old-boy system," said the woman, who lowered her voice when the mayor walked into the coffee shop where she was meeting with KFF Health News. Now, she said, she avoids the hospital if her children need care.
Nationwide, most people sued in debt collection cases never challenge them, a response experts say reflects widespread misunderstanding of the legal process and anxiety about coming to court.
At the center of the McAlester hospital's collection efforts for decades has been Hackler & Hackler.
Donald Hackler was city attorney in McAlester for 13 years in the '70s and '80s and a longtime member of the local Lions Club and the Scottish Rite Freemasons.
Daughter Deborah Hackler, who joined the family firm 30 years ago, has been a deacon at the First Presbyterian Church of McAlester and served on the board of the local Girl Scouts chapter, according to the McAlester News-Capital newspaper, which named her "Woman of the Year" in 2007. Since 2001, she also has been a municipal judge in McAlester, hearing traffic cases, including some involving people she has sued on behalf of the hospital, municipal and county court records show.
For years, the Hacklers' debt collection cases were often heard by Judge James Bland, who has retired from the bench and now sits on the hospital board. Bland didn't respond to an inquiry for interview.
Hackler declined to speak with KFF Health News after her recent court appearance. "I'm not going to visit with you about a current client," she said before leaving the courthouse.
Howard, the hospital CEO, said he couldn't discuss the lawsuits either. He said he didn't know the hospital took its patients to court. "I had to call and ask if we sue people," he said.
Howard also said he didn't know Deborah Hackler. "I never heard her name before," he said.
Despite repeated public records requests from KFF Health News since September, the hospital did not provide detailed information about its financial arrangement with Hackler.
McAlester Mayor John Browne, who appoints the hospital's board of trustees, said he, too, didn't know about the lawsuits. "I hadn't heard anything about them suing," he said.
At the century-old courthouse in downtown McAlester, it's not hard to find the lawsuits, though. Every month or two, another batch fills the docket in the small-claims court, now presided over by Judge Brian McLaughlin.
After court recently, McLaughlin, who is not from McAlester, shook his head at the stream of cases and patients who almost never show up to defend themselves, leaving him to issue judgment after judgment in the hospital's favor.
"All I can do is follow the law," said McLaughlin. "It doesn't mean I like it."
About This Project
"Diagnosis: Debt" is a reporting partnership between KFF Health News and NPR exploring the scale, impact, and causes of medical debt in America.
The series draws on original polling by KFF, court records, federal data on hospital finances, contracts obtained through public records requests, data on international health systems, and a yearlong investigation into the financial assistance and collection policies of more than 500 hospitals across the country.
Additional research was conducted by the Urban Institute, which analyzed credit bureau and other demographic data on poverty, race, and health status for KFF Health News to explore where medical debt is concentrated in the U.S. and what factors are associated with high debt levels.
The JPMorgan Chase Institute analyzed records from a sampling of Chase credit card holders to look at how customers' balances may be affected by major medical expenses. And the CED Project, a Denver nonprofit, worked with KFF Health News on a survey of its clients to explore links between medical debt and housing instability.
KFF Health News journalists worked with KFF public opinion researchers to design and analyze the "KFF Health Care Debt Survey." The survey was conducted Feb. 25 through March 20, 2022, online and via telephone, in English and Spanish, among a nationally representative sample of 2,375 U.S. adults, including 1,292 adults with current health care debt and 382 adults who had health care debt in the past five years. The margin of sampling error is plus or minus 3 percentage points for the full sample and 3 percentage points for those with current debt. For results based on subgroups, the margin of sampling error may be higher.
Reporters from KFF Health News and NPR also conducted hundreds of interviews with patients across the country; spoke with physicians, health industry leaders, consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.
Charity Watkins sensed something was deeply wrong when she experienced exhaustion after her daughter was born.
At times, Watkins, then 30, had to stop on the stairway to catch her breath. Her obstetrician said postpartum depression likely caused the weakness and fatigue. When Watkins, who is Black, complained of a cough, her doctor blamed the flu.
About eight weeks after delivery, Watkins thought she was having a heart attack, and her husband took her to the emergency room. After a 5½-hour wait in a North Carolina hospital, she returned home to nurse her baby without seeing a doctor.
When a physician finally examined Watkins three days later, he immediately noticed her legs and stomach were swollen, a sign that her body was retaining fluid. After a chest X-ray, the doctor diagnosed her with heart failure, a serious condition in which the heart becomes too weak to adequately pump oxygen-rich blood to organs throughout the body. Watkins spent two weeks in intensive care.
She said a cardiologist later told her, "We almost lost you."
In a study published Jan. 8 in JAMA Internal Medicine, researchers found that nearly 1 in 4 hospital patients who died or were transferred to intensive care had experienced a diagnostic error. Nearly 18% of misdiagnosed patients were harmed or died.
In all, an estimated 795,000 patients a year die or are permanently disabled because of misdiagnosis, according to a study published in July in the BMJ Quality & Safety periodical.
Some patients are at higher risk than others.
Women and racial and ethnic minorities are 20% to 30% more likely than white men to experience a misdiagnosis, said David Newman-Toker, a professor of neurology at Johns Hopkins School of Medicine and the lead author of the BMJ study. "That's significant and inexcusable," he said.
Researchers call misdiagnosis an urgent public health problem. The study found that rates of misdiagnosis range from 1.5% of heart attacks to 17.5% of strokes and 22.5% of lung cancers.
Heart failure "should have been No. 1 on the list of possible causes" for Watkins' symptoms, said Ronald Wyatt, chief science and chief medical officer at the Society to Improve Diagnosis in Medicine, a nonprofit research and advocacy group.
Maternal mortality for Black mothers has increased dramatically in recent years. The United States has the highest maternal mortality rate among developed countries. According to the Centers for Disease Control and Prevention, non-Hispanic Black mothers are 2.6 times as likely to die as non-Hispanic white moms. More than half of these deaths take place within a year after delivery.
Research shows that Black women with childbirth-related heart failure are typically diagnosed later than white women, said Jennifer Lewey, co-director of the pregnancy and heart disease program at Penn Medicine. That can allow patients to further deteriorate, making Black women less likely to fully recover and more likely to suffer from weakened hearts for the rest of their lives.
Watkins said the diagnosis changed her life. Doctors advised her "not to have another baby, or I might need a heart transplant," she said. Being deprived of the chance to have another child, she said, "was devastating."
Racial and gender disparities are widespread.
Women and minority patients suffering from heart attacks are more likely than others to be discharged without diagnosis or treatment.
Minorities are less likely than whites to be diagnosed early with dementia, depriving them of the opportunities to receive treatments that work best in the early stages of the disease.
Misdiagnosis isn't new. Doctors have used autopsy studies to estimate the percentage of patients who died with undiagnosed diseases for more than a century. Although those studies show some improvement over time, life-threatening mistakes remain all too common, despite an array of sophisticated diagnostic tools, said Hardeep Singh, a professor at Baylor College of Medicine who studies ways to improve diagnosis.
"The vast majority of diagnoses can be made by getting to know the patient's story really well, asking follow-up questions, examining the patient, and ordering basic tests," said Singh, who is also a researcher at Houston's Michael E. DeBakey VA Medical Center. When talking to people who've been misdiagnosed, "one of the things we hear over and over is, ‘The doctor didn't listen to me.'"
Racial disparities in misdiagnosis are sometimes explained by noting that minority patients are less likely to be insured than white patients and often lack access to high-quality hospitals. But the picture is more complicated, said Monika Goyal, an emergency physician at Children's National Hospital in Washington, D.C., who has documented racial bias in children's health care.
In a 2020 study, Goyal and her colleagues found that Black kids with appendicitis were less likely than their white peers to be correctly diagnosed, even when both groups of patients visited the same hospital.
Although few doctors deliberately discriminate against women or minorities, Goyal said, many are biased without realizing it.
"Racial bias is baked into our culture," Goyal said. "It's important for all of us to start recognizing that."
Demanding schedules, which prevent doctors from spending as much time with patients as they'd like, can contribute to diagnostic errors, said Karen Lutfey Spencer, a professor of health and behavioral sciences at the University of Colorado-Denver. "Doctors are more likely to make biased decisions when they are busy and overworked," Spencer said. "There are some really smart, well-intentioned providers who are getting chewed up in a system that's very unforgiving."
Doctors make better treatment decisions when they're more confident of a diagnosis, Spencer said.
In an experiment, researchers asked doctors to view videos of actors pretending to be patients with heart disease or depression, make a diagnosis, and recommend follow-up actions. Doctors felt far more certain diagnosing white men than Black patients or younger women.
"If they were less certain, they were less likely to take action, such as ordering tests," Spencer said. "If they were less certain, they might just wait to prescribe treatment."
That may help explain why patients with darker complexions are less likely to receive a timely diagnosis with conditions that affect the skin, from cancer to Lyme disease, which causes a red or pink rash in the earliest stage of infection. Black patients with Lyme disease are more likely to be diagnosed with more advanced disease, which can cause arthritis and damage the heart. Black people with melanoma are about three times as likely as whites to die within five years.
The covid-19 pandemic helped raise awareness that pulse oximeters — the fingertip devices used to measure a patient's pulse and oxygen levels — are less accurate for people with dark skin. The devices work by shining light through the skin; their failures have delayed critical care for many Black patients.
Seven years after her misdiagnosis, Watkins is an assistant professor of social work at North Carolina Central University in Durham, where she studies the psychosocial effects experienced by Black mothers who survive severe childbirth complications.
"Sharing my story is part of my healing," said Watkins, who speaks to medical groups to help doctors improve their care. "It has helped me reclaim power in my life, just to be able to help others."
The number of older adults with disabilities — difficulty with walking, seeing, hearing, memory, cognition, or performing daily tasks such as bathing or using the bathroom — will soar in the decades ahead, as baby boomers enter their 70s, 80s, and 90s.
But the healthcare system isn't ready to address their needs.
That became painfully obvious during the COVID-19 pandemic, when older adults with disabilities had trouble getting treatments and hundreds of thousands died. Now, the Department of Health and Human Services and the National Institutes of Health are targeting some failures that led to those problems.
One initiative strengthens access to medical treatments, equipment, and web-based programs for people with disabilities. The other recognizes that people with disabilities, including older adults, are a separate population with special health concerns that need more research and attention.
Lisa Iezzoni, 69, a professor at Harvard Medical School who has lived with multiple sclerosis since her early 20s and is widely considered the godmother of research on disability, called the developments "an important attempt to make healthcare more equitable for people with disabilities."
"For too long, medical providers have failed to address change in society, changes in technology, and changes in the kind of assistance that people need," she said.
Among Iezzoni's notable findings published in recent years:
Most doctors are biased. In survey results published in 2021, 82% of physicians admitted they believed people with significant disabilities have a worse quality of life than those without impairments. Only 57% said they welcomed disabled patients.
"It's shocking that so many physicians say they don't want to care for these patients," said Eric Campbell, a co-author of the study and professor of medicine at the University of Colorado.
While the findings apply to disabled people of all ages, a larger proportion of older adults live with disabilities than younger age groups. About one-third of people 65 and older — nearly 19 million seniors — have a disability, according to the Institute on Disability at the University of New Hampshire.
Doctors don't understand their responsibilities. In 2022, Iezzoni, Campbell, and colleagues reported that 36% of physicians had little to no knowledge of their responsibilities under the 1990 Americans With Disabilities Act, indicating a concerning lack of training. The ADA requires medical practices to provide equal access to people with disabilities and accommodate disability-related needs.
Among the practical consequences: Few clinics have height-adjustable tables or mechanical lifts that enable people who are frail or use wheelchairs to receive thorough medical examinations. Only a small number have scales to weigh patients in wheelchairs. And most diagnostic imaging equipment can't be used by people with serious mobility limitations.
Iezzoni has experienced these issues directly. She relies on a wheelchair and can't transfer to a fixed-height exam table. She told me she hasn't been weighed in years.
Among the medical consequences: People with disabilities receive less preventive care and suffer from poorer health than other people, as well as more coexisting medical conditions. Physicians too often rely on incomplete information in making recommendations. There are more barriers to treatment and patients are less satisfied with the care they do get.
Egregiously, during the pandemic, when crisis standards of care were developed, people with disabilities and older adults were deemed low priorities. These standards were meant to ration care, when necessary, given shortages of respirators and other potentially lifesaving interventions.
There's no starker example of the deleterious confluence of bias against seniors and people with disabilities. Unfortunately, older adults with disabilities routinely encounter these twinned types of discrimination when seeking medical care.
Such discrimination would be explicitly banned under a rule proposed by HHS in September. For the first time in 50 years, it would update Section 504 of the Rehabilitation Act of 1973, a landmark statute that helped establish civil rights for people with disabilities.
The new rule sets specific, enforceable standards for accessible equipment, including exam tables, scales, and diagnostic equipment. And it requires that electronic medical records, medical apps, and websites be made usable for people with various impairments and prohibits treatment policies based on stereotypes about people with disabilities, such as COVID-era crisis standards of care.
"This will make a really big difference to disabled people of all ages, especially older adults," said Alison Barkoff, who heads the HHS Administration for Community Living. She expects the rule to be finalized this year, with provisions related to medical equipment going into effect in 2026. Medical providers will bear extra costs associated with compliance.
Also in September, NIH designated people with disabilities as a population with health disparities that deserves further attention. This makes a new funding stream available and "should spur data collection that allows us to look with greater precision at the barriers and structural issues that have held people with disabilities back," said Bonnielin Swenor, director of the Johns Hopkins University Disability Health Research Center.
One important barrier for older adults: Unlike younger adults with disabilities, many seniors with impairments don't identify themselves as disabled.
"Before my mom died in October 2019, she became blind from macular degeneration and deaf from hereditary hearing loss. But she would never say she was disabled," Iezzoni said.
Similarly, older adults who can't walk after a stroke or because of severe osteoarthritis generally think of themselves as having a medical condition, not a disability.
Meanwhile, seniors haven't been well integrated into the disability rights movement, which has been led by young and middle-aged adults. They typically don't join disability-oriented communities that offer support from people with similar experiences. And they don't ask for accommodations they might be entitled to under the ADA or the 1973 Rehabilitation Act.
Many seniors don't even realize they have rights under these laws, Swenor said. "We need to think more inclusively about people with disabilities and ensure that older adults are fully included at this really important moment of change."
On the presidential campaign trail, former President Donald Trump is, once again, promising to repeal and replace the Affordable Care Act — a nebulous goal that became one of his administration's splashiest policy failures.
"We're going to fight for much better healthcare than Obamacare. Obamacare is a catastrophe," Trump said at a campaign stop in Iowa on Jan. 6.
The perplexing revival of one of Trump's most politically damaging crusades comes at a time when the Obama-era health law is even more popular and widelyused than it was in 2017, when Trump and congressional Republicans proved unable to pass their own plan to replace it. That failed effort was a big part of why Republicans lost control of the House of Representatives in the 2018 midterms.
Despite repeated promises, Trump never presented his own Obamacare replacement. And much of what Trump's administration actually accomplished in healthcare has been reversed by the Biden administration.
Still, Trump secured some significant policy changes that remain in place today, including efforts to bring more transparency to prices charged by hospitals and paid by health insurers.
Trying to predict Trump's priorities in a second term is even more difficult given that he frequently changes his positions on issues, sometimes multiple times.
The Trump campaign did not respond to a request for comment.
Perhaps Trump's biggest achievement is something he rarely talks about on the campaign trail. His administration's "Operation Warp Speed" managed to create, test, and bring to market a covid-19 vaccine in less than a year, far faster than even the most optimistic predictions.
Many of Trump's supporters, though, don't support — and some even vehemently oppose — covid vaccines.
Here is a recap of Trump's healthcare record:
Public Health
Trump's pandemic response dominates his overall record on healthcare.
More than 400,000 Americans died from covid over Trump's last year in office. His travel bans and other efforts to prevent the global spread of the virus were ineffective, his administration was slower than other countries' governments to develop a diagnostic test, and he publicly clashed with his own government's health officials over the response.
Ahead of the 2020 election, Trump resumed large rallies and other public campaign events that many public health experts regarded as reckless in the face of a highly contagious, deadly virus. He personally flouted public health guidance after contracting covid himself and ending up hospitalized.
At the same time, despite what many saw as a politicizationof public health by the White House, Trump signed a massive covid relief bill (after first threatening to veto it). He also presided over some of the largest boosts for the National Institutes of Health's budget since the turn of the century. And the mRNA-based vaccines Operation Warp Speed helped develop were an astounding scientific breakthrough credited with helping save millions of lives while laying the groundwork for future shots to fight other diseases including cancer.
Abortion
Trump's biggest contribution to abortion policy was indirect: He appointed three Supreme Court justices, who were instrumental in overturning the constitutional right to an abortion.
During his 2024 campaign, Trump has been all over the place on the red-hot issue. Since the Supreme Court overturned Roe v. Wade in 2022, Trump has bemoaned the issue as politically bad for Republicans; criticized one of his rivals, Florida Gov. Ron DeSantis, for signing a six-week abortion ban; and vowed to broker a compromise with "both sides" on abortion, promising that "for the first time in 52 years, you'll have an issue that we can put behind us."
He has so far avoided spelling out how he'd do that, or whether he'd support a national abortion ban after any number of weeks.
More recently, however, Trump appears to have mended fences over his criticism of Florida's six-week ban and more with key abortion opponents, whose support helped him get elected in 2016 — and whom he repaid with a long list of policy changes during his presidency.
Among the anti-abortion actions taken by the Trump administration were a reinstatement of the "Mexico City Policy" that bars giving federal funds to international organizations that support abortion rights; a regulation to bar Planned Parenthood and other organizations that provide abortions from the federal family planning program, Title X; regulatory changes designed to make it easier for healthcare providers and employers to decline to participate in activities that violate their religious and moral beliefs; and other changes that made it harder for NIH scientists to conduct research using fetal tissue from elective abortions.
All of those policies have since been overturned by the Biden administration.
Health Insurance
Unlike Trump's policies on reproductive health, many of his administration's moves related to health insurance still stand.
For example, in 2020, Trump signed into law the No Surprises Act, a bipartisan measure aimed at protecting patients from unexpected medical bills stemming from payment disputes between healthcare providers and insurers. The bill was included in the $900 billion covid relief package he opposed before signing, though Trump had expressed support for ending surprise medical bills.
His administration also pushed — over the vehement objections of health industry officials — price transparency regulations that require hospitals to post prices and insurers to provide estimated costs for procedures. Those requirements also remain in place, although hospitals in particular have been slow to comply.
Medicaid
While first-time candidate Trump vowed not to cut popular entitlement programs like Medicare, Medicaid, and Social Security, his administration did not stick to that promise. The Affordable Care Act repeal legislation Trump supported in 2017 would have imposed major cuts to Medicaid, and his Department of Health and Human Services later encouraged states to require Medicaid recipients to prove they work in order to receive health insurance.
Drug Prices
One of the issues the Trump administration was most active on was reducing the price of prescription drugs for consumers — a top priority for both Democratic and Republican voters. But many of those proposals were blocked by the courts.
One Trump-era plan that never took effect would have pegged the price of some expensive drugs covered by Medicare to prices in other countries. Another would have required drug companies to include prices in their television advertisements.
A regulation allowing states to import cheaper drugs from Canada did take effect, in November 2020. However, it took until January 2024 for the FDA, under Trump's successor, to approve the first importation plan, from Florida. Canada has said it won't allow exports that risk causing drug shortages in that country, leaving unclear whether the policy is workable.
Trump also signed into law measures allowing pharmacists to disclose to patients when the cash price of a drug is lower than the cost using their insurance. Previously pharmacists could be barred from doing so under their contracts with insurers and pharmacy benefit managers.
Veterans' Health
Trump is credited by some advocates for overhauling Department of Veterans Affairs healthcare. However, while he did sign a major bill allowing veterans to obtain care outside VA facilities, White House officials also tried to scuttle passage of the spending needed to pay for the initiative.
Medical Freedom
Trump scored a big win for the libertarian wing of the Republican Party when he signed into law the "Right to Try Act," intended to make it easier for patients with terminal diseases to access drugs or treatments not yet approved by the FDA.
But it is not clear how many patients have managed to obtain treatment using the law because it is aimed at the FDA, which has traditionally granted requests for "compassionate use" of not-yet-approved drugs anyway. The stumbling block, which the law does not address, is getting drug companies to release doses of medicines that are still being tested and may be in short supply.
Trump said in a Jan. 10 Fox News town hall that the law had "saved thousands and thousands" of lives. There's no evidence for the claim.
KEOKUK, Iowa — Folks in this Mississippi River town hope a new federal program can revive the optimism engraved long ago in a plaque on the side of their hospital.
"Dedicated to the Future of Health Care in the Tri-State Area," the sign declares. "May 11, 1981."
More recent placards posted at the facility's entryways are ominous, however. "Closed," they say. "No Trespassing."
The Keokuk hospital, which served rural areas of Iowa, Illinois, and Missouri, closed in October 2022. But new owners plan to reopen the hospital with the help of a new federal payment system. The Rural Emergency Hospital program guarantees hospitals extra cash if they provide emergency and outpatient services but end inpatient care.
"We've been without a hospital for over a year — and I don't think anybody in Keokuk or the surrounding areas will be picky in any way, shape, or form," said Kathie Mahoney, mayor of the town of about 9,800 people. She said residents would prefer to have a full-service hospital with inpatient beds, even though those types of beds had been used sparingly in recent years.
The revival of the Keokuk hospital would mark a small victory in the nationwide struggle to save rural hospitals, which continue to close due to staffing shortages, low reimbursement rates, and declining patient numbers. The new federal program, which went into effect in January 2023, is meant to stem the closures. But there have been growing pains, said George Pink, deputy director of the North Carolina Rural Health Research Program, which tracks hospital closures and conversions.
Just 18 of the more than 1,700 eligible rural hospitals nationwide have applied for and won the new designation. Many hospitals are reluctant to give up inpatient services entirely, and some are concerned about how other payment streams could be affected, rural health leaders say. The new designation's unclear definition of "rural" has also caused confusion.
"We are still in an era of rural hospital closures," Pink said. Nine hospitals closed in 2023, and that number could rise in 2024, he said. An influx of federal relief funds during the pandemic kept struggling hospitals afloat, but now that money is largely gone.
The Rural Emergency Hospital program is the first new federal payment model for hospitals since 1997. Dora Hughes, acting chief medical officer of the Centers for Medicare & Medicaid Services, said the new model's criteria are outlined by statute and "hospitals should consider specific circumstances before making the decision to apply."
The federal agency is providing outreach to rural communities and welcomes feedback, Hughes wrote in an email to KFF Health News.
Now, rural health leaders and federal lawmakers are working quickly to tweak the new program to attract more applicants, said Carrie Cochran-McClain, chief policy officer of the National Rural Health Association.
Currently, facilities that convert to rural emergency hospitals receive a 5% increase in Medicare payments, plus an average annual payment of about $3.2 million, in exchange for giving up their expensive inpatient beds and focusing solely on emergency and outpatient care. Rural hospitals with no more than 50 beds, like Keokuk's, that closed after the law was signed on Dec. 27, 2020, are eligible to apply for the program and reopen with emergency and outpatient services.
More than 100 rural hospitals nationwide have inquired about converting, said Janice Walters, interim executive director for the Rural Health Redesign Center, which has a federal grant to provide technical assistance to hospitals that want to apply.
But only about a quarter of those inquiries are likely to become a rural emergency hospital, and persuading more troubled hospitals to make the leap would require regulators to make changes, Walters said.
Her advice? "Give them 10 beds to just take care of their community."
In a journal article published last year, general surgeon Sara Schaefer worried about the unintended consequences of getting rid of rural inpatient beds. Schaefer, who spent six months of medical school at a small rural Idaho hospital, said she saw firsthand how difficult it was for the hospital to transfer patients to bigger facilities, which were often too full to take them.
"There has to be a better way," said Schaefer, who is also a research fellow at the Center for Healthcare Outcomes & Policy at the University of Michigan.
The rural health association's Cochran-McClain said lawmakers are considering changes that could allow the hospitals to:
Keep overnight beds for patients who need moderate levels of care, such as those with pneumonia or in need of physical therapy after surgery.
Allow participation in a federal drug discount program called 340B, which provides hospitals with extra revenue.
Keep inpatient psychiatric or rehabilitation units open.
Clarify eligibility, including which facilities qualify under the definition of "rural" and whether the hospitals that closed before the 2020 date in the law can apply.
Updates to the law could affect communities nationwide. In Fort Scott, Kansas, where the hospital closed in late 2018, Mayor Matthew Wells said the community wants the eligibility date pushed back. U.S. Sen. Jerry Moran (R-Kan.) introduced a bill in December that, if passed, would push eligibility back to 2015.
"This is a matter of life and death to my community," Wells said. "I see a clear path, but the federal regulations in particular make that path nearly impossible."
In Holly Springs, Mississippi, hospital chief executive Kenneth Williams said he doesn't understand the federal definition of "rural." His hospital, Alliance Healthcare Hospital, was one of the first to win the new Rural Emergency Hospital designation in early 2023. He laid off staff and shut down his inpatient beds. Then, CMS officials called to tell him they had made a mistake.
"And I said, 'Wait a minute,'" Williams said. The hospital, which is about an hour south of Memphis, Tennessee, doesn't meet the current criteria of rural, they told him. Williams, an internal medicine doctor, bought the hospital in 1999 and has been trying to keep it running since.
Federal regulators are now asking Williams to convert the facility into another type of Medicare payment model, such as the sole community hospital with inpatient beds that it was before. Williams said that would be difficult: "What kind of transition can I make, especially with reduced services?"
In Keokuk, the hospital fits the current requirements. Insight Health Group, the Michigan company that bought the shuttered facility last March, plans to apply for the new federal designation as soon as it obtains state permits under new Iowa regulations tailored to rural emergency hospitals. It would be the first such hospital in the state.
Like many other rural hospitals struggling to survive, Keokuk's shuttered several key departments years ago, including its birthing and inpatient psychiatric units. In 2021, the last full year it was open, the hospital averaged fewer than three inpatients per night, according to data posted by the Iowa Hospital Association.
More than half of the three-story building would remain mothballed if the facility reopened under the new designation, but the emergency department could serve patients again as soon as late summer, said Atif Bawahab, Insight"s chief strategy officer.
Bruce Mackie has worked 32 years at the hospital, including 10 years as director of plant operations. The new owners kept him on to watch over the building. Beds, high-tech scanners, and lab equipment remain, but most of the clocks have stopped. "It's spooky," he said.
Even if the services are more limited than before, Mackie said, "everybody wants the hospital to reopen. This city needs an ER."
Former HHS Secretary Alex Azar is chairman of LifeScience Logistics, a company Florida is paying $39 million to manage its Canadian drug importation program.
This article was published on Monday, January 15, 2024 in KFF Health News.
The Food and Drug Administration's unprecedented approval of Florida's plan to import drugs from Canada was made possible only after Alex Azar, as the Trump administration's Health and Human Services secretary, certified that bringing medicines over the border could be done safely.
Azar made the historic declaration in September 2020, just two months before his boss, former President Donald Trump, lost reelection.
Now, Azar's involved in the business of making importation happen. He is chairman of the board of LifeScience Logistics, a Dallas-based company that Florida is paying as much as $39 million to help manage its Canadian drug importation program, not including the cost of drugs.
LifeScience officials confirmed Azar's position but didn't respond to questions about how much he is paid or whether he's involved in the Florida work. Azar didn't return messages left with his employers or sent to a personal email address.
The revolving door between government and private sector jobs is well documented. It's common for top U.S. officials in both parties to leave government service for what are often far better-paid jobs or board seats at companies in the industries they formerly regulated.
About 57% of presidential Cabinet-level officials later served on corporate boards of directors, according to a 2019 study by researchers at Boston and Harvard universities in The Journal of Politics, which examined 84 Cabinet members who served from 1992 to 2014.
"In general, we favor Cabinet secretaries not going into industries which they once regulated, because the possibility of conflicts of interest are unavoidable," said Robert Weissman, president of Public Citizen, a government watchdog group.
He called Azar's case atypical because his approval of drug importation was opposed by the pharmaceutical industry, in which Azar was formerly employed. Drugmakers argue the policy puts patients at risk of consuming counterfeit medicines. Azar joined the LifeScience board in January 2022, one year after the end of Trump's term and about a year after Florida contracted with LifeScience in late 2020.
Katie Hernandez, a spokesperson for LifeScience Logistics, said in a statement that the company, which manages nearly 6 million square feet of warehouse storage across 11 states, signed its deal with Florida before Azar joined the board.
Ivana Katic, assistant professor of organizational behavior at the Yale School of Management, said that Azar's position at LifeScience "can appear as a conflict of interest" because his policy decision as HHS secretary later benefited him professionally.
Azar was a deputy secretary at HHS during the George W. Bush administration before joining pharmaceutical giant Eli Lilly and Co. as a top executive in 2007, remaining there until months before joining the Trump administration.
Weissman, who supports drug importation, said he doubts Azar had any personal benefit in mind before his decision. Florida Gov. Ron DeSantis had pushed Trump to authorize importation from Canada, and the former president had said he supported importation before Azar certified it was safe.
Canadian drug importation has been the subject of decades of debate. While the U.S. does not regulate most drug costs, Canada does, generally resulting in lower prices than across the border.
In 2018, Azar called importation a "gimmick" because Canada's pharmaceutical market isn't large enough to meet U.S. demand. Indeed, the Canadian government has repeatedly warned the U.S. against importation, promising to block any plan that poses a risk of causing shortages in Canada.
The country has implemented regulations "to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada," Health Canada, which regulates drug safety, said in a Jan. 8 statement after the FDA's approval of Florida's plan. "This includes all drugs that are eligible for bulk importation to the U.S., including those identified in Florida's bulk importation plan, or any other US state's future importation programs."
Under its contract with Florida, LifeScience Logistics must buy drugs from Canadian suppliers, contract with a lab to verify their authenticity, store the medicines, and ship them to state agencies for distribution. LifeScience built a 100,000-square-foot facility in Lakeland, Florida, to warehouse drugs imported from Canada.
President Joe Biden supported drug importation during his 2020 campaign, but after the election his administration moved slowly to advance the process. Colorado has an importation application pending with the FDA, while several other states have passed laws allowing for importation. DeSantis has accused the Biden administration of slow-walking a decision, and his administration filed a lawsuit over the FDA's delay.
Florida's importation plan will save the state up to $180 million in the first year of the program, the state said. The importation program wouldn't aid consumers directly. It's instead aimed at helping state agencies, including its prisons, health department, and Medicaid program, obtain lower-cost drugs for HIV and AIDS, diabetes, and other conditions.
Florida's plan still faces many hurdles. On top of Canada's reluctance to participate in U.S. importation programs, some drug manufacturers have deals with Canadian wholesalers preventing them from exporting medicines, and the FDA decision is likely to face a legal challenge by drugmakers.
The drug industry's major lobbying group, the Pharmaceutical Research and Manufacturers of America, or PhRMA, previously sued to stop Azar's importation decision. It's expected to file suit to block Florida's program as well.
A PhRMA spokesperson declined to comment on Azar's role.
Kevin Stansbury, the CEO of Lincoln Community Hospital in the 800-person town of Hugo, Colorado, is facing a classic Catch-22: He could boost his rural hospital's revenues by offering hip replacements and shoulder surgeries, but the 64-year-old hospital needs more money to be able to expand its operating room to do those procedures.
"I've got a surgeon that's willing to do it. My facility isn't big enough," Stansbury said. "And urgent services like obstetrics I can't do in my hospital, because my facility won't meet code."
Besides securing additional revenue for the hospital, such an expansion could keep locals from having to drive the 100 miles to Denver for orthopedic surgeries or to deliver babies.
Rural hospitals throughout the nation are facing a similar conundrum. An increase in costs amid lower payments from insurance plans makes it harder for small hospitals to fund large capital improvement projects. And high inflation and rising interest rates coming out of the pandemic are making it tougher for aging facilities to qualify for loans or other types of financing to upgrade their facilities to meet the ever-changing standards of medical care.
"Most of us are operating at very low margins, if any margin at all," Stansbury said. "So, we're struggling to find the money."
Aging hospital infrastructure, particularly in rural areas, is a growing concern. Data on the age of hospitals is hard to come by, because hospitals expand, upgrade, and refurbish different parts of their facilities over time. A 2017 analysis by the American Society for Health Care Engineering, a part of the American Hospital Association, found that the average age of hospitals in the U.S. increased from 8.6 years in 1994 to 11.5 years in 2015. That number has likely grown, industry insiders say, as many hospitals delayed capital improvement projects, particularly during the pandemic.
Research published in 2021 by the capital planning firm Facility Health Inc., now called Brightly, found that U.S. health care facilities had deferred about 41% of their maintenance and would need $243 billion to complete the backlog.
Rural hospitals don't have the resources of larger hospitals, particularly those in hospital chains, to fund billion-dollar expansions.
Most of today's rural hospitals were opened with funding from the Hill-Burton Act, passed by Congress in 1946. That program was rolled into the Public Health Service Act in the 1970s and, by 1997, had funded the construction of nearly 7,000 hospitals and clinics. Now, many of those buildings, particularly those in rural areas, are in dire need of improvements.
Stansbury, who is also board chair of the Colorado Hospital Association, said at least a half-dozen rural hospitals in the state need significant capital investment.
Harold Miller, president and CEO of the Center for Healthcare Quality and Payment Reform, a think tank in Pittsburgh, said the major problem for small rural hospitals is that private insurance is no longer covering the full cost of providing care. Medicare Advantage, a program under which Medicare pays private plans to provide coverage for seniors and people with disabilities, is a major contributor to the problem, he said.
"You're basically taking patients away from what may be the best payer that the small hospital has, and pushing those patients onto a private insurance plan, which doesn't pay the same way that traditional Medicare pays and ends up also using a variety of techniques to deny claims," Miller said.
Rural hospitals also must staff their emergency rooms with physicians round-the-clock, but the hospitals get paid only if someone comes in.
Meanwhile, labor costs coming out of the pandemic have increased, and inflation has driven up the cost of supplies. Those financial headwinds will likely push more rural hospitals out of business. Hospital closures dropped during the pandemic, from a record 18 closures in 2020 to a combined eight closures in 2021 and 2022, according to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina-Chapel Hill, as emergency relief funds kept them open. But that life support has ended, and at least nine more closed in 2023. Miller said closures are reverting to pre-pandemic rates.
That raises concerns that some hospitals might invest in new facilities and end up shutting down anyway. Miller said only a small portion of rural hospitals might be able to make a meaningful difference to their bottom lines by adding new services.
Lawmakers have tried to help. California, for example, has loan programs charging low to no interest that rural hospitals can participate in, and hospital representatives are urging Colorado legislators to approve similar support.
At the federal level, Rep. Yadira Caraveo, a Colorado Democrat, has introduced the bipartisan Rural Health Care Facilities Revitalization Act, which would help rural hospitals get more funding for capital projects through the U.S. Department of Agriculture. The USDA has been one of the largest funders of rural development through its Community Facilities Programs, providing over $3 billion in loans a year. In 2019, half of the more than $10 billion in outstanding loans through the program helped health care facilities.
"Otherwise, facilities would have to go to private lenders," said Carrie Cochran-McClain, chief policy officer for the National Rural Health Association.
Rural hospitals might not be very attractive to private lenders because of their financial constraints, and thus may have to pay higher interest rates or meet additional requirements to get those loans, she said.
Caraveo's bill would also allow hospitals that already have loans to refinance at lower interest rates, and would cover more categories of medical equipment, such as devices and technology used for telehealth.
"We need to keep these places open, even not just for emergencies, but to deliver babies, to have your cardiology appointment," said Caraveo, who is also a pediatrician. "You shouldn't have to drive two, three hours to get it."
"They're trying to do this while they're doing their regular jobs running a hospital," Juliar said. "A lot of times when there are funding opportunities, for example, the timing may be just too tight for them to put together a project."
Some funding is contingent on the hospital raising matching funds, which may be difficult in distressed rural communities. And most projects require hospitals to cobble together funding from multiple sources, adding complexity. And since these projects often take a long time to put together, rural hospital CEOs or board members sometimes leave before they come to fruition.
"You get going at something and then key people disappear, and then you feel like you're starting all over again," she said.
Expansion of Lincoln Community Hospital could keep locals from having to drive the 100 miles to Denver for orthopedic surgeries or to deliver babies.(Lincoln Health)
The hospital in Hugo opened in 1959 after soldiers coming back from World War II decided that Lincoln County on the eastern Colorado plains needed a hospital. They donated money, materials, land, and labor to build it. The hospital has added four family practice clinics, an attached skilled nursing facility, and an off-site assisted living center. It brings in specialists from Denver and Colorado Springs.
Stansbury would like to build a new hospital roughly double the size of the current 45,000-square-foot facility. With inflation easing and interest rates likely to go down this year, Stansbury hopes to get financing lined up in 2024 and to break ground in 2025.
"The problem is, every day I wake up, it gets more expensive," Stansbury said.
When hospital officials first contemplated building a new hospital three years ago, they estimated a total project cost of about $65 million. But inflation skyrocketed and now interest rates have gone up, pushing the total cost to $75 million.
"If we have to wait another couple of years, we may be pushing up closer to $80 million," Stansbury said. "But we've got to do it. I can't wait five years and think the costs of construction are going to go down."