Hospitals argue they need the extra money because they have higher costs.

This article was published on Tuesday, February 13, 2024 in KFF Health News.

By Phil Galewitz and Colleen DeGuzman

In the battle to control healthcare costs, hospitals are deploying their political power to protect their bottom lines.

The point of contention: For decades, Medicare has paid hospitals — including hospital-owned physician practices that may not be physically located in a hospital building — about double the rates it pays other doctors and facilities for the same services, such as mammograms, colonoscopies, and blood tests.

The rationale has been that hospitals have higher fixed costs, such as 24/7 emergency rooms and uncompensated care for uninsured people.

Insurers, doctors, and consumer advocates have long complained it's an unequal and unfair arrangement that results in higher costs for patients and taxpayers. It's also a profit incentive for hospitals to buy up physician practices, which health economists say can lead to hospital consolidation and higher prices.

In December, the House passed a bill that included a provision requiring Medicare to pay the same rates for medical infusions, like chemotherapy and many treatments for autoimmune conditions, regardless of whether they're done in a doctor's office or clinic owned by a hospital or by a different entity. The policy, known as site-neutral payment, has sparked a ferocious lobbying battle in the Senate, not the first of its kind, with hospitals determined to kill such legislation.

Don't bet against them. The House legislation would save Medicare an estimated $3.7 billion over a decade, according to the Congressional Budget Office. To put this in perspective, the program is projected to pay hospitals upward of $2 trillion during that same period. But hospitals have long argued that any adoption of site-neutral payments would force them to cut jobs or services, or close facilities altogether — particularly in rural areas. And senators are listening.

"The Senate is very much attuned to rural concerns," Sen. Ron Wyden (D-Ore.), who chairs the Finance Committee, told KFF Health News. His panel has jurisdiction over Medicare, the health program for seniors and people with disabilities.

"I have heard lots of questions about how these proposals would affect rural communities and rural facilities," he said. "So we're taking a look at it."

Outpatient departments at rural hospitals can have outsize importance to their communities. Taking any funding away from stand-alone rural hospitals is seen as risky. Scores have closed in the past decade due to financial problems. With fewer patients, rural hospitals often struggle to attract doctors and update technology amid rising costs.

Sen. Bill Cassidy (R-La.), a physician who also serves on the Finance Committee, indicated he was apprehensive about the legislation.

"In some cases," he said, higher Medicare payments for hospitals are "justified."

"In some cases, it doesn't seem to be," he said. He told KFF Health News he was planning to introduce legislation on the issue but didn't provide details, and his office didn't respond to inquiries.

As the two senators show, the issue doesn't break cleanly along partisan lines. In December, the House easily passed the Lower Costs, More Transparency Act, the broader bill that included this Medicare payment change, with 166 Republicans and 154 Democrats voting in favor.

"It's more about how close different members are to the hospital industry," said Matthew Fiedler, a former White House health economist under President Barack Obama and now a senior fellow at the Brookings Institution.

The American Hospital Association describes the site-neutral policy as a "cut" to hospital Medicare payments and said in a statement to a House subcommittee that it "disregards important differences in patient safety and quality standards required in these facilities."

Chip Kahn, president and CEO of the Federation of American Hospitals, which represents for-profit hospitals, offered a similar characterization of the House-passed legislation. "This is no time for so-called ‘site neutral' Medicare cuts that could harm beneficiaries," he said in a statement. He urged lawmakers to drop the policy from the broader bill and instead prioritize access to hospital care for patients by not only protecting Medicare, but also strengthening the healthcare safety net.

Hospitals argue they need the extra money because they have higher costs, said Salama Freed, an assistant professor of health policy and management at George Washington University and a nonresident fellow at KFF. But "it doesn't necessarily warrant the amount that they end up getting paid for this," she said.

The Medicare Payment Advisory Commission, which advises Congress on the program, has recommended implementing site-neutral payments for over a decade.

"This is not a hospital cut. It is rolling back an unethical price increase," said Mark Miller, a former MedPAC executive director who's now an executive vice president at Arnold Ventures, a philanthropy founded by John and Laura Arnold, an energy industry investor and an attorney, respectively.

Large hospital systems with the money to buy physician practices, Miller said, have exploited the disparity between Medicare payments to physician offices and hospitals to increase their revenue and consolidate.

Arnold Ventures advocates for site-neutral payments and its leaders have discussed the issue with lawmakers. (The organization has also provided funding for KFF Health News.)

Miller said he's hopeful the site-neutral provision of the House bill will be part of a larger government spending bill that must be passed next month to keep the government open. If lawmakers need to offset the bill's costs, "then it is more likely to get in the funding package," he said.

Though the House-passed legislation is viewed as an "incremental" change, said Fiedler, it faces a rough path forward. Evening out Medicare payment for physician-administered drugs, hospitals fear, could lead to similar moves for other outpatient services.

"Hospitals have a lot of money at stake and will fight this hard," he said. "Hospitals feel if they lose here, down the road there will be more substantial steps."

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

Colleen DeGuzman: cdeguzman@kff.org, @acolleendg

Two-thirds of the 48 million beneficiaries who have had their eligibility reviewed so far got their coverage renewed. 

This article was published on Wednesday, February 7, 2024 in KFF Health News.

By Phil Galewitz

Halfway through what will be the biggest purge of Medicaid beneficiaries in a one-year span, enrollment in the government-run health insurance program is on track to return to roughly pre-pandemic levels.

Medicaid, which covers low-income and disabled people, and the related Children's Health Insurance Program grew to a record 94 million enrollees as a result of a rule that prohibited states from terminating coverage during the nation's public health emergency.

But since last April, states have removed more than 16 million people from the programs in a process known as the "unwinding," according to KFF estimates compiled from state-level data.

While many beneficiaries no longer qualify because their incomes rose, millions of people have been dropped from the rolls for procedural reasons like failing to respond to notices or return paperwork. But at the same time, millions have been reenrolled or signed up for the first time.

The net result: Enrollment has fallen by about 9.5 million people from the record high reached last April, according to KFF. That puts Medicaid and CHIP enrollment on track to look, by the end of the unwinding later this year, a lot like it did at the start of the coronavirus pandemic: about 71 million people.

"What we are seeing is not dissimilar to what we saw before the pandemic — it is just happening on a bigger scale and more quickly," said Larry Levitt, executive vice president for health policy at KFF.

Enrollment churn has long been a feature of Medicaid. Before the pandemic, about 1 million to 1.5 million people nationwide fell off the Medicaid rolls each month — including many who still qualified but failed to renew their coverage, Levitt said.

During the unwinding, many people have been disenrolled in a shorter time. In some ways — and in some states — it's been worse than expected.

The Biden administration predicted about 15 million people would lose coverage under Medicaid or CHIP during the unwinding period, nearly half due to procedural issues. Both predictions have proven low. Based on data reported so far, disenrollments are likely to exceed 17 million, according to KFF — 70% due to procedural reasons.

But about two-thirds of the 48 million beneficiaries who have had their eligibility reviewed so far got their coverage renewed. About one-third lost it.

The federal government has given most states 12 months to complete their unwinding, starting with the first disenrollments between last April and October.

Timothy McBride, a health economist at Washington University in St. Louis, said the nation's historically low unemployment rate means people who lose Medicaid coverage are more likely to find job-based coverage or be better able to afford plans on Obamacare marketplaces. "That is one reason why the drop in Medicaid is not a lot worse," he said.

There are big differences between states. Oregon, for example, has disenrolled just 12% of its beneficiaries. Seventy-five percent have been renewed, according to KFF. The rest are pending.

At the other end of the spectrum, Oklahoma has dumped 43% of its beneficiaries in the unwinding, renewing coverage for just 34%. About 24% are pending.

States have varying eligibility rules, and some make it easier to stay enrolled. For instance, Oregon allows children to stay on Medicaid until age 6 without having to reapply. All other enrollees get up to two years of coverage regardless of changes in income.

Jennifer Harris, senior health policy advocate for Alabama Arise, an advocacy group, said her state's Medicaid agency and other nonprofit organizations communicated well to enrollees about the need to reapply for coverage and that the state also hired more people to handle the surge. About 29% of beneficiaries in Alabama who've had eligibility reviews were disenrolled for procedural reasons, KFF found.

"Things are even keel in Alabama," she said, noting that about 66% of enrollees have been renewed.

State officials have told the legislature that about a quarter of people disenrolled during the unwinding were reenrolled within 90 days, she said.

One of a handful of states that have refused to expand Medicaid under the Affordable Care Act, Alabama had about 920,000 enrollees in Medicaid and CHIP in January 2020. That number rose to about 1.2 million in April 2023.

More than halfway into the unwinding, the state is on track for enrollment to return to pre-pandemic levels, Harris said.

Joan Alker, executive director of the Georgetown University Center for Children and Families, said she remains worried the drop in Medicaid enrollment among children is steeper than typical. That's particularly bothersome because children usually qualify for Medicaid at higher household income levels than their parents or other adults.

During the unwinding 3.8 million children have lost Medicaid coverage, according to the center's latest data. "Many more kids are falling off now than prior to the pandemic," Alker said.

And when they're dropped, many families struggle to get them back on, she said. "The whole system is backlogged and the ability of people to get back on in a timely fashion is more limited," she said.

The big question, Levitt said, is how many of the millions of people dropped from Medicaid are now uninsured.

The only state to survey those disenrolled — Utah — discovered about 30% were uninsured. Many of the rest found employer health coverage or signed up for subsidized coverage through the Affordable Care Act marketplace.

What's happened nationwide remains unclear.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

Regulators say drugmakers illegitimately use the patents to prevent competitors from offering cheaper generics.

This article was published on Wednesday, January 31, 2024 in KFF Health News.

By Elisabeth Rosenthal

The Federal Trade Commission has challenged the validity of over 100 drug product patents, focusing on devices used to deliver medicines, like inhalers and autoinjectors, in an effort to increase competition and potentially lower some prices.

The FTC says drugmakers illegitimately use the patents to prevent competitors from offering cheaper generic alternatives.

It's the first time the FTC has tried the tactic, said Hannah Garden-Monheit, director of the FTC's Office of Policy Planning.

"We are using all the tools we have to bring down drug prices and reduce barriers to generic competition," she said in an interview.

President Joe Biden has instructed his Federal Trade Commission to be more aggressive in reining in the pharmaceutical industry. Under its chairperson, Lina Khan, the agency is aggressively testing the limits of its powers in pursuit of that goal.

The targeted patents cover devices that propel medicines for asthma and emphysema into the lungs or inject epinephrine to treat a severe allergic attack. Drugmakers list them in the FDA's "Orange Book," which can afford the products greater protection from generic competition.

Many of the medicines delivered by the devices are decades old, years off patent. But manufacturers have long tweaked the delivery methods, patenting the changes, in ways that sometimes make the drugs more convenient to administer.

They might, for example, change the propellant in an inhaler or add a counter that tells a patient how many doses are left. Autoinjectors mean patients don't see a needle or syringe but merely press a device with a hidden needle against the skin to deliver the medicine. Some autoinjectors even talk patients through the process.

Though there has long been a procedure for disputing the validity of Orange Book-listed patents, it is rarely used.

In challenging Orange Book listings, the FTC is trying to cut away at what are known as patent thickets. While a single patent once would cover a single active medicine, many drugs today are protected by half a dozen patents or more, creating additional obstacles for cheaper generics seeking to enter the market.

The move is critically important because drugmakers frequently extend the 20-year patent protection of a drug by changing the delivery device or method. For example, instead of a pill, they make a capsule. Or instead of a dose every six hours, they create a longer-acting, once-a-day version. They can also alter the process by which a drug is made — so-called "process patents."

Each tweak gets a new patent, which the manufacturer then adds to its official compendium of drug patents. There is no advance scrutiny of listings by regulators.

Generic drugmakers wishing to make a copycat version of a branded drug generally have to challenge the patents in court. But merely listing a patent in the Orange Book automatically triggers a 2½-year delay of FDA approval of a litigating generic competitor.

The FTC says patent law protects active ingredients, not delivery methods.

The pharmaceutical industry, already battling the Biden administration's plan to negotiate prices of some drugs for Medicare patients, says it wants more clarity about which aspects of its products can be patented.

"The underlying statute is not clear about listing certain types of drug delivery device patents, and the industry has long asked for the FDA to provide guidance," said Megan Van Etten, a spokesperson for Pharmaceutical Research and Manufacturers of America, the industry trade group, in an email. "We're disappointed that the FTC has characterized companies as acting inappropriately rather than help seek the clarity the industry needs to ensure compliance."

After an FTC challenge, companies have 30 days to withdraw or amend the patent or show it is valid. Some have already backed down.

"We've had some significant wins," Garden-Monheit said. After the FTC's challenge, drugmaker GSK, formerly GlaxoSmithKline, withdrew all patents on two popular inhalers for asthma, Advair and Flovent, both of which contained old off-patent medicines but nonetheless cost hundreds of dollars. Amneal Pharmaceuticals withdrew patents on its epinephrine injector.

Still, the deadline for companies to respond to the first set of warning letters has passed and only about 30% of those that received them answered, leaving the commission to ponder its next steps. The FTC could take a drugmaker to court to seek a cease-and-desist order.

And Garden-Monheit said the agency is poised to look at other types of patents that may be invalid, which pile up to add to the thicket. There are thousands of patents in the Orange Book.

"We are taking a close and active look at this," Garden-Monheit said. "Companies who haven't received a letter from us challenging a patent shouldn't think they're off the hook."

Elisabeth Rosenthal: erosenthal@kff.org, @RosenthalHealth

While national pharmacy chains like CVS and Walgreens were dispensing fewer of the highly addictive drugs, Publix's sales were soaring.

This article was published on Monday, January 29, 2024 in KFF Health News.

By Ian Hodgson, Tampa Bay Times and Christopher O'Donnell, Tampa Bay Times

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.

Ian Hodgson, Tampa Bay Times: ihodgson@tampabay.com, @IanJHodgson