In early July, as the COVID-19 pandemic slammed rural America, the president of a small Kansas hospital sat down on a Friday afternoon and wrote the president of the United States to plead for help.
“I do not intend to add to your burden,” said Brian Williams, a retired Army lieutenant colonel and Desert Storm combat veteran. He said his hospital, Labette Health, was “like a war zone,” inundated with unvaccinated patients. A department head had threatened to resign, saying he could not “watch one more body be carried out.”
But Williams wasn’t seeking pandemic relief.
Instead, he asked President Joe Biden to confront pharmaceutical manufacturers Eli Lilly and Co., Novo Nordisk and others for refusing to honor a federal drug discount program for hospitals and clinics. The program gives Williams millions to pay staff members, ensure remote clinics remain open and provide charity care for patients unable to pay, he said.
“During a global pandemic, I think health care workers deserve a little bit more respect than to have resources taken away,” Williams said in an interview with KHN and InvestigateTV. “Every one of those [drug] companies, I looked them up, and they were not suffering tremendous [financial] losses, as hospitals were.”
Eli Lilly’s stock price increased nearly 40% and the company’s value rose by $59 billion in the first seven months of 2021. In the same period, Labette Health lost $1.2 million in revenue just from the missed savings on prescriptions, Williams said.
Lilly and other manufacturers, though, are holding their ground. They refuse to offer discounts to thousands of hospital-contracted pharmacies, saying the program has grown beyond its intended use and lacks federal checks and balances against duplicate discounts and other abuses. In lawsuits, they contend the billions in discounted sales they provide are rarely passed on to patients and instead are swallowed up by middlemen like contract pharmacies and third-party administrators.
Congress created the so-called 340B program in 1992 to provide extra funding for hospitals and clinics, especially those serving the poor and elderly. The purpose, lawmakers wrote, is to “stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”
Companies that want their drugs covered by Medicaid or Medicare Part B are required to offer 340B discounts, typically 25% to 50% off what they might otherwise pay. Hospitals and clinics buy the drugs at the discount and then are reimbursed by an insurance company, Medicare or Medicaid at the higher negotiated rate. The difference is kept by the hospital or clinic to use as it sees fit.
The law does not require patients to benefit directly, a nuance that has fueled great conflict about how the program works and should be regulated.
The 340B program’s reach exploded after federal regulators ruled in 2010 that hospitals and clinics could contract with an unlimited number of retail pharmacies such as Walgreens and CVS, which are paid a fee to dispense the discounted drugs. The growth, coupled with long-held questions about regulatory authority, puts the program at a tipping point, with patients stuck in the middle, industry experts say.
The number of pharmacies contracted to work with 340B hospitals to dispense the discounted drugs has soared. It’s reached more than 31,000 nationwide this year from just over 1,700 in 2010, according to an analysis of federal data by InvestigateTV and KHN.
One eye-popping statistic: The drugs purchased under 340B climbed to $38 billion in 2020 from $5.3 billion in 2010, according to the Health Resources and Services Administration, or HRSA, which oversees the program.
Interests on both sides of the program — hospitals and drugmakers — say they are at the mercy of a program designed with the best of intentions, now run amok, hijacked by for-profit companies and wealthy hospitals trying to profit from its largesse.
Adam J. Fein, chief executive of the industry research organization Drug Channels Institute, estimates that nearly half the nation’s retail, mail and specialty pharmacies now profit from 340B: The program, he said, is “essentially taking over the pharmacy industry.”
Legal fights about the program have landed before the U.S. Supreme Court, which is slated to hear arguments this month in American Hospital Association v. Becerra. The hospital industry is challenging a 2018 rule by the Trump administration to cut reimbursement on certain 340B drugs by 28.5%. As Biden’s HHS secretary, Xavier Becerra has upheld the rule.
Most important, the administration says, is to make sure providers use the savings to benefit patients. In an interview with KHN and InvestigateTV, Rear Adm. Krista Pedley, director of the Office of Special Health Initiatives, which oversees the program within Becerra’s agency, said, “We need legislative changes to help make that happen and require that.”
‘Deeply Troubling’
When Sen. Joe Manchin (D-W.Va.) asked during a June appropriations hearing about pharmaceutical companies denying the discounts, Becerra said the drugmakers are violating the law.
“I hope what you’ll do is give us more authority” to regulate the program, Becerra said.
Manchin responded: “I really think we could do that in a bipartisan way, because I’ll tell ya, we’re all being affected.”
As California’s attorney general, Becerra led a coalition of national lawmakers calling for the federal government to hold the manufacturers accountable for their “deeply troubling” actions to undermine the program. At HHS, Becerra put the companies on notice.
Drugmakers — Lilly, AstraZeneca, Novo Nordisk, Sanofi, Novartis and United Therapeutics — took the matter to court, filing several lawsuits. This month, a federal judge ruled that the companies are not required to provide the discounts. A judge in Lilly’s case criticized the “unilateral” action by drugmakers but ruled that the U.S. government’s effort to force them to honor the discounts was invalid.
Notably, U.S. District Court Judge Sarah Evans Barker in Indianapolis wrote that manufacturers believe they are “at the mercy of a system run amok” and that the program “can no longer be held together and implemented fairly” solely through the agency’s guidance and inconsistent messaging.
Becerra requested $17 million annually for 340B program oversight, a $7 million bump. The money would establish a dispute review panel and increase the audits the agency does on manufacturers as well as the providers.
Williams — at his small hospital in rural Parsons, Kansas — said the nearly $4.3 million the hospital gains each year from 340B has allowed him to add a full-time position for case management, increase staffing hours, develop after-school programs and open clinics in impoverished towns that lacked health care.
The hospital has about 20 pharmacies under active contracts, according to the federal database. Williams said it includes locally owned shops like Bowen Pharmacy as well as corporate giants like Walgreens and Walmart, sites that are convenient for patients. A pharmacy added in 2019 is in Frisco, Texas — a mail-order facility that ships specialty drugs directly to patients’ homes.
Patients, Williams said, directly benefit from the federal program: “I’d love to have the CEO of Eli Lilly come here and I’ll take him around and I’ll show him a town of 1,200 where 40% of the population live below the poverty level.”
“Some of our patients come there on a bicycle or in a wheelchair,” Williams said. “I can go 30 minutes in any direction and find pretty tough people living in pretty … pretty austere circumstances.”
One Hospital, 300 Pharmacies
Vanderbilt University Medical Center, based in Nashville, has added three regional hospitals, clinics and providers in recent years — growth that has fueled its rise in contract pharmacies from zero in 2010 to 300 this year. The pharmacies, which reach across Tennessee and all the way to California, “in each instance serve VUMC patients,” Vanderbilt spokesperson John Howser said.
Financial filings do not disclose how much Vanderbilt gains annually from the 340B program, and Howser declined to disclose the amount. The medical system’s operating revenue grew $649 million, or 13%, to $5.5 billion in fiscal year 2021 compared with 2020, according to its latest financial disclosure. Its operating profit rose 25% to $177 million in 2021 compared with 2020.
According to an amicus brief filed in March for the American Hospital Association v. Becerra case, Vanderbilt spends more than $500 million annually on community benefits, such as charity care. Revenue from the 340B program supports low-income programs including medication assistance, home infusion medications and a pharmacy program at a health clinic run by students.
In the brief, Vanderbilt states the government’s cut in Medicare reimbursement has cost the system $12.4 million in 340B savings and will “impact VUMC’s ability to continue to fund community benefit programs at historic levels.”
Large regional health systems have been particularly active in expanding their contract pharmacy networks. The top three — University of Michigan Hospitals and Health Centers, Cambridge Public Health Commission in Massachusetts and Henry Ford Hospital in Detroit — had zero contracts with outside pharmacies in 2010, and each now has more than 500.
InvestigateTV and KHN contacted the 10 providers with the most contract pharmacies and asked why they saw such growth, how much revenue 340B generates and how the money was used.
