Three Democratic and three Republican U.S. House members asked the U.S. Health and Human Services Department (HHS) on Friday “to move quickly to enforce the law and begin assessing civil monetary penalties on manufacturers that have denied 340B pricing to providers.”
“The slow pace of HHS’s enforcement efforts to date has emboldened additional companies to begin unlawfully overcharging covered entities and threatens the integrity of the 340B program,” the bipartisan bloc told HHS Secretary Xavier Becerra in a Jan. 21 letter released to news organizations this morning.
“Healthcare providers who rely on the 340B program and the patients they serve are suffering and cannot wait much longer for HHS to protect the program’s integrity,” the lawmakers said.
The U.S. Health Resources and Services Administration (HRSA), which runs the 340B program, said this morning that “HHS is in receipt of the letter and as is standard practice will respond to the members of Congress.”
Reps. Abigail Spanberger (D-Va.), Cindy Axne (D-Iowa), Doris Matsui (D-Calif.), David McKinley (R-W.Va.), Dusty Johnson (R-S.D.), and John Katko (R-N.Y.) wrote Friday’s letter to Becerra.
In March 2021, the lawmakers got a bipartisan group of 220 other House members to sign a letter to the then-acting HHS secretary seeking immediate action against Lilly, AstraZeneca, Sanofi, Novartis, Novo Nordisk, United Therapeutics—the first six manufacturers to impose conditions on 340B pricing when covered entities use contract pharmacies. Since then, six more manufacturers have adopted similar 340B policies—AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Merck, and UCB.
Democrats Spanberger, Axne, Matsui and Republicans McKinley, Johnson, and Chris Stewart Utah) also are the lead sponsors of House legislation to keep hospitals from losing eligibility for 340B discounts because of changes in patient and payer mix caused by the COVID-19 pandemic. There is a companion bill in the Senate. The American Hospital Association last week urged Congress to pass the legislation soon.
Groups Applaud Letter
Groups and individuals that represent 340B covered entities applauded the six House members for their letter to Becerra.
“Allowing drug companies to limit access to drugs for vulnerable patients is harmful,” said Ryan White Clinics for 340B Access (RWC-340B) President Shannon Stephenson. “The actions of the 12 drug companies’ are shameful, destructive, and must stop. We need to focus on fighting health consequences from the pandemic, instead of fighting manufacturers trying to limit access to life saving drugs.”
“This letter highlights the urgent need for the [Biden] administration to act aggressively to enforce the law and prevent drug manufacturers from denying CHCs the savings provided by the 340B statute,” said Steve Carey, federal legislative strategist for state community health center associations.
Jesse Milan, president and CEO of AIDS United, said, “The 340B program is a vital pillar of [the] safety net, providing millions of dollars in funding to cash-strapped, frontline HIV service organizations across the country, which enables them to provide care and services to those in need. We at AIDS United support efforts to stop pharmaceutical companies from continually shrinking these organizations’ resources through over-charging for their medications. The lives of people living with and vulnerable to HIV are on the line.”
Stacey Hughes, executive vice president of the American Hospital Association, said, “We echo this call for the Department of Health and Human Services’ Health Resources and Services Administration to take swift and decisive action to halt these pernicious tactics from pharmaceutical manufacturers and ensure that 340B drugs remain available and accessible to vulnerable patients and communities across the country.”
“The unconscionable and illegal actions by drug manufacturers to restrict 340B discounts puts the health of millions of Americans at risk—especially underrepresented people who have suffered the most during the pandemic,” said Bruce Siegel, president and CEO of America’s Essential Hospitals.
“The actions of these companies are weakening the safety net and threatening the health of patients and the sooner they are reversed, the better,” said Maureen Testoni, president and CEO of hospital group 340B Health.