Bayer and EMD Serono told customers Wednesday they will cap a $340 billion discount on drugs dispensed through contract pharmacies, the announcement comes just days after three Another drug manufacturer won the court on this issue.
Starting March 1, Bayer and EMD will only offer a $340 billion drug discount to hospitals and their affiliates that are registered as insured units of $340 billion, the companies said in a letter to customers. . The decisions make Bayer and EMD two of about 20 companies that restrict discounts of $340 billion distributed through external pharmacies.
Bayer said the program had “deviated from its original purpose” of helping safety-net hospitals increase access to drugs for vulnerable, low-income populations.
Bayer did not respond to a request for comment. EMD said in a statement that the policy change does not deny a single sale to any entity covered by 340B and it supports the mission of the program.
Monday’s ruling in the Third Circuit Court of Appeals largely supported the three drug companies to impose limits on 340B drug discounts provided to hospitals in the safety net through contract pharmacies. . The three-judge panel concluded that the Department of Health and Human Services could not require AstraZeneca, Novo Nordisk and Sanofi to supply the 340B discount drug purchased by hospitals to an unlimited number of community pharmacies. copper and specialty. Two similar cases are pending in federal appeals courts.
The three companies welcomed the ruling. Hospital associations say it will result in greater profits for pharmaceutical companies at a cost to the hospitals and low-income people they serve.
The 340B plan offers hospitals that treat low-income and uninsured patients up to 50% off drug prices. Participation has increased dramatically over the past two decades, prompting drug manufacturers and policymakers to scrutinize whether hospitals are abusing the program.
Monday’s ruling could prompt another Experts say manufacturers have not limited sales of the 340B drug to contracted pharmacies to act.
Because of the ruling, HHS will not take any enforcement action against manufacturers that restrict sales of the drug 340B, said Emily Cook, a healthcare partner at law firm McDermott Will & Emery. “Monday’s decision has opened an avenue for drugmakers to impose more restrictions than they have imposed so far on the sale of the drug 340B,” she said.
More 340B hospitals can invest in their IT systems to meet drug manufacturers’ 340B data requirements To demonstrate that discounted drugs are benefiting vulnerable populations, said Ricky Yuen, principal of consulting firm ZS.
“The implication for 340B hospitals is that their contractual pharmacy savings continue to suffer, unless they comply with the many requirements of these drug manufacturers to submit claims data to open extended the price of 340B back to many contract pharmacies,” he said in a report. email.
In 2010, HHS allowed 340B hospitals to use more than one contract pharmacy, and since then, the compound annual growth rate of 340B purchases has increased by about 25%. Drugmakers began restricting the sale of the drug 340B to outside pharmacies in 2020, alleging that the practice has resulted in more drugs being placed on the black market and, in some cases, drug manufacturers double the price of the same drug.
In addition to two other pending lawsuits involving contract pharmacies, there are two pending lawsuits related to the administrative dispute resolution process between hospitals and drug manufacturers 340B and drug manufacturers. Another lawsuit concerns the 340B plan’s definition of a patient and whether that definition is consistent with 340B.
Earlier this month, a federal judge ordered HHS to develop a plan to repair underpayments to 340B hospitals between 2018 and 2021 under a rule the Supreme Court found in June to be unlawful. France. In 2018, the Centers for Medicare and Medicaid Services cut the 340B reimbursement by nearly 30% and redistributed it to all hospitals.
Cook said CMS expects to release more information on repayment plans in April. She said the hospitals may not agree to the terms and file a lawsuit.
The American Hospital Association sent a letter to HHS on Wednesday requesting a meeting to discuss a repayment plan.
