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On December 14, 2020, the U.S. Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register defining an administrative dispute resolution (ADR) process for the 340B Drug Pricing Program (340B Program). The Final Rule takes effect 30 days after that date of publication, on January 13, 2021. The Final Rule establishes an ADR process for two types of disputes:
“Claims by covered entities that may have been overcharged for covered outpatient drugs purchased from manufacturers”; and
“Claims by manufacturers of 340B drugs, after a manufacturer has conducted an audit of a covered entity . . . . that a covered entity may have violated the prohibitions against duplicate discounts [i.e., that a Medicaid rebate was invoiced for a drug purchased at the 340B ceiling price] or diversion [i.e., that the covered entity transferred 340B drugs to a person that is not a 340B ‘patie
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On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing Program (340B Program). The ADR process will allow covered entities and drug manufacturers to formally request agency review of alleged 340B violations.
The ADR process will begin amid contentious disputes about the scope and future of the 340B Program. In recent months, multiple drug manufacturers have taken unilateral action to curtail the availability of 340B pricing dispensed through a covered entity’s contracted pharmacies. HRSA, the agency responsible for overseeing the 340B Program, has not yet issued a final opinion on those actions. Members of Congress have urged HRSA to take enforcement action against the manufacturers for violations of the Public Health Services Act. Covered entities and the
Reply
Dec. 16, 2020
Attorney General William Tong today led a bipartisan coalition of attorneys general urging the U.S. Department of Health and Human Services (HHS) to hold accountable drug manufacturers that are unlawfully imperiling access to affordable prescriptions for low-income patients.
Subscribe Drug manufacturers are unlawfully attempting to disrupt arrangements that have long made it easier for low-income Americans to access prescription drugs. HHS must immediately step in to protect vulnerable patients from the unlawful and unacceptable actions of these drug manufacturers. The 340b Drug Pricing Program has strong bipartisan support from lawmakers and leaders nationwide, and HHS should not allow drug makers to unilaterally ignore their obligations, said Attorney General Tong.
28 State AGs Demand HHS Sec Azar Enforce Laws on 340B Drug Pricing businesswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from businesswire.com Daily Mail and Mail on Sunday newspapers.
During height of coronavirus pandemic, nine rogue drug companies announce
they are refusing to provide certain drugs at the legally required ‘340B price’
as required by section 340B of the U.S. Health Services Act
California AG Xavier Becerra, U.S. President-elect Joe Biden’s nominee to be next HHS Secretary, is among the signers of letter to outgoing HHS Secretary Alex Azar asking he address drug companies’ refusal to follow drug pricing laws
WASHINGTON (December 14, 2020) AIDS Healthcare Foundation (AHF) praised 28 U.S. state attorneys general who have drawn a line in the sand to protect an essential part of the healthcare safety net: the 340B Drug Pricing Program against the limitless greed of the drug industry. In their December 14 letter, the bipartisan group of elected attorneys general demand that U.S. Health and Human Services (HHS) Secretary Alex Azar take immediate steps to enforce the law “to address drug companies’ unlawful refusal to provide critical