The Biden administration said yesterday it is delaying by six months the effective date of a Trump administration final rule to let drug manufacturers report multiple best prices on their products if states opt to participate in value-based purchasing (VBP)
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The federal fine for overcharging a 340B covered entity just went up from $5,883.00 to $5,953.00 per each instance of overcharging.
The U.S. Health and Human Services Department (HHS) Office of Inspector General (OIG) posted its annual inflation adjustments to
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U.S. manufacturers of insulin and diabetes-related treatments asked a federal judge on Friday to dismiss two health centers’ antitrust class action over the companies’ denials of 340B pricing when covered entities use contract pharmacies.
In a Nov. 11 joint
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Kaiser Health News (KHN), a nonprofit health care news organization whose stories are widely and freely republished and rebroadcast, released an in-depth article and news video today about the 340B program and the fight over 340B contract pharmacy.
According to
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Program integrity is crucial to the management of a covered entity’s 340B operations. Key components include knowing what is expected of the covered entity and having the right questions to ask your third party administrator about their practices and software. The purpose of this article is to highlight valuable objectives to have in place to ensure continuous program oversight and compliance with 340B guidelines and regulations. In this piece, I focus in particular on compliance and oversight related to patient eligibility and include important questions 340B providers must ask to both optimize their program performance and ensure compliance.
One of the driving principles of HRSA’s 340B Program Integrity Guide is that there must be a formalized process related to program operational oversight that will ensure compliance with 340B requirements.
To meet the definition of patient, covered entities must establish a relationship with their patients such that the entity will maintain records of the individuals’
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Drug manufacturer Eli Lilly late yesterday filed notice that it is appealing a federal district judge’s Oct. 29 ruling partially in Lilly’s favor and partially for the federal government on the legality of Lilly’s denials of 340B ceiling prices when
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In a major organizational change, the U.S. Health Resources and Services Administration (HRSA) has redefined the job of Director of the Office of Pharmacy Affairs (OPA), the HRSA unit that runs the 340B program.
For the first time in 340B
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Although Congress was able to pass a $1.2 trillion bipartisan infrastructure package last week, the nearly $1.8 trillion Build Back Better bill remains bogged down by infighting among Democrats. Its numerous drug pricing provisions will likely undergo changes prior to
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