One to watch today. Oversight of the 340B program is reportedly moving from HRSA to CMS this month, though nothing is official yet. Below that, what covered entities can do about manufacturer data demands, and a Medicare audit finding worth knowing about.
340B oversight may be moving from HRSA to CMS
340B Report says the administration is expected to shift oversight of the 340B program out of HRSA and into CMS this month. It is attributed to an unnamed source and nothing has been announced, so treat it as a heads-up rather than a done deal. If it holds, it changes who writes the rules and who enforces them for covered entities and contract pharmacy arrangements alike. Read more at 340B Report →
What covered entities can do about manufacturer 340B data demands
Eli Lilly has already suspended 340B pricing for hospitals that did not meet its claims-data policy, and Tampa General Hospital sued over the price increases that followed. This piece is about what a covered entity can do now rather than waiting to see how the litigation lands. Worth reading if you are sitting on a manufacturer data demand and hoping it goes quiet. Read more at Frier Levitt →
Medicare Part D paid $588 million for drugs that had gone over the counter
A federal audit found Medicare Part D sponsors paid roughly $588 million from 2021 through 2023 for medications that had already transitioned from prescription to over-the-counter status. The HHS Office of Inspector General pointed to outdated FDA information and the lack of a clear process on the CMS side. Numbers like that tend to become audit priorities later. Read more at Pharmacy Podcast Network →
Why the letter of intent matters more than people think
An attorney’s view from both sides of a pharmacy deal, focused on the letter of intent and what actually protects a buyer or a seller once things get complicated. Useful background if you are thinking about buying or selling a pharmacy. Read more at Boesen and Snow Law →
This update is general information about developments in pharmacy law and regulation. It is not legal advice, it does not create an attorney-client relationship, and it should not be relied on as a substitute for advice about your own situation. Prior results do not guarantee a similar outcome. If you have a specific question about your pharmacy, call or write and we will talk about it properly.
Law Office of Bhavesh Desai | Bhavesh Desai, Pharm.D., Esq.
18085 Watson Way, Yorba Linda, CA 92886 | (909) 618-7299
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