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HPM and Riparian to Co-Host Webinar on CMS Misclassification Penalties Rule

FDA Law

(HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements.

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Reminder: HPM and Riparian to Co-Host Webinar on CMS Misclassification Penalties Rule

FDA Law

(HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements.

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Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law

Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) It did not.

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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law

Hull & JP Ellison At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care.