article thumbnail

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.

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Get Up To Speed on Medicare Inflation Rebates: HPM Issues Memorandum Summarizing CMS Final Rule; HPM and Riparian to Co-Host Webinar

FDA Law

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates. The webinar will explore the legal and operational considerations for drug manufacturers.

article thumbnail

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.

article thumbnail

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. Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. By Andrew J.