Stephanie Trunk

1 month ago | afslaw.com | Stephanie Trunk

On Highlights of the conversation include:Evolving regulations for off-label pharmaceutical promotion. Enhancing a firm’s global footprint by building trust with sovereign governments. Examining new compliance challenges stemming from AI technology. Navigating US Food and Drug Administration guidance as an unreliable indicator of enforcement priorities. Increasing scrutiny of the role of medical affairs. Finding balance between patient access and regulatory compliance. Contacts

Nov 24, 2024 | mondaq.com | Stephanie Trunk

This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks. Our alert on CMS' release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here.

Nov 22, 2024 | jdsupra.com | Shoshana Golden |Stephanie Trunk

This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks. Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here.

Nov 21, 2024 | afslaw.com | Stephanie Trunk |Shoshana Golden

Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here. The PFS final rule can be found here, with the companion CMS fact sheet available here. Both rules are effective January 1, 2025. Below is an overview of the relevant provisions for pharmaceutical manufacturers and the pharma community.

Nov 21, 2024 | natlawreview.com | Stephanie Trunk

This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks. Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here.