2023, Labelling and Payment Processing

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

Labelling

Labelling Drug Pricing Compounding Payment Processing

NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Putting Patients First Blog

JULY 2, 2024

The discussion focused on CMS’ 2023 listening sessions during implementation of the first round of negotiations and identified lessons learned to inform future listening sessions and broader patient engagement strategies. It is crucial to consider how off-label uses will be evaluated and incorporated into the negotiation process.

Drug Pricing

Drug Pricing Insurance Coverage and Processing HIPAA Labelling

Pharmacist Digest

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Stay Connected