Newsletters

11.20.24

J&J Sues HRSA Over Agency’s Challenge of its Rebate Model

On November 12, Johnson & Johnson (J&J) filed suit against the Health Resources and Services Administration (HRSA) in D.C. federal district court, arguing that the 340B statute explicitly provides flexibility for manufacturers to decide how to offer 340B pricing, either through upfront ...


11.07.24

CMS Releases Proposed Forms to Effectuate Medicare MFP Under the IRA of IPAY 2026 and IPAY 2027

On October 28, CMS requested public comment​ on four proposed information collections (ICRs) it intends to impose on drug manufacturers and pharmacies in order to effectuate maximum fair prices (MFP) under the Inflation Reduction Act (IRA's) Medicare Drug Price Negotiation Program for ...


10.16.24

CMS Releases RFI on Medicare $2 Drug List Model

On October 9, the CMS published a Request for Information (RFI) on its proposed Medicare $2 Drug List Model.


10.10.24

CMS Releases Final 2027 IRA Negotiation Guidance

On October 2, the Centers for Medicare & Medicaid Services (CMS) released final guidance outlining how the agency will implement the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program (the “Program”) for initial price applicability year (IPAY) 2027, the ...


10.03.24

CMS Guidance on Expectations for State Compliance with Medicaid and CHIP Renewal Requirements

On September 20, the Centers for Medicare & Medicaid Services (CMS) issued guidance detailing the timeline and expectations for states to fully comply with federal Medicaid and Children’s Health Insurance Program (CHIP) renewal requirements.


10.03.24

OIG Report Calls for Additional Oversight of Remote Patient Monitoring in Medicare

On September 24, the HHS Office of Inspector General (OIG) released a report calling for “additional oversight of remote patient monitoring in Medicare.”


09.26.24

FTC Sues PBMs Over Insulin Pricing, While Express Scripts Sues Commission Over PBM Interim Report

On September 20, the Federal Trade Commission (FTC) filed its first administrative complaint against PBMs under Chair Lina Khan, alleging "anticompetitive and unfair rebating practices” by the three largest PBMs that have inflated insulin prices.


08.22.24

The Inflation Reduction Act Infographic: Overview of Announced Drug Prices

On August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) announced the “maximum fair prices (MFPs)” for the first 10 drugs subject to the Medicare drug negotiation program.