EpiPen RICO Ruling Opens Door for Private AKS Enforcement
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
Drug Pricing Initiatives During the Trump Presidency
The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more
A few weeks ago, Regs & Eggs focused on nine health-related issues that were not included in the Fiscal Year (FY) 2025 President’s Budget. Another policy absent from the budget was the Administration’s plan to address drug...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
Despite a busy 2022, drug pricing remains a hot topic at the federal and state levels, with a number of recent developments and trends worth monitoring heading into 2023. In the past year, the FTC increasingly focused on the...more
Inflation Reduction Act: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022. Republican leaders on the House Energy & Commerce and...more
After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more
Biden Administration Releases FY 2023 Budget - The Biden Administration’s proposed Budget of the U.S. Government for FY 2023 (see also the accompanying fact sheet) includes proposals relevant to drug manufacturers....more
Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more
Over the past year, we saw significant developments in managed care regulation at the federal and state levels, and we anticipate the rapid pace of change to continue in 2021. In this webinar, attendees will hear an analysis...more
On November 20, President Trump held a press briefing at which he unveiled two long-awaited actions to reduce prescription drug costs. Both actions had been called for in Executive Orders he issued this summer. Although each...more
The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more