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Administrative Procedure Act Constitutional Challenges Centers for Medicare & Medicaid Services (CMS)

Goodwin

Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

Goodwin on

On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

Mintz - Health Care Viewpoints

Deregulatory Push by Trump Administration Picks Up Speed

It’s no secret that President Trump, his Cabinet, and other executive branch leaders are prioritizing deregulatory activities over more historical federal governance approaches. Indeed, one of President Trump’s earliest...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges

As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more

Mintz - Health Care Viewpoints

EnforceMintz —Could the Supreme Court’s Decision in Jarkesy Mean the End to HHS Civil Monetary Penalty Authorities as We Know...

Last June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy, which holds that the Seventh Amendment entitles a defendant to a jury trial when the Securities and Exchange Commission (SEC)...more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Holland & Knight LLP

Price Transparency in Hospitals – Is Hospital Pricing Data a Protected Trade Secret?

Holland & Knight LLP on

By this point, it's no secret the cost of healthcare services can vary dramatically between different providers of the same services. The Bush, Obama, Trump and Biden administrations all pushed for price transparency in...more

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