Xavier Hardy

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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

5/13/2025 / Administrative Procedure Act , Appeals , Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Drug Pricing , Inflation Reduction Act (IRA) , Judicial Review , Medicare , Pharmaceutical Industry , Prescription Drugs

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

2/14/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Chevron Deference , Constitutional Challenges , Loper Bright Enterprises v Raimondo , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , SCOTUS

The Uncertain Landscape of Medicare Agent/Broker Compensation Rules

In the Proposed Medicare Advantage and Part D Rules for 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to how Medicare Advantage organizations (MAOs) are allowed to contract with and...more

7/11/2024 / Administrative Procedure Act , Agents , Brokers , Centers for Medicare & Medicaid Services (CMS) , Contract Terms , Fees , Medicare , Medicare Advantage , Medicare Advantage Organizations (MAOs) , Medicare Part D

Did the Tenth Circuit Just Put the Final Nail in the Coffin for Challenges to the Use of “Statewide Average Premium” in Risk...

On December 31, 2019, the Tenth Circuit Court of Appeals upheld the Department of Health & Human Services’ Affordable Care Act (ACA) risk adjustment methodology in New Mexico Health Connections v. HHS, No. 18-2186 (10th Cir....more

1/9/2020 / Administrative Procedure Act , Affordable Care Act , Arbitrary and Capricious , Budget Neutrality Policy , Co-Op , Department of Health and Human Services (HHS) , Risk Adjustment Formula , Risk Management

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