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Administrative Procedure Act Constitutional Challenges Healthcare

Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

Jones Day on

On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more

Stevens & Lee

Presidential Memorandum Calls for Scrutiny and Fast-Track Repeal of Regulations

Stevens & Lee on

President Trump issued a Memorandum on April 6 directing the heads of all executive departments and agencies to identify on a fast-track basis (60 days) certain categories of “unlawful and potentially unlawful” regulations...more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

Jones Day on

No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

Littler

New York Court Issues Decision and Order Declaring the DOH’s August 2024 Reimbursement Rate Adjustment for Fiscal Intermediaries...

Littler on

On March 20, 2025, a New York Supreme Court Justice in Albany County issued a decision and order declaring the New York State Department of Health (NY DOH)’s August 2024 implementation of an administrative rate reimbursement...more

McDermott Will & Emery

Post-Chevron Insights and Resources

McDermott Will & Emery on

On June 28, 2024, in Loper Bright Enterprises v. Raimondo, the US Supreme Court overruled the decades-old Chevron doctrine. This decision means that courts must now determine the meaning of federal statutes and effectively...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

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