News & Analysis as of

Final Rules Federal Food Drug and Cosmetic Act (FFDCA) Centers for Medicare & Medicaid Services (CMS)

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

Venable LLP on

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

Foley & Lardner LLP

LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements

Foley & Lardner LLP on

On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024....more

King & Spalding

Final Rule on VBP, Patient Assistance and Line Extensions Presents Opportunity and Risk for Drug Manufacturers

King & Spalding on

Trump Administration Finalizes Rulemaking on Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes - On December 21, 2020, the Centers for Medicare & Medicaid Services...more

ArentFox Schiff

Investigations Newsletter: HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute

ArentFox Schiff on

HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute - On November 20, 2020, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services (HHS) published...more

Foley & Lardner LLP

2021 Medicare Remote Patient Monitoring FAQs: CMS Issues Final Rule

Foley & Lardner LLP on

On December 1, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized new policies related to remote patient monitoring aka remote physiologic monitoring or “RPM,” reimbursed under the Medicare program. The...more

Foley Hoag LLP - Medicaid and the Law

CMS Weighs in on FDA Importation Rule

On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more

Holland & Knight LLP

Healthcare Law Update: July 2019

Holland & Knight LLP on

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

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