A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more
4/3/2025
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Medical Devices ,
Regulatory Authority ,
Regulatory Requirements ,
Vacated
The Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET), effective August 12, 2024, to provide “transparent, predictable, and expedited national...more
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
In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more
2/27/2024
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Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Cost-Sharing ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Medicaid ,
Medicare ,
OIG
After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more
10/11/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Emergency Use Authorization (EUA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
Proposed Rules ,
Shareholders
In the 12-month period starting in April 2021, over 100,000 people have died from drug overdoses, a 28.5% increase from the same period the year before. While the opioid crisis has been a declared public health emergency...more
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule,...more