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
4/28/2025
/ Administrative Procedure Act ,
Appeals ,
Clinical Laboratories ,
Constitutional Challenges ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Judicial Authority ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Authority
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more
The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more
1/29/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Incentives ,
Medicare ,
Organ Transplant Centers ,
Penalties ,
Regulatory Requirements ,
Value-Based Care
The Federal Trade Commission ("FTC") intends to "strengthen and modernize" the Health Breach Notification Rule with revamped and increased scrutiny on entities holding health information, including health apps, websites, and...more
The United States Department of Agriculture ("USDA") published the Strengthening Organic Enforcement ("SOE") Final Rule to improve farm-to-market traceability, deter and detect instances of organic fraud, increase oversight,...more
On November 7, 2022, the U.S. Food and Drug Administration ("FDA") sent the Food Safety Modernization Act ("FSMA") Final Rule on Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal...more
The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more
12/6/2017
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Hospitals ,
HRSA ,
Medicare ,
MedPAC ,
OIG ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Section 340B