The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more
Additional States Implement Notice Requirements for Healthcare Transactions -
In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions....more
On August 18, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-05 (Advisory Opinion), in which the OIG warned that it would likely issue sanctions under the Federal anti-kickback statute (AKS) if a...more
On May 2, 2023, legislators approved the $229 billion New York State FY 2023-2024 Budget Bill (“the Budget”), which was signed by Governor Hochul on May 3, 2023. Article VII of the Budget touches almost every aspect of the...more
5/8/2023
/ Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Home Health Care ,
Hospitals ,
Life Sciences ,
New York ,
Patient Privacy Rights ,
Reproductive Healthcare Issues ,
State Budgets
On May 2, 2023, legislators approved the $229 billion New York State FY 2023-2024 Budget Bill (“the Budget”), which was signed by Governor Hochul on May 3, 2023. Article VII of the Budget touches almost every aspect of the...more
5/8/2023
/ Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Home Health Care ,
Hospitals ,
Life Sciences ,
New York ,
Patient Privacy Rights ,
Reproductive Healthcare Issues ,
State Budgets
What To Do When The Government Knocks On Your Lab’s Door -
The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more
7/15/2022
/ Clinical Laboratories ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Healthcare ,
Hospitals ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Industry ,
Price Transparency ,
Virus Testing
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
11/17/2021
/ 510(k) RTA ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Infectious Diseases ,
Life Sciences ,
New Guidance ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health