On March 14, 2025, as part of a spending bill to avert a federal government shutdown, Congress extended COVID-era telehealth “waivers” applicable to Medicare until September 30, 2025. These were originally scheduled to end...more
As the year comes to a close, the government has signaled a specific focus on clinical laboratories for 2023. On December 6, 2022, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued...more
Mark Schena, the President of Arrayit Corporation, has been found guilty by a jury for violations of the Eliminating Kickbacks in Recovery Act (EKRA), healthcare fraud, wire fraud, and securities fraud....more
9/13/2022
/ Bribery ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Enforcement Actions ,
False Statements ,
Healthcare ,
Healthcare Fraud ,
Indictments ,
Kickbacks ,
Misleading Statements ,
Securities Fraud ,
Statutory Violations ,
Virus Testing ,
Wire Fraud
The Department of Health and Human Services Office of Inspector General (OIG) recently released a Data Brief summarizing the findings of a review of program integrity risks related to telehealth services reimbursed by...more
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
I. Biden Administration Requirement for Insurance Companies to Cover Cost of At-Home COVID-19 Tests -
On January 10, 2022, the U.S. Department of Health and Human Safety (HHS) announced that the Biden-Harris...more
1/12/2022
/ Billing ,
Coronavirus/COVID-19 ,
Employer Group Health Plans ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Infectious Diseases ,
Medical Reimbursement ,
New Regulations ,
Over The Counter Drugs (OTC) ,
Virus Testing
At the start of the COVID-19 pandemic, each state and the federal government announced various states of public health emergencies which enabled them to suspend or modify various laws, rules, and regulations to accommodate...more
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