This Diagnosing Health Care episode examines the fraud and abuse enforcement landscape in the telehealth space and considers ways telehealth providers can mitigate their enforcement risks as they move into the new year. Hear...more
This Diagnosing Health Care episode dives into the key business operations and legal considerations for reshoring active pharmaceutical ingredient (or “API”) and finished drug product manufacturing to the United States. The...more
10/13/2020
/ 3D Printing ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Foreign Manufacturers ,
Generic Drugs ,
Offshoring ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reshoring ,
Supply Chain ,
Tax Credits
In this Diagnosing Health Care episode, hear how the government’s fraud and abuse enforcement priorities have shifted as a result of the COVID-19 pandemic and how compliance programs must also pivot to mitigate new risks. The...more
8/6/2020
/ Compliance ,
Coronavirus/COVID-19 ,
Corporate Misconduct ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Qui Tam ,
Relators ,
Risk Mitigation
On March 22, 2020, the U.S. Food and Drug Administration (“FDA”) issued guidance, for immediate implementation, that aims to increase the availability of ventilators and other respiratory devices needed to address the...more
On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02, approving an arrangement under which a pharmaceutical manufacturer provides...more
1/30/2020
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Civil Monetary Penalty ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Manufacturers ,
New Guidance ,
OIG ,
Patient Assistance Programs ,
Patient Safety ,
Pharmaceutical Industry
As addressed in a previous Epstein Becker Green (“EBG”) Client Alert, earlier this summer, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a “request for information” (“RFI”) regarding...more
Employers in the technology, media, and telecommunications industry continue to face numerous workplace management and compliance challenges under changing laws. From evolving mandates regarding benefits and momentum toward...more
On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more
On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more
On March 25, 2014, the U.S. District Court for the District of Minnesota held that a magnetic resonance imaging ("MRI") provider, a lay entity (i.e., not owned or controlled by physicians), did not violate the state's...more
A significant barrier to the interstate practice of telehealth is closer to being broken down. The Federation of State Medical Boards ("FSMB") recently completed and distributed a draft Interstate Medical Licensure Compact...more