In the wake of the global pandemic, which forced manufacturers, trade organizations, and all other players in the health care industry to rethink how to provide medical education and communication on new product offerings to...more
In a highly watched case relating to the ability of pharmaceutical manufacturers to support patient copay assistance, the Southern District of New York recently denied Pfizer’s request for a declaratory judgment that two...more
I. Introduction -
While 2020 was a year like no other in many ways, the challenges posed by the global COVID-19 pandemic do not appear to have stalled the Department of Justice’s (DOJ) health care fraud enforcement...more
2/3/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
OIG ,
Telemedicine
Telemedicine providers – whether they are established or new to the space – should examine the type of conduct DOJ has recently focused on and adapt their compliance systems accordingly. Providers should also consider the...more
Why It Matters -
In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more
10/7/2020
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Electronic Health Record Incentives ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Machine Learning ,
OCR ,
Security Risk Assessments
As the world’s health care facilities grapple with the devastating and unexpected operational struggles brought by COVID-19, nursing homes and long-term care facilities face the added challenge of protecting their residents...more
The initiation of a government investigation is often a stressful and anxiety-producing event for a health care company. The Department of Justice (DOJ) is known for its aggressive investigation and prosecution of health care...more
9/9/2019
/ Civil Liability ,
Compliance Management Systems ,
Cooperative Compliance Regime ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Internal Controls ,
Third-Party ,
Whistleblowers