On January 4, 2023, the Department of Justice issued a press release stating that Jet Medical Inc. has agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment. Jet Medical and two...more
1/12/2023
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Manufacturers ,
Medical Billing Codes ,
Medical Devices ,
Medicare ,
Physician Medicare Reimbursements ,
Settlement
The COVID-19 Public Health Emergency (PHE) is expected to prompt unprecedented levels of regulatory enforcement activity that is focused on the use of telemedicine. In fact, fraudulent and abusive telehealth practices was an...more
7/16/2021
/ Audits ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Privacy ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FQHC ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
OIG ,
Public Health Emergency ,
Relief Measures ,
Rural Health Care Providers ,
Telehealth
On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more
7/9/2021
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Group Purchasing Organizations (GPO) ,
Manufacturers ,
Medical Devices ,
Medicare ,
OIG ,
Open Payments ,
Prescription Drugs ,
Sunshine Act
The Centers for Medicare & Medicaid Services (CMS) issued updated guidance on the thresholds that Applicable Manufacturers and Group Purchasing Organizations are required to report annually under the Sunshine Act (42 U.S.C. §...more
11/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Consumer Price Index ,
Covered Recipients ,
Data Collection ,
Department of Justice (DOJ) ,
Group Purchasing Organizations (GPO) ,
Manufacturers ,
Nurse Practitioners ,
Open Payments ,
Physicians ,
Social Security Act ,
Sunshine Act
In February, the Department of Justice (DOJ) successfully leveraged a new weapon to target pharmacies as it battles the nation’s opioid crisis. The new approach utilizes court-ordered temporary restraining orders (TROs) that...more
4/3/2019
/ Controlled Substances ,
DEA ,
Department of Justice (DOJ) ,
License Suspensions ,
Opioid ,
Order to Show Cause ,
Pharmacies ,
Preliminary Injunctions ,
Prescription Drugs ,
Substance Abuse ,
TRO
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS