In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead.
Hear from a dynamic group of...more
In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead....more
Last June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy, which holds that the Seventh Amendment entitles a defendant to a jury trial when the Securities and Exchange Commission (SEC)...more
1/17/2025
/ Administrative Law Judge (ALJ) ,
Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
SCOTUS ,
SEC v Jarkesy ,
Securities and Exchange Commission (SEC) ,
Securities Fraud
Like most industries, the health care sector is grappling with the uses of artificial intelligence (AI) and what AI means for the future. At the same time, many health care companies already have integrated algorithms and AI...more
2/13/2024
/ Algorithms ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Medicare Advantage ,
Natural Language Processing ,
Popular ,
Qui Tam ,
Whistleblowers
After the Department of Justice (“DOJ”) announced its Civil Cyber-Fraud Initiative in October 2021, many in the False Claims Act (“FCA”) bar expected an onslaught of enforcement actions and qui tam cases. The initiative...more
2/12/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
Enforcement ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Fraud ,
Regulatory Standards ,
Risk Assessment ,
Securities and Exchange Commission (SEC) ,
Settlement
From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human...more
2/13/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
OIG ,
Overpayment ,
Policies and Procedures ,
Regulatory Requirements ,
Self-Disclosure Requirements
For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more
4/29/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Department of the Interior ,
Enforcement Actions ,
Enforcement Authority ,
FBI ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medical Billing Codes ,
Medicare ,
OIG ,
Provider Relief Fund ,
Telemedicine ,
USPS
A few weeks ago, we posted about a publication by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) of responses to certain frequently asked questions (FAQs) received from the health...more
On Friday, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued responses to a series of frequently asked questions (FAQs), in an effort to provide some level of regulatory...more
Nearly one year ago, on January 25, 2018, the Department of Justice’s (DOJ) Regulatory Reform Task Force issued a memorandum entitled “Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases.” Many...more
1/8/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances Act ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Litigation Strategies ,
OIG ,
Opioid ,
Physicians ,
Regulatory Requirements
Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more
12/31/2015
/ Aetna ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CIGNA ,
CLIA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
OIG ,
PAMA ,
Stark Law
Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees...more
8/4/2015
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Leased Employees ,
Management Agreements ,
Medicaid ,
Medicare ,
OIG ,
Patient Referrals