2023 was a busy year across several federal agencies in terms of issuing compliance guidance for corporations, including health care companies. For example, the Department of Justice (DOJ) issued significant compliance...more
2/15/2024
/ American Bar Association (ABA) ,
Clawbacks ,
Compensation ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
New Guidance ,
OIG ,
Risk Management ,
White Collar Crimes
Government enforcement activities focused on tele-fraudsters remained active in 2023, but did not break substantial new ground. Several significant criminal resolutions last year involved allegations that were similar to each...more
Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more
10/4/2023
/ Advisory Opinions ,
Billing ,
Carve Out Provisions ,
Clinical Laboratories ,
Competition ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Physicians ,
Risk Management
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
During a recent panel discussion hosted virtually by the American Bar Association, attorneys from the Department of Justice (DOJ) and certain U.S. Attorneys’ Offices known for health care fraud enforcement provided valuable...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
As many of our readers know, as a result of the public health emergency caused by COVID-19, effective March 1, 2020, the U.S. Department of Health and Human Services (“HHS”) issued blanket waivers of its authority under...more
Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray. Subsys is powerful and highly...more
6/26/2019
/ Chapter 11 ,
Commercial Bankruptcy ,
Corporate Integrity Agreement ,
Deferred Prosecution Agreements ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Executive Compensation ,
False Claims Act (FCA) ,
Guilty Pleas ,
Healthcare ,
Kickbacks ,
OIG ,
Qui Tam ,
Racketeering
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
Earlier this week, the Office of Inspector General for the Department of Health and Human Services (“OIG”) posted its fiscal year (“FY”) 2016 data about Medicaid Fraud Control Units (“MFCUs”) across the country....more
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
Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more
2/26/2013
/ Anti-Kickback Statute ,
Compliance ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Durable Medical Equipment ,
Enforcement ,
False Claims Act (FCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Fraud ,
Healthcare ,
Home Health Care ,
Medicare ,
Off-Label Promotion ,
OIG ,
Pharmaceutical Industry ,
Whistleblowers