Members of the industry should be on the lookout for proposed rules related to this Order and take advantage of all public comment periods.
The White House issued an executive order “Ensuring Essential Medicines, Medical...more
The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more
7/31/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
FQHC ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Public Safety ,
Safe Harbors
The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and...more
A HHS Final Rule for Exchange plans states that coupons and copay cards offered directly by drug manufacturers can be counted towards a patient’s annual cost-sharing limit.
The Department of Health and Human Services (HHS)...more
In what has been considered a huge win for community pharmacists, the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) issued an Advisory Opinion on May 19, 2020.
The Advisory...more
On March 11, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a voluntary model within the Medicare Part D program that would allow certain Part D plans to cap Medicare beneficiaries’ out-of-pocket costs for...more
On March 10, 2020 the Centers for Medicare & Medicaid Services released a memo to Medicare Advantage Organizations and Part D Sponsors to inform them of their obligations and permissible flexibilities related to disasters and...more
The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more
3/9/2020
/ Call Letter ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Cost-Sharing ,
Health Care Providers ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Reporting Requirements
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
2/3/2020
/ Anti-Kickback Statute ,
Criminal Penalties ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Electronic Medical Records ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare Fraud ,
Investigations ,
Kickbacks ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Software ,
Whistleblowers
Home Health Care Employees Plead Guilty in Multi-Million Dollar Medicaid Fraud Scheme -
Two individuals pled guilty in Pennsylvania federal court to conspiracy to defraud the Pennsylvania Medicaid program and commit...more
1/24/2020
/ Anti-Kickback Statute ,
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 ,
Home Health Agencies ,
OIG ,
Whistleblowers
DOJ News -
Manufacturer to Pay Over $37.5 Million to Resolve False Claims Act Allegations -
On January 15, 2015, the DOJ announced that ResMed Corp., a manufacturer of durable medical equipment, agreed to pay over...more
1/20/2020
/ Anti-Kickback Statute ,
Clinical Trials ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Indictments ,
Misrepresentation ,
Physicians ,
Qui Tam ,
Settlement ,
Tax Deductions ,
Tax Fraud ,
Tax Returns ,
Whistleblowers
Headlines that Matter for Companies and Executives in Regulated Industries -
DOJ News -
Government Intervenes Against Integrated Health Care System in False Claims Act Suit-
The Department of Justice (the DOJ)...more
Omnicare and CVS Face Fraudulent Billing Lawsuit -
On Tuesday, the US Attorney’s Office for the Southern District of New York announced a False Claims Act lawsuit against Omnicare, Inc. and its parent company, CVS Health...more
12/20/2019
/ CVS ,
Department of Justice (DOJ) ,
Dismissals ,
False Claims Act (FCA) ,
Government Investigations ,
Medicaid ,
Medicare ,
Medicare Part D ,
Omnicare ,
Pharmacies ,
Prescription Drugs ,
Rite Aid ,
State Attorneys General ,
TRICARE ,
Whistleblowers
Ten Former NFL Players Charged with Defrauding League's Health Care Benefits Plan -
On December 12, the DOJ unsealed two indictments charging ten retired NFL players with defrauding the league's retiree health care...more
12/18/2019
/ Administrative Monetary Penalties ,
Athletes ,
Corporate Monitoring ,
Criminal Conspiracy ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Ericsson ,
Foreign Corrupt Practices Act (FCPA) ,
Fraud ,
Healthcare Fraud ,
Indictments ,
IRS ,
Medical Equipment ,
NFL ,
Offshore Funds ,
Price Manipulation ,
Prison ,
Pump and Dump ,
Restitution ,
Sentencing ,
Sports ,
Tax Avoidance ,
Tax Fraud
Defense Vehicle Manufacturer Accused of Defrauding the Government by $1.2 Billion -
On Tuesday, December 3, the United States District Court for the District of Columbia unsealed a six-year-old False Claims Act complaint...more
12/9/2019
/ Anti-Kickback Statute ,
Clinical Laboratory Testing ,
Criminal Prosecution ,
Defense Sector ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Guilty Pleas ,
Healthcare Fraud ,
Manufacturers ,
Medicaid ,
Medicare ,
Settlement ,
Stark Law ,
TRICARE ,
United Auto Workers
Headlines that Matter for Companies and Executives in Regulated Industries -
Kentucky Hospital Agrees to Pay $10 Million to Resolve False Claims Act Allegations -
Jewish Hospital & St. Mary’s Healthcare Inc. d/b/a...more
11/25/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Compounding ,
Drug Testing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Laboratories ,
Medicaid ,
Medicare ,
Pharmacies ,
Prescription Drugs ,
Settlement
Delays inclusion of the US territories under the Medicaid Drug Rebate Program until April 1, 2022 -
CMS issued an Interim Final Rule that further delays the inclusion of the US territories in the definitions of “States”...more
Compound Ingredient Supplier to Pay Over $22 Million to Resolve Allegations Brought Under Qui Tam Provisions of FCA -
On November 7, 2019, the Department of Justice (DOJ) announced that Fagron Holding USA LLC (Fagron) had...more
11/18/2019
/ Alstom ,
Civil Monetary Penalty ,
Corporate Officers ,
Criminal Convictions ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Healthcare Fraud ,
Insider Trading ,
Medicare ,
Qui Tam ,
TRICARE ,
Whistleblowers
Third Circuit Holds False Claims Act Relator Lacks Standing and Right to Intervene in Related Criminal Case -
In a matter of first impression, the Third Circuit held last week that a relator who filed an action under the...more
11/8/2019
/ Alternate Remedy ,
Annual Reports ,
Antitrust Violations ,
Criminal Antitrust Litigation ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
DOJ Strike Force ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Motion to Dismiss ,
Motion To Intervene ,
Public Procurement Policies ,
Qui Tam ,
Relators ,
Securities and Exchange Commission (SEC) ,
Standing ,
Subsequent Litigation ,
Tax Crimes
Kickback Allegations Settled for $20.25 Million -
Sanford Health, Sanford Medical Center, and Sanford Clinic (collectively, Sanford), a South Dakota health system, will pay $20.25 million to settle allegations that they...more
Former Drugstore Executive Receives Two-Year Sentence, Ordered to Pay $6.3 Million for Kickback Scheme -
A Pennsylvania federal judge sentenced a former Rite-Aid advertising executive to two-years imprisonment and ordered...more
10/29/2019
/ Criminal Convictions ,
Criminal Prosecution ,
False Claims Act (FCA) ,
HUBZone ,
Indictments ,
Insider Trading ,
JPMorgan Chase ,
Kickbacks ,
Market Manipulation ,
Rare Earth Metals ,
Restitution ,
Rite Aid ,
SBA ,
Securities and Exchange Commission (SEC) ,
State Contractors ,
Wire Fraud
DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases -
On October 8, 2019, Assistant Attorney General Brian Benczkowski announced new guidance for federal prosecutors evaluating whether a corporation is unable...more
10/21/2019
/ Corporate Criminal Fines ,
Corporate Misconduct ,
Criminal Investigations ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Sentencing Guidelines ,
Healthcare Facilities ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
New Guidance ,
Prescription Drugs
Genetic Testing Company and Three Principals Settle FCA Allegations for $42.6 Million -
On October 9, 2019, New Orleans-based laboratory company UTC Laboratories Inc. (RenRX) agreed to pay $41.6 million, and its three...more
Late Friday, September 27, 2019, President Trump signed the Fair and Accurate Medicaid Pricing Act into law as part of the Continuing Appropriations Act....more
Nissan and its Former CEO Settle Charges for Fraudulently Concealing More than $140 Million in Compensation and Retirement Benefits -
This week, the Securities and Exchange Commission (SEC) announced a settlement with...more
9/30/2019
/ Anti-Kickback Statute ,
Bribery ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Insider Trading ,
Opioid ,
Patient Referrals ,
Securities and Exchange Commission (SEC) ,
Settlement ,
Stark Law ,
Travel Act