With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year....more
The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more
12/27/2023
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Inflation Adjustments ,
Inflation Reduction Act (IRA) ,
Infrastructure Investment and Jobs Act (IIJA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Rebates ,
Section 340B ,
Supply Chain ,
Supply Shortages
The Internal Revenue Service (IRS) has issued guidance on the pharmaceutical excise tax that may apply to certain drug manufacturers, producers, and importers that fail to negotiate a drug-pricing agreement with the US...more
The Centers for Medicare & Medicaid Services (CMS) has issued its annual final rules related to both the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for calendar year 2023 (the HOPPS...more
After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more
8/23/2022
/ Abbreviated New Drug Application (ANDA) ,
American Rescue Plan Act of 2021 ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Inflation Reduction Act (IRA) ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
New Legislation ,
Prescription Drugs ,
Section 340B
The Centers for Medicare & Medicaid Services (CMS) published the proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the Proposed Rule) on...more
1/27/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Fees ,
Medical Loss Ratio ,
Medicare ,
Medicare Advantage ,
Medicare Modernization Act ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Rebates ,
Social Security Act
The United States Supreme Court has agreed to hear a case that has a direct impact on the 340B Drug Discount Program (the 340B Program) and how Medicare will reimburse hospitals for dispensing of 340B covered drugs, as well...more
With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more
2/1/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Final Rules ,
Government Agencies ,
Healthcare Fraud ,
Healthcare Reform ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Reimbursements
The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more
11/18/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Fraud ,
Health Care Providers ,
Medicaid ,
Medical Devices ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Remuneration ,
Speaker Programs ,
TRICARE
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
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
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
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
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
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
34 Individuals Charged in $258 Million Medicare and Medicaid Fraud Schemes -
Twenty-six individuals in the state of California, fourteen of whom were doctors or medical professionals, and eight individuals in Arizona and...more
9/23/2019
/ Anti-Kickback Statute ,
Controlled Substances ,
Criminal Conspiracy ,
Criminal Convictions ,
Criminal Prosecution ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Facilities ,
Hospitals ,
Kickbacks ,
Medicaid ,
Medicare ,
Pharmacies ,
Prescription Drugs ,
Private Equity Firms ,
Stark Law
NY Ambulette Owners Plead Guilty to $8.6 Million Health Care Kickback Scheme -
On September 5, the Department of Justice announced that two New York ambulette owners pleaded guilty to one count of conspiracy to offer and...more
9/13/2019
/ Anti-Kickback Statute ,
Deferred Prosecution Agreements ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Guilty Pleas ,
Insider Trading ,
Kickbacks ,
Medicare ,
Securities and Exchange Commission (SEC) ,
Whistleblowers
Medical Device Exec Sentenced to 42 Months in Prison for $4.6 Million Kickback Scheme, Co-Conspirator Awaits Sentencing -
On August 29, the Department of Justice announced that a Tennessee health care executive, Brenda...more
9/9/2019
/ Anti-Kickback Statute ,
Bribery ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Pharmacies ,
Prison ,
SBA ,
TRICARE
Whistleblower Collects on Cybersecurity FCA Case -
On July 31, 2019, Cisco Systems agreed to pay $8.6 million in civil damages to settle claims that it sold video surveillance technology with known security flaws to several...more
Telemarketing Business Agrees to Pay $2.5 Million to Settle FCA Allegations of Telemedicine Scheme -
The US Attorney’s Office for the Middle District of Florida, in collaboration with the US Attorney’s Office for the...more
8/12/2019
/ Department of Justice (DOJ) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Indictments ,
Kickbacks ,
Medicare ,
Physicians ,
Settlement ,
Telemarketing