Precision Lens Pays $12 Million to Resolve FCA and AKS Violations -
Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more
8/5/2024
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Fraud ,
Healthcare ,
Insurance Fraud ,
Kickbacks ,
Medicare ,
Reimbursements ,
Settlement ,
Stark Law ,
Telemarketing ,
Whistleblowers
Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more
7/31/2024
/ Anti-Kickback Statute ,
Beneficiaries ,
Bring Your Own Device (BYOD) ,
But For Causation ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement ,
Fair Market Value ,
False Claims Act (FCA) ,
Health Insurance ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Oral Argument ,
Physician Compensation Arrangements ,
Policies and Procedures ,
Portability ,
Settlement ,
Stark Law ,
TRICARE ,
Valuation
Previously, we discussed how the US Supreme Court’s opinion in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce could create opportunities for private litigants to challenge health...more
7/30/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Loper Bright Enterprises v Raimondo ,
Payment Systems ,
Regulatory Agenda ,
SCOTUS ,
Secretary of HHS ,
Stark Law
Federal Court Dismisses $680 Million FCA Suit -
On July 23, a Maryland federal judge, Ellen L. Hollander, dismissed a $680 million False Claims Act (FCA) suit that was previously revived by the US Supreme Court. The suit...more
The US Supreme Court recently overturned its ruling in Chevron USA, Inc. v. Natural Resources Defense Council, Inc., changing the landscape for federal agency rulemaking and actions, particularly in the health care industry....more
Texas Pharmaceutical Marketer Sentenced for $59 Million Medications Fraud Conspiracy -
On July 12, Quintan Cockerell, a Texas pharmaceutical marketer, was sentenced to over two years in prison and ordered to pay more than...more
7/22/2024
/ Conspiracies ,
False Claims Act (FCA) ,
Fraud ,
Hospice ,
Kickbacks ,
Medicaid ,
Medicare ,
Paycheck Protection Program (PPP) ,
Prescription Drugs ,
Sentencing ,
Settlement
DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing -
On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...more
7/15/2024
/ Anti-Kickback Statute ,
Assisted Living Facilities (ALFs) ,
Controlled Substances Act ,
Department of Justice (DOJ) ,
False Billing ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fraud ,
Medicare ,
Opioid ,
Prescription Drugs ,
Rite Aid ,
Settlement
Health Care Fraud and Money Laundering of $18 Million Leads to Prison Sentence for New York Pharmacy Owners -
Two pharmacy owners from New York have been sentenced for using their pharmacies to submit fraudulent claims to...more
Teva and DOJ May Reach Settlement in Closely Watched AKS Lawsuit -
On June 16, Teva Pharmaceuticals filed a request with the First Circuit Court of Appeals seeking to hold in abeyance its interlocutory appeal concerning...more
6/24/2024
/ Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Fraud ,
Interlocutory Appeals ,
Kickbacks ,
Money Laundering ,
Sentencing ,
Settlement ,
Teva Pharmaceuticals ,
Vaccinations ,
Wire Fraud
Chicago Laboratory Owner Charged with Defrauding Medicare in $60 Million COVID-19 Test Kit Scheme -
The Chicago-based owner of two laboratories, Zoom Labs Inc. and Western Labs Co., has been charged with health care fraud...more
6/17/2024
/ Chronic Care Managment (CCM) ,
Coronavirus/COVID-19 ,
Damages ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
HRSA ,
Kickbacks ,
Medicaid ,
Medicare ,
Medicare Fraud ,
Penalties ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
TRICARE ,
Uninsured Patients
District Court Declines to Stay Case Pending Resolution of FCA Causation Standard Issue Before Court of Appeals -
Earlier this week, a Massachusetts federal judge denied a motion to stay proceedings filed by Medtronic,...more
6/10/2024
/ Anti-Kickback Statute ,
Appeals ,
Causation ,
Criminal Convictions ,
Cryptocurrency ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare Fraud ,
Mail Fraud ,
Ponzi Scheme
Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...more
3/15/2024
/ American Medical Association ,
Centers for Medicare & Medicaid Services (CMS) ,
Cyber Attacks ,
Cybersecurity ,
Health Care Providers ,
Healthcare ,
Insurance Industry ,
Medicare Part B ,
Payment Systems ,
Policies and Procedures ,
Popular ,
Prescription Drug Coverage ,
Prescription Drugs ,
Ransomware
As those in the reproductive health space scramble to keep up with the ever-changing landscape of mifepristone (Mifeprex) access, it seems that every party must have their say.
The last three months have seen updates from...more
With the approval of the modified mifepristone Risk Evaluation and Mitigation Strategy (REMS), it has been a momentous few weeks in the reproductive health legal space.
Modification to the REMS for Mifepristone...more
With the new year underway, the ArentFox Schiff Health Care team highlights 10 of the most pressing legal issues facing the industry in 2023.
End of the COVID-19 Public Health Emergency. After being in effect for more than...more
2/17/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Inflation Reduction Act (IRA) ,
No Surprises Act (NSA) ,
Popular ,
Proposed Rules ,
Public Health Emergency ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Telehealth
On November 18, 2022, a collection of organizations and providers that oppose abortion filed suit against the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS), seeking — among...more
Most violations of the Health Information Portability and Accountability Act (HIPAA) are addressed through administrative enforcement action. But, in some circumstances of improper conduct affecting the privacy or security of...more
A pair of reports recently issued by the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) highlight the important role telehealth services have played in ensuring access to medical...more
9/21/2022
/ Beneficiaries ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Fee-for-Service ,
Fraud ,
Medicare ,
Medicare Advantage ,
OIG ,
Public Health Emergency ,
Telehealth
On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that...more
8/1/2022
/ Anti-Kickback Statute ,
Bribery ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement ,
False Claims Act (FCA) ,
Fraud ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare Fraud ,
OIG ,
Telehealth ,
Telemedicine
Beginning January 1, 2022, all state licensed or certified health care facilities and providers must follow extensive rules for providing a "good faith estimate" of health care charges to uninsured and self-pay patients prior...more
Makes Permanent Telehealth Behavioral Health Rules -
CMS published the 2022 Physician Fee Schedule Final Rule on November 2, 2021. The Rule keeps intact CMS’s temporary physician supervision requirements related to the...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.
...more
3/3/2021
/ 21st Century Cures Act ,
Anti-Kickback Statute ,
Bonuses ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Commercially Reasonable Efforts ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Fair Market Value ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Profit Sharing ,
Safe Harbors ,
Stark Law ,
Value-Based Care
Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more
2/17/2021
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Digital Health ,
DMEPOS ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Manufacturers ,
Medical Devices ,
OIG ,
Safe Harbors ,
Stark Law ,
Technology ,
Value-Based Care
As part of its recent rulemaking process, the Centers for Medicare and Medicaid Services (CMS) finalized a new exception to the Physician Self-Referral Law (the Stark Law) to protect arrangements where limited remuneration is...more
Lawmakers remain in negotiations among the three key committees in the House of Representatives: Energy & Commerce, Ways & Means, and Education & Labor, along with the Senate Committee on Health, Education, Labor and Pensions...more