Is there a limit on the number of times the federal government can request extensions of the 60-day period under seal to decide whether to intervene in a qui tam relator's False Claims Act (FCA) case? The appellants in U.S....more
12/6/2023
/ Abuse of Discretion ,
Appeals ,
Defense Strategies ,
False Claims Act (FCA) ,
Government Investigations ,
Medicare ,
Qui Tam ,
Relators ,
Rules of Civil Procedure ,
Statute of Limitations ,
Time Extensions ,
Tolling
This legislative session, Florida has joined Arkansas and Oklahoma among the most regulatory-minded states with respect to pharmacy benefit plans and programs as well as pharmacy benefit managers (PBMs). Florida's...more
5/19/2023
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Governor DeSantis ,
Health Insurance ,
Medicare ,
Medicare Part D ,
New Legislation ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Regulatory Reform ,
State Health Plans
Keeping track of a dizzying number of injunctions and stays by multiple federal district courts and courts of appeal involving three separate federal COVID-19 vaccination mandates with a couple exceptions is no small task....more
12/23/2021
/ Administrative Authority ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Covered Employer ,
Employer Mandates ,
Executive Orders ,
Federal Contractors ,
Federal Property and Administrative Services Act (FPASA) ,
Health Care Providers ,
Healthcare Facilities ,
Medicaid ,
Medicare ,
Order to Lift Stay ,
OSHA ,
Preemption ,
Preliminary Injunctions ,
Stays ,
Temporary Regulations ,
Vaccinations ,
Virus Testing ,
Workplace Safety
Florida healthcare providers billing federal programs may again face a complicated COVID-19 quandary. The U.S. Court of Appeals for the Eleventh Circuit has denied the state of Florida's request for an injunction against the...more
12/9/2021
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Governor DeSantis ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Interim Final Rules (IFR) ,
Medicaid ,
Medicare ,
New Legislation ,
Preemption ,
Stays ,
Vaccinations
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
10/18/2021
/ Abuse of Discretion ,
Anti-Kickback Statute ,
Appeals ,
Attorney-Client Privilege ,
Comment Period ,
Criminal Investigations ,
Discovery ,
Draft Guidance ,
Evidence ,
Failure To State A Claim ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Kickbacks ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Patient Referrals ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Scienter
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
4/28/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Jury Verdicts ,
Medicaid ,
Medical Devices ,
Medicare ,
Medtronic ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Stark Law ,
TRICARE
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
4/15/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Appeals ,
Criminal Conspiracy ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Jury Trial ,
Jury Verdicts ,
Kickbacks ,
Laboratories ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reversal ,
TRICARE
To date, there has been little consistency in how Health Insurance Portability and Accountability Act (HIPAA) requirements are enforced by the U.S. Department of Health and Human Services (HHS), or the amount of settlements...more
2/5/2021
/ Anti-Kickback Statute ,
Attorney-Client Privilege ,
Civil Monetary Penalty ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Medicare ,
PHI ,
Physicians ,
Stark Law ,
WA Supreme Court
Earlier this year, the Office of the National Coordinator for Health Information Technology (ONC) published a final rule (ONC Rule) addressing interoperability, information blocking and patient access to data. The ONC Rule...more
10/20/2020
/ 21st Century Cures Act ,
Coronavirus/COVID-19 ,
Criminal Convictions ,
Damages ,
Department of Health and Human Services (HHS) ,
Double Damages ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Information Blocking Rules ,
Kickbacks ,
Medical Devices ,
Medical Records ,
Medicare ,
ONC ,
PACT Act ,
Self-Referral ,
Willful Violations
Neurosurgeons' Compensation in Top 10 Percent Nationwide Gives Rise to Stark Act and FCA Claims -
In United States ex re. Bookwalter v. UPMC, 946 F. 3d 162 (3d Cir. 2019), the court ruled that the relators stated a Stark...more
2/25/2020
/ Americans with Disabilities Act (ADA) ,
Anti-Kickback Statute ,
Assisted Living Facilities (ALFs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Diagnostic Tests ,
DMEPOS ,
Durable Medical Equipment ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Objective Falsity ,
Ownership Interest ,
Physicians ,
Protected Activity ,
Stark Law
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
10/15/2019
/ Administrative Procedure Act ,
Affordable Care Act ,
Anti-Kickback Statute ,
Article III ,
Attorney-Client Privilege ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Convictions ,
Dismissals ,
Disproportionate Share Adjustments ,
Draft Guidance ,
Enforcement Actions ,
European Medicines Agency (EMA) ,
False Advertising ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Lanham Act ,
Medical Devices ,
Medicare ,
Patient Engagement Advisory Committee (PEAC) ,
Patient Referrals ,
Physicians ,
Prescription Drugs ,
Standing ,
Stark Law
CMS Regulation -
District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements -
The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more
7/10/2019
/ Advertising ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Commercial Speech ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Social Security Act ,
Unduly Burdensome
Regulation -
CMS Contemplating Telemedicine Changes -
The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more
9/7/2018
/ Advisory Opinions ,
Anti-Competitive ,
Anti-Kickback Statute ,
Antitrust Litigation ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Common Ownership ,
Creditors ,
Debt Collection ,
Debtors ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Exempt-Employees ,
Failed Legislation ,
Failure To State A Claim ,
False Claims Act (FCA) ,
FDCPA ,
Former Employee ,
GPOs ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
Medicare Shared Savings Program ,
OIG ,
Patients ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Physicians ,
Popular ,
Proposed Rules ,
Public Comment ,
Putative Class Actions ,
Quality Payment Program (QPP) ,
Qui Tam ,
Safe Harbors ,
Self-Referral ,
Standing ,
Stark Law ,
Summary Judgment ,
Technology Sector ,
Telehealth ,
Telemedicine ,
Whistleblowers
Enforcement -
OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor -
On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
5/30/2018
/ Adverse Action ,
Advisory Opinions ,
Affordable Care Act ,
Anti-Kickback Statute ,
Antitrust Litigation ,
Beneficiaries ,
Biosimilars ,
CMMI ,
Competition ,
Constructive Discharge ,
Department of Health and Human Services (HHS) ,
Distributors ,
Drug Pricing ,
Employer Liability Issues ,
Enforcement ,
Failure To State A Claim ,
False Claims Act (FCA) ,
FDCPA ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Kickbacks ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Request For Information ,
Section 340B ,
Sherman Act ,
Statute of Limitations
Antitrust -
FTC Announces Revised Hart-Scott-Rodino Thresholds for Acquisitions and Exclusive Licenses -
The Federal Trade Commission (FTC) has announced this year's revisions to the thresholds under the...more
2/28/2018
/ Antitrust Violations ,
Biosimilars ,
BPCIA ,
CAFA ,
Cartwright Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Eleventh Amendment ,
Enforcement Actions ,
Ex Parte ,
Exclusive Licenses ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FRCP 8 ,
FRCP 9(b) ,
Frivolous Lawsuits ,
Hart-Scott-Rodino Act ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Insurer Liability ,
Interviews ,
Medicare ,
Physicians ,
Retaliation ,
Reverse Payment Settlement Agreements ,
Unfair Competition
OIG Advisory Opinions -
Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized -
On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
9/6/2017
/ Anti-Kickback Statute ,
Anti-Steering Rules ,
Appeals ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EMTs ,
Expert Testimony ,
False Claims Act (FCA) ,
False Statements ,
Food and Drug Administration (FDA) ,
FRCP 9(b) ,
Health Care Providers ,
Health Insurance ,
Hip Replacement ,
Hospitals ,
Litigation Strategies ,
Manufacturers ,
Medicaid Reimbursements ,
Medicare ,
Medicare Part D ,
Misrepresentation ,
OIG ,
Patient Safety ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Defects ,
Qui Tam ,
Retaliation ,
Reversal ,
Witness Preparation
Prompt Payment Discounts Not an Anti-Kickback Statute Violation -
In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more
12/29/2016
/ Anti-Kickback Statute ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
False Advertising ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Form 10-K ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Hospital Mergers ,
Kickbacks ,
Long Term Care Facilities ,
Marketing ,
Medicaid ,
Medical Devices ,
Medicare ,
Off-Label Use ,
Omnicare ,
Peer Review ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Medicare Reimbursements ,
Prompt Payment ,
Qui Tam ,
Relators ,
Skilled Nursing Facility ,
Summary Judgment ,
Whistleblower Protection Policies ,
Whistleblowers
Religious institutions commonly make payments to or receive payments directly or indirectly from governmental agencies for services rendered; e.g., day cares that benefit from public scholarships, hospitals that participate...more
6/18/2015
/ Abercrombie & Fitch ,
Affordable Care Act ,
Catholic Diocese ,
Contraceptive Coverage Mandate ,
Contraceptives ,
Disparate Impact ,
Disparate Treatment ,
EBSA ,
Educational Institutions ,
EEOC v Abercrombie ,
Employment Discrimination ,
Equal Employment Opportunity Commission (EEOC) ,
False Claims Act (FCA) ,
Grants ,
Healthcare ,
Hiring & Firing ,
Housing Discrimination ,
Medicaid ,
Medicare ,
Qui Tam ,
Reasonable Accommodation ,
Religion ,
Religious Discrimination ,
Religious Institutions ,
Religious Schools ,
SCOTUS ,
Sexual Abuse ,
Sexual Assault ,
Title VII