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
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Draft Guidance ,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
Thomas Stephenson Winter ex rel. U.S. v. Gardens Reg'l. Hosp. and Med. Ctr., Inc., 953 F.3d 1108 (9th Cir. 2020), the court of appeals reversed a district court order dismissing the plaintiff's qui tam False Claims Act (FCA)...more
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
CMS Regulation -
CMS and ONC Unveil Proposals Transforming Interoperability and Patient Access to Data -
The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health...more
3/1/2019
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Electronic Health Record Incentives ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
ONC ,
Opioid ,
Proposed Rules
Regulation -
OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor -
On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more
12/20/2018
/ Advisory Opinions ,
Americans with Disabilities Act (ADA) ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
EPSDT ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medical Devices ,
Medicare Advantage ,
Notice of Proposed Rulemaking (NOPR) ,
OIG ,
Protected Class ,
Remuneration ,
Safe Harbors ,
Screening Procedures ,
Telemedicine ,
Unfair or Deceptive Trade Practices
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
Deceptive Trade Practices -
Meat Exporter Had No Duty Under FCA to Pay for Beef Inspection -
In United States ex rel. Barrick v. Parker-Migliorini Int'l, LLC, 878 F. 3d 1224 (10th Cir. 2017), the court affirmed...more
2/20/2018
/ Agricultural Workers ,
All Natural ,
Arbitration ,
Arbitration Agreements ,
Beverage Manufacturers ,
Breach of Warranty ,
Class Certification ,
Class Members ,
Conditional Certification ,
Court Appearances ,
Credit Card Surcharges ,
Double Damages ,
Economic Loss Doctrine ,
Email ,
Equal Protection ,
Exporters ,
Fair Labor Standards Act (FLSA) ,
False Claims Act (FCA) ,
False Statements ,
Farms ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Former Employee ,
FSMA ,
GMO ,
Hiring & Firing ,
Hospitality Industry ,
Independent Contractors ,
Inspections ,
Liquidated Damages ,
Minimum Wage ,
Misleading Statements ,
Misrepresentation ,
Motion to Dismiss ,
Negligent Misrepresentation ,
Non-Solicitation Agreements ,
Notice Requirements ,
Opt-In ,
Over-Time ,
Qui Tam ,
Restaurant Industry ,
Retailers ,
Rule 9(b) ,
Sherman Act ,
State Labor Laws ,
State Law Claims ,
Summary Judgment ,
Tip Credit ,
Tip-Pooling ,
Unfair or Deceptive Trade Practices ,
Unlawful Trade Practices Acts ,
USDA ,
Wage and Hour ,
Wage Statements
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
Medicaid -
Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law -
By Eddie Williams -
In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more
6/7/2017
/ Anti-Kickback Statute ,
Antitrust Violations ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
DSM ,
Enforcement Actions ,
Failure To Warn ,
False Claims Act (FCA) ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medicaid Act ,
Misrepresentation ,
Noerr-Pennington Doctrine ,
OCR ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmacies ,
Preemption ,
Prescription Drugs ,
Sherman Act ,
Stark Law ,
Third-Party Liability ,
Unfair or Deceptive Trade Practices ,
Warning Labels
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