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
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Draft Guidance ,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
4/15/2021
/ 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
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
Several recent cases concern challenges to executive orders relating to COVID-19 limiting the ability of churches to assemble and imposing other limitations. Beginning with appellate decisions, these cases are summarized in...more
7/17/2020
/ Abortion ,
Appeals ,
Churches ,
Coronavirus/COVID-19 ,
Executive Orders ,
Fiduciary Duty ,
Free Exercise Clause ,
Governor Cooper ,
Governor Newsom ,
Governor Northam ,
Governor Pritzker ,
Governor Sisolak ,
Health Insurance ,
Injunctions ,
Operators of Essential Services ,
Public Health Emergency ,
Religious Freedom Restoration Act (RFRA) ,
Religious Institutions ,
SCOTUS ,
Shelter-In-Place ,
South Bay United Pentecostal Church v Newsom ,
Vicarious Liability
The U.S. Supreme Court ruled 7-2 in Our Lady of Guadalupe School v. Morrissey-Berru, Nos. 19-267 and 19-348 (July 8, 2020), that the First Amendment ministerial exception doctrine bars courts from entertaining an age or...more
7/13/2020
/ Age Discrimination ,
Appeals ,
Disability Discrimination ,
Employment Discrimination ,
First Amendment ,
Freedom of Religion ,
Ministerial Exception ,
Our Lady of Guadalupe School v Morrissey-Berru ,
Religious Schools ,
Reversal ,
SCOTUS ,
Teachers
Regulation -
FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat -
On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more
12/24/2018
/ Americans with Disabilities Act (ADA) ,
Appeals ,
Beverage Manufacturers ,
Biotechnology ,
Brand ,
Breweries ,
Class Action ,
Comment Period ,
Consent Agreements ,
Constitutional Challenges ,
Copyright ,
Dismissals ,
Dormant Commerce Clause ,
Due Process ,
Equal Protection ,
EU ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Intellectual Property Litigation ,
Interstate Commerce ,
Joint Statements ,
Local Ordinance ,
Misrepresentation ,
New Legislation ,
NLEA ,
Preemption ,
Public Comment ,
Putative Class Actions ,
Regulatory Oversight ,
Remand ,
Restaurant Industry ,
Reversal ,
Summary Judgment ,
Trademark Registration ,
Trademarks ,
USDA ,
Vacated ,
Website Accessibility
Key Cases -
Establishment Challenge to Presidential Proclamation Subject to Rational Basis Review -
In Trump v. Hawaii, 138 S.Ct. 2392 (2018), the U.S. Supreme Court ruled 5-4 that the lowest level of constitutional...more
9/26/2018
/ Appeals ,
Breach of Contract ,
Churches ,
Confessions ,
Constitutional Challenges ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Dismissals ,
Employment Contract ,
Employment Discrimination ,
Establishment Clause ,
Fair Employment Practices Act ,
Federal Agency Taskforce ,
First Amendment ,
Foreign Nationals ,
Freedom of Religion ,
Health and Safety ,
Immigration and Nationality Act ,
Immunization Exemptions ,
Merger Agreements ,
Mergers ,
Motion to Dismiss ,
Muslims ,
National Security ,
Personal Belief Exemption ,
Police ,
Prayer ,
Priests ,
Protective Orders ,
Public Accommodation ,
Religious Discrimination ,
Religious Freedom Restoration Act (RFRA) ,
Religious Institutions ,
RLUIPA ,
School Districts ,
Sexual Abuse ,
Students ,
Subject Matter Jurisdiction ,
Subpoenas ,
Summary Judgment ,
Title VII ,
Trump Administration ,
Trump v Hawaii ,
US Department of State ,
Zoning Laws
Wage and Hour -
Decision Upholds Class Action Waivers in Arbitration Clauses, Resolves Circuit Split -
The U.S. Supreme Court issued a long-awaited decision in Epic Systems Corp. v. Lewis on May 21, 2018, holding that...more
6/12/2018
/ Age Discrimination ,
Agricultural Sector ,
Americans with Disabilities Act (ADA) ,
Appeals ,
Arbitration ,
Arbitration Agreements ,
Baby Products ,
Banks ,
Beverage Manufacturers ,
Breweries ,
Business Torts ,
Class Action ,
Class Action Arbitration Waivers ,
Competition ,
Consumer Protection Laws ,
Cybersecurity ,
Data Breach ,
Data Security ,
Debit and Credit Card Transactions ,
Department of Labor (DOL) ,
Disability Discrimination ,
Dismissals ,
Distributors ,
Economic Loss Doctrine ,
Epic Systems Corp v Lewis ,
Equal Employment Opportunity Commission (EEOC) ,
Failure To State A Claim ,
Fair Labor Standards Act (FLSA) ,
False Advertising ,
False Statements ,
Federal Arbitration Act ,
Financial Institutions ,
Food Labeling ,
Food Manufacturers ,
Former Employee ,
FTC Act ,
Grocery Stores ,
Hackers ,
Hiring & Firing ,
Lanham Act ,
Menu-Labeling ,
Misleading Statements ,
Negligence ,
Nutrition Facts Labels ,
Organic ,
Over-Time ,
Personal Information Protection Act ,
Personally Identifiable Information ,
Popular ,
Preemption ,
Product Packaging ,
Putative Class Actions ,
Reasonable Accommodation ,
Regulatory Agenda ,
Remand ,
Restaurant Industry ,
Retailers ,
Reversal ,
Rulemaking Process ,
Savings Clause ,
SCOTUS ,
Standing ,
State Law Claims ,
Summary Judgment ,
Unfair or Deceptive Trade Practices ,
USDA ,
Wage and Hour
Since 1990, the U.S. Supreme Court has expressly construed a neutral law of general applicability as consistent with the free exercise clause. Deeming Colorado's public accommodations law just such a law, the Colorado Court...more
6/8/2018
/ Administrative Agencies ,
Americans with Disabilities Act (ADA) ,
Anti-Discrimination Policies ,
Appeals ,
Churches ,
Colleges ,
Defamation ,
Dismissals ,
Equal Employment Opportunity Commission (EEOC) ,
Establishment Clause ,
Fair Labor Standards Act (FLSA) ,
Fiduciary Duty ,
First Amendment ,
Free Exercise Clause ,
Free Speech ,
Funeral Homes ,
Hiring & Firing ,
Historic Preservation ,
Hospitals ,
LGBTQ ,
Masterpiece Cakeshop Ltd v Colorado Civil Rights Commission ,
Minimum Wage ,
New Rules ,
Preliminary Injunctions ,
Priests ,
Private Sector ,
Property Owners ,
Public Accommodation ,
Public Funds ,
Race Discrimination ,
Religious Discrimination ,
Religious Freedom Restoration Act (RFRA) ,
Religious Institutions ,
Restaurant Industry ,
Retaliation ,
Reversal ,
Same-Sex Marriage ,
SCOTUS ,
Sex Discrimination ,
Sexual Stereotyping ,
Summary Judgment ,
Teachers ,
Title VII ,
Transgender ,
Trump Administration ,
Trustees ,
Trusts ,
Universities ,
Unpaid Wages ,
Wage and Hour ,
Writ of Prohibition
A South Florida court of appeal compelled arbitration against a nursing home in a negligence lawsuit after upholding a severability clause despite an unenforceable cap on non-economic damages and prohibition on punitive...more
3/12/2018
/ AHLA ,
Appeals ,
Arbitration ,
Arbitration Agreements ,
Burden of Proof ,
Limitation of Liability Clause ,
Negligence ,
Non-Economic Damages ,
Nursing Homes ,
Public Policy ,
Punitive Damages
Timely Topics -
By Shannon B. Hartsfield -
The U.S. Department of Health and Human Services (HHS) announced on Jan. 18, 2018, the creation of a new division within its Office for Civil Rights (OCR). OCR is described as...more
1/29/2018
/ Abortion ,
Affordable Care Act ,
Appeals ,
Assisted Suicide ,
BOLI ,
Breach of Contract ,
Catholic Church ,
Charter Schools ,
Church Plans ,
Churches ,
Contraceptive Coverage Mandate ,
Defamation ,
Department of Health and Human Services (HHS) ,
Employee Benefits ,
Employee Retirement Income Security Act (ERISA) ,
Establishment Clause ,
Executive Orders ,
Federal Funding ,
Federal Housing Administration (FHA) ,
Fees ,
First Amendment ,
Fourteenth Amendment ,
Freedom of Religion ,
Hospitals ,
Injunctive Relief ,
Interim Final Rules (IFR) ,
Internet ,
Medicaid ,
New Guidance ,
Nonprofits ,
OCR ,
Preliminary Injunctions ,
Priests ,
Proposed Rules ,
Public Accommodation ,
Public Health Service Act ,
Race Discrimination ,
Religious Discrimination ,
Religious Exemption ,
Religious Freedom Restoration Act (RFRA) ,
Religious Institutions ,
Religious Schools ,
Retirement Plan ,
RLUIPA ,
Same-Sex Marriage ,
Sexual Conduct ,
Sexual Orientation Discrimination ,
Summary Judgment ,
Trump v Hawaii ,
USCIS ,
Vetting
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
Timely Topics -
A draft executive order of President Donald Trump relating to religious freedom proposes several material changes to federal law. First, it would require the executive branches to recognize a broad scope...more
2/9/2017
/ Appeals ,
Assisted Suicide ,
Charitable Donations ,
Church Plans ,
Constitutional Challenges ,
Contraceptive Coverage Mandate ,
Disparate Impact ,
Employee Retirement Income Security Act (ERISA) ,
Establishment Clause ,
Executive Branch ,
First Amendment ,
Free Exercise Clause ,
Freedom of Religion ,
ISIS ,
Ministerial Function ,
Pensions ,
Religious Discrimination ,
Religious Displays ,
Religious Expression ,
Religious Institutions ,
Religious Schools ,
Retirement Plan ,
RLUIPA ,
Same-Sex Marriage ,
Tax Exempt Entities ,
Taxable Income ,
Terrorist Threats ,
Title VII ,
Trump Administration ,
Zoning Laws
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 keep ministry supporters and members abreast of developments through newsletters, correspondence and other communications. Sometimes, the developments reported are embarrassing to those...more
5/21/2015
/ Affordable Care Act ,
Appeals ,
CFOs ,
Contraceptive Coverage Mandate ,
Defamation ,
Establishment Clause ,
False Statements ,
First Amendment ,
Gender Discrimination ,
Religious Freedom Restoration Act (RFRA) ,
Religious Institutions ,
Religious Schools ,
RLUIPA ,
Scholarships ,
Sex Discrimination ,
Sexual Harassment ,
Tax Credits ,
Title VII