In the third and final episode of Florida Capital Conversations' healthcare privacy series, Tallahassee attorneys Shannon Hartsfield and Eddie Williams join hosts Nathan Adams and Mia McKown to discuss the challenges of...more
Fired Pastor's Ousting During Church Service Did Not Violate His Free Exercise Rights Anthony J. Sirven In Couzens v. City of Forest Park, Ohio, 114 F.4th 571, 574 (6th Cir. 2024), church leaders hired off-duty municipal...more
11/4/2024
/ Anti-Discrimination Policies ,
Churches ,
Constitutional Challenges ,
Free Exercise Clause ,
Free Speech ,
Gay Conversion Therapy ,
Health Care Providers ,
Hiring & Firing ,
Human Rights Act ,
Ministerial Exception ,
Nonprofits ,
Public Accommodation ,
Public Schools ,
Religion ,
Religious Freedom Restoration Act (RFRA) ,
Retaliation ,
Sexual Orientation ,
State Constitutions ,
Title IX ,
Title VII ,
TX Supreme Court
Florida enacted Senate Bill (SB) 264 (Chapter 2023-33, Laws of Florida) in May 2023 to limit select persons from "foreign countries of concern" from owning, having a controlling interest in or acquiring an interest in certain...more
1/2/2024
/ Beneficial Owner ,
China ,
Commercial Leases ,
Commercial Property Owners ,
Controlling Stockholders ,
Critical Infrastructure Sectors ,
Cuba ,
EB-5 ,
Foreign Nationals ,
Health Care Providers ,
Iran ,
New Legislation ,
North Korea ,
Real Estate Investments ,
Registration Requirement ,
Residential Property Owners ,
Rulemaking Process ,
Russia ,
State Contractors ,
Syria ,
Venezuela
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
The executive and judicial branches do not see eye-to-eye on the scope of PREP Act immunity. The U.S. Department of Health and Human Services (HHS), under the current administration, has taken umbrage at how lower courts have...more
1/15/2021
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Fourth Amendment ,
Health Care Providers ,
Immunity ,
Infectious Diseases ,
Liability ,
Preemption ,
Public Health Emergency ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Vaccinations
The Public Readiness and Emergency Preparedness Act, Public Law 109-148, Div. C, ยง 2 (2005) (PREP Act), as amended, authorizes the Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to...more
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
One year's probation is the sentence for a physician who violated the Health Insurance Portability and Accountability Act (HIPAA) and obstructed a criminal investigation in United States v. Luthra, No. 18-1980, 2020 WL...more
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
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 -
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
Enforcement -
OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals -
On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more
3/27/2017
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Centers for Medicare & Medicaid Services (CMS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Free Health-Related Services ,
Health Care Providers ,
Health Insurance ,
Hospital Mergers ,
Hospitals ,
Market Allocation Scheme ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Safe Harbors ,
Sherman Act ,
Unfair or Deceptive Trade Practices ,
Value-Based Purchasing
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
Timely Topics -
The Internal Revenue Service (IRS) issued on Dec. 17, 2015, a memorandum instructing its examiners not to conduct employment tax audits of churches without getting in touch with a high-ranking Treasury...more
If the Internal Revenue Service (IRS) had a moratorium on enforcing ยง501(c)(3) electioneering restrictions against churches and religious organizations, the IRS states that it has been lifted incident to the settlement and...more
8/7/2014
/ 501(c)(3) ,
Audits ,
Charitable Donations ,
Churches ,
Electioneering ,
Employee Retirement Income Security Act (ERISA) ,
Health Care Providers ,
IRS ,
Religious Institutions ,
Retirement Plan ,
Settlement ,
Tax Exempt Entities