New Florida legislation, Senate Bill 768 (2023), amending the Patient Self-Referral Act of 1992 (the Act), also known as the Florida "mini-Stark law," has been signed by Gov. Ron DeSantis and is set to take effect on July 1,...more
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Draft Guidance ,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
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
The Emergency Medical Treatment & Labor Act (EMTALA) requires a hospital with an emergency department (ED) to provide "an appropriate medical screening examination" when an individual comes to the ED and a request is made on...more
8/7/2018
/ EMTALA ,
False Claims Act (FCA) ,
Health Insurance ,
Hospitals ,
Medicaid ,
Medicare ,
Motion to Dismiss ,
Patients ,
Physicians ,
Qui Tam ,
Whistleblowers
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
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
Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more
10/19/2016
/ Arbitration ,
Arbitration Agreements ,
Centers for Medicare & Medicaid Services (CMS) ,
Contract Terms ,
Department of Health and Human Services (HHS) ,
Ethics ,
Federal Arbitration Act ,
Health Care Providers ,
Healthcare ,
Long Term Care Facilities ,
Long-Term Care ,
Medicaid ,
Medicare ,
Nurse Practitioners ,
OIG ,
Patients ,
Policies and Procedures ,
Privacy Concerns ,
Privacy Policy ,
Quality Assurance Programs ,
Regulatory Standards ,
Right to Privacy ,
Skilled Nursing Facility ,
Social Media ,
Social Security Act ,
Technology
The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more
9/29/2015
/ Audits ,
Compliance ,
Covered Entities ,
Dental Practice ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
Healthcare ,
Hospice ,
Hospitals ,
HRSA ,
MCOs ,
Medicaid ,
Medicaid Reimbursements ,
Medical Reimbursement ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Skilled Nursing Facility
Long-term care companies in Florida need to dust off their regulatory compliance plans to see if updates are needed in light of several bills that passed during the regular legislative session of 2015. If they are signed by...more
5/28/2015
/ Assisted Living Facilities (ALFs) ,
Biologics ,
Continuing Care Retirement Communities ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hospitals ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Nursing Homes ,
Ombudsman ,
Skilled Nursing Facility ,
Vaccinations
The U.S. Department of Health and Human Services' Office of Inspector General (OIG) issued a new Special Fraud Alert on June 25, 2014, that focuses on certain compensation arrangements between laboratories and referring...more