Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more
11/3/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Cost-Sharing ,
Fraud and Abuse ,
Generic Drugs ,
Health Care Providers ,
Medicare ,
Medicare Part D ,
OIG ,
Out-of-Pocket Expenses ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Subsidies
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Draft Guidance ,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
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
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
Florida Governor Ron DeSantis recently signed House Bill 369, Chapter No. 2019-159, Laws of Florida, which became effective on July 1, 2019. The primary focus of the bill relates to substance abuse services. For example, the...more
7/3/2019
/ Anti-Kickback Statute ,
Certification Requirements ,
Exceptions ,
Governor DeSantis ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
New Legislation ,
Patients ,
Substance Abuse ,
Supervisors
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
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
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