The Food and Drug Administration (“FDA”) has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand. On February 21, 2025, the FDA updated...more
According to a federal district judge in Mississippi, a cancer center’s investors bought themselves a lawsuit because of a conscious decision not to structure the ownership arrangement in compliance with a safe harbor. A...more
On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.” This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more
9/19/2024
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Healthcare ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Stark Law ,
Statutory Interpretation
The Office of the National Coordinator for Health Information Technology (ONC) and the HHS Office for Civil Rights (OCR) have recently launched a joint HIPAA Security Risk Assessment (SRA) Tool. The tool is designed to assist...more
Two False Claims Act (“FCA”) cases have recently been decided by the United State Supreme Court, further clarifying one aspect of the FCA. In the recent decisions in U.S. ex rel Proctor v. Safeway, Inc. and U.S. ex rel....more
7/21/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Whistleblowers
Fraud enforcement actions by the United States Department of Justice (USDOJ) continue to rise against companies and individuals related to their applications for and receipt of COVID-19 benefits. It appears that no type of...more
Telemedicine saw a dramatic increase during the COVID-19 pandemic. A recent study from the U.S. Department of Health and Human Services (HHS), released in December 2021, showed an increase in Medicare telemedicine visits...more
9/14/2022
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medical Reimbursement ,
Medicare ,
OIG ,
Patient Access ,
Telehealth ,
Telemedicine
AMA Provides a No Surprises Tool-Kit -
As most health care providers know by now, the No Surprises Act (NSA) prohibits out-of-network health care providers from balance billing commercially insured patients, in certain...more
7/25/2022
/ Criminal Convictions ,
Data Management ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
HIPAA Privacy Rule ,
OCR ,
Opioid ,
Patient Privacy Rights ,
PHI ,
Prescription Drugs ,
Reproductive Healthcare Issues ,
Ruan v United States ,
SCOTUS ,
Surprise Medical Bills
Prosecutions related to the submission of claims to Tricare for compounded pain creams continue. The Eleventh Circuit Court of Appeals affirmed convictions against a Florida pharmacist, physician, and Navy veteran for their...more
6/20/2022
/ Anti-Kickback Statute ,
Criminal Prosecution ,
Drug Compounding ,
Enforcement Actions ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Indictments ,
Kickbacks ,
Military Service Members ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
TRICARE
HELPFUL HINTS -
The Federal No Surprises Act The Federal No Surprises Act (the “Act”) became fully effective on January 1, 2022. The Act protects enrollees in group and individual market plans (including ERISA plans) and...more
1/25/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Biden v Missouri ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Healthcare Workers ,
Infectious Diseases ,
Mental Health ,
National Federation of Independent Business v Department of Labor and OSHA ,
New Legislation ,
OIG ,
OSHA ,
Surprise Medical Bills ,
Vaccinations
On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) announced additional measures to provide home health agencies (“HHA”) greater flexibility when treating patients during the National Emergency....more
Effective March 23, 2020, the Alabama Board of Medical Examiners (“ABME”), adopted emergency rules to provide for the issuance of emergency certificates of qualifications for physicians, physician assistants and...more
In response to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) has significantly expanded access to telehealth services for Medicare beneficiaries....more
On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). EKRA is part of the “Support for Patients and Communities Act,” comprehensive legislation designed to address the opioid crisis. ...more
Some very important and potentially game-changing legislation was recently passed. On Oct. 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (or EKRA) – a statute that potentially eliminates legal...more
Anthem, Inc., the country’s second largest insurer has agreed to pay $16 million to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) and take corrective action to settle potential violations...more
11/13/2018
/ Anthem Insurance ,
Cyber Attacks ,
Data Breach ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Hackers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
OCR ,
Personally Identifiable Information ,
Settlement Agreements
With the continued proliferation of qui tam False Claims cases showing no signs of slowing down, not only must providers consider the amount of any monetary settlements, they must also consider whether the Office of Inspector...more
On March 28, 2018, Alabama adopted a data privacy law, the Alabama Data Breach Notification Act of 2018 (SB318). While Alabama is one of the last states to adopt such an act, the Act is notable in its requirements, and...more
On June 2, 2017, Anderson, S.C.-based AnMed Health and the Department of Health and Human Services Office of Inspector General entered into the largest settlement under the Emergency Medical Treatment and Labor Act...more
According to the United States Government, fraud and abuse recovery has an excellent return for each investment dollar spent. According to the Health Care Fraud and Abuse Control (HCFAC) Program Report,released by the...more
2/16/2017
/ Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Obstruction of Justice ,
OIG ,
Physicians ,
Settlement ,
Unjust Enrichment
Doctors must educate themselves and particularly their staff on the legal obligations to protect the confidentiality of medical records and how to properly respond to subpoenas and requests for patients’ health information....more
The Supreme Court decided Universal Health Services v. U.S. ex rel. Escobar on June 16, 2016 in which it ruled the implied false certification theory, previously recognized in several circuits, can form the basis for False...more
9/7/2016
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Health Care Providers ,
Healthcare Fraud ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Medicaid ,
Mental Health ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers
In an effort to review and examine compliance with the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations ("HIPAA"), the Department of Health and Human Services Office for Civil...more
The Department of Health and Human Services’ (HHS) Center for Medicare and Medicaid Services (CMS) published its final rule on Friday, February 12, 2016. The final rule clarifies two key sections of the often described 60-Day...more
With the increase of Qui Tam lawsuits alleging violations of the federal False Claims Act ("FCA"), it is important to understand that FCA liability maybe predicated on whether the alleged wrongful act violated a condition of...more