On May 13, 2019, the U.S. House of Representatives Energy and Commerce Committee proposed draft legislation banning surprise medical bills, also known as balance bills, through a cap on any out-of-network charges. ...more
With the introduction of RACs, ZPICs, and UPICs, the administrative process for Medicare payment disputes has resulted in three to five year delays in adjudicating claims while providers are faced with almost certain...more
On Friday, September 14, 2018, U.S. District Judge Steven Merryday for the Middle District of Florida sentenced Dr. John Janick of Port Charlotte to five months in prison and three years of supervised release, plus...more
On June 22, 2018, a years-long dispute culminated with the Texas Supreme Court finding that Healthcare Partnership, a subsidiary of Xerox, the former fiscal agent contractor for the Texas Medicaid program, was solely...more
On January 22, 2018, Senate Bill 321, sponsored by Sen. Blake Tillery (R-Vidalia), was heard in Georgia’s Senate Committee on Judiciary. This bill seeks to increase the amount of civil monetary penalties for false or...more
On January 11, 2018, the United States District Court for the Middle District of Florida set aside a nearly $350 million False Claims Act (FCA) jury verdict rendered in February 2017 against a group of fifty-three skilled...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
On October 5, 2017, in United States of America ex rel. Swoben v. Scan Health Plan, et al. (“Swoben”), Judge John F. Walter of the United States District Court for the Central District of California granted United Health...more
On August 16, 2017, the Centers for Medicare and Medicaid Services (CMS) released the Hospice Compare website. This website joins a variety of other CMS “Compare” websites – including Inpatient Rehabilitation Facility...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
8/18/2017
/ Cosmetics ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On July 13, 2017, the Department of Justice, in conjunction with the Department of Health and Human Services, announced the largest series of health care charges in American history. The government charged 412 individuals,...more
On July 18, 2017, the Government Accountability Office (GAO) issued a follow-up report entitled “Update on Agency Efforts to Improve 340B Program Oversight.” In its initial report in 2011, the GAO highlighted the inherent...more
In this year’s legislative session, members of Georgia’s House and Senate attempted to pass legislation on “surprise billing” for healthcare consumers. This proposed legislation sought to establish notice and disclosure...more
On January 17, 2017, the Department of Health and Human Services (HHS) released a Final Rule announcing a three-prong appellate process change in an effort to decrease the growing Medicare appeals backlog at the...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
8/23/2016
/ 510(k) RTA ,
Advertising ,
Draft Guidance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
LabMD ,
Medical Devices ,
Pharmaceutical Industry ,
Social Media ,
Software
On June 30, 2016, the Department of Justice published an Interim Final Rule adjusting for inflation the civil monetary penalties arising from violations of the False Claims Act (FCA). Currently, civil monetary penalties range...more
On July 21, 2016, two former executives of Acclarent, Inc., a medical device company owned by Johnson & Johnson, Inc., were found guilty of ten misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA), following a...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
5/20/2016
/ Abbreviated New Drug Application (ANDA) ,
App Developers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Medical Foods ,
OIG ,
Pharmaceutical Industry ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
On April 19, 2016, the United States Supreme Court heard oral arguments in a hotly anticipated False Claims Act (FCA) case: Universal Health Services, Inc. v. United States ex rel. Escobar. The Court will decide whether the...more
This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more