Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
The Centers for Medicare & Medicaid Services (CMS) published an interim final rule implementing the Most-Favored-Nation (MFN) Model for Medicare Part B drugs and biologics in the November 27, 2020, Federal Register (the...more
On September 13, 2020, President Donald Trump issued an Executive Order, “Lowering Drug Prices by Putting America First,” to direct the Secretary of Health and Human Services (HHS) to implement new payment models under...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 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
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
5/22/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Domain Names ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Mobile Health Apps ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Trademarks
On April 19, 2017 a coalition of hospitals and safety-net providers, known as the 340B Coalition, submitted correspondence urging the government to implement regulations that would subject pharmaceutical manufactures to civil...more
The United States Government Accountability Office (GAO) recently released a report entitled “Medicare Part B Drugs: Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals” (“the...more
7/14/2015
/ Beneficiaries ,
GAO ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Medicare Part B ,
Physicians ,
Prescription Drug Coverage ,
Prescription Drugs ,
Section 340B