On October 20, 2023, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an unfavorable Advisory Opinion No. 23-08 to a supplier of cochlear implants coupled with external sound...more
Operators and managers of assisted living facilities (“ALFs”) and skilled nursing facilities (“SNFs”) have been dealt a tremendous responsibility to ensure the safety and welfare of their residents during the COVID-19...more
Every year, health lawyers, providers, consultants, and government experts from across the country convene in Baltimore for the American Health Lawyers Association’s Institute on Medicare and Medicaid Payment Issues, the most...more
House Bill 198, proposed this year to amend Georgia’s Certificate of Need (“CON”) laws, has failed to garner the necessary votes in the House, missing the crucial Crossover Day deadline needed to pass the legislation. In...more
On August 17, 2018, the Centers for Medicare and Medicaid Services (CMS) published its final rule for the Hospital Inpatient Prospective Payment System (IPPS) for fiscal year 2019. ...more
On June 14, 2018, the Office of the Inspector General (OIG) issued an advisory opinion regarding a proposed contractual arrangement between offerors of Medicare Supplemental Health Insurance policies, commonly referred to as...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
A recent Senate bill would lift the ban on expansion of physician-owned hospitals imposed by the Patient Protection and Affordable Care Act (PPACA). Senator James Lankford (R-OK) introduced this bill on May 16, 2017. 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
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
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