The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently published a new resource titled General Compliance Program Guidance (“GCPG”), which is described as a reference guide for the...more
AGG’s Home Health & Hospice team publishes a quarterly newsletter covering legal and regulatory topics specific to the home and community-based healthcare industry. The fields of end-of-life and home healthcare present...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup 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
A new California law – Assembly Bill 1278, which was signed by the Governor on September 29, 2022 – requires physicians to provide patients with notice of the federal Open Payments database. The federal Open Payments program...more
The United States District Court for the Southern District of New York recently rejected Pfizer’s request for a declaration that its co-pay program would not violate the Anti-Kickback Statute (“AKS”). The case is Pfizer Inc....more
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
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
In August 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced an updated and enhanced PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code)....more
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
Since the April 2013 effective date of the Final Rule implementing the “National Physician Payment Transparency Program: Open Payments” (also known as the federal “Sunshine Law”), CMS has been annually collecting information...more
Over the past few months, several clients have alerted us to the delayed or discontinued status of their clinical trials due to the COVID-19 pandemic. Studies typically conducted in physicians’ offices, clinics, or hospitals...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 and highlights articles from members of AGG outside the Food and Drug practice....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 and highlights articles from members of AGG outside the Food and Drug practice....more
We received a number of questions from pharmaceutical and medical device clients over the past several months regarding how to continue “Lunch and Learn” programs for healthcare professionals during the COVID-19 pandemic....more
CMS previously issued a notice on March 9, 2020, emphasizing a hospital’s ongoing duties to provide appropriate medical screening exams (MSE) to individuals presenting to an emergency department (ED) of a hospital pursuant to...more
Extraordinary times call for extraordinary measures – this is the approach the Centers for Medicare and Medicaid Services (“CMS”) has taken with respect to the federal Physician Self-Referral Law (the “Stark Law”) by issuing...more
CMS Announces Hospice Capitation Rates for Medicare Advantage -
The U.S. Centers for Medicare and Medicaid Services (CMS) recently released the capitation rates for hospice care through the value-based insurance design...more
On March 9, 2020, CMS issued a memorandum to State Survey Agency Directors regarding the implications of COVID-19 on providers’ EMTALA obligations. ...more
Novel coronavirus (“2019-nCoV”, also known as “SARS-CoV-2”) and the disease it causes – “coronavirus disease 2019” (abbreviated as “COVID-19”) has garnered significant public attention since being declared a Public Health...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
The “National Physician Payment Transparency Program: Open Payments” requires certain manufacturers of drugs, devices and certain other products to disclose annually to the Centers for Medicare and Medicaid Services (CMS)...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 April 4, 2019, the Department of Justice (DOJ) announced settlements with three pharmaceutical companies, Jazz Pharmaceuticals plc (Jazz), Lundbeck LLC (Lundbeck), and Alexion Pharmaceuticals (Alexion), related to...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
In a letter dated March 19, 2019, U.S. Senate Finance Committee Chairman Chuck Grassley of Iowa and Ranking Member Ron Wyden of Oregon wrote to the Department of Health and Human Services (HHS) Office of Inspector General...more