On June 6, 2025, the Office of Inspector General (OIG) issued Advisory Opinion 25-03 (the “Opinion”), offering guidance for structuring telehealth collaborations in a manner that complies with the federal Anti-Kickback...more
7/3/2025
/ Advisory Opinions ,
Anti-Kickback Statute ,
Contract Terms ,
Health Care Providers ,
Healthcare ,
Kickbacks ,
Medicaid ,
Medicare ,
OIG ,
Safe Harbors ,
Telehealth
The 340B Drug Program requires pharmaceutical manufacturers participating in the Medicaid program to provide covered outpatient drugs at significantly reduced prices to certain health care organizations and programs, referred...more
Telehealth—the provision and coordination of healthcare remotely by means of telecommunications technology—is now an essential tool in the delivery of health care services. The COVID-19 pandemic created an incentive for...more
On July 20, 2020, the Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) issued the OPA Program Update 2020. In addition to adopting new Covered Entity registration and recertification...more
8/18/2020
/ Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Health Clinics ,
Hospitals ,
HRSA ,
Medicaid ,
Medicare ,
Office of Pharmacy Affairs (OPA) ,
Office of Pharmacy Affairs Information System (OPAIS) ,
Pharmacies ,
Prescription Drug Coverage ,
Recertification ,
Registration Requirement ,
Section 340B
The Centers for Medicare & Medicaid Services (CMS) recently revised regulations (the "Regulations") for the Programs of All-Inclusive Care for the Elderly (PACE), making significant changes to ownership restrictions,...more