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
The U.S. Health Resources and Services Administration (HRSA) published a final rule (the Rule) on December 14, 2020, which outlined the requirements and procedures for the 340B pharmacy program's administrative dispute...more
1/7/2021
/ Administrative Proceedings ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Filing Requirements ,
Final Rules ,
HRSA ,
Manufacturers ,
Office of Pharmacy Affairs (OPA) ,
Pharmacies ,
Section 340B
As detailed in a press release from the U.S. Department of Health and Human Services (HHS), "Metropolitan Community Health Services, doing business as Agape Health Services (Metro), has agreed to pay $25,000 to the U. S....more
8/27/2020
/ Compliance ,
Compliance Monitoring ,
Corrective Action Plans (CAPs) ,
Covered Entities ,
Electronic Protected Health Information (ePHI) ,
Failure To Implement ,
FQHC ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
OCR ,
Risk Assessment ,
Risk Management ,
Settlement
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
A HIPAA Business Associate ("Business Associate") is an individual or entity who performs or furnishes activity or service for or on behalf of a HIPAA Covered Entity ("Covered Entity") involving the use or disclosure of...more