On May 17, 2021, the Health Resources and Services Administration (HRSA) sent letters to six drug manufacturers notifying them that their actions placing restrictions on access to 340B-discounted drug prices by health care...more
Members of Congress of both parties are requesting that the Department of Health and Human Services (HHS) take action to ensure that providers participating in the 340B drug pricing program can continue to receive discounted...more
The Health Resources and Services Administration (HRSA) has issued guidance eliminating a longstanding enforcement position that delayed the ability of hospitals participating in the 340B drug pricing program to use...more
Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more
12/13/2018
/ Affordable Care Act ,
Civil Monetary Penalty ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
Health Care Providers ,
Hospitals ,
HRSA ,
Manufacturer Liability ,
Office of Pharmacy Affairs Information System (OPAIS) ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more
10/25/2018
/ Audits ,
Corrective Actions ,
Covered Entities ,
Drug Pricing ,
Eligibility ,
Guidance Update ,
Health Care Providers ,
HRSA ,
Manufacturers ,
Pharmacies ,
Prescription Drugs ,
Provider Payments ,
Registration Requirement ,
Section 340B ,
Self-Disclosure Requirements
The Government Accountability Office (GAO) issued a report on June 28, 2018 regarding federal oversight of compliance at 340B program contract pharmacies. The 340B drug pricing program requires drug manufacturers to sell...more