On September 10, the Health Resources and Services Administration (HRSA) announced $25.5 billion in new funding that will be made available to health care providers to reimburse health care related expenses and revenue losses...more
On December 14, 2020, the Health Resources and Services Administration (HRSA) published in the Federal Register a final regulation to implement a 340B drug pricing program administrative dispute resolution (ADR) process. The...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
The Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) has created a COVID-19 Resources page on its website providing information for 340B drug pricing program stakeholders. In particular,...more
3/25/2020
/ Audits ,
Coronavirus/COVID-19 ,
Covered Entities ,
Group Purchasing Organizations (GPO) ,
Health Care Providers ,
HRSA ,
New Guidance ,
Prescription Drug Coverage ,
Prescription Drugs ,
Public Health Emergency ,
Section 340B ,
Telehealth ,
Telemedicine
Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more
1/30/2020
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Discounts ,
Drug Pricing ,
GAO ,
Health Care Providers ,
Hospitals ,
HRSA ,
Information Reports ,
Medicaid ,
Medicare ,
Medicare Part B ,
MedPAC ,
New Guidance ,
Non-Profit Hospitals ,
Pay Reductions ,
Prescription Drugs ,
Provider Payments ,
Regulatory Agenda ,
Regulatory Oversight ,
Section 340B ,
State and Local Government
Both the House and Senate are expected to consider legislation to address high drug prices when Congress returns. Meanwhile, the Administration has faced roadblocks to several of its high-profile proposals to address drug...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