On January 10, 2020, the U.S. Government Accountability Office (GAO) released a report (the Report) analyzing HRSA’s oversight of 340B eligibility requirements for nongovernmental hospitals. The Report concludes that HRSA…
HRSA announced that it has awarded Apexus LLC the prime vendor contract again after a competitive bid process. Apexus has been the 340B Prime Vendor since 2004. The contract term…
Last week, Apexus published a tool which states for the first time HRSA’s policy that all non-FQHC federal grantees are required to register each of their off-site locations as separate…
On October 9, 2019, the White House issued two executive orders with potential implications on HRSA’s ability to enforce its sub-regulatory guidance, including its patient definition, against covered entities. In…
340B Health reports that Capt. Krista Pedley, the Director of OPA, stated last week at the Medicaid Drug Rebate Conference that OPA is reevaluating its enforcement of 340B program guidance…
The Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting for November 13, 2019, 8:30…
In June 2018, Genesis Health Care, Inc., an FQHC in South Carolina, filed a lawsuit challenging its removal from the 340B program. HRSA removed Genesis from the 340B program following…
On July 9, 2019, HRSA issued an Information Collection Request (ICR) announcing that it would be embarking on a two year study entitled, “Assessing Care and Health Outcomes Among RWHAP…
On July 8, 2019, RWC-340B submitted a comment letter in response to the HRSA Information Collection Request (ICR) published in the Federal Register on May 9, 2019. In the ICR,…
On June 18, 2019, HRSA issued an information collection request (ICR) regarding the guidelines for manufacturer audits of 340B covered entities and the OPA informal dispute resolution process to resolve…