HRSA Audit Results Reveal Manufacturer Overcharges
On January 28, 2020, HRSA posted results of its 340B Program audit of four pharmaceutical manufacturers in fiscal year 2019. Three of the four audited manufacturers were found to have…
MedPAC Finds No Clear Link Between 340B Program and Increased Drug Spend
On January 17, 2020, the Medicare Payment Advisory Commission (MedPAC) held its first meeting of the year, including a session discussing a report requested by the House Energy and Commerce…
GAO Issues Report Criticizing HRSA Oversight of Nongovernmental Hospitals
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 Awards Prime Vendor Agreement to Apexus
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…
CMS Issues Informational Bulletin on State Duplicate Discount Practices
On January 8, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an Informational Bulletin (Bulletin) outlining CMS’s view of current “best practices” by states to avoid 340B duplicate…
DC Circuit Rules on 340B Medicare Advantage Discriminatory Reimbursement Case
The federal appeals court for the District of Columbia Circuit recently ruled in favor of the Humana Medicare Advantage plan in a case by a 340B covered entity contending that…
Apexus Publishes Tool for Grantee Combined Purchasing and Distribution Requests
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…
AIR340B Releases Updated Study on Charity Care Rates at 340B Hospitals
Earlier this month, the Alliance for Integrity and Reform of 340B (“AIR340B”), a national advocacy group funded largely by pharmaceutical companies, released an update to their previous reports on charity…
New All-Agency Executive Orders May Undermine 340B Guidance
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…
OPA Reevaluates 340B Program Policies
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…