Regulators need to provide a clearer direction for the 22-year-old federal program that provides drug discounts to safety net hospitals, researchers argued in a new paper.
The RAND Corp. said the so-called 340B program faces uncertainty when it comes to eligibility and transparency that pose challenges to healthcare providers and drug companies.
"Policymakers need a clear, objective description of the 340B program and the challenges it faces on the road ahead,” said Andrew Mulcahy, the report’s lead author, in a statement.
"There are increasingly divergent views on the program’s purpose and the role it should play in supporting safety net providers."
The study comes as the Health Resources and Services Administration develops additional regulations to shape the 340B program.
The agency issued a rule last month allowing hospitals to continue to use the program to purchase "orphan drugs" more cheaply.
RAND said regulators must consider how best to determine eligibility for the program, and how to address record-keeping challenges that resulted from the "orphan drug" rule.