Action on 340B reform is shifting attention away from Capitol Hill and toward regulators and the courts, according to Bass, Berry & Sims attorney Jeff Davis. In an article for hfma, Jeff notes that while bipartisan lawmakers have explored major changes to the 340B Drug Pricing Program, “it’s an uphill battle in Congress to get bipartisan support to make major 340B changes,” making near-term legislative reform unlikely. As a result, the focus has moved to the Health Resources & Services Administration (HRSA) and ongoing litigation.
Jeff explains that increasing drug manufacturer restrictions and legal challenges have intensified pressure on regulators, prompting providers to press for clearer enforcement against manufacturers. “Where the focus is lying now is on HRSA activity and activity in the courts,” he said, pointing to disputes over contract pharmacies, patient eligibility, and data reporting requirements. That urgency is growing as providers call on HRSA to intervene, with Jeff observing, “You’re seeing providers calling on HRSA to take action and tell the manufacturers they’re not permitted to do that.”
The full article, “Federal 340B overhaul bill unlikely this year,” was published by hfma on April 20 and is available online.