What’s Changing in 340B: Key Developments for Covered Entities in 2027

The HRSA rebate pilot is the most significant change on the horizon, with potential impacts to how entities receive their 340B savings. It initially covers 17 drugs - a list that was recently reduced - but expect it to grow in future years.

• The drug is bought at wholesale acquisition cost (WAC), a dramatically higher price.
• Then, the covered entity has 45 days to submit data for a rebate.
• The manufacturer has ten days after a completed submission to pay a rebate equal to WAC minus the 340B price.

The model raises two concerns. First, it requires fronting the full cost of expensive drugs, which strains cash flow for smaller organizations. Second, it shifts much of the power to decide whether a claim qualifies from providers to manufacturers.

However, the pilot's path to launch is also far from settled. HRSA released ten approved manufacturer rebate plans on Oct. 1, and within days, lawmakers and hospitals moved to stop or delay the program. On Oct. 9, a bipartisan group of lawmakers introduced a new bill - the 340B Rebate Model Delay Act - which would delay the pilot until Dec. 31, 2028. The same day, the American Hospital Association (AHA), the Maine Hospital Association, and four hospitals filed a complaint in the U.S. District Court in Maine to strike down the pilot. The group also filed a motion for a temporary restraining order to halt the pilot before Jan. 1, 2027.

This isn't the first round. The same Maine court blocked HRSA's original rebate pilot from taking effect on Jan. 1, 2026 after a lawsuit from the same two associations and three of the same hospitals, leading to HRSA withdrawing that pilot and unveiling a revamped version. The new complaint argues HRSA violated administrative law by underestimating the pilot's administrative and financial burdens on covered entities. According to the hospitals, HRSA dismissed providers' concerns while accepting manufacturers' claims at face value.

For now, Jan. 1. 2027 remains the start date. A court order or new law could change that, but covered entities should plan as if the pilot will launch on schedule and should stay ready to adjust if it doesn't.