I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed to major changes in how the 340B Program operates. However, the HRSA audits had limited effect, the court invalidated the Orphan Drug Rule, and the reverberations of the Orphan Drug litigation killed the 340B mega-regulation.
January 2018 began with a new 340B reimbursement rule and new litigation over that rule posing a very real threat to how hospitals use 340B drugs. Then Congress issued a formal Report on legislative and regulatory modifications needed in the 340B Program. Will 2018 finally be the game-changing year for 340B? Continue Reading This Year May be a Game Changer for 340B Drug Discount Program, Take Two