Managing a 340B program isn't difficult because the rules are ambiguous. It's difficult because the rules are clear, the stakes are significant, and the organizational infrastructure most covered entities have built around the program was never designed to carry that weight. The compliance burden lives...
340B compliance in 2026 demands more than enrollment and policy documentation. Covered entities must maintain real-time oversight of patient eligibility, contract pharmacy arrangements, and audit-ready documentation. All under intensified HRSA scrutiny. Organizations treating compliance as a periodic exercise rather than a continuous operational function are...
Timing in 340B compliance isn't about how fast you move. It's about whether you're moving on the right issue at the right moment. Programs that overreact to every regulatory update exhaust their teams on non-issues. Programs that delay on known internal gaps hand HRSA the...