The 2015 340B Coalition Annual Summer Conference, held July 13-15 in Washington, D.C., was bigger than ever this year, with over 1300 attendees, 60% of whom were from covered entities across the United States. Hudson Headwaters participated in its dual roles — as a community health center, and as a management services vendor. We enjoyed speaking with all who stopped by our booth, meeting so many new people interested in the 340B program and catching up with friends and clients.
Once again, this year’s conference was all about compliance. In every panel discussion and breakout session the message was clear: compliance lies with the covered entity. OPA Deputy Director Michelle Herzog emphasized covered entity responsibility during a HRSA Update panel, stating “Compliance starts at registration.” The highest priority for HRSA continues to be program integrity. HRSA plans to conduct 200 audits by the end of September, Herzog reported, and hopes to begin audits of manufacturers in 2015. Herzog discussed the possibility of stricter guidelines for manufacturers including potential manufacturer recertification.
Herzog also discussed the new “track and trace” legal requirements, noting that HRSA is meeting regularly with the FDA to address implications this policy has on the 340B program. She commended those covered entities that have reached out to the FDA with their concerns and encouraged everyone to “stay tuned.”
Another hot topic at this year’s conference was specialty drugs. Spending on specialty drugs is predicted to quadruple by 2020. It has become increasingly difficult for covered entities to purchase specialty drugs due to issues of accessibility and financial impact. Managing specialty drugs requires ongoing patient education and coaching, and sometimes requires sophisticated coordination of care. Additionally, there are challenges in terms of reimbursement and coordination of benefits, potentially requiring the use of specialty distribution.
And there was more. The “21st Century Cures” bill passed with no 340B-specific provisions, meaning increased potential for sustained government interest in the program. As covered entities, we need to be prepared for changes associated with this piece of legislation. The focus appears to be on greater consistency within the 340B program. In preparation for legislative changes, keep these key points in mind: one, be able to demonstrate how your entity is using the program to benefit patients; two, carefully consider who benefits from your 340B program, particularly in contract pharmacy arrangements; and three, focus on program compliance.
As a covered entity as well as management service provider, Hudson Headwaters has a unique perspective, and a wealth of experience that can be put to your entity’s advantage. In addition to management services, we offer independent auditing and consulting services. Compliance lies with you, but we’re here to help. Don’t wait until HRSA is knocking at your door to prepare your entity for a potential audit. Ensure your program compliance now. Give us a call, or shoot us an email. We want your program to be the best it can be.
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