The 2016 340B Coalition Summer Conference was held July 11th-13th in Washington, DC. With well over 1,400 attendees, the event was the largest 340B national conference to date. Health care providers, contract pharmacies, pharmaceutical manufacturers, vendors, and other stakeholders were all in attendance to hear the latest news and to find out what to expect in the near future.
The Hudson Headwaters 340B Pharmacy Services Team was in attendance. We presented at the conference, attended many informative sessions, and enjoyed interacting with current and prospective clients at our booth. Vice President, Jim Donnelly, was a moderator in a pre-conference workshop focused on 340B essentials and Business Development Manager, Kim Barron, presented our first-hand 340B experience, focused primarily on 340B best practices and shared our perspective on current 340B developments during a Vendor Perspectives Session.
Compliance was again the main concern of many of those who presented and visited our booth. Since 2012, HRSA has been attentive in making improvements and protecting the integrity of the program. To date, 585 audits have been completed and HRSA is on track to complete 200 covered entity audits this year.
The proposed Mega Guidance is now targeted for publication in December 2016. It still remains unclear if the document will be updated based on the comments received from all stakeholders or if it will be released as initially published. Captain Pedley addressed one concern surrounding “materiality”. Many of those in attendance and who submitted comments feared they would have to make significant changes to processes in reporting non-compliance to manufacturers. She communicated that it is not HRSA’s intent to change “materiality” in the proposed Mega Guidance. Covered entities should still have policies and procedures specific to “materiality” in determining whether to report non-compliance to manufacturers.
As expected, Specialty Drugs remained a hot topic at the conference. Specialty drugs account for less than 2% of all prescriptions, however, they make up more than 30% of spending on all prescription drugs. New projections estimate that specialty drug spending will comprise more than 50% of total drug spending by 2018. Not surprisingly, the number of Specialty Pharmacies exhibiting at the conference grows each year. While covered entities can certainly benefit from such contract pharmacy arrangements, it is important to note that prescriber and patient education can make or break a specialty pharmacy arrangement.
Additional comments included the final rule on civil monetary penalties and 340B ceiling price, which is expected in November 2016. And, as at previous conferences, covered entities were once again encouraged to communicate with HRSA, Primary Care Associations and other stakeholders to continue to uphold and protect program integrity.
Our goal as a participating Covered Entity and Vendor is to collaboratively protect the integrity of the program through preparation for upcoming program reform. Interested in protecting program integrity? Reach out to learn more about our services and how Hudson Headwaters 340B Pharmacy Services can help you meet your goals. Give us a call (855-835-340B) or send an email (340Bsolutions@hhhn.org). We’re in this together, so let’s do it right.