Hudson Headwaters made its first public appearance as a 340B vendor at the National 340B Coalition Conference in Washington, DC. July 14 -16. Hundreds of conference participants stopped by the booth to discuss the current 340B environment and inquire about what Hudson Headwaters Pharmacy Services team brings to the market. It was great to meet new folks, and to see so many of our current clients there.
A predominant tone of this year’s conference was related to the tension between PhRMA (Pharmaceutical Research and Manufacturers of America) and SNHPA (Safety Net Hospitals for Pharmaceutical Access).
PhRMA believes there is a lack of firm guidance at the federal level. In their view, it creates a situation with “no guardrails” to prevent the program from uncontrolled growth, with applications being approved that are inconsistent with the program’s intent. PhRMA also believes the DSH (Disproportionate Share Hospital) metric currently used for determining a safety-net hospital’s 340B eligibility is a flawed as it relates to serving vulnerable populations in their communities.
SNHPA strongly disagrees with PhRMA’s perceived disconnect between the DSH formula and the outpatient populations served by safety-net hospitals eligible for 340B. As to program management, SNHPA states that the current 340B program does have defined guidelines, noting increased oversight and improvements newly being applied (with additional funding for the OPA).
The long awaited omnibus rule or “Mega Reg”, delayed due to the Orphan Drug ruling, may help settle some of the arguments around loose interpretations of how the 340B program may be used. The Mega Regulation is expected to be released toward the end of 2014.
The Orphan Drug ruling has also added fuel to the fire between PhRMA and the 340B community. Though PhRMA believes the Orphan Drug case is closed, Commander Pedley stated that HRSA would issue an Interpretive Rule on the Orphan Drug Exclusion. This would allow rural hospitals and cancer hospitals to purchase 340B-priced Orphan drugs when prescribed for the non-orphan indication. This Interpretive rule was published and effective July 21, 2014, and can be viewed here.
Last, but certainly not least from the list of this year’s National Conference takeaways, was the continued focus on compliance and increased oversight of 340B programs by HRSA. This is likely to result in an increase in 340B audits in the upcoming year. All 340B participants must be proactive in their readiness efforts.
At Hudson Headwaters, we’re here to help you get (and stay) prepared for all types of audits. Programs we manage have received 100% favorable results during HRSA audits. If your goal is simply to improve on your current auditing techniques, or if you are expecting or facing a HRSA audit, don’t hesitate to engage our experts and learn how our audit readiness services can help you and your program.
Call or email. We’re standing by, ready to help.
Hudson Headwaters 340B Pharmacy Services
9 Carey Road, Queensbury, NY 12804