Skip to content
4 min read

Highlights from the 340B Coalition Winter Conference

A team from Hudson Headwaters attended the 11th Annual 340B Coalition Winter Conference in San Francisco, CA February 4-6, 2015.  This was Hudson Headwaters’ first time as both exhibitor and presenter at the annual winter conference.

News and Updates

Hot topics at this year’s conference included: compliance and audit readiness, HRSA’s upcoming 340B comprehensive guidance (anticipated in June), developments in the Orphan drug exclusion, and Medicaid/Medicaid Managed Care 340B policies.

  • CDR Krista Pedley, Director of HRSA’s Office of Pharmacy Affairs (OPA), gave a brief update on the 340B program and advised that in place of last years’ anticipated “Mega Reg”, HRSA will issue comprehensive guidance in June 2015. She also noted that at this time, HRSA’s July 2014 interpretive rule on Orphan Drugs still stands. PhRMA also has a pending lawsuit against HHS for its interpretive ruling that allows certain 340B hospitals to include Orphan Drugs in their 340B programs.
  • Jim Donnelly, Hudson Headwaters’ VP of Pharmacy Services, presented about the importance of compliance for HRSA grantees.  He stressed that it is an entity’s responsibility to understand their own program and implement tools and documentation to prepare for upcoming audits, whether independent or HRSA instigated.  Donnelly also participated in a panel discussion focused on Sliding Fee programs and 340B, Medicaid 340B policies and other 340B compliance issues.
  • The number one concern for most 340B covered entities is compliance and audit preparation. Hudson Headwaters offers a comprehensive audit package tailored to each entity’s 340B program.  With more than 13 years of 340B experience, Hudson Headwaters is uniquely equipped to assist with internal and independent audits of 340B programs, in part because we are the only 340B management services provider (vendor) that is also a 340B covered entity.

Call us when you need us!  855-835-340B