The 19th Annual 340B Coalition Conference was held July 13-15, 2015 in Washington, D.C. The conference covered the latest developments in the 340B program, including how Congress has recently addressed 340B, the status of the mega-guidance and new reports from the U.S. Government Accountability Office (GAO), and the U.S. Department of Health and Human Services (HHS) Office of Inspector General. There was also discussion on the latest trends and implications of stepped-up audit activity by the Health Resources and Services Administration (HRSA), additional compliance matters and innovative ways that Covered Entities (CEs) use their 340B savings to achieve their mission.
A brief synopsis of the key takeaways from workshops, networking activities and breakout sessions is below.
HRSA Updates | Mega Guidelines
HRSA submitted guidance on the 340B Federal Drug Pricing Program (340B Program) to the federal Office of Management and Budget (OMB) for review on May 6, 2015. The guidance, entitled “340B Program Omnibus Guidelines,” is anticipated to address a broad range of 340B Program topics, including the patient definition, Contract Pharmacy compliance requirements, hospital eligibility criteria and eligibility of off-site outpatient locations. The proposed guidance is still in review by OMB. There will be an opportunity for public comment before the guidance is finalized.
On July 10, 2015, the GAO released a report on the 340B Program. The report concluded that the program has created incentives for 340B CEs to prescribe more drugs and more expensive drugs, particularly in the area of cancer care.
Several organizations, including HHS and the American Hospital Association have expressed concern that GAO’s methodology was flawed, including inadequately accounting for patient health status and outcomes.
Drug Supply Chain Security Act for Dispensers | Track and Trace
The FDA announced on June 30, 2015 that it “does not intend to take action against dispensers” that fail to capture and maintain product tracing information from their trading partners prior to November 1, 2015. This delay in enforcement of the Drug Supply Chain Security Act (DSCSA) product tracing requirements for dispensers is a result, in part, of the FDA’s failure to issue guidance to 340B Contract Pharmacies. The current 340B “ship-to, bill-to” process is organized so that Contract Pharmacies never take possession of prescription drug transaction materials. As it stands, 340B Contract Pharmacies are unable to receive prescription drugs for CEs entities unless:
- The FDA establishes 340B Contract Pharmacies exemption
- A Contract Pharmacy obtains a wholesaler state license in order to become an authorized trading partner under DSCSA and develops a procedure to provide the “transaction documents” known as T3—transaction history, transaction information and transaction statement
The goal of the DSCSA is to develop a standard to track drugs throughout the supply chain at the individual package level in order to protect consumers from potentially dangerous drugs, including those that are counterfeit, stolen or tainted.
21st Century Cures Act
Congress passed the 21st Century Cures Act on July 10, 2015. The act will help to modernize healthcare, encourage greater innovation, support research and streamline the system to deliver better, faster cures. The draft 340B Program language was pulled from the final legislation; however, it is possible it could reappear in the Senate’s version due out in the fall. Review of the proposed language provides insight into what future legislative reform may include, such as:
- Patient eligibility definition clarification
- HRSA’s authority to enforce regulations
- Lack of transparency on how CEs use savings that align with the intent of the program
- New requirements on 340B Contract Pharmacy arrangements
Specialty Pharmacy in the 340B Program
Specialty pharmaceuticals represent the fastest growing segment of the U.S. prescription drug market. Currently, many CEs are struggling to obtain specialty pharmaceuticals at 340B prices through manufacturers’ and payers’ limited distribution specialty networks. Access and specialty drug purchases can present challenges for any health system; however, CEs are finding it even more difficult when buying or trying to obtain specialty drugs at 340B prices. Entering into 340B Contract Pharmacy arrangements with specialty pharmacies is one solution to overcome specialty challenges while maintaining 340B program integrity.
Pinnacle Can Help You
In the dynamic 340B marketplace, Pinnacle Health Communications, LLC has the expertise, insight and successful track record to support your 340B needs through development of key resources designed to help strengthen your marketing position while educating your clients and prospects on the opportunities inherent in the 340B program.
If you would like to hear more about how Pinnacle can help you, please contact us.