340B Drug Pricing Program Division

The 340B Program requires pharmaceutical manufacturers to extend upfront discounts on covered outpatient medications purchased by federally registered covered entities. Congress passed the 340B Program as part of the Veterans Health Care Act in November of 1992. The program’s intent was to aid safety-net providers whom serve the nation’s most vulnerable patient populations in “stretching scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” Pharmaceutical discounts extended to covered entities range anywhere from 15 to 60 percent. RWJBarnabas Health (RWJBH) has been able to transform these savings into increased access to care and medication for eligible patients in underserved communities with the greatest need.

The RWJBH 340B Program began with a single hospital over 10 years ago. The health system has since expanded into six disproportionate share hospitals (DSH) and one hemophilia treatment center registered with the Health Resources and Services Administration (HRSA) as 340B covered entities. The program is due to expand at the beginning of 2022 with the addition of Trinitas Regional Medical Center to RWJBH, elevating the DSH count to seven. Each covered entity has Contracted Pharmacy agreements with a local retail network, including our own retail pharmacies. These arrangements further increase access to affordable medication for our eligible patients.

The RWJBH pharmacy enterprise has a central role in the initiation, operations, compliance and auditing of this complex program. This requires a coordinated effort between local facilities and the corporate pharmacy 340B team with the support of our 340B software vendor. The 340B team ensures RWJBH covered entities provide all required data to essential external vendors and routinely conduct data integrity reviews to maintain accuracy and compliance.

RWJBH facilities participating in the 340B Program are subject to audit by drug manufacturers, HRSA, and internal audit from the Corporate 340B Division. Failure to comply with 340B Program requirements could result in refund of discounts back to a manufacturer(s) or potential expulsion from the program. During 2021, the Corporate Pharmacy 340B Team successfully converted RWJBH’s third party application (TPA) for 340B operations and compliance to Verity Solutions. The transition presented additional mechanisms for increased patient 340B eligibility, greater flexibility conducting internal audits, and reduced Pharmacy Buyer functions through enhanced automation. The team spent much of 2021 streamlining the new TPA system, addressing unforeseen obstacles post go-live and assisting with training of all RWJBH 340B stakeholders.

In 2021, the Corporate Pharmacy 340B Team successfully conducted 60 routine audits of RWJBarnabas Health covered entities in addition to over 6,000 individual claim audits in the new TPA. Additionally, the team fielded 3 manufacturer and Medicaid duplicate discount inquiries and audited invoicing and ordering for the health system’s 31 different contract pharmacy agreements. The Team’s efforts, executed with limited resources, helped to ensure compliant 340B Program utilization. Through continuous evaluation of 340B Program operations, the team has continued to increase efficiencies and maximize program benefits for the RWJBarnabas Health System.

340B Drug Pricing Program Divsion Leadership