340B Covered Entity and Contract Pharmacy Regulatory and Contract Support
With our specialized and in-depth experience in Pharmacy Law, Frier Levitt is uniquely positioned to represent both Section 340B in-house and contract pharmacies participating in the Federal 340B program.
The 340B Drug Discount Program, which is administered and monitored by the Office of Pharmacy Affairs under the Health Resources and Services Administration (HRSA), requires drug manufacturers to provide outpatient drugs to eligible healthcare organizations and covered entities at significantly reduced prices.
340B healthcare organizations and covered entities may elect to provide outpatient drugs as a service of their own, commonly referred to as an in-house pharmacy. Additionally, many 340B eligible healthcare organizations and covered entities elect to dispense 340B drugs to patients through contract pharmacy services, an arrangement in which the 340B covered entity signs a contract with a pharmacy to provide pharmacy services. These pharmacies may include independent pharmacies, community retail pharmacies, chain based pharmacies, and specialty pharmacies.
Frier Levitt assists pharmacies with 340B matters, including:
- Becoming a 340B In-House or Contract Pharmacy, including eligibility and compliance with on-going requirements, such as 340B database compliance, recertification, drug diversion, duplicate discounts, and program audit preparation
- Service Agreements between Contract Pharmacy and Covered Entities with an emphasis on regulatory compliance with Federal and State Laws and tailored to evolving PBM reimbursements
- Vendor agreements related to 340B operations of In-House and Contract Pharmacies
- PBM and third party payor audits pertaining to the Pharmacy’s 340B claims
- Implementation of 340B operations Compliance Programs
- Response and defense of HRSA Section 340B audits
If you are 340B in-house or contract pharmacy, or are looking to become one, contact Frier Levitt today to speak to an attorney.