The 340B Pharmacy Program has a few challenging components to it. Covered entities must:
- Ensure the pharmacy and the state it operates in doesn’t collect the Medicaid rebate
- Ensure the patients receiving 340B prescriptions are eligible to do so
- Maintain compliance
- Pass Health Resources and Services Administration’s (HRSA) audits to maintain their 340B status.
Now, drug manufacturers are challenging HRSA’s 2010 guidance. The guidance is for covered entities and contract pharmacies that work together to offer 340B prescriptions to eligible patients. Many covered entities, including FQHCs, utilize the 340B Pharmacy Program through contract pharmacies, such as Walgreens and CVS. This allows the covered entity to receive immense savings.
The National Association of Community Health Centers (NACHC) is concerned that if enough manufacturers start challenging the program’s contract pharmacy involvement, it could hinder the benefits the covered entity is able to provide its patient base. This is still an unfolding issue and we’ll keep you updated as it progresses.
The best way to avoid this manufacturer challenge altogether is to have an in-house 340B Pharmacy, if you don’t already. We can assist you with building a 340B Pharmacy that benefits your patient base, establish a 340B Pharmacy Program compliance toolkit and work independent internal and external audits to ensure you’re prepared for a HRSA audit.