Perspective: Proposed Mega Guidance

As the industry awaits HRSA’s Mega Guidance that would cover the definition of a patient, compliance requirements for Contract Pharmacies, and criteria for hospital eligibility in the 340B program,RxStrategies shares the following anticipated key Mega Guidance themes and RxStrategies’ view on working with its clients to prepare:

1. Anticipated modest tightening of patient definition. Ensure your electronic medical record (EMR) data is complete and current.
   
2. Restrictions on the number of Contract Pharmacies a Covered Entity (CE) may have. RxStrategies’ client Contract Pharmacy (CP) networks are within expected standards.
   
3. Significant focus on program compliance and audit activities (both internal and external). Providers are encouraged to continue to implement 340B compliance focus (including RxStrategies 340BCompliance Plus).
   
4. Increased tracking and accountability requirement on CEs including, required transparency of proceeds details and flow. Senior leadership should implement processes to appropriately document the use of 340B proceeds.
   
5. Implementation of formal audit requirements, including:

– Establish formal retention period (5 years)
– Increased internal audit within CEs
– Formally require external third party audit, annually

It is recommended that CEs establish a 340B team with a designated 340B lead for audit review. That team can work through internal CE program assessement to ensure adequate compliance and self-audit reviews are in place today. 

Contact us to discuss how RxStrategies can assist your program.

Ensure Program Integrity: RxStrategies 340B Compliance Plus

This comprehensive solution assists clients and partners to proactively prepare for the additional oversight and responsibilities associated with a transparent 340B program.

Our team of 340B program experts works closely with CEs to support your program integrity, including:

1. Design customized Policies and Procedures with each CE and work with Contract Pharmacy sites to reinforce specific details.
2. Confirm accurate details of HRSA registration (initial and ongoing updates) and 340B program operations.
3. On-site consultation with clients to complete CE systemic compliance readiness review.

Read more about RxStrategies 340B Compliance Plus program or contact us to discuss how to get started.

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