The Jury Is Out: The New 340B Guidance Continues to Require Clarity

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As PBIRx provides HRSA Compliance Audits with many 340B covered entities nationwide we must always be abreast of the newest guidelines so that we can be best in class for our clients.  A testimony to that is the recent engagement of PBIRx services for a second HRSA Compliance Audit for a major 340B hospital plan in Massachusetts. A few months after a PBIRx Audit last year, this 340B Covered Entity was audited by HRSA and passed with no issues because they had the opportunity to implement the PBIRx recommendations to be compliant with the 340B Program. 

The 340B Drug Pricing Program Omnibus Guidance, 90 pages published in the August 28^th Register (80 Fed. Reg. 52300) does provide more specificity relative to the definition of a 340B patient and what is considered a 340B eligible drug under the program:

• The prescription must be written by an “employee” or “independent contractor” of the facility or clinic and authorized to bill for services provided by such employee or independent contractor at such facility or clinic.
• A prescription written by a provider that is NOT an employee or independent contract, but has privileges or credentials at the 340B hospital is NOT an allowable 340B prescription.
•  A prescription written by a provider, who was referred by the employee or independent contractor, and who resides at a non covered (not in the 340B database) healthcare organization is NOT an allowable 340B prescription.
• Federal and state laws govern whether the employee or independent contractor of the facility can issue a prescription via telemedicine and/or telepharmacy.
• Services provided to a patient MUST be provided at the facility or location that has registered for the 340B program and is listed on the public 340B database. This covered entity must be able to not only access the patient’s health records, but also access documentation to prove that the covered entity has established a relationship with the patient.

     Another major change or clarification in the guidance is that 340B covered entities cannot prescribe 340B eligible drugs to inpatients upon discharge. The inpatient must make another “outpatient” appointment before their prescription is 340B eligible.

As the complexity increases in HRSA guidelines for 340B entities, look to PBIRx, which provides a team of experts with longevity in several HRSA guideline areas to ensure that your PBIRx HRSA Compliance Audit Report and follow up takes away any concern of your 340B status, as a result of a HRSA audit failure.