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1. GPO Prohibition Compliance Expected Once Enrolled and on OPA's 340B Database:
OPA will remove covered entities (and their offsite outpatient locations) from the program for non-compliance with the GPO prohibition if OPA determines that the covered entity, its off-site outpatient departments, or contract pharmacies purchased covered outpatient drugs from a hospital's GPO account at any point after the covered entity is enrolled and appeared on the 340B database.
2. Hospitals May Carve-Out Off-Site Outpatient Departments to Avoid GPO Prohibition at Off-Site Locations:
In an interesting twist, OPA indicated that providers can be selective with their enrollments relative to off-site outpatient departments in order to purchase GPO drugs at the off-site locations. The below criteria must be met in order to pursue this option:
- Off-site must be at a different physical address than the parent (i.e., outside of the four walls of this hospital);
- Off-site is not on the OPA 340B database;
- Off-site GPO drugs are purchased through a separate pharmacy wholesaler account than 340B drugs for the participating parent; and
- Hospital maintains records to demonstrate compliance with GPO prohibition (e.g., proof that no GPO drugs are transferred from the off-site to the parent or other 340B-registered sites.
3. GPO/340B Inventory Replenishment Models Prohibited:
In short, creative inventory models used to replenish GPO-purchased drugs with 340B covered outpatient drugs are not acceptable ways to comply with the GPO prohibition. No covered outpatient drugs can be purchased through a GPO under any circumstance. Outpatient drugs provided to non-340B patients must be purchased using a non-GPO account. Hospitals subject to the GPO exclusion have until April 7, 2013 to make changes to non-compliant replenishment models per a new FAQ posted on OPA's website.
4. GPO Prohibition Included in OPA Audits:
Providers should assess their existing practices, as well as policies and procedures to ensure compliance as OPA continues to expand their audit work.
5. Nofity OPA if a Wholesaler/Manufacturer Does Not Provide a Drug at 340B Pricing:
It has come to our attention that covered entities may purchase covered outpatient drugs under GPO pricing when 340B pricing is unavailable. This could be a violation of the GPO prohibition. Covered entities should contact OPA if 340B pricing is not available, and they will review the allegations to ensure manufacturers/wholesalers are complying with the 340B pricing requirements.
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