Two New FAQs on 340B Group Purchasing Prohibition

by admin | March 1, 2013 6:59 am

March 1, 2013—The Office of Pharmacy Affairs (OPA) and Apexus/340B Prime Vendor Program (PVP) have each issued lengthy FAQs fleshing out OPA’s new interpretation of the 340B statute’s “GPO prohibition.”

The 340B law prohibits disproportionate share (DSH), children’s, and free-standing cancer hospitals from participating in group purchasing organizations for 340B drugs, which are for outpatients only.[ms-protect-content id=”2799″]

OPA had offered limited guidance on the GPO exclusion’s parameters until Feb. 7, when it issued a policy release[1] invalidating drug-replenishment systems that use GPOs to make initial purchases of drugs and subsequently replace them with 340B-purchased drugs. It gave affected hospitals until April 7 to comply with the drug-replenishment requirements in the new policy. Hospitals that violate the prohibition will be removed from the 340B program, including all of their enrolled outpatient sites and contract pharmacies, OPA said. They might also be required to repay manufacturers. To be considered for reinstatement, they would first have to demonstrate their ability to comply with the requirement.

In its FAQ, OPA said a hospital had the following options if it cannot meet the April 7 deadline.

“The hospital can notify OPA of their non-compliance and submit a self-report with a corrective action plan. OPA will handle situations on a case by case basis.”
“The hospital could request that OPA remove the sites that are out of compliance and re-enroll the sites when they are compliant. This would be difficult if the non-compliant sites are within the four walls of the hospital (which it is very likely they are), but on the chance that these non-compliant sites would meet the four criteria laid out in the policy release, this might be a practical option.”
“The hospital could request to be removed from the 340B program and re-enroll during the next regular registration period once the hospital determines it is in compliance with all 340B program requirements.”

The OPA FAQ[2] has 19 questions and answers and the PVP version[3] has 40. PVP also issued a document[4] entitled “340B GPO Prohibition and Wholesaler WAC Account Load Options” that it said is intended “to facilitate 340B compliance in the marketplace.”[/ms-protect-content]

Endnotes:

a policy release: http://www.hrsa.gov/opa/programrequirements/policyreleases/prohibitionongpoparticipation020713.pdf
The OPA FAQ: http://www.hrsa.gov/opa/faqs/index.html#gpo1
the PVP version: https://docs.340bpvp.com/documents/public/resourcecenter/faq/FAQs_PolicyImplementation_HospitalSpecific_GPO_Exclusion.pdf
a document: https://docs.340bpvp.com/documents/public/resourcecenter/GPOProhibition_WholesalerWACAccount_LoadOptions.pdf

Source URL: https://340bemployed.org/two-new-faqs-on-340b-group-purchasing-prohibition/