Apexus Contracting 340B GPO Prohibition and Wholesaler WAC Account Load Options A Feb. 7, 2013 HRSA Policy Release1 provided clarification for hospitals subject to the Group Purchasing Organization (GPO) Prohibition. Apexus is providing this document to facilitate 340B compliance in the marketplace; the information contained in this document is not legal advice. Key Messages 1. Establishing an outpatient non-GPO (i.e., PVP Non-340B) account provides a compliant method for obtaining covered outpatient drugs for non-340B eligible outpatients of these hospitals. Such an account is useful if the hospital elects to carve-out Medicaid or uses replenishment in mixed-use areas. 2. For entities using a replenishment model, replenishment orders may result in a physical inventory in the mixed-use area that is composed of a variety of contract purchases. The following should be met: • 340B accumulation occurs only for 340B eligible patients; • 340B ineligible outpatients generate accumulation only for orders on an outpatient nonGPO/WAC account and • Hospitals maintain auditable records of policies, procedures, and transactions. HRSA expects that covered entities will comply with the GPO Prohibition as soon as possible prior to the August 7 deadline. 3. HRSA expects hospitals to establish compliant practices in accordance with the GPO Policy Release by August 7, 2013.2 Hospitals should immediately move toward compliance with this requirement, and go forward with these compliant practices. • Effective August 7, 2013: - Hospitals may use up existing GPO inventory. - If the hospital is unable to establish compliant practices in accordance with the GPO Prohibition, the hospital should self-report3 to HRSA. - If a covered entity is unable to be in compliance by August 7, the covered entity must immediately notify HRSA, and will be terminated from the program. - No new inventory for ineligible 340B outpatients should be purchased through a GPO. 1 2 3 http://www.hrsa.gov/opa/programrequirements/policyreleases/prohibitionongpoparticipation020713.pdf http://www.hrsa.gov/opa/faqs/index.html#GPO See 340 University Tool “Self-Reporting Non-Compliance”: https://www.340bpvp.com/resource-center/other-resources/other-tools/ Contact Us! Apexus | 340B Prime Vendor Program 888.340.2787 | ApexusAnswers@340BPVP.com www.340BPVP.com R To bring value to hospitals subject to the GPO Prohibition, Apexus has worked with wholesalers to make the non-340B contracted products and Apexus generic source contracts available in the non-GPO/WAC account. Account Load Options Outpatient Contracts or Pricing Definition Wholesaler Account: Wholesaler Account: 340B Primary Non GPO/WAC 340B/PHS Manufacturer calculates prices for 340B covered outpatient drugs according to the 340B statutory formula YES NO Apexus PVP Sub-340B Reflects pricing that is negotiated with branded and/or generic manufacturers offering sub-340B pricing. YES NO Apexus PVP Sub-WAC Apexus PVP sub-WAC contracted pricing allows entities to order covered outpatient drugs in situations that would otherwise require the entity to pruchase at WAC pricing. This pricing is negotiated without regard to 340B pricing; use of this pricing is GPO Prohibition compliant. Pricing is negotiated for outpatient covered drugs at sub-WAC or GPO-similar. NO YES Apexus ValueAdded Other value-added contracts are for non-covered drugs such as vaccines, blood glucose monitoring supplies, prescription vials and labels, discounts on service contracts such as pharmacy automation hardware and software and so on. YES YES YES YES YES YES NO NO NO NO Apexus Generics Apexus provides a generic source portfolio for outpatient covered and non-covered Portfolio (AGP) drugs; this portfolio provides discounted contract pricing that has no reference to the 340B ceiling pricing, although it can be lower than 340B. It is subcontracted to wholesalers and extended to Apexus participants un the AGP. Individual Hospital Agreement A hospital obtains discounts based on the individual hospital’s negotiation with a manufacturer (single entity contract). Name Name GPO Non-Acute GPOs obtain discounts from vendors on outpatient drugs based on the collective buying power of the GPO members. GPO or Wholesaler Generic Source GPOs and wholesalers obtain discounts from manufacturers based on the collective buying power of the GPO or wholesaler members/customers. Quick GPO Self-Assessment Our hospital2 should be able to answer NO to all of the following: 1. Use GPO purchased covered outpatient drugs for 340B ineligible outpatients in OPA-registered participating clinics? 2. Have systems (or vendor systems) set up to use GPO purchased covered outpatient drugs for 340B ineligible outpatients? This information is provided only as a reference to encourage 340B program integrity. This information has not been endorsed by the HRSA and is not dispositive in determining compliance with or participatory status in the 340B Drug Pricing Program. 340B stakeholders are ultimately responsible for 340B program compliance and compliance with all other applicable laws and regulations. Apexus encourages each stakeholder to include legal counsel as part of its program integrity efforts. Contact Us! Apexus | 340B Prime Vendor Program 888.340.2787 | ApexusAnswers@340BPVP.com www.340BPVP.com R