Understanding the GPO Prohibition
Topics
• Overview • Compliant Operations • Self-Assessment • Top FAQs • Resources
GPO PROHIBITION: OVERVIEW
Background
• Why now? • Environment • Opportunities and challenges for stakeholders • Importance of compliance
Statute: GPO Prohibition
• A condition of 340B eligibility for: – Disproportionate Share – Children's Hospitals – Free Standing Cancer Hospitals
• 340B Statute states the hospital: – “…does not obtain covered outpatient drugs
through a group purchasing organization or other group purchasing arrangement…”
Registration: GPO Prohibition
• OPA GPO certification form, signed by authorizing official states such hospitals: – “...will not participate in a group purchasing
organization or group purchasing arrangement for covered outpatient drugs as of the date of this listing on the OPA website." OPA GPO Certification Form
Policy Release: GPO Prohibition
• Published February 7, 2013 • Represents clarification of OPA policy; not new
policy • Major Points
– Scope and certification of compliance – Where it applies – Date of compliance – Replenishment – Sanctions
• Comply by: April 7, 2013
COMPLIANT OPERATIONS
Accumulators and Eligibility
Accumulator: Inpatient GPO
Inpatients
Outpatients: offsite, unregistered
outpatient clinics
Accumulator: 340B
340B eligible outpatients
Accumulator: Non-340B WAC
340B ineligible outpatients
Medicaid carve- out Lost charges
Clinics within 4-walls but not 340B
eligible In-house pharmacy
open to public
We use ceftriaxone 1 g (order quantity 25 vials)
Compliant 340B In Mixed-Use Areas
Mixed-Use Inventory
Drug Administration
Accumulator
Drug Order
Inpatient GPO
WAC 340B
From Which Do I Order?
Accumulator: Inpatient GPO
26 vials used
Accumulator: 340B
10 vials used
Accumulator: Non-340B WAC
5 vials used
We are under our PAR for ceftriaxone 1 g (order quantity 25 vials)
ORDER
From Which Do I Order?
Accumulator: Inpatient GPO
15 vials used
Accumulator: 340B
27 vials used
Accumulator: Non-340B WAC
5 vials used
We are under our PAR for ceftriaxone 1 g (order quantity 25 vials)
ORDER
From Which Do I Order?
Accumulator: Inpatient GPO
20 vials used
Accumulator: 340B
10 vials used
Accumulator: Non-340B WAC
5 vials used
We are under our PAR for ceftriaxone 1 g (order quantity 25 vials)
ORDER
Inpatient
GPO
• GPO Contract • DSH Inpatient GPO
Contracts (DSH only) • GPO or Wholesaler
Generic Source Program • Individual Hospital
Agreement
Outpatient
340B
• PHS/340B • PVP 340B (if enrolled in PVP)
• PVP Non-340B (if enrolled in PVP)
• Apexus Generic portfolio (AGP) (if enrolled in PVP)
• Individual Hospital Agreement
Outpatient
Non-340B/WAC
• WAC Pricing • PVP Non-340B (if enrolled
in PVP)
• Apexus Generic Portfolio (AGP) (if enrolled in PVP)
• Individual Hospital Agreement (single entity only)
Wholesaler Account Setup -DSH/PED/CAN with GPO Prohibition
Update: Account Load Options
Full document available, click on link provided to download: https://docs.340bpvp.com/documents/public/resourcecenter/GPOProhibition_WholesalerWACAccount_LoadOptions.pdf
SELF-ASSESSMENT OF GPO COMPLIANCE
GPO: Focus Here
• What outpatient accounts does the entity have?
• How does the entity purchase drugs for ineligible outpatients?
GPO: Can’t Use It Here…
Does the entity, subject to the GPO Prohibition, use a GPO for covered outpatient drugs in any of the following circumstances? – In OPA-registered (or within entity’s 4 walls)
participating clinics for 340B ineligible patients or when 340B is not available
– Via a contract pharmacy
GPO: Could Use It Here…
Does the entity, subject to the GPO Prohibition, use a GPO for covered outpatient drugs only in certain off-site outpatient hospital facilities that meet all of the following criteria?
1. Are located at a different physical address than the parent; 2. Are not registered on the OPA 340B database as participating
in the 340B Program; 3. Purchase drugs through a separate pharmacy wholesaler
account than the 340B participating parent; and 4. The hospital maintains records demonstrating that any
covered outpatient drugs purchased through the GPO at these sites are not utilized or otherwise transferred to the parent hospital or any outpatient facilities registered on the OPA 340B database.
GPO: TOP FAQS
AA Our DSH patients fall into only two categories: they are either 340B eligible or inpatients. Why do we need a WAC account?
AA Does our DSH need to be able to show an initial WAC purchase
for every existing item in inventory?
What about for new items after April 7,
2013?
AA
Our hospital won’t be
compliant by April 7, 2013. What should I
do?
From Apexus Answers Can our DSH obtain covered
outpatient drugs via a GPO through
its contract pharmacy?
GPO: Special Situations
• GPO private label products • IVIG • Drug shortages • Non-covered outpatient drugs • Own-use • One pharmacy serving 340B registered and
unregistered clinics (GPO and 340B inventory at same location)
• IV Solutions • Individual contracts
Resources
• OPA website: – www.hrsa.gov/opa
• Apexus website: – www.340BPVP.com
• Apexus Answers Call Center – M-F 7:30 am-5:30 pm CT – Email: [email protected] – Live chat – Phone: (888) 340-BPVP (340-2787)
• 340B University tools & resources – www.340bpvp.com/resource-center/340b-university