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: ApexusAnswers@340bpvp.com – Live chat – Phone: (888) 340-BPVP (340-2787)

• 340B University tools & resources – www.340bpvp.com/resource-center/340b-university