Optimizing The 340B Program
Promoting Integrity, Access, & Value
To deliver clinically and cost-effective pharmacy services
This educational product created by:
Health Resources and Services Administration | Office of Pharmacy Affairs
340B Peer-to-Peer Program
340B 101:
The Basics
Purpose of Activity
The purpose of this module is to illustrate the history, intent and
statutory principles of the 340B Drug Pricing Program.
Topic Guide
Intent of the program
340B pricing
determination
Entity eligibility
Entity enrollment
procedure
Program requirements
and prohibitions
Program guidance
and policy
Patient eligibility
determination
Drug-delivery options
Available resources
Creation of the 340B Program
Certain safety net
covered entities
Outpatient drugs
340B
Program
Price discounts
Required for all
manufacturers in
Medicaid
Intent of the 340B Program
Stretch scarce federal
resources1
Reach more eligible
patients1
Reduce price of
pharmaceuticals
for patients
Expand services
offered to
patients
Provide more
comprehensive services1
Provide services to
more patients
1. HR Rep No. 102–384, pt 2, at 12 (1992).
340B Program Evolution
2010
2004
1996
1992
1993
Contract
Pharmacy,
1st
Guidelines
Patient
Definition
340B Statute
Vendors
Affordable
Care Act
1st
Proposed
Regulations
340B Price
340B
Drug Pricing Program
25%–50%
of the average wholesale price
The 340B price is actually considered a “ceiling” price
Can offer subceiling prices
Drug
Manufacturers
340B Covered Drugs
• Outpatient prescription
drugs
• Over-the-counter drugs
(with prescription)
• Clinic-administered drugs
• Biologics (prescription)
• Insulin
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• Inpatient drugs
• Vaccines
340B Eligible Entities
› Hospital Types
› Federal Grantees
• Comprehensive hemophilia
treatment centers
•
•
•
•
•
•
• Federally qualified health
centers/lookalikes
• Urban/638 health center
• Ryan White programs
Disproportionate share hospitals
Children’s hospitals*
Critical access hospitals*
Free-standing cancer hospitals*
Rural referral centers*
Sole community hospitals*
• Sexually transmitted
disease/tuberculosis
• Title X family planning
*340B
eligible through Section 7101 of the Affordable Care Act (ACA)
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Hospital Eligibility Criteria
Non-profit/
Govt. Contract
DSH%
Group Purchasing Organization (GPO)
*
Prohibition
Orphan Drug* Applies?
Disproportionate Share Hospital (DSH)
Yes
>11.75%
Yes
No
Children’s Hospital (PED)
Yes
>11.75%
Yes
No
Free-standing Cancer Hospital (CAN)
Yes
>11.75%
Yes
Yes
Critical Access Hospital (CAH)
Yes
N/A
No
Yes
Rural Referral Center (RRC)
Yes
>8%
No
Yes
Sole Community Hospital (SCH)
Yes
>8%
No
Yes
Entity Type
*340B
eligible through Section 7101 of the Affordable Care Act (ACA)
Hospital Outpatient Facilities
› In order for outpatient facilities to become eligible for
the 340B Program:
– The outpatient facility must be an integral part of the
hospital
– The outpatient facility must be included as reimbursable on
the covered entity’s most recently filed Medicare Cost
Report
– To register additional outpatient facilities, complete the
online Register an Outpatient Facility registration at:
http://opanet.hrsa.gov/OPA/CERegister.aspx
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340B Enrollment Procedure
http://opanet.hrsa.gov/OPA/CERegister.aspx
Determine
Eligibility
Enroll online
Submit Forms
to OPA as
directed
Await decision
from OPA
340B Implementation
› Ensure entity is listed correctly in the OPA 340B
database
› Set up an account with wholesaler using 340B ID for
purchasing
• Wholesalers will not ship discounted drugs unless 340B ID is an
exact match to the 340B database
› Prepare operational and logistical monitoring, auditing,
and compliance processes and procedures
›
Utilize available resources
• Prime Vendor Program for sub-ceiling 340B pricing, value-added
services and for technical assistance
340B Prohibitions and Requirements
Prohibitions
Diversion
Duplicate
Discounts
Duplicate Discount Prohibition
Duplicate Discount
Accessing the 340B discount AND Medicaid Rebate on the same drug
Carve In
(use 340B with Medicaid)
Carve Out
(do not use 340B with
Medicaid)
• Medicaid Exclusion File at: http://opanet.hrsa.gov/opa/CEMedicaidExtract.aspx
• Medicaid Exclusion Tutorial at: http://www.hrsa.gov/opa/medicaidexclusion.htm
• State policies
• Entities should contact their state Medicaid offices for state-specific requirements for
using 340B with Medicaid patients.
Fed Regist. 2000;65(51):13983–4.
Diversion Prohibition
› Diversion occurs when:
• A drug is provided to an individual who is not a
patient of that entity
• Required to follow patient definition guidelines1
• A drug is dispensed in an area of a larger facility that
is not eligible (e.g., an inpatient service, a noncovered clinic)
• Entities should enroll all eligible outpatient or
satellite sites
1. Fed Regist.1996;61(207):55156–8.
GPO Prohibition
› GPO prohibition prohibits certain entities from
purchasing any covered outpatient drugs through a
GPO or other group-purchasing arrangement, even if
items are available at a lower price through the GPO.
DSHs
GPO Prohibition
Only Applies to
PEDs
CANs
Hospitals can continue to purchase all products for inpatient operations through a GPO,
even if their outpatient departments participate in 340B.
The Orphan Drug Exclusion
› The orphan drug exclusion prohibits certain entities from
purchasing orphan drugs at 340B discount prices.
CAHs
Orphan Drug
Exclusion Only
Applies to
SCHs
RRCs
CANs
› The Orphan Drug Product Designation Database can be found at:
›
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm
340B Guidance and Policy
Patient Definition
http://www.hrsa.gov/opa/federalregister.htm
Contract Pharmacy
Federal
Register Notice
Outpatient Facilities
Audits and Dispute
Resolution
Duplicate Discounts
340B Proposed Regulations
Civil Monetary Penalties
Regulations (Proposed)
Dispute Regulation
Patient Definition
For eligibility, three components must always be considered
regarding the individual and his/her associated prescription:
Entity has established a relationship and
maintains records of care
Patient must receive health-care services
from health-care professional
employed/contracted with entity, and
entity must maintain responsibility for the
care provided
Patient receives health care consistent with
range of services from the covered entity
(hospitals are exempt)
Fed Regist. 1996;61(207):55156–8.
Drug Delivery
Contract Pharmacies
› 340B Program allows entities to have multiple contract
pharmacies for increased patient access to cost-effective
pharmaceuticals
› Covered entity purchases the drug, but “ship to/bill to”
procedure may be used
› Covered entity retains legal title to all drugs purchased under
340B and must pay for all 340B drugs
›
Fed Regist. 2010;75(43):10272–9.
340B Usage Considerations
Federal grantees
• Scope of grant limitations
Hospital facilities
• Integral part of the hospital
• On most recently filed cost report
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340B Program Resources
Integrity
Program integrity assures stakeholders that the 340B
Program’s intent is being met and that rules are being
followed.
Access
Access to services under the 340B Program is important
because it ensures that entities and their patients have the
means to fully utilize the program’s benefits.
Value
The value that program participation brings to entities is
essential for stretching scarce entity resources.
Office of Pharmacy Affairs (OPA)
› Administrates over the 340B Drug-Pricing Program
› Develops innovative pharmacy service models and
provides technical assistance to help entities
implement effective pharmacy programs
› Serves as a federal resource about pharmacy
› Emphasizes the importance of comprehensive
pharmacy services functioning as integral part of
primary health care
Integrity
Prime Vendor Program(PVP)
› Relationships and networking
› Policy analysis
› Education
o 340B University
› Technical assistance
o Apexus Answers Call center
o 340B tools and resources
o www.340bpvp.com
Access
Prime Vendor Program (PVP)
› Negotiation of
o 340B sub-ceiling pricing
o Discounts on value-added products, services, and supplies
› Overcharge recovery
› Pricing transparency
› Reports and tools
› Technical assistance
Value
340B Resource Information
Health Resources and Services Administration
http://www.hrsa.gov/opa/
http://www.hrsa.gov/publichealth/clinical/patientsafety/index.html
340B Prime Vendor Program
Managed by Apexus
1-888-340-2787
ApexusAnswers@340bpvp.com
https://www.340bpvp.com/
Thank you for viewing this 340B tutorial developed by :
Health Resources and Services Administration
Office of Pharmacy Affairs
340B Peer-to-Peer Program
You can view additional 340B educational products and tools specifically developed to
assist 340B-participating entities create and maintain processes to ensure 340B
program integrity at:
www.hrsa.gov/opa/peertopeer/