The 340B Drug Pricing Program: The Basics

The 340B Drug Pricing Program:
The Basics
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Learning Objectives
1
2
3
Intent of the
program
340B Pricing
determination
Entity
eligibility
4
5
Program
requirements
and
prohibitions
6
Entity
enrollment
procedure
Program
guidance
and policy
7
8
9
Patient
eligibility
determination
Drug delivery
options
Available
resources
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What is 340B?
340 entities?
340 drugs on the
formulary?
Year it was
created?
340 pharmacies?
340 hospitals?
340 lawyers that
got together
340
manufacturers
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Creation of the 340B Program
340B
DRUG PRICING
PROGRAM
$
Drug
Manufacturers
Outpatient
Drugs
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Intent of the 340B Program
Safety net
providers
340B Eligible
Entities
SAVINGS
Improve
financial
stability
Stretch dollars
to serve
vulnerable
patients
Patients
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The 340B Price
340B
DRUG PRICING
PROGRAM
25-50%
of the average wholesale price
The 340B price is actually a “ceiling” price
Can offer sub-ceiling prices
Drug
Manufacturers
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The 340B Price
340B
DRUG PRICING
PROGRAM
25-50%
of the average wholesale price
The 340B price is actually a “ceiling” price
OFFICE OF
PHARMACY AFFAIRS
Drug
Manufacturers
Centers for Medicare
and Medicaid Services
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340B Entity Eligibility
The eligibility to purchase
at the 340B price belongs
only to the entities
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340B Entity Eligibility
Consolidated Health Centers
Comprehensive hemophilia
diagnostic treatment centers
Federally Qualified Health
Center, or FQHC look-alikes
Native Hawaiian health
centers
Family planning (Title X)
Urban Indian organizations
Certified tuberculosis clinics
Ryan White Care Act
(Parts A, B, C, D) grantees
Certain disproportionate share
hospitals (>11.75%)
Black lung clinics
Certified sexually transmitted
disease clinics
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340B Enrollment Procedure
ELIGIBLE ENTITIES MUST ENROLL
FORMS AND ENROLLMENT INFORMATION
http://www.hrsa.gov/opa
Click on “Legal Resources”
ADMISSION PROCESS
Submit completed form to OPA
OPA verifies eligibility
Participation begins next quarterly database update
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340B Enrollment Procedure
FIND THE FORM
http://www.hrsa.gov/opa/legalresources.htm
COMPLETE THE FORM
Click on “Introduction to 340B”
DEADLINES
participation begins 1 month after the enrollment deadline
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340B Statute Requirements
and Prohibitions
340B Legislation
Program Components
Price
Formula
Eligible
Entities
Requirements
& Prohibitions
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340B Statute Requirements
and Prohibitions
Prime Vendor
Audit
Resell/
Transfer
Prohibition
Duplicate
Discount
Prohibition
Disproportionate
Share Hospital
GPO
Exclusion
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340B Regulation and Policy
Interpreting the legislation and
implementing the 340B Program
may at times be a challenge
OFFICE OF
PHARMACY AFFAIRS
Federal Register
Notice publication
www.hrsa.gov/opa
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340B Regulation and Policy
1 entity has established relationship & maintains
records of care
2 patient receives health care services from
health care professional employed/contracted
with entity
Definition
of a Patient
OFFICE OF
PHARMACY AFFAIRS
3 patient receives health care consistent with
range of services from the covered entity
Federal Register
Notice publication
www.hrsa.gov/opa/federalregister.htm
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340B Regulation and Policy
If three requirements are not met, the person is
not eligible for 340B drugs
Definition
of a Patient
OFFICE OF
PHARMACY AFFAIRS
Federal Register
Notice publication
www.hrsa.gov/opa/federalregister.htm
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340B Implementation Options
340B Eligible
Entities
Entities expressed
interest in new ways
to increase access to
340B drugs
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340B Implementation Options
340B Eligible
Entities
OFFICE OF
PHARMACY AFFAIRS
Alternative Methods
Demonstration Projects
www.hrsa.gov/opa/alternativemethods.htm
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340B Program Resources:
Integrity
Access
Value
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Integrity Resource:
Office of Pharmacy Affairs (OPA)
Administers
340B program
Develops
innovative
pharmacy
service models
and supports
technical
assistance
Serves as
Federal resource
for pharmacy
practice
Integrity
Importance of Comprehensive Pharmacy Services
• Access to affordable drugs
• Efficient pharmacy management
• Application of “best practices”
• Systems to improve patient outcome
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Access Resource:
Pharmacy Services Support Center (PSSC)
Helps eligible
entities,
implement and
optimize the
340B program
Provides
information
resources,
policy analysis &
education
Access
Operates
• Call Center
• Outreach Program
• Web Site
• Pharmacy Technical Assistance Program
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Value Resource:
Prime Vendor Program (PVP)
Negotiates subceiling prices
Helps with
access to drug
distribution
solutions
Offers value
added products
and services
Offered at no
cost to entity
Value
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Staying connected to the 340B World
ASHP meetings
June and December
APHA meeting
April
340B Coalition meetings
January and July
APhA Pharmacy Today
Access For All
Network at various
entity specific meetings
(NACHC, NAPH, Primary
Care Associations,etc.)
SNHPA
http://www.safetynetrx.org
HRSA
http://www.hrsa.gov/opa/
PSSC
http://pssc.aphanet.org/
Prime Vendor Program
http://340bpvp.com
The Monitor
List Serves
Others…
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Contacts:
OFFICE OF
PHARMACY AFFAIRS
Pharmacy Services
Support Center
www.hrsa.gov/opa
1-800-628-6297
[email protected]
pssc.aphanet.org
Prime Vendor
Program
1-888-340-2787
[email protected]
www.340bpvp.com
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Thank You!
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