Transcript HRSA`s Office of Pharmacy Affairs 340B Drug Pricing Program from

Office of Pharmacy Affairs
340B Drug Pricing Program
Bradford R. Lang JD, MPH
Public Health Analyst
US Dept. of Health and Human Services
Health Resources and Services Administration
Office of Pharmacy Affairs
Learning Objectives
• Describe HRSA’s Office of
Pharmacy Affairs’ (OPA) mission &
goals
• List the entity types that utilize the
340B Drug Pricing Program
• Describe the enrollment procedure
• List requirements & prohibitions of
the 340B Drug Pricing Program
Office of Pharmacy Affairs
Mission:
Promote access to clinically and
costeffective pharmacy services
340B/
Prime Vendor
Program
Patient Safety
and Clinical
Pharmacy Services
Collaborative
Program Administration
• Three Legs of the OPA/340B
Program
– Federal Team
– Pharmacy Services
Support Center
(PSSC/ PharmTA)
– 340B Prime Vendor
Program (PVP)
OPA/340B
Program
FEDS
What is the 340B Drug Pricing
Program?
• Section 340B of the Public Health Service Act
• Provides discounts on outpatient drugs to certain
safety-net covered entities
• Covered drugs are only for covered entity
patients
• Manufacturers that participate in Medicaid must
sign a Pharmaceutical Pricing Agreement (PPA)
that obligates them to participate in the 340B
program
HRSA Pharmacy Programs
• Pharmacy services in HRSA programs
& safety-net partners are growing
rapidly
> $6,000,000,000
340B purchases
340B Eligible Entities
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Federally Qualified Health Centers (FQHC)
Comprehensive Hemophilia Treatment Centers
Ryan White Programs (Parts A, B, C, D)
Sexually Transmitted Disease/Tuberculosis Programs
(STD/TB)
Title X Family Planning Clinics
Urban / 638 Tribal Programs
Federally Qualified Health Center Look-Alikes
(FQHC-LA)
Disproportionate Share Hospitals (DSH)
Children’s Hospitals – NEW September 2009
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New Entities in Health Care Reform
Covered Entity Non-profit/
DSH%
Type
govt contract
GPO
Exclusion
New Orphan
Drug
Provision
Applies
Estimated
Number of
Eligible
Hospitals
Children’s
Hospital
Yes
>11.75
Yes
Yes
85
Free-standing
Yes
Cancer Hospital
>11.75
Yes
Yes
5 – 12
Critical Access
Hospital
Yes
N/A
No
Yes
1233
Rural Referral
Center
Yes
>8
No
Yes
115
Sole Community Yes
Hospital
>8
No
Yes
175
Growth of Section 340B Covered Entity Sites
Program Benefits
• Average savings of 25-50% on outpatient
drug purchases for 340B covered entities
• Savings may be used to:
– Reduce price of pharmaceuticals for
patients
– Expand drug formularies
– Expand services offered to patients
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Program Prohibitions
• Diversion
– Drug provided to a non-patient
– Drug dispensed in an area of a larger facility that is
not included in the defined covered entity (e.g. an
inpatient service, a non-covered clinic)
– Non-covered services
• Duplicate Discounts
– 340B Discount + Medicaid Rebate on same drug
– Covered Entities must report Medicaid billing status to
OPA
Patient Definition
• Established relationship between covered entity
and individual (maintenance of the medical record)
• Responsibility for individual’s health care remains
with covered entity – not just provider of low-cost
medication
• Individual receives health care service or range of
services from the covered entity consistent with
grant funding
Patient Definition exemptions
• Disproportionate Share Hospitals are
exempt from last requirement since they
do not receive grant funding, however,
only integral parts of the hospital may
participate
• ADAPs are exempt; however, the State
establishes their own eligibility criteria for
identifying who is a “patient”
Federal Register Notice Pending
• Definition of Patient –72 FR 1543
– Clarifies previous FR Notice of October 1996
– Provides specific guidance and examples
– A clear and enforceable definition to help
ensure against diversion and support 340B
program integrity
Program Requirements
• Auditable Records
– Covered Entities must maintain auditable records
that demonstrate compliance with all Program
requirements.
– Subject to audit by government or the manufacturer.
• Updating entity records
– Covered Entities have an ongoing responsibility to
notify OPA of any change in eligibility.
– Covered Entities should also notify OPA of any
updates in their information.
Enrollment & Participation
• There are 3 suggested steps for 340B
participation:
– determine eligibility
– complete enrollment
– utilize resources
340B Enrollment
To participate, eligible providers must enroll
in the 340B program:
• Complete forms
• Submit forms to OPA
www.hrsa.gov/opa/dsh.htm
DEADLINES- 1 month before the start of the quarter
Eligibility Requirements for Disproportionate
Share Hospitals (DSH)
• DSH Adjustment Percentage >11.75% for most
recent cost reporting period
• Ownership:
– is owned or operated by a unit of State or local
government
– public or private non-profit corporation which is
formally granted governmental powers by a unit of
State or local government
– a private non-profit hospital which has a contract with
a State or local government
• Non-participation in GPO for Outpatient Drugs
New Entities in Health Care Reform
Covered Entity Non-profit/
DSH%
Type
govt contract
GPO
Exclusion
New Orphan
Drug
Provision
Applies
Estimated
Number of
Eligible
Hospitals
Children’s
Hospital
Yes
>11.75
Yes
Yes
85
Free-standing
Yes
Cancer Hospital
>11.75
Yes
Yes
5 – 12
Critical Access
Hospital
Yes
N/A
No
Yes
1233
Rural Referral
Center
Yes
>8
No
Yes
115
Sole Community Yes
Hospital
>8
No
Yes
175
340B Program Registration Form for DSH
340B Program Registration Form for DSH
340B Program Registration Form for DSH
340B Program Registration Form for DSH
340B Delivery Options
340B Eligible
Entities
Source: Dr. Barbara Brice, consultant, PSSC
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Contract Pharmacy Services
• The Covered Entity purchases the drug,
but “ship to - bill to” procedure may be
used.
• The Covered Entity retains legal title to all
drugs purchased under 340B. The
Covered Entity must pay for all 340B
drugs.
• The contract pharmacy is subject to audits
– diversion and duplicate discount
FRN on Contract Pharmacy
Effective April 5, 2010
• Contract Pharmacy –72 FR 1540
– Updates previous FR Notice of August,1996
– Builds upon experience with Demonstration
Projects
– Incorporates multiple contract pharmacies as
standard option
– Visit www.hrsa.gov/opa for details
340B Database
• Who can use the database?
 Manufacturers, wholesalers, contract
pharmacies, covered entities, the public
• How can we access the database?
 Go to our website at
http://opanet.hrsa.gov/opa/Login/MainMenu.aspx
OPA Website:
http://www.hrsa.gov/opa
How Do I Contact the OPA Team?
• OPA
1-800-628-6297
www.hrsa.gov/opa
www.hrsa.gov/patientsafety
• PSSC
1-800-628-6297
http://pssc.aphanet.org
• PVP
1-888-340-2787
http://www.340bpvp.com