Transcript The 340B Drug Pricing Program: Your Guide to Participation

The 340B Drug Pricing Program:
The Basics
Paul Shank
Health & Human Services Consultant, Health Resources and Services Administration
Healthcare Systems Bureau, Office of Pharmacy Affairs
North Carolina Hospital Association
August 26, 2010
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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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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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340B Entity Eligibility
The eligibility to
purchase at the 340B
price belongs only to
the entities
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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
Prime Vendor
Audit
Resell/
Transfer
Prohibition
Duplicate
Discount
Prohibition
Disproportionate
Share Hospital
GPO
Exclusion
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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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CAH Pre-registration Checklist
Step 1. Verify Eligibility
Step 2. Identify 340B eligible out-patient settings and
services where 340B drugs will/may be used.
Step 3. Evaluate medication use trends for all 340B eligible
out-patient settings to determine financial impact.
Step 4.Determine if 340B medications will be used for
Medicaid patients.
Step 5. Consider pharmacy service model and operational
systems.
Step 6. Consider 340B PVP participation by visiting:
https://www.340bpvp.com/public/
Step 7.Complete 340B Registration Forms found at
https://opanet.hrsa.gov/OPA/Registration/RegistrationMain.aspx
Step 8. Request Free Technical Assistance for
implementation!
Contact PSSC with any questions (1-800-628-6297 or
[email protected]).
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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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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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Duplicate Discounts
on 340B Drugs
340B & Medicaid: Avoiding
Duplicate Discounts
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Duplicate Discounts
on 340B Drugs
When does a duplicate discount occur?
A duplicate discount occurs when the same drug is:
Purchased with an up-front
340B discount
And
Credited with a back-end
transaction Medicaid rebate
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340B Enrollment
Form
A 340B covered entity is required to indicate
on the 340B Enrollment Form if it intends to
bill Medicaid for Drugs purchased at 340B
prices.
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Billing Medicaid
• “If a drug is purchase by or on behalf of a Medicaid
beneficiary, the amount billed may not exceed the
entity’s actual acquisition cost for the drug, as
charged by the manufacturer at a price consistent
with the Veterans Health Care Act of 1992, plus a
reasonable dispensing fee established by the State
Medicaid agency.”
– ftp//ftp.hrsa.gov/bphc/pdf/opa/FR05131994.pdf, pg. 25112
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Time for a Poll!
Do you currently have an outpatient/retail pharmacy?
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An Overview
• The desire to increase patient access to
affordable medications.
• Entity contracts with one pharmacy per site.
• Entity purchases and owns the medications.
• The contract pharmacy provides
professional, administrative, and clerical
services.
• Detailed receiving/dispensing records.
• Diversion prevention tracking system.
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Implementation
• Form a Pharmacy Project Team.
• Establish Project mission and philosophy.
• Complete 340B Program application.
• Complete pharmacy needs assessment.
–Should you consider an outside pharmacy
management vendor?
• Evaluate potential contract pharmacies.
–RFP if needed
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Time for a Poll!
Do you have space, expertise, and resources
to build a retail pharmacy in your facility?
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Implementation:
Evaluating the Pharmacy
• Consider the importance of comprehensive
pharmacy services as an integral component of
primary health care.
• Comprehensive pharmacy services include patient
access to affordable pharmaceuticals, application of
"best practices" and efficient pharmacy
management and the application of systems that
improve patient outcomes through safe and
effective medication use.
• How will your contract pharmacy meet your needs
for comprehensive pharmacy services?
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Time for a Poll!
Do you have a pharmacy in your area that could be contracted
to dispense 340B drugs?
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Implementation
• Select a wholesaler.
• Sign Prime Vendor Program agreement.
• Develop an audit plan.
• Develop a formulary system.
• Develop a Policy and Procedures Manual.
• Choose pharmacy, negotiate contract,
submit the Self-certification Form.
(ftp://ftp.hrsa.gov/bphc/pdf/opa/CPSelfCert.pdf)
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“The Flow”
Entity
Money Collects:
Flow
- Payments collected
by pharmacy
Drug
Flow
Pays:
- Wholesaler for drugs
-Contract pharmacy a
per prescription
dispensing fee
-Admin fees as
negotiated
- Opens account with
wholesaler as a bill to
ship to arrangement
Wholesaler
Contract Pharmacy
Collects:
Collects:
- Money from - A per prescription
entity
dispensing fee from entity
- Patient payments
- 3rd party reimbursement
on behalf of entity
Pays:
- Collections due to the
entity
- Delivers
drugs to
contract
pharmacy
Patient
Pays:
- Pharmacy
amount due for
prescription as
determined by
entity
- Dispenses drugs to
- Receives drugs
patients
from contract
- Manages and stores drug pharmacy
inventory owned by entity
- Often orders drugs on
entity’s behalf
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The Patient Safety & Clinical Pharmacy Services
Collaborative (PSPC) 2.0
• The mission of this Collaborative is to advance the delivery of
world class care by spreading the integration of clinical
pharmacy services and patient safety principles to improve
health outcomes in safety-net populations.
• HRSA invites you to form a team with other health care
organizations in your community to take part in this exciting
and unprecedented opportunity!
• The PSPC Participation Package is NOW available at
www.hrsa.gov/patientsafety.
• Don’t delay, the deadline to submit a completed Participation
Packages is July 31, 2009!
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What if?
• What if we would like to have more than
one contract pharmacy per site?
• What if we have an in-house pharmacy that
we would like to supplement?
• What if…..?
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Medicaid, Medicare & Third-Party Payers
How does 340B work with these various payers?
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Time for a Poll!
What is your OUTPATIENT Medicaid volume?
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Time for a Poll!
What is your Medicaid MCO volume for Medicaid patients?
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Time for a Poll!
What is your OUTPATIENT Medicare volume?
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Help!
Health Resources and Services Administration
Pharmacy Services Support Center at
American Pharmacists Association
PSSC Call Center:
(202) 429-7518
Or
(800) 628-6297
Email: [email protected]
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