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a trusted partner in Navigating the
complexities of the 340B world.
1
The Federal 340B Program was
established to benefit certain
federal grantee organizations
and hospitals that serve a high
proportion of low-income and
uninsured populations. The
purpose is to allow eligible
entities to “stretch scarce
resources” for the benefit of the
entities and ultimately the
disadvantaged patients that
they serve. However, eligible
2
entities quickly realize that
navigating the federal and state
regulations and guidelines
related to 340B operational
practices for 340B pharmacy
services, can be complex -
leaving many unanswered
questions.
Without a knowledgable and
reliable source of information,
entities are often left to go-it-
3
alone or to rely on vendors
for implementation and
compliance advice. However,
ultimately, the entity is
responsible for all operations
and compliance. We focus on
providing information and tools
so entities can build their own
in-house 340B expertise and
the capability to monitor and
audit 340B information and
reports.
EXPERIENCE YOU CAN TRUST
With over ten years of direct 340B compliance and business analysis experience, Demers & Associates
has worked with hundreds of entities across the spectrum nationally; hospitals, community health centers,
and Ryan White organizations, to name a few. Our role is to assist in implementation and compliance of
operations, but also leave the entity with information and resources to build the future efficiency and
success of the pharmacy program.
Pharmacy Consulting
Specializing in the
Federal 340B Program
Demers & Associates,
established in 2009, is a
trusted, independent
source of reliable
compliance and
operational
information.
DEMERS & ASSOCAITES, INC / DEBRA.DEMERS@DEMERSASSOCIATES.COM / 401.335.3784
1
Compliance and Integrity:
♦ Develop i6nternal
reporting and audit
processes
♦ HRSA audit
preparedness
evaluation and
improvement plan
♦ Monthly and quarterly
audit and reporting
♦ Entity enrollment,
registration, and
recertification support
340B Entity Pharmacy
Business Plan (for start-up or
existing program
expansion):
♦ Financial analysis
2
♦ Pharmacy ROI
♦ 340B training and
compliance review
♦ Policies and
procedures
♦ Assessment for
operational
improvement and
increased 340B
savings
♦ Integrity assessment
and 340B auditing
Contract pharmacy:
♦ RFP preparation and
review
♦ Analysis of RFP
submissions
♦ Pharmacy vendor
contracting review
♦ Contract Pharmacy
reporting and
auditing
Compliance and Integrity
Company Expertise
Since 2003, Debra Demers
has been focused on 340B
pharmacy program policy,
analysis and operations:
● Providing federal and state
340B policy guidance to
build and improve 340B
compliance of all entity
types.
● Complete external 340B
audit and compliance
assessment to assist in
understanding and
improving 340B compliance
and operations.
● Offering extensive
experience working with
state Medicaid programs to
navigate 340B billing
requirements and assist in
leveraging state – 340B
entity partnerships (win-win).

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Navigating the Complex 340B World

  • 1. a trusted partner in Navigating the complexities of the 340B world. 1 The Federal 340B Program was established to benefit certain federal grantee organizations and hospitals that serve a high proportion of low-income and uninsured populations. The purpose is to allow eligible entities to “stretch scarce resources” for the benefit of the entities and ultimately the disadvantaged patients that they serve. However, eligible 2 entities quickly realize that navigating the federal and state regulations and guidelines related to 340B operational practices for 340B pharmacy services, can be complex - leaving many unanswered questions. Without a knowledgable and reliable source of information, entities are often left to go-it- 3 alone or to rely on vendors for implementation and compliance advice. However, ultimately, the entity is responsible for all operations and compliance. We focus on providing information and tools so entities can build their own in-house 340B expertise and the capability to monitor and audit 340B information and reports. EXPERIENCE YOU CAN TRUST With over ten years of direct 340B compliance and business analysis experience, Demers & Associates has worked with hundreds of entities across the spectrum nationally; hospitals, community health centers, and Ryan White organizations, to name a few. Our role is to assist in implementation and compliance of operations, but also leave the entity with information and resources to build the future efficiency and success of the pharmacy program. Pharmacy Consulting Specializing in the Federal 340B Program Demers & Associates, established in 2009, is a trusted, independent source of reliable compliance and operational information. DEMERS & ASSOCAITES, INC / DEBRA.DEMERS@DEMERSASSOCIATES.COM / 401.335.3784
  • 2. 1 Compliance and Integrity: ♦ Develop i6nternal reporting and audit processes ♦ HRSA audit preparedness evaluation and improvement plan ♦ Monthly and quarterly audit and reporting ♦ Entity enrollment, registration, and recertification support 340B Entity Pharmacy Business Plan (for start-up or existing program expansion): ♦ Financial analysis 2 ♦ Pharmacy ROI ♦ 340B training and compliance review ♦ Policies and procedures ♦ Assessment for operational improvement and increased 340B savings ♦ Integrity assessment and 340B auditing Contract pharmacy: ♦ RFP preparation and review ♦ Analysis of RFP submissions ♦ Pharmacy vendor contracting review ♦ Contract Pharmacy reporting and auditing Compliance and Integrity Company Expertise Since 2003, Debra Demers has been focused on 340B pharmacy program policy, analysis and operations: ● Providing federal and state 340B policy guidance to build and improve 340B compliance of all entity types. ● Complete external 340B audit and compliance assessment to assist in understanding and improving 340B compliance and operations. ● Offering extensive experience working with state Medicaid programs to navigate 340B billing requirements and assist in leveraging state – 340B entity partnerships (win-win).