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Background
During the
first few years after enactment and implementation
of Section 340B, entities explored issues related
to eligibility and that of their patients, and looked
for ways to take advantage of the significant savings
they could experience by participating in the program.
Entities also became more familiar with the requirements
for providing a pharmacy service and discovered that
start up costs and the expertise required to set up
an in-house pharmacy operation often created considerable
burdens.
Community
Health Center groups, in particular, worked with the
pharmacy affairs office at HRSA to develop other options
for full participation in the 340B Program, including
provision of pharmacy services. As a result of these
discussions, HRSA published a final notice on August
23, 1996, that outlined guidance for setting up contracted
pharmacy arrangements between a 340B-eligible entity
and a local pharmacy. A growing number of community
pharmacists are taking advantage of the opportunities
for involvement in patient care in their community.
How
do I set up a Contracted Pharmacy?
Eligible entities can choose to contract with a local
pharmacy to provide pharmacy services for their patients.
In addition, entities that have more than one site
can contract with one pharmacy per delivery site.
The
Office of Pharmacy Affairs (OPA) will not review actual
contracts between 340B Covered Entities and Contracted
Pharmacies. Parties must have their own legal counsel
review all contracts or other legal documents to ensure
that all Federal, State and local requirements have
been met.
The agreement
between the covered entity and the pharmacy should
include those elements outlined in the Contract
Pharmacy Services Model Agreement. These
guidelines are designed to facilitate program implementation
in covered entities that wish to utilize contracted
pharmacy services to dispense 340B outpatient drugs
but do not have access to an "in-house"
pharmacy. A Sample
Contract is available as a reference tool.
Self
Certification Process
In order to ensure that drug manufacturers and drug
wholesalers recognize contracted pharmacy arrangements,
covered entities that elect to utilize a contract
pharmacy are required to submit to the OPA a self
certification that they have signed an agreement with
the contract pharmacy.
The agreement
must contain the provisions as noted in the Contracted
Pharmacy Services Guidelines. An
original, signed
Self
Certification Form must be sent to:
Office
of Pharmacy Affairs
5600 Fishers Lane
Parklawn Building, Mail Stop 10C-03
Rockville, MD 20857
Additional
Information about Contracted Pharmacy
The following
are PDF documents prepared or supported by the PSSC
that eligible or participating entities as well as
pharmacists may find useful in learning more about
contracted pharmacy. Please contact the PSSC
at 800-628-6297 or pssc@aphanet.org
if you have any questions about these materials.
Contracted
Pharmacy Services, by Katheryne Richardson,
PharmD, is one of nine sections taken from the ACU/PSSC
340B Pharmacy Resource Series and provides an overview
of contracted pharmacy services.
The
Bridge to 340B Comprehensive Pharmacy Services Solutions
in Underserved Populations, created by
Medpin and supported by PSSC, is a training manual
for pharmacists, medical directors, and managers at
safety net clinics across the country who are seeking
to better understand their options for improving the
value of their pharmacy-related services.
Implementing
a Comprehensive 340B Contracted Pharmacy Service,
created by Medpin and supported by PSSC,
is a helpful tool that focuses on implementing a comprehensive
340B contracted pharmacy service and is aimed at pharmacists
that are considering how to develop a closer business
relationship with 340B-eligible health care providers.
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