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Q:
Can our facility use other drug discount purchasing
programs in addition to 340B?
A:
For the most part, the 340B program does
not prevent a health center or other participating
entity from using additional discount purchasing programs
in addition to the 340B program. However, you do need
to be aware that a Medicaid rebate may not be sought
for a drug that was purchased through the 340B Drug
Pricing Program. The participating entity must make
sure it has a mechanism in place to prevent this type
of "duplicate discount" from occurring,
so the manufacturer is not providing both a 340B discount
on the front end of the transaction, as well as a
Medicaid rebate on the back end. The exception
is that disproportionate share hospitals are not permitted
to participate in a GPO or other group purchasing
arrangement for
covered outpatient drugs.
Q:
A manufacturer that our facility would like to purchase
from says that they are not accepting any new clients
for the current quarter. Can they do this?
A:
No. If your facility is currently participating
in the 340B Drug Pricing Program for the present quarter
and listed in the 340B participating entity database
posted on the Office of Pharmacy Affairs web site,
the manufacturer cannot deny your facility 340B pricing
for covered drugs specific to your grant. Please direct
the manufacturer to the HRSA Pharmacy Services Support
Center (800-628-6297) if they have questions.
Q:
If a clinic is enrolled in 340B as an FQHC, but also
wants to receive 340B pricing as a Title X clinic,
does the clinic have to re-enroll in 340B as a Title
X clinic?
A:
If a clinic receives Title X funding and
is already enrolled in the 340B Program as a Federally
Qualified Health Center, but also wants to receive
340B pricing as a Title X clinic, the clinic should
enroll in the 340B Program a second time, even though
it will create two records in the 340B Program database.
It is important when a clinic is purchasing a drug
that the Drug Company or wholesaler be able to identify
that the clinic is eligible to purchase that particular
drug for the Title X grant project.
Q:
Do we have to opt out of our Group Purchasing Organization
for inpatient drugs?
A:
The disproportionate share hospital Group
Purchasing Organization prohibition only applies to
outpatient purchase. You only have to opt out your
GPO for outpatient drugs.
Q:
How come the effective date of our contracted pharmacy
arrangement is different from what we submitted? How
can we find out our effective date?
A:
The Office of Pharmacy Affairs will send an email
notification that will give the effective date of
the arrangement to the covered entity and the contracted
pharmacy. Do not assume that the date that the organization
submitted is the effective date. If possible, OPA
staff will enter the contracted pharmacy arrangement
in the database as soon as the information is verified.
Q:
How will I know that my entity has been accepted into
the 340B Program?
A:
The Office of Pharmacy Affairs will always
send an EMAIL confirmation to the contact person listed
on the enrollment forms of the covered entity IF an
email address has been provided. If a covered entity
does not receive an email confirmation that the entry
has been made in the 340B database, it should not
assume that everything is okay. The Office of Pharmacy
Affairs no longer mails confirmation letters of enrollment.
Q:
What do I need to do to participate in the 340B Drug
Pricing Program?
A:
Entities must register their facilities
with the Office of Pharmacy Affairs. Go to the PSSC
web site at http://pssc.aphanet.org
and click the link “About The 340B Program” and
select Registration Forms. Find the form(s) indicated
for your entity type and send the completed form to
the Office of Pharmacy Affairs. Should you require
assistance in locating the form for your entity type,
please contact the PSSC . STD and TB entities must
work through their state program directors. For more
information, please contact the PSSC (http://pssc.aphanet.org)
at 1-800-628-6297 or email at pssc@aphanet.org
Q:
What is the certification process for STD/TB entities?
A:
Clinics meeting the requirements for 340B-eligibility
as Sexually Transmitted Disease and Tuberculosis entities
must apply for the 340B Drug Pricing Program through
their CDC state program director. The recertification
process takes place in the last calendar quarter each
year.
Different
states operate the application process differently:
(1) some states certify the entire state or a local
health department. That department then serves as
the provider and supplies the individual clinics with
the STD/TB medications or (2) the program director
certifies individual entities and/or health departments.
All certified entities (both by state and individual
sites) are certified through the Centers for Disease
Control and Prevention (CDC). The approved entities
are listed in the 340B entity database.
The
annual certification process begins with e-mailed
information and instructions from PSSC and the CDC
in October of each year. PSSC manages this process
and additional information can be provided by PSSC
staff at cdc.pssc@aphanet.org.
Q:
Who signs the state/local government contract form
for DSH facilities?
A:
Any supervising official at the state or
local government can sign the form. Typically, a county
commissioner or your health departments are good places
to start in order to find out who signs the form.
Q:
What does it mean when a hospital is “formally granted
governmental powers” as it relates to eligibility
for participating in 340B?
A:
A DSH is said to be “formally granted governmental
powers” when the State formally delegates to
the DSH a type of power(s) usually exercised by the
State, for the purpose of providing health care
services to the medically indigent population of the
State. The determination of whether or not a
DSH meets eligibility for 340B based on “formally
granted governmental powers” will be evaluated by
OPA on a case-by-case basis.
Q:
Why does the Office of Pharmacy Affairs require our
Medicaid billing number?
A:
Covered
entities that fill Medicaid patient
prescriptions with 340B drugs must provide the
Office of Pharmacy Affairs (OPA) with their
Medicaid provider number, which is placed in an
exclusion file. OPA posts it on the OPA web
site
(http://opanet.hrsa.gov/opa/Login/ExclusionFiles.aspx)
to ensure that the state does not request a
Medicaid rebate from a manufacturer for the
already discounted 340B drugs. Section 340B
requires entities to have a process in place to
prevent this illegal double discount– that is,
where the manufacturer provides both a 340B
discount on the front end of the transaction,
and a Medicaid rebate on the back end of the
transaction.
However, if a facility is "carving out"
Medicaid patients from their 340B program
activities (and therefore, purchasing drugs
at a non-340B price for their Medicaid
patients), the facility's provider number
is not placed in the exclusion file, the
entity is reimbursed according to the state
Medicaid rates, and the state agency
includes the transaction in its calculations
for manufacturer rebate.
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