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Q:
Do
critical access hospitals qualify for the 340B Program?
A:
Critical access hospitals do not qualify
for the 340B Drug Pricing Program because they do
not have a Medicare DSH Adjustment Percentage.
Q:
How would I know if my facility qualifies as a Disproportionate
Share hospital?
A: To be eligible to participate in the 340B
Drug Pricing Program as a disproportionate share hospital
(DSH), the hospital must meet three requirements:
1.
The hospital must have a Medicare DSH Adjustment Percentage
greater than 11.75%.
2.
The hospital must:
a.
Be owned or operated by a unit of State or local
government or
b.
Be a public or private non-profit corporation which
is formally granted governmental powers by a unit
of State or local government; or
c.
Be a private non-profit hospital which has a contract
with a State or local government to provide health
care services to low income individuals who are
not entitled to benefits under title XVIII of the
Social Security Act or eligible for assistance under
the State plan of this title
3.
The hospital must opt out of its Group Purchasing
Organization for its covered outpatient drug purchases.
The
Center for Medicare and Medicaid Services (CMS) determines
your DSH Adjustment Percentage, based on information
submitted by your Fiscal Intermediary. CMS, in turn,
provides a list with the percentages to HRSA's Office
of Pharmacy Affairs on a quarterly basis. This list
must show a DSH Adjustment Percentage of at least
11.75% for OPA to consider your facility eligible
for the 340B Program.
Q:
Which patients are eligible? Do they have to be below
a certain income level?
A:
The 340B Program does not have any income
requirements. Any patient of a participating 340B
entity is considered a 340B patient provided the entity
maintains control of the patient's medical records
and has the primary responsibility for the patient's
care. For more information, please refer to the October
1996 Final Notice Regarding Section 602 of the Veterans
Health Care Act of 1992 Patient and Entity Eligibility.
ftp://ftp.hrsa.gov/bphc/pdf/opa/FR10241996.pdf
.
Q:
Are there any circumstances in which a mental health
center would qualify to participate in the 340B Program?
A:
No free standing mental health facility
can qualify under the 340B drug pricing program as
an eligible entity, because mental health facilities
were not included in the 340B legislation; however,
there are special cases where programs can participate:
1.
If a mental health outpatient clinic is listed on
a Disproportionate Share Hospital's Medicare cost
report then that program can participate under the
larger entity.
2.
If a Community Health Center (under a 330 grant)
has a mental health program that is a part of the
facility, then mental health services can be provided
and 340B drugs purchased.
In
other cases, a Community Health Center may make a
referral to a mental health facility, but ultimately
the responsibility for care lies with the CHC and
would require the patient to return to the CHC's pharmacy
for a prescription
Q:
Under the 340B Program, are inmates of jails eligible
to participate as 340B patients? Are the jails considered
eligible entities?
A:
Jails cannot be considered 340B eligible
entities under the 340B legislation. Only if residents
of the jail are patients of an eligible covered entity,
then the patients can gain access to 340B drugs, but
the jail facility itself cannot participate in the
340B Drug Pricing Program.
In
only a few cases, jails have been able to fall under
the designation of a disproportionate share hospital.
In these cases, the jails are listed as outpatient
facilities on a hospital's Medicare Cost Report and
the physicians of the hospitals provide care to the
inmates. The inmates are considered patients of the
hospital.
Q:
Can we use 340B drugs on our Medicaid and Medicare
patients?
A:
Any individual that meets the definition
of a “patient” of a covered entity is eligible to
receive covered out patient drugs purchased under
the 340B program. An individual is considered a 340B
patient provided the entity maintains control of the
patient's medical records and has the primary responsibility
for the patient's care. For more information, please
refer to the Final Notice Regarding Section 602 of
the Veterans Health Care Act of 1992 Patient and Entity
Eligibility, issued on October 1996. http://pssc.aphanet.org/pdfs/FR10241996.pdf.
However,
when an entity is providing 340B drugs to its Medicaid
patients, the entity must have a process in place
to avoid a duplicate 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. This type of duplicate
discount is prohibited under 340B(a)(5) of the Public
Health Service Act. Under guidelines issued by the
Secretary, covered entities that purchase 340B drugs
for their Medicaid patients must bill Medicaid at
Actual Acquisition Cost (AAC) plus the state allowable
dispensing fee. The HRSA Office of Pharmacy Affairs
sends the state Medicaid agency your Pharmacy Medicaid
Provider Number in an exclusion file, and directs
the state not to seek a Medicaid rebate on your drug
transactions. The exclusion file is a reference for
the state Medicaid agencies to use to avoid double
dipping.
Instead
of this process, HRSA guidelines allow entities to
“carve out” its Medicaid patients from the 340B Program,
and not use 340B drugs for its Medicaid patients.
Under this scenario, Medicaid prescriptions are filled
with drugs purchased at market cost, the entity's
provider number is not placed in the exclusion file,
and the state agency knows that it is free to pursue
the Medicaid rebate from the manufacturer.
For
more information, please refer to the Final Notice
Regarding Section 602 of the Veterans Health Care
Act of 1992 Duplicate Discounts and Rebates on Drug
Purchases – June 231993.
ftp://ftp.hrsa.gov/bphc/pdf/opa/FR05071993b.pdf.
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