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Q:
What drugs are covered under the 340B Drug Pricing
Program?
A:
“Covered outpatient drugs” under the 340B
Drug Pricing Program can include any drug used in
an outpatient setting, except vaccines. Both prescription
drugs and over-the-counter (OTC) drugs for which a
prescriber writes a prescription can be covered by
the 340B program, or purchased by covered entities
at or below the 340B statutory ceiling price. Medical/surgical
supplies are not covered, except that Family Planning
clinics (receiving Title X grant funding) can receive
340B rates for contraceptive intrauterine devices
(IUD). Also, the 340B Prime Vendor Program has negotiated
special pricing on some medical supply products for
participating entities.
Q:
I heard that inpatient drugs are now included in the
340B Drug Pricing Program for DSH facilities?
A:
No, this is not correct. It is important
to note that the 340B program can only be used for
purchases of outpatient drugs and this continues to
be the case. However, under the new Medicare law,
Disproportionate Share Hospitals (DSHs) participating
in the 340B program now have their inpatient drug
purchases excluded from the Medicaid "best price"
calculation. DSHs still cannot purchase their inpatient
drugs under the 340B program, but drug manufacturers
now have more incentive to choose to provide discounts
on these drugs to participating 340B DSHs.
Q:
Is there a pricing list to figure out the cost of
drugs?
A:
No. Manufacturers consider 340B pricing
to be proprietary information and have challenged
attempts to disclose it beyond CMS (Centers for Medicare
& Medicaid Services). Entities can estimate the
340B price by taking 50% of the Average Wholesale
Price (AWP), the average 340B discount found in studies
on the pricing. The AWP is a public number found in
resources like the REDBOOK. The actual price may be
lower or higher than this, however. Entities can also
work directly with a manufacturer or wholesaler to
determine 340B prices. Entities may also wish to work
with the 340B Prime Vendor, HPPI, to ensure that they
are receiving a 340B price. To learn more about the
340B Prime Vendor Program for 340B covered entities,
visit our web site at: http://pssc.aphanet.org/about/primevendor.htm
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Q:
Where can I get a list of prime vendor suppliers and
distributors?
A:
If you go to the prime vendor web site at
www.340bpvp.com
you can find a listing of suppliers and distributors.
Q:
Does the Office of Pharmacy Affairs post the pricing
information on the web site?
A: No. Manufacturers consider 340B pricing
to be proprietary information that should be protected
between the drug manufacturers and CMS (Centers for
Medicare & Medicaid Services). Entities can estimate
the 340B price by taking 50% of the AWP. The AWP is
a public number found in resources like the REDBOOK.
However, many entities receive sub-ceiling 340B prices
on drugs, meaning the entities receive pricing that
is significantly lower than the minimum discount the
manufacturer is required to provide. Entities can
also work directly with a manufacturer or wholesaler
to determine 340B prices.
Q:
I'm calling from a drug manufacturing company. We
recently lowered our 340B price for a covered drug.
Are we allowed to raise the 340B price back up to
the ceiling price even after we have lowered it?
A: The price can always be lowered during
any given quarter, but the price cannot be raised
until the start of the next quarter, and can never
be raised above the 340B ceiling price for that quarter.
Q:
We have patients who have commercial (third party)
insurance. Are those patients eligible to receive
340B drugs or is the 340B Drug Pricing Program just
for the uninsured?
A: The covered entity can use 340B drugs
for all patients of the facility. For commercially-insured
patients, the entity can bill the insurance company
at the rate that they will pay. The 340B Program law
and guidelines do not dictate how the entity is to
bill third parties or address how reimbursement amounts
are to be used. An entity should take its entire payor
mix, including third party insurance coverage, into
account as they set sliding scale co-payment fees,
and plan for other health care services.
Q:
May I continue to bill Medicaid for 340B outpatient
drugs used on Medicaid patients?
A:
Yes, but you may
only bill 340B-purchased drugs at the
acquisition price plus the dispensing fee
established by the State Medicaid Agency. Some
entities choose to purchase "off 340B contract,"
which is termed "carving out Medicaid." An
entity that carves out Medicaid would NOT have
to bill at the acquisition cost, but could bill
at the negotiated rate.
Q:
What is the Medicare DSH add-on payment?
A:
The Medicare payment add-on, or the Medicare
Disproportionate Share Adjustment, is an additional
Medicare payment to hospitals which treat a high percentage
of low-income patients. The factors used to calculate
this adjustment are the sum of the ratios of Medicare
Part A Supplemental Security Income (SSI) patient
day to total Medicare patient days, and Medicaid patient
days to total patient days in the hospital. For more
information, please contact the Centers for Medicare
& Medicaid Services (CMS) and/or visit this web
site: http://cms.hhs.gov/statistics/feeforservice/dsh/default.asp
.
Q:
Can you tell me how to calculate the Medicaid drug
pricing rebate?
A:
Visit the Center for Medicare and Medicaid
at http://www.cms.hhs.gov/ and go to the Medicaid
section. If your questions are not answered there,
you can call them toll free at 877-267-2323.
Q:
Can you give me information on inpatient pricing?
A:
Hospitals that participate in the 340B Drug
Pricing Program may have their inpatient drug purchases
excluded from the Medicaid Best Price calculation.
The intent of this exclusion is to allow manufacturers
to extend 340B-equivalent pricing on inpatient drugs
without lowering their Medicaid Best Price. There
is no additional inpatient drug application process
you need to go through at HRSA to obtain the lower
prices on inpatient drugs. It is up to the manufacturer
to decide whether it wants to lower its prices for
these participating DSH entities.
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