Introduction to 340B Drug Pricing Program
The 340B Drug Pricing Program resulted
from enactment of Public Law 102-585,
the Veterans Health Care Act of 1992,
which is codified as Section 340B of the
Public Health Service Act. Section 340B
limits the cost of covered outpatient
drugs to certain federal grantees, federally-qualified
health center look-alikes and qualified
disproportionate share hospitals. Significant
savings on pharmaceuticals may be seen
by those entities that participate in
this program.
The
Pharmacy Services Support Center
(PSSC) is a non-profit organization
based at the American Pharmacists Association
(APhA). This resource was established
in 2002 through a contract with HRSA to
assist eligible safety-net providers optimize
the value of the 340B Program. The organization’s
primary mission is to bring comprehensive
pharmacy services to patients at 340B-eligible
health care delivery sites to improve
medication use and advance patient care.
PSSC provides program guidance and free
technical assistance to all 340B covered
entities. To find out more, or to request
technical assistance, visit the PSSC
website or call 1-800-628-6297.
In
addition to the cost savings available
through the 340B Program, the 340B
Prime Vendor Program (PVP) provides
additional savings to 340B participants
registered with the Prime Vendor. The
PVP is managed by Apexus Inc.® (formerly
HPPI) through a contract awarded by HRSA.
The mission of the PVP is to improve access
to affordable medications for all 340B
covered entities. The program currently
provides access to 340B sub-ceiling prices
for over 2,800 drug products, access to
multiple wholesale distributors at favorable
rates, and access to other related value-added
products. The PVP is free to all 340B
covered entities, but the covered entity
must enroll in the PVP. For more information,
visit the PVP
website or call 1-888-340-2787.
Organizations
eligible for the 340B discount
(A)
Federally-qualified health center
(as defined in section 1905(l)(2)(B) of
the Social Security Act). This
category includes:
-
FQHC Look-alikes
- Consolidated
Health Centers (Sec.330(e) Public Health
Service Act)
- Migrant
Health Centers (Sec.330 (g) Public Health
Service Act)
- Health
Care for the Homeless (Sec.330(h) Public
Health Service Act)
- Healthy
Schools/Healthy Communities
- Health
Centers for Residents of Public Housing
(Sec. 330(i) Public Health Service Act)
- Office
of Tribal Programs or urban Indian organizations
(P.L. 93-638 and 25 USCS §1651)
(B) A family planning project
receiving a grant or contract under Sec.
1001 PHSA (42 USCS§3001)
(C)
An entity receiving a grant under subpart
II of part C of Title XXVI of the Ryan
White Care Act (RWCA) (relating
to categorical grants for outpatient early
intervention services for HIV disease)
- Early HIV Intervention Services Categorical
Grants (Title III of the RWCA)
(D)
A State-operated AIDS Drug Assistance
Program (ADAP) receiving financial
assistance under the RWCA
(E)
A black lung clinic receiving
funds under Section 427(a) of the Black
Lung Benefits Act (30 USCS§901)
(F)
A comprehensive hemophilia diagnostic
treatment center receiving a
grant under section 501(a)(2) of the SSA
(G)
A Native Hawaiian Health Center
receiving funds under the Native Hawaiian
Health Care Act of 1988 (42 USCS§11701)
(H)
An urban Indian organization
receiving funds under title V of the Indian
Health Care Improvement Act (25 USCS§1601)
(I)
Any entity receiving assistance under
title XXVI of the Social Security Act
(other than a State or unit of local government
or an entity described in subparagraph
(D)), but only if the entity is certified
by the Secretary
(J)
An entity receiving funds under section
318 (42 USCS §247c) (relating
to treatment of sexually transmitted diseases)
or section 317(j)(2)
(42 USCS§247b(j)(2)) (relating to
treatment of tuberculosis) through a State
or unit of local government, but only
if the entity is certified by the Secretary
(K)
A disproportionate share hospital
(as defined in section 1886(d)(1)(B))
of the SSA -
(i)
is owned or operated by a unit of State
or local government, is a public or
private non-profit corporation which
is formally granted governmental powers
by a unit of State or local government,
or is 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 under this title;
(ii) for the most recent cost reporting
period that ended before the calendar
quarter involved had a disproportionate
share adjustment percentage (as determined
under section 1886(d)(5)(F) of the Social
Security Act) greater than 11.75 percent
or was described in section 1886(d)(5)(F)(i)(II)
of such Act; and
(iii)
does not obtain covered outpatient drugs
through a group purchasing organization
or other group purchasing arrangement.
If
your organization is an eligible program
or DSH, you must submit a request
to participate to the Office of Pharmacy
Affairs (OPA) with your Medicaid billing
information and the appropriate form:
Keep
Covered Entity Information Up to Date
It
is very important that OPA have information
that is accurate and up to date, particularly
the covered entity's exact name and street
address. It is the responsibility of each
covered entity to contact the OPA with
any changes.
While the entity is eligible to participate
in the program by virtue of its status,
it must notify the OPA of its intention
to participate by completing and submitting
the appropriate registration form. Once
the OPA receives this information, the
entity will be eligible to receive pharmaceuticals
at the 340B discounted price at the beginning
of the next calendar quarter. The
quarterly deadlines for data submission
to OPA are December 1 for the quarter
beginning January 1; March 1 for the quarter
beginning April 1; June 1 for the quarter
beginning July 1; and September 1 for
the quarter beginning October 1.
It is the entity's responsibility to tell
its wholesaler or manufacturer that it
is registered for 340B discount prices
when it places an order.
If
you have any questions regarding this
program, please call the HRSA Pharmacy
Services Support Center, 800-628-6297.
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