|
July
2005
Table
of Contents
Introduction
Part I: Major Elements of the PHS
Drug Pricing Program
- Brief
history of the development of 340B
- Main
Provisions of the 340B Legislation
- The
Office of Pharmacy Affairs (OPA)
- The
Pharmaceutical Pricing Agreement
-
The Covered Entity Database
- Program
Guidelines
- How
340B Discounts Help Covered Entities Improve
Services
- Technical
Assistance
- Prime
Vendor Program
- Grant
Statement
- Alternative
Method Demonstrations
Part
II: Guidance for Hemophilia Treatment Centers
- Deciding
Whether to Register as a Covered Entity
- Submitting
the Necessary Information to be a Covered Entity
- Confidential
Drug Pricing Information
- Avoiding
Duplicate Discounts/Rebates
- Avoiding
Drug Diversion
- Audit
Requirements
- Dispute
Resolution
- What
to Do If Factor Replacement Products Are Not
Available at 340B Prices
-
Freedom of Choice Regarding FRP
and Avoidance of Conflict of Interest
-
Contract Pharmacy Services
- Billing
Private Insurance Carriers
- Using
340B Income
- Role
of the OPA
- Role
of the GSB
- Role
of Regional Grantees
Part
III: Appendices
Appendix A: Section 340B of the
Public Health Service Act
Appendix B: Pharmaceutical Pricing
Agreement (PPA)
Appendix C: Compilation of Published
HRSA Guidelines
- General
Guidance
- Duplicate
Discounts and Rebates on Drug Purchases
- Entity
Guidelines
-
DSH Outpatient Facility Guidelines
- New
Drug Pricing
- Definition
of a Patient
- Contract
Pharmacy Services
- Manufacturer
Audit Guidelines
- Dispute
Resolution Process
- The
State ADAP Section 340B Rebate Option
- Program
Guidance Clarification re Mechanism to Prevent
Duplicate Discounts
Appendix D: Grants Management
Documents re Program Income
- Sections
of the HHS Grants Management Regulation
- Sections
of the PHS Grants Policy Statement
- Letter
to Grantees dated May 23, 2003
Introduction
This
manual has been prepared by the U.S. Department
of Health and Human Services (HHS), Health Resources
and Services Administration (HRSA), Maternal and
Child Bureau (MCHB), Division of Services for
Children with Special Health Needs (DSCSHN), Genetic
Services Branch (GSB) to provide guidance and
reference material for Hemophilia Treatment Centers
(HTCs) eligible to participate in the Drug Pricing
Program authorized by section 340B of the Public
Health Service Act (PHS Act). It provides information
on the authorizing legislation, the program’s
method of operation, and specifics on how HTCs
can become approved covered entities and make
effective use of 340B discounts while complying
with its statutory requirements. The manual does
not establish policy for either the HTC Grant
Program or the 340B Drug Pricing Program. Its
purpose is to provide background information and
practical advice on how HTCs can operate in compliance
with 340B policy and related HTC program policy.
Although GSB will update this manual to incorporate
new policy developments, HTCs should make use
of the information resources listed below to keep
up to date with new developments as they occur,
especially on the Web site for the Health Resources
and Services Administration, Healthcare Systems
Bureau (HSB), Office of Pharmacy Affairs (OPA)
.
The
manual is divided into three main sections:
-
The first section provides a general description
of the 340B program, its history and how it
is administered by the OPA.
-
The second section provides specifics on how
the 340B program can be used by HTCs, emphasizing
the aspects of the program which are most likely
to concern them.
-
The third section is made up of four appendices:
- The
complete text of section 340B of the PHS
Act
- The
current version of the Pharmaceutical Pricing
Agreement (PPA) which manufacturers must
sign to continue to participate in the Medicaid
program
- A
compilation of all of HRSA’s 340B
program guidelines published to date
- Grants
management guidance concerning program income.
General
Information Resources
References
are made throughout the manual to accessing information
and advice from two key HRSA organizations, OPA
in HSB and GSB in MCHB. In addition, through
a contract managed by OPA, the HRSA Pharmacy Services
Support Center (PSSC) is now handling routine
inquiries about the 340B program. The following
addresses should be used to acquire information
from these organizations:
OPA:
Web site: http://www.hrsa.gov/opa
General phone number: (301) 593-4353
HRSA PSSC:
2215 Constitution Avenue, NW
Washington, DC 20037
Web site: http://pssc.aphanet.org
E-mail address: pssc@aphanet.org
Use
the web site to register with the PSSC to receive
information on new events and developments in
the 340B program and gain access to other online
resources.
General
phone number: 1-800-628-6297
MCHB
GSB:
General phone number: (301) 443-1080
MCHB Web site: http://mchb.hrsa.gov
Part
I: The Major Elements of the Public Health Service
Drug Pricing Program
A.
Brief history of the development of 340B
The
340B Drug Pricing Program was established by Section
340B of the PHS Act which requires drug manufacturers
to provide discounts or rebates to a specified
set of U.S. Department of Health and Human Services
(HHS) assisted programs and hospitals that meet
the criteria in the Social Security Act (SSA)
for serving a disproportionate share of low income
patients. It was enacted on November 4, 1992
as part of the Veterans Health Care Act of 1992
(VHCA92). This legislation was a follow-up to
the Medicaid Drug Rebate Program (MDR Program)
enacted as part of the Omnibus Budget Reconciliation
Act of 1990 (OBRA90).
The
MDR Program requires manufacturers to give Medicaid
a rebate of 15.1 percent of the average manufacturer’s
price (AMP) or the AMP less the best manufacturer’s
price (BMP), whichever is lower. As originally
enacted, the calculation of BMP included sales
to directly operated Federal health care programs
such as the medical systems operated by the Department
of Veterans Affairs (VA) and the U.S. Department
of Defense (DoD). As a result, drug manufacturers
were reluctant to continue to sell drugs to direct
Federal health care programs at the very advantageous
prices they had in the past because it could increase
the rebates they had to pay to Medicaid. Overall,
prices paid for drugs by directly operated Federal
health care programs rose after the enactment
of OBRA 90.
Sections
601 and 603 of VHCA92 corrected the problem for
direct Federal health care programs by removing
their drug sales from the calculation of BMP and
mandating minimum price reductions for purchases
made by the VA for its own and other Federal health
care operations. Section 602 of VHCA92 created
section 340B of the PHS Act which provides ceilings
on outpatient drug prices for certain HHS programs
and disproportionate share hospitals. These sales
were also excluded from the calculation of BMP.
See Appendix A for the text of 340B.
B.
Main Provisions of the 340B Legislation
Agreements
with manufacturers
As
a condition for continued participation in Medicaid,
drug manufacturers must sign an agreement with
the Secretary of HHS requiring their sales to
the covered entities to be at or below the ceiling
prices mandated by section 340B. Failure to sell
covered drugs at these prices could result in
a manufacturer being prohibited from receiving
payments for its products from the Medicaid program.
Ceiling
prices
For
single source and innovator, multiple source drugs,
the 340B ceiling price is the average manufacturer
price (AMP) reduced by the Medicaid rebate percentage.
For over-the-counter and generic drugs, the 340B
ceiling price is the AMP reduced by 11 percent.
The AMP is a term developed for the Medicaid Rebate
Program (MR Program) and is defined in section
1927 of the Social Security Act (SSA). In general,
the AMP is based on the weighted average of prices
paid by wholesalers for drugs distributed to the
retail pharmacy class of trade. It excludes sales
to Federal health care systems and the covered
entities.
The
covered entities
The
law designates the following selected grantees
as eligible to be covered entities if they receive
funds from the programs specified in 340B:
-
Community Health Centers
-
Migrant Health Centers
-
Homeless Health Centers
-
Public Housing Health Centers
-
Black Lung Clinics
-
Native Hawaiian Centers
-
School-based Health Centers
-
HIV Early Intervention Projects
-
AIDS Drug Assistance Programs
-
Other Ryan White AIDS Projects
-
Hemophilia Treatment Centers (HTCs)
-
Tribal Health Centers
-
Urban Indian Health Centers
-
Sexually Transmitted Disease Clinics
-
Tuberculosis Clinics
-
Title X Family Planning Clinics
The
law also defines two types of non-grantees as
eligible to be covered entities:
- Federally
Qualified Health Center Look-Alikes recognized
by HRSA
-
Disproportionate Share Hospitals if they
- Carry
out certain specified State or local government
health care programs
- Have
a disproportionate share adjustment percentage
greater than 11.75 percent
- Do
not participate in any group purchasing
arrangements for covered outpatient drugs
Requirements
for covered entities
A
covered entity must comply with the following
statutory requirements to access 340B discounts:
-
Not request a discount for a drug subject to
a Medicaid rebate; the Secretary established
a mechanism to ensure compliance before the
statutory deadline of one year after enactment
(See page 23 for the details of how the mechanism
works.)
-
Not resell or otherwise transfer a discounted
drug to a person who is not a patient of the
entity
-
Permit the Secretary and manufacturers to audit
entity records pertaining to the drug in question,
in accordance with procedures established by
the Secretary, to ensure compliance with the
first two requirements
-
Repay the manufacturer the amount of 340B discounts
received for any violations of the first two
requirements, if the manufacturer seeks restitution
Other
provisions
-
The Secretary is required to
- Develop
and implement a process for the certification
of certain eligible tuberculosis and sexually
transmitted disease clinics and non-governmental
entities participating in the programs established
by Titles I and II of the Ryan White CARE
Act, excluding AIDS Drug Assistance Programs
(ADAPs)
- Develop
a prime vendor program to serve the covered
entities
-
Notify manufacturers and State Medicaid
agencies of the identity of the covered
entities
-
Manufacturers are not prohibited from charging
a price for a drug that is lower than the maximum
price that may be charged under 340B.
C.
The Office of Pharmacy Affairs
(OPA)
Shortly
after the enactment of section 340B in 1992, the
responsibility for administering the law was assigned
to HRSA. To carry out this task, HRSA established
the Bureau of Primary Health Care (BPHC), Office
of Drug Pricing (ODP). In June, 2000, the mission
of the office was broadened to include more general
assistance for pharmacy programs and its name
was changed to the Office of Pharmacy Affairs
(OPA). In February 2003, OPA was moved to a new
Division of Health Care Development (DHCD) and
became the Pharmacy Affairs Branch (PAB). In
September 2004, PAB was moved to the Healthcare
Systems Bureau (HSB) as the Office of Pharmacy
Affairs (OPA).
The
mission and functions for OPA are as follows:
As
the primary pharmacy resource for HHS health care
programs, OPA promotes universal access to clinically
and cost effective pharmacy services by:
- maximizing
the value of the 340B Program for eligible entities
by
-
managing the Pharmaceutical Pricing Agreement
with pharmaceutical manufacturers who participate
in the Medicaid program,
-
maintaining a database of covered entities
and organizations eligible to become covered
entities, including status of certifications,
where required,
-
publishing guidelines and/or regulations
to assist covered entities, drug manufacturers,
and wholesalers to use the Drug Pricing
Program (DPP) and comply with the requirements
of section 340B,
-
implementing and overseeing the 340B Prime
Vendor Program (PVP) that provides drug
distribution and price negotiation services
for the covered entities,
-
coordinating the 340B implementation activities
of programs in HRSA, the Centers for Disease
Control and Prevention (CDC), the Indian
Health Service (IHS), and the Office of
the Assistant Secretary for Health’s
(OASH) Office of Public Health and Science
(OPHS) that provide support to entities
eligible to access the DPP,
-
providing a full range of technical assistance
to eligible and participating entities,
-
working with the Centers for Medicare and
Medicaid Services (CMS) and the Department
of Veterans Affairs (VA), which operate
related drug rebate and discount programs,
to coordinate policies and operations, and
-
maintaining liaison with grantee associations,
professional organizations, the pharmaceutical
industry, and trade associations concerning
drug pricing and pharmacy issues,
- supporting
HRSA health centers, States, and other delivery
systems as they develop quality programs for
affordable drug benefits through
-
managing clinical pharmacy demonstration
projects,
-
assisting health centers and other grantees
to make optimum use of resources available
for pharmacy services,
- demonstrating
innovative methods of delivering pharmacy
services, and
- providing
technical assistance to grantees, States,
local governments, and other health care
delivery systems to plan and implement pharmacy
services,
- serving
as a Federal Government resource for pharmacy
practice through
-
developing and maintaining cooperative relationships
with national pharmacy and governmental
organizations to share information and build
infrastructure for safety-net providers,
- compiling
and marketing pharmacy “models that
work” for States and communities,
- developing
a technical assistance center for pharmacy
practice, and
- providing
model pharmacy products (such as sample
contracts and business plans) for safety-net
health care providers, and
- carrying
out special projects as assigned by the Administrator.
Information
about the 340B Program and other pharmacy program
developments can be obtained from the OPA Web
site at .
Pharmacy
Services Support Center (PSSC)
OPA’s
ability to carry out its mission was enhanced
through the award of a 5-year contract at the
end of FY 2002 to the American Pharmacists Association
(APhA) to operate the HRSA PSSC. APhA is the
largest professional association of pharmacists
in the United States with 50,000 members including
practicing pharmacists, pharmaceutical scientists,
students, pharmacy technicians, and others. The
association provides professional information
and education for pharmacists and is an advocate
for improved health through the provision of comprehensive
pharmaceutical care. Additionally, the American
Association of Colleges of Pharmacy (AACP) and
other national pharmacy associations will participate
in the contract to ensure that the new center
is equipped to provide timely information on pharmacy
practice.
Services
to be provided by the PSSC include:
- Helping
OPA conduct policy and pharmacoeconomic analyses
on effective pharmacy practice and program needs
of HRSA grantees;
-
Providing information, evaluation, and recommendations
to community health networks and community service
organizations concerning innovative approaches
in all practice settings for affordable, quality
pharmaceutical services, including the effective
use of the 340B drug pricing program; and
-
Recruiting and managing a pharmacy consultant
pool that will be available to provide on-site
technical assistance to health centers and other
providers supported by HRSA.
As
the PSSC develops over the life of the contract,
it is expected that its role in providing supporting
professional services for providers eligible to
participate in the 340B drug pricing program will
grow. Check the PSSC web site ( for the latest
developments. Eligible entities can obtain a
PSSC ID to receive information on new events and
developments in the 340B program and have access
to other online resources.
D.
The Pharmaceutical Pricing Agreement
Section
340B requires drug manufacturers, as a condition
of continued participation in the Medicaid program,
to sign an agreement with the Secretary of HHS
to sell covered outpatient drugs to the covered
entities at prices that do not exceed the limitations
specified by the law. As of March 2005, there
were 692 drug manufacturers participating in the
340B Program.
The
full text of the current agreement is in Appendix
B.
Manufacturers’
responsibilities
- Adhere
to the pricing limitations in section 340B
- Provide
HRSA access to information needed to administer
the 340B Program and retain supporting documentation
for at least 3 years after its creation
- Permit
HRSA to use Medicaid rebate data submitted by
manufacturers to CMS that is needed for administering
the 340B Program
-
Participate in the PVP unless otherwise agreed
to by the Secretary of HHS
- Use
HRSA published procedures for resolving disputes
with covered entities and conducting audits
to determine if there has been any drug diversion
- Maintain
the confidentiality of audit information obtained
from the covered entities
Secretary’s
responsibilities
-
Maintain accessible data on the identity of
covered entities, updated quarterly
-
Develop and implement a mechanism for preventing
duplicate price reductions (see page 23 for
how this works)
-
Require covered entities to retain purchasing
records and claims for Medicaid reimbursement
for at least 3 years
-
Maintain the confidentiality of information
disclosed by the manufacturers, except as necessary
to carry out Section 340B
E.
The Covered Entity Database
As
required by the Pharmaceutical Pricing Agreement
(PPA) and Section 340B of the PHS Act, OPA maintains
a database of covered entities authorized to purchase
outpatient drugs at 340B prices. The data are
updated quarterly and can be downloaded from the
OPA Web site ( which is easily accessible by manufacturers,
covered entities, State agencies, and any other
parties interested in the administration of the
PHS DPP. The data include multiple entries for
covered entities that operate at more than one
site.
The
following Table I shows the trends in the number
of covered entity sites registering as covered
entities in the PHS DPP, broken down by type of
program, since the end of its first full year
of operation at the beginning of 1994. Over this
period the number of sites has more than doubled.
The program continues to grow at the rate of about
10 percent per year.
Table
I
Number
of Covered Entity Sites, 1994-2005
|
Type
of Entity |
Jan
94 |
Jan
96 |
Jan
98 |
Jan
01 |
Jan
03 |
Jan
04 |
Jan
05 |
|
Community
Hlth. Ctrs. |
342 |
451 |
670 |
1,064 |
1,412 |
1,805 |
2,301 |
|
Migrant
Hlth. Ctrs. |
69 |
99 |
122 |
165 |
182 |
178 |
113 |
|
Homeless
Hlth. Ctrs. |
39 |
105 |
84 |
118 |
155 |
171 |
128 |
|
Pub.
Housing Hlth. Ctrs. |
9 |
53 |
19 |
18 |
17 |
21 |
18 |
|
Fed.
Qualified Hlth. Ctr. Lookalikes |
56 |
34 |
92 |
96 |
130 |
146 |
163 |
|
Black
Lung Clinics |
1 |
1 |
1 |
4 |
5 |
5 |
10 |
|
Native
Hawaiian Hlth. Ctrs. |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
|
School-based
Hlth. Ctrs. |
0 |
9 |
11 |
13 |
13 |
12 |
merged
w/CHC |
|
AIDS
Drug Assistance Programs |
1 |
26 |
25 |
49 |
52 |
54 |
54 |
|
Other
Ryan White AIDS grantees |
76 |
204 |
170 |
189 |
211 |
247 |
347 |
|
Hemo.
Treatment Ctrs. |
20 |
53 |
57 |
59 |
66 |
69 |
72 |
|
Subtotal,
HRSA covered entity sites |
613 |
1,035 |
1,251 |
1,775 |
2,243 |
2,708 |
3,211 |
|
Tribal
Hlth. Ctrs. |
0 |
34 |
45 |
64 |
86 |
92 |
100 |
|
Urban
Indian Ctrs. |
9 |
11 |
12 |
13 |
16 |
16 |
17 |
|
Subtotal,
IHS covered entity sites |
9 |
45 |
57 |
77 |
102 |
108 |
117 |
|
STD
Clinics |
162 |
236 |
459 |
688 |
916 |
1,154 |
1,342 |
|
TB
Clinics |
166 |
171 |
404 |
714 |
1,003 |
1,069 |
1,024 |
|
Subtotal,
CDC covered entity sites |
328 |
407 |
863 |
1,402 |
1,919 |
2,223 |
2,366 |
|
Title
X Family Planning Clinics (OPHS) |
4,068 |
4,607 |
4,773 |
4,768 |
4,928 |
5,269 |
5,190 |
|
Disproportionate
Share Hospitals |
122 |
160 |
238 |
332 |
446 |
578 |
1,026 |
|
Total,
all covered entity sites |
5,140 |
6,254 |
7,182 |
8,354 |
9,638 |
10,886 |
11,910 |
F.
Program Guidelines
Since
its inception, HRSA has used guidelines published
in the Federal Register (FR) to administer
the 340B Program.
Appendix
C includes all of the guidelines published as
final notices through mid 2005. The text includes
only the final statement of the guidelines, not
the responses to comments received on the proposed
guidelines. The OPA Web site contains the complete
text of the notices published in the FR
including all of the responses to comments received.
The
guidelines in Appendix C cover the following topics:
-
General program guidance including eligibility
criteria for covered entities, definition of
a covered outpatient drug, calculation of the
ceiling price, general information for manufacturers
and covered entities, and confidentiality provisions
-
The mechanism to prevent a Medicaid rebate on
a 340B discounted drug
-
Entity guidelines including procedures for avoiding
drug diversion, requirements to maintain records
of purchases of covered outpatient drugs and
of any claims for Medicaid reimbursement for
audit purposes, use of purchasing agents and
wholesalers, and a clarification that manufacturers
may not impose prior conditions, such as requiring
their own assurance of action to prevent drug
diversion, before selling drugs at the ceiling
prices
-
Eligibility of outpatient facilities of disproportionate
share hospitals to be covered entities
-
Guidelines for pricing new drugs introduced
by manufacturers
-
Definition of a patient of a covered entity
-
Guidelines for contract pharmacy services, including
a model agreement format and suggested contract
provisions
-
Guidelines for manufacturer audits of covered
entities
-
Recommended dispute resolution process
-
Recognition of the State AIDS Drug Assistance
Program rebate option
-
Recognition of the option for covered entities
to purchase outpatient drugs at regular market
prices for their Medicaid patients
G.
How 340B Discounts Help Covered
Entities Improve Services
The
purpose of the 340B Program is to lower the cost
of acquiring covered outpatient drugs for selected
health care providers so that they can stretch
their resources in order to serve more patients
or improve services. Additional program resources
are generated if drug acquisition costs are lowered
but revenue from grants or health insurance reimbursements
are maintained or not reduced as much as the 340B
discounts or rebates. This permits HHS programs
to provide additional financial capacity to assisted
health care providers without increasing the Federal
budget for the grant or other assistance programs
that confer eligibility for the discounts. This
method of augmenting their resources carries out
the Congressional intent expressed in the House
Commerce Committee’s (HCC) report on the
legislation (H.R. Report 102-384, 102nd
Congress, 2nd Session, Part 2, page
12) which states, “In giving these ‘covered
entities’ access to price reductions theCommittee
intends to enable these entities to stretch scarce
Federal resources as far as possible, reaching
more eligible patients and providing more comprehensive
services.” If the covered entities were
not able to access resources freed up by the drug
discounts when they apply for grants and bill
private health insurance, their programs would
receive no assistance from the enactment of section
340B and there would be no incentive for them
to become covered entities.
As
required by the law and the PPA, drug manufacturers
must charge covered entities a price for an outpatient
drug that does not exceed the average manufacturer
price (AMP) reduced by the Medicaid rebate percentage
of 15.1 percent. Covered entities are free to
negotiate lower prices if they have sufficient
purchasing power. The chart below provides a
general picture of how 340B prices compare to
other Federal price reduction or discount programs
in reference to average wholesale prices (AWP).
It is based on a slide in a presentation entitled
“State Opportunities under the 340B DDP”
prepared by the Public Hospital Pharmacy Coalition
(PHPC), a leading member of the 340B Coalition,
a group of advocacy organizations representing
the programs eligible to participate in 340B.
It shows that the 340B prices are among the best
available, coming in lower than the prices on
the Federal Supply Schedule (FSS). However, they
fall short of the discounts achieved by the VA’s
contract prices negotiated under the authority
of section 603 of the Veterans Health Care Act
for selected direct Federal health care programs.
The complete presentation is available on the
PHPC’s web site, www.phpcrx.org.
[D]
Covered
entities use 340B income for a variety of purposes
within their overall missions and the general
purposes of the grants they receive. For example,
community health centers use 340B income primarily
to improve services for medically uninsured patients
whose declared income is below 200 percent of
the poverty line and pay for services on a sliding
scale. Centers have increased the number of patients
receiving discounted services and increased the
discounts in the sliding scale fee schedule.
Both community health centers and disproportionate
share hospitals often use 340B income to offset
unreimbursed costs of providing prescription drug
services to under-insured or uninsured patients.
Most
covered entities have used 340B income to provide
services to more patients with little or noresources
than they could otherwise afford to serve. Others
have added services for their current service
populations. Consistent with this overall pattern,
hemophilia treatment centers (HTCs) use the extra
income from the 340B discount to maintain or expand
supporting services and as well as provide factor
replacement products to uninsured patients.
H.
Technical Assistance
Since
the implementation of the 340B program in 1992,
OPA, then the ODP, has placed a major emphasis
on providing technical assistance to both eligible
and participating entities. This assistance was
provided primarily by phone consultations with
in-house staff. However, during FY 1998, the Office
expanded technical assistance resources by augmenting
its in-house capacity with expert consultants.
Since then the level of technical assistance has
continued to grow.
With
the broadening of OPA’s mission, technical
assistance now includes advice on delivering effective
clinical pharmacy services as well as making appropriate
use of the 340B program. This broadened
technical assistance has been a critical component
of OPA’s support for clinical pharmacy demonstrations
and comprehensive pharmacy assistance grants awarded
to individual and networks of health centers.
All eligible entities can request technical assistance
from OPA on 340B operational issues or to obtain
advice on efficient and effective pharmacy management.
The
most efficient way to request technical assistance
is to use the OPA Web site. Click on “Pharmacy
Technical Assistance (PharmTA)” on the home
page. This leads to the PharmTA page which contains
a menu providing information about the services
available. To request assistance on a specific
topic, click on “Apply for Pharmacy TA.”
This leads to a form which can be used to request
technical assistance online. E-mail responses
are provided within 2 business days. You can
also request assistance by phone, toll-free, at
1-866-PharmTA (1-866-742-7682).
I.
Prime Vendor Program (PVP)
The
340B PVP has been developed to carry out section
340B(a)(8):
The
Secretary shall establish a prime vendor program
under which covered entities may enter into
contracts with prime vendors for the distribution
of covered outpatient drugs. If a covered entity
obtains drugs directly from a manufacturer,
the manufacturer shall be responsible for the
costs of distribution.
In
the private sector, a prime vendor is an organization
that provides total drug purchasing and distribution
services for a single health care facility or
network of facilities. PVs provide consolidated
drug purchasing and frequent deliveries so that
hospitals and clinics do not need to maintain
large drug inventories. Health care facilities
use prime vendors to lower distribution costs,
reduce response times for making critical drugs
available, and reduce inventory costs.
In
designing the 340B PVP, HRSA included price negotiation
services as an essential component to try to take
advantage of the purchasing volume of the covered
entities. As section 340B(a)(10) explicitly states,
manufacturers are not prohibited from charging
a price for a drug that is lowerthan the maximum
price permitted by the 340B program. Including
price negotiation in the PVP thus creates an opportunity
to bring substantial additional value to the covered
entities.
The
current PV agreement, approved by the HRSA Administrator
on September 10, 2004, designates Health Purchasing
Partners International (HPPI) as the 340B PV.
HPPI is a group purchasing organization serving
more than 8,000 health care organizations by assisting
them to lower and control their supply costs.
Through its relationship with Novation, a supply
chain management company which is responsible
for negotiating a portfolio drug and medical supply
pricing agreements, HPPI manages over $20 billion
in combined annual purchasing power in its non-PV
business. The expectation is that HPPI can draw
on this experience and its relationships with
drug manufacturers to benefit the covered entities
that join the PV program.
The
previous PV agreement, approved by the Administrator
on September 10, 1999, was with AmerisourceBergen,
a national drug and medical supply wholesaler.
The foundation of the agreement was drug distribution
services with price negotiation as an additional
service. This arrangement had limited success
because covered entities using different wholesalers
were reluctant to switch in order to join the
PV program. Although AmerisourceBergen was able
to negotiate additional discounts for a wide variety
of generic drugs, it was unable to obtain additional
discounts from brand name manufacturers.
The
foundation of the current PV agreement is price
negotiation and is structured so that a wide variety
of drug wholesalers can participate. All three
national wholesalers, AmerisourceBergen, Cardinal
Health, and McKesson Pharmaceutical, participate
in the PV program as well as several regional
distributors. HPPI’s PV operations are
easily able to accommodate other distributors
if requested to do so by prospective covered entity
members.
HPPI
has created a special Web site for the 340B PV
program. It can be accessed at http://www.340bpvp.com.
The phone number for the PV program is 1-888-340-2787.
On the Web site, HPPI states its PV mission as
serving covered entity members in 3 primary roles:
-
Negotiating sub-ceiling 340B pricing on branded
and generic pharmaceuticals
-
Establishing distribution solutions and networks
that improve access to affordable medications
-
Providing other value-added products and services
The
Web site includes a link to instructions for completing
the downloadable 3-page 340B Prime Vendor Participating
Agreement. Prospective members need to print and
complete two copies of the 340B Prime Vendor Participation
Agreement and then submit two originals to HPPI
by mail. The address is: 340B Prime Vendor Member
Services/HPPI, Attn: 340B Prime Vendor, 125 East
John Carpenter Freeway, Irving, TX 75062-2324.
Once accepted as a member, the entity will receive
one of the original agreements countersigned by
HPPI. When the agreement is officially executed
by both parties, the entity’s distributor
and contracted suppliers will be notified and
instructed to use the prime vendor program contract
pricing in all future covered outpatient drug
transactions.
In
its first 6 months of operation as the 340B PV,
HPPI has made substantial progress in delivering
services to covered entities. Participation has
increased from 465 entities to 937. Annual sales
volume increased to $1.7 billion. Negotiations
began with at least five brand name drug manufacturers.
HPPI also offers discounts on a variety of other
management and operational “value added”
services such as patient assistance program software,
contract pharmacy implementation and support services |