Ryan White CARE Act
Improved Oversight Needed to Ensure AIDS Drug Assistance Programs Obtain Best Prices for Drugs Gao ID: GAO-06-646 April 26, 2006The CARE Act authorized grants to the states and certain territories for AIDS Drug Assistance Programs (ADAP) to purchase and provide HIV/AIDS drugs to eligible individuals. An ADAP's coverage--who and what is covered--is determined by each ADAP's eligibility and other program criteria, and ADAPs may establish waiting lists for eligible individuals. ADAPs may purchase their drugs through the 340B federal drug pricing program, which provides discounts on certain drugs to covered entities. The Health Resources and Services Administration (HRSA) oversees ADAPs and is responsible for monitoring the prices they pay. GAO was asked to examine (1) coverage differences among ADAPs, (2) how the prices ADAPs reported paying for HIV/AIDS drugs compare to 340B prices, (3) how HRSA monitors the drug prices ADAPs pay, and (4) how the 340B prices compare to other selected federal drug pricing programs.
Variation in each ADAP's program design and funding from various sources contributes to differences in coverage among the 52 ADAPs GAO reviewed. Each ADAP has considerable flexibility in designing eligibility and other program criteria to determine who will be covered by the program. Consequently, an individual eligible for ADAP services in one state may not be eligible for services in another. ADAPs varied in the extent to which they received funding from sources in addition to the CARE Act ADAP base grants, such as state funds or transfers of funds from other CARE Act grants. Eligibility and other program design criteria also varied among ADAPs that had waiting lists of eligible individuals in fiscal year 2004, as did the amount and sources of additional funding for those ADAPs. In their quarterly reports to HRSA, some ADAPs reported prices that were above the 340B price for some of the 10 drugs GAO compared. These 10 drugs accounted for 73 percent of ADAP drug spending. If ADAPs choose to use the 340B program, they may purchase drugs from manufacturers either through the direct purchase option, receiving the 340B price up front, or through the 340B rebate option, paying full price and receiving a rebate later. The 340B prices are not disclosed to ADAPs, but participating manufacturers agree to sell at the 340B prices. However, all 25 ADAPs that used the 340B direct purchase option reported a price that was above the 340B price. All but 3 of the 27 ADAPs using the 340B rebate option reported prices higher than the 340B price for one or more drugs. These prices may not have been the final prices these ADAPs paid, however, because they may not have included all rebates eventually received. HRSA is responsible for monitoring whether ADAPs obtain the best prices available for drugs. HRSA has identified the 340B prices as a measure of an ADAP's economical use of grant funds. However, HRSA does not routinely determine whether the prices ADAPs report are no higher than the 340B prices. Also, quarterly reports do not reflect the rebates eventually received by ADAPs using the rebate option to purchase drugs. Without considering the final ADAP rebate amount on a drug purchase, HRSA cannot determine whether the final drug prices paid were at or below the 340B price. ADAPs that purchase drugs at 340B prices paid more for some drugs than certain federal agencies did for the same drugs under the federal ceiling price program. ADAPs do not have access to this program. The 340B prices were also higher than some of the prices available through the 340B prime vendor program, which negotiates drug prices on behalf of participating 340B entities including ADAPs. The 340B prices, including the 340B prime vendor prices, were lower than the Medicaid rebate program prices available to state Medicaid programs, for each of the drugs GAO could compare.
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
April 2006:
Ryan White Care Act:
Improved Oversight Needed to Ensure AIDS Drug Assistance Programs
Obtain Best Prices for Drugs:
AIDS Drug Assistance Programs:
GAO-06-646:
GAO Highlights:
Highlights of GAO-06-646, a report to congressional requesters.
Why GAO Did This Study:
The CARE Act authorized grants to the states and certain territories
for AIDS Drug Assistance Programs (ADAP) to purchase and provide
HIV/AIDS drugs to eligible individuals. An ADAP‘s coverage”who and what
is covered”is determined by each ADAP‘s eligibility and other program
criteria, and ADAPs may establish waiting lists for eligible
individuals. ADAPs may purchase their drugs through the 340B federal
drug pricing program, which provides discounts on certain drugs to
covered entities. The Health Resources and Services Administration
(HRSA) oversees ADAPs and is responsible for monitoring the prices they
pay.
GAO was asked to examine (1) coverage differences among ADAPs, (2) how
the prices ADAPs reported paying for HIV/AIDS drugs compare to 340B
prices, (3) how HRSA monitors the drug prices ADAPs pay, and (4) how
the 340B prices compare to other selected federal drug pricing programs.
What GAO Found:
Variation in each ADAP‘s program design and funding from various
sources contributes to differences in coverage among the 52 ADAPs GAO
reviewed. Each ADAP has considerable flexibility in designing
eligibility and other program criteria to determine who will be covered
by the program. Consequently, an individual eligible for ADAP services
in one state may not be eligible for services in another. ADAPs varied
in the extent to which they received funding from sources in addition
to the CARE Act ADAP base grants, such as state funds or transfers of
funds from other CARE Act grants. Eligibility and other program design
criteria also varied among ADAPs that had waiting lists of eligible
individuals in fiscal year 2004, as did the amount and sources of
additional funding for those ADAPs.
In their quarterly reports to HRSA, some ADAPs reported prices that
were above the 340B price for some of the 10 drugs GAO compared. These
10 drugs accounted for 73 percent of ADAP drug spending. If ADAPs
choose to use the 340B program, they may purchase drugs from
manufacturers either through the direct purchase option, receiving the
340B price up front, or through the 340B rebate option, paying full
price and receiving a rebate later. The 340B prices are not disclosed
to ADAPs, but participating manufacturers agree to sell at the 340B
prices. However, all 25 ADAPs that used the 340B direct purchase option
reported a price that was above the 340B price. All but 3 of the 27
ADAPs using the 340B rebate option reported prices higher than the 340B
price for one or more drugs. These prices may not have been the final
prices these ADAPs paid, however, because they may not have included
all rebates eventually received.
HRSA is responsible for monitoring whether ADAPs obtain the best prices
available for drugs. HRSA has identified the 340B prices as a measure
of an ADAP‘s economical use of grant funds. However, HRSA does not
routinely determine whether the prices ADAPs report are no higher than
the 340B prices. Also, quarterly reports do not reflect the rebates
eventually received by ADAPs using the rebate option to purchase drugs.
Without considering the final ADAP rebate amount on a drug purchase,
HRSA cannot determine whether the final drug prices paid were at or
below the 340B price.
ADAPs that purchase drugs at 340B prices paid more for some drugs than
certain federal agencies did for the same drugs under the federal
ceiling price program. ADAPs do not have access to this program. The
340B prices were also higher than some of the prices available through
the 340B prime vendor program, which negotiates drug prices on behalf
of participating 340B entities including ADAPs. The 340B prices,
including the 340B prime vendor prices, were lower than the Medicaid
rebate program prices available to state Medicaid programs, for each of
the drugs GAO could compare.
What GAO Recommends:
GAO recommends that HRSA require ADAPs to report the final prices they
paid for drug purchases, net of rebates, and that HRSA routinely
determine whether these prices paid are at or below the 340B prices.
HRSA stated that these steps would be labor intensive and it lacks
capacity to carry out such oversight. We believe there are cost-
effective processes HRSA could use.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Marcia Crosse at (202)
512-7119 or crossem@gao.gov.
[End of Section]
Contents:
Letter:
Background:
Results in Brief:
Variation in Program Design and Funding Contributes to Coverage
Differences among ADAPs:
Some ADAPs Reported HIV/AIDS Drug Prices that Were Higher than the 340B
Prices:
HRSA Does Not Routinely Determine Whether Drug Prices ADAPs Report
Paying Are Higher than the 340B Prices:
HIV/AIDS Drug Prices Are Sometimes Higher Under the 340B Program than
Some Federal Programs:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Prenatal HIV Testing and Perinatal HIV Transmission Rates
within States:
Background:
Prenatal HIV Testing Encouraged to Reduce HIV Perinatal Transmission:
Appendix II: State Approaches to Identifying and Notifying Partners of
HIV-Infected Individuals of Possible HIV Exposure:
Background:
States Use Various Approaches to Elicit Information and Notify Partners
of Possible HIV Exposure:
Appendix III: Scope and Methodology:
Appendix IV: Comments from the Health Resources and Services
Administration:
Appendix V: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Key CARE Act Title II Grants through which ADAPs May Receive
Funds:
Table 2: ADAP Program Eligibility by Income Ceiling, Reported for ADAP
Grant Year 2004:
Table 3: Program Eligibility and Other Criteria, Reported for ADAP
Grant Year 2004:
Table 4: Number of Drugs Included in ADAP Formularies and ADAPs that
Cover Fuzeon, Reported for ADAP Grant Year 2004:
Table 5: Additional ADAP Funding Sources and Amounts by ADAP, Fiscal
Year 2004:
Table 6: Total Additional ADAP Funding as a Percentage of the CARE Act
ADAP Base Grants and Total Additional Funding Per ELC by ADAP, Fiscal
Year 2004:
Table 7: ADAPs with Waiting Lists and Number of Months Each Had Waiting
Lists, Fiscal Year 2004:
Table 8: Ranking of 13 ADAPs with Waiting Lists among the 46 ADAPs that
Received Additional Funding Per ELC; Fiscal Year 2004:
Table 9: 25 340B Direct Purchase ADAPs that Reported Prices for the Top
10 HIV/AIDS Drugs that Were Above 340B Prices; 2003:
Table 10: Ranking of Top 10 HIV/AIDS Drugs from Lowest (1) to Highest
(5) Unit Price Across Drug Programs; 2003:
Table 11: Percentage of Unit Price Increases or Decreases from 2000 to
2003 for Top 10 HIV/AIDS Drugs:
Abbreviations:
ADAP: AIDS Drug Assistance Program:
AIDS: acquired immunodeficiency syndrome:
AMP: average manufacturer price:
CARE Act: Ryan White Comprehensive AIDS Resources Emergency Act of
1990:
CDC: Centers for Disease Control and Prevention:
CMS: Centers for Medicare & Medicaid Services:
ELC: estimated living AIDS case:
EMA: eligible metropolitan area:
FCP: federal ceiling price:
FDA: Food and Drug Administration:
FSS: federal supply schedule:
HAART: highly active antiretroviral therapy:
HHS: Department of Health and Human Services:
HIV: human immunodeficiency virus:
HRSA: Health Resources and Services Administration:
IOM: Institute of Medicine:
NASTAD: National Alliance of State and Territorial AIDS Directors:
NDC: national drug code:
OIG: Office of Inspector General:
OPA: Office of Pharmacy Affairs:
PCRS: partner counseling and referral services:
STD: sexually transmitted disease:
VA: Department of Veterans Affairs:
United States Government Accountability Office:
Washington, DC 20548:
April 26, 2006:
The Honorable Michael B. Enzi:
Chairman Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Mark E. Souder:
Chairman Subcommittee on Criminal Justice, Drug Policy, and Human
Resources:
Committee on Government Reform:
House of Representatives:
The Honorable Tom Coburn, M.D.
The Honorable Judd Gregg:
United States Senate:
Since the first cases of acquired immunodeficiency syndrome (AIDS) were
identified in the United States nearly 25 years ago, advancements in
prescription drug treatments have significantly reduced AIDS mortality
and slowed the progression from a human immunodeficiency virus (HIV) -
positive diagnosis to AIDS.[Footnote 1] The introduction of combination
drug treatments--highly active antiretroviral therapy (HAART)--in 1996
was followed by a decline in the number of AIDS deaths and new AIDS
cases in the United States for the first time since the beginning of
the epidemic.[Footnote 2] While drug treatments have extended the
lifespan of those living with HIV/AIDS, the number of new HIV
infections has not decreased. The Department of Health and Human
Services's (HHS) Centers for Disease Control and Prevention (CDC)
estimates approximately 40,000 people are newly infected annually. CDC
also estimates that between 1,039,000 and 1,185,000 people in the
United States were living with HIV/AIDS at the end of 2003. The number
of people with HIV/AIDS is likely to have risen since then, and CDC
estimates that, as of December 2004, it included 415,193 individuals
with AIDS.
The Ryan White Comprehensive AIDS Resources Emergency Act of 1990 (CARE
Act),[Footnote 3] administered by HHS's Health Resources and Services
Administration (HRSA), was enacted to address the needs of
jurisdictions, health care providers, and people with HIV/AIDS and
their family members.[Footnote 4] Title II of the CARE Act[Footnote 5]
authorizes AIDS Drug Assistance Program (ADAP) grants to states,
including the District of Columbia, and certain territories[Footnote 6]
specifically to operate ADAPs. ADAPs purchase and provide HIV/AIDS
drugs to infected individuals who meet eligibility requirements. Each
state and territory is given broad authority under the CARE Act to
design its own program. The scope of an ADAP's coverage--who and what
is covered--is determined by each ADAP's program design, which includes
criteria for who is eligible to receive drugs, and other criteria such
as the number and types of drugs it will provide. There are no uniform
program design criteria across ADAPs.
ADAPs are a critical source of prescription drugs for low-income people
with HIV/AIDS who have no or limited prescription drug coverage and are
the programs of last resort for these individuals.[Footnote 7] In
fiscal year 2005, CARE Act funding for ADAP grants was $787.5 million.
As the number of people who know their HIV-positive status grows, the
number of people with HIV/AIDS needing to rely on ADAPs will likely
increase. Some ADAPs have struggled to meet the demand for their
services. Limited resources have contributed to ADAPs establishing
waiting lists for eligible individuals and taking other measures that
restrict access.
Grants under Title II of the CARE Act are subject to conditions set out
by HRSA in the notice of grant award, including conditions related to
ADAP drug prices.[Footnote 8] One of these conditions identifies 340B
drug prices as the measure of ADAPs' economical use of grant funds.
Under Section 340B of the Public Health Service Act, drug manufacturers
provide discounts on certain outpatient drugs to covered
entities;[Footnote 9] a 340B price, sometimes referred to as a 340B
ceiling price, is established for each covered drug that entities
purchase. ADAPs are allowed to purchase drugs through the Section 340B
program and are required to submit quarterly HIV/AIDS drug pricing
reports to HRSA that indicate what they paid for drugs. Other federal
drug pricing programs are used by federal agencies to purchase HIV/AIDS
drugs, including the federal supply schedule (FSS) and federal ceiling
price (FCP) programs. State Medicaid programs receive rebates from drug
manufacturers for purchases of certain outpatient drugs including HIV/
AIDS drugs through the federal Medicaid drug rebate program. ADAPs are
not authorized by statute to purchase drugs under these other drug
pricing programs.
As Congress prepares for the reauthorization of CARE Act programs, you
asked us to examine certain aspects of ADAPs. Specifically, we are
reporting on (1) how each ADAP's program design and funding sources
contribute to differences in coverage among ADAPs, including those
ADAPs with waiting lists, (2) how the prices that ADAPs report to HRSA
they paid for HIV/AIDS drugs compare to the 340B prices, (3) how HRSA
monitors the drug prices ADAPs pay, and (4) how the 340B prices for
HIV/AIDS drugs compare to prices under selected federal drug pricing
programs. You also asked us to provide information on state prenatal
HIV testing and perinatal HIV transmission rates, and state approaches
to identifying and notifying partners of HIV-infected individuals; this
information is provided in appendixes I and II, respectively.
To report on these issues, we reviewed the 1990 CARE Act, and
subsequent amendments, HRSA policy manuals, HHS's Office of Inspector
General (OIG) reports on the CARE Act and ADAPs, Institute of Medicine
(IOM) reports on the CARE Act, and other related reports, and
documents. We interviewed HRSA and HHS OIG officials, as well as
officials from the National Alliance of State and Territorial AIDS
Directors (NASTAD) and the Association of State and Territorial Health
Officials.
We reviewed 52 ADAPs to determine what program design elements
contribute to the coverage differences among ADAPs.[Footnote 10] We
analyzed and compared data ADAPs reported to HRSA for grant year 2004
on program design elements such as eligibility income levels for
individuals, enrollment caps, the number of drugs covered, and funding
from various sources during fiscal year 2004.[Footnote 11] We also
analyzed and compared these data among ADAPs with waiting lists of
eligible individuals.
To compare the prices that ADAPs reported paying for HIV/AIDS drugs to
340B prices for such drugs, we first determined which HIV/AIDS drugs
were the top ten by ADAP expenditure using 2002 data, the most recently
available expenditure data at the time of our analysis. These drugs
accounted for 73 percent of ADAP drug spending. We then compared the
prices ADAPs reported paying for the top ten HIV/AIDS drugs to the 340B
program prices for those same drugs. For this comparison, we used the
2003 340B program prices and the purchase prices that 52 ADAPs provided
in their quarterly reports submitted to HRSA for 2003. At the time of
our analysis, 2003 was the most recent full year of ADAP drug price
data.
To determine how HRSA monitors the prices ADAPs pay for HIV/AIDS drugs,
we interviewed HRSA officials. To determine how the 340B prices compare
with prices under selected federal drug pricing programs, we used the
2003 prices for the 340B drug pricing program from HRSA and compared
them to FSS and FCP program prices from the Department of Veterans
Affairs (VA), which administers these pricing programs. To determine
how the 340B prices compare with the Medicaid prices, we calculated
prices state Medicaid agencies paid including rebates states received
under HHS's Centers for Medicare & Medicaid Services' (CMS) Medicaid
drug rebate program. We found the data from these sources to be
sufficient and reliable for our analyses.
Appendix III provides a more detailed explanation of the scope and
methodology for this report. We performed our work from July 2004
through April 2006, in accordance with generally accepted government
auditing standards.
Background:
In 1990, Congress passed the CARE Act to address the needs of
jurisdictions, health care providers, and people with HIV/AIDS and
their family members. The CARE Act authorizes grants to eligible
metropolitan areas (EMA) under Title I, and to states and territories
under Title II.[Footnote 12] Title II of the CARE Act authorizes the
grants by which states and certain territories receive funds
specifically to operate ADAPs. ADAPs purchase HIV/AIDS drugs for
enrolled low-income people who are uninsured or underinsured. Each
state and territory is responsible for and has significant flexibility
in determining its ADAP eligibility criteria for who receives services,
the services it provides, and which drugs to include in its
formularies.
States and certain territories receive ADAP base grants distributed by
a formula based on each grantee's proportion of total estimated living
AIDS cases (ELC).[Footnote 13] The ADAP grant program, administered by
HRSA's HIV/AIDS Bureau, distributed $787.5 million or 38 percent of the
about $2.1 billion in CARE Act funding for fiscal year 2005. ADAPs may
receive funds from various other Title II grants awarded to states and
territories, including Title II base grants and Severe Need grants.
(See table 1.) Severe Need grants are made to states and certain
territories with a need for funding to increase access to drugs.
Table 1: Key CARE Act Title II Grants through which ADAPs May Receive
Funds:
Grant: Base Grant;
Purpose: Support primary and home-based health care, insurance
coverage, medications, support services, and early intervention
services, such as HIV counseling, testing, and referral;
Eligible grantees: States and territories[A];
Distribution: Distributed based 80 percent on each grantee's proportion
of all ELCs and 20 percent on each grantee's proportion of all ELCs
located outside EMAs.[B] Minimum grants of $200,000 are provided for
states with less than 90 ELCs; $500,000 for states with 90 or more
ELCs; and $50,000 for territories.
Grant: ADAP Base Grant;
Purpose: Provide medications, drug treatment adherence and support
efforts,[C] and health insurance coverage with prescription drug
benefits;
Eligible grantees: States and certain territories[D];
Distribution: Distributed based on each grantee's proportion of all
ELCs.
Grant: Severe Need Grant;
Purpose: Provide increased access to HIV/AIDS drugs;
Eligible grantees: States and certain territories[D] with a severe need
for a grant to increase access to medications;
Distribution: Distributed based on each grantee's proportion of all
ELCs; grantees must agree to match 25 percent of their severe need
grant and not to impose ADAP eligibility requirements stricter than
those in place on January 1, 2000.[E].
Source: HRSA.
[A] In addition to the 50 states, base grants are authorized for the
District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin
Islands, American Samoa, the Commonwealth of the Northern Mariana
Islands, the Republic of the Marshall Islands, the Federated States of
Micronesia, and the Republic of Palau.
[B] Under Title I of the CARE Act, EMAs are metropolitan areas with a
population of at least 500,000 and more than 2,000 reported AIDS cases
in the last 5 calendar years.
[C] Drug treatment adherence and support efforts are intended to
increase individuals' ability to comply with the treatment regimen, for
example, by providing care for depression.
[D] In addition to the 50 states, these grants are authorized for the
District of Columbia, the Commonwealth of Puerto Rico, Guam, and the
Virgin Islands.
[E] To be eligible for a Severe Need grant, a jurisdiction must have
met one of four eligibility criteria as of January 1, 2000. It must
have limited (1) the eligibility of ADAP enrollees to those with
incomes at or below 200 percent of the federal poverty level, (2) the
number of ADAP enrollees by using medical eligibility restrictions, (3)
the number of antiretroviral drugs covered in its drug formulary, or
(4) the number of opportunistic infection medications to less than 10
in its drug formulary. (Opportunistic infections are illnesses such as
parasitic, viral, and fungal infections, and some types of cancer, some
of which usually do not cause disease in people with normal immune
systems.) In addition, a jurisdiction must also have agreed to provide
a 25 percent match and not impose eligibility requirements more
restrictive than those in place on January 1, 2000. According to HRSA,
grantees can provide funds or in-kind services to meet the matching
requirements.
[End of table]
ADAPs serve as the HIV/AIDS drug assistance program of last resort for
individuals who, for example, cannot afford to pay for drugs, do not
have insurance coverage for drugs, or do not qualify for other federal
programs such as Medicaid that provide HIV/AIDS services to eligible
individuals. Medicaid is the largest source of federal funding for HIV/
AIDS health care services. In fiscal year 2005, Medicaid provided an
estimated $5.7 billion in HIV/AIDS health care assistance.[Footnote 14]
Because Medicaid funds HIV/AIDS health care services, including drugs,
to eligible individuals, state eligibility determinations for Medicaid
are important in determining eligibility for ADAPs that provide HIV/
AIDS services as a last resort.[Footnote 15] Individuals who have
received HIV/AIDS drugs through their state Medicaid programs and who
are dual eligibles--eligible for both Medicaid and Medicare--will be
affected by the Medicare Part D prescription drug benefit implemented
in January 2006. Rather than receiving their drug coverage under
Medicaid, dual eligibles will be covered by private insurance plans
provided through Part D. Since Medicaid drug benefits vary from state
to state, and Medicare Part D plans vary, which dual eligibles, if any,
will be able to receive ADAP drug coverage as a last resort will also
vary.
Unlike Medicaid, under which states receive more federal funds when
their expenditures increase, due, for example, to greater enrollment,
ADAPs do not receive additional federal funds when they have more
eligible individuals than funds to provide services. When an ADAP
cannot cover everyone it determines is eligible for its services, it
may, but is not required to, establish a waiting list. ADAPs may
establish waiting lists anytime that they determine it is necessary and
the number of ADAPs with waiting lists is not constant. Since ADAPs may
also cap the number of individuals they are willing to enroll for
services, the ADAPs with waiting lists may not represent all eligible
individuals who are not being served. During fiscal year 2004, there
were 14 ADAPs that reported having waiting lists for at least part of
the year.[Footnote 16]
When eligible individuals are on ADAP waiting lists, there are limited
drug assistance options available to help those who qualify until they
can be served by the ADAP. If they do not qualify for these options,
the result can be an interruption of needed drug treatment. According
to HHS's HIV treatment guidelines, if an individual's HAART regimen is
interrupted, the individual can develop drug resistance upon resuming
treatment.[Footnote 17] Individuals who develop drug resistance can
transmit drug-resistant strains of the HIV virus. Among the drug
assistance options are pharmaceutical manufacturers' patient assistance
programs that provide free or cost-reduced drugs, non-ADAP pharmacy
assistance programs using Title I funds,[Footnote 18] and state-
sponsored pharmacy assistance programs. An ADAP-eligible individual's
ability to use these options may be limited by factors such as
availability in a particular state, financial and medical eligibility
criteria for the individual, and coverage duration.
ADAPs and the 340B Drug Pricing Program:
Section 340B of the Public Health Service Act requires drug
manufacturers, as a condition of their payment under Medicaid, to sign
a pharmaceutical pricing agreement with the Secretary of Health and
Human Services. Drug manufacturers agree to charge covered entities,
including ADAPs, that participate in the 340B drug pricing program
prices for certain outpatient drugs that do not exceed an amount
determined by statutory formula--the 340B price.[Footnote 19] HRSA's
Office of Pharmacy Affairs (OPA), within the Healthcare Systems Bureau,
administers the 340B program and calculates the 340B prices on a
quarterly basis,[Footnote 20] which are below the average manufacturer
price (AMP).[Footnote 21] ADAPs are eligible to participate in the 340B
drug pricing program and receive 340B drug prices for the HIV/AIDS
drugs they cover.[Footnote 22] Like the other covered entities, an
ADAP's participation in the 340B program is voluntary--they may choose,
for example, to negotiate drug prices themselves with drug companies.
For an ADAP to purchase drugs through the 340B program, it must inform
both OPA and the HIV/ AIDS Bureau's Division of Service Systems to
activate its status as a 340B covered entity.
ADAPs participating in the 340B program have options for how they
purchase drugs. Generally, ADAPs can purchase drugs through either the
340B direct purchasing option (sometimes referred to as point-of-
purchase) or through the 340B rebate option. ADAPs choose one of these
options when they activate their status as a 340B entity. Under the
direct purchase option, ADAPs purchase drugs from drug manufacturers or
through a third-party such as a drug purchasing agent. Using the 340B
direct purchase option, ADAPs receive the 340B price discount up front.
Under the rebate option, ADAPs typically contract with entities such as
a pharmacy network or pharmacy benefits management company for the
purchase of covered drugs. ADAPs later request a 340B rebate from the
drug manufacturers. ADAPs that have activated their 340B status and are
using the 340B direct purchase option can also use the 340B prime
vendor to negotiate for them.[Footnote 23] The prime vendor assists
covered entities by negotiating drug prices at or below the 340B drug
prices. Participation in this program is voluntary, but ADAPs that
utilize the 340B rebate option or those that negotiate prices
themselves and do not participate in the 340B drug pricing program are
not eligible to participate in the prime vendor program.
Grants under Title II of the CARE Act are subject to conditions set out
in the notice of grant award, including conditions related to ADAP drug
prices. One of these conditions identifies 340B prices as the measure
of ADAPs' economical use of grant funds. Specifically, the notice
states that "HHS and Congress expect that states will use every means
at their disposal to secure the best price available for all products
on their ADAP formularies in order to achieve maximum results with
these funds." Further, the notice requires grantees to "adopt at least
one defined cost-saving practice for their ADAP program that is equal
to or more economical than the 340B Drug Pricing Program and its Prime
Vendor Program."[Footnote 24] For example, ADAPs may negotiate prices
with drug manufacturers that are at or below the 340B prices for the
same drugs. However, HHS does not disclose to ADAPs or the prime vendor
what the 340B prices are for the drugs they purchase because of
statutory provisions relating to the confidentiality of certain drug
pricing information.[Footnote 25] All ADAPs submit quarterly HIV/AIDS
drug pricing reports to the HIV/AIDS Bureau that indicate what they
paid. The Bureau can request that OPA compare the ADAP price reports to
the 340B prices, but OPA does not share its price comparisons with the
Bureau due to the confidentiality of the 340B prices. If a state or
territory does not comply with the grant conditions, HRSA can either
restrict the use of its current grant funds or deny the state or
territory future grant funds.
Other Federal Drug Pricing Programs:
Federal agencies and state Medicaid programs purchase drugs subject to
other statutory provisions regarding prices. The FSS has prices
available to all federal government purchasers for the drugs listed on
the schedule. Another program, FCP, is the maximum price that drug
manufacturers can charge four agencies--the Department of Defense, the
VA, the Public Health Service, and the Coast Guard--for brand-name
drugs listed on the FSS, even if the FSS prices are higher.[Footnote
26] State Medicaid programs receive rebates on their covered drugs,
including HIV/AIDS drugs, through the federal Medicaid drug rebate
program. The minimum Medicaid rebate amount is 15.1 percent of AMP.
ADAPs are not authorized to purchase drugs under these drug pricing
programs, except for the District of Columbia ADAP, which purchases
drugs using the FCP.
Results in Brief:
Variation in ADAPs' program design and funding amounts from the CARE
Act and other sources contributes to differences in coverage among the
52 ADAPs we reviewed. ADAP program eligibility and other design
criteria, including income ceilings, program enrollment caps, and drug
formularies, that states and territories establish vary considerably.
For example, each ADAP determines a maximum income level, or income
ceiling, as a criterion for an individual's eligibility for enrollment.
ADAPs reported income ceilings for the 2004 grant year that ranged from
125 percent of the federal poverty level in North Carolina to 556
percent in Massachusetts. Also, of the 52 ADAPs, 16 reported that they
have limits on the assets that individuals enrolled in the program are
allowed to have. Twelve ADAPs reported having caps on program
enrollment or on amounts expended per individual for HIV/AIDS drugs.
The total number of drugs ADAPs included on their formularies ranged
from 20 in Colorado to 1,000 in Massachusetts, New Hampshire, and New
Jersey. Because of the variation in program criteria, an individual
eligible for ADAP services in one state may not be eligible for
services in another. The funding that some ADAPs reported receiving
from sources other than the ADAP base grant, such as transfers from
Title II base grants, and states' or other governmental entities'
funds, also varied among ADAPs for fiscal year 2004. Funding from these
various sources significantly increased funds available to cover
individuals for some ADAPs. For example, the California ADAP, which had
an ADAP base grant of about $89.6 million, received about $123.5
million in total additional funding. Eligibility and other program
design criteria also varied among ADAPs that had waiting lists of
eligible individuals in fiscal year 2004, as did the amount and sources
of additional funding for those ADAPs.
Some ADAPS reported prices to HRSA for some of the top 10 HIV/AIDS
drugs that were higher than the 340B program prices. Drug manufacturers
that agree to participate in the 340B drug pricing program agree to
sell HIV/AIDS drugs to 340B entities, including ADAPs that participate
in the program, at prices no higher than 340B prices. ADAPs are
expected to secure the best price available for drugs on their
formularies whether they use the 340B program, including the 340B prime
vendor, or negotiate drug prices on their own with drug manufacturers.
In our analysis using the top 10 HIV/AIDS drugs by ADAP expenditures,
we found that in calendar year 2003 all of the 25 ADAPs that used the
340B direct purchase option reported prices to HRSA that were higher
than the 340B price for at least one of the top 10 drugs. For example,
7 of the 25 ADAPs reported purchasing the drug Viramune at prices
higher than the 340B price. Of the 27 ADAPs that used the 340B rebate
option to purchase drugs in 2003, all except 3 ADAPs reported paying
drug prices that were higher than the 340B prices for many of the top
10 drugs. However, the prices that ADAPs using the rebate option report
to HRSA for each drug they purchase may not reflect the rebates that
they eventually receive and therefore may not be the final prices these
ADAPs pay for the drugs.
Although HRSA is responsible for monitoring whether ADAPs are complying
with grant conditions, it does not routinely compare the drug prices
ADAPs pay to 340B prices. A HRSA HIV/AIDS Bureau official said that the
Bureau has occasionally asked OPA to compare the prices ADAPs report
they paid for drugs to the 340B prices and provide the results. Bureau
and OPA officials also said that they are discussing plans for OPA to
begin making routine comparisons of drug prices. However, the ADAP drug
price information that OPA currently uses to make its comparisons is
not complete. The prices ADAPs report paying do not include all rebates
they receive under the 340B rebate option. Also, OPA does not
systematically check whether the prices obtained by the 340B prime
vendor program are at or below the 340B prices. Without the final ADAP
rebate amount on a drug purchase, HRSA cannot determine whether the
final drug prices paid were at or below the 340B price.
The 340B program prices were higher for some of the top 10 drugs than
the 340B prime vendor prices and the prices federal agencies paid for
the same drugs under the FSS and FCP drug pricing programs. Using the
top 10 HIV/AIDS drugs by ADAP expenditures, we compared 2003 drug
prices under the 340B prime vendor, FSS, FCP, and Medicaid rebate drug
pricing programs to the 340B prices. We found that the FCP and 340B
prime vendor prices were lower than the 340B prices for 6 of the 7
drugs that had prices available under all five programs. The 6 HIV/AIDS
drugs were Combivir, Epivir, Sustiva, Trizivir, Zerit, and Ziagen. The
Medicaid rebate program prices, available to state Medicaid programs,
were the highest of all the drug pricing programs for 3 of the 7 drugs
for which we had prices from all programs. The 3 drugs were Norvir,
Sustiva, and Trizivir.
We are making recommendations to the Administrator of the Health
Resources and Services Administration to require that all ADAPs report
final prices they paid for drugs that reflect any discounts or rebates
received, and to routinely determine whether the prices ADAPs paid for
the drugs they purchased were at or below the 340B prices. In
commenting on these recommendations, HRSA stated that it would like to
verify final drug prices but this would be labor intensive because
reports ADAPs currently provide do not contain the needed information.
HRSA further stated that it lacks the resources to conduct a
comprehensive price comparison, but is making efforts to develop
systems to allow ADAPs to check drug prices. We believe that, while
monitoring the prices paid for all the drugs on each ADAP's formulary
might be challenging, HRSA could use a cost-effective, automated
process to compare ADAP reported prices to 340B prices for selected
drugs and could modify its schedule of ADAP reports to allow for rebate
reconciliation.
Variation in Program Design and Funding Contributes to Coverage
Differences among ADAPs:
The program eligibility and other criteria that ADAPs establish and
additional funding that some ADAPs receive vary and contribute to
coverage differences among the 52 ADAPs we reviewed. As a result, an
individual eligible for ADAP services in one state may not be eligible
in another state. Also, some of the ADAPs received funding from sources
other than ADAP base grants, such as Severe Need grants, transfers from
Title I grants or Title II base grants, and contributions from their
state or territory. The additional funding that some ADAPs received in
fiscal year 2004 significantly increased funds available to support
ADAP enrollees and services. Eligibility and other program design
criteria varied among ADAPs that had waiting lists of eligible
individuals in fiscal year 2004, as did the amount and sources of
additional funding for those ADAPs. This variation among ADAPs with
waiting lists contributes to coverage differences, just as it does
among all ADAPs.
Variation in ADAPs' Eligibility and Other Program Criteria Contributes
to Coverage Differences among ADAPs:
ADAP program eligibility and other criteria, including income ceilings,
copayments, and drug formularies, that states and territories establish
vary considerably and contribute to coverage differences among ADAPs.
According to the National ADAP Monitoring Project,[Footnote 27] some
ADAPs use these criteria and others that can limit access to their
services to contain program costs. Because these criteria vary among
ADAPs, a person determined eligible and who receives certain ADAP
services in one jurisdiction may not be eligible or receive the same
ADAP services in another.
Income level is one program eligibility criterion that varies among
ADAPs. Each ADAP has an income ceiling, which is the maximum income an
individual can have and be eligible for the program. Among the 52 ADAPs
included in our review, income ceilings reported to HRSA for the 2004
grant year ranged from the most restrictive at 125 percent of the
federal poverty level,[Footnote 28] or $11,638, in North Carolina to
the most generous at 556 percent, or $51,764, in Massachusetts. (See
table 2.) Eleven ADAPs had income ceilings that were 200 percent or
less of the federal poverty level. Sixteen ADAPs reported income
ceilings that were 400 percent or greater than the federal poverty
level.
Table 2: ADAP Program Eligibility by Income Ceiling, Reported for ADAP
Grant Year 2004:
ADAP: Alabama;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: $23,275;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 250%.
ADAP: Alaska[B];
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 34,890;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Arizona;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Arkansas;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: California;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 37,240;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: Colorado;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Connecticut;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 37,240;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: Delaware;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 46,550;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 500%.
ADAP: District of Columbia;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 37,240;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: Florida;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 32,585;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 350%.
ADAP: Georgia;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Hawaii[C];
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 42,800;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: Idaho;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
ADAP: Illinois;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 37,240;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: Indiana;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Iowa;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
ADAP: Kansas;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Kentucky;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Louisiana;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
ADAP: Maine;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Maryland;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 37,240;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: Massachusetts;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 51,764;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 556%.
ADAP: Michigan;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 41,895;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 450%.
ADAP: Minnesota;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Mississippi;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 37,240;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: Missouri;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Montana;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 30,723;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 330%.
ADAP: Nebraska;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
ADAP: Nevada;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 37,240;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: New Hampshire;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: New Jersey;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 46,550;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 500%.
ADAP: New Mexico;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: New York;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 45,340;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 487%.
ADAP: North Carolina;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 11,638;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 125%.
ADAP: North Dakota;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 37,240;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: Ohio;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 46,550;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 500%.
ADAP: Oklahoma;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
ADAP: Oregon;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
ADAP: Pennsylvania;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 35,378;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 380%.
ADAP: Puerto Rico[D];
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
ADAP: Rhode Island;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: South Carolina;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: South Dakota;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Tennessee;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Texas;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
ADAP: Utah;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 37,240;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 400%.
ADAP: Vermont;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
ADAP: Virginia;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Washington;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: West Virginia;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 23,275;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 250%.
ADAP: Wisconsin;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 27,930;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 300%.
ADAP: Wyoming;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Dollars: 18,620;
Eligibility income ceiling and its percent of the federal poverty
level[A]: Percent: 200%.
Source: GAO analysis of ADAP data.
Note: The ADAP 2004 grant year covered April 1, 2004, through March 31,
2005.
[A] The HHS 2004 federal poverty level for a single person was $9,310
except as noted.
[B] The HHS 2004 federal poverty level for Alaska was $11,630.
[C] The HHS 2004 federal poverty level for Hawaii was $10,700.
[D] The HHS 2004 federal poverty level was not defined for Puerto Rico;
we calculated the eligibility income ceiling for Puerto Rico by
multiplying Puerto Rico's 200 percent income ceiling by the federal
poverty level of $9,310.
[End of table]
Of the 52 ADAPs we reviewed, 29 reported to HRSA that their programs
had one or more program design limitations, which also contributed to
coverage differences among ADAPs for grant year 2004. These included a
limit on an individual's assets, copayment requirements, caps on
program enrollment, or caps on expenditures per individual enrollee.
(See table 3.) Sixteen ADAPs reported that they have a limit on assets
that enrollees are allowed to have, 9 reported having a copayment for
drugs provided, 7 reported having a cap on the number of individuals
enrolled, and 5 reported having a cap on amounts expended per enrollee
for HIV/AIDS drugs. Eight ADAPs reported using more than one of these
criteria.
Table 3: Program Eligibility and Other Criteria, Reported for ADAP
Grant Year 2004:
ADAP: Alabama;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Alaska;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Arizona;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Arkansas;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: X;
Caps on expenditures per enrollee[D]: [Empty].
ADAP: California;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: X;
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Colorado;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: X;
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Connecticut;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Delaware;
Enrollee asset limitation[A]: X;
Copayments[B]: X;
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: District of Columbia;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Florida;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Georgia;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Hawaii;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Idaho;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: X;
Caps on expenditures per enrollee[D]: X.
ADAP: Illinois;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: X.
ADAP: Indiana;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Iowa;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Kansas;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: X;
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Kentucky;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Louisiana;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Maine;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Maryland;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: X;
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Massachusetts;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Michigan;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Minnesota;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Mississippi;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Missouri;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: X.
ADAP: Montana;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: X;
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Nebraska;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Nevada;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: New Hampshire;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: New Jersey;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: New Mexico;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: New York;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: North Carolina;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: X;
Caps on expenditures per enrollee[D]: [Empty].
ADAP: North Dakota;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Ohio;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Oklahoma;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: X;
Caps on expenditures per enrollee[D]: X.
ADAP: Oregon;
Enrollee asset limitation[A]: X;
Copayments[B]: X;
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Pennsylvania;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Puerto Rico;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Rhode Island;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: South Carolina;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: X;
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: South Dakota;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: X;
Caps on expenditures per enrollee[D]: X.
ADAP: Tennessee;
Enrollee asset limitation[A]: X;
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Texas;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: X;
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Utah;
Enrollee asset limitation[A]: X;
Copayments[B]: X;
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Vermont;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Virginia;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Washington;
Enrollee asset limitation[A]: X;
Copayments[B]: X;
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: West Virginia;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Wisconsin;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Wyoming;
Enrollee asset limitation[A]: [Empty];
Copayments[B]: [Empty];
Caps on number of enrollees[C]: [Empty];
Caps on expenditures per enrollee[D]: [Empty].
ADAP: Total ADAPs;
Enrollee asset limitation[A]: 16;
Copayments[B]: 9;
Caps on number of enrollees[C]: 7;
Caps on expenditures per enrollee[D]: 5.
Sources: GAO analysis of HRSA and ADAP data.
Note: The ADAP 2004 grant year covered April 1, 2004, through March 31,
2005.
[A] An enrollee asset limitation is a maximum amount of assets, as
defined by each ADAP, that an individual may have and be eligible to
receive drug assistance from the respective ADAP. The asset limitations
were reported as either the ADAP had a limitation or it did not, or by
the dollar amount of the ADAP's limit. For those ADAPs reporting a
dollar amount, the range was from $2,500 in Colorado to $25,000 in
Florida, Minnesota, and New York.
[B] A copayment is money that an individual must pay to receive the
ADAP's drug assistance. The copayments were reported as either the ADAP
had a fixed or sliding scale copayment or it did not.
[C] The cap on the number of enrollees is a maximum number of eligible
individuals who will be able to receive the ADAP's drug assistance. The
caps were reported as either the ADAP had a cap or it did not, or by
the number of ADAP enrollees allowed. For the 5 ADAPs that reported an
enrollee cap number, the range was from 75 in South Dakota to 3,600 in
North Carolina.
[D] A cap on expenditures per enrollee is the maximum dollar amount for
drug assistance that an ADAP will provide an eligible individual. The
caps were reported as either the ADAP had a cap or it did not, or by
the dollar amount of the ADAP's cap. For the five ADAPs that reported
an expenditure cap, the range was from $1,200 per month in Idaho to
$24,000 per year in Illinois.
[End of table]
The number and type of drugs covered under ADAPs' drug formularies vary
and can also contribute to coverage differences among ADAPs. ADAPs are
not required to cover particular drugs or a minimum number of drugs.
The Food and Drug Administration (FDA) has approved 27 HIV/AIDS drugs
in four drug classes.[Footnote 29] According to NASTAD, the majority of
ADAPs cover several drugs in three of the classes.[Footnote 30] In the
ADAP 2004 grant year, 26 ADAPs reported that they covered Fuzeon, which
is the only FDA-approved drug in the fourth class of drugs--fusion
inhibitors.[Footnote 31] (See table 4.) The more drugs an ADAP covers
under its formulary, the more likely it is that eligible individuals
will receive the prescribed drugs they need, and that individuals who
develop resistance to a particular HIV/AIDS drug regimen will have
other drug treatment options available. In grant year 2004, the number
of drugs included in ADAPs' formularies ranged from 20 drugs in
Colorado to 1,000 drugs in Massachusetts, New Hampshire, and New
Jersey.[Footnote 32] Thirty-nine ADAPs reported they had 100 or fewer
drugs, including 15 with fewer than 50 drugs on their formularies.
Table 4: Number of Drugs Included in ADAP Formularies and ADAPs that
Cover Fuzeon, Reported for ADAP Grant Year 2004:
ADAPs: Alabama;
Drugs in formulary: 32;
Fuzeon included: [Empty].
ADAPs: Alaska;
Drugs in formulary: 63;
Fuzeon included: [Empty].
ADAPs: Arizona;
Drugs in formulary: 46;
Fuzeon included: Yes.
ADAPs: Arkansas;
Drugs in formulary: 46;
Fuzeon included: Yes.
ADAPs: California;
Drugs in formulary: 152;
Fuzeon included: [Empty].
ADAPs: Colorado;
Drugs in formulary: 20;
Fuzeon included: [Empty].
ADAPs: Connecticut;
Drugs in formulary: 176;
Fuzeon included: Yes.
ADAPs: Delaware;
Drugs in formulary: 241;
Fuzeon included: [Empty].
ADAPs: District of Columbia;
Drugs in formulary: 67;
Fuzeon included: [Empty].
ADAPs: Florida;
Drugs in formulary: 57;
Fuzeon included: Yes.
ADAPs: Georgia;
Drugs in formulary: 51;
Fuzeon included: [Empty].
ADAPs: Hawaii;
Drugs in formulary: 89;
Fuzeon included: [Empty].
ADAPs: Idaho;
Drugs in formulary: 39;
Fuzeon included: [Empty].
ADAPs: Illinois;
Drugs in formulary: 74;
Fuzeon included: Yes.
ADAPs: Indiana;
Drugs in formulary: 77;
Fuzeon included: Yes.
ADAPs: Iowa;
Drugs in formulary: 37;
Fuzeon included: Yes.
ADAPs: Kansas;
Drugs in formulary: 52;
Fuzeon included: Yes.
ADAPs: Kentucky;
Drugs in formulary: 45;
Fuzeon included: [Empty].
ADAPs: Louisiana;
Drugs in formulary: 21;
Fuzeon included: Yes.
ADAPs: Maine;
Drugs in formulary: 36;
Fuzeon included: Yes.
ADAPs: Maryland;
Drugs in formulary: 99;
Fuzeon included: Yes.
ADAPs: Massachusetts;
Drugs in formulary: 1,000;
Fuzeon included: [Empty].
ADAPs: Michigan;
Drugs in formulary: 178;
Fuzeon included: Yes.
ADAPs: Minnesota;
Drugs in formulary: 131;
Fuzeon included: [Empty].
ADAPs: Mississippi;
Drugs in formulary: 45;
Fuzeon included: Yes.
ADAPs: Missouri;
Drugs in formulary: 272;
Fuzeon included: Yes.
ADAPs: Montana;
Drugs in formulary: 105;
Fuzeon included: [Empty].
ADAPs: Nebraska;
Drugs in formulary: 100;
Fuzeon included: [Empty].
ADAPs: Nevada;
Drugs in formulary: 59;
Fuzeon included: [Empty].
ADAPs: New Hampshire;
Drugs in formulary: 1,000;
Fuzeon included: [Empty].
ADAPs: New Jersey;
Drugs in formulary: 1,000;
Fuzeon included: Yes.
ADAPs: New Mexico;
Drugs in formulary: 65;
Fuzeon included: [Empty].
ADAPs: New York;
Drugs in formulary: 495;
Fuzeon included: Yes.
ADAPs: North Carolina;
Drugs in formulary: 55;
Fuzeon included: Yes.
ADAPs: North Dakota;
Drugs in formulary: 85;
Fuzeon included: [Empty].
ADAPs: Ohio;
Drugs in formulary: 74;
Fuzeon included: [Empty].
ADAPs: Oklahoma;
Drugs in formulary: 48;
Fuzeon included: [Empty].
ADAPs: Oregon;
Drugs in formulary: 62;
Fuzeon included: Yes.
ADAPs: Pennsylvania;
Drugs in formulary: 600;
Fuzeon included: Yes.
ADAPs: Puerto Rico;
Drugs in formulary: 63;
Fuzeon included: [Empty].
ADAPs: Rhode Island;
Drugs in formulary: 65;
Fuzeon included: Yes.
ADAPs: South Carolina;
Drugs in formulary: 52;
Fuzeon included: Yes.
ADAPs: South Dakota;
Drugs in formulary: 41;
Fuzeon included: [Empty].
ADAPs: Tennessee;
Drugs in formulary: 80;
Fuzeon included: Yes.
ADAPs: Texas;
Drugs in formulary: 31;
Fuzeon included: [Empty].
ADAPs: Utah;
Drugs in formulary: 39;
Fuzeon included: Yes.
ADAPs: Vermont;
Drugs in formulary: 80;
Fuzeon included: [Empty].
ADAPs: Virginia;
Drugs in formulary: 62;
Fuzeon included: Yes.
ADAPs: Washington;
Drugs in formulary: 125;
Fuzeon included: Yes.
ADAPs: West Virginia;
Drugs in formulary: 30;
Fuzeon included: [Empty].
ADAPs: Wisconsin;
Drugs in formulary: 67;
Fuzeon included: Yes.
ADAPs: Wyoming;
Drugs in formulary: 73;
Fuzeon included: [Empty].
ADAPs: Total ADAPs;
Drugs in formulary: 52;
Fuzeon included: 26.
Sources: GAO analysis of HRSA and ADAP data.
Notes: Fuzeon is a fusion inhibitor medication for individuals who have
used other anti-HIV drugs but still have ongoing HIV viral replication;
it was approved by the FDA in 2003. Fuzeon is to be used with a
combination of medications for individuals with limited treatment
options.
[End of table]
Variation in Funding Amounts from Sources Other than the ADAP Base
Grant Can Contribute to Coverage Differences among ADAPs:
Most ADAPs received funding from various sources, in addition to ADAP
base grants. The amounts of funding and sources varied among ADAPs. The
additional funding that ADAPs received can contribute to differences in
the number of individuals served and the level of services provided. In
fiscal year 2004, 46 of 52 ADAPs we reviewed reported receiving
additional funds from sources that included Severe Need grants,
transfers from Title II base grants, transfers from Title I grants,
contributions from the state or territory, and other sources. Nineteen
ADAPs received funds from three or more of the additional funding
sources. (See table 5.)
Table 5: Additional ADAP Funding Sources and Amounts by ADAP, Fiscal
Year 2004:
ADAP: Alabama;
Title II Severe Need grant[A]: Severe Need grant: $824,913;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: $206,228;
Title II base grant transfer[B]: $0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: $2,500,000;
Other funding sources[E]: $0;
Total additional ADAP funding: $3,531,141.
ADAP: Alaska;
Title II Severe Need grant[A]: Severe Need grant: 0;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 50,000;
Other funding sources[E]: 0;
Total additional ADAP funding: 50,000.
ADAP: Arizona;
Title II Severe Need grant[A]: Severe Need grant: 0;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 1,000,000;
Other funding sources[E]: 78,546;
Total additional ADAP funding: 1,078,546.
ADAP: Arkansas;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 330,810;
Other funding sources[E]: 393,000;
Total additional ADAP funding: 723,810.
ADAP: California;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 12,168,628;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 63,934,245;
Other funding sources[E]: 47,370,750;
Total additional ADAP funding: 123,473,623.
ADAP: Colorado;
Title II Severe Need grant[A]: Severe Need grant: 660,427;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 165,107;
Title II base grant transfer[B]: 136,000;
Title I grant transfer from EMA[C]: 560,254;
Contributions from jurisdiction funds[D]: 934,134;
Other funding sources[E]: 3,212,522;
Total additional ADAP funding: 5,668,444.
ADAP: Connecticut;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 606,678;
Other funding sources[E]: 0;
Total additional ADAP funding: 606,678.
ADAP: Delaware;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 832,382;
Total additional ADAP funding: 832,382.
ADAP: District of Columbia;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 400,000;
Other funding sources[E]: 0;
Total additional ADAP funding: 400,000.
ADAP: Florida;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 1,916,336;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 9,000,000;
Other funding sources[E]: 0;
Total additional ADAP funding: 10,916,336.
ADAP: Georgia;
Title II Severe Need grant[A]: Severe Need grant: 2,789,298;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 697,324;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 1,540,022;
Contributions from jurisdiction funds[D]: 11,305,339;
Other funding sources[E]: 0;
Total additional ADAP funding: 16,331,983.
ADAP: Hawaii;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 440,535;
Other funding sources[E]: 0;
Total additional ADAP funding: 440,535.
ADAP: Idaho;
Title II Severe Need grant[A]: Severe Need grant: 54,663;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 13,666;
Title II base grant transfer[B]: 261,150;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 163,461;
Other funding sources[E]: 300,000;
Total additional ADAP funding: 792,940.
ADAP: Illinois;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 7,000,000;
Other funding sources[E]: 5,619,843;
Total additional ADAP funding: 12,619,843.
ADAP: Indiana;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 2,720,419;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 102,331;
Total additional ADAP funding: 2,822,750.
ADAP: Iowa;
Title II Severe Need grant[A]: Severe Need grant: 0;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 0;
Total additional ADAP funding: 0.
ADAP: Kansas;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F,H];
Contributions from jurisdiction funds[D]: 400,000;
Other funding sources[E]: 550,000;
Total additional ADAP funding: 950,000.
ADAP: Kentucky;
Title II Severe Need grant[A]: Severe Need grant: 481,282;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 120,320;
Title II base grant transfer[B]: 100,000;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 90,000;
Other funding sources[E]: 199,462;
Total additional ADAP funding: 991,064.
ADAP: Louisiana;
Title II Severe Need grant[A]: Severe Need grant: 1,628,705;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 407,176;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 422,638;
Total additional ADAP funding: 2,458,519.
ADAP: Maine;
Title II Severe Need grant[A]: Severe Need grant: 0;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 57,638;
Other funding sources[E]: 125,327;
Total additional ADAP funding: 182,965.
ADAP: Maryland;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 65,250;
Title I grant transfer from EMA[C]: 105,925;
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 2,100,000;
Total additional ADAP funding: 2,271,175.
ADAP: Massachusetts;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 104,819;
Contributions from jurisdiction funds[D]: 747,990;
Other funding sources[E]: 1,900,000;
Total additional ADAP funding: 2,788,809.
ADAP: Michigan;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 5,500,000;
Total additional ADAP funding: 5,500,000.
ADAP: Minnesota;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 1,100,000;
Other funding sources[E]: 2,743,522;
Total additional ADAP funding: 3,843,522.
ADAP: Mississippi;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 1,093,008;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 750,000;
Other funding sources[E]: 0;
Total additional ADAP funding: 1,843,008.
ADAP: Missouri;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 771,167;
Title I grant transfer from EMA[C]: 1,549,422;
Contributions from jurisdiction funds[D]: 669,000;
Other funding sources[E]: 1,913,547;
Total additional ADAP funding: 4,921,136.
ADAP: Montana;
Title II Severe Need grant[A]: Severe Need grant: 36,525;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 9,131;
Title II base grant transfer[B]: 178,548;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 7,120;
Total additional ADAP funding: 231,324.
ADAP: Nebraska;
Title II Severe Need grant[A]: Severe Need grant: 130,445;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 32,611;
Title II base grant transfer[B]: 74,000;
Title I grant transfer from EMA[C]: 0[F]; Contributions from
jurisdiction funds[D]: 115,938;
Other funding sources[E]: 160,000;
Total additional ADAP funding: 512,994.
ADAP: Nevada;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 65,250;
Contributions from jurisdiction funds[D]: 1,350,947;
Other funding sources[E]: 0;
Total additional ADAP funding: 1,416,197.
ADAP: New Hampshire;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F,H];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 0;
Total additional ADAP funding: 0.
ADAP: New Jersey;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 13,050,000;
Total additional ADAP funding: 13,050,000.
ADAP: New Mexico;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 0;
Total additional ADAP funding: 0.
ADAP: New York;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 2,524,145;
Title I grant transfer from EMA[C]: 5,870,000;
Contributions from jurisdiction funds[D]: 33,000,000;
Other funding sources[E]: 64,500,000;
Total additional ADAP funding: 105,894,145.
ADAP: North Carolina;
Title II Severe Need grant[A]: Severe Need grant: 1,511,429;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 377,857;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 8,355,195;
Other funding sources[E]: 3,338,000;
Total additional ADAP funding: 13,582,481.
ADAP: North Dakota;
Title II Severe Need grant[A]: Severe Need grant: 0;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0;
Title II base grant transfer[B]: 85,400;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 32,000;
Total additional ADAP funding: 117,400.
ADAP: Ohio;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 300,000;
Contributions from jurisdiction funds[D]: 7,843;
Other funding sources[E]: 20,000;
Total additional ADAP funding: 327,843.
ADAP: Oklahoma;
Title II Severe Need grant[A]: Severe Need grant: 419,165;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 104,791;
Title II base grant transfer[B]: 486,486;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 786,000;
Other funding sources[E]: 361,000;
Total additional ADAP funding: 2,157,442.
ADAP: Oregon;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 300,000;
Other funding sources[E]: 5,650,000;
Total additional ADAP funding: 5,950,000.
ADAP: Pennsylvania;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 10,452,000;
Other funding sources[E]: 6,044,000;
Total additional ADAP funding: 16,496,000.
ADAP: Puerto Rico;
Title II Severe Need grant[A]: Severe Need grant: 2,661,337;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[I];
Title II base grant transfer[B]: 3,455,671;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 2,093,000;
Other funding sources[E]: 0;
Total additional ADAP funding: 8,210,008.
ADAP: Rhode Island;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 700,000;
Total additional ADAP funding: 700,000.
ADAP: South Carolina;
Title II Severe Need grant[A]: Severe Need grant: 1,382,225;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 345,556;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 500,000;
Other funding sources[E]: 0;
Total additional ADAP funding: 2,227,781.
ADAP: South Dakota;
Title II Severe Need grant[A]: Severe Need grant: 0;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0;
Title II base grant transfer[B]: 330,744;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 0;
Total additional ADAP funding: 330,744.
ADAP: Tennessee;
Title II Severe Need grant[A]: Severe Need grant: 0;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 0;
Total additional ADAP funding: 0.
ADAP: Texas;
Title II Severe Need grant[A]: Severe Need grant: 5,943,843;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 1,485,961;
Title II base grant transfer[B]: 500,000;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 28,538,504;
Other funding sources[E]: 0;
Total additional ADAP funding: 36,468,308.
ADAP: Utah;
Title II Severe Need grant[A]: Severe Need grant: 0;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 0;
Total additional ADAP funding: 0.
ADAP: Vermont;
Title II Severe Need grant[A]: Severe Need grant: 0;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 175,000;
Other funding sources[E]: 130,000;
Total additional ADAP funding: 305,000.
ADAP: Virginia;
Title II Severe Need grant[A]: Severe Need grant: 1,707,470;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 426,867;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0;
Contributions from jurisdiction funds[D]: 2,612,200;
Other funding sources[E]: 0;
Total additional ADAP funding: 4,746,537.
ADAP: Washington;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 800,487;
Contributions from jurisdiction funds[D]: 4,842,484;
Other funding sources[E]: 925,000;
Total additional ADAP funding: 6,567,971.
ADAP: West Virginia;
Title II Severe Need grant[A]: Severe Need grant: 153,553;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 38,388;
Title II base grant transfer[B]: 75,000;
Title I grant transfer from EMA[C]: 0[F,H];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 180,000;
Total additional ADAP funding: 446,941.
ADAP: Wisconsin;
Title II Severe Need grant[A]: Severe Need grant: 374,441;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 93,610;
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F,H];
Contributions from jurisdiction funds[D]: 186,658;
Other funding sources[E]: 855,317;
Total additional ADAP funding: 1,510,026.
ADAP: Wyoming;
Title II Severe Need grant[A]: Severe Need grant: 0[G];
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: 0[G];
Title II base grant transfer[B]: 0;
Title I grant transfer from EMA[C]: 0[F];
Contributions from jurisdiction funds[D]: 0;
Other funding sources[E]: 0;
Total additional ADAP funding: 0.
ADAP: Total;
Title II Severe Need grant[A]: Severe Need grant: $20,759,721;
Title II Severe Need grant[A]: State matching funds for Severe Need
grant: $4,524,593;
Title II base grant transfer[B]: $26,941,952;
Title I grant transfer from EMA[C]: $10,932,179;
Contributions from jurisdiction funds[D]: $194,795,599;
Other funding sources[E]: $169,334,307;
Total additional ADAP funding: $427,288,351.
Sources: GAO analysis of HRSA and ADAP data.
[A] To be eligible for a Severe Need grant, a jurisdiction must have
met one of four eligibility criteria as of January 1, 2000. It must
have limited (1) the eligibility of ADAP enrollees to those with
incomes at or below 200 percent of the federal poverty level, (2) the
number of ADAP enrollees by using medical eligibility restrictions, (3)
the number of antiretroviral drugs covered in its drug formulary, or
(4) the number of opportunistic infection medications to less than 10
in its drug formulary. (Opportunistic infections are illnesses such as
parasitic, viral, and fungal infections, and some types of cancer, some
of which usually do not cause disease in people with normal immune
systems.) In addition, a jurisdiction must also have agreed to provide
a 25 percent match and not impose eligibility requirements more
restrictive than those in place on January 1, 2000. According to HRSA,
grantees can provide funds or in-kind services to meet the matching
requirements.
[B] The Title II base grant transfers are CARE Act funds that were
awarded to the state or territory where the ADAP is located, and that
the respective state or territory decides to provide or transfer to the
ADAP program.
[C] Title I grant transfers from EMAs are CARE Act funds that were
awarded to EMAs in the state or territory where the ADAP is located,
and that the EMA decides to provide or transfer to the ADAP program.
[D] Contributions from jurisdiction funds are additional funds provided
by the state or territory where the ADAP is located to the ADAP
program.
[E] Other funding sources may include drug rebates ADAPs receive from
manufacturers against prices paid for drug purchases. These rebates do
not actually constitute additional funding. However, we were unable to
identify the amounts attributable to drug rebates in these ADAPs'
reports.
[F] State did not have an EMA.
[G] State was not eligible for a grant.
[H] The state did not have its own EMA but a portion of the state was
included in an EMA in another state.
[I] HRSA officials told us that the agency did not require Puerto Rico
to provide matching funds.
[End of table]
The number of ADAPs that reported receiving funding from sources other
than ADAP base grants and the amounts they received for fiscal year
2004 varied:
² Severe Need grants: Fifteen states and Puerto Rico received Severe
Need grant funds for their ADAPs ranging from about $37,000 in Montana
to about $6 million in Texas.[Footnote 33] The total amount of funds
from Severe Need grants these ADAPs received was about $20.8 million.
² Title II base grant transfers: Eighteen ADAPs reported receiving
transfers from their respective jurisdiction's Title II base grants.
These transfers ranged from $65,250 in Maryland to about $12.2 million
in California. The total amount of these transfers was about $26.9
million.
² Title I grant transfers from EMAs: Nine ADAPs reported receiving
Title I fund transfers from the EMAs in their states ranging from
$65,250 in Nevada to about $6 million for New York. The total amount of
Title I grantee transfers was about $10.9 million.
² Contributions from state and Puerto Rico funds: Thirty-five ADAPs
reported receiving contributions from their respective jurisdiction's
non-CARE Act funds ranging from about $8,000 in Ohio to about $64
million in California. For example, states can appropriate funds to be
used by their respective ADAPs. The total amount of these contributions
was about $194.8 million--the largest total amount received from the
various sources.
Other sources: Thirty-two ADAPs reported receiving funding from other
sources[Footnote 34] ranging from about $7,000 in Montana to $64.5
million in New York. The total amount of funds received from these
sources was about $169.3 million.
Among the ADAPs that reported receiving funding from sources other than
ADAP base grants, the total dollar amounts received ranged from $50,000
in Alaska to about $123.5 million in California. Six ADAPs--Iowa, New
Hampshire, New Mexico, Tennessee, Utah, and Wyoming--did not report
receiving any additional funding.
The amount of additional funding some ADAPs received significantly
increased their funds available to support ADAP enrollees and services.
The increases in funding per ELC and as a percent of the ADAP base
grant varied among the ADAPs. (See table 6.) For example, the highest
amount of additional funding received per ELC was $3,604, or 171
percent of the ADAP base grant, in Idaho. The lowest amount of
additional funding received--excluding the 6 ADAPs with no additional
funds--per ELC was $61, or 3 percent of the ADAP base grant, in the
District of Columbia. Of the 46 ADAPs that received additional funding,
8 ADAPs--California, Colorado, Idaho, Minnesota, North Carolina, North
Dakota, Oregon, and South Dakota--received total additional funding
that was more than 100 percent of the ADAP base grants to their states.
Ten ADAPs--Alaska, Arizona, Connecticut, District of Columbia, Florida,
Louisiana, Maryland, Massachusetts, Ohio, and South Carolina--received
total additional funding that was less than 20 percent of the ADAP base
grants to their states.
Table 6: Total Additional ADAP Funding as a Percentage of the CARE Act
ADAP Base Grants and Total Additional Funding Per ELC by ADAP, Fiscal
Year 2004:
ADAP: Alabama;
Total additional ADAP funding: $3,531,141;
ADAP base grant: $7,004,635;
Total additional ADAP funding as percentage of the ADAP base grant: 50;
Total additional ADAP funding per ELC with rank among 46 ADAPs:
Dollars: $1,064;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
18.
ADAP: Alaska;
Total additional ADAP funding: 50,000;
ADAP base grant: 472,602;
Total additional ADAP funding as percentage of the ADAP base grant: 11;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 223;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
42.
ADAP: Arizona;
Total additional ADAP funding: 1,078,546;
ADAP base grant: 8,392,903;
Total additional ADAP funding as percentage of the ADAP base grant: 13;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 271;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
41.
ADAP: Arkansas;
Total additional ADAP funding: 723,810;
ADAP base grant: 3,116,716;
Total additional ADAP funding as percentage of the ADAP base grant: 23;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 494;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
34.
ADAP: California;
Total additional ADAP funding: 123,473,623;
ADAP base grant: 89,623,465;
Total additional ADAP funding as percentage of the ADAP base grant:
138;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
2,907;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
4.
ADAP: Colorado;
Total additional ADAP funding: 5,668,444;
ADAP base grant: 5,607,928;
Total additional ADAP funding as percentage of the ADAP base grant:
101;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
2,133;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
8.
ADAP: Connecticut;
Total additional ADAP funding: 606,678;
ADAP base grant: 11,315,018;
Total additional ADAP funding as percentage of the ADAP base grant: 5;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 113;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
44.
ADAP: Delaware;
Total additional ADAP funding: 832,382;
ADAP base grant: 3,202,722;
Total additional ADAP funding as percentage of the ADAP base grant: 26;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 548;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
32.
ADAP: District of Columbia;
Total additional ADAP funding: 400,000;
ADAP base grant: 13,842,594;
Total additional ADAP funding as percentage of the ADAP base grant: 3;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 61;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
46.
ADAP: Florida;
Total additional ADAP funding: 10,916,336;
ADAP base grant: 80,386,630;
Total additional ADAP funding as percentage of the ADAP base grant: 14;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 287;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
40.
ADAP: Georgia;
Total additional ADAP funding: 16,331,983;
ADAP base grant: 23,684,951;
Total additional ADAP funding as percentage of the ADAP base grant: 69;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,455;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
14.
ADAP: Hawaii;
Total additional ADAP funding: 440,535;
ADAP base grant: 2,084,512;
Total additional ADAP funding as percentage of the ADAP base grant: 21;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 446;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
36.
ADAP: Idaho;
Total additional ADAP funding: 792,940;
ADAP base grant: 464,163;
Total additional ADAP funding as percentage of the ADAP base grant:
171;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
3,604;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
1.
ADAP: Illinois;
Total additional ADAP funding: 12,619,843;
ADAP base grant: 25,746,254;
Total additional ADAP funding as percentage of the ADAP base grant: 49;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,034;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
20.
ADAP: Indiana;
Total additional ADAP funding: 2,822,750;
ADAP base grant: 6,529,924;
Total additional ADAP funding as percentage of the ADAP base grant: 43;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 912;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
24.
ADAP: Iowa;
Total additional ADAP funding: 0;
ADAP base grant: 1,305,985;
Total additional ADAP funding as percentage of the ADAP base grant: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank: --
.
ADAP: Kansas;
Total additional ADAP funding: 950,000;
ADAP base grant: 2,045,495;
Total additional ADAP funding as percentage of the ADAP base grant: 46;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 991;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
22.
ADAP: Kentucky;
Total additional ADAP funding: 991,064;
ADAP base grant: 4,086,741;
Total additional ADAP funding as percentage of the ADAP base grant: 24;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 512;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
33.
ADAP: Louisiana;
Total additional ADAP funding: 2,458,519;
ADAP base grant: 13,829,935;
Total additional ADAP funding as percentage of the ADAP base grant: 18;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 375;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
39.
ADAP: Maine;
Total additional ADAP funding: 182,965;
ADAP base grant: 833,383;
Total additional ADAP funding as percentage of the ADAP base grant: 22;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 463;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
35.
ADAP: Maryland;
Total additional ADAP funding: 2,271,175;
ADAP base grant: 25,746,254;
Total additional ADAP funding as percentage of the ADAP base grant: 9;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 186;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
43.
ADAP: Massachusetts;
Total additional ADAP funding: 2,788,809;
ADAP base grant: 14,684,416;
Total additional ADAP funding as percentage of the ADAP base grant: 19;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 401;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
37.
ADAP: Michigan;
Total additional ADAP funding: 5,500,000;
ADAP base grant: 11,002,763;
Total additional ADAP funding as percentage of the ADAP base grant: 50;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,055;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
19.
ADAP: Minnesota;
Total additional ADAP funding: 3,843,522;
ADAP base grant: 3,010,727;
Total additional ADAP funding as percentage of the ADAP base grant:
128;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
2,693;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
6.
ADAP: Mississippi;
Total additional ADAP funding: 1,843,008;
ADAP base grant: 5,795,703;
Total additional ADAP funding as percentage of the ADAP base grant: 32;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 671;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
30.
ADAP: Missouri;
Total additional ADAP funding: 4,921,136;
ADAP base grant: 7,409,723;
Total additional ADAP funding as percentage of the ADAP base grant: 66;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,401;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
15.
ADAP: Montana;
Total additional ADAP funding: 231,324;
ADAP base grant: 310,145;
Total additional ADAP funding as percentage of the ADAP base grant: 75;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,574;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
12.
ADAP: Nebraska;
Total additional ADAP funding: 512,994;
ADAP base grant: 1,107,661;
Total additional ADAP funding as percentage of the ADAP base grant: 46;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 977;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
23.
ADAP: Nevada;
Total additional ADAP funding: 1,416,197;
ADAP base grant: 4,738,678;
Total additional ADAP funding as percentage of the ADAP base grant: 30;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 631;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
31.
ADAP: New Hampshire;
Total additional ADAP funding: 0;
ADAP base grant: 755,319;
Total additional ADAP funding as percentage of the ADAP base grant: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank: --
.
ADAP: New Jersey;
Total additional ADAP funding: 13,050,000;
ADAP base grant: 34,877,598;
Total additional ADAP funding as percentage of the ADAP base grant: 37;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 789;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
25.
ADAP: New Mexico;
Total additional ADAP funding: 0;
ADAP base grant: 2,127,024;
Total additional ADAP funding as percentage of the ADAP base grant: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank: --
.
ADAP: New York;
Total additional ADAP funding: 105,894,145;
ADAP base grant: 124,956,784;
Total additional ADAP funding as percentage of the ADAP base grant: 85;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,788;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
9.
ADAP: North Carolina;
Total additional ADAP funding: 13,582,481;
ADAP base grant: 12,834,095;
Total additional ADAP funding as percentage of the ADAP base grant:
106;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
2,233;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
7.
ADAP: North Dakota;
Total additional ADAP funding: 117,400;
ADAP base grant: 92,543;
Total additional ADAP funding as percentage of the ADAP base grant:
127;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
2,730;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
5.
ADAP: Ohio;
Total additional ADAP funding: 327,843;
ADAP base grant: 10,909,930;
Total additional ADAP funding as percentage of the ADAP base grant: 3;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 63;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
45.
ADAP: Oklahoma;
Total additional ADAP funding: 2,157,442;
ADAP base grant: 3,655,707;
Total additional ADAP funding as percentage of the ADAP base grant: 59;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,279;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
17.
ADAP: Oregon;
Total additional ADAP funding: 5,950,000;
ADAP base grant: 4,225,989;
Total additional ADAP funding as percentage of the ADAP base grant:
141;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
2,971;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
3.
ADAP: Pennsylvania;
Total additional ADAP funding: 16,496,000;
ADAP base grant: 27,090,216;
Total additional ADAP funding as percentage of the ADAP base grant: 61;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,285;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
16.
ADAP: Puerto Rico;
Total additional ADAP funding: 8,210,008;
ADAP base grant: 22,598,388;
Total additional ADAP funding as percentage of the ADAP base grant: 36;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 767;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
27.
ADAP: Rhode Island;
Total additional ADAP funding: 700,000;
ADAP base grant: 1,911,506;
Total additional ADAP funding as percentage of the ADAP base grant: 37;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 773;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
26.
ADAP: South Carolina;
Total additional ADAP funding: 2,227,781;
ADAP base grant: 11,736,984;
Total additional ADAP funding as percentage of the ADAP base grant: 19;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 400;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
38.
ADAP: South Dakota;
Total additional ADAP funding: 330,744;
ADAP base grant: 204,654;
Total additional ADAP funding as percentage of the ADAP base grant:
162;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
3,410;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
2.
ADAP: Tennessee;
Total additional ADAP funding: 0;
ADAP base grant: 12,018,438;
Total additional ADAP funding as percentage of the ADAP base grant: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank: --
.
ADAP: Texas;
Total additional ADAP funding: 36,468,308;
ADAP base grant: 50,471,351;
Total additional ADAP funding as percentage of the ADAP base grant: 72;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,524;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
13.
ADAP: Utah;
Total additional ADAP funding: 0;
ADAP base grant: 1,980,565;
Total additional ADAP funding as percentage of the ADAP base grant: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank: --
.
ADAP: Vermont;
Total additional ADAP funding: 305,000;
ADAP base grant: 382,007;
Total additional ADAP funding as percentage of the ADAP base grant: 80;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,685;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
11.
ADAP: Virginia;
Total additional ADAP funding: 4,746,537;
ADAP base grant: 14,498,751;
Total additional ADAP funding as percentage of the ADAP base grant: 33;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 691;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
29.
ADAP: Washington;
Total additional ADAP funding: 6,567,971;
ADAP base grant: 7,966,718;
Total additional ADAP funding as percentage of the ADAP base grant: 82;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,739;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
10.
ADAP: West Virginia;
Total additional ADAP funding: 446,941;
ADAP base grant: 1,303,875;
Total additional ADAP funding as percentage of the ADAP base grant: 34;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 723;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
28.
ADAP: Wisconsin;
Total additional ADAP funding: 1,510,026;
ADAP base grant: 3,179,514;
Total additional ADAP funding as percentage of the ADAP base grant: 47;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
1,002;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
21.
ADAP: Wyoming;
Total additional ADAP funding: 0;
ADAP base grant: 160,347;
Total additional ADAP funding as percentage of the ADAP base grant: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars: 0;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank: --
.
ADAP: Total;
Total additional ADAP funding: $427,288,351;
ADAP base grant: $ 727,320,929;
Total additional ADAP funding as percentage of the ADAP base grant:
59%;
Total additional ADAP funding per ELC with rank among 46 ADAPs: Total
additional ADAP funding per ELC with rank among 46 ADAPs: Dollars:
[Empty];
Total additional ADAP funding per ELC with rank among 46 ADAPs: Rank:
[Empty].
Sources: HRSA and GAO analysis.
Note: A dash indicates an ADAP that did not receive additional funding
and could not be ranked.
[End of table]
ADAPs with Waiting Lists Also Varied in Program Design and Additional
Funding Sources and Amounts:
The eligibility and other program design criteria and additional
funding ADAPs received varied among ADAPs with waiting lists and can
contribute to coverage differences. When an ADAP cannot cover everyone
it determines is eligible for its services, it may, but is not required
to, establish a waiting list. HRSA's HIV/AIDS Bureau does not have
guidance on what conditions should trigger an ADAP to establish a
waiting list. In fiscal year 2004, 14 ADAPs had waiting lists of
individuals they determined were ADAP eligible but the programs were
unable to serve.[Footnote 35] (See table 7.) Due to the lack of
reliable data on both the number of unduplicated individuals on a list
and the length of time individuals spend on waiting lists, we could not
determine, for example, the exact number of individuals during a
specific period who were on waiting lists. Based on data ADAPs with
waiting lists reported to HRSA for fiscal year 2004, the average number
of individuals on waiting lists for a particular ADAP and among ADAPs
varied.[Footnote 36] For example, Montana's monthly average ranged from
5 to 14 individuals during fiscal year 2004, while North Carolina's
monthly average ranged from 38 to 861. We do not know whether any ADAP
turned away individuals who would have been eligible without
establishing a waiting list.
Table 7: ADAPs with Waiting Lists and Number of Months Each Had Waiting
Lists, Fiscal Year 2004:
ADAPs: Alabama;
Number of Months: 12.
ADAPs: Alaska;
Number of Months: 10.
ADAPs: Arkansas;
Number of Months: 4.
ADAPs: Colorado;
Number of Months: 10.
ADAPs: Idaho;
Number of Months: 9.
ADAPs: Indiana;
Number of Months: 2.
ADAPs: Iowa;
Number of Months: 5.
ADAPs: Kentucky;
Number of Months: 12.
ADAPs: Montana;
Number of Months: 11.
ADAPs: Nebraska;
Number of Months: 3.
ADAPs: North Carolina;
Number of Months: 12.
ADAPs: Oregon;
Number of Months: 2.
ADAPs: South Dakota;
Number of Months: 12.
ADAPs: West Virginia;
Number of Months: 12.
Sources: HRSA and GAO analysis.
[End of table]
Eligibility and other program design criteria reported for ADAP grant
year 2004 varied among ADAPs with waiting lists. For example, for:
² Income ceilings: Among the 14 ADAPs with waiting lists, income
ceilings ranged from the most restrictive at 125 percent of the poverty
level, or $11,638 in North Carolina to the most generous at 330 percent
of the poverty level, or $30,723 in Montana.
² Enrollment and service caps: Among the 14 ADAPs with waiting lists, 6
ADAPs capped the number of enrollees, and two capped the amount they
expend per individual for all HIV/AIDS drugs.
² Drug formularies: Among the 14 ADAPs with waiting lists, the total
number of drugs on their formularies ranged from 20 drugs in Colorado
to 105 drugs in Montana.
In fiscal year 2004, the majority of ADAPs received funding from other
sources in addition to ADAP base grants. The majority of ADAPs with
waiting lists--13 of 14--also received additional funding. For example,
for:
² Severe Need grants: Among the 14 ADAPs with waiting lists, 8 received
funds from Severe Need grants.[Footnote 37]
² Title II base grant transfers: Among the 14 ADAPs with waiting lists,
8 received transfers of Title II base grant funds.
² Title I grant transfers from EMAs: Among the 14 ADAPs with waiting
lists, only one ADAP--Colorado--received a Title I transfer.
² Contributions from state and Puerto Rico funds: Among the 14 ADAPs
with waiting lists, 9 received these contributions.
² Other sources: Among the 14 ADAPs with waiting lists, 10 ADAPs
reported receiving funding from other sources.[Footnote 38],[Footnote
39] Among those 10 ADAPs, the amount of funds from other sources ranged
from about $7,000 in Montana to about $5.6 million in Oregon.
Of the 13 ADAPs with waiting lists that received additional funding in
fiscal year 2004, 5--Colorado, Idaho, North Carolina, Oregon, and South
Dakota--were among the 10 ADAPs that received the most additional
funding per ELC. (See table 8.) Idaho at $3,604 per ELC, South Dakota
at $3,410 per ELC, and Oregon at $2,971 per ELC respectively ranked the
highest among the 46 ADAPs that received additional funding. The rank
order of the remaining 10 ADAPs with waiting lists among all ADAPs that
received additional funding ranged from seventh--North Carolina at
$2,233 per AIDS case--to forty-second--Alaska at $223 per ELC.
Table 8: Ranking of 13 ADAPs with Waiting Lists among the 46 ADAPs that
Received Additional Funding Per ELC;
Fiscal Year 2004:
ADAPs with waiting lists that received additional funding: Idaho;
Rank among 46 ADAPs by additional funding per ELC: 1;
Additional funding per ELC: $3,604.
ADAPs with waiting lists that received additional funding: South
Dakota;
Rank among 46 ADAPs by additional funding per ELC: 2;
Additional funding per ELC: 3,410.
ADAPs with waiting lists that received additional funding: Oregon;
Rank among 46 ADAPs by additional funding per ELC: 3;
Additional funding per ELC: 2,971.
ADAPs with waiting lists that received additional funding: North
Carolina;
Rank among 46 ADAPs by additional funding per ELC: 7;
Additional funding per ELC: 2,233.
ADAPs with waiting lists that received additional funding: Colorado;
Rank among 46 ADAPs by additional funding per ELC: 8;
Additional funding per ELC: 2,133.
ADAPs with waiting lists that received additional funding: Montana;
Rank among 46 ADAPs by additional funding per ELC: 12;
Additional funding per ELC: 1,574.
ADAPs with waiting lists that received additional funding: Alabama;
Rank among 46 ADAPs by additional funding per ELC: 18;
Additional funding per ELC: 1,064.
ADAPs with waiting lists that received additional funding: Nebraska;
Rank among 46 ADAPs by additional funding per ELC: 23;
Additional funding per ELC: 977.
ADAPs with waiting lists that received additional funding: Indiana;
Rank among 46 ADAPs by additional funding per ELC: 24;
Additional funding per ELC: 912.
ADAPs with waiting lists that received additional funding: West
Virginia;
Rank among 46 ADAPs by additional funding per ELC: 28;
Additional funding per ELC: 723.
ADAPs with waiting lists that received additional funding: Kentucky;
Rank among 46 ADAPs by additional funding per ELC: 33;
Additional funding per ELC: 512.
ADAPs with waiting lists that received additional funding: Arkansas;
Rank among 46 ADAPs by additional funding per ELC: 34;
Additional funding per ELC: 494.
ADAPs with waiting lists that received additional funding: Alaska;
Rank among 46 ADAPs by additional funding per ELC: 42;
Additional funding per ELC: 223.
Sources: GAO analysis of HRSA and ADAP data.
[End of table]
Some ADAPs Reported HIV/AIDS Drug Prices that Were Higher than the 340B
Prices:
Some ADAPs reported prices to HRSA that they paid for some of the top
10 HIV/AIDS drugs purchased during 2003 that were higher than the 340B
program prices.[Footnote 40] However, the reported prices may not be
the final prices paid by ADAPs that receive rebates on the purchase
price of their drugs. States and territories are expected to use every
means at their disposal to secure the best price possible for HIV/AIDS
drugs and are also required to adopt at least one cost-saving practice
that is equal to or more economical:
than the 340B and prime vendor programs.[Footnote 41] While HRSA has
identified 340B prices as the measure of cost effectiveness, HHS does
not provide ADAPs with the 340B prices to use as a guide when
purchasing HIV/AIDS drugs due to statutory provisions regarding the
confidentiality of information used to determine them. Drug
manufacturers that participate in the 340B program are aware of the
340B prices, and as a condition of their participation in the Medicaid
program, have agreed to sell HIV/AIDS drugs to those ADAPs that use the
340B direct purchase or rebate options at prices no greater than the
340B prices.[Footnote 42] We found that among both the 25 ADAPs that
used the direct purchase option and the 27 that used the rebate option
to purchase their drugs in 2003, nearly all of the ADAPs reported drug
prices that were higher than the 340B prices for at least one of the
top 10 drugs.
All of the 25 ADAPs that used the 340B direct purchase option to buy
HIV/AIDS drugs in 2003 reported prices that were higher than the 340B
prices for at least one of the top 10 HIV/AIDS drugs.[Footnote 43] (See
table 9.) For example, 7 ADAPs reported prices that were above the 340B
price for Viramune. Three ADAPs reported prices that were more than the
340B price for at least 8 of the 10 drugs--Delaware (10), Oklahoma (9),
and Kentucky (8). All 25 ADAPs reported prices that were more than the
340B price for the drug Norvir. Since ADAPs are not provided the 340B
prices, they may be unknowingly paying more than the 340B price for a
drug.[Footnote 44] Because the 340B, the 340B prime vendor, the FCP,
and Medicaid drug prices are not public, we indicate only whether a
reported price is above the 340B price.
Table 9: 25 340B Direct Purchase ADAPs that Reported Prices for the Top
10 HIV/AIDS Drugs that Were Above 340B Prices;
2003:
ADAP: Alabama;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Arizona;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Arkansas;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: X;
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: X;
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Colorado;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: X;
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Delaware;
Combivir: X;
Epivir: X;
Norvir[A]: X;
Sustiva: X;
Trizivir: X;
Viracept: X;
Viramune: X;
Viread: X;
Zerit: X;
Ziagen: X.
ADAP: District of Columbia;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: N/A;
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Florida;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Georgia;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Hawaii;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: X;
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Iowa;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Illinois;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: X;
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Kentucky;
Combivir: X;
Epivir: X;
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: X;
Viracept: X;
Viramune: N/A;
Viread: X;
Zerit: X;
Ziagen: X.
ADAP: Louisiana;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Mississippi;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: X;
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: N/A;
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Montana;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: X;
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Nebraska;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: New Mexico;
Combivir: X;
Epivir: X;
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: X;
Viread: [Empty];
Zerit: X;
Ziagen: X.
ADAP: Nevada;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: X;
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Ohio;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Oklahoma;
Combivir: X;
Epivir: X;
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: X;
Viracept: X;
Viramune: X;
Viread: X;
Zerit: X;
Ziagen: X.
ADAP: Puerto Rico;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: X;
Viread: X;
Zerit: X;
Ziagen: [Empty].
ADAP: South Carolina;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: [Empty];
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Tennessee;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: X;
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Texas;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: N/A;
Trizivir: [Empty];
Viracept: [Empty];
Viramune: N/A;
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Virginia;
Combivir: [Empty];
Epivir: [Empty];
Norvir[A]: X;
Sustiva: [Empty];
Trizivir: [Empty];
Viracept: [Empty];
Viramune: X;
Viread: [Empty];
Zerit: [Empty];
Ziagen: [Empty].
ADAP: Total;
Combivir: 4;
Epivir: 4;
Norvir[A]: 25;
Sustiva: 4;
Trizivir: 4;
Viracept: 3;
Viramune: 7;
Viread: 7;
Zerit: 5;
Ziagen: 4.
Sources: HRSA and GAO analysis.
N/A = ADAP did not purchase the drug.
Notes: An empty table cell indicates that the ADAP purchased the drug
and paid at or below the 340B price for that drug. To compare the
prices that ADAPs reported paying for HIV/AIDS drugs to 340B prices for
such drugs, we first determined which HIV/AIDS drugs were the top 10 by
ADAP expenditure using 2002 data, the most recently available
expenditure data. We then compared the prices ADAPs reported they paid
for the top 10 HIV/AIDS drugs to the 340B program prices for those same
drugs. For this comparison, we used the 2003 340B program prices and
the purchase prices that 52 ADAPs provided in their quarterly reports
submitted to HRSA for 2003. At the time of our analysis, 2003 was the
most recent full calendar year of ADAP drug price data.
[A] In December 2003, Abbott Laboratories, the manufacturer of Norvir,
an HIV/AIDS protease inhibitor, substantially increased the wholesale
price per patient. In February 2004, Abbott Laboratories announced a
permanent Norvir price freeze for ADAPs at the price in place prior to
the December 2003 re-pricing.
[End of table]
Among the 27 ADAPs that reported they used the 340B rebate option in
2003, most reported prices for the top 10 HIV/AIDS drugs that were
above the 340B prices. The 3 ADAPs that reported HIV/AIDS drug prices
at or below the 340B prices, and the number of drugs they purchased at
these prices were Kansas (3), Washington (3), and Pennsylvania (1).
ADAPs using the 340B rebate option report the prices they paid for
drugs to HRSA, but these reports may not reflect the drug rebates ADAPs
may eventually receive that would determine the final amount paid for
the drug. The ADAPs that use the 340B rebate option almost always
reported HIV/AIDS drug prices higher than the 340B prices. An OPA
official told us that there is no reporting that reconciles the rebate
savings an ADAP may receive against the price it pays for a drug.
ADAPs that negotiate their own HIV/AIDS drug discounts with drug
manufacturers, or use the 340B prime vendor to negotiate drug discounts
for them, are expected to negotiate prices equal to or less than the
340B prices.[Footnote 45] However, HHS does not disclose to the ADAPs
or the 340B prime vendor what the 340B prices are that they should not
exceed. A HRSA official told us that the ADAPs' and the 340B prime
vendor's negotiating position is disadvantaged because they rely on the
drug manufacturers they negotiate with to tell them whether the
negotiated prices are equal to or better than the 340B prices.
In 2003, 10 ADAPs joined together to negotiate HIV/AIDS drug prices
directly with drug manufacturers. These ADAPs formed a task force under
the auspices of NASTAD to directly negotiate drug prices with eight
drug manufacturers for HIV/AIDS antiretroviral drug discounts on behalf
of all ADAPs.[Footnote 46] According to the ADAP task force
representatives we interviewed, the negotiated drug discounts they
agreed to were the total of the 340B discount plus whatever additional
discounts they could negotiate. The representatives said that the
discounts they agreed to were lower than prices available under the
340B program, but we did not verify the representatives' claim. The
quarterly reports that ADAPs provide the Bureau do not indicate whether
a drug price is the result of negotiations conducted by an ADAP or
other options such as the 340B direct purchase or rebate. All of these
10 ADAPs reported prices on their 2003 quarterly reports that were more
than the 340B price for at least 1 of the top 10 drugs.
HRSA Does Not Routinely Determine Whether Drug Prices ADAPs Report
Paying Are Higher than the 340B Prices:
HRSA's HIV/AIDS Bureau is responsible for monitoring grantees'
compliance with the conditions of their grants, including those related
to HIV/AIDS drug prices. HRSA does not routinely compare the HIV/AIDS
drug prices ADAPs report they pay to 340B program prices. When
comparisons are made, they may not be complete, because the prices
ADAPs report paying may not include all rebates they may receive under
the 340B rebate option. If an ADAP is found to be out of compliance,
HRSA can restrict the ADAP's use of its current funds or deny it future
grant funds.
To monitor ADAP drug prices, a Bureau official told us that the Bureau
had only occasionally requested that ADAP drug prices be compared to
the 340B prices. For example, the Bureau has requested some spot checks
rather than conducting quarterly price comparisons using the ADAPs'
quarterly drug price reports. No Bureau official has access to the 340B
price information. HRSA's OPA administers the 340B drug pricing
program, including the 340B prime vendor program, and has access to the
340B prices and the prime vendor's negotiated prices.[Footnote 47]
Therefore, to determine how ADAP reported prices compare to 340B
prices, the Bureau has to request that OPA make these price
comparisons. When OPA makes the price comparisons at the Bureau's
request, the comparison results that OPA provides indicate whether an
ADAP reported price is below, above, or close to the 340B price, or may
show, for example, that a drug's price is within a percentage range
above or below the 340B price for that drug. According to the Bureau
and OPA officials, requests for these comparisons are not routinely
made by the Bureau.
The results of OPA price comparisons do not necessarily show whether
final prices paid by ADAPs using the rebate option are higher than the
340B prices. According to HRSA officials, the drug prices reported paid
by ADAPs that use the rebate option are not reflective of the final
prices because they have not been reconciled by factoring in rebate
savings.[Footnote 48] A Bureau official and an OPA official stated that
without the reconciled ADAP rebate savings information on a particular
drug purchased, it cannot be determined whether the final drug prices
paid are at or below the 340B prices or whether ADAPs that use the
rebate purchase option are paying more than the 340B price for any
drugs.
Based on its finding that HRSA did not conduct systematic monitoring of
340B prices, in December 2005, the HHS OIG recommended that HRSA
develop monitoring mechanisms to compare the 340B prices to the prices
paid by 340B entities, which include ADAPs.[Footnote 49] During the
course of our review, Bureau and OPA officials told us that they were
discussing plans for OPA to begin making routine comparisons of the
prices reported by the ADAPs to the 340B prices. As of April 2006,
final decisions have not been made about when the comparisons will
begin, how often they will be made during a year, or whether the
results will be shared with the ADAPs. If the price comparisons do not
include the rebates ADAPs receive and 340B prime vendor prices, the
comparisons cannot indicate whether the prices all ADAPs paid for their
drugs were at or below the 340B prices.
HIV/AIDS Drug Prices Are Sometimes Higher Under the 340B Program than
Some Federal Programs:
ADAPs that purchase HIV/AIDS drugs at the 340B prices paid more for
some of the top 10 drugs by expenditure than prices for these same
drugs paid under the 340B prime vendor program and prices federal
agencies pay under the FSS and FCP drug pricing programs. ADAPs paid
less for their top 10 drugs than drugs purchased under the Medicaid
program.[Footnote 50] ADAPs do not have access to the federal drug
pricing programs. In our comparison of drug prices in 2000 to drug
prices in 2003, all but one of the top 10 drug prices that we included
in our analysis increased under the 340B, FSS, and FCP. During the same
period, all top 10 drug prices for which we had data available
decreased under the Medicaid program.
340B Prices for Several Top 10 HIV/AIDS Drugs Were Higher than Prices
Under Other Federal Drug Pricing Programs:
The results of our analysis show that the 340B prices paid in 2003 for
most of the top 10 HIV/AIDS drugs were higher than prices under the FCP
and 340B prime vendor programs, but lower than Medicaid
prices.[Footnote 51] We compared 2003 drug prices under four drug
pricing programs--340B prime vendor,[Footnote 52] FCP, FSS, and
Medicaid rebate--to the 340B prices. Seven of the top 10 HIV/AIDS
drugs--Combivir, Epivir, Norvir, Sustiva, Trizivir, Zerit, and Ziagen-
-had 2003 prices available for comparison under all five drug pricing
programs. The price comparisons are indicated by rank, rather than by
the drug prices, because the prices for the 340B, the 340B prime
vendor, the FCP, and Medicaid are not public. (See table 10.)
Table 10: Ranking of Top 10 HIV/AIDS Drugs from Lowest (1) to Highest
(5) Unit Price Across Drug Programs;
2003:
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Combivir;
340B price: 3;
340B prime vendor price: 2;
Federal ceiling price: 1;
Federal supply schedule price: 5;
Medicaid price[B]: 4.
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Viracept;
340B price: 2;
340B prime vendor price: NPA;
Federal ceiling price: NPA;
Federal supply schedule price: 1;
Medicaid price[B]: 3.
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Sustiva;
340B price: 4;
340B prime vendor price: 3;
Federal ceiling price: 1;
Federal supply schedule price: 2;
Medicaid price[B]: 5.
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Norvir;
340B price: 1;
340B prime vendor price: 4;
Federal ceiling price: 2 (tied);
Federal supply schedule price: 2 (tied);
Medicaid price[B]: 5.
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Zerit;
340B price: 3;
340B prime vendor price: 1;
Federal ceiling price: 2;
Federal supply schedule price: 5;
Medicaid price[B]: 4.
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Trizivir;
340B price: 3;
340B prime vendor price: 2;
Federal ceiling price: 1;
Federal supply schedule price: 4;
Medicaid price[B]: 5.
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Epivir;
340B price: 3;
340B prime vendor price: 2;
Federal ceiling price: 1;
Federal supply schedule price: 5;
Medicaid price[B]: 4.
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Ziagen;
340B price: 3;
340B prime vendor price: 2;
Federal ceiling price: 1;
Federal supply schedule price: 5;
Medicaid price[B]: 4.
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Viramune;
340B price: 1;
340B prime vendor price: NPA;
Federal ceiling price: NPA;
Federal supply schedule price: NPA;
Medicaid price[B]: NPA.
Top 10 HIV/AIDS drugs ranked by ADAP expenditure[A]: Viread;
340B price: 3;
340B prime vendor price: NPA;
Federal ceiling price: 1;
Federal supply schedule price: 2;
Medicaid price[B]: 4.
Sources: GAO analysis of HRSA, VA, and CMS data.
NPA = no price was available for the drug.
Notes: The unit price for a drug is the price for a unit of the dosage
form and strength involved indicated by the National Drug Code (NDC).
Each FDA-approved drug has at least one NDC which is a universal
product identifier number for human drugs maintained by FDA. An NDC
indicates a drug's manufacturer or distributor, a drug's strength,
dosage form and formulation, and its package size. For the 10 drugs we
used, we determined the NDC for each drug that was most commonly
purchased by 52 ADAPs, and used the price for that NDC for our
comparisons. For example, since Sustiva has more than one NDC, we chose
the Sustiva NDC that was most commonly purchased by ADAPs to identify
which of Sustiva's drug prices to use for our comparison. For a drug
marked NPA, there was no price available using the NDC we identified
under the drug pricing program. The available 2003 prices were for
brand name drug prices. The comparisons are indicated by rank, rather
than price, because only the FSS prices are publicly available.
[A] The drugs were the top 10 by ADAP drug expenditures for 2002, the
most recent expenditure data available at the time of the analysis.
[B] The Medicaid price is the average amount state Medicaid programs
paid net of the basic rebate provided under the Medicaid Drug Rebate
Program.
[End of table]
We found that for six of the seven drugs that had prices available
under all five programs--Combivir, Epivir, Sustiva, Trizivir, Zerit,
and Ziagen--FCP and the 340B prime vendor prices were lower than 340B
prices. The FSS price for one of the seven drugs--Sustiva--was lower
than the 340B price. Although some drug prices under FCP and FSS were
lower than the 340B prices, ADAPs do not have access by statute to
these two federal drug pricing programs.[Footnote 53] The 340B price
was the lowest for one of the seven drugs--Norvir. Medicaid prices were
the highest of all the pricing programs for three of the seven drugs--
Norvir, Sustiva, and Trizivir. (See table 10.)
Fuzeon is the only fusion inhibitor approved for individuals who have
used other anti-HIV drugs, but still have ongoing HIV-viral
replication. It was approved in 2003 by FDA, and was therefore not
among the top 10 HIV/AIDS drugs by ADAP expenditures for 2002 that we
included in our analysis. However, we compared the 2003 340B price for
Fuzeon to prices under the other pricing programs included in our
analysis. In comparing the 2003 Fuzeon prices under the five drug
pricing programs, we found that Fuzeon's 340B price was higher than
both the FCP and FSS prices, but lower than either the 340B prime
vendor price or Medicaid price.
Changes in Drug Prices Varied Widely Among HIV/AIDS Drugs and Among
Drug Pricing Programs:
We found wide variability in the percentage change in unit price among
the top 10 HIV/AIDS drugs and among the 340B, FCP, FSS, and Medicaid
rebate pricing programs.[Footnote 54] Because ADAPs provide drug
coverage for eligible individuals over longer periods due to improved
drug treatments, and increased life expectancy, the cost of HIV/AIDS
drugs over time is an important concern for ADAPs. We analyzed the
changes in the prices of the top 10 HIV/AIDS drugs under these programs
by comparing the prices in 2000 to the prices in 2003. (See table 11.)
From 2000 to 2003, all available prices for the top 10 HIV/AIDS drugs
increased under the 340B, FCP, and FSS, except for Norvir which had a
decrease in its 340B price.[Footnote 55] During the same period, all
available drug prices decreased under the Medicaid program.
Table 11: Percentage of Unit Price Increases or Decreases from 2000 to
2003 for Top 10 HIV/AIDS Drugs:
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Combivir;
340B price: 7.95;
Federal ceiling price: 18.42;
Federal supply schedule: 7.52;
Medicaid price[B]: -5.94.
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Viracept;
340B price: 116.91;
Federal ceiling price: NPA;
Federal supply schedule: NPA;
Medicaid price[B]: -1.56.
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Sustiva;
340B price: 16.60;
Federal ceiling price: 1.93;
Federal supply schedule: 1.78;
Medicaid price[B]: -1.92.
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Norvir;
340B price: - 41.68;
Federal ceiling price: 3.63;
Federal supply schedule: 3.63;
Medicaid price[B]: -13.77.
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Zerit;
340B price: 6.94;
Federal ceiling price: 29.15;
Federal supply schedule: 87.95;
Medicaid price[B]: -11.66.
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Trizivir;
340B price: NPA;
Federal ceiling price: NPA;
Federal supply schedule: NPA;
Medicaid price[B]: -2.46.
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Epivir;
340B price: 7.90;
Federal ceiling price: 24.84;
Federal supply schedule: 7.53;
Medicaid price[B]: -6.18.
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Ziagen;
340B price: 8.08;
Federal ceiling price: 8.49;
Federal supply schedule: 7.53;
Medicaid price[B]: -5.48.
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Viramune;
340B price: 113.59;
Federal ceiling price: NPA;
Federal supply schedule: NPA;
Medicaid price[B]: NPA.
Top 10 HIV/AIDS drugs ranked by expenditure[A]: Viread;
340B price: NPA;
Federal ceiling price: NPA;
Federal supply schedule: NPA;
Medicaid price[B]: NPA.
Sources: GAO analysis of HRSA, VA, and CMS data.
NPA = no price was available for the drug.
Notes: The unit price for a drug is the price for a unit of the dosage
form and strength involved indicated by the National Drug Code (NDC).
Each FDA-approved drug has at least one NDC which is a universal
product identifier number for human drugs maintained by FDA. An NDC
indicates a drug's manufacturer or distributor, a drug's strength,
dosage form and formulation, and its package size. For the 10 drugs we
used, we determined the NDC for each drug that was most commonly
purchased by 52 ADAPs in 2003, and used the price for that NDC for our
comparisons. For example, since Sustiva has more than one NDC, we chose
the Sustiva NDC that was most commonly purchased by ADAPs to identify
which of Sustiva's drug prices to use for our comparison. For a drug
marked NPA, there was no price available using the NDC we identified
under the drug pricing program for either 2000 or 2003 or both, so no
calculations could be made. The available 2000 and 2003 prices were for
brand name drug prices. No 2000 prices were available for the 340B
prime vendor.
[A] The drugs were the top 10 by ADAP expenditures for 2002, the most
recent expenditure data available at the time of the analysis.
[B] The Medicaid price is the average amount state Medicaid programs
paid net of the basic rebate provided under the Medicaid Drug Rebate
Program.
[End of table]
All four drug pricing programs had prices that we could compare for 6
of the 10 HIV/AIDS drugs--Combivir, Epivir, Norvir, Sustiva, Zerit, and
Ziagen. Among the four programs, the price changes varied widely. Under
both FCP and FSS, prices for the 6 drugs increased between 2000 and
2003. The FCP price increases ranged from 1.93 percent for Sustiva to
29.15 percent for Zerit. The FSS price increases ranged from 1.78
percent for Sustiva to 87.95 percent for Zerit. The FSS had the lowest
percentage increase in price from 2000 to 2003 for four of the six
drugs--Combivir, Epivir, Sustiva, and Ziagen. Medicaid prices for all
six drugs decreased with changes ranging from -13.77 percent for Zerit
to -1.92 for Sustiva. The 340B prices increased for 5 of the 6 drugs--
from 6.94 percent for Zerit to 16.60 percent for Sustiva, and decreased
for 1 of the 6--Norvir--by -41.68 percent.
Among the same 6 HIV/AIDS drugs, the price increases and decreases
varied widely among the drugs and by drug pricing program. For example,
Combivir prices ranged from its highest price increase--FCP's 18.42
percent--to its only price decrease--Medicaid's -5.94 percent. Sustiva
prices ranged from its highest price increase--340B's 16.60 percent--to
its only price decrease--Medicaid's -1.92 percent. Norvir prices ranged
from its only highest price increase--FCP's and FSS's 3.63 percent--to
its lowest price decrease--340B's -41.68 percent. Zerit prices ranged
from its highest price increase--FCP's 87.95 percent--to its only price
decrease--Medicaid's -11.66 percent.
Conclusions:
As the number of people with HIV/AIDS live longer due to improved drug
treatments, the demand for ADAP services will increase, and
expenditures by ADAPs for HIV/AIDS drugs will also likely increase.
Therefore, it is important that ADAPs achieve the maximum benefit with
the funds provided to them for drug purchases, and to do this, they
have been given access to the 340B program. However, HRSA does not
systematically and routinely determine whether ADAPs, particularly
those using the 340B rebate option or those that have negotiated drug
prices, are acquiring drugs at prices at or below the 340B prices. The
HHS OIG has previously identified shortcomings in HRSA's oversight of
the 340B program and recommended that HRSA verify manufacturers'
calculations of 340B prices and monitor their compliance with program
requirements; HRSA acknowledged the need to increase its oversight.
HRSA also needs to determine whether ADAPs are purchasing drugs at
prices at or below the 340B prices. While monitoring the prices paid
for all the drugs on each ADAP's formulary might be challenging, as
some formularies have as many as 1,000 drugs, HRSA could routinely
compare ADAP reported prices to 340B prices for selected drugs. For
instance, all antiretrovirals could be compared, which would include
the top 10 drugs we used in our drug pricing analysis and which
represented 73 percent of the total ADAP drug expenditures in 2002.
Ensuring that the prices are reported on a schedule to allow for the
rebate reconciliation could also help HRSA to better monitor the final
prices paid for the drugs and to gauge whether ADAPs are achieving
maximum results with their grant funds.
Recommendations for Executive Action:
To ensure that ADAPs are obtaining the best prices for drugs they
provide, we recommend that the Administrator of the Health Resources
and Services Administration take the following two actions:
² require that all ADAPs report final prices they paid for drugs, and
that those final prices reflect any discounts or rebates received.
² routinely determine whether the prices ADAPs paid for the drugs they
purchased were at or below the 340B prices.
Agency Comments and Our Evaluation:
HRSA provided written comments on a draft of this report. HRSA
commented that the report highlights a key issue facing ADAPs and HRSA
in administering the program, but the agency raised concerns about its
ability to implement our recommendations. The comments are reprinted in
appendix IV.
HRSA stated that it would like to verify final drug prices but this
would be labor intensive because reports ADAPs currently provide do not
contain the needed information. Specifically, HRSA noted that ADAPs may
receive rebate checks many months after the drugs were purchased, which
complicates the task of comparing prices. HRSA further stated that it
is taking steps to develop the information it will require to determine
whether the prices ADAPs paid for the drugs they purchased are at or
below the 340B prices, but that it lacks the resources to conduct
manual cost comparisons on a large scale. HRSA noted that it is making
efforts to develop systems to allow ADAPs to check drug prices and that
the agency has requested that drug manufacturers who participate in the
340B program voluntarily submit quarterly 340B prices on covered drugs
to HRSA for comparison with the government computed 340B ceiling
prices.
As we stated in the draft report, ADAPs' financial data submitted to
HRSA contain information on the total expected rebate savings but not
the rebate expected on the purchase of a specific drug, which is the
information needed to make drug price comparisons to the 340B prices.
While we recognize that monitoring the prices paid for all the drugs on
each ADAP's formulary might be challenging, HRSA could compare ADAP
reported prices to 340B prices for selected drugs and could modify its
schedule of ADAP reports to allow for rebate reconciliation. For
example, HRSA could compare ADAP reported prices to 340B prices for all
antiretrovirals, which would include the top 10 drugs we used in our
drug pricing analysis and which represented over 70 percent of the
total ADAP drug expenditures in a year. HRSA indicated that a manual
comparison would be required, but in conducting our analysis we created
a computer program that automatically compared information from the
ADAP reports with the 340B prices, and HRSA could construct a similar
cost-effective, automated process. Further, HRSA's plans to develop
systems that allow ADAPs to check drug prices would be a useful tool in
assisting the ADAPs to obtain the best prices, but would still not
fulfill HRSA's responsibilities to oversee the programs to ensure
compliance with the conditions of the grants. Given that we found ADAPs
reported prices that were above the 340B prices, we believe that HRSA
needs to take additional steps to monitor the program.
HRSA also provided technical comments, which we have incorporated where
appropriate.
We are sending copies of this report to the Secretary of Health and
Human Services, the Administrator of Health Resources and Services
Administration, the Director of the Centers for Disease Control and
Prevention, and to interested congressional committees. We will also
make copies available to others upon request. In addition, the report
will be available on GAO's Web site at [Hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-7119 or crossem@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made major contributions to
this report are listed in appendix V.
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
Appendix I: Prenatal HIV Testing and Perinatal HIV Transmission Rates
within States:
In 2000, approximately 6,000 to 7,000 women infected with the human
immunodeficiency virus (HIV), gave birth in the United States and an
estimated 280 to 370 HIV-infected infants were born, according to the
Centers for Disease Control and Prevention (CDC). When pregnant women
are infected with HIV, they can transmit the virus to their infants
during pregnancy, during labor and delivery, or after delivery through
breast feeding. Antiretroviral therapy can reduce the risk of HIV
transmission from mother to child. According to CDC, the prevention of
perinatal HIV transmission depends on routine testing of pregnant women
for HIV and the use of antiretroviral drug treatment and obstetrical
interventions. This appendix provides information on prenatal HIV
testing and perinatal HIV transmission rates in certain states with and
without mandatory HIV testing of newborns.
Background:
In 1994, a pediatric acquired immunodeficiency syndrome (AIDS) clinical
trials study group demonstrated that the risk of HIV transmission from
mother to child could be reduced by nearly 70 percent if the
antiretroviral drug, zidovudine, is administered to the mother during
pregnancy, during labor and delivery, and to the baby after
birth.[Footnote 56] In 1995, as a result of these findings, CDC issued
guidelines calling for universal counseling of pregnant women about the
risk of AIDS and the benefits of HIV testing. The guidelines
recommended voluntary testing of all pregnant women and providing
information about antiretroviral treatment for those women testing
positive.[Footnote 57] In 1999, the Institute of Medicine (IOM) issued
a report on preventing perinatal transmission of HIV.[Footnote 58] The
report described factors that lead to perinatal transmission including
the lack of prenatal HIV testing and antiretroviral therapy for HIV-
infected women and HIV-exposed infants. IOM recommended that the U.S.
adopt a national policy of universal HIV testing, with patient
notification, as a routine component of prenatal care. Subsequent to
this recommendation, in its 2001 revised guidelines, CDC endorsed
universal HIV testing as a routine part of prenatal care. Under CDC's
prenatal HIV testing guidelines women would have the right to refuse
HIV testing, and CDC makes it clear that existing state laws must be
followed. In 2005, the U.S. Preventive Services Task Force recommended
that clinicians screen all pregnant women for HIV.[Footnote 59]
Prenatal HIV Testing Encouraged to Reduce HIV Perinatal Transmission:
All 50 states, the District of Columbia, and Puerto Rico have policies
or have enacted laws regarding HIV testing of pregnant women to help
reduce perinatal HIV transmission. The majority of states have adopted
a policy of voluntary testing of pregnant women that is consistent with
CDC's guidelines. The eight states we contacted--California,
Connecticut, Illinois, Louisiana, Michigan, New Jersey, New York, and
North Carolina--use two approaches to testing pregnant women. Three
states routinely include HIV tests in a standard battery of prenatal
testing but a woman can refuse to be tested for HIV. In the other five
states, a woman is counseled during prenatal care and must consent to
an HIV test, usually in writing. Few states collect the data needed to
determine statewide perinatal HIV transmission rates. Six of the eight
states we contacted, however, reported that the number of HIV-positive
newborns declined in their state from 1997 to 2002.
States Encourage Prenatal Testing of Pregnant Women to Help Reduce
Perinatal HIV Transmission:
All 50 states, the District of Columbia, and Puerto Rico have policies
or have enacted laws regarding HIV testing of pregnant women to help
reduce perinatal HIV transmission, and most are consistent with CDC's
guidelines. CDC guidelines recommend HIV counseling and voluntary
testing for all pregnant women and support a woman's right to refuse
testing. According to a 2004 report on state approaches to HIV testing
for mothers and newborns, most states, the District of Columbia, and
Puerto Rico rely on voluntary HIV testing that follows CDC
guidelines.[Footnote 60] All eight states in our review require
providers to give, or at least offer, pregnant women HIV counseling or
information related to testing. Seven of the eight states have specific
requirements that providers offer or perform HIV tests on pregnant
women, but performing the test is contingent on obtaining informed
consent.[Footnote 61]
Allowing pregnant women to opt-out of HIV testing is the approach to
HIV testing that CDC recommends. Under this approach, pregnant women
are notified that an HIV test is routinely included in the standard
battery of prenatal tests for all pregnant women, but they can decline
HIV testing. Officials from three of the eight states we contacted--
California, North Carolina, and Michigan--said that their states use an
opt-out approach. Officials from the remaining five states--
Connecticut, Illinois, Louisiana, New Jersey, and New York--said their
states use the opt-in approach. Under this approach, pregnant women
typically receive HIV counseling during prenatal care but must
specifically consent to an HIV antibody test, usually in writing.
Connecticut and New York supplement the opt-in approach with mandatory
newborn HIV testing requirements. CDC has stated that the opt-in
approach is associated with lower testing rates than either the opt-out
or the mandatory newborn HIV testing approach.[Footnote 62]
Connecticut and New York have enacted laws that require HIV testing of
newborns. Under Connecticut's newborn testing law enacted in 1999, HIV
testing must be offered to pregnant women and newborn testing is
mandatory if the pregnant woman refuses to be tested.[Footnote 63]
Under New York's newborn testing law enacted in 1997, newborns are
required to be tested for HIV, regardless of whether the mother's HIV
status is known. The testing is done with or without the mother's
consent. Officials from Connecticut and New York told us that their
mandatory newborn testing laws resulted in an increase in the number of
pregnant women who were tested for HIV. A Connecticut official stated
that the rate of HIV testing of pregnant women before the state's
mandatory testing law passed was about 25 percent and since the law was
enacted, the state's testing rate has increased to 90 percent or more.
Similarly, New York officials told us that prenatal HIV testing has
increased. Data on New York prenatal testing show that the prenatal HIV
testing rate had increased from 64 percent in 1997 to 95 percent in
2003.
Few States We Contacted Collect the Data Needed to Determine Statewide
Perinatal HIV Transmission Rates:
Less than half of the states we contacted collected data sufficient to
calculate a statewide perinatal HIV transmission rate in 2002.[Footnote
64] Of the eight states we contacted, three--Connecticut, New Jersey,
and New York--reported data sufficient to calculate their statewide
perinatal HIV transmission rate for 2002. The 2002 perinatal HIV
transmission rates for these states were 0.0 percent, 3.0 percent, and
3.1 percent, respectively. One state, New Jersey, reported sufficient
data that showed its perinatal HIV transmission rate declined from 13.3
percent in 1997 to 3.0 percent in 2002. The perinatal transmission
rates calculated for different states may not be directly comparable
because of variations in the specific procedures used to collect or
categorize the data. For example, while New York includes newborns who
have had a single positive test for HIV in its count of HIV-positive
newborns along with those newborns whose HIV-positive status has been
confirmed by a second test, other states may use different approaches
to collecting data.
Although data collected by most of the states we contacted were not
sufficient to calculate statewide perinatal HIV transmission rates,
some states collected information on the number of HIV-positive
newborns for the 2 years we inquired about. Six of the eight states we
contacted--California, Connecticut, Michigan, North Carolina, New
Jersey, and New York--reported that the number of HIV-positive newborns
declined in their state in 2002 compared to 1997. Louisiana reported an
increase in the number of HIV-positive newborns in 2002 compared to
1997. Louisiana officials said that the number of newborns with HIV in
1997 was unusually low. The change in the number of HIV-positive
newborns from 1997 to 2002 was not reported by the remaining state--
Illinois--because the data on HIV-positive newborns were not available
for 1997.
[End of section]
Appendix II: State Approaches to Identifying and Notifying Partners of
HIV-Infected Individuals of Possible HIV Exposure:
Research suggests that most new HIV infections originate from HIV-
infected persons not yet aware of their infection.[Footnote 65] This
emphasizes the need to identify HIV-infected persons and link them with
appropriate services as soon as possible. The Ryan White CARE Act
Amendments of 1996 provided for states to take action to require a good
faith effort be made to notify spouses who may have been exposed to
HIV.[Footnote 66] Partner counseling and referral services (PCRS)
assist HIV-infected persons with notifying their partners, including
spouses, of their exposure to HIV.[Footnote 67] This appendix provides
information on state approaches to identifying and notifying partners
of HIV-infected individuals of possible HIV exposure.
Background:
In 1996, legislation amending the CARE Act also prohibited CARE Act
grants to any state that did not take administrative or legislative
action to require that a good faith effort be made to notify the spouse
of an HIV-infected individual that he or she may have been exposed to
HIV and should seek testing. CDC, in coordination with the Health
Resources and Services Administration (HRSA), took the lead in
determining state compliance with the requirement. In December 1996,
CDC asked the states to certify compliance with the spousal
notification requirement and to submit a summary of additional actions
taken or planned for assuring that a good faith effort is made to
notify spouses of a known HIV-infected person. Because states had been
administering partner notification programs that included spouses for
years, particularly programs for syphilis and other sexually
transmitted diseases (STD), the actions states certified were both
ongoing efforts and additions to their PCRS programs that were designed
to specifically address the spousal notification requirements. In 1997,
CDC approved the certifications of compliance submitted by all states,
the District of Columbia, and five territories.[Footnote 68]
In August 1999, the Department of Health and Human Services' (HHS)
Office of Inspector General issued a report on state implementation of
their CDC-approved plans for the spousal notification
requirement.[Footnote 69] The HHS Inspector General reported that all
11 sampled states had followed up on the actions reported to and
approved by CDC for compliance with the spousal notification
requirement. For example, states were revising training materials,
revising counseling guidelines, and retraining counselors based on the
spousal notification requirement. Also, several states were undertaking
promising notification efforts, according to the report. The HHS
Inspector General recommended that states make additional efforts to
ensure maximum notification while ensuring confidentiality.
States Use Various Approaches to Elicit Information and Notify Partners
of Possible HIV Exposure:
We contacted 12 states to determine what approaches they use to
identify and notify partners of HIV-infected individuals.[Footnote 70]
These 12 states said they use various approaches in conducting HIV
partner notification activities as part of their PCRS programs. These
activities include eliciting partner information from known HIV-
infected individuals--referred to as index cases[Footnote 71]--and
notifying the partners of their possible exposure to the virus. The
states use a variety of entities and individuals trained to conduct
these activities. Of the 12 states we contacted, 10 have statutory or
regulatory provisions that require or permit certain health care
entities or workers to notify partners without the consent of the index
case. Some states reported integrating their HIV activities with
established programs that are focused on syphilis and other STDs.
States Conduct HIV Partner Notification Activities Using a Variety of
Trained Workers:
Officials from all 12 states we contacted reported having PCRS programs
that include eliciting information about the partners of individuals
known to be infected with HIV, notifying the partners of their possible
exposure to the virus, and providing the partners with counseling and
testing services. Officials in all 12 states said that they use public
health care workers known as disease intervention specialists for
conducting partner notification activities.[Footnote 72] Four states
also use physicians;
three states use community-based organizations;
one state uses staff at counseling and testing sites;
and one state uses staff working in jails to help conduct partner
notification activities.
Officials from all 12 states told us that the state provides training
for the individuals who conduct partner notification activities for
their PCRS programs" . These individuals are trained to use various
techniques for eliciting information from index cases, their partners,
and their social associates, and for notifying partners of their
possible exposure to HIV or other communicable diseases. Officials from
all 12 states said they provide CDC-developed training and other
training for disease intervention specialists.[Footnote 73] In
addition, some state officials said they provide training to other
groups that are involved in PCRS. For example, New York officials said
that the state department of health conducts PCRS training with a
variety of groups, including community-based organizations and staff
working in jails, to improve their skills in eliciting information
about partners. Massachusetts officials told us that they were training
community-based organization staff in how to elicit partner information
and notify exposed partners in an effort to integrate them into
prevention services, and California officials said that they were
training staff working at community-based organizations and disease
counseling and testing sites.
States Primarily Use Interviews to Identify Partners and Various
Methods to Notify Them of Their Possible Exposure to HIV:
Generally, all 12 states use similar methods to obtain identifying
information about partners of persons known to be infected with HIV and
notifying the partners of their possible exposure to the virus. The
states elicit information about HIV-exposed partners primarily through
interviewing the index cases about their direct sex and needle-sharing
partners. Some states also use interviews and a technique called
clustering to identify social associates of the index case that may be
at risk of exposure to HIV. In clustering, states may try to obtain
information about things such as buildings where drug use occurs or
other venues frequented by HIV-infected individuals. Because
participation in PCRS is voluntary, some index cases may opt not to
participate and may not provide information about their partners and
other contacts. For example, New York officials we contacted said that
the proportion of HIV index cases that do not provide partner
identifying information is quite high. They do not know what percent of
index cases refuse to divulge the information versus the health care
provider's failure to ask or record the information. In 2003, New York
City health care providers submitted 5,213 reports to the city's HIV
Epidemiology Program that were completed on patients with a new
diagnosis of HIV. Seventy-five percent of the reports did not list a
partner of the newly diagnosed HIV-positive patients.
Once partners are identified, states primarily use three CDC-suggested
methods to notify them of their possible exposure to HIV.[Footnote 74]
These methods are (1) client self-referral, in which index cases notify
partners, (2) contract referral, in which a time frame is negotiated
and agreed to with index cases for them to notify partners, and (3)
provider referral, in which the health care provider or health
department conducts the follow-up with partners.
In all 12 states we contacted, index cases retain the option of
notifying their partners that they have exposed them to HIV. Although
they have this option, index cases may prefer to receive assistance
from individuals trained in partner notification. For example, North
Carolina officials said that most index cases prefer to have trained
disease intervention specialists do the notification on their behalf
because of concerns with confronting their partners about their HIV
infection and having exposed them to the virus. When index cases opt to
notify their partners, it is difficult for the health department to
track whether partners indeed have been notified. Eight of the 12
states negotiate agreements with index cases that include, for example,
that index cases will notify their partners by a certain date or the
state may notify the partners. In Connecticut, such agreements are in
writing and outline how partners will be informed, how it will be
confirmed that partners were notified, and what follow-up is required
when partner counseling and referral services are not provided.
In all 12 states, health care providers or workers may notify partners.
With this CDC-suggested method, index cases request provider assistance
with partner notification and may give the provider identifying
information such as addresses and phone numbers to follow-up with their
partners. Research suggests that the use of health care providers or
workers is more effective than the index cases notifying partners of
their possible exposure to HIV.[Footnote 75]
Of the 12 states we contacted that conduct partner notifications, 10
have statutory or regulatory provisions that require or permit certain
health care workers or entities, such as physicians and health
departments, to notify partners, including spouses, of their possible
exposure to HIV without the consent of the index case.[Footnote 76] In
New York, North Carolina, and Texas, statutory or regulatory provisions
require that public health officials or health departments notify
partners, including spouses,[Footnote 77] of their possible exposure to
HIV. In California, Connecticut, Florida, Kentucky, Missouri, New York,
Pennsylvania, and Washington the provisions permit health care
providers, public health officials, or health departments to notify
partners, including spouses, of their possible exposure to
HIV.[Footnote 78] In California where physicians are permitted to
notify partners, a California official told us that the health
department is trying to get physicians more involved in partner
notification but said that generally physicians do not have the time or
staff to conduct the notifications. In the remaining 2 states--
Massachusetts and Minnesota--public health officials or health
departments may notify partners, including spouses, only with the
consent of the index case. Moreover, Massachusetts has an HIV-specific
confidentiality provision that explicitly prohibits health care
providers and facilities from disclosing an individual's name or HIV
test results without the individual's written informed consent.
Massachusetts officials said that they believe the number of partners
notified is lower in states with strict confidentiality laws compared
to states without strict laws.
Some states use the Internet as a tool for contacting and notifying
partners of known HIV-infected individuals. A California official told
us that the Internet provides a new opportunity to facilitate partner
notification. Officials from Minnesota, Missouri, Pennsylvania, and
Texas said they obtain information, such as Web site addresses and
associated chat rooms that partners use, partners' screen names, and e-
mail addresses, from index cases and use the Internet to initiate
contact and send messages to partners. Officials from three states
expressed concern about using the Internet and visiting certain Web
sites to contact partners because of confidentiality concerns or
provisions that prohibit employees from visiting sexually-oriented
sites. The extent to which states use the Internet for HIV partner
notification varies. For example, Kentucky, New York, and Washington
State officials said that their use of the Internet is limited to
certain geographic areas within the state.
After partners are contacted and notified about their possible exposure
to HIV, they are usually counseled about HIV and offered testing. CDC
guidelines state that counseling should consist of providing a
description of the ways in which HIV is transmitted, the importance of
obtaining test results, the meaning of HIV test results, and ways to
prevent future exposure to HIV. Officials from all 12 states we
contacted said that disease intervention specialists that notify
partners of their possible exposure to a communicable disease encourage
them to get tested. Officials from these states said that when partners
have been exposed to more than one communicable disease, such as
syphilis and HIV, they will encourage partners to get tested for both
diseases. Officials in California and Connecticut told us that when
index cases are co-infected and want health department assistance with
informing their partners about possible exposure to syphilis but not
HIV, the partners will not be told about their exposure to HIV.
Instead, the partners may be told that the risk behavior that exposed
them to syphilis may have also exposed them to HIV and that getting
tested for both is recommended.
The participation of HIV index cases and partners in PCRS program
activities varies among the states. As previously mentioned,
participation in state PCRS is voluntary. New York officials told us
that the number of index cases that do not provide partner identifying
information is quite high, but they do not know what percentage of
index cases refuse to divulge this information. Pennsylvania Department
of Health officials told us that in 2004, there were over 300 HIV-
positive cases in the state, and that 89, or less than one-third, used
PCRS. A California state official told us that because the state does
not use name-based reporting of individuals diagnosed with HIV, the
state is not able to track those who received partner services and how
many actually got tested. PCRS data collected by CDC show wide
variability in elicitation and notification activities among states.
Among 10 of the 12 states in our review,[Footnote 79] CDC data for 2002
show that the percentage of index cases interviewed for PCRS ranged
from about 46 percent to 100 percent. Similarly, the percentage of
partners elicited who were located and notified ranged from about 42
percent to 83 percent. Among partners who were located and notified,
about 89 percent received counseling, and approximately 90 percent of
partners who were counseled were then tested for HIV.
Seven States Have Integrated HIV and STD Partner Notification
Activities and Training:
Health officials from 7 of the 12 states we contacted said they have
combined certain activities in their HIV and STD programs to facilitate
partner notification. In these 7 states, staff that conduct partner
notification are trained in notifying partners of their exposure to HIV
and other STDs. For example, Texas state public health officials said
that their PCRS program integrates HIV and STD activities. They said a
large percentage of their HIV cases are also infected with syphilis,
and disease intervention specialists that are trained in all STDs can
notify partners of their exposure regardless of the disease. In Texas,
local health departments that have separate HIV and STD units have been
encouraged to consolidate their efforts. Florida officials said that
information from a syphilis outbreak among men who have sex with men
shows that in 2004, 28 percent of these men were infected with HIV at
the time they were diagnosed with syphilis. These officials said that
from a resource standpoint, it does not make sense to have one person
notify partners about their exposure to HIV and another person notify
them about syphilis. Florida maximizes its resources by using the same
staff to conduct all STD notifications. North Carolina health officials
told us that their HIV and STD programs are totally integrated because
it is hard to separate HIV and STD prevention efforts. North Carolina
disease intervention specialists are trained in all STDs and can notify
partners of their exposure to HIV and other STDs. Washington officials
said that some, but not all, of their STD and HIV programs are
integrated. In some jurisdictions the programs are divided while in
others the staff is shared. They said that small health departments are
more integrated because they cannot afford to have separate staff doing
partner notification for the different diseases.
[End of section]
Appendix III: Scope and Methodology:
The Ryan White Comprehensive AIDS Resources Emergency Act of 1990 (CARE
Act) authorized grants to states, territories, and metropolitan areas
to provide health care, medications, and support services to
individuals and families affected by AIDS. The CARE Act Amendments of
1996 authorized AIDS Drug Assistance Program (ADAP) grants for states,
including the District of Columbia, and certain territories
specifically to operate their own ADAPs to purchase and provide HIV/
AIDS medications to eligible individuals. We examined how program
design and funding sources contributed to differences in coverage--who
and what is covered--among ADAPs, how the prices ADAPs reported paying
for HIV/AIDS drugs compare to prices under the 340B program, how HRSA
monitors the drug prices ADAPs pay, and how the 340B prices compare to
selected other federal drug pricing programs. We also developed
information on state prenatal HIV testing and perinatal HIV
transmission rates and state approaches to identifying and notifying
partners of HIV-infected individuals of possible exposure to HIV.
ADAP Coverage Differences Analysis:
To determine how program design and funding sources contributed to the
coverage differences among 52 ADAPs in the states--including the
District of Columbia--and Puerto Rico, we reviewed and summarized
program eligibility criteria, including enrollment limitations, and
funding sources available to ADAPs, including and in addition to the
CARE Act ADAP base grants. We obtained data from ADAP profile reports
submitted to HRSA by 52 ADAPs and analyzed the ADAP grant year 2004
data covering the period April 1, 2004, through March 31, 2005. We did
not verify the data reported by ADAPs. In our analysis of funding
sources available to ADAPs, we determined the total amount of
additional funding each ADAP reported for fiscal year 2004, and
calculated the percentage that this total represented of each ADAP's
fiscal year 2004 base grant. The percentages were then compared among
the ADAPs to show which programs had more or less additional funding
than their ADAP base grants. We also determined for each ADAP how much
the total additional ADAP funding represented on a per estimated living
AIDS case (ELC) basis.[Footnote 80]
To examine coverage for ADAPs with waiting lists, we used HRSA ADAP
waiting list data for fiscal year 2004. When an ADAP has more eligible
individuals than it has funds to provide services and cannot cover
everyone it determines is eligible for its services, it may establish a
waiting list. We determined that the available data were not reliable
to establish the number of unduplicated individuals on waiting lists
during a year or the length of time an individual was on a waiting list
before being served by the ADAP, but this data were sufficiently
reliable to indicate whether or not a waiting list existed and what
were the average number of individuals on lists.
ADAP HIV/AIDS Drug Pricing Analysis:
For our ADAP drug pricing analysis, we used the top 10 HIV/AIDS drugs
by expenditure among those purchased by ADAPs in 2002, the most current
expenditure data available at the time of our review. The expenditures
for these 10 drugs represented 73 percent of total ADAP drug
expenditures in 2002. The 10 drugs were Combivir, Epivir, Norvir,
Viracept, Sustiva, Trizivir, Viramune, Viread, Zerit, and Ziagen;
these drugs are all brand name drugs.
We used the purchase prices for these 10 drugs that 52 ADAPs provided
on their quarterly drug pricing reports submitted to HRSA for 2003--the
most recent full calendar year of ADAP drug price data available at the
time of our analysis. ADAPs report the following data to HRSA for the
drugs they purchase: (a) the drug by national drug code (NDC);[Footnote
81] (b) the quantity for a 30-day supply by units; (c) the unit price;
(d) the total cost of the drug (the quantity by units multiplied by the
unit price); (e) the dispensing fee; and (f) the gross price (the total
cost of the drug plus the dispensing fee).
To determine how the prices an ADAP reported it paid compared to the
340B price for any of the top 10 drugs it purchased in 2003, we
compared each ADAP's 2003 average price over the four quarters to the
2003 340B price for the same drug. For each of the 10 drugs they
purchased, each ADAP also reported that drug's NDC identifier. Because
all ADAPs did not purchase the same version of the same drug, we used
the NDCs each ADAP reported to determine which drug's price to compare
to the 340B price. We then categorized the ADAPs by those using the
340B direct option, and those using the 340B rebate option, and
determined how many drugs they reported at prices above the 340B
prices. ADAPs that use the 340B rebate option reported to HRSA the drug
prices that they paid which may not reflect the drug rebate amount they
may later have received from a drug manufacturer.
To determine how the 340B prices for some HIV/AIDS drugs compared to
prices available through selected federal drug pricing programs, we
compared prices for the top 10 drugs across five federal drug pricing
programs. We used the 2003 prices[Footnote 82] from the following
federal drug pricing programs to make price comparisons: (a) the 340B
prices provided by HRSA's Office of Pharmacy Affairs; (b) the 340B
prime vendor negotiated prices provided by HRSA's Office of Pharmacy
Affairs;[Footnote 83] (c) federal supply schedule (FSS) prices provided
by the Department of Veterans Affairs (VA) Pharmacy Benefits
Management; (d) the federal ceiling prices (FCP) provided by the VA
Pharmacy Benefits Management; and (e) Medicaid prices[Footnote 84] that
we calculated using publicly available pricing data and rebate data
provided by the Centers for Medicare & Medicaid Services (CMS). Because
a drug may have more than one NDC, ADAPs did not always report the same
NDC for the same drug they purchased. For each of the 10 drugs, we
determined the NDC that was most commonly purchased by 52 ADAPs during
2003.[Footnote 85] We used the 10 most commonly purchased NDCs in 2003
for the price comparisons we did among the five federal drug pricing
programs. However, the 340B prime vendor, the FSS, the FCP, and
Medicaid did not have prices for all 10 drugs. In addition some federal
drug pricing programs did not have a price for a particular common NDC
that could be used to compare prices across federal pricing
programs.[Footnote 86] Although we had the drug prices from all the
federal drug pricing programs, only the FSS prices are publicly
available. To prevent the possible calculation of a non-public drug
price, we used rankings to indicate which drug pricing program had the
lower prices for the drugs. We ranked a drug "1" under a particular
drug pricing program when that program had the drug's lowest price for
the drug across the drug pricing programs. We ranked a drug "5" when
that program had the drug's highest price for the drug across the drug
pricing programs.
To determine whether the five federal drug pricing programs had price
increases or decreases over time for the 10 drugs, we compared the
prices in 2000 to the prices in 2003 for the ADAPs' most commonly
purchased NDC for each drug in 2003 across the federal drug pricing
programs. When a federal drug pricing program was missing a price for
either 2000 or 2003 or both, no price comparison could be made. No
price comparisons could be made for the 340 prime vendor prices because
no 2000 drug price data were available. Some of the drug prices are not
publicly available, so we reported only the drugs' percent of price
increase or decrease so that a specific drug's price could not be
determined.
To assess the reliability of the drug pricing data from HRSA, VA, and
CMS, we (1) reviewed existing documentation related to the data
sources, and (2) electronically tested the data to identify any obvious
problems with completeness or accuracy. We determined that the HIV/AIDS
drug pricing data were sufficiently reliable for the purposes of this
report.
Prenatal HIV Testing and Perinatal HIV Transmission:
To develop information on state prenatal HIV testing and perinatal HIV
transmission within states, we reviewed data on approaches that states
use to test pregnant women and newborns for HIV and studies and reports
by CDC, the Institute of Medicine, and various states related to
prenatal testing for and perinatal transmission of HIV. We also
requested prenatal HIV testing and perinatal HIV transmission data for
1997 and 2002,[Footnote 87] from eight states--California, Connecticut,
Illinois, Louisiana, Michigan, New Jersey, New York, and North
Carolina, to determine their statewide perinatal transmission rates.
These states were selected based on (1) their high cumulative numbers
of HIV infections among children as of 2002; (2) variations in the type
of approaches they followed for HIV testing of pregnant women;
and (3) geographic location. In addition, we interviewed officials from
each of the eight states' departments of health to discuss prenatal
testing for HIV and perinatal HIV transmission within the states. We
used a definition of perinatal transmission rate that describes the
frequency with which newborns contract HIV through exposure by pregnant
women immediately preceding, during, or immediately following birth. We
calculated statewide perinatal HIV transmission rates by dividing the
number of newborns that tested positive for HIV by the number of live
births to pregnant women that tested HIV positive. The majority of the
eight states did not have complete data on prenatal HIV testing and
perinatal HIV transmissions for the 2 years we requested.
To assess the reliability of data the eight states collected and
provided to us, we reviewed the data for accuracy and completeness and
discussed the information with state officials. We determined that data
limitations, such as incomplete information on live births to pregnant
women who tested HIV-positive, precluded us from accurately calculating
statewide perinatal transmission rates for five of the eight states. We
therefore report such data only for Connecticut, New Jersey, and New
York.
Partner Notification of HIV Exposure:
To determine what approaches states are using to identify and notify
partners of HIV-infected individuals, we reviewed reports related to
partner notification programs; reviewed and analyzed data from CDC's
2002 PCRS database and states' Web sites; and contacted 12 states in
2004 and 2005.[Footnote 88] Of the 12 states we contacted, seven--
California, Florida, Massachusetts, Minnesota, New York, North
Carolina, and Texas--were recommended by CDC and the National Alliance
of State and Territorial AIDS Directors (NASTAD) because of their
innovation in partner notification efforts. The other five states--
Connecticut, Kentucky, Missouri, Pennsylvania, and Washington--were
randomly selected. We interviewed officials from CDC, NASTAD, HRSA, and
the 12 states.
To assess the reliability of these data, we held discussions with CDC
officials about the completeness and accuracy of the data in their
databases and any limitations associated with the information. We also
followed up with states about the accuracy of the data they provided.
Based on our review of the data and discussions with CDC and state
officials, we determined that CDC's 2002 PCRS data and the data states
provided were sufficiently reliable for the purposes of this report.
We performed our work from June 2004 through April 2006, in accordance
with generally accepted government auditing standards.
[End of section]
Appendix IV: Comments from the Health Resources and Services
Administration:
Department Of Health & Human Services:
Health Resources and Services Administration:
April 20 2006:
TO: Marcia Crosse:
Director, Health Care:
Government Accountability Office:
FROM: Administrator:
SUBJECT: Comments on Draft Report: "RYAN WHITE CARE ACT: Improved
Oversight Needed to Ensure AIDS Drug Assistance Programs Obtain Best
Prices for Drugs" (Code # GAO-06-646):
Thank you for the opportunity to provide comments on the above subject
draft report. Attached please find our comments.
Questions may be referred to Gail Lipton in HRSA's Office of Federal
Assistance Management (OFAM) at (301) 443-6509.
Signed by:
Betty James Duke
Attachment:
Department of Health and Human Service's Comments on the Government
Accountability Office's Draft Report: "RYAN WHITE CARE ACT: Improved
Oversight Needed to Ensure AIDS Drug Assistance Programs Obtain Best
Prices for Drugs" (Code # GAO-06-646):
The Department has reviewed the draft Government Accountability Office
(GAO) report, titled: "RYAN WHITE CARE ACT: Improved Oversight Needed
to Ensure AIDS Drug Assistance Programs Obtain Best Prices for Drugs."
The Department believes that the report has highlighted one of the key
issues facing ADAPs and the administration of these programs both at
the State level and within the Health Resources and Services
Administration (HRSA).
GAO Recommendation:
To ensure that ADAPs are obtaining the best prices for drugs they
provide, we recommend that the Administrator of HRSA take the following
actions:
* Require that all ADAPs report final prices they paid for drugs, and
that those final prices reflect any discounts or rebates received.
HRSA Response:
While HRSA would like to have the capacity to verify final prices after
discounting rebates, a current obstacle as the GAO noted in its report
on page 32: ".there is no reporting that reconciles the rebate savings
an ADAP may receive against the price it pays." Further, acquiring this
data and reconciling it would be a labor intensive task both on the
part of ADAPs and HRSA staff.
HRSA staff have verified, through recent discussions with ADAPs, that
rebates paid by the manufacturer after the drugs are purchased are not
routinely itemized thus, making it difficult to conduct a comparison
analysis. In addition, receipt of rebate checks can come many months
after the drugs were purchased, further complicating a comparison of
the price initially paid to determine the final price.
GAO Recommendation:
* Routinely determine whether the prices ADAPs paid for the drugs they
purchased were at or below the 340B prices.
HRSA Response:
HRSA has taken several actions to develop both the information it will
require and the internal resource capacity needed to properly analyze
and report this data to ADAPs. In fiscal year (FY) 2005, HRSA
instituted a new ADAP Quarterly Reporting (AQR) System (OMB approval #
0915-0294). As a requirement of the new system, ADAPs are required to
report the prices they have paid for all medications on their formulary
during the quarter. In addition, the AQR also collects information on
the type of additional funds including rebates that the ADAPs receive
each quarter. The AQR was implemented with the FY 2005 grant year. This
reporting system was designed to produce several reports that would be
reviewed by HRSA to determine if ADAPs are purchasing medications at or
below the 340B ceiling price. As the GAO Report notes, considerable
resources within HRSA will be needed to conduct a comprehensive price
comparison. HRSA does not have the resource capability to perform
manual cost comparisons on a large scale.
The GAO Report also identifies problems associated with the current
lack of 340B price transparency. The Office of the Inspector General
(OIG) has advocated for increased 340B price transparency in a previous
report (Deficiencies in the Oversight of the 340B Drug Pricing Program,
OEI-05-02-00072). One suggestion proposed by OIG was to institute a
password-protected web-based query function to allow entities to check
the prices they paid against 340B ceiling prices, while still
protecting the confidentiality of the manufacturers' data. Due to
legally required confidentiality, HRSA cannot provide manufacturer's
price data.
There are efforts within HRSA to develop systems that will allow
entities to submit the prices paid for a market basket of products to
assess the appropriateness of the aggregate drug prices paid. This is
part of the President's FY 2007 budget. In the interim, HRSA requested
in a letter dated December 30, 2005, that all pharmaceutical
manufacturers who have signed 340B Pharmaceutical Pricing Agreements
voluntarily submit quarterly 340B price files on covered outpatient
drugs to HRSA. HRSA compares these manufacturer price files with
Government-computed 340B ceiling prices. Computed prices are also
compared with the major wholesale distributor price files. To the
extent permitted by the manufacturers, these verified prices will be
made available on the password-protected PV Web site.
[End of section]
Appendix V: GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse, (202) 512-7119 or crossem@gao.gov:
Acknowledgements:
In addition to the contact above, James McClyde, Assistant Director;
Robert Copeland; Helen Desaulniers; Cathy Hamann; Martha Kelly; Daniel
Ries; Opal Winebrenner; Craig Winslow; and Suzanne Worth made key
contributions to this report.
[End of section]
Related GAO Products:
HIV/AIDS: Changes Needed to Improve the Distribution of Ryan White CARE
Act and Housing Funds. GAO-06-332. Washington, D.C.: February 28, 2006.
Ryan White CARE Act: Factors that Impact HIV and AIDS Funding and
Client Coverage. GAO-05-841T. Washington, D.C.: June 23, 2005.
HIV/AIDS: Use of Ryan White CARE Act and Other Assistance Grant Funds.
GAO/HEHS-00-54. Washington, D.C.: March 1, 2000.
HIV/AIDS Drugs: Funding Implications of New Combination Therapies for
Federal and State Programs. GAO/HEHS-99-2. Washington, D.C.: October
14, 1998.
(290523):
FOOTNOTES
[1] HIV is the virus that causes AIDS. Throughout this report, we use
the common term HIV/AIDS to refer to HIV disease, inclusive of cases
that have progressed to AIDS. When we use these terms alone, HIV refers
to the disease without the presence of AIDS, and AIDS refers
exclusively to HIV disease that has progressed to AIDS.
[2] HAART drug regimens usually combine three or more drugs and are
used to suppress the progression of the disease HIV/AIDS by reducing
the amount of the HIV virus in a person's blood. HAART therapy can cost
about $12,000 or more per person annually.
[3] Pub. L. No. 101-381, 104 Stat. 576 (codified as amended at 42
U.S.C. §§ 300ff--300ff-111 (2000)). Unless otherwise indicated,
references to the CARE Act are to current law.
[4] See also GAO, HIV/AIDS: Changes Needed to Improve the Distribution
of Ryan White CARE Act and Housing Funds, GAO-06-332 (Washington, D.C.:
Feb. 28, 2006).
[5] The 1990 CARE Act added a new title XXVI to the Public Health
Service Act. In general, because Part A of that new title, which
authorizes grants to metropolitan areas, was established by Title I of
the CARE Act, it is commonly referred to as Title I, and because Part
B, which authorizes grants to states and territories, was established
by Title II of the CARE Act, it is commonly referred to as Title II.
[6] In addition to the 50 states, ADAP grants are authorized for the
District of Columbia, the Commonwealth of Puerto Rico, Guam, and the
Virgin Islands.
[7] ADAPs and other programs funded through CARE Act grants serve as
the payers of last resort for eligible individuals who have no other
private or public source available for the services they need. HRSA
policy provides that ADAPs are to identify and evaluate other potential
sources of payment for drugs to ensure that the ADAPs are the payers of
last resort.
[8] Under the CARE Act, states and territories determine which drugs
approved by the Food and Drug Administration to include on their ADAP
drug formularies. Drug formularies are a preferred list of drug
products that typically limit the number of drugs available within a
therapeutic class for purposes of drug purchasing, dispensing, and
reimbursement.
[9] 42 U.S.C. § 256b (2000). Other entities eligible to purchase drugs
through the 340B program include, for example, community health
centers, hemophilia treatment centers, and HIV early intervention
projects.
[10] Our analyses of ADAPs throughout this report include the 50
states, the District of Columbia, and Puerto Rico.
[11] For our analyses, the ADAP grant year 2004 covered the period
April 1, 2004, through March 31, 2005, and the fiscal year 2004 covered
the period October 1, 2003, through September 30, 2004.
[12] EMAs are metropolitan areas with a population of at least 500,000
and more than 2,000 reported AIDS cases in the last 5 calendar years.
[13] HRSA calculates a jurisdiction's ELCs by using data from the CDC
on the reported AIDS case counts for the last 10 years and weights
those numbers to account for the likelihood of deaths. See also GAO-06-
332 for a discussion of ELCs.
[14] Medicaid is a jointly funded federal-state health care program
that covers certain low-income families, and certain individuals who
are aged or disabled. By statutory formula, the federal government
matches from 50 to 83 percent of each state's reported Medicaid
expenditures for medical assistance.
[15] Eligibility criteria for Medicaid programs vary among the states.
States have latitude within federal guidelines to design their
individual Medicaid programs with respect to eligibility, services,
payment, and whether to include prescription drug coverage. Although
all state Medicaid programs have drug coverage, the HIV/AIDS drug
coverage provided varies among states.
[16] Reliable data were not available to determine the number of
unduplicated individuals on waiting lists during a year or the length
of time an individual was on a waiting list before being served by the
ADAP.
[17] HHS's Guidelines for the Use of Antiretroviral Agents in HIV-1-
Infected Adults and Adolescents generally recommend the HAART drug
treatment, which includes combination regimens of three drugs, and does
not recommend one-drug regimens. The guidelines are updated regularly.
[18] Under Title I of the CARE Act, HRSA provides grants to EMAs;
some EMAs use Title I grants to provide HIV/AIDS pharmaceutical
assistance.
[19] If a drug manufacturer fails to sell drugs at or below the 340B
prices, it can be dropped as a participating drug provider in the 340B
and Medicaid programs.
[20] Prior to October 1, 2005, CMS calculated the 340B prices
quarterly.
[21] 42 U.S.C. § 256b(a)(1) (2000). AMP is the average price paid to
the manufacturer for a drug by wholesalers for drugs distributed to the
retail pharmacy class of trade. 42 U.S.C. § 1396r-8(k)(1) (2000). AMP
is used to calculate the 340B price and by CMS to calculate the
Medicaid rebate--the amount state Medicaid programs receive from drug
manufacturers for covered drugs through the federal Medicaid rebate
program.
[22] 42 U.S.C. § 256b(a)(4)(E) (2000).
[23] Section 340B of the Public Health Service Act requires the
Secretary of Health and Human Services to establish a prime vendor
program for 340B covered entities. 42 U.S.C. § 256b(a)(8) (2000).
[24] Citing HHS policy that grantees must expend funds used for drug
purchases in the most economical manner feasible, HRSA requested
comments on a proposed requirement that all covered entities receiving
grants participate in, or demonstrate good cause for not participating
in, the 340B program. 63 Fed. Reg. 56,656, 56,657 (Oct. 22, 1998). HRSA
later announced instead that, to increase participation in the 340B
program, it would add a statement in its notice of grant award on the
need for grantees to determine if their drug purchasing practices meet
federal requirements for reasonable and cost effective purchasing. 65
Fed. Reg. 6,383 (Feb. 9, 2000).
[25] 42 U.S.C. § 1396r-8(b)(3)(D) (2000).
[26] Drug manufacturers that do not make drugs available through the
FSS and FCP programs may not receive payments for drugs from Medicaid,
certain federal agencies, or any covered entity receiving funds under
the Public Health Service Act. 38 U.S.C. § 8126(a)(4) (2000).
[27] The National ADAP Monitoring Project, an initiative of the Henry
J. Kaiser Family Foundation and NASTAD, issues a report on its annual
survey of all jurisdictions receiving ADAP base grants. The survey
provides data on the status of ADAP programs and assesses key trends.
[28] The HHS 2004 federal poverty level for a single person was $9,310;
the poverty levels were higher for Alaska ($11,630) and Hawaii
($10,700). The poverty level was not defined for Puerto Rico.
[29] The HIV/AIDS drug classes are protease inhibitors, nucleoside/
nucleotide reverse transcriptase inhibitors, non-nucleoside reverse
transcriptase inhibitors, and fusion inhibitors.
[30] National ADAP Monitoring Project's Annual Report (Washington,
D.C., April 2005).
[31] Fuzeon is for individuals who have used other anti-HIV drugs but
still have ongoing HIV viral replication;
it was approved by the FDA in 2003. Fuzeon is to be used with a
combination of medications for individuals with limited treatment
options.
[32] ADAPs may include in their formularies drugs to prevent or treat
opportunistic infections and other HIV-related conditions.
[33] There were 25 grantees eligible to receive ADAP Severe Need grants
in fiscal year 2004. To receive these grants, eligible grantees must
agree to match 25 percent of the funds. Of the 25 eligible grantees in
fiscal year 2004, 16 received the grants, and 15 agreed to make the
match. HRSA awarded a grant to Puerto Rico but did not require it to
provide matching funds.
[34] Other funding sources may include drug rebates ADAPs receive from
manufacturers against prices paid for drug purchases. These rebates do
not actually constitute additional funding. However, we were unable to
identify the amounts attributable to drug rebates in these ADAPs'
reports.
[35] In 2005, HRSA reported that all ADAPs that maintained waiting
lists determined individuals' eligibility before placing them on the
lists. Maximizing Access to Medications through Efficient Use of CARE
Act Resources (Department of Health and Human Services, Health
Resources and Services Administration, HIV/AIDS Bureau, May 2005).
[36] The average number of individuals on a monthly waiting list could
represent the total number of individuals on the list during the entire
month, or the total number of individuals on the list at any time
during the entire month.
[37] Three states whose ADAPs had waiting lists were eligible to
receive Severe Need grants in fiscal year 2004, but did not apply.
[38] Other funding sources may include drug rebates ADAPs receive from
manufacturers against prices paid for drug purchases. These rebates do
not actually constitute additional funding. However, we were unable to
identify the amounts attributable to drug rebates in these ADAPs'
reports.
[39] In June 2004, the President announced that $20 million would be
used to provide HIV/AIDS drug assistance to over 1,700 individuals then
on ADAP waiting lists in 10 states. The 10 ADAPs were in Alabama,
Alaska, Colorado, Idaho, Iowa, Kentucky, Montana, North Carolina, South
Dakota, and West Virginia. However, these funds were not distributed to
the ADAPs. HRSA contracted with Chronimed StatScript Pharmacy, a
pharmaceutical distributor, to provide the HIV/AIDS drugs directly to
these individuals. Chronimed began providing drugs in October 2004, the
first month of fiscal year 2005. The contract with Chronimed, now known
as BioScript, was extended by HRSA through March 2006 to allow the
approximately $1 million of remaining funds to be used.
[40] The drugs were the top 10 drugs by expenditure that ADAPs
purchased in 2002, the most current expenditure data available at the
time of our analysis. The expenditures for these 10 drugs represented
73 percent of the total ADAP drug expenditures in 2002. The 10 drugs
were Combivir, Viracept, Sustiva, Norvir, Zerit, Trizivir, Epivir,
Ziagen, Viramune, and Viread. See appendix III for a more detailed
description of our methodology.
[41] A HRSA official told us in 2005 that four ADAPs--District of
Columbia, Kentucky, Michigan, and Pennsylvania--had special pricing
arrangements other than under the 340B program;
these pricing arrangements were to be at least equivalent to the 340B
prices. The District of Columbia had access to the FCP;
Kentucky used a direct purchase option with a fixed price contract;
Michigan had a voluntary rebate agreement with drug manufacturers;
and Pennsylvania had a mandated drug manufacturer rebate. As of
February 2006, all ADAPs except the District of Columbia, which has FCP
access, were either 340B direct purchase or rebate ADAPs.
[42] If a drug manufacturer does not comply with the 340B program
pricing requirements, it can be dropped as a participating drug
provider in the 340B and Medicaid programs.
[43] We received the 340B prices from HRSA for our analysis. The 340B
drug prices are not publicly available, so we do not report any pricing-
related information that would allow a specific drug's 340B price to be
determined. See appendix III for an explanation of our price comparison
methodology.
[44] In a general review of the 340B program, the HHS OIG testified
that in some cases drug manufacturers may not bill 340B covered
entities the correct 340B prices. The Department of Health and Human
Services Office of Inspector General, Testimony of Stuart Wright,
Deputy Inspector General for Evaluation and Inspections, on 340B Drug
Pricing Program Oversight and Administration, before the Subcommittee
on Oversight and Investigations of the U.S. House Committee on Energy
and Commerce (Washington, D.C.: Department of Health and Human
Services, 2005.)
[45] The 340B prime vendor assists 340B covered entities, including
ADAPs that use the 340B direct purchase option, by negotiating drug
prices at or below the 340B drug prices.
[46] The 10 ADAPs represented were: California, Florida, Hawaii,
Illinois, Maryland, Massachusetts, New Jersey, New York, North
Carolina, and Texas. All of the ADAPs except Hawaii and North Carolina
were among the top ten ADAPs based on total cumulative AIDS cases
reported from the beginning of the epidemic through December 2003. The
eight drug manufacturers involved in the negotiations were: Abbott
Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb Company,
Gilead Sciences, GlaxoSmithKline, Hoffman-La Roche, Inc., Merck &
Company, and Pfizer, Inc. The ADAP representatives in these
negotiations said that they negotiated on behalf of all ADAPs, not just
the 10 task force members, and each ADAP decided if it wanted to take
advantage of the negotiated prices.
[47] An OPA official told us that OPA does not routinely monitor
whether the prices negotiated by the 340B prime vendor are at or below
the 340B prices, but plans to develop a monitoring system.
[48] ADAPs' financial data submitted to HRSA contain information on the
total expected rebate savings but not the rebate expected on the
purchase of a specific drug, which is the information needed to make
drug price comparisons to the 340B prices. ADAPs report the total
amount of projected drug rebates they expect to receive on their ADAP
profile reports. The rebates they report can include (1) the section
340B drug discount program rebates, (2) negotiated rebates, and (3) the
NASTAD task force negotiated rebates. ADAPs can also report their
sources of funding, such as rebates, on another report--the ADAP
quarterly data report. Neither report asks ADAPs to list the amount of
rebates they receive by drug or to provide their rebate agreements.
[49] The Department of Health and Human Services Office of Inspector
General, Testimony of Stuart Wright, Deputy Inspector General for
Evaluation and Inspections, on 340B Drug Pricing Program Oversight and
Administration, before the Subcommittee on Oversight and Investigations
of the U.S. House Committee on Energy and Commerce (Washington, D.C.:
Department of Health and Human Services, 2005.)
[50] For purposes of this report, the Medicaid price is the average
amount state Medicaid programs paid net of the basic rebate provided
under the Medicaid Drug Rebate Program.
[51] The drugs were the top 10 drugs by expenditure that ADAPs
purchased in 2002, the most current expenditure data available at the
time of our analysis. The expenditures for these 10 drugs represented
73 percent of the total ADAP drug expenditures in 2002. The 10 drugs
were Combivir, Viracept, Sustiva, Norvir, Zerit, Trizivir, Epivir,
Ziagen, Viramune, and Viread. See appendix III for an explanation of
our price comparison methodology.
[52] For purposes of this comparison, we have treated the 340B prime
vendor as a separate drug pricing program since it may have different
prices than the 340B prices for the same brand name drugs.
[53] The Institute of Medicine (IOM) and the HHS OIG have previously
recommended allowing ADAPs to purchase HIV/AIDS drugs at FCP drug
discount prices because those prices would be lower than the 340B
prices. However, both the IOM and OIG also raised concerns about
whether drug companies might be less willing to invest in HIV/AIDS drug
research if they might experience revenue losses from providing lower
drug prices to additional entities such as ADAPs. Institute of Medicine
of the National Academies, Public Financing and Delivery of HIV/AIDS
Care: Securing the Legacy of Ryan White (Washington, D.C.: The National
Academies Press, 2005, and the Department of Health and Human Services
Office of Inspector General, AIDS Drug Assistance Program Cost
Containment Strategies (Washington, D.C.: Department of Health and
Human Services, 2000).
[54] The 340B prime vendor program was not included in this comparison
because drug prices for 2000 were not available.
[55] In December 2003, Abbott Laboratories, the manufacturer of Norvir,
a HIV/AIDS protease inhibitor, substantially increased the wholesale
price per patient. In February 2004, Abbott Laboratories announced a
permanent Norvir price freeze for ADAPs at the price in place prior to
the December 2003 re-pricing.
[56] E.M. Connor et al. "Reduction of Maternal-Infant Transmission of
Human Immunodeficiency Virus Type 1 with Zidovudine Treatment," The New
England Journal of Medicine, 331, 1173-80 (1994).
[57] Department of Health and Human Services, Centers for Disease
Control and Prevention, "U.S. Public Health Service Recommendations for
Human Immunodeficiency Virus Counseling and Voluntary Testing for
Pregnant Women," Morbidity and Mortality Weekly Report, vol. 44 (1995).
[58] Institute of Medicine, "Reducing the Odds: Preventing Perinatal
Transmissions of HIV in the United States," (National Academy Press,
Washington, D.C.: 1999).
[59] The United States Preventive Services Task Force is a source of
recommendations and guidelines for screening tests, counseling,
immunizations, and use of medications for disease prevention. It is
composed of medical experts and sponsored by the Department of Health
and Human Services' Agency for Healthcare Research and Quality.
[60] The Henry J. Kaiser Family Foundation State Health Facts Online,
"50 State Comparisons: HIV Testing for Mothers and Newborns, 2004."
http://www.statehealthfacts.org/cgi-
bin/healthfacts.cgi?action=compare&category=HIV%2fAIDS&subcategory=HIV+T
es ting&topic=HIV+Testing+for+Mothers+and+Newborns> (downloaded Jan.
19, 2006).
[61] Officials in the remaining state, Louisiana, said that in all of
their perinatal prevention efforts with providers they emphasize
routine offering of HIV tests as the standard of care supported by
federal guidelines.
[62] Centers for Disease Control and Prevention, "HIV Testing Among
Pregnant Women--United States and Canada, 1998-2001", Morbidity and
Mortality Weekly Report, vol. 51, no. 45 (2002).
[63] This mandatory testing requirement does not apply when parents
object based on conflicts with their religious tenets and practice.
[64] Perinatal transmission rate is defined as the frequency with which
newborns contract HIV through exposure by pregnant women immediately
preceding, during, or immediately following birth. We calculated
statewide perinatal HIV transmission rates by dividing the number of
newborns that tested positive for HIV by the number of live births to
pregnant women that tested HIV-positive.
[65] G. Marks, N. Crepaz, J. W. Senterfitt, and R. S. Janssen, "United
States: Meta-Analysis of High-Risk Sexual Behavior in Persons Aware and
Unaware They Are Infected with HIV in the United States," Journal of
Acquired Immune Deficiency Syndromes, vol. 39, no. 4 (2005).
[66] Pub. L. No. 104-146, § 8, 110 Stat. 1346, 1372 (codified at 42
U.S.C. § 300ff-27a (2000)). The statute defines a spouse as "any
individual who is the married partner of an HIV-infected patient, or
who has been the married partner of that patient at any time within the
10-year period prior to the diagnosis of HIV infection."
[67] CDC's PCRS guidance for HIV defines PCRS as a prevention activity
with the goals of (1) providing services to HIV-infected persons and
their sex and needle-sharing partners so they can avoid infection or
prevent transmission to others, and (2) helping partners gain earlier
access to individualized counseling, HIV testing, medical evaluation,
treatment, and other prevention services.
[68] The five territories included Guam, the Northern Mariana Islands,
the Republic of Palau, the Commonwealth of Puerto Rico, and the Virgin
Islands.
[69] Department of Health and Human Services Office of Inspector
General, The Ryan White CARE Act: Implementation of the Spousal
Notification Requirement (Washington, D.C.: Department of Health and
Human Services, 1999).
[70] The 12 states we contacted were California, Connecticut, Florida,
Kentucky, Massachusetts, Minnesota, Missouri, New York, North Carolina,
Pennsylvania, Texas, and Washington.
[71] Index case is a generic term for a person who has tested positive
for HIV and is asked to name spouses and partners at the start of the
notification process.
[72] Disease intervention specialists interview patients, at-risk
individuals, and those infected with STDs (including HIV), and ensure
appropriate examination, treatment, and follow-up to persons exposed or
infected with an STD. Pennsylvania uses its field staff to perform
duties similar to those of disease intervention specialists in other
states. In this report, we refer to these Pennsylvania field staff as
disease intervention specialists.
[73] CDC training includes courses such as Introduction to STD
Intervention, Fundamentals of STD Intervention, and HIV Partner
Counseling and Referral Services.
[74] Centers for Disease Control and Prevention, Program Operations
Guidelines for STD Prevention: Partner Services (Atlanta, Ga.: Centers
for Disease Control and Prevention, 2001).
[75] Suzanne E. Landis et al., "Results of a Randomized Trial of
Partner Notification in Cases of HIV Infection in North Carolina," The
New England Journal of Medicine, vol. 326, no. 2, 101-106 (1992). Beth
A. Macke and Julie E. Maher, "Partner Notification in the United
States: An Evidence-Based Review," American Journal of Preventive
Medicine, vol. 17, no. 3, 230-242, (1999).
[76] In some of these states, physicians or health departments may
notify partners only when certain conditions are met, such as when the
index case has been advised to notify partners but refuses. Some states
have provisions also permitting parties other than health care
providers or health departments to notify partners.
[77] The North Carolina provision applies only to notification of
spouses; state officials told us that they generally notify partners
with the consent of the index case.
[78] One New York provision requires public health officials to notify
partners; another permits physicians to notify partners.
[79] CDC's 2002 PCRS data did not include data from Massachusetts and
Missouri. CDC told us that Massachusetts did not use its CDC HIV
prevention funds for PCRS so it was not required to report PCRS data.
Missouri's data did not pass CDC's reliability tests.
[80] HRSA calculates a jurisdiction's ELCs using data from CDC on the
reported AIDS case counts for the last 10 years and weights those
numbers to account for the likelihood of deaths. See also GAO, HIV/
AIDS: Changes Needed to Improve the Distribution of Ryan White CARE Act
and Housing Funds, GAO-06-332 (Washington, D.C.: Feb. 28, 2006) for a
discussion of ELCs.
[81] Each drug approved by the Food and Drug Administration has at
least one national drug code (NDC) which is a universal product
identifier number for a human drug. An NDC indicates a drug's
manufacturer or distributor, a drug's strength, dosage form and
formulation, and its package size and types.
[82] The 2003 price data were the most recent data available at the
time of our review.
[83] We treated the 340B prime vendor as a separate drug pricing
program for price comparison purposes. Section 340B of the Public
Health Service Act required the Secretary of Health and Human Services
to establish a prime vendor program for 340B covered entities. 42
U.S.C. § 256(a)(8) (2000). Because the prime vendor negotiates its own
prices, it can have different prices than the 340B prices for the same
drugs.
[84] For purposes of this report, the Medicaid price is the average
amount state Medicaid programs paid net of the basic rebate provided
under the Medicaid Drug Rebate Program.
[85] For the 10 drugs we used, we determined which NDC for each drug
that was most commonly purchased by 52 ADAPs, and used the price for
that NDC for our comparisons. For example, since Sustiva has more than
one NDC, we chose the Sustiva NDC that was most commonly purchased by
ADAPs to identify which of Sustiva's drug prices to use for our
comparison.
[86] Even if a drug discount program had no price available for the
most commonly purchased NDC we used, it may have had prices for the
same drug under a different NDC than we used.
[87] Data for 2002 were the latest available at the time of our initial
data request.
[88] The 12 states that we contacted were California, Connecticut,
Florida, Kentucky, Massachusetts, Minnesota, Missouri, New York, North
Carolina, Pennsylvania, Texas, and Washington.
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