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entitled 'Ryan White CARE Act: Health Resources and Services
Administration's Implementation of Certain Provisions Hampered by Lack
of Timely and Accurate Information' which was released on September 30,
2009.
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
September 2009:
Ryan White Care Act:
Health Resources and Services Administration's Implementation of
Certain Provisions Hampered by Lack of Timely and Accurate Information:
GAO-09-1020:
GAO Highlights:
Highlights of GAO-09-1020, a report to congressional requesters.
Why GAO Did This Study:
Under the CARE Act, funds are made available to assist over 530,000
individuals affected by HIV/AIDS. Grantees directly provide services to
individuals (clients) or arrange with service providers to do so. The
Department of Health and Human Services’s (HHS), Health Resources and
Services Administration (HRSA), which administers CARE Act programs, is
required to cancel balances of grants that are unobligated after one
year and redistribute amounts to grantees in need. HRSA began to
collect client-level data in 2009. Under the CARE Act, states and
territories receive grants for AIDS Drug Assistance Programs (ADAP),
which provide HIV/AIDS drugs. GAO was asked to examine elements of the
CARE Act. In this report, we review: (1) HRSA’s implementation of the
unobligated balance provisions, (2) HRSA’s actions to collect client-
level data, and (3) the status of ADAP waiting lists. GAO reviewed
reports and agency documents and interviewed federal officials,
officials from 13 state and 5 local health departments chosen based on
location and number of cases, and other individuals knowledgeable about
HIV/AIDS.
What GAO Found:
The lack of timely and accurate information reporting by grantees has
delayed HRSA’s distribution of certain grants and has placed at risk
HRSA’s ability to obligate these funds. The late submission of actual
unobligated balances for the 2007 grant year delayed HRSA’s ability to
determine grantees’ unobligated balances and redistribute these funds
to other grantees. A number of grantees were late in their submissions.
For example, 21 of the 56 metropolitan areas submitted their
information beyond the date initially set by HRSA. Additionally, some
grantees reported inaccurate unobligated balances, which required HRSA
staff to correspond with grantees and request revised information,
creating additional delays. HRSA is authorized to obligate fiscal year
2007 funds for a 3-year period and is at risk of losing the authority
to make grants from these funds. HRSA officials said they have made
changes to how they implement the unobligated provisions in an effort
to avoid these issues in the future.
HRSA has taken actions to collect client-level data by implementing a
new data collection and reporting system. However, some grantees and
service providers did not submit the initial reports by HRSA’s
deadline. HRSA set a July 31, 2009, submission deadline for grantees’
initial reports, but 100 of 638 grantees did not meet this deadline.
Client-level data includes information such as the dates clients were
served, the types of services provided, and the clients’ health status.
HRSA has implemented a system to collect data on the number of unique
clients from grantees and service providers that will allow HRSA to
determine the services each client received and the outcomes of these
services. In order for HRSA to collect this information, grantees and
service providers must first collect the data using their own systems,
and HRSA has provided technical and financial assistance so that they
can develop these systems. For example, under a project initiated in
2009, HRSA awarded approximately $4 million to CARE Act grantees for
the development of their own client-level data collection systems.
The number of ADAPs with waiting lists and the number of individuals on
those lists is increasing. In the first quarter of grant year 2008
(April 1, 2008, through June 30, 2008), 2 ADAPs had waiting lists with
a total of 55 people on those lists; this grew to 3 ADAPs and a total
of 112 people in the fourth quarter of the year, and increased to 4
ADAPs and 136 individuals in August 2009. Kentucky, Montana, Nebraska,
and Wyoming were each maintaining a waiting list for ADAP services in
August 2009; Nebraska had the largest number of individuals (71), and
Wyoming had the smallest number (5). ADAP officials expressed concern
that they will have to establish or expand waiting lists or implement
other cost-control measures, such as limiting the number of drugs they
make available.
What GAO Recommends:
GAO recommends that HRSA take action to ensure it obtains timely and
accurate information on grantees’ unobligated balances. HHS reviewed a
draft of the report, but did not comment on the recommendations.
View [hyperlink, http://www.gao.gov/products/GAO-09-1020] or key
components. For more information, contact Marcia Crosse at (202) 512-
7114 or crossem@gao.gov.
[End of section]
Contents:
Letter:
Background:
Lack of Timely, Accurate Information Places at Risk Certain Funds, and
HRSA Has Unsuccessfully Attempted to Obtain Needed Information:
HRSA Has Taken Actions to Collect Client-Level Data, but Some Grantees
Did Not Submit Initial Reports by the Deadline:
The Number and Size of ADAP Waiting Lists Is Increasing:
Conclusions:
Recommendations for Executive Action:
Agency Comments:
Appendix I: Comments from the Department of Health and Human Services:
Appendix II: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Number of Grantees Submitting Late FSRs by Amount of Time:
Table 2: Description of Data Submitted for Ryan White HIV/AIDS Program
Services Reports:
Table 3: ADAPs with Waiting Lists and the Number of Individuals on
Those Lists, Grant Year 2008 First Quarter, Grant Year 2008 Fourth
Quarter, and as of August 10, 2009:
Figure:
Figure 1: Timeline for 2007 Part A and Part B Grants and Unobligated
Balance Provisions:
Abbreviations:
ADAP: AIDS Drug Assistance Program:
AIDS: acquired immunodeficiency syndrome:
CARE Act: Ryan White Comprehensive AIDS Resources Emergency Act of
1990:
CDC: Centers for Disease Control and Prevention:
DGMO: Division of Grants Management Operations:
EMA: eligible metropolitan area:
FSR: Financial Status Report:
HAB: HIV/AIDS Bureau:
HHS: Department of Health and Human Services:
HIV: human immunodeficiency virus:
HRSA: Health Resources and Services Administration:
NASTAD: National Alliance of State and Territorial AIDS Directors:
RDR: Ryan White HIV/AIDS Program Data Report:
RSR: Ryan White HIV/AIDS Program Services Report:
RWTMA: Ryan White HIV/AIDS Treatment Modernization Act of 2006:
SPNS: Special Projects of National Significance:
TGA: transitional grant area:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
September 29, 2009:
The Honorable Michael B. Enzi:
Ranking Member:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Richard Burr:
United States Senate:
The Honorable Tom A. Coburn:
United States Senate:
The Honorable Lisa Murkowski:
United States Senate:
It has been more than 28 years since the first cases of acquired
immunodeficiency syndrome (AIDS) in the United States were reported in
June 1981. Since that time, approximately 1.7 million Americans have
been infected with human immunodeficiency virus (HIV), including more
than 580,000 who have died.[Footnote 1] The Centers for Disease Control
and Prevention (CDC) estimates that approximately 1.1 million people
were living with HIV infection in the United States at the end of 2006,
and that there were 56,300 new HIV infections in that year.[Footnote 2]
The Ryan White Comprehensive AIDS Resources Emergency Act of 1990 (CARE
Act), administered by the Department of Health and Human Services's
(HHS) 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 3] Each year
CARE Act programs provide assistance to over 530,000 mostly low-income,
underinsured, or uninsured individuals living with HIV/AIDS. Under the
CARE Act, approximately $2.2 billion in grants were made to states,
localities, and others in fiscal year 2009. CARE Act programs have been
reauthorized three times (1996, 2000, and 2006) and are scheduled to be
reauthorized again in 2009.[Footnote 4] The Ryan White HIV/AIDS
Treatment Modernization Act of 2006 (RWTMA) reauthorized CARE Act
programs for fiscal year 2007 through fiscal year 2009.
Part A of the CARE Act provides for grants to selected metropolitan
areas--known as eligible metropolitan areas (EMA) and transitional
grant areas (TGA)--that have been disproportionately affected by the
HIV/AIDS epidemic.[Footnote 5] Part B provides for grants to states,
the District of Columbia, and territories and associated jurisdictions
to improve quality, availability, and organization of HIV/AIDS
services,[Footnote 6] including grants specifically for AIDS Drug
Assistance Programs (ADAP).[Footnote 7] ADAPs provide medications for
the treatment of HIV/AIDS. Program funds may also be used to purchase
health insurance for eligible clients and for services that enhance
access to, adherence to, and monitoring of drug treatments. ADAP grants
accounted for about 37 percent of the total $2.2 billion in CARE Act
grants awarded in fiscal year 2009. 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 sources available for
the services they need. Some ADAPs have struggled to meet the demand
for their services and have established waiting lists for eligible
individuals who will be served when space in the program becomes
available and have taken other measures that restrict access and
control costs. For example, in the past ADAPs have required that
individuals make a copayment in order to receive a drug and have placed
caps on expenditures per enrollee.[Footnote 8]
Most CARE Act funding is distributed to grantees either as base or
supplemental grants. Base grants are distributed by formula, and HRSA
uses a grantee's share of living HIV/AIDS cases to determine the amount
of base grants. Supplemental grants are generally awarded through a
competitive process based on the demonstration of severe need and other
criteria. Grantees may deliver services directly to individuals
(clients) or arrange with service providers to provide client services.
[Footnote 9]
RWTMA added provisions regarding the obligation of funds by Part A and
Part B grantees. In the past, some CARE Act grantees did not obligate
all of their funds in some years, while others obligated all of their
funds.[Footnote 10] RWTMA provided that base and supplemental grants
were available for obligation by the grantee for a 1-year period
beginning on the date awarded funds first became available to the
grantee (i.e., the grant year). It also required HRSA to cancel any
unobligated balances at the end of the grant year, recover funds that
had been disbursed to grantees, and redistribute these funds to
grantees in need as supplemental grants.[Footnote 11] Under
appropriations acts enacted since RWTMA, funds for these grants are
available for obligation by HRSA for a 3-year period. For example,
fiscal year 2007 appropriations are available until September 30, 2009.
[Footnote 12]
In 2009, HRSA began requiring the collection of client-level data from
grantees and service providers. Client-level data refers to information
on each client receiving CARE Act-funded services, such as the dates
services were received, the types of services provided, and current
health status. Previously, grantees and service providers submitted
only aggregate data to HRSA on those being served. To help ensure the
accountability of CARE Act funds, HRSA has begun to collect client-
level data. Implementing a client-level data collection and reporting
system can allow HRSA to obtain accurate information on the medical and
support services received by each unique client served with CARE Act
funds. HRSA requires grantees and service providers to complete
specified reports and transfer these reports electronically to HRSA.
As Congress prepares to reauthorize CARE Act programs, you asked us to
examine various elements of CARE Act programs. In this report, we
review (1) HRSA's first year implementation of the unobligated balance
provisions; (2) the actions taken by HRSA to collect client-level data,
and (3) the number and size of ADAP waiting lists.
To examine the first year implementation of the unobligated balance
provisions, we reviewed all grant year 2007 Part A and Part B carryover
requests that were provided to us by HRSA,[Footnote 13] including those
based on grantees' estimated unobligated balances and those based on
grantees' actual unobligated balances. We also reviewed all grant year
2007 Part A and B financial status reports provided to us by HRSA. We
reviewed HRSA documentation on grantees' carryover requests and
financial status reports as well as HRSA documentation on grantees'
unobligated balances at the end of grant year 2007. We interviewed HRSA
officials and asked follow-up questions related to the calculation of
unobligated balances, discrepancies in the carryover requests and
financial status reports, grantee estimates of their unobligated
balances that differed from their actual unobligated balances, and
information provided by grantees that we found to be incorrect. We
determined that the information provided to us by HRSA was sufficiently
reliable for our purposes.
To examine the actions taken by HRSA to collect client-level data, we
reviewed statements, manuals, and other materials on the implementation
of client-level data collection by HRSA, grantees, and service
providers. We focused on 2009, the first year grantees and service
providers were required by HRSA to submit client-level data, including
deadlines for data submission. In addition, we interviewed officials at
HRSA as well as officials from 12 state and 5 local health departments
who are knowledgeable about the CARE Act and the client-level data that
grantees and service providers must collect.[Footnote 14] We also
interviewed officials from the Henry J. Kaiser Family Foundation, the
National Alliance of State and Territorial AIDS Directors (NASTAD), and
other organizations knowledgeable about client-level data.
To examine the number and size of ADAP waiting lists, we obtained and
reviewed the ADAP Quarterly Data Reports submitted to HRSA by ADAP
grantees covering the first quarter of grant year 2008 (April 1, 2008,
through June 30, 2008) and the fourth quarter of grant year 2008
(January 1, 2009, through March 31, 2009).[Footnote 15] These reports
contain information on waiting lists. We reviewed the ADAP Quarterly
Data Reports and asked HRSA officials follow-up questions about the
accuracy of the data, and determined that the data were sufficiently
reliable for our purposes. We also obtained updated data from HRSA on
ADAP waiting lists as of August 10, 2009, and determined that the data
were sufficiently reliable for our purposes after discussing the data
with HRSA officials. We reviewed published information on ADAPs. We
interviewed HRSA officials knowledgeable about ADAPs and interviewed
officials from 13 states, which we chose based on their geographic
location, size, and number of HIV/AIDS cases, about their ADAPs.
[Footnote 16] In addition, we interviewed officials from the Henry J.
Kaiser Family Foundation, NASTAD, and other organizations knowledgeable
about ADAPs.
We conducted this performance audit from April 2009 through September
2009 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
Background:
RWTMA includes provisions related to unobligated balances, client-level
data, and ADAPs.
Unobligated Balance Provisions and Impact on Funding:
RWTMA includes provisions to encourage grantees to obligate their grant
funds in the year in which they were awarded. RWTMA provides that Part
A and Part B grant funds are available for obligation for a one-year
period beginning on the date funds first become available (referred to
as the grant year for the award).[Footnote 17] RWTMA requires HRSA to
cancel the unobligated balance of grant awards at the end of a grant
year and to require grantees to return any amounts from such balances
that have been disbursed to them. However, in the case of base grants,
a grantee may submit a request to carry over the unobligated balance
prior to the end of the grant year. If HRSA approves the request, the
unobligated balance that is approved for carryover (carryover funds) is
available to the grantee for expenditure for a one-year period
beginning upon the expiration of the grant year (referred to as a
carryover year). Under the RWTMA unobligated balance provisions, HRSA
is required to cancel any unexpended balance of carryover funds at the
end of the carryover year. HRSA must make the canceled balances from
the grant awards (that is, funds that were not eligible or approved for
carryover and carryover funds that remain after the carryover year)
available as supplemental grants for the first fiscal year beginning
after the fiscal year in which HRSA obtains the information necessary
for determining the balance available. Part A grantees with greater
than 2 percent of their base grant awards unobligated at the end of the
grant year and Part B grantees with greater than 2 percent of their
Part B and ADAP base awards unobligated at the end of the grant year
incur a penalty. RWTMA requires HRSA to reduce the amount of those
grants by the same amount as the unobligated balance for the first
fiscal year beginning after the fiscal year in which HRSA obtains the
information necessary for determining the unobligated balance. The
grant funds that become available as a result of these reductions are
also to be made available as supplemental grants.[Footnote 18]
RWTMA's authorization of appropriations for base and supplemental
grants under Parts A and B provided that amounts appropriated for a
fiscal year would be available for obligation until the end of the
second succeeding fiscal year. Further, under appropriations acts
enacted since RWTMA, funds for grants under Parts A and B, to which the
unobligated balance provisions apply, are available for obligation for
a 3-year period.[Footnote 19] In fiscal year 2007, for example, funds
were made available for obligation until September 30, 2009--the end of
the 2009 federal fiscal year. Thus, as HRSA recognized in its guidance
regarding the unobligated balance provisions, the initial obligation of
funds, cancellation of unobligated balances, return of amounts
disbursed to grantees, and the recompetition and redistribution of
supplemental grants would need to occur within the 3-year window.
In order to implement the RWTMA unobligated balance provisions, HRSA
created a multistep process for grantees and issued a policy notice to
grantees explaining this process.[Footnote 20] HRSA's process for
implementing the unobligated balance provisions in grant year 2007
included five steps. First, a grantee wishing to carry over funds was
required to submit a carryover request to HRSA with an estimated
unobligated balance of base grant funds 60 days prior to the end of the
grant year. In addition to the estimated unobligated balance, the
initial carryover request also had to contain a viable plan and
detailed budget for the use of the funds, and a description of the
grantee's capacity to utilize the funds within one-grant year. Part A
grantees had to submit their initial carryover request to HRSA by
January 1, 2008. Part B grantees had to submit their initial carryover
request to HRSA by February 1, 2008.
The second step of the 2007 grant year process was the evaluation of
the initial carryover requests. HRSA authorized grantees that obtained
approval before the end of the 2007 grant year to carryover 50 percent
of the amount they requested in this initial carryover request. To
authorize the use of the carryover funds, HRSA issued these grantees a
notice of grant award that explained to the grantees that HRSA had
effectively transferred the carryover funds from their grant year 2007
account into their grant year 2008 account, though balances remained,
in effect, available to the grantees for obligation until the end of
grant year 2007.[Footnote 21] HRSA officials explained that they did
not authorize the full amount of the initial carryover request because
they believed it was possible that the grantees that requested waivers
would incur obligations greater than anticipated in the 60-day
estimate. HRSA officials stated that they wanted to authorize the
carryover of a portion of the unobligated balance so that grantees with
approved carryover requests would have a longer period of time to
obligate the carried over funds.
For step three of HRSA's 2007 grant year unobligated balance process,
grantees were required by HRSA to submit a Financial Status Report
(FSR) 90 days after the end of the grant year. The FSR contains, among
other things, a grantee's actual unobligated balance. For Part A
grantees, FSRs were due on June 1, 2008. For Part B grantees, FSRs were
due on June 30, 2008. HRSA can extend the deadlines for grantees for
submission of their FSRs and granted extensions for 30 to 180 days.
For step four of the process, although not required by HRSA for grant
year 2007, grantees could submit a final carryover request based on
their actual unobligated balances. Those grantees that had their
initial carryover requests approved and had been authorized by HRSA to
carry over 50 percent of their unobligated balances at that time, could
apply for the remaining funds (the difference between the 50 percent
they had already been authorized to carry over by HRSA and their actual
unobligated balance). HRSA then authorized the use of the additional
amount of carryover funds by issuing a notice of grant award.
For step five of this process, grantees with unobligated balances of
greater than 2 percent of their grant year 2007 Part A, Part B, and
ADAP base grants were assessed a penalty. This penalty was a
corresponding reduction in grant year 2009 funds.[Footnote 22] In
addition, Part A and B grantees with unobligated balances of greater
than 2 percent for grant year 2007 were ineligible to receive
supplemental grants in grant year 2009. For Part A grantees this meant
that they were not eligible to receive grant year 2009 Part A
supplemental grants. For Part B base grantees this resulted in
ineligibility to receive grant year 2009 Part B supplemental grants.
For Part B ADAP grantees, an unobligated balance of greater than 2
percent does not result in ineligibility for ADAP supplemental grants.
Instead, ineligibility for the ADAP supplemental grant occurs when a
grantee has not obligated at least 75 percent of its ADAP grant award
within 120 days of the award.[Footnote 23]
Figure 1 shows a timeline for Part A and B grant distribution and the
unobligated balance provisions.
Figure 1: Timeline for 2007 Part A and Part B Grants and Unobligated
Balance Provisions:
[Refer to PDF for image: timeline]
Federal fiscal year: 2007;
Part A Grant year: March 1: Grantee receives grant;
Part B Grant Year: April 1: Grantee receives the grant award. The 12-
month period to obligate funds begins.
Federal fiscal year: 2008;
Part A Grant year: January 1: Carryover request due.
Part B Grant Year: February 1: 60 days prior to the end of the grant
year, grantees file their estimated unobligated balance. Grantees may
file an initial carryover request to retain any unobligated base
grants.
Federal fiscal year: 2009;
Part A Grant year: June 1: FSR due.
Part B Grant Year: July 1: 90 days after the grant year ends, grantees
must file a Financial Status Report (FSR), which includes the actual
amount of the grantee’s unobligated balance. Any unobligated balances
at this point are canceled and amounts disbursed are returned to HRSA,
unless the grantee has submitted a carryover request and it has been
approved. The FSR is the basis for determining the applicability of the
unobligated balance provisions.
Source: GAO analysis of HRSA guidance.
[End of figure]
HRSA canceled and recovered $13,764,295 in combined grant year 2007
Part B base and supplemental unobligated balances from 16 Part B
grantees with unobligated balances of greater than 2 percent. In
addition, these 16 grantees' grant year 2009 awards were reduced by a
total of $19,677,483 as a penalty for incurring an unobligated balance
of greater than 2 percent in grant year 2007. Of this, $4,441,865 was
from Part B base grants and $15,235,618 was from ADAP base grants.
Client-Level Data:
Prior to RWTMA, HRSA used the Ryan White HIV/AIDS Program Data Report
(RDR) to collect information on CARE Act services from grantees and
their service providers. However, RDR was unable to collect client-
level data with unique identifying information. Consequently, there was
no way of knowing if the clients counted as being served by one
provider were also included in the counts of those being served by
other providers. Therefore, totaling the number of clients receiving
services across providers could result in clients being counted more
than once. Additionally, the lack of client-level data meant that HRSA
was unable to assess the quality of care given to clients or
sufficiently account for the use of CARE Act funds.
HRSA now collects client-level data to help ensure accountability of
CARE Act funds. A client-level data collection and reporting system
contains information unique to each client receiving CARE Act-funded
services, such as their socio-demographic characteristics, the services
provided, and each client's current health status. Because the system
collects client-specific information rather than only aggregate-level
data, HRSA can obtain a more accurate measure of the number of clients
being served than was available using RDR.
ADAP Funding and Activities:
Each ADAP 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 such
as the number and types of drugs it will provide to its clients, and
the income levels to qualify for services. However, RWTMA required that
each grantee establish an ADAP formulary that covers all core classes
of antiretroviral medications.[Footnote 24]
ADAP grants totaled approximately $821 million in fiscal year 2009. Of
this amount, $780 million was provided to grantees as ADAP base grants,
which are awarded by formula and are based on a grantee's share of
living HIV/AIDS cases. The remaining $41 million was distributed to
grantees as ADAP supplemental grants.[Footnote 25] These grants are
distributed to ADAPs that demonstrate a severe need to increase the
availability of HIV/AIDS drugs.[Footnote 26]
ADAPs must balance client need with available resources. In previous
years, many ADAPs have had to institute waiting lists and other cost
containment measures because of insufficient funds to provide services
to all individuals who qualify. In our 2006 report, we found that in
fiscal year 2004, 14 ADAPs had waiting lists of individuals they
determined were eligible for assistance but they were unable to serve.
[Footnote 27] According to NASTAD and the Henry J. Kaiser Family
Foundation, since 2002 a total of 20 different ADAPs have had waiting
lists at some point. The largest number of individuals on waiting lists
across all grantees at any time was 1,629 in May 2004. However, they
reported that there were no individuals on waiting lists as of
September 2007.[Footnote 28] NASTAD, the Henry J. Kaiser Family
Foundation, and others have cited several factors that contributed to
the elimination of waiting lists as of September 2007. These reasons
included HRSA's awarding $39.5 million in ADAP supplemental grants in
September 2007, states' increasing their contributions to
ADAPs,[Footnote 29] and the continued implementation of Medicare Part D
prescription drug coverage.[Footnote 30]
Lack of Timely, Accurate Information Places at Risk Certain Funds, and
HRSA Has Unsuccessfully Attempted to Obtain Needed Information:
The lack of timely and accurate information has delayed HRSA's
distribution of unobligated balances as supplemental grants and places
at risk HRSA's ability to obligate these funds. HRSA has attempted to
develop timely information on grantee obligations but was unsuccessful
doing so for grant year 2007.
The Lack of Timely, Accurate Information Has Delayed HRSA's
Redistribution of Funds and Places at Risk HRSA's Ability to Obligate
Funds in the Required Time Frame:
The lack of timely and accurate information in grantees' FSRs regarding
grant year 2007 unobligated balances has delayed HRSA's distribution of
Part B supplemental grants, and places at risk HRSA's ability to
redistribute these funds by September 30, 2009, after which it will no
longer have the authority to redistribute the funds. Because of late
FSR submissions, as of September 14, 2009, HRSA had not yet
redistributed funds that it canceled and recovered from grantees' 2007
unobligated balances. However, as HRSA recognized in its guidance
regarding the unobligated balance provisions, the entire process for
canceling and recovering grant funds and making the corresponding
awards of supplemental grants must occur within the 3-year period of
availability of those Part B funds.[Footnote 31]
For HRSA's grant year 2007 process, Part A grantees were required to
submit their FSRs by June 1, 2008, and Part B FSRs were to be submitted
to HRSA by June 30, 2008. The FSR contains, among other information, a
grantee's actual unobligated balance. HRSA uses the grantees' actual
unobligated balances, as reported on their FSRs, to determine the total
amount of unobligated balance funds that will be available for
redistribution through supplemental grants. Without complete, accurate,
and timely information from grantees about their unobligated balances,
HRSA is unable to redistribute unobligated balance funding through the
Part A and Part B supplemental grants.[Footnote 32]
Many Part A and B grantees submitted their FSRs late, and some
submitted their FSRs more than 120 days after the deadline. Of the 56
Part A grantees, 21 submitted FSRs after the June 1, 2008, deadline. Of
the 59 Part B grantees, 24 submitted FSRs after the June 30, 2008,
deadline. Table 1 shows the number of days after the deadline that Part
A and Part B grantees submitted their FSRs.
Table 1: Number of Grantees Submitting Late FSRs by Amount of Time:
Part A Grantees:
30 to 60 days after deadline: 3;
61 to 90 days after deadline: 5;
91 to 120 days after deadline: 3;
121 days or more after deadline: 10;
Total late final FSRs: 21.
Part B Grantees:
30 to 60 days after deadline: 3;
61 to 90 days after deadline: 7;
91 to 120 days after deadline: 10;
121 days or more after deadline: 4;
Total late final FSRs: 24.
Source: GAO analysis of HRSA data.
[End of table]
HRSA officials stated that grantees were often delayed in submitting
their FSRs because of their end-of-the-year workload, which includes
the need to submit grant applications and multiple reports for their
formula and supplemental funding. HRSA officials stated that grantees
normally request extensions for submitting their FSRs, and 60-day
extensions are typically granted. HRSA officials stated that in grant
year 2007, due to the new process HRSA implemented to address the
unobligated balance provisions, grantees had to implement separate
tracking of the expenditure of current grant year base grant and
supplemental funds, and the expenditure of carryover funding from
previous years. HRSA officials also stated that grantees had difficulty
implementing the separate tracking of these funds. HRSA officials
stated that due to grantees' difficulty tracking funds separately, some
grantees' FSRs reported inaccurate unobligated balances, which required
HRSA staff to correspond with grantees and request revised information,
creating additional delays. According to HRSA officials, in addition to
experiencing difficulty tracking funds, grantees were dealing with
other factors including late receipt of final invoices from
contractors, delays in receipt of ADAP rebates, and staff vacancies.
[Footnote 33]
While HRSA has typically approved grantees' requests for extensions in
submitting their FSRs, the tardiness of grantees' FSR submissions and
HRSA's need to correspond with grantees to address their inaccuracies
has delayed HRSA's ability to determine the amount of unobligated
balances available for redistribution to grantees through Part B
supplemental grants. In April 2009, HRSA officials stated that they
planned to distribute Part B supplemental grants in May 2009. However,
as of September 14, 2009, HRSA had not distributed the 2009 Part B
supplemental grants. As a consequence, HRSA had not yet fully
implemented the unobligated balance provisions for the first time. HRSA
officials stated that they plan to implement changes to improve the
timeliness of their process. For example, HRSA officials also stated
that beginning in grant year 2009 they will no longer approve grantees'
requests for extensions for their FSR submissions. Additionally,
beginning in grant year 2009, FSRs will be due 30 days after the end of
the grant year instead of the grant year 2007 deadline of 90 days after
the end of the grant year.
In Its 2007 Process, HRSA Attempted to Develop Timely Information on
Grantees' Unobligated Balances but Was Unsuccessful:
In its 2007 process, HRSA tried to develop timely information on
grantees' unobligated balances, but these efforts were unsuccessful.
For grant year 2007, in order to gain information on grantees'
unobligated balances so that it could begin to determine how much
funding would be available for distribution as supplemental grants and
so that it could provide grantees with a full year to obligate
carryover funds, HRSA requested that grantees submit estimates of their
unobligated balances 60 days before the end of the 2007 grant year.
Because unobligated balance funds that grantees decide not to carry
over and unobligated balance funds from carryover requests that are not
approved by HRSA are available for redistribution through supplemental
grants, HRSA officials needed to complete processing of the carryover
requests before they could determine the amount of funding that and
could be made available as supplemental grants.
Many grantees' estimates of their unobligated balances in advance of
the end of the grant year differed from their actual unobligated
balances at the end of the grant year. In accordance with HRSA's
requirements, many Part A and Part B grantees submitted estimates of
their unobligated balances with requests to carryover these funds 60
days before the end of the grant year, but their estimates proved to be
substantially different from the actual unobligated balances reported
on their FSRs. Of the 29 Part A grantees that submitted initial
carryover requests, compared to the actual unobligated balances they
submitted on their FSRs, 25 overestimated their unobligated balances,
two grantees underestimated their unobligated balances, and two
grantees correctly estimated their unobligated balances. Among the
grantees that overestimated their balances were nine grantees that were
ultimately able to obligate all of their funding by the end of the
grant year and therefore did not need to carry over any funds. Of the
24 Part B grantees that completed initial carryover requests, compared
to the actual unobligated balances they submitted on their FSRs, 18
overestimated their unobligated balances. Two of these grantees, New
York and New Jersey, overestimated their unobligated balances by more
than the amount they received from HRSA based on their initial
carryover requests and had to request that HRSA return the grant year
2007 carryover funds that the grantees had previously requested be
transferred into their grant year 2008 accounts.[Footnote 34] Six
grantees underestimated their unobligated balances. Nine grantees that
overestimated their balances were ultimately able to obligate all of
their funds by the end of the grant year and did not need to carryover
any unobligated balances.
The process of approving grantees' initial carryover requests sometimes
extended into the 2008 grant year. As a result, grantees were not
authorized to use carryover funds at the expiration of the 2007 grant
year as provided for by RWTMA. HRSA officials stated that the
implementation of procedures to process, approve, and authorize
carryover funding required significant staff time from the HRSA project
officer, grants management staff, and program managers. The HRSA
process called for staff to review these initial carryover requests,
approve them, and authorize carryover funding to be transferred from
the grantees' 2007 accounts into their 2008 accounts. HRSA officials
stated that the multiple grantee submissions, which often included
revised proposals, resulted in processing delays and confusion for HRSA
staff. On average, it took HRSA staff 3 months to complete processing
of Part A grantees' initial unobligated balance carryover requests and
4 months for Part B grantees. Because grantees were only given until
the end of grant year 2008 to expend carry over funds, grantees who
received authorization to carryover funds after the start of the grant
year did not have the entire grant year to expend these funds.
In light of HRSA's difficulty implementing procedures related to the
submission of initial carryover requests and the differences between
grantees' estimated and actual unobligated balances, HRSA has decided
to discontinue its process of approving initial carryover waiver
requests based on estimated unobligated balances.
HRSA Has Taken Actions to Collect Client-Level Data, but Some Grantees
Did Not Submit Initial Reports by the Deadline:
HRSA has taken actions to collect client-level data by implementing a
new data collection and reporting system. It has also provided
financial and technical assistance to grantees and service providers
implementing their own client-level data and reporting systems. In
addition, HRSA developed a timeline for the submission of reports
covering the initial reporting period using client-level data, but some
grantees did not submit the initial reports by the deadline.
HRSA Has Taken Actions to Collect Client-Level Data by Implementing a
New Data Collection and Reporting System:
HRSA has taken actions to collect client-level data from CARE Act
grantees and service providers. Beginning in December 2007, after the
initial design and development of a client-level data collection and
reporting demonstration project, HRSA held meetings with CARE Act
grantees, national organizations, and federal agencies to discuss
collecting and reporting client-level data. Topics discussed included
data collection and reporting barriers, data elements to be collected,
how the data would be used, and the technical assistance that would be
available from HRSA. Using information from these sessions, HRSA
finalized the Ryan White HIV/AIDS Program Services Report (RSR), its
client-level data collection and reporting system. RSR consists of
three reports: the Grantee Report, the Service Provider Report, and the
Client Report. RSR was submitted to the Office of Management and Budget
for approval in November 2008, which granted approval for HRSA to
collect data from grantees and service providers using RSR in March
2009.
HRSA stated that RSR will improve information on the clients served,
the services provided to clients, and the outcomes of the services
provided. RSR is designed to provide HRSA with a more accurate measure
of the number of unique clients receiving CARE Act-funded services by
assigning each individual an encrypted Unique Client Identifier thereby
allowing the tracking of individuals who receive services from multiple
providers.[Footnote 35] Because RSR will contain client-specific data,
HRSA will be able to determine the services each client received and
the outcomes of these services.
RSR is part of a process through which HRSA plans to collect
information, including client-level data, from grantees and service
providers funded under CARE Act Parts A, B, C, D, and F.[Footnote 36]
First, the grantees and service providers collect data using their own
data collection systems. Second, the grantees and service providers
report the data to HRSA in specified reports using RSR.[Footnote 37]
HRSA has stated that it intends to use the data collected through RSR
to generate reports on the use of CARE Act funds and the providers that
receive them. HRSA reports are expected to provide client-level
information on the characteristics of the clients served, the types of
services they received from the provider, and their current health
status. Additionally, HRSA has stated that it intends to conduct
detailed analyses of national and regional information about clients
and services.
HRSA Has Provided Financial and Technical Assistance to Grantees to
Develop Their Own Client-Level Data Collection and Reporting Systems:
HRSA provided financial assistance to CARE Act grantees to develop or
adapt their client-level data collection and reporting systems so that
they could submit the required information to RSR. There are grantees
who must develop new systems while other grantees' systems require
modification to enable them to generate data compatible with the
requirements of RSR. HRSA administered a Special Projects of National
Significance (SPNS) initiative in fiscal year 2008 and another in
fiscal year 2009 to provide funds to support CARE Act grantees in
developing client-level data systems that could be used to report
information to RSR.[Footnote 38] Under the fiscal year 2008 SPNS
initiative, HRSA awarded 17 grants ranging from $87,000 to $200,000 to
all 17 CARE Act Parts A and B grantees that applied for funding. Under
the fiscal year 2009 SPNS initiative, HRSA awarded a total of
approximately $4 million to all 57 Parts C and D grantees that applied
for funding. Officials from 4 of the 17 health departments we
interviewed stated that they received financial assistance from HRSA to
develop and implement a client-level data collection and reporting
system. Two of these health departments received $200,000 each. One of
these health departments used the funding to help build its own new
system while the other department used the funding to adapt its current
system to be compatible with CAREWare, a free, data collection system
available through HRSA's Web site. In addition to the SPNS funds, HRSA
has made other funding available for infrastructure development. In
2008, HRSA provided a total of more than $1 million to 15 CARE Act Part
C grantees that included funds for them to develop their client-level
data systems. As of April 2009, HRSA was reviewing 72 applications for
infrastructure development grants.
HRSA also provided technical assistance to CARE Act grantees and
service providers to develop client-level data collection and reporting
systems. HRSA established the Technical Assistance Resources, Guidance,
Education & Training Web site to provide information and resources,
such as help desk support. HRSA conducted training sessions and
webcasts to provide information on issues relating to implementing a
client-level data system. Additionally, HRSA established the RSR Triage
Committee to monitor and address the technical assistance needs of
grantees. The committee meets weekly to discuss technical assistance
concerns of grantees and monitors contractors charged with addressing
technical concerns on behalf of HRSA. Officials from 7 of the 17 health
departments we interviewed told us that they received technical
assistance from HRSA to develop and implement a client-level data
collection and reporting system. For example, one state grantee told us
that HRSA provided a 2-day training session on CAREWare in November
2008. The HRSA official returned in March 2009 to provide assistance in
implementing the CAREWare system.[Footnote 39]
The state and local health departments that we interviewed have taken
steps to implement a client-level data collection and reporting system
that can report client-level data to RSR. Officials from all 17 health
departments we spoke with stated that they either already had a client-
level data system or were implementing such a system. Officials from
six health departments indicated that they either currently use or plan
to use CAREWare. The other eleven said they will use or plan to use a
customized or vendor-distributed client-level information data system.
Officials from 8 of the 17 departments stated that they had a system to
collect client-level data before HRSA's requirement to implement such a
system.[Footnote 40]
Officials from 10 of the 17 health departments we interviewed had
concerns or challenges with implementing a client-level data collection
and reporting system and reporting client-level data to HRSA. For
example, officials from three health departments stated they were
concerned about how to train service providers and other partners to
collect client-level data. An official from 1 of these 3 health
departments mentioned that it had been a challenge for his state to
train the 100 case managers in the state to report client-level data in
a consistent manner. Additionally, officials from three departments
stated that they were concerned with potential breaches in the
confidentiality of client information when data are entered into the
RSR system.
HRSA Developed a Timeline for Submitting the Initial Reports to RSR,
but Some Grantees Did Not Submit Initial Reports by the Deadline:
HRSA developed a timeline for grantees to submit their initial reports
to RSR, but some grantees did not submit initial reports. The initial
RSR reporting period covered January 1, 2009, through June 30, 2009;
however, the deadlines varied for the different reports.[Footnote 41]
Table 2 provides a description of the reports to be submitted to RSR by
grantees and service providers and the deadline for the initial
reporting period for each report.
Table 2: Description of Data Submitted for Ryan White HIV/AIDS Program
Services Reports:
Report: Grantee report;
Party responsible for completing the report[A]: CARE Act Part A, B, C,
D, or F grantees[C];
Description of data collected: Information about the grantee
organization and the service providers that it funded;
Deadline for initial reporting period[B]: July 31, 2009.
Report: Service provider report;
Party responsible for completing the report[A]: Service providers who
provide CARE Act-funded services;
Description of data collected: Information about the service provider
and the CARE Act services it delivers;
Deadline for initial reporting period[B]: September 15, 2009.
Report: Client report;
Party responsible for completing the report[A]: Service providers that
deliver and/or pay for direct client services with CARE Act funds;
Description of data collected: Information about each client that
receives services funded by the CARE Act such as demographic data, HIV
clinical information, and medical and support services received at the
service provider;
Deadline for initial reporting period[B]: September 15, 2009.
Source: GAO analysis of HRSA data:
[A] For the initial reporting period of January 1, 2009, through June
30, 2009, and the first annual reporting period of January 1, 2009,
through December 31, 2009, only service providers receiving CARE Act
funds to provide outpatient/ambulatory medical care and/or case
management services will be required to submit a Client Report. All
service providers will eventually be required to submit Client Reports.
[B] The submission deadline for Grantee Reports is July 31, 2009.
Grantees must approve the Service Provider Reports and the Client
Reports entered by service providers by September 15, 2009.
[C] Only Part F Minority AIDS Initiative grantees must complete this
report.
[End of table]
While most grantees submitted a Grantee Report to HRSA by the July 31,
2009 deadline, some did not do so. For the initial RSR reporting
period, 538 of 638 (about 84 percent) CARE Act grantees submitted
Grantee Reports to HRSA by the deadline. According to HRSA officials,
as of August 13, 2009, of the 100 grantees and service providers that
had not submitted their required reports, 50 had started the submission
process and 50 had not begun. HRSA officials told us that they are
contacting the grantees to determine the cause of the reporting delays.
HRSA officials also stated that they are aware that some grantees have
had problems generating data in the RSR-required format.
The Number and Size of ADAP Waiting Lists Is Increasing:
The number of individuals on ADAP waiting lists increased during grant
year 2008 and has continued to increase in 2009. In the first quarter
of grant year 2008 (April 1, 2008, through June 30, 2008), 2 ADAPs had
waiting lists with a total of 55 people on those lists. In the fourth
quarter of grant year 2008 (January 1, 2009, through March 31, 2009),
there were 3 ADAPs with waiting lists, but the number of individuals on
the lists had increased to 112. By August 10, 2009, the most recent
date for which data were available at the time of our analysis, these
numbers had grown to 136 individuals on 4 ADAP waiting lists. Overall,
this represents an increase of 147 percent (from 55 to 136) in the
number of individuals on waiting lists from the first quarter of grant
year 2008 to August 2009. Kentucky, Montana, Nebraska, and Wyoming all
had waiting lists in August 2009. Nebraska had the largest ADAP waiting
list with 71 individuals while Wyoming had the smallest list with 5
individuals. Five ADAPs had waiting lists at some point during the time
period we examined. Montana had a waiting list at all three points
while Kentucky and Wyoming had a waiting list at one of those times.
Indiana and Nebraska had a waiting list at two points. Table 3 lists
the grantees with ADAP waiting lists and the number of individuals on
those lists.
Table 3: ADAPs with Waiting Lists and the Number of Individuals on
Those Lists, Grant Year 2008 First Quarter, Grant Year 2008 Fourth
Quarter, and as of August 10, 2009:
Grantee: Indiana;
Number of individuals on waiting lists:
Grant year 2008 first quarter: 50;
Grant year 2008 fourth quarter: 51;
August 10, 2009[A]: 0.
Grantee: Kentucky;
Number of individuals on waiting lists:
Grant year 2008 first quarter: 0;
Grant year 2008 fourth quarter: 0;
August 10, 2009[A]: 36.
Grantee: Montana;
Number of individuals on waiting lists:
Grant year 2008 first quarter: 5;
Grant year 2008 fourth quarter: 19;
August 10, 2009[A]: 24.
Grantee: Nebraska;
Number of individuals on waiting lists:
Grant year 2008 first quarter: 0;
Grant year 2008 fourth quarter: 42;
August 10, 2009[A]: 71.
Grantee: Wyoming;
Number of individuals on waiting lists:
Grant year 2008 first quarter: 0;
Grant year 2008 fourth quarter: 0;
August 10, 2009[A]: 5.
Grantee: Total;
Number of individuals on waiting lists:
Grant year 2008 first quarter: 55;
Grant year 2008 fourth quarter: 112;
August 10, 2009[A]: 136.
Source: GAO analysis of ADAP Quarterly Reports and HRSA.
[A] Waiting list information as of August 10, 2009 was the most recent
data available at the time of our analysis.
[End of table]
We also found that the total number of individuals enrolled in ADAPs
increased during grant year 2008.[Footnote 42] In the first quarter of
grant year 2008, 164,849 individuals were enrolled in ADAPs. The number
enrolled by the fourth quarter of grant year 2008 was 177,746, an
increase of 7.8 percent. Similarly, the number of individuals receiving
at least one medication from an ADAP increased. In the first quarter of
grant year 2008, 121,075 received at least one medication while 134,019
individuals received at least one medication in the fourth quarter of
grant year 2008, an increase of 10.7 percent.
The increase in the number and size of ADAP waiting lists, as well as
the increase in the number of individuals enrolled in and receiving
medications through ADAPs, indicates increased financial pressure on
ADAPs as ADAPs balance client needs with available resources. HRSA
officials told us that because of financial pressures they are closely
monitoring five ADAPs--Arizona, Arkansas, California, Kentucky, and
Iowa--for the initiation or expansion of waiting lists or other cost-
control measures. For example, Arkansas is considering establishing an
ADAP waiting list while Kentucky projects that additional individuals
will be added to its waiting list. Arizona's ADAP reduced the number of
drugs on its formulary effective July 1, 2009, because of a budgetary
shortfall.[Footnote 43] Additionally, Arizona's ADAP still anticipates
a budgetary shortfall this grant year even with the reduced number of
drugs on its formulary and is considering additional cost-control
measures.
ADAP officials we interviewed also indicated that ADAPs were under
increasing financial pressure. For example, Hawaii officials expressed
concern that they will have to establish a waiting list. They stated
that they are facing higher drug prices and an increasing number of
people enrolled in their ADAP. Washington state officials noted that
they are facing ADAP budget constraints. An advisory committee has
developed a number of possible cost-control measures to stay within
budget, including reducing the number of drugs on the ADAP formulary
and reducing payments to pharmacies and medical laboratories.
Conclusions:
HRSA has been working to implement the unobligated balance provisions
of RWTMA since its enactment in December 2006. As a result of the
requirement to cancel unobligated balances and, in some cases, penalize
grantees, HRSA implemented complex processes that have been difficult
for grantees to comply with, thus delaying HRSA's first implementation
of the requirement. To implement the unobligated balance provisions,
HRSA has required information on the amount of unobligated balances at
the end of the grant year that some grantees either did not provide in
a timely manner or that was inaccurate, or both. Three years after
enactment of RWTMA, HRSA was continuing to develop its process for
implementing the provisions and making adjustments based on some
grantees' continued inability to comply with the process that HRSA
established. In addition, at least one key provision, the use of Part B
supplemental grants to redistribute unobligated funds, has yet to occur
for the first time. Because funds for these grants are only available
until September 30, 2009, HRSA is at risk of losing the authority to
make these grants.
HRSA officials told us that, for grant years 2008 and 2009, they have
changed their process for implementing the unobligated balance
provisions in order to alleviate the burden on staff and to ensure that
HRSA has the information it needs to implement the unobligated balance
provisions in a timely manner. However, even with a changed process,
HRSA will continue to depend upon grantees to provide useful
information on their unobligated balances in a timely manner. This will
not be achieved if grantees continue to provide information after the
deadline by which it is required. HRSA must have complete, accurate,
and timely information from grantees to complete the entire process to
redistribute unobligated balances as supplemental grants within the
period given for obligation of funds for Part A and Part B of the CARE
Act.
Recommendations for Executive Action:
To help ensure that HRSA is able to implement the unobligated balance
provisions in a timely manner, we recommend that the Secretary of HHS
instruct the administrator of HRSA to take the following two actions to
obtain timely and accurate information on grantees' unobligated
balances:
* Identify the causes of grantees' difficulties in providing a timely
and accurate accounting of their unobligated balances.
* Ensure that grantees adhere to deadlines for submission of their
unobligated balances by developing steps to assist them in overcoming
the causes of difficulties identified in accounting for unobligated
balances.
Agency Comments:
HHS reviewed a draft of the report, but did not comment on our
conclusions and recommendations. HHS' comments are reprinted in
appendix I. We incorporated HHS comments and technical comments as
appropriate.
We are sending copies of this report to the Secretary of Health and
Human Services. The report is also available at no charge on GAO's Web
site at [hyperlink, http://www.gao.gov].
If you or your staffs have any questions, please contact me at (202)
512-7114 or crossem@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may found on the last page
of this report. Other staff who made major contributions to this report
are listed in appendix II.
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
Appendix I: Comments from the Department of Health and Human Services:
Department Of Health& Human Services:
Office Of The Secretary:
Assistant Secretary or Legislation:
Washington, DC 20201:
September 23, 2009:
Marcia Crosse:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Mr. Crosse:
Enclosed are comments on the U.S. Government Accountability Office's
(GAO) report entitled: "Ryan White Care Act: Health Resources and
Services Administration's Implementation of Certain Provisions Hampered
by Lack of Timely and Accurate Information (GAO-09-1020).
The Department appreciates the opportunity to review this report before
its publication.
Sincerely,
Signed by:
Andrea Palm:
Acting Assistant Secretary for Legislation:
Enclosure:
[End of letter]
Department Of Health & Human Services:
Health Resources and Services Administration:
Rockville MD 20857:
September 23, 2009:
To: Marcia Crosse:
Director, Health Care:
U.S. Government Accountability Office:
From: Administrator:
Subject: Government Accountability Office Draft Report: "Ryan White
Care Act: Health Resources and Services Administration's Implementation
of Certain Provisions Hampered by Lack of Timely and Accurate
Information" (GAO-09-1020):
This is in response to the GAO's request for comments on the draft
report, "Ryan White Care Act: Health Resources and Services
Administration's Implementation of Certain Provisions Hampered by Lack
of Timely and Accurate Information" (GAO-09-1020). Attached are the
Health Resources and Services Administration's comments. If you have
any questions, please contact Patricia A. Reese in HRSA's Office of
Federal Assistance Management at (301) 443-0270.
Signed by:
Mary K. Wakefield, Ph.D., R.N.
Attachment:
Health Resources and Services Administration's Comments on the GAO
Draft Report - "Ryan White Care Act: Health Resources and Services
Administration's Implementation of Certain Provisions Hampered by Lack
of Timely and Accurate Information" (GAO-09-1020):
General Comments:
The Health Resources and Services Administration has reviewed the GAO's
draft report and has the following comments. In addition, the tables in
this draft are not in sequential order: table 7 is on page 15, table 1
is on page 23, table 3 is on page 24, and there is no table 2 listed.
[End of section]
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse, (202) 512-7114 or crossem@gao.gov:
Acknowledgments:
In addition to the contact above, Thomas Conahan, Assistant Director;
Robert Copeland, Assistant Director; Leonard Brown; Romonda McKinney
Bumpus; Cathleen Hamann; Sarah Resavy; Rachel Svoboda; and Jennifer
Whitworth made key contributions to this report.
[End of section]
Footnotes:
[1] HIV is the virus that causes AIDS. In 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] These were the most recent estimates available at the time of this
report.
[3] Pub. L. No. 101-381, 104 Stat. 576 (codified as amended at 42
U.S.C. §§ 300ff through 300ff-121). The 1990 CARE Act added title XXVI
to the Public Health Service Act. Unless otherwise indicated,
references to the CARE Act are to the current title XXVI.
[4] CARE Act programs were previously reauthorized by the Ryan White
CARE Act Amendments of 1996 (Pub. L. No. 104-146, 110 Stat. 1346), the
Ryan White CARE Act Amendments of 2000 (Pub. L. No. 106-345, 114 Stat.
1319), and the Ryan White HIV/AIDS Treatment Modernization Act of 2006
(Pub. L. No. 109-415, 120 Stat. 2767).
[5] EMAs are areas that have a population of 50,000 persons or more and
had a cumulative total of more than 2,000 new AIDS cases during the
most recent 5-year period. TGAs are areas that have a population of
50,000 persons or more and had a cumulative total of 1,000 to 1,999 new
AIDS cases during the most recent 5-year period. Prior to RWTMA, all
metropolitan areas that received Part A funding were classified as
EMAs. In fiscal year 2009, there were 24 EMAs and 32 TGAs according to
HRSA.
[6] These territories and associated jurisdictions are American Samoa,
the Commonwealth of the Northern Mariana Islands, the Commonwealth of
Puerto Rico, the Federated States of Micronesia, Guam, Palau, the
Republic of the Marshall Islands, and the U.S. Virgin Islands.
[7] The ADAP in each state, the District of Columbia, territory, and
associated jurisdiction is eligible for this funding.
[8] GAO, Ryan White CARE Act: Improved Oversight Needed to Ensure AIDS
Drug Assistance Programs Obtain Best Prices for Drugs, [hyperlink,
http://www.gao.gov/products/GAO-06-646] (Washington, D.C.: Apr. 26,
2006), 16-17.
[9] A service provider is an agency that provides direct services to
clients and their affected family members or provides support such as
administrative or technical services to grantees. Service providers may
be directly funded through one or more CARE Act parts; through
agreements with one or more grantees; or through subcontracts with a
grantee's fiscal intermediary (i.e., an administrative agent of the
grantee).
[10] Grantees obligate funds when they commit them for a specific
purpose that will require payment during the same period of time when
the funds were committed or a future period of time. Funds that have
not been so committed by grantees are unobligated.
[11] The unobligated balance provisions do not apply to Part A and Part
B Minority AIDS Initiative grants. These grants are available to all
Part A and B grantees as competitive, supplemental funding. For more
information on Minority AIDS Initiative grants, see GAO, Ryan White
CARE Act: Implementation of the New Minority AIDS Initiative
Provisions, [hyperlink, http://www.gao.gov/products/GAO-09-315]
(Washington, D.C.: March 27, 2009).
[12] We also examined the unobligated balance provision in a previous
report. See GAO, Ryan White CARE Act: Effects of Certain Funding
Provisions on Grant Awards, [hyperlink,
http://www.gao.gov/products/GAO-09-894] (Washington, D.C.: Sept. 18,
2009).
[13] Carryover requests are also referred to as waivers of the
cancellation of unobligated balances.
[14] We interviewed officials from 12 state health departments and 5
local health departments. We interviewed the following state health
departments: California, Delaware, Florida, Hawaii, Indiana, Missouri,
Nebraska, North Carolina, Ohio, Pennsylvania, Rhode Island, and
Washington. We interviewed the following local health departments:
Harris County, Tex.; Maricopa County, Ariz.; Memphis, Tenn.; New York,
N.Y.; Sacramento County, Calif. We selected health departments to
achieve a range in geographic locations and the number of HIV cases
among jurisdictions.
[15] We reviewed and analyzed ADAP Quarterly Data Reports if the
grantee submitted reports for both the first and fourth quarters of the
2008 grant year. Consequently, we reviewed the reports of 52 of the 59
grantees. Louisiana did not submit an ADAP quarterly report for the
first quarter of grant year 2008 and the U.S. Virgin Islands did not
submit a report for the fourth quarter of grant year 2008. American
Samoa, the Commonwealth of the Northern Mariana Islands, the Federated
States of Micronesia, and the Republic of the Marshall Islands did not
submit reports for either the fist or fourth quarters of grant year
2008. Palau also did not submit a report for either quarter, but it
also did not receive any ADAP funding in grant year 2008.
[16] We interviewed officials from the following ADAPs: Arizona,
California, Delaware, Florida, Hawaii, Indiana, Missouri, Nebraska,
North Carolina, Ohio, Pennsylvania, Rhode Island, and Washington.
[17] Provisions establishing a one-year period for the obligation of
funds apply to Part A base and supplemental grants to metropolitan
areas, and all Part B grants to states and territories and associated
jurisdictions--that is, Part B and ADAP base grants, Part B and ADAP
supplemental grants, and supplemental grants for emerging communities.
(Emerging communities are those metropolitan areas that do not qualify
as EMAs or TGAs, but have 500-999 cumulative reported AIDS cases during
the most recent 5-year period. Emerging community grants are
distributed to states, which then pass them through to emerging
communities.)
[18] The availability of funds for supplemental grants is subject to
hold-harmless provisions that protect grantees' grant amounts at
specified levels.
[19] Revised Continuing Appropriations Resolution, 2007, Pub. L. No.
110-5, § 2, 121 Stat. 8, 31; Consolidated Appropriations Act, 2008,
Pub. L. No. 110-161, div. G, title II, 121 Stat. 1844, 2170; Omnibus
Appropriations Act, 2009, Pub. L. No. 111-8, div. F, title II, 123
Stat. 524, 763-64.
[20] Department of Health and Human Services, Health Resources and
Services Administration. HIV/AIDS Bureau. Policy Notice 07-09: The
Unobligated Balances Provision (2007). [hyperlink,
http://hab.hrsa.gov/law/0709.htm].
[21] HRSA accomplished this by deobligating funds from the grantees'
2007 grant year accounts and reobligating the funds to their 2008 grant
year accounts. For grantees that incurred 2007 grant year obligations
for which the use of CARE Act funds was appropriate, HRSA adjusted the
accounts through a similar process at the end of the grant year,
effectively transferring funds back to the grant year 2007 accounts.
[22] Grantees are not penalized in the year immediately following the
year in which they have unobligated balances in excess of 2 percent.
Because the grantee submits the actual unobligated balance on the FSR
90 days after the grant year ends, grants for the next year have
already been made by the time HRSA has received the information
necessary to determine which grantees have an unobligated balance
greater than 2 percent. As a result, there is a one-year lag time
between when the unobligated balance occurs and when the penalty is
assessed. For example, if a grantee had an unobligated balance of three
percent in grant year 2007, the grantee's FSR would have been filed in
grant year 2008, and the dollar amount of the 2007 unobligated balance
would have been deducted from the grantee's award in grant year 2009.
[23] Since its inception, the CARE Act has required Part B grantees to
obligate 75 percent of their entire Part B grant within certain time
frames and repay any unobligated balance to HRSA for reallocation to
Part B grantees. States had 150 days to meet this requirement in the
first year of the program and have had 120 days in subsequent years.
HRSA requires Part B grantees to report this obligation within 150 days
on an FSR. In addition, grantees that do not obligate this 75 percent
are ineligible for ADAP supplemental grants.
[24] A formulary is a drug list that establishes the number of drugs
available within a therapeutic class for purposes of drug purchasing,
dispensing, and reimbursement. Antiretroviral medications are used to
combat the reproduction of the HIV virus and to slow the progression of
HIV-related disease. ADAPs must cover at least one drug from each of
the six antiretroviral drug classes.
[25] Annual appropriations acts specify the total amount of funding for
ADAPs. Five percent of this funding is reserved for ADAP supplemental
grants.
[26] Severe need is when a grantee is unable to provide medications
consistent with Public Health Service guidelines.
[27] [hyperlink, http://www.gao.gov/products/GAO-06-646], 28.
[28] National Alliance of State and Territorial AIDS Directors and the
Henry J. Kaiser Family Foundation, National ADAP Monitoring Project
Annual Report (Washington, D.C.: 2009) 10.
[29] In addition to federal funding, ADAPs can also receive funding
from other sources such as state budgets.
[30] The Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 added a new prescription drug benefit, Part D, to the Medicare
program. Some ADAP clients were eligible for Medicare Part D benefits
and thus, ADAPs were able to reduce costs because they no longer had to
pay all the prescription drug costs for these individuals.
[31] HRSA's entire unobligated balance process includes the initial
obligation of funds, cancellation of unobligated balances, return of
amounts disbursed to grantees, and the recompetition and redistribution
of supplemental grants.
[32] The Part B supplemental grant program is a new program established
by RWTMA. It provides for grants in fiscal years in which
appropriations for Part B exceed a specified amount and serves as a
mechanism for redistributing (1) carryover funds that are not expended
by the end of the carryover year, (2) unobligated balances that
grantees do not request to carryover, and (3) funds HRSA obtains
through penalties assessed on grantees who exceed the 2 percent
threshold for unobligated balances. No funds had been distributed as of
September 14, 2009, under this program. Grant year 2009 is the first
year funds will be available through this program.
[33] Twenty-seven Part B grantees purchase drugs exclusively through a
federal drug discount program, under which they pay full price and
receive a rebate at some point in the future. Federal regulations
generally applicable to state and local government grantees require
them to disburse these rebates before requesting additional cash
payments. Thus, grantees receiving drug rebates must prioritize
spending these funds and several grantees said that this makes it more
difficult to obligate grant funds in the grant year. See GAO-09-894.
[34] According to HRSA, New York submitted an initial carryover request
for $2,491,742. HRSA approved its request for 50 percent of the
funding, which was $1,245,871. New York then submitted its final FSR
with an actual unobligated balance of $0 and requested that the
carryover funds be deobligated from the grant year 2008 account and
reobligated into the grant year 2007 account, because New York had been
able to obligate the entire $2,491,742 for CARE Act purposes.
Similarily, according to HRSA, New Jersey submitted an initial
carryover request for $911,621. HRSA approved its request for 50
percent of the funding, which was $455,810. HRSA deobligated this
amount from New Jersey's 2007 grant and reobligated these funds to New
Jersey's 2008 grant. New Jersey then submitted its final FSR with an
actual unobligated balance of $169,057 and requested that $286,574 in
carryover funds be deobligated from grant year 2008 and reobligated to
the grant year 2007, because New Jersey had been able to obligate all
but $169,057.
[35] HRSA has stated that there will still be some degree of
duplication due to error, and has estimated the total error rate will
be 8.8 percent. Duplication will occur when two different clients
receive the same identifier because of a recording error, such as a
mistake in recording a client's date of birth. An error may also occur
when a client receives two different identifiers. For example, this
might occur when a client changes his or her last name.
[36] Part C provides for grants to public and private nonprofit
entities to provide early intervention services, such as HIV testing
and ambulatory care. Part D provides for grants to public and private
nonprofit entities for family-centered comprehensive care to children,
youth, and women and their families. Part F provides for grants for
demonstration and evaluation of innovative models of HIV/AIDS care
delivery for hard-to-reach populations, training of health care
providers, and for Minority AIDS Initiative grants.
[37] A grantee or service provider can use a customized client-level
data collection system, a vendor-distributed client-level data
collection system, or HRSA's CAREWare to collect client-level data. A
customized client-level data collection system is created by a grantee
or service provider to collect client-level data. A vendor-distributed
client-level data collection system is created by a vendor. On its Web
site, HRSA maintains a list of vendors whose data systems meet HRSA's
reporting requirements or are progressing toward meeting these
requirements. CAREWare is a free, comprehensive electronic health
information system that is available to grantee and service providers
through HRSA's Web site. CAREWare generates data for RDR and is also
capable of collecting the needed client-level data for RSR.
[38] According to HRSA, the SPNS initiatives fund innovative models of
care and support for HIV/AIDS care. RWTMA authorized SPNS funding to
assist CARE Act grantees in developing their own standard electronic
client-level information data systems so that they could report their
client-level data to HRSA.
[39] HRSA also consulted with vendors to make sure that their client-
level data software was compatible with RSR.
[40] While some grantees already had client-level data collection and
reporting systems in place, HRSA officials told us that they still
needed to assist these grantees in making the systems compatible with
RSR.
[41] After the initial reporting period of January 1, 2009, through
June 30, 2009, grantees and service providers must also submit reports
for the entire 2009 calendar year. In subsequent years, grantees and
service providers will only submit reports on an annual basis. HRSA
officials said that they anticipate that grantees and service providers
will continue to report aggregate data using RDR for calendar years
2009 and 2010 to allow HRSA to monitor the CARE Act services provided
to clients while transitioning to RSR.
[42] Individuals who are enrolled in an ADAP are eligible to receive
medications through the program; however, they may not actually receive
ADAP medications. For example, this could occur if an individual was
receiving medications from another source.
[43] Because fewer drugs are covered, reducing the number of drugs on a
formulary may reduce costs.
{End of section]
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