[Senate Hearing 109-419]
[From the U.S. Government Publishing Office]
S. Hrg. 109-419
ADDRESSING DISPARITIES IN THE FEDERAL
HIV/AIDS CARE PROGRAMS
=======================================================================
HEARING
before the
FEDERAL FINANCIAL MANAGEMENT, GOVERNMENT
INFORMATION, AND INTERNATIONAL
SECURITY SUBCOMMITTEE
of the
COMMITTEE ON
HOMELAND SECURITY AND
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
----------
JUNE 23, 2005
----------
Printed for the use of the Committee on Homeland Security
and Governmental Affairs
ADDRESSING DISPARITIES IN THE FEDERAL HIV/AIDS CARE PROGRAMS
S. Hrg. 109-419
ADDRESSING DISPARITIES IN THE FEDERAL
HIV/AIDS CARE PROGRAMS
=======================================================================
HEARING
before the
FEDERAL FINANCIAL MANAGEMENT, GOVERNMENT
INFORMATION, AND INTERNATIONAL
SECURITY SUBCOMMITTEE
of the
COMMITTEE ON
HOMELAND SECURITY AND
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
__________
JUNE 23, 2005
__________
Printed for the use of the Committee on Homeland Security
and Governmental Affairs
U.S. GOVERNMENT PRINTING OFFICE
22-197 WASHINGTON : 2006
_____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800
Fax: (202) 512�092250 Mail: Stop SSOP, Washington, DC 20402�090001
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
SUSAN M. COLLINS, Maine, Chairman
TED STEVENS, Alaska JOSEPH I. LIEBERMAN, Connecticut
GEORGE V. VOINOVICH, Ohio CARL LEVIN, Michigan
NORM COLEMAN, Minnesota DANIEL K. AKAKA, Hawaii
TOM COBURN, Oklahoma THOMAS R. CARPER, Delaware
LINCOLN D. CHAFEE, Rhode Island MARK DAYTON, Minnesota
ROBERT F. BENNETT, Utah FRANK LAUTENBERG, New Jersey
PETE V. DOMENICI, New Mexico MARK PRYOR, Arkansas
JOHN W. WARNER, Virginia
Michael D. Bopp, Staff Director and Chief Counsel
Joyce A. Rechtschaffen, Minority Staff Director and Chief Counsel
Trina D. Tyrer, Chief Clerk
FEDERAL FINANCIAL MANAGEMENT, GOVERNMENT INFORMATION, AND INTERNATIONAL
SECURITY SUBCOMMITTEE
TOM COBURN, Oklahoma, Chairman
TED STEVENS, Alaska THOMAS CARPER, Delaware
GEORGE V. VOINOVICH, Ohio CARL LEVIN, Michigan
LINCOLN D. CHAFEE, Rhode Island DANIEL K. AKAKA, Hawaii
ROBERT F. BENNETT, Utah MARK DAYTON, Minnesota
PETE V. DOMENICI, New Mexico FRANK LAUTENBERG, New Jersey
JOHN W. WARNER, Virginia MARK PRYOR, Arkansas
Katy French, Staff Director
Sheila Murphy, Minority Staff Director
John Kilvington, Minority Deputy Staff Director
Liz Scranton, Chief Clerk
C O N T E N T S
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Opening statements:
Page
Senator Coburn............................................... 1
Senator Lautenberg........................................... 3
Senator Carper............................................... 18
Prepared statement:
Senator Akaka................................................ 31
WITNESSES
Thursday, June 23, 2005
Robert S. Janssen, M.D., Director, Divisions of HIV/AIDS
Prevention, National Center for HIV, STD and TB Prevention,
Coordinating Center for Infectious Diseases, Centers for
Disease Control and Prevention, U.S. Department of Health and
Human Services................................................. 5
Deborah Parham Hopson, Ph.D., Associate Administrator, HIV/AIDS
Bureau, Health Resources and Services Administration, U.S.
Department of Health and Human Services........................ 8
Michael Montgomery, Chief, Office of AIDS, California Department
of Health Services, and Chair, National Alliance of State and
Territorial AIDS Directors..................................... 11
Marcia G. Crosse, Ph.D., Director, Health Care, U.S. Government
Accountability Office.......................................... 15
Alphabetical List of Witnesses
Crosse, Marcia G., Ph.D.:
Testimony.................................................... 15
Prepared statement........................................... 59
Hopson, Deborah Parham, Ph.D.:
Testimony.................................................... 8
Prepared statement........................................... 43
Janssen, Robert S., M.D.:
Testimony.................................................... 5
Prepared statement........................................... 32
Montgomery, Michael:
Testimony.................................................... 11
Prepared statement........................................... 49
APPENDIX
Letter sent to Mr. Walker, dated June 23, 2005................... 106
Chart entitled ``$300 Billion in Revenue, $300 Million in Federal
Research Funding,'' submitted by Senator Coburn................ 108
Chart entitled ``EMA Funding Amounts per AIDS Case, fiscal year
2004,'' submitted by Senator Coburn............................ 109
Hearing Background Materials submitted by Senator Coburn:
(1) Ryan White CARE Act Background......................... 111
(2) HIV/AIDS Statistics.................................... 133
(3) Federal HIV/AIDS Spending.............................. 139
(4) HIV Reporting.......................................... 164
(5) AIDS Drug Assistance Programs.......................... 290
(6) Advancing HIV Prevention............................... 313
(7) Baby AIDS.............................................. 339
(8) Rapid HIV Tests........................................ 380
(9) Hold Harmless.......................................... 420
(10) Submitted Testimony.................................... 430
Questions and responses for the Record from:
Dr. Janssen.................................................. 443
Ms. Hopson................................................... 455
Mr. Montgomery............................................... 458
Ms. Crosse................................................... 464
ADDRESSING DISPARITIES IN THE FEDERAL HIV/AIDS CARE PROGRAMS
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THURSDAY, JUNE 23, 2005
U.S. Senate,
Subcommittee on Federal Financial Management,
Government Information, and International Security,
of the Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:33 p.m., in
room SD-562, Dirksen Senate Office Building, Hon. Tom Coburn,
Chairman of the Subcommittee, presiding.
Present: Senators Coburn, Carper, and Lautenberg.
OPENING STATEMENT OF SENATOR COBURN
Senator Coburn. The hearing will come to order. Senator
Carper is on his way I understand. So we do not delay our
panelists and those testifying, we will start.
Today's hearing will examine the financial status of the
Ryan White CARE Act, the Nation's largest provider of AIDS-
specific services, which Congress is expected to reauthorize
later this year.
I had the privilege of authoring the 2000 reauthorization
of this important law and, as a practicing physician, I have
cared for numerous patients with HIV who relied upon the CARE
Act for their medical needs.
Twenty years ago, I delivered a baby girl who would become
the first child I ever delivered to die from AIDS. I discovered
she was infected with HIV after I diagnosed her mother with
full-blown AIDS and a full-blown pneumocystis infection. The
mother died 2\1/2\ weeks after we learned she had the disease.
Her daughter struggled through 7 years of treatment before she
succumbed to the same fate as her mother.
Back then, much was still not known about HIV and AIDS. Few
medical therapies were available to treat the disease. The
epidemic was believed to be almost entirely centered in a few
metropolitan areas and among very specific groups of high-risk
individuals. Even within the public health community, fear and
lack of knowledge about this new disease left many of those
living with the virus unable to access the care that did exist
and fear of stigmatization kept many others from even seeking
testing or treatment.
Today, HIV affects every State in our Nation, and the virus
does not discriminate against any particular race, gender, age
or sexual behavior. Medical breakthroughs, however, have
dramatically transformed HIV infection for many into a chronic,
manageable disease and, thereby, have delayed the onset of
AIDS.
In 1990, Congress passed the Ryan White CARE Act to provide
for the unmet health needs of persons living with HIV disease.
The CARE Act was named after Ryan White, an Indiana teenager
whose courageous struggle with HIV/AIDS and against AIDS-
related discrimination, helped educate our Nation.
While the face of AIDS has changed, our Federal response
has been slow to adapt to those changes. Funding for the CARE
Act has increased dramatically from $257 million in 1991 to
over $2 billion in 2005. Yet thousands of Americans with HIV
are on waiting lists for access to life-saving AIDS
medications, and many others face formulary restrictions. And
while patients in Kentucky and West Virginia have died while on
waiting lists for treatment provided by the AIDS Drug
Assistance Program, one of the metropolitan areas is actually
receiving CARE Act funds for the deceased.
Furthermore, tens of millions of CARE Act dollars go
unspent annually in some jurisdictions, while other States find
themselves faced with cutting patients' access to life-saving
AIDS drugs. These disparities have been created by a number of
factors. First, the CARE Act continues to distribute Federal
funds based not upon the number of people with HIV but rather
AIDS, the end stage of HIV infection. It often takes up to 10
years for AIDS to develop after HIV infection, and now, thanks
to new innovations, even later.
Because AIDS cases comprise only a fraction of the total
population of those living with HIV, this misplaced emphasis as
a basis for the CARE Act funding ignores the vast majority of
those with HIV. These affected communities are being ignored
and not receiving a fair share of Federal support.
Studies have shown that those with HIV but not AIDS are
much more likely to be women, African-American, Hispanic, and
those who live in rural areas.
Incorporating HIV data into funding formulas and prevention
strategies will ensure we stay in front of the disease, and
that resources are directed towards where the disease is headed
rather than where it was a decade ago.
In 2000, Congress sought to eliminate these disparities and
treat all people with HIV/AIDS equally under the CARE Act--by
incorporating all those living with HIV, rather than just those
diagnosed with AIDS, in funding formulas. The law requires that
beginning no later than fiscal year 2007, cases of HIV disease
reported to and confirmed by the Director of the Center of
Disease Control and Prevention as sufficiently accurate and
reliable will be the basis for CARE Act funding priorities and
formulas.
Funding disparities have also been created by a ``hold-
harmless'' provision in Title I of the CARE Act. This hold-
harmless provision was intended to ensure that no eligible
metropolitan area (EMA) suffered from dramatic funding
decreases from one year to the next. While well intentioned,
this hold-harmless provision has ironically caused harm in many
areas, and all but one of the 51 EMAs would fare better if the
hold-harmless provision was eliminated altogether.
Last year, the San Francisco EMA received 92 percent of all
hold-harmless funding. As a result, San Francisco receives
twice the amount per AIDS case as every other EMA, and actually
received funding for AIDS patients that have long since passed
away. The city finds itself in a unique position where it must
find ways to spend excess money on nonessential services while
its reported AIDS cases continue to drop.
In sharp contrast, the largest AIDS service provider in the
country in Washington, DC, the D.C. EMA, is faced with dire
financial problems that have forced the closing of several
offices, and massive staff layoffs, despite a growing
population affected by HIV/AIDS.
In addition, some States benefit from ``double
countings''--when AIDS cases are actually counted twice, once
for funding under Title I and again under Title II. States that
receive Title I funding receive 38 percent more per AIDS case
than States without an EMA.
Beyond simply addressing the formulas to ensure funding
equity, services provided by the CARE Act must also be updated.
When it became law 15 years ago, few medical therapies existed
and the CARE Act primarily provided social services and end-of-
life care for those with HIV/AIDS. What wonderful progress we
have made.
Since that time, medical breakthroughs have contributed to
a great transformation in the lives of those with HIV. AIDS
deaths have dropped significantly and, for many, HIV has become
a chronic rather than a terminal disease.
As a result, more Americans are living with HIV than ever
before, and the cost of life-saving drugs is considerable. A
drug combination including Fuzeon, for example, can cost
between $30,000 and $35,000 a year to treat a single patient.
This incredible cost to provide essential treatment underscores
the need to prioritize core medical services and effective
prevention. Let me say that again, prioritize core medical
services and effective prevention.
The U.S. Federal Government is expected to spend nearly $20
billion on HIV/AIDS related programs this year alone, and we as
a Nation have committed ourselves to provide billions of
dollars worth of medication and care services to those living
with HIV in Africa and elsewhere.
Clearly, there is no acceptable reason why with such a
large financial investment any American living with HIV can not
access medically necessary care.
I look forward to hearing from our witnesses today, who
include Dr. Marcia Crosse, Director of the Government
Accountability Office's Public Health and Military Health Care
Issues; Dr. Deborah Hopson, Associate Administrator of the
Health Resources and Services Administration's HIV/AIDS Bureau;
Dr. Robert Janssen, Director of the Division of HIV/AIDS
Prevention of the National Center for HIV, STD, and TB
Prevention at the Centers for Disease Control and Prevention;
and Dr. Michael Montgomery, Chief of the Office of AIDS for the
California Department of Health Services.
Senator Lautenberg.
OPENING STATEMENT OF SENATOR LAUTENBERG
Senator Lautenberg. Thanks, Mr. Chairman. I note with
respect your background and your interest and your view on
things, but I do appreciate your calling this hearing and
giving us an opportunity to examine the implementation of the
Ryan White CARE Act.
I was proud to be an original cosponsor of this legislation
when it was first enacted by Congress in 1990. And as most
know, it was named after Ryan White, a young Indiana person
whose brave struggle against AIDS-related discrimination helped
to educate our Nation.
The good news is--and we heard it from Senator Coburn--is
that in the years since this legislation was passed, we have
seen dramatic breakthroughs and treatments, and today a
diagnosis of AIDS is no longer a death sentence. The bad news
is that it is still a very serious problem, and it continues to
spread.
More than 30,000 people in my home State of New Jersey are
living with HIV or AIDS. The number increased 3.5 percent over
a 6-month period last year. Of those 30,000 New Jerseyians with
HIV and AIDS, more than one-third are women. New Jersey ranks
first in the percentage of women diagnosed with AIDS within the
United States and third in the number of pediatric AIDS cases.
I once visited a ward in Jersey City where pediatric AIDS
victims were housed, and it was a tragic sight to witness.
Today, Ryan White CARE reaches more than half a million
Americans every year, and it is our Nation's largest program
specifically targeted to help people living with HIV disease.
The CARE Act was amended and reauthorized in 1996 and once
again in 2000. It is due for another reauthorization by
September 30 of this year.
When the CARE Act was authorized by the Senate in 1990 no
funds were appropriated in the original Labor HHS budget that
year. I worked hard, along with Senator Byrd from West
Virginia, to find funding for the original CARE Act. I also
worked to ensure that smaller cities which had high per capita
rates of AIDS were included in the Title I funding formula. By
way of example, I worked to include Jersey City as one of the
special targeted recipients of aid along with the Newark
metropolitan area. Overall, New Jersey has six areas that are
eligible to receive funds under Title I of the CARE Act.
I hope this Subcommittee will support the reauthorization
of this important program. I also urge my colleagues to oppose
any effort to shift funding from areas with the high
concentrations of HIV and AIDS cases.
Mr. Chairman, I believe that while the costs have, I think,
been effectively put to good use, I think that you have to have
some kind of a structure to get things to the patients and the
people who ought to be cautious about the fact that AIDS are
transmittable and have a violent outcome.
I thank you very much, and look forward to hearing from our
witnesses.
Senator Coburn. I am going to ask the witnesses to limit
their testimony to 10 minutes, and I am also going to make a
comment about availability of your testimony. This is directed
toward the Administration and not the individuals sitting here,
because I know the vetting process under which your testimony
goes.
Three hours before this Subcommittee hearing we received
testimony. That is totally unacceptable for us to discuss a
subject as serious as this, and the Administration proves
itself incapable or incompetent to bring forth testimony on a
hearing that they have been aware of for 2 weeks. So I would
hope that you would take that message back so that in fact we
can do the job. Without timely availability of testimony, which
I understand neither Dr. Janssen or Dr. Hopson, is your fault,
it is difficult. The fact is that timeliness and availability
of testimony allows us to do a better job here, and ultimately
fund this program better.
I want to recognize Dr. Robert Janssen, Director of HIV/
AIDS Prevention, National Center for Infectious Disease to go
first, and Dr. Hopson, Associate Administrator for HIV Health
Resources and Services Administration in Department of Health
and Human Services to go second, and Dr. Michael Montgomery,
Chief of Office of AIDS, Department of Health and Human
Services, Sacramento, California, followed by Dr. Crosse,
Director, Public Health and Military Health Care Issues.
Dr. Janssen.
TESTIMONY OF ROBERT S. JANSSEN, M.D.,\1\ DIRECTOR, DIVISIONS OF
HIV/AIDS PREVENTION, NATIONAL CENTER FOR HIV, STD, AND TB
PREVENTION, COORDINATING CENTER FOR INFECTIOUS DISEASES,
CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Dr. Janssen. Thank you, Mr. Chairman. Thank you, Senator
Lautenberg. Thank you for the opportunity to discuss trends in
HIV and AIDS in the United States and the status of HIV
surveillance systems.
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\1\ The prepared statement of Dr. Janssen appears in the Appendix
on page 32.
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At the National HIV/AIDS Prevention Conference held in
Atlanta last week, CDC announced that there are now an
estimated 1,039,000 to 1,185,000 Americans living with HIV or
AIDS. This is an increase from the 850,000 to 950,000 reported
5 years ago.
Due to more effective treatment, people are living longer
and healthier lives after a diagnosis of HIV. Despite the
growing pool of persons capable of transmitting the virus, we
estimate that the number of persons becoming newly infected
last year has remained constant over the last 10 years, at
approximately 40,000 new infections per year, as you can see in
this figure.
CDC's analysis of trends in HIV diagnoses includes all new
HIV diagnoses with or without an AIDS diagnosis in the 32
States that have conducted confidential name-based HIV/AIDS
case reporting for at least 4 years. Between 2000 and 2003,
125,800 people were diagnosed with HIV infection in these 32
States. During 2000-2003, the overall rate of HIV diagnoses,
that is, the number of diagnoses per 100,000 people, remained
stable. It was 19.5 in 2000, and 19.7 in 2003. However, sharp
racial disparities continue to exist. Rates of HIV diagnoses
among African-Americans are significantly higher than among
other racial and ethnic groups.
Looking at trends by risk, the annual diagnoses among men
who have sex with men, or MSM, increased 11 percent during this
4-year period. MSM accounted for 44 percent of HIV cases in
this time period.
The annual number of diagnoses associated with high-risk
heterosexual contact remained roughly stable from 2000 to 2003,
while new diagnoses associated with injection drug use declined
slightly.
In 2003, the highest rate of HIV diagnosis was among
African-American males, 103 per 100,000 population. That is a
rate that is nearly three times the rate among Hispanic males
and seven times the rate among white males. The rate of HIV
diagnoses among African-American females in 2003 was 53 cases
per 100,000. That is almost five times higher than among
Hispanic females, and more than 18 times higher than among
white females. Among American Indians/Alaska Natives, the rate
of HIV diagnosis among males was slightly higher than the rate
of white males, and the rate among females was twice that among
white females. The lowest rates by gender are among Asian/
Pacific Islander males and females.
AIDS cases and deaths reported from all U.S. States and
territories continue to provide a valuable measure of the
impact of the disease. Data on the number of new AIDS cases
provide us with measures of late-state disease, but are not
reflective of the entire HIV epidemic. HIV progresses to AIDS
in an untreated person in approximately 8 to 10 years, and even
longer for persons receiving treatment. The number of persons
diagnosed with and dying of AIDS after the introduction of
highly active antiretroviral therapy dropped dramatically until
1998, and since then has remained relatively constant.
African-Americans continue to be most severely affected by
AIDS. In 2003, rates of AIDS cases were highest among African-
Americans, next highest among Hispanics, then American Indian/
Alaska Natives, then whites, and lowest among Asian/Pacific
Islanders.
From the end of 1999 through the end of 2003, the number of
persons in the United States living with AIDS increased 30
percent, from a little over 311,000 to nearly 406,000.
CDC is responsible for ensuring the integrity of the
national HIV/AIDS surveillance system to accurately monitor the
epidemic in the United States. CDC also provides funding and
technical assistance and coordinates activities with States to
aggregate data that comprises this national system. As with
other diseases, individual State governments have statutory and
regulatory authority for HIV/AIDS reporting and data
protection, including the decision as to what methods will be
used for disease reporting, such as name-based or code-based.
Except for HIV, all other reported infectious diseases,
including AIDS, are routinely reported to States using name-
based reporting systems. States then remove names before
submitting the data to CDC.
Since the beginning of the epidemic, AIDS surveillance has
been the cornerstone of national, State, and local efforts to
monitor the scope and impact of the HIV epidemic. AIDS
surveillance data, however, no longer accurately describe the
full extent of the epidemic, as effective therapies slow the
progression of HIV disease. To more accurately describe the
epidemic, in 1999 CDC recommended that all States implement
reporting of HIV diagnoses and advised that cases be reported
to local and State health departments by name.
To reach the goal of nationwide high-quality HIV data, as
of today, CDC is now moving from advising to recommending
jurisdictions use name-based HIV reporting, using the same
name-based approach currently used for AIDS surveillance
nationwide. Currently, 38 States and five territories have
adopted name-based HIV reporting, seven States, the City of
Philadelphia, and the District of Columbia have code-based
reporting, in which a code is reported to the health
department. Five States have name-to-code reporting, in which a
name is reported to the health department and the health
department creates a code.
There are 14 areas that use codes, and in those areas 13
different codes are used. Because all States do not use a
uniform name-based approach to HIV reporting, there are
limitations to the current national HIV reporting database.
These limitations include national data on HIV diagnoses are
not representative of some high morbidity areas, for example,
California, whose data are not included.
Despite a growing number of States with quality systems,
the staggered implementation of HIV reporting means HIV data at
the national level are currently less accurate than AIDS data
at the national level.
In 1999, CDC published a set of performance standards for
HIV reporting systems. CDC reports HIV infection data only from
areas conducting confidential name-based reporting because this
reporting has been shown to routinely achieve high levels of
accuracy and reliability. Confidential name-based surveillance
systems have been shown to best meet the necessary performance
standards. Studies have also shown that implementing code-based
and name-to-code systems are more expensive to implement than
confidential name-based systems. Currently, only confidential
name-based HIV reporting integrated with AIDS surveillance data
can be used by States to identify and remove cases that are
counted in more than one State--a process we call de-
duplication--before they can be incorporated into CDC's
national surveillance database.
The last Ryan White CARE Act reauthorization called for an
Institute of Medicine study of States' HIV surveillance systems
and their adequacy and reliability for the purpose of using
such data as the basis for CARE Act formula grant allocation.
The reauthorization also called for the Secretary of the
Department of Health and Human Services to make a determination
regarding use of HIV data for CARE Act formulas.
The Institute of Medicine issued a report, ``Measuring What
Matters,'' on allocation, planning and quality assessment for
the CARE Act. Based on the report findings in June 2004, the
Secretary determined that HIV data not be used for purposes of
making formula grants under Titles I and II of the Ryan White
CARE Act and that estimated living AIDS cases continue to be
utilized until such time as high-quality HIV data are available
nationwide.
We continue to work closely with the States to help them
adopt and implement high-quality HIV surveillance systems.
Having all States collect HIV information in the same manner
will ensure the Nation has reliable and valid data to monitor
and describe the scope of the epidemic, to assure equitable
distribution of resources to those with greatest need, and to
plan for and evaluate prevention, care and treatment programs.
A uniform system is needed for measuring HIV incidence. It is
also needed for evaluating HIV and AIDS care in the United
States.
We have recently launched the Morbidity Monitoring Project,
that is a study which, when fully, funded will allow nationwide
estimates of the quality of HIV and AIDS care, also reasons why
people are not receiving care and information on sexual and
drug use risk behavior.
Again, I want to thank you, Mr. Chairman, and the
Committee, for this opportunity to talk about HIV and AIDS
trends in the United States and HIV surveillance systems.
Thank you.
Senator Coburn. Dr. Hopson.
TESTIMONY OF DEBORAH PARHAM HOPSON, Ph.D.,\1\ ASSOCIATE
ADMINISTRATOR, HIV/AIDS BUREAU, HEALTH RESOURCES AND SERVICES
ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Ms. Hopson. Good afternoon. Mr. Chairman, Members of the
Subcommittee, thank you for the opportunity to meet with you
today on behalf of the Health Resources and Services
Administration to discuss the programs of the Ryan White
Comprehensive AIDS Resources Emergency Act, also known as the
CARE Act.
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\1\ The prepared statement of Ms. Hopson appears in the Appendix on
page 43.
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We certainly appreciate, Dr. Coburn, your continuing
support that you and your colleagues have for the CARE Act
programs. Your interest in the CARE Act services is certainly
welcome, given the state of today's epidemic as just described
by the CDC.
The Ryan White CARE Act is the centerpiece of our domestic
response to care and treatment needs of low-income people
living with HIV and AIDS. Currently funded at $2.1 billion, it
provides primary health care, life saving medications and
support services to individuals who lack health insurance and
financial resources to provide for themselves. On two
occasions, including his most recent State of the Union
Address, President Bush has addressed the importance of this
program and has called for the timely reauthorization of the
Ryan White CARE Act.
Since its last reauthorization we have been able to provide
antiretroviral treatment, primary care and support services to
over half a million people annually in the United States,
Puerto Rico, the Virgin Islands and Pacific Basin. Fifty
percent of these individuals live below the Federal poverty
level, less than 10 percent had any private health insurance,
and less than 30 percent were enrolled in Medicaid. In 2003
over half of the Ryan White clients were African-American. The
Ryan White CARE Act programs have provided important benefits
to these populations. Overall, AIDS mortality is down, and
lives have been extended with HIV/AIDS medications purchased
through the AIDS Drug Assistance Program, also known as ADAP.
Pregnant women have been provided with care that has allowed
them to give birth to children free from HIV infection, and
thousands have received support services that have allowed them
to access and remain in health care.
Although we are making progress in providing services to
people living with HIV and AIDS, the epidemic is not over and
will be in need of our continuing attention for some time to
come. The President and the Secretary understand the dynamics
and severity of the epidemic, and they are committed to
ensuring the Department's HIV/AIDS programs are as effective as
possible in preventing infection and treating those who become
infected.
During the past 5 years we have recognized that as
essential as the CARE Act has been to serve Americans living
with HIV and AIDS, it is an imperfect instrument in need of
revitalization. Despite record levels of funding, we continue
to face waiting lists for life saving drugs through the ADAP,
and there are marked disparities in access to quality medical
treatment across the country. As minority populations are
increasingly and disproportionately impacted by HIV/AIDS,
changes to existing systems of care designed for an earlier
epidemic are increasingly urgent. We are challenged as never
before to make sure that Federal funds are directed where they
are most needed and used for the most vital purposes.
President Bush has laid out three principles for the
reauthorization of the CARE Act: First, that we should focus
Federal resources on life-extending medical care such as
antiretroviral drugs, doctor visits, and lab tests, core
services that are critical to maintain the health and well-
being of people living with HIV and AIDS; second, that we
provide greater flexibility so that CARE Act resources can be
targeted to areas of greatest need; and third, that we ensure
accountability in all that we do.
Based on the new CDC data, it is estimated, as Dr. Janssen
has just said, that there are between 1 million and 1.2 million
people living with HIV disease in the United States.
Approximately 40,000 new HIV infections and over 18,000 AIDS
related deaths occur per year. Of those living with HIV
disease, 74 percent are male, 47 percent are African-Americans,
while 34 percent are white and 17 percent are Hispanic.
In addition to challenges related to poverty and lack of
adequate health insurance, individuals living with HIV disease
commonly face other problems. About 22 percent of those with
HIV/AIDS were infected through injection drug use. An estimated
20 to 50 percent of people living with HIV/AIDS suffer from
mental illness, both related and unrelated to their infection,
and co-infection with hepatitis B and C is an increasing
problem.
As I stated earlier, each year the CARE Act programs,
primarily through grants to States, metropolitan areas,
providers and educators, reach more than half a million
underserved persons, more than half of those living with HIV/
AIDS in the United States. Since AIDS was first recognized the
pattern and treatment of HIV disease has shifted. Now we can
strive to manage HIV/AIDS as a chronic disease.
More than 2,700 providers funded by the CARE Act programs
are providing primary care and treatment, and are building
networks with other public and private providers to respond the
response to the epidemic. Innovative outreach programs and
community based points of entry, such as public health, faith-
based, social service and substance abuse treatment
organizations help to extend CARE Act services to hard-to-reach
and at-risk populations.
Since the initiation of the CARE Act programs in 1990,
perinatal transmission of HIV has declined dramatically. Less
than 2 percent of all CARE Act HIV positive clients are
children under 12 or younger, due in large part to the advances
in prevention of perinatal transmission. The CDC reports that
in 25 States with long-standing confidential name-based HIV
reporting, cases of HIV/AIDS and infants born to HIV-infected
mothers declined 74 percent over the 10-year period from 1994
until 2003.
Access to antiretroviral therapy for the CARE Act
population has been expanded through the cost saving mechanisms
being used by individual State ADAPs and other discount
programs. Antiretroviral therapy has led to longer, healthier
lives for individuals living with HIV and AIDS. As a result,
almost one-third of the CARE Act population is age 45 or older.
ADAP, which provides funds to States to purchase life
saving medications, is the single largest CARE Act program
because of the high cost of medication and the growing number
of people living with HIV and AIDS. In fiscal year 2005, HRSA
distributed $787.5 million in ADAP funds to States, and the
fiscal year 2006 President's Budget request includes a $10
million increase for ADAP. The ADAP program reaches
approximately 90,000 people every month. This program is State-
defined and thus differs in eligibility criteria and
formularies from State to State.
The epidemiology and treatment of HIV has shifted in recent
years to a more chronic disease model requiring a changing
continuum of services to support this model. This shift and the
success of new treatment has resulted in longer life spans and
an overall increase in the demand for care and related
treatments.
Going forward, the greatest challenge is reaching people
who have nowhere else to turn, especially as HIV/AIDS
prevalence, health care costs and the burden of HIV among
uninsured and underinsured increases. Resources are likely to
become more and more strained as the CARE Act's outreach
efforts, coupled with CDC's prevention initiatives continue to
successfully identify individuals living with HIV disease.
These newly infected individuals are more likely to be low
income, to be minority and to have complex co-morbidities, as I
mentioned before. Many will live in rural areas. Strengthening
health care and community organizations capable of serving
these populations will be an increasingly important role in the
CARE Act's next decade.
Mechanisms to allocate funds must be cognizant of these
changes: ``hold-harmless'' provisions, formulas based on AIDS
rather than HIV, and allowing funds that have not been put to
work in a timely manner to roll over or revert to the Treasury
rather than giving DHHS the necessary flexibility and authority
to reprogram resources to communities in need, must be re-
engineered.
We take great pride in the advances in care and support for
people living with HIV/AIDS that have been made by the CARE Act
program over these last 15 years. We are thankful to you for
your help and that of the dedicated providers and communities
all over the country. However, we are humbled by the
significant challenges that remain to reach people living with
HIV/AIDS who have nowhere else to go for care in an age of
increasing HIV/AIDS prevalence, increasing health care costs,
and a growing burden of HIV among the uninsured and
underinsured.
We will soon be releasing an expanded set of policy points
based upon the President's principles. We intend these to serve
as guideposts for discussion and deliberation on the very tough
issues we must face together: how we ensure that the most
vulnerable and needy in this country receive life saving
treatment, how to work more effectively with State and local
governments and communities impacted by HIV, how to hold
ourselves and our partners more accountable for the use of
Federal tax dollars, and importantly, how to advance HIV
prevention in this Nation.
We look forward to working with you to revitalize the CARE
Act.
Thank you.
Senator Coburn. Thank you, Dr. Hopson. Mr. Montgomery.
TESTIMONY OF MICHAEL MONTGOMERY,\1\ CHIEF, OFFICE OF AIDS,
CALIFORNIA DEPARTMENT OF HEALTH SERVICES, AND CHAIR, NATIONAL
ALLIANCE OF STATE AND TERRITORIAL AIDS DIRECTORS
Mr. Montgomery. Good afternoon, Mr. Chairman and
distinguished Members of the Subcommittee. My name is Michael
Montgomery, Chief of the Office of AIDS for the California
Department of Health Services. I am also the Chair of the
National Alliance of State and Territorial AIDS Directors, or
NASTAD. I want to thank you for inviting me to speak with you
today to discuss the importance of the Ryan White CARE Act in
helping States provide comprehensive care and treatment
services to persons living with HIV and AIDS.
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\1\ The prepared statement of Mr. Montgomery appears in the
Appendix on page 49.
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State AIDS Directors appreciate the long-standing support
of the U.S. Senate for the Ryan White CARE Act programs.
Assuring that all people with HIV and AIDS, regardless of
geographic location, have equal access to appropriate and high
quality HIV and AIDS services is our highest priority.
I would like to share with you some of the views of my
fellow State AIDS Directors in addition to those in the State
of California. I have limited my comments to those that address
disparities in the CARE Act or are issues covered in the
ongoing GAO investigation.
California's Office of AIDS administers California's HIV/
AIDS prevention and care programs which are funded by Federal
and State funds, including CARE Act Title II funds. HIV
infections have penetrated nearly every metropolitan and rural
community in our State. California remains an epicenter of the
AIDS epidemic with 137,213 cumulative cases, and 57,308
individuals living with AIDS as of May 31, 2005. Today
California has 37,531 reported HIV, non-AIDS cases.
In Federal fiscal year 2005, California received $221
million in Ryan White funding for Titles I and II, including
$31 million for the Title II base, $90 million for ADAP, and
$169,000 for our single emerging community, Bakersfield.
California has nine Title I eligible metropolitan areas that
are funded at $99 million. Governor Schwarzenegger and the
California legislature have demonstrated their commitment to
HIV/AIDS care and treatment by providing $111 million in the
State General Fund in spite of California's continuing budget
deficit.
For people with HIV the CARE Act is the safety net under
other public programs such as Medicaid and Medicare. The Ryan
White programs must adapt to fill the gaps particular to each
State. ADAPs work closely with their State Medicaid programs to
ensure that ADAPs remain the payer of last resort. In
particular, State ADAPs will be working to fill gaps in
coverage for those enrolled in the new Medicare prescription
drug plans, and those who have incomes over 150 percent of the
Federal poverty level. As the payer mixes and cost of delivery
of care vary across the country, it makes the exercise of
comparing CARE Act programs from one State to another
exceedingly challenging.
Annually ADAPs serve approximately 136,000 clients or about
30 percent of the people with HIV and AIDS estimated to be
receiving care nationally.
In conjunction with my colleagues from New York, I helped
establish NASTAD's ADAP Crisis Task Force to negotiate with the
pharmaceutical industry on behalf of all ADAPs. Although the
larger States have the bargaining power, we feel it is critical
that all ADAPs, large and small, have access to the same prices
and discounts. The task force began negotiations in March 2003
with eight manufacturers of AIDS drugs. As a result of this
highly successful public/private partnership, we received
supplemental discounts, rebates and price freezes that achieved
an estimated $90 million in savings during fiscal year 2004.
ADAPs receive the lowest available prices in the country for
antiretroviral therapies.
Understanding that there are disparities between States and
what they are able to offer in terms of the level of services,
State AIDS Directors recommend keeping the Title II base
formula as is. Equity among the States cannot be achieved
simply by rearranging the $334 million in the Title II base,
and the problem in geographic disparities cannot be solved on
the back of Title II alone. The entire CARE Act must have
responsibility to achieve equity for persons living with HIV
and AIDS.
When looking at per AIDS case funding disparities from
State to State, one needs to take into consideration Title III,
Title IV and part F in addition to Title I and II. In the
reauthorization of the CARE Act in 2000 language was included
which directed HRSA to prioritize Title III funding and non-
Title I areas. This has been notably successful in moving
toward geographic equity in funding, and any analysis of per
AIDS expenditures while looking at Titles I and II alone
distorts the equation.
Disparities in the availability of resources affect the
accessibility and equality of HIV services both within and
between States. State AIDS Directors recognize that the multi-
Title structure of the Ryan White CARE Act contributes to the
challenges faced by some States in effectively addressing the
needs of persons living with HIV and AIDS. In many States the
current structure is a contributing factor to funding
disparities that affects availability, accessibility and
quality of services both within and between States, as well as
the coordination of HIV care and efficient delivery of
essential services.
While the Ryan White CARE Act cannot be viewed as the sole
mechanism for equalizing these inherent differences, the
current structure of the CARE Act leaves many States struggling
with the delivery and coordination of HIV services while trying
to meet the legislative mandates to provide for the public
health of its citizens.
In recommending retaining the current structure of the CARE
Act, State AIDS Directors do so while establishing the
following two goals which are reflective of our vision for
improved HIV care services in the Nation.
1. To enhance the availability of ADAP resources and
services for persons living with HIV and AIDS in need in all
areas of the Nation; and
2. To provide additional resources to States with
chronically insufficient Title II base funds by strengthening
the emerging communities' mechanism.
Time does not permit for me to describe the details of
these proposals which are outlined in my submitted testimony,
and NASTAD's recommendations to guide the 2005 Reauthorization
of the Ryan White CARE Act.
State AIDS Directors believe the current Emerging
Communities provision should be modified to address the needs
of States with a severe lack of Title II base resources that
fund critical primary care and support services. Authorized in
2000 the Title II Emerging Communities Supplemental Grant
sought to address the challenges faced by areas with a
significant burden of AIDS cases, but that lack the density of
cases to be a Title I EMA.
Since its creation, emerging communities have been subject
to significant funding fluctuations due in large part to
emerging communities not permanently being eligible once they
begin receiving funds. The number of areas eligible for these
supplemental grants has continued to diminish over the 5-year
reauthorization period because of reductions in the number of
AIDS cases. In the past 4 years, 14 emerging communities have
been eliminated altogether.
We strongly support incorporation of HIV data in CARE Act
distribution formulas. We believe the use of HIV cases in
addition to AIDS cases in CARE Act allocation formulas is
preferable and more closely reflects the epidemic than living
AIDS cases.
Forty-three jurisdictions have name-based HIV reporting,
with the remaining 13 jurisdictions utilizing a name or a name-
to-code system for reporting HIV cases. Several jurisdictions
have only recently implemented HIV reporting, both code and
name-based, and therefore their HIV data is not yet considered
mature enough to use in funding formulas.
To incorporate HIV data in fiscal year 2007, CDC will need
to develop a methodology to estimate HIV cases for these
States. State AIDS Directors urge that the CDC be required to
work with the States when developing this methodology.
California is the only State among the five largest that
uses an HIV reporting system different than its AIDS reporting
system. The Schwarzenegger administration is concerned that by
not converting to a names-based HIV reporting system,
California risks losing its fair share of CARE Act funds when
the funding formula changes. While legislative attempts were
unsuccessful this year to change from a code to name-based
reporting, a spirited dialogue in California continues.
Having said that, State AIDS Directors unanimously agree
that our Federal funds should not be withheld in order to force
States to switch reporting systems. We believe surveillance is
within the domain of the States. The States should determine
what methodology best serves the needs of their citizens.
State AIDS Directors unanimously agree that expiring
unexpended funds must be put back into the CARE Act rather than
return to the Treasury as is currently the case. Our ADAP
proposal would redistribute unobligated and expiring funds from
all titles back into the ADAP program. Unspent funds typically
result from delays in notice of grant awards from the Federal
Government, from timing issues related to subcontracting of
services, payroll savings due to State hiring delays or
freezes, expenditure of other grant funds for similar services,
or unanticipated fluctuations in spending at the State level.
California currently has $5,319 in carryover.
States with excessive and chronic amounts of unobligated
funds need immediate technical assistance from HRSA to address
issues that are hindering a State from spending their award. We
support providing HRSA the authority to move unobligated funds
from States with an identified need lower than the Federal
funds appropriated to States with chronic shortages.
State AIDS Directors support the continuation of a hold-
harmless provisions for the Title II base at a reduced rate of
loss. From California's perspective the hold-harmless
provisions is necessary to protect California from under-
funding resulting from the estimated living AIDS case formula,
which underestimates California's actual living AIDS cases by
30 percent, a $20 million loss to the State in current year's
Title II funding.
Experience shows that after the last reauthorization due to
the unintended consequences of changes in the law, 30 States
were held harmless from significant funding losses. With
limited funding, as well as three consecutive years of cuts to
the Title II base, these disparities cannot be corrected via
major shifts in Title II resources without impacting critical
existing services in jurisdictions that would lose funding.
However, we support the removal of the second hold-harmless
provision to the overall Title II award that has resulted in
the unintended effect of reducing the amount of money available
for the ADAP supplemental allocation due to significant
fluctuations in the emerging communities funding.
I hope my remarks have illustrated the critical importance
of the Ryan White CARE Act to California and the complexities
of addressing disparities, and that you will consider the
recommendations I have outlined.
Thank you for the opportunity to speak to you today. I look
forward to answering any questions you may have.
Senator Coburn. Thank you, Mr. Montgomery. Dr. Crosse.
TESTIMONY OF MARCIA G. CROSSE, Ph.D.,\1\ DIRECTOR, HEALTH CARE,
U.S. GOVERNMENT ACCOUNTABILITY OFFICE
Ms. Crosse. Mr. Chairman and Members of the Subcommittee, I
am pleased to be here today to discuss the Ryan White CARE Act.
As we have heard, the CARE Act makes funds available to States
and localities to provide health care, medications and support
services to individuals and families affected by HIV and AIDS.
---------------------------------------------------------------------------
\1\ The prepared statement of Ms. Crosse appears in the Appendix on
page 59.
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In fiscal year 2004 over $2 billion in funding was provided
through the CARE Act, the majority of which was distributed
through Title I grants to eligible metropolitan areas, or EMAs,
and Title II grants to States, the District of Columbia, and
territories. Metropolitan areas qualify as EMAs if they have a
total of 2,000 reported AIDS cases in the previous 5 years.
Titles I and II use formulas to distribute grants according to
a jurisdiction's reported counts as AIDS cases.
The Care Act reauthorizations in 1996 and 2000 modified the
original funding formulas. Prior to 1996 the CARE Act measured
a jurisdiction's caseload by its cumulative count of AIDS
cases, which is the number of AIDS cases, both living and
deceased, recorded since reporting began in 1981. The 1996
reauthorization changed the measurement to an estimation of the
number of living AIDS cases. This switch would have resulted in
shifts of funding away from jurisdictions with a longer history
of the disease and a higher proportion of deceased cases.
To ease these funding shifts, the CARE Act includes hold-
harmless provisions under Title I and Title II that protect
grantees from decreases in funding from one year to the next.
Title I of the CARE Act also includes a grandfather clause for
EMAs that guarantees once a metropolitan area has become an
EMA, it will continue to receive funding under Title I even if
its caseload drops below the threshold for eligibility.
The most recent reauthorization of the CARE Act in 2000
maintained these modifications, and it further specified that
HIV cases should be used in funding formulas no later than
2007, as we have heard. HIV case counts have not been used to
date to distribute funding under the CARE Act.
To assist the Subcommittee in its consideration of the CARE
Act, my testimony provides our preliminary findings on some of
the issues we are reviewing for the Chairman and other
requesters. My remarks today will focus on selected provisions
of the CARE Act. Specifically I will discuss: The impact of
CARE Act provisions on the distribution of funds that is based
upon the number of AIDS cases in metropolitan areas; the impact
of the CARE Act's hold-harmless provisions and a grandfather
clause on the distribution of funds; and the potential shifts
in funding among grantees if HIV case counts had been
incorporated in fiscal year 2004 funding formulas.
Our analysis shows that certain CARE Act Title I and Title
II provisions related to the distribution of funds to
metropolitan areas result in variability between the amounts of
funding per case among grantees. As you will see in the figure,
States that have EMAs within their borders receive more funding
for estimated living AIDS cases than those without EMAs because
cases within EMAs are counted twice, once to determine Title I
funding to EMAs and once again to determine a State's Title II
grant. For example, States with no AIDS cases in EMAs receive
about $3,600 per AIDS case. States with 75 percent or more of
their cases in EMAs received about $5,000 per AIDS case, or as
the Chairman noted, 38 percent more funding than States with no
EMA.
If the total Title I and Title II funding had been
distributed equally per AIDS case among all grantees, each
State would have received about $4,800 per AIDS case.
Metropolitan areas that have been affected by the epidemic,
but do not have the necessary numbers of AIDS cases to become
EMAs, may qualify for funding as emerging communities under
Title II. As the figure shows, the allocation of these grants
is made by separating eligible jurisdictions into two tiers
based on their reported numbers of AIDS cases. Because one-half
of the total emerging communities grant award is allocated to
each tier regardless of how many cases are in each tier, in
fiscal year 2004, jurisdictions in one tier with a total of
15,994 cases received $313 per case, while jurisdictions in the
other tier with a total of 4,754 cases received $1,052 per
case.
The hold-harmless provisions under Titles I and II, and the
grandfather clause for EMAs under Title I sustain the funding
and eligibility of CARE Act grantees by guaranteeing either a
certain percentage of previous years' funding amounts or an
EMA's eligibility to receive funding. These provisions make it
more difficult for CARE Act funding to track the most current
distribution of the epidemic.
As this figure shows, Title I's hold-harmless provisions
for EMAs has primarily benefited the San Francisco EMA, which
received over 90 percent of the fiscal year 2004 Title I hold-
harmless funding. San Francisco is the only EMA that has
deceased cases factored into its allocation because it is the
only EMA with hold-harmless funding that dates back to the mid
1990s when funding was based on the cumulative count of AIDS
cases, living and dead. In essence, deceased cases are still
being used to determine funding for San Francisco, with the
result that the city's funding is equivalent to what an EMA
with 84 percent more living cases would have received.
As you can see in the next figure, the grandfather clause
in Title I maintained the funding for 29 or the 51 EMAs that
became eligible for Title I base grants in the past. These
EMAs, however, would not have qualified for Title I base grants
in fiscal year 2004 based upon their case counts which were
below the eligibility threshold of 2,000 reported AIDS cases in
the last 5 calendar years. Four of these EMAs had fewer
reported cases than any of the cities receiving emerging
communities funding.
All States have established HIV case reporting systems, and
the 2000 reauthorization of the CARE Act required that HIV
cases be used in determining formula funding no later than
fiscal year 2007. However, CDC, as we have heard, currently
only accepts name-based case counts, the States shown in our
figure in blue. Therefore, State reported HIV cases that used
codes rather than names would not be counted in allocating CARE
Act funds if HIV case counts were used in funding formulas.
As shown in the figure in orange, 12 States, the District
of Columbia and Philadelphia, Pennsylvania have some form of a
code-based system rather than a name-based system. CDC does not
accept the code-based data principally because methods have not
been developed to make certain that a code-reported HIV case
does not represent an individual already counted in another
jurisdiction.
While we are aware of some of the limitations of HIV data,
as an example of what might occur, we used two approaches to
examine the potential impact of using HIV cases in addition to
AIDS cases on fiscal year 2004 Title II base grant
distributions.
The first approach reflects the data that would be used if
funding allocations were based on the HIV and AIDS case counts
currently received by CDC.
Under the second approach we used the same HIV and AIDS
case counts as our first approach for the jurisdictions where
CDC accepts HIV data, but supplemented these data with the HIV
case counts collected by the other States and the District of
Columbia from which CDC did not accept HIV data.
AS shown in this figure, for each approach we estimated the
impact if funding was distributed equally per case, both
without hold-harmless or minimum grant provisions, shown on the
two figures on the left, and with such provisions, shown on the
right.
Our analyses indicate that under either approach to
including HIV cases, at most 14 percent of CARE Act Title II
base funding would have shifted, with southern States being the
primary beneficiaries. Some States, however, could have seen
large increases or decreases. Changes in funding would be
largely offset, at least initially, if the funding formulas
included hold-harmless and minimum grant provisions.
In conclusion, the services provided under the CARE Act
have filled important gaps in communities throughout the
country, but as Congress reviews this Act, we believe it is
important to understand how variable this funding can be. Today
I have highlighted a few of the issues that are relevant to
this review. For each or these issues, we found that the
provisions of the CARE Act have impacted the extent to which
funds have been distributed in proportion to the incidence of
HIV and AIDS. It is clear that the level of funding available
per case is quite variable, depending upon where an individual
lives.
The way cases from EMAs are counted twice, the tiered
allocation of funds to emerging communities, the hold-harmless
provisions and the grandfathering of EMAs have all resulted in
considerably more funding going to some communities than others
with equivalent numbers of cases.
The inclusion of HIV cases in the funding formulas would
also result in variable funding depending in part upon the type
of reporting system used in each State.
Mr. Chairman, this completes my prepared statement. I would
be happy to respond to any questions you or other members of
the Subcommittee may have at this time.
Senator Coburn. Thank you, Dr. Crosse.
I am going to recognize my Ranking Member and good friend
for an opening statement, and then we will take up the
questioning.
OPENING STATEMENT OF SENATOR CARPER
Senator Carper. I appreciate the opportunity first of all
to welcome our witnesses. I apologize for being delayed and
missing at least the very beginning of some of the opening
statements, and pleased that I had a chance to hear from each
of you.
I think Senator Coburn as a physician has probably
forgotten more about these issues than I know, so I come to
this hearing really as an opportunity to learn. I understand
that the Ryan White CARE Act was first enacted, in 1990. And
Senator Lautenberg was there as a page. [Laughter.]
Senator Carper. And he is still with us.
It is named after a very courageous teenager who struggled
not only with AIDS but also against discrimination as we all
recall, so there is fear and prejudice as well.
These days I think we have made a whole lot of progress. We
have lived to see it both in terms of combating this stigma and
in combating the disease itself. I think we will all agree that
we have a good long ways to go. The CARE Act, nonetheless, has
been one of the chief Federal programs in this fight against
HIV and AIDS.
I think we can all agree that our goal in examining the
Ryan White Act today is to ensure that Americans living with
HIV/AIDS can get needed care and services.
The Ryan White program serves an estimated, I am told,
533,000 people each year, and it provides not only vital
prescription drugs, but needed support services to help
patients stay on those drugs and to adhere to a complex drug
regimen.
My own State of Delaware has done, we believe, a good job
of providing needed health services to those with HIV and AIDS.
We have made quality health care a priority, and are fortunate
to be able to offer a generous Medicaid program, a very
generous AIDS drug program and a high-quality Ryan White
services.
Our witnesses that we have heard from here today have been
discussing a number of different issues, largely focusing on
the funding of Ryan White. Since I believe this is a
jurisdiction of this Subcommittee, and several of these issues
that deal with variations in the level of funding and care
around our country, we have been hearing, and we are going to
hear some more about some of the States getting more funding
than others, about some States having ADAP waiting lists while
others are unable to serve everyone and so forth. I think it is
imperative that we ensure that any living person with HIV or
AIDS receives a high standard of care no matter where he or she
lives, whether it is New Jersey or Delaware or Oklahoma.
However, I think it is important that we keep in mind
several issues when considering the data that we are hearing
today. Let me mention a couple of those. First, the Ryan White
CARE Act on the whole is working. We have lengthened the time
from HIV infection to the onset of AIDS. People are living
longer and they are living healthier. We can always strengthen
the program but I think we have done a fair job so far.
Second, as we consider whether we are appropriately
distributing funding, I think we should ensure that we are
looking at the whole picture. GAO has presented some various
data today on the per case funding around the country and on
ADAP waiting lists. However, we should consider a few issues,
namely, whether per case funding is the best way to examine
Ryan White funding distribution, and whether we can look at
Ryan White funding in a vacuum. In every single State the
burden placed on Ryan White depends on what percentage of the
HIV/AIDS population is enrolled in Medicaid and how generous
that State's Medicaid is. It depends on what percent of people
with HIV/AIDS are enrolled in Medicare and what percent have
private insurance.
So the needs of different areas of the country, both in
terms of funding and needed services, are going to vary. I
think it is important that we consider this whole picture
finally.
If we determine that there are inequities, then we ought to
seek to address them, but we should keep in mind that many of
our cities, where over 70 percent of people with HIV/AIDS still
do reside, have built up successful public health
infrastructures to combat this disease, and we want to be
careful not to jeopardize or dismantle those.
I hope the issues that are brought up here today can inform
not only me, but the upcoming debate on reauthorization. Ryan
White has always been a bipartisan issue, and I hope that this
Congress in this year will continue that tradition, and we can
work together with our friends in the House of Representatives
to produce a bipartisan reauthorization package.
Again to our witness, thanks for coming.
And, Mr. Chairman, thanks for letting me give this belated
opening statement.
Senator Coburn. Thank you, Senator Carper.
We have a vote on, and I think I will recess the
Subcommittee so that we can go vote and come back. It will take
us about 10 minutes, hopefully.
The Subcommittee stand in recess.
Senator Lautenberg. Mr. Chairman, may I ask before we go to
adjournment, to be able to submit some questions to the
witnesses in writing?
Senator Coburn. Absolutely.
Senator Lautenberg. And to include a letter written by
myself and several other Senators from California and New York
to Mr. Walker, who is the Comptroller General of the United
States, regarding GAO studies?\1\
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\1\ The letter to Mr. Walker appears in the Appendix on page 106.
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Senator Coburn. Without objection.
Senator Lautenberg. Thank you.
Senator Coburn. And we will stand in recess until we get
back from the vote.
[Recess.]
Senator Coburn. The Subcommittee will come back to order.
I am going to start with some questions, and I think
Senator Carper will be returning. We did put into the record
questions that Senator Lautenberg wanted to have asked.
Dr. Janssen, in your testimony you said CDC is moving from
advising to recommending jurisdictions use name-based
reporting. What is the practical impact of that change in
terminology? Will CDC withhold financial resources, for
example, if a jurisdiction does not follow CDC's
recommendations?
Dr. Janssen. First, we have heard from a number of
jurisdictions about CDC recommendations, jurisdictions that
would like to move from code-based to name-based systems, and
they felt that a stronger recommendation from CDC would help
them be able to move through their State legislatures and
through their regulatory processes to change their systems.
Senator Coburn. So that might mean if they heard from
Congress about that, too, might be beneficial?
Dr. Janssen. I can only speak from a CDC perspective about
that, but at least that is what we have been told by health
departments. So it is a stronger recommendation than we had
made in 1999. The reason for it is really several-fold. As many
people have mentioned already, we do not currently include
code-based data. The reason is that we have not completely even
developed methods for evaluating code-based data within a State
or even between States. We have completed, and just completed
at the end of last year, a pilot evaluation of several code-
based systems that gave us mixed results. Based on that, we are
attempting to develop a full evaluation system of those code-
based systems.
Senator Coburn. Tell me what mixed results means?
Dr. Janssen. Some States found that they were having
trouble meeting the standards we published in 1999, and at
least in one case in the pilot they did meet the standards, in
addition which we think that--CDC works with the Council of
State and Territorial Epidemiologists who develop lists of
reportable diseases, and we felt that HIV should be, like other
infectious diseases, reported by name and reported voluntarily
by the States.
We do not intend to withhold funds from States that
continue to collect data by codes. Even though we do note that
in many cases this seems to be a cumbersome process, it also is
more expensive, and at this point there are no data to suggest
that code-based data collection systems are better than name-
based systems.
The reason for code-based systems originally were based on
very valid concerns from members of affected communities about
potential discrimination and about potential non-public health
uses of data.
Senator Coburn. I understand that. I understand the
background on it. Well, given the fact that the law says name-
based reporting, and they have about 18 months to do it, why
would we not send a stronger signal to say: You need to be
moving here?
Dr. Janssen. Well, I think this is a strong signal. I think
the shift from an advisory condition to a recommendation is
actually a very large move on the basis for CDC and for the
Department, and I think that does signify a major shift, and I
think there are a number of jurisdictions right now who are
looking at how difficult it is to use code-based systems, and
concerned, as Mr. Montgomery noted, about potentially losing
Ryan White funds because of the use of code-based systems.
Senator Coburn. That is my whole point. If, in fact, the
law says you will use HIV name reporting and, in fact, in his
testimony, Mr. Montgomery said that the CDC will need to
develop a methodology to establish estimates of HIV cases for
these States. That is not what the law says. And I am not sure
CDC has the authorization under the Ryan White Act to do that,
because of what the law states, as the primary author of that
bill in the year 2000. Is it your understanding that the law
does not allow for that, and only counted cases of HIV disease
reported to and confirmed by CDC? That is what the law says CDC
will be acceptable for Federal funding. So is it clear to CDC
that is what the law says?
Dr. Janssen. Absolutely. What we are doing is working--we
feel very strongly that the best data are reported cases. For
some purposes we have to use modeled estimates for data, but
for this case, we feel very strongly that the best data are
case counts of reports.
Senator Coburn. And we know that because that is a public
health strategy that has worked in numerous other diseases,
correct?
Dr. Janssen. Including AIDS.
Senator Coburn. Right. Let me refer to something--I keep
wanting to call on you, Dr. Parham. I am sorry. Dr. Hopson
talked about the decline in perinatal transmission of HIV. Why
did that come about?
Dr. Janssen. It has come about because of the effectiveness
of any antiretrovirals for preventing mother to child
transmission, from the old 076 trial. And now what is happening
more recently is that mothers are on HAART, and that even more
effectively reduces transmission. AZT by itself cut it in half.
HAART now reduces it to less than 2 percent.
Senator Coburn. What about the fact that affected mothers
who are pregnant who are tested for HIV so we know their
status?
Dr. Janssen. Right, that is also part of it. The first
thing we have to have is the intervention, and then once we
have that, we need to identify the people who benefit from that
intervention, and in fact, as you pointed out, that is what
getting people tested has done.
Senator Coburn. Actually, I would portend to you that it is
reversed. You need to identify. Because what we did know before
we had the 076 study and before we had HAART therapy, that if
in fact we eliminated breast feeding from women that
transmitted--we knew what the percentage was of transmittable
disease in terms of pregnancy, and if in fact we eliminated
breast feeding, and if we did a caesarian section. And we did
some of the other things that lessened the disease.
So that is one of the things that kind of troubles me about
this. Knowing the vectors and treating them with respect, but
also knowing where the risk factors are has to become a
complete part of our model.
The other thing I wanted to talk with you about, on names-
based reporting, is that if States are going to be compliant
for 2007 funding that would mean they need to start next month.
Is that right?
Dr. Janssen. They would need to start as soon as possible.
Senator Coburn. How will they meet the requirements under
the 2000 CARE Act if they have not started in July?
Dr. Janssen. We have been working with, and intend to
continue to work with, health departments and provide as much
support as we possibly can to enable them to meet the
obligations that they have.
Senator Coburn. Is that something different than you told
me before in terms of HIV name-reporting under the law?
Dr. Janssen. No. I think what we are doing is we are making
a recommendation for name-based reporting, and we have been and
will continue to work with States to develop the best systems
that they can use.
Senator Coburn. All right.
Mr. Montgomery, has California conducted any evaluation of
its HIV reporting system for accuracy and reliability?
Mr. Montgomery. We have had insufficient funding to do a
complete study of it. We have studied how closely we are
adhering to CDC standards, and in most of the measures we are,
except for the percentage that report Social Security numbers.
But we believe our system is very accurate. It is also, as Dr.
Janssen implied, very cumbersome, and it has been in operation
for nearly 3 years, and we have only two-thirds of the
prevalent cases reported, so it obviously has some challenges.
Senator Coburn. A California performance review recently
found the State will risk losing up to $50 million annually in
Ryan White CARE Act funds if the CDC does not confirm
California's reported HIV cases for fiscal year 2007.
California can prevent this loss if it converts its HIV
reporting system to names-based AIDS reporting system. You have
a names-based AIDS reporting system, correct?
Mr. Montgomery. We do.
Senator Coburn. And are there difficulties with that
reporting system?
Mr. Montgomery. There are not.
Senator Coburn. All right.
Dr. Hopson, Mr. Montgomery and NASTAD have proposed
requiring unobligated funds be redistributed back into the ADAP
fund. This could result in $30 million more for ADAP next year,
and most likely much smaller amounts in the years that follow.
Can you comment on his proposal?
Ms. Hopson. I have not see the NASTAD proposal, so, no I
cannot comment at this time.
Senator Coburn. Can you provide for us the total amount
spent by the CARE Act on planning activities for the past 2
years?
Ms. Hopson. That I can provide. For the years in question,
2003 and 2004 in the Title I program, we spent $30.3 million
for planning council support. This represents 2.4 percent of
the Title I appropriation for those years.
In Title II the consortia spent $48.7 million on grantee
planning and evaluation, on consortia needs assessment plan and
evaluation activities, and that represented 2.3 percent of the
Title III appropriation for those years.
And in the Title III program we have a planning grant
program. We did not fund any planning grants in 2004, but we
did fund five planning grants in 2003, and the amount was for
$299,058, which is 0.07 percent of the Title III appropriation
for those years.
Senator Coburn. OK, thank you. Do you believe that the
priority of the CARE Act should first and foremost be to
provide direct medical care and medication to Americans living
with HIV/AIDS, regardless of geography, and only after that
should other non-essential funds be used?
Ms. Hopson. Yes, I do, and certainly the first principle
that President Bush outlined was that we should focus the
Federal resources, meaning the Ryan CARE Act resources, on life
extending medical care such as antiretroviral therapy, doctors
visits, and lab tests and so forth. These are the core services
that many are talking about in terms of the CARE Act, so, yes,
that is the first principle that the President has outlined and
the way that we should look at prioritizing funding--
prioritizing how we fund grantees in the Ryan White CARE Act.
Senator Coburn. Should unspent CARE Act funds then be
redistributed to where there is a need?
Ms. Hopson. That is another one of the President's
principles that he has outlined, is that we need to have
flexibility so that the Secretary of HHS would have flexibility
to redistribute funds to the areas of greatest need or to
target those funds, better target those funds.
Senator Coburn. Dr. Crosse, based on the charts that you
put up there in terms of the disproportion--and I know there is
some question about whether that accurately reflects care given
with all the other models of care and organizations that have
been there--is there any recommendation that you can make to us
that would help us redistribute fairly under Title I, Title II,
Title III and Title IV--given the least harm to those in place,
organizations that are offering services, but yet create a
fairer and more equitable distribution of funds based on care
and outcome?
Ms. Crosse. Well, I do not think that we could give you a
simple recommendation on what to do. Among all of the things
that we have examined for this testimony, we found all these
provisions that are leading to variability in the funding, and
that are not necessarily counterbalanced by other provisions
that we have not discussed today.
Clearly, some of the provisions I think are more distorting
of the funding than others. Things such as minimum grant
provisions may be necessary, for example, for States with very
small numbers of cases in order to be able to maintain any sort
of a program at all. But we certainly have some concerns about
some of the hold-harmless funding, whether that should be
maintained with as gradual a decline as it has been in the
previous reauthorizations, or whether it is essential in all of
these programs at all.
As you correctly pointed out, the hold-harmless funding for
the EMAs primarily benefits one. If that hold-harmless
provision were eliminated, depending upon the assumptions you
make, at most we believe three EMAs might lose money. The other
48 of the 51 EMAs would gain money, including 18 of the 21 that
are receiving hold-harmless funding. So there clearly are some
distortions in the way that the current bill has played out.
It does not take into account necessarily the variability
in need across States, which is a much more complex question,
but clearly the funding provided by the Federal Government
through this program is not in proportion to the prevalence of
the disease as it currently stands.
Senator Coburn. Dr. Janssen, I am going to enter into the
record an article that was place in the Atlanta paper by
Associated Press,\1\ based on the CDC's press release in terms
of your new data. And I have one or two questions. Of that
number, what percentage are unaware of their HIV status?
---------------------------------------------------------------------------
\1\ Article from the Associated Press appears in the Appendix on
page 136.
---------------------------------------------------------------------------
Dr. Janssen. We estimate that about 25 percent of people
living with HIV are unaware of their HIV status.
Senator Coburn. So 250,000 people in this country are
unaware of their HIV status.
Dr. Janssen. Approximately, yes.
Senator Coburn. Which means they are going to rapidly
progress over the next 8 to 10 years. They are also going to
infect others. And what is the CDC's position on how we
approach that 250,000 people?
Dr. Janssen. In April 2003, we launched Advancing HIV
Prevention. A large part of that is focusing on increasing
testing, availability of testing, and recommending testing. The
first part of that is routine offering in medical care
settings. We will be coming out with new guidelines at the end
of this year based on making recommendations about more routine
testing and screening in health care settings. Those should be
available by September or October of this year.
We also have been encouraging and stimulating the use of
rapid testing for outreach purposes. We have an article that
will be published tomorrow in the Morbidity and Mortality
Weekly Report, on a model that we are calling Social Networks,
where people who are living with HIV recruit friends, sex
partners, drug-using network partners to come in and get
tested, people who they think may be infected who do not know
if they are infected. We are reporting those data tomorrow
which showed that about 5.7 percent of people recruited in nine
demonstration projects that we funded tended to be new HIV
diagnoses. That is about 2\1/2\ times what we routinely get out
of our counseling-testing system.
Senator Coburn. Is there any concern on your part that this
level incidence of HIV may be getting ready to bump up from
40,000 cases?
Dr. Janssen. I think that as we look at a variety of
different pieces of data to try to triangulate on what that
real number is, I think my major concern is that number is not
going down. The increase we are seeing in HIV reports among men
who have sex with men are of concern. What we do not know is
whether they reflect new infections or whether we are seeing
more testing.
Because of Advancing HIV Prevention, I am anticipating we
may see a bump in HIV reports because of increases in
diagnoses, so that is going to be confusing. Our HIV
surveillance, incidence surveillance system is being
implemented right now. We anticipate having our first national
HIV incidence estimate ready by mid fall of 2006.
Senator Coburn. I want you to look at this chart.\1\ We
drew this chart up just so you can see the disparity that is
happening through Ryan White funding now. I think there are six
other EMAs in California that suffer directly because of the
excess protections that are afforded San Francisco. That is all
of the EMAs in the country. And if you look at that, what you
can see is a significant disproportion, so it is pretty hard to
defend--even though there are wonderful programs in the San
Francisco EMA, it is pretty hard to defend this kind
disproportion funding. Ideally we would like to see it higher
for everybody, but the point is, is the CARE Act going to have
to be changed to straighten that out, and in a gentle way that
does not disrupt the institutional structures that are there?
---------------------------------------------------------------------------
\1\ The chart entitled ``EMA Funding Amounts per AIDS Case, fiscal
year 2004,'' submitted by Senator Coburn appears in the Appendix on
page 109.
---------------------------------------------------------------------------
In 2003, you launched the new initiative, Dr. Janssen,
Advancing HIV Prevention, with four key strategies that
emphasized routine HIV testing. How many States have adopted
those strategies?
Dr. Janssen. We have not done a systematic assessment of
the number of States that have adopted strategies. However, in
the new Health Department Cooperative Agreement, which the
funding began January 2004, we did put some directives into the
language in that announcement. The first was that community
planning groups would prioritize people living with HIV as the
No. 1 priority group for prevention interventions in their
jurisdictions. In addition to which we encouraged use of
changing testing, looking at where they are getting higher
yields, moving money from one place to another in terms of
getting better yields in terms of testing.
In 2003 and 2004, we purchased 700,000 rapid tests for use
in out of medical care settings. In 2005 we spent $2.3 million
on the oral fluid test, again for increasing access to testing
away from medical care settings, out in the community.
In addition, for community based organizations we have in
the new program announcement that was funded June 1 last year,
about two-thirds of the funds--I am sorry--about 60 percent of
the funds in that new program announcement were all directed
Advancing HIV Prevention activities.
Senator Coburn. So you have markedly increased rapid
testing. On the STD clinics that you fund through prevention,
are these recommendations in terms of the Advancing HIV
Prevention incorporated in those grants, in that money for the
CDC funded STD clinics?
Dr. Janssen. For HIV testing and activities in those STD
clinics, yes.
Senator Coburn. So they are following this advancing
program.
Dr. Janssen. They are. And what we will be encouraging more
this year, some clinics have developed an opt-out approach to
testing. There is an example in Texas actually where they have
been doing this for a number of years, and we are looking at
other STD clinics as demonstration projects later this year to
actually implement opt-out testing in those settings.
Senator Coburn. Mr. Montgomery, I want to give you a chance
to respond to anything that we might have said about this or
any other area. I do not want you to feel cut off as you leave
here, and I do look forward to working with you to solve the
problems in California because there is a concentration, but
just as important is solving the problems here in Washington,
DC with the unmet need that is not being met. And if you have
anything you would like to say, I would love to hear it.
Mr. Montgomery. Thank you for the opportunity. Yes, I have
a couple things I would like to say, and one is I wanted to
clarify the earlier discussion about the need for estimated
cases to incorporate HIV in 2007. I was talking about both
names-based and code-based reporting, but the systems that are
immature is really what I was addressing.
I would like to go back to comments I made in my testimony,
and say that I think that the discussion of using AIDS cases as
a measure of equity is a very complicated issue. I appreciate
that in your question to GAO, you included Title III and Title
IV and Part F in that formula, and I would really encourage you
to ask GAO to look at all titles and how that affects the per-
AIDS case formula.
In California's case if you use Title I and Title II,
California is above average for the per-AIDS case measure. If
you add in Title III, IV and Part F, California is below
average in terms of the average expenditure per case.
Senator Coburn. That is a great challenge. We will ask it.
Mr. Montgomery. And I think that is a measure of the
reauthorization in 2000 that you worked so hard on, there was
language put in there to encourage HRSA to direct Title III
funds to non-EMA areas, and that has had an impact, and I
congratulate you on putting that in the language.
And I would also encourage you to discuss with GAO looking
at the effect of using an estimated living AIDS case formula,
which inherently underestimates in some jurisdictions the
impact of the epidemic. For California it underestimates our
epidemic significantly, and it underestimates our living AIDS
cases by 30 percent, which is a profound effect.
Senator Coburn. But that is where we find ourselves in
trouble. We are afraid to go out and test.
Look, this is a treatable controllable epidemic. It is
controllable. If we will all get tested and all get treated, we
can break the back of the AIDS epidemic as you wanted to do,
Dr. Janssen. But the fact is, nobody has the courage to stand
up and say we need to treat this. We need to go after those
people that are going to discriminate on the basis of this
disease, and then we need, as a Nation, to stop this. The best
HIV prevention is to test everybody and know where they are so
that they, first of all, can be treated early with life saving
drugs so they do not progress, and so they do not infect
anybody else.
Just to give a little history, when I was here in 1996,
ACOG refused to recommend prenatal testing of pregnant women
for HIV, refused adamantly. Well, you cannot treat pregnant
women with HIV if you do not know their status.
Now that we are following a public health strategy on HIV
for pregnancy, what have we seen? We have seen a 76 percent
reduction in infection. That means people are going to have to
get treated, whereas before that, they were not being treated,
and their life would be limited.
So my caution is, is for us all to take our biases out of
the room and say, ``How do we treat this disease as a Nation?''
We can make a big difference next year if we all will just say,
``Let us do the right thing. Let us test. Let us go after this
disease. Let us not let one innocent person, one individual in
this country get this disease.'' We could do that. But it takes
all of us walking from all stripes of life, every angle, every
philosophy, working together and say the enemy is not each
other, the enemy is the disease, and we need to go after the
disease.
Anybody else want to offer any comments? Dr. Crosse.
Ms. Crosse. Yes. I would just, in response to Mr.
Montgomery, let him know that as part of the work we are doing
for the Chairman and the other requesters, we are examining
other portions of the CARE Act.
Senator Coburn. I want to thank each of you. You will be
receiving some extra questions from us in written form. We
would love to have you send those back to us within 2 weeks.
And I will give Senator Carper an opportunity to ask
questions because I was just about ready to dismiss the panel.
Senator Carper. I am glad you are still here. I have just
one question. I think I am going to ask Dr. Janssen, if you
would, to respond to this for me, please. I think you spoke to
this in your testimony, but I want to come back and revisit it.
It seems that most stakeholders support distributing Ryan
White funds based on the number of HIV cases in an area instead
of the number of AIDS cases in a particular area, at least that
is my sense. However, I am concerned that a number of States,
including my own State of Delaware, may be in danger of losing
a large portion of our funding because CDC will not accept the
type of HIV data that we collect and that some other folks
collect. I think your testimony notes that name-based reporting
has been shown to--and I think these may be your words in your
testimony--achieve high levels of accuracy and reliability. But
you do not seem to be saying that code-based reporting cannot
be improved or made more accurate.
In fact, the Institute of Medicine did a study, a study I
think you reference in your testimony. They recommended that
CDC accept HIV data from all States, including those that have
code-based systems. The Institute of Medicine has also said
that duplicate cases could be estimated and that procedures
could be developed to adjust for this.
What I would just ask, is CDC pursuing this option? Should
I be worried that in 2007 CDC will not accept my State's data
and maybe the data of some other States as well?
Dr. Janssen. In terms of coded identifiers, we have
conducted an evaluation, a pilot evaluation last year which
ended early this year, and which I had told Senator Coburn that
showed mixed results in terms of how some of these codes
worked. In some areas they worked, in some not, at least in a
pilot.
We still are in the process of developing a full evaluation
of coded identifiers. So even that effort has not been
developed. It is possible to develop it and we are working on
it.
A bigger concern, however, is de-duplication across
jurisdictions, from one State to another. In an area, such as
Maryland, Washington, DC, and Virginia, up to 20 percent of
cases could be reported from more than one jurisdiction. So
there is a lot of overlap. Nationwide it is about 2 percent I
believe, where----
Senator Carper. So you could have one person whose case is
being reported in the District, and the same person whose case
is reported in the State of Maryland?
Dr. Janssen. In Maryland, yes.
Senator Carper. And would you say that is unusual?
Dr. Janssen. That is unusual. It is more like 2 percent
nationwide. I have to check with Dr. McKenna, who is our
surveillance----
Senator Carper. Where is Dr. McKenna?
Dr. Janssen. Right here. So it is 4 percent for AIDS and 9
percent for HIV. So 20 percent is pretty high. The problem is
when you have different codes across those boundaries, it is
virtually impossible to de-duplicate cases.
We have talked about this a fair amount, and we believe
from an academic perspective conceptually one might be able to
develop such methods, but practically, we are not convinced it
is possible. So that, I think, is probably for us--and was
mentioned earlier--the most difficult problem is trying to de-
duplicate cases across State boundaries.
There is also a problem within States with codes, and we
have not--it is not proven; it is a conceptual problem--and
that is in jurisdictions it is not just the HIV test that is
reported to the health department. CD-4 counts are reported,
viral loads are reported. So someone in care might be reported
to the health department 7, 8, or 10 times a year. Over years
they could be reported 40 or 50 times to the health department.
If they go to different providers and the code is changed in
just one way, they would be counted multiple times.
So that becomes a problem where you have people who are in
care reported multiple times, and then you have somebody who is
just diagnosed and not in care. And so they end up not being
represented equally with the people who are in care. So that is
a potential problem with codes even within a State.
So your question was, can codes be made to work better than
names or even as good as names? At this point we have no
evidence that codes are better than names. We have evidence, as
Mr. Montgomery mentioned, in California, for example, where
actually the system is fairly cumbersome and difficult and
expensive.
So those are some of the reasons that we are recommending
that States use name-based systems.
Senator Carper. Anybody else on the panel want to take a
shot at what I just asked? Mr. Montgomery, did you?
Mr. Montgomery. We now have 3 years of experience of
operating a codes-based system and it is an extremely
complicated system. We think it is very accurate. But we think
that it is, as Dr. Janssen said, very expensive, and has caused
backlogs within the health department, so we are concerned
about our ability to carry out a code-based system.
Senator Carper. OK. A quick follow up, if I could, Dr.
Janssen. You mentioned a pilot study that was conducted
earlier. When was that, this year, last year?
Dr. Janssen. It was finished at the end of last year in
terms of data collection. Analysis was done in the spring.
Senator Carper. And you mentioned that there is a more
comprehensive evaluation. Is it under way or planned?
Dr. Janssen. Being developed.
Senator Carper. And when would you expect that to be done?
Dr. Janssen. The end of next year, 2006.
Senator Carper. Our thanks to each of you. Thanks for
joining us. And I learned a new word today, de-duplicate.
[Laughter.]
This is a good job we have, we learn something every day.
That is my new word.
Senator Coburn. I would just like unanimous consent to
enter this article into the record.\1\ The Los Angeles Times
reported that county health officials are being allowed to
peruse medical records in California, complete with patient
names, to ensure the cases are being reported.
---------------------------------------------------------------------------
\1\ The article from the Los Angeles Times appears in the Appendix
on page 231.
---------------------------------------------------------------------------
If it is true, that would undermine the whole concept of a
code-based system. The fact is, as California right now,
through your office, is recommending that it is going to have
to spend $500,000, I believe, is to formally evaluate the
system and determine whether the system meets CDC's minimum
guidelines.
We are running short on time, and we know what the law
says. The message ought to be, get a names-based system since
the names-based system on AIDS is working and not being
violated, and we know it works, and we know we are going to
have better success. And you are going to save a lot of money,
and that money that you save is going to treat a lot of folks.
Thank you each for being here.
[Whereupon, at 4:21 p.m., the Subcommittee was adjourned.]
A P P E N D I X
----------
PREPARED STATEMENT OF SENATOR AKAKA
Thank you, Mr. Chairman, for having this hearing today and allowing
me to address the Subcommittee regarding the effectiveness of the Ryan
White Comprehensive AIDS Resources Emergency (CARE) Act.
The Centers for Disease Control and Prevention (CDC) announced that
as of the end of 2003, more than a million people in the United States
were estimated to be living with HIV. This bleak statistic is a return
to levels experienced in the 1980s. The HIV/AIDS epidemic is growing
among traditionally under-served and hard-to-reach populations. In my
home state of Hawaii, as of December 31, 2004, there were 2,779 people
infected with HIV or who have AIDS, as reported by the Department of
Health. Of that total, 19 percent were Asian/Pacific Islander, 11
percent were Native Hawaiians, 6 percent were Hispanic and 5 percent
were African-Americans. It is estimated by Hawaii's STD/AIDS Prevention
Branch that there are an equal number of people infected, but who do
not know it. A growing number of these reported cases are among Native
Hawaiian and Pacific Islanders.
People are living longer with HIV. However, the rate of infection
remains at unacceptable levels. Meanwhile, the President's proposed
budget has not adequately funded the CARE Act. While funding may be
described as level, the number of people living with the disease is
growing. This means fewer dollars are available to help people in need.
If this trend continues, we will see more sick people not receiving the
care they so desperately need to stay alive, which is why we must
increase funding for the CARE Act. It is frustrating to me to see
funding remain level, while demand grows for the vital services that
the CARE Act provides.
Mr. Chairman, as the number of Americans living with HIV crosses
the one million mark, the CARE Act represents yet another vital Federal
health care program that is not receiving adequate funding. Increasing
funding for the CARE act will expand health care services for HIV
positive/AIDS patients, to eliminate wait lists for AIDS drug
assistance programs, to provide housing for those in need, and to
ensure that women, children and families impacted by HIV/AIDS receive
the adequate care and counseling they need. We know that getting people
into treatment early slows the decline of their immune systems and
saves money by allowing people to continue to work.
At the same time, we must remain diligent in our prevention
message. Governments, at all levels, must redouble their prevention
efforts, especially in minority communities because the epidemic
continues to grow disproportionately among people of color, women and
young people. Also, access to quality health care services for all
persons with HIV/AIDS, regardless of geographic location, needs to be a
priority.
Mr. Chairman, the need to provide health care services for HIV
positive and AIDS patients continues to grow. Again, thank you for
calling today's hearings. I look forward to our witnesses' testimony.
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