[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
_____________________________________________________________________________
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        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

                                 ------                                
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

                              ----------                              


                        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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Janssen appears in the Appendix 
on page 32.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Hopson appears in the Appendix on 
page 43.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Montgomery appears in the 
Appendix on page 49.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \1\ The letter to Mr. Walker appears in the Appendix on page 106.
---------------------------------------------------------------------------
    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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