[Senate Hearing 109-846] [From the U.S. Government Publishing Office] S. Hrg. 109-846 ENSURING EARLY DIAGNOSIS AND ACCESS TO TREATMENT FOR HIV/AIDS: CAN FEDERAL RESOURCES BE MORE EFFECTIVELY TARGETED? ======================================================================= 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 SECOND SESSION ---------- APRIL 26, 2006 ---------- Printed for the use of the Committee on Homeland Security and Governmental Affairs U.S. GOVERNMENT PRINTING OFFICE 28-242 PDF WASHINGTON : 2007 ------------------------------------------------------------------ For sale by Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2250. Mail: Stop SSOP, Washington, DC 20402-0001 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 Driessnack 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 Carper............................................... 4 WITNESSES Wednesday, April 26, 2006 Kevin Fenton, M.D., Director, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services........................ 6 Deborah Parham Hopson, Associate Administrator, HIV/AIDS Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services................................... 8 Marcia Crosse, Director, Health Care, U.S. Government Accountability Office.......................................... 9 M. Beth Scalco, Director, HIV/AIDS Program, Louisiana Office of Public Health, and Past Chair, National Alliance of State and Territorial AIDS Directors..................................... 20 Michael Weinstein, President, AIDS Healthcare Foundation......... 23 Alphabetical List of Witnesses Crosse, Marcia: Testimony.................................................... 9 Prepared statement........................................... 55 Fenton, Kevin, M.D.: Testimony.................................................... 6 Prepared statement........................................... 31 Hopson, Deborah Parham: Testimony.................................................... 8 Prepared statement........................................... 46 Scalco, M. Beth: Testimony.................................................... 20 Prepared statement........................................... 64 Weinstein, Michael: Testimony.................................................... 23 Prepared statement........................................... 76 APPENDIX Questions and responses for the Record from: Dr. Fenton................................................... 80 Ms. Hopson................................................... 94 Ms. Crosse................................................... 100 Ms. Scalco................................................... 105 Mr. Weinstein with an attachment............................. 108 Charts submitted by Senator Coburn for the Record................ 129 Additional copy submitted by Senator Coburn for the Record....... 134 ENSURING EARLY DIAGNOSIS AND ACCESS TO TREATMENT FOR HIV/AIDS: CAN FEDERAL RESOURCES BE MORE EFFECTIVELY TARGETED? ---------- WEDNESDAY, APRIL 26, 2006 U.S. Senate, Federal Financial Management, Government Information, and International Security Subcommittee, of the Committee on Homeland Security and Governmental Affairs, Washington, DC. The Subcommittee met, pursuant to notice, at 2:27 p.m., in room SD-342, Dirksen Senate Office Building, Hon. Tom Coburn, Chairman of the Subcommittee, presiding. Present: Senators Coburn and Carper. OPENING STATEMENT OF SENATOR COBURN Senator Coburn. Thank you. We are going to start early. We are going to have a vote here in a few minutes which will mean we will have to interrupt the hearing, so I am going to go on and start, if I may. I want to welcome all of our witnesses today. I want to thank you for the timeliness of your testimony and thank you for taking the time to be here. Today's hearing examines domestic efforts to promote early diagnosis of HIV infection and ensure access to AIDS treatment. It has been nearly 25 years since the first cases of what would become known as AIDS were recognized. As a physician during much of this time period, I experienced the heartbreak of watching some of my patients, including mothers and children, succumb to this mysterious and incurable illness in the early days of the epidemic when effective treatments had not yet been developed. Even today, with the availability of revolutionary anti- retroviral treatments that have transformed a disease that was a death sentence into a manageable disease for many, it is still heartbreaking to deliver an HIV diagnosis to a patient and agonize with each one to determine how they can afford these life saving, yet extremely expensive, medications. As a physician, I believe it is essential that if we are to end this epidemic, we must make every effort to promote early diagnosis and ensure access to treatment for all those who are infected. We must also empower those who are infected and those who are not infected to prevent HIV from taking another life. This may require rethinking and reevaluating past and present policies and reconsidering ideas that have long ago been abandoned or even demonized. It is no secret that I have had many differences with some within the AIDS community, Federal health agencies, and even with the drug companies that produce the miraculous AIDS drugs that now many take for granted regarding how we could best address this disease. But we must not let our differences of opinions allow us to make enemies of those with different viewpoints, for we all hold the same common goal: Ending AIDS and the same common enemy, HIV. So many of the medical advances that my patients and those affected by HIV around the world benefit from today are the result of activists who forced the government to act on this epidemic when so many preferred to look away because they disapproved of the behaviors that were associated with this disease. Unfortunately, so much of how we have all reacted to the AIDS epidemic has been based on fear. Lack of knowledge led to fear. Fear led to discrimination and stigma. Discrimination and stigma led to fear. And fears became the basis of our response to HIV/AIDS. The results have been tragic. Consider that the U.S. Government spends more than $20 billion a year on HIV/AIDS prevention, care, and research annually, yet more than one million Americans are now living with HIV/AIDS. Up to 59 percent of those Americans are not in regular care. More than 40,000 Americans become newly infected with HIV every year. It has not changed over the last 6 to 7 years, and this number has actually been unchanging for over a decade, as that chart will show.\1\ There are some estimates that it is as high as 60,000 new cases a year. The fact that we don't know for sure tells us we have a problem. --------------------------------------------------------------------------- \1\ The chart referred to appears in the Appendix on page 132. --------------------------------------------------------------------------- More than a quarter of those who are infected do not know they are infected. Hundreds of patients are on waiting lists for AIDS drugs, and more than half a million Americans have already died from this disease. As many as 45 percent of persons testing positive for HIV received their first positive test result less than a year before the AIDS was diagnosed. With an average of 10 years between HIV infection and an AIDS diagnosis, this suggests that people are living with HIV for many years before they are aware of their infection and may be unknowingly spreading the virus to others. To address these shortcomings, fear must be replaced with hope. We have the knowledge, the resources, and the commitment to provide hope to every American who is living with HIV/AIDS. But to do so, we must update our policies to ensure that all of those living with HIV have access to the hope that treatment can provide. This means we must also remove the barriers to testing. Fear-based policies continue to serve as deterrents to testing and diagnosis and deny the benefits of those miraculous AIDS drugs that the early activists fought so hard to make available to thousands of Americans today, often until it is far too late to prevent the inevitable. One example of the hope that can result from eliminating barriers to testing is the great success that has resulted from the baby AIDS laws in New York and Connecticut that require every newborn to be tested for HIV antibodies and treatment provided to affected mothers and infants. New York passed a law requiring HIV testing of all newborns in 1996. According to data we received just this week, the results of this law have been dramatic.\1\ The proportion of all pregnant women being aware of their HIV status at delivery has increased from 64 percent in 1997 to 95 percent in 2004. The number of HIV-infected infants in New York dropped from more than 500 a year to 8 in 2003. Furthermore, mothers and impacted infants are receiving care. --------------------------------------------------------------------------- \1\ The chart referred to appears in the Appendix on page 131. --------------------------------------------------------------------------- Connecticut passed a similar law in 1999 requiring that newborns be tested for HIV antibodies if their mother's HIV status was unknown. Prior to the law, only 28 percent of pregnant women were documented as being tested for HIV.\2\ Prenatal testing rates for other diseases were over 90 percent, which demonstrates how the unusual counseling regulations for HIV testing discouraged testing. After the law was enacted, this number of pregnant women being tested for HIV jumped to 90 percent. In the year that the law passed, 70 HIV-exposed newborns were born with five infants infected with the virus. Since that time, over 300 HIV-exposed infants have been born with only five infants becoming infected. The last baby infected with HIV to be recorded in the State was in 2001, meaning Connecticut's laws essentially eliminated baby AIDS. --------------------------------------------------------------------------- \2\ The charts referred to appear in the Appendix on pages 129-130. --------------------------------------------------------------------------- The success of these laws are rare victories in our battles against HIV and AIDS. The Government Accountability Office (GAO) today releases its second report this year that examines some of the issues involved in providing access to treatment and early intervention. The report reminds us of facts that we already know, such as most new HIV infections originate from HIV- infected persons not yet aware of their status. This emphasizes the need to identify HIV-infected persons and link them with appropriate services as soon as possible. It raises other issues of concern, such as ADAPs with waiting lists may not represent all eligible individuals who are not being served. And it points to opportunities where policy makers can do a better job to maximize the impact of the tens of billions of dollars that we are directing every year towards our HIV/AIDS efforts. Coincidentally, GAO's reports come at a time when Congress is faced with reauthorization of the Ryan White CARE Act, which is the largest HIV/AIDS-specific Federal care program. While the program's authorization expired 6 months ago, efforts are currently being made to renew the program, and I know of at least one bill that has been introduced in both the House of Representatives and the Senate that would do so taking account of many of GAO's findings as well as the issues I have outlined and others that we will explore today. I look forward to hearing from our witnesses today, who include Dr. Marcia Crosse, Director of Government Accountability Office's Public Health and Military Health Care Issues; Dr. Deborah Hopson, Associate Administrator of the Health Resources and Services Administration, HIV/AIDS Bureau; Dr. Kevin Fenton, Director of the National Center for HIV, STD, and TB Prevention at the Centers for Disease Control and Prevention; Ms. Beth Scalco, Director, HIV/AIDS Program, Louisiana Office of Public Health; and Michael Weinstein, President of the AIDS Healthcare Foundation, the Nation's largest provider of HIV/AIDS medical care. Prior to you coming in, Senator Carper, I announced that we were going to have a vote. I will go vote if you will do youre opening statement. I will be right back and we will try to keep things going. Senator Carper. OK, sounds good. OPENING STATEMENT OF SENATOR CARPER Senator Carper [presiding]. Thanks, Mr. Chairman, and before you leave, let me just say that the Chairman of the Subcommittee has been very involved in these issues for some time and is one of the co-authors of the last reauthorization. I know he has been very much involved in our efforts to reauthorize the Ryan White CARE Act this time, as well. Thank you for joining us. We look forward to your testimony and to the opportunity to ask some questions of you, and our second panel, as well. The Ryan White CARE Act was first enacted, I believe in 1990. I was still in the House of Representatives at the time. Since then, we have made great progress, both in combatting the stigma that was once associated with the disease, but I think also in combatting the disease itself. We still have a long ways to go, but the CARE Act has been, I think, one of the chief Federal programs, at least, in the 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 needed services. The Ryan White program is working to do that, at least that is what I am told, for over 500,000 people each year. The program provides not only vital prescription drugs, but also needed support services to help patients stay on those drugs and adhere to complex drug regimens. In my State of Delaware, we have done, we think, a good job of providing needed health services to those with HIV and AIDS. We can always do better. Everything we do, we can do better, and that includes here. But we have made quality health care a priority and are fortunate to be able to offer what we think is a generous Medicaid program, a very generous AIDS drug assistance program, and high-quality Ryan White services. The witnesses that are here today before us, this panel and our next panel, will discuss a number of issues, largely focusing on the AIDS drug assistance program, on prevention and testing efforts, and on notification efforts. However, they will also be addressing a number of issues pertaining to the Ryan White authorization as a whole. At least, that is what I am told. I understand that the Senate HELP Committee and the House Energy and Commerce Committee are working together in a bipartisan way to come to agreement on the Ryan White Reauthorization Act, and I hear they are making significant progress and I hope that the authorization can be completed this year. As we consider reauthorization of this program, I think it is important that we keep in mind that the program, on the whole, is working. We have lengthened the time from HIV infection to the onset of AIDS, which is a good thing. People with HIV and AIDS are living longer and living healthier. That is obviously a good thing. Of course, we can, as I said earlier, do more to strengthen the program, and we now face new challenges as the face of the disease itself evolves. I think, for the most part, we have done a good job, a commendable job. One of the goals of reauthorization should be to ensure that we can get the most out of our Federal investment in this program. We should ensure that the distribution of funding to States and cities under the CARE Act both supports the existing treatment infrastructure that we have built up over the last several years and also ensures that we address discrepancies in funding where they are present. We should ensure that the Ryan White dollars are spent in a smart way and that they are spent as a payer of last resort. We should also ensure that any unused funds are reinvested in the program in some way. I hope that the issues that are brought up before us today can inform the upcoming debate on reauthorization. Ryan White has always been seen as a bipartisan issue and I am hopeful that this year, the Congress will continue that tradition and that we can work together with the House to produce a bipartisan reauthorization package to send to the President for his signature. I think with that having been said, I am going to recess the Congress, go and vote myself, and I suspect that the Chairman will be back very shortly and begin your testimony. So I would just ask that we stand in recess for a few moments until the return of the Chairman and I will see you all then. Thank you. [Recess.] Senator Coburn [presiding]. Let me introduce, if I may, our first panel. I would ask our panel members to limit their testimony to 5 minutes. We have read your testimony. Then we will have questions afterward. Dr. Kevin Fenton is Director of the National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention. He joined CDC in January 2005 as Chief of the National Syphilis Elimination Effort, leading a revitalization of this program to end the sustained transmission of syphilis in the United States. Prior to his work at CDC, Dr. Fenton was the Director of the HIV and Sexually Transmitted Infections Department of the United Kingdom's Health Promotion Agency. Dr. Deborah Parham Hopson is the Associate Administrator for HIV/AIDS in the U.S. Department of Health and Human Services' Health Resources and Services Administration. Dr. Hopson was appointed Associate Administrator for HIV/AIDS at HRSA on July 29, 2002. As Associate Administrator for the AIDS Bureau, Dr. Hopson is responsible for directing the Ryan White Comprehensive AIDS Resources Emergency Care Act Program, which provides medical care, treatment, referrals, and social services to people living with and affected by HIV/AIDS throughout the United States. She administers a budget of $2.02 billion that funds services for some 530,000 individuals each year. Dr. Marcia Crosse is Director for the Health Care Group at the Government Accountability Office. She has been responsible for overseeing multiple projects in the areas of biomedical research, bioterrorism, disease surveillance, HIV/AIDS, medical product safety, organ transplantation, and pharmaceutical regulation. She has been employed at GAO since 1985. I want to thank each of you again for being here, and I want to express publicly how much I depend on GAO, what a great functioning component of the U.S. Government they are, and how valuable they are to us as Members of Congress in being able to do our work. Dr. Fenton, I will recognize you first and then we will go to Dr. Hopson and then to Dr. Crosse. Welcome. TESTIMONY OF KEVIN FENTON, M.D.,\1\ DIRECTOR, NATIONAL CENTER FOR HIV, STD, AND TB PREVENTION, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dr. Fenton. Good afternoon. Thank you. Good afternoon, Mr. Chairman. My name is Kevin Fenton and I am the Director of the National Center for HIV, STD, and TB Prevention at the Centers for Disease Control and Prevention. Thank you for the opportunity to discuss CDC's progress in reducing barriers to HIV testing and improving opportunities for early diagnosis and linkage to care. --------------------------------------------------------------------------- \1\ The prepared statement of Dr. Fenton appears in the Appendix on page 31. --------------------------------------------------------------------------- Twenty-five years ago, the first cases of HIV were reported in the United States. Although the struggle to prevent new infections is not over, we have made substantial progress and achieved major successes. For instance, the dramatic decrease in mother-to-child or perinatal HIV transmission is one of the great success stories of HIV prevention. We have also seen declines in the number of HIV and AIDS cases attributed to injecting drug use. Despite such major successes, HIV infection and AIDS remain a leading cause of illness and death in the United States. The numbers are sobering. CDC estimates that currently, 1 to 1.2 million people in the United States are infected with HIV, and of these, roughly a quarter are undiagnosed and at high risk of transmitting HIV. This undiagnosed group is of great concern to us because they are not able to take advantage of medical treatment and because we believe that transmission by people who are unaware that they are HIV positive account for more than half of new HIV infections every year. Currently, CDC has a number of efforts underway to encourage early diagnosis of HIV infection. In 2003, CDC launched the Advancing HIV Prevention Initiative, or AHP, which reinforces CDC's evidence-based approach that routine HIV testing implemented in a variety of settings will reduce barriers to HIV testing, improve opportunities for early diagnosis and linkage to prevention and care, and help reduce the number of new infections. CDC also encourages its funded partners to take HIV testing out into the community by using rapid tests in non-traditional settings and in health care settings that provide episodic care. In addition, CDC is currently updating guidelines for testing in health care settings, making HIV testing more routine. Finally, the President's 2007 budget contains an increase in funding aimed at increasing the number of people who know their HIV serostatus through promoting rapid testing in areas of high HIV incidence. I would like to highlight one AHP demonstration project that we are particularly encouraged about. This project used social network strategies to reach persons at high risk of HIV infection in communities of color and demonstrated the feasibility of using these social networks to encourage HIV counseling, testing, and referral services. This strategy has proved to be very successful in reaching persons with undiagnosed HIV infection. In addition to reducing barriers to HIV testing and increasing the opportunity for early diagnosis, CDC is proposing to revise our guidelines for HIV testing of adults, adolescents, and pregnant women in health care settings. The revised guidelines will focus on increasing routine HIV screening of patients in health care settings, fostering the earlier detection of HIV infection, identifying and counseling persons with unrecognized HIV infection, and linking them to clinical and preventive services and further reducing perinatal transmission of HIV in the United States. Detecting HIV infection earlier through HIV screening has been shown to be cost effective, even in settings of low prevalence. The new guidelines will recommend routine or opt- out HIV screening in health care settings and are intended for providers in all health care settings. The guidelines do not modify existing guidelines for HIV counseling, testing, and referral for high-risk persons who seek HIV testing in non- clinical settings. As you know, to further support the goal of diagnosing HIV infections earlier and increasing access to care, the President's 2007 budget includes an increase of $93 million for CDC HIV prevention programs. Three major testing components are included: Testing in health care and non-clinical settings, in jails, and with injecting drug users. CDC will work collaboratively with other HHS agencies in these efforts. We anticipate testing more than three million persons and identifying over 46,000 infections. In closing, over the past 25 years, our Nation has made progress in preventing morbidity and mortality related to HIV. CDC remains committed to helping people live longer, healthier lives by preventing new HIV infections and protecting the health of those already infected. Thank you again for this opportunity and I look forward to answering any questions. Senator Coburn. Thank you, Dr. Fenton. Dr. Hopson. TESTIMONY OF DEBORAH PARHAM HOPSON,\1\ ASSOCIATE ADMINISTRATOR, HIV/AIDS BUREAU, HEALTH RESOURCES AND SERVICES ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Ms. Hopson. Mr. Chairman, thank you for the opportunity to meet with you today on behalf of the Health Resources and Services Administration. Last year, I testified before the Subcommittee regarding the domestic HIV/AIDS care programs and I am happy to be here today to discuss ways to ensure early diagnosis and improve access to treatment for Americans living with HIV and AIDS. I certainly appreciate your continuing support for the Ryan White CARE Act programs. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Hopson appears in the Appendix on page 46. --------------------------------------------------------------------------- The Ryan White CARE Act is the centerpiece of our domestic response to care and treatment for low-income, uninsured, and under-insured individuals living with HIV/AIDS. Currently funded at over $2 billion, it provides primary health care, live-saving medications, and support services to individuals who lack health insurance and financial resources to provide adequate health care for themselves. As you noted, the authorization of the Ryan White CARE Act expired 6 months ago. President Bush in his State of the Union Address stressed the importance of this program and asked Congress to reform and reauthorize the Ryan White CARE Act and provide new funding to States so that we can end the waiting list for AIDS medicines in America. Since its last reauthorization, we have been able to provide anti-retroviral treatment, primary care, and support services to over half a million people annually in the United States, Puerto Rico, Guam, the Virgin Islands, and eligible U.S. territories in the Pacific. In 2004, an estimated 65 percent of these individuals were racial minorities, 33 percent were women, and 87 percent were either uninsured or received public health benefits. The Ryan White CARE Act programs have provided important benefits to these populations. Overall, AIDS mortality is down and lives have been extended through HIV medications purchased through the AIDS Drug Assistance Program, also known as ADAP. Pregnant HIV- positive 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, the epidemic continues and will be in need of our attention for some time to come. The President and 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. We have recognized that as essential as the Ryan White CARE Act has been to serve Americans with HIV and AIDS, it is in need of revitalization to safeguard its critical mission. Despite record levels of funding, we continue to face waiting lists for life-saving funds through the ADAP and there are marked disparities in access to quality medical treatment across the country. As minority populations are increasing and disproportionately impacted by HIV/AIDS, changes to the existing systems of care designed for an earlier epidemic are increasingly urgent. Each year, CARE Act programs, primarily through grants to States, metropolitan areas, providers, and educators, we reach an estimated 571,000 people. Since AIDS was first recognized, the pattern and treatment of HIV disease has shifted. We now strive to manage HIV/AIDS as a chronic disease. Early diagnosis and improved access to HIV care and treatment are key to what the CARE Act stands for. The CARE Act programs are successful at counseling and testing. More than 800,000 HIV tests were administered in CARE Act sites. And the important thing to note is over 85 percent of the people tested in CARE Act sites returned for their results. We think that this is because the CARE Act sites are not only testing sites, but they are primary care delivery sites, as well. Going forward, we take great pride in the advances of HIV/ AIDS care and treatment that have been made by the CARE Act programs over the past 16 years. However, we are humbled by the significant challenges that remain for 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 under- insured. The Administration has emphasized five key principles for reauthorization of the CARE Act: Serve the neediest first; focus on life-saving and life-extending services; increase prevention efforts; increase accountability; and increase flexibility. The President has made fighting the spread of AIDS a top priority of his Administration and he will continue to work with Congress to encourage prevention and provide appropriate care and treatment to those suffering from the disease. Today, people with HIV/AIDS are living longer, healthier lives, in part because of the CARE Act. In order to make this legislation more responsive in the future, the Administration urges Congress to take into account the above-stated principles in the reauthorization of the CARE Act. Thank you for the opportunity to discuss the Ryan White CARE Act today and for your dedication and interest in this important piece of legislation. Senator Coburn. Thank you, Dr. Hopson. Dr. Crosse. TESTIMONY OF MARCIA CROSSE,\1\ DIRECTOR, HEALTH CARE, U.S. GOVERNMENT ACCOUNTABILITY OFFICE Ms. Crosse. Mr. Chairman, I am pleased to be here today to discuss the AIDS Drug Assistance Programs, or ADAPs, that receive funds under the Ryan White CARE Act and to provide a summary of our report that we are releasing today, prepared at your and others' request. The report discusses ADAP's program design, their funding sources, and drug purchasing. It also discusses our examination of State prenatal HIV testing and perinatal HIV transmission rates and State approaches to identifying and notifying partners of HIV-infected individuals. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Crosse appears in the Appendix on page 55. --------------------------------------------------------------------------- Despite progress in drug treatments and the reduction of AIDS mortality in the United States, challenges remain concerning the availability of these drugs for individuals with HIV or AIDS. Because of the variation in program criteria, an individual eligible for ADAP services in one State may not be eligible for or receive the same ADAP services in another. ADAP income ceilings for individuals, program enrollment caps, and drug formularies vary considerably among ADAPs. For example, each ADAP determines a maximum income level or income ceiling as a criterion for an individual's eligibility for enrollment. ADAPs reported income ceilings that range from 125 percent of the Federal poverty level in North Carolina to 556 percent in Massachusetts. Sixteen ADAPs reported that they had limits on the assets that individuals enrolled in the program are allowed to have. Twelve ADAPs reported having caps on program enrollment or on amounts expended per individual. And the total number of drugs ADAPs included on their formularies ranged from 20 in Colorado to 1,000 in Massachusetts, New Hampshire, and New Jersey. In order to make maximum use of the funding they receive, ADAPs are expected to secure the best prices available for the drugs on their formularies. ADAPs may, but are not required to purchase their drugs through the 340B Federal drug pricing program, under which drug manufacturers provide discounts on certain drugs. HRSA has identified the 340B prices as a measure of ADAPs' economical use of grant funds, but HHS does not disclose 340B prices to the ADAPs. We found that some ADAPs reported prices that were higher than the 340B prices for selected HIV/AIDS drugs. However, these reported prices may not have reflected any rebates ADAPs eventually received. While HRSA is responsible for monitoring whether ADAPs obtain the best prices available for drugs, it does not routinely compare the drug prices ADAPs report to the 340B prices, and without the final ADAP rebate amount on a drug purchase, HRSA cannot determine whether the final drug prices paid were at or below the 340B price. We are recommending that HRSA require ADAPs to report the final prices they paid for drugs, net of any rebates, and that HRSA routinely determine whether these prices are at or below the 340B prices. Turning to approaches to reduce the spread of HIV, all 50 States, the District of Columbia, and Puerto Rico have policies or have enacted laws regarding HIV testing of pregnant women to help reduce the transmission of HIV to newborns. However, among the eight States we examined, three States followed CDC's recommendations to routinely include HIV tests in standard prenatal testing while allowing a woman to refuse to be tested for HIV. The other five States require that a woman specifically consent to an HIV test, usually in writing, before the test can be performed. But two of these States, as you noted, Connecticut and New York, have mandatory newborn testing if the mother has refused an HIV test. Six of the eight States report that the number of HIV-positive newborns has declined, however, in a positive development. Among other efforts to reduce the transmission of HIV, States used various approaches in eliciting information from known HIV-infected individuals about their sexual partners. But the participation of these individuals varies and not all partners can be reached to be notified. For example, CDC data showed that States interviewed between 46 percent and 100 percent of known HIV-infected individuals to elicit the identities of their partners and were able to notify between 42 percent and 83 percent of those partners that they had been exposed to HIV. Further, in the 12 States we examined, 10 have statutory or regulatory provisions that require or permit the notification of partners, including spouses, without the consent of the known HIV-infected individual. However, in the remaining two States, Massachusetts and Minnesota, public health officials or the health department may notify partners, including spouses, only with the consent of the HIV-infected individual. Mr. Chairman, this concludes my prepared remarks. I would be happy to answer any questions you or other Members of the Subcommittee may have. Thank you. Senator Coburn. Thank you, Dr. Crosse. Dr. Fenton, I am going to start with you, if I may. Four years ago, Dr. Gerberding stated in her first speech as Director of CDC that 40,000 or more new HIV infections occur every year in the United States and it was unacceptable and our goal is to substantially reduce and ultimately prevent. If you look at that chart \1\ and the fact that CDC now admits at least 40,000 new infections every year, which has not declined, what is the explanation for that? --------------------------------------------------------------------------- \1\ The chart referred to appears in the Appendix on page 132. --------------------------------------------------------------------------- Dr. Fenton. In reviewing that chart and in assessing our successes of our prevention interventions, I think there are two key questions that we need to ask ourselves. First, are we doing the right prevention interventions or do we have effective interventions and are we delivering them at the right level to have the necessary impact on our HIV epidemic? Or, second, as the epidemic is evolving, are we actually targeting our prevention interventions in the right areas for the right communities at risk? CDC has a program of continually evaluating the effectiveness of our prevention programs. Over the past decade, we have been involved in monitoring the outcomes of our prevention activities and using our surveillance data to evaluate the effectiveness of our prevention interventions. We have systematically developed effective behavioral interventions and we have embarked upon a program of diffusing these effective interventions to communities and individuals at high risk of acquiring HIV. We have also used core prevention indicators to evaluate the effectiveness of programs at the local level. Program consultants are required to interview our grantees to ensure that local implementation of our prevention programs are being done as anticipated. Senator Coburn. Let me ask it in a little different way. We are going to spend over $20 billion this year in this country on domestic HIV/AIDS and we are climbing every year as we work on this very difficult problem. When are we going to see a decline in the new infections? Maybe we are not having more new infections, maybe we are diagnosing more that were in the resilient population. That may be the answer. But if you were an average American out there paying their taxes and--$18 billion to $20 billion, we started out very low and through the great work of AIDS activists, we are where we are today, when are we going to see that go this way? And this opinion, you are not going to be held to this. Just give us an opinion. [Laughter.] I have got 4 more years here. I promise I won't hold you to it. Dr. Fenton. I am not in a position to say exactly when we are going to be seeing a decline or a change in the epidemic curve, but I do know that we have had successes in preventing HIV transmission in some areas. We are beginning to see declines in new HIV diagnoses among injecting drug users. And earlier in my testimony, I mentioned the declines and the successes in perinatal HIV. Senator Coburn. Right. Dr. Fenton. More recently, our surveillance data is suggesting that we are seeing reductions in new diagnoses among African-American women. So taken as a whole, it may be very difficult to predict exactly when we will see declines in new diagnoses, but we are seeing successes. I think the key is actually identifying what elements of our--why are we seeing the successes---- Senator Coburn. What is working and what isn't? Dr. Fenton [continuing]. And ensure that we either extend these and continue to implement these nationally. Senator Coburn. Fifteen months ago, CDC unveiled its Advancing HIV Prevention Initiative. How many States have enacted the recommendations and what is being done to assist all the States to adopt those recommendations? And by the way, for our audience, those are recommendations that just follow common public health precepts that have been proven for years to work which were just introduced by CDC 15 months ago. Dr. Fenton. The Advancing HIV Prevention Initiative was actually launched in 2003 and there are a number of interventions which were included in those, including universal HIV testing of pregnant women, confidential partner notification, and rapid testing. I would like to report on our progress on each of these. Senator Coburn. OK. Dr. Fenton. As far as our interventions for pregnant women are concerned, in 2004, CDC recommended implementation of an opt-out testing approach in which women are notified that an HIV test will be routinely included in the standard battery of tests to be done. Since CDC's recommendation for opt-out testing, seven States have specifically authorized opt-out prenatal HIV screening in legislation. In November 2005, the American College of Obstetricians and Gynecologists further published a legislative tool kit of State laws and suggested legislative language that should be used to actually aid the requirement of opt-out testing for pregnant women. As far as monitoring States and what exactly is happening as far as HIV testing and counseling is concerned, CDC conducted a survey and analysis of all relevant State statutes addressing HIV testing and counseling. An electronic database of these State laws will be posted on the agency website within the next month. This information really has provided a very comprehensive inventory of laws which really gives a sense of where States are in terms of requiring mandatory HIV testing, pre-testing and post-test counseling, and testing of pregnant women. As far as our progress on partner notification is concerned, it is a condition for all States receiving Federal funds for HIV and STD prevention that they should have confidential partner notification as a component of partner counseling and referral services. So all CDC grantees are expected to deliver on this intervention. And then finally, as far as rapid HIV testing is concerned, all CDC grantees are encouraged to use their HIV prevention funds to purchase rapid HIV tests for various clinical and non- clinical sites. Senator Coburn. Dr. Hopson, Department of HHS has announced the Ninth Annual Ryan White CARE Act Grantee Conference in August, and according to the invitation letter, all participants and presenters are responsible for their own travel, hotel, and registration fees; which should come from CARE Act funds. I have two questions for you. One is, is it really a necessity to have that conference every year when the bill hasn't changed? And number two, couldn't that money be much better spent by redirecting it to an ADAP program? Ms. Hopson. Thank you. The Ryan White CARE Act grantee meeting is held every other year, so we don't hold it every year, and we began holding it when the CARE Act programs were combined into the HIV/AIDS Bureau. So this is the fourth biannual meeting. What we have found is that it is the time where we are able to provide technical assistance to our grantees. As I said in my testimony, this is a time when the CARE Act hasn't changed but the environment in which we are operating has changed. There are lots of changes in Medicare. There are changes in Medicaid. There are changes in other parts of the health care financing world, as well. There are also clinical changes and clinical updates. And so we use this as a time to provide technical assistance to our grantees. Because we have so many grantees, we are not able to get out and visit each one of them and we find that when we bring them together, they are able to learn from each other. This is a time that is well spent and money that we also believe is well spent. Senator Coburn. How much money is it? Ms. Hopson. I will have to provide that for the record. Senator Coburn. Thank you. The President's reauthorization principles that he put forward would require at least 70 percent of all CARE Act funds to be spent on primary medical care and treatment, and I heartily endorse that. Titles II and III are already spending more than 75 percent of their funds on such purposes, according to GAO. Title I does not, and I understand that most Title IV consumers already have their primary care paid for by either SCHIP or Medicaid. How do you envision the 75 percent primary care floor affecting the roles and services impacted by Title I and Title IV? Ms. Hopson. For Title I, we do realize that most of the money does pay for primary care medical services or medications and we believe most of the grantees--when you look at it overall about 54 percent is the amount that they spend on primary care services. So we believe that if the law does pass and it says 75 percent must be spent on primary care and treatment, then the grantees will have to look and see how they will reallocate funds so that they could meet that requirement. In terms of Title IV, we realize that there are many of the patients who are eligible for Medicaid and receive their care paid for that way and we are looking to see what would be included in the primary care services. We broadly define that as not only services that are provided for people when they come in for care, but also, we need to provide outreach to get people in care and keep them in care. Those services are vitally important, particularly when you look at the Title IV population, which is largely minority women and their children. There are unique challenges that they face in order to get to care and to remain in care, and so we look at a package of services as part of comprehensive primary care. The Title IV program will try to reprioritize those services, or prioritize such that the Ryan White CARE Act does pay for the primary care services and the necessary support services to get people into care and to keep them in care. Senator Coburn. OK. I have gone over my 5 minutes. Senator Carper, I am going to come back for another round. Senator Carper. Good. Thanks. On our second panel, one of our panelists is Beth Scalco, who is, I think, the Director of the Louisiana HIV/AIDS program. Louisiana is, as we all know, now struggling with the aftermath of Hurricane Katrina, so it is arguably necessary that they have the flexibilities to address some of the new challenges. I have two questions. One is does the current Ryan White program do enough to give States like the Gulf Coast States and the localities the flexibility to address their specific needs? That is my first question. And second, is there anything more that we ought to be doing in this area? Dr. Hopson would you start with that and we will just take it from there. Ms. Hopson. Hurricane Katrina was certainly something that we have never seen the likes of before in this country and there are many systems that were impacted by that, including the Ryan White CARE Act program. There were many, many evacuees from New Orleans and the other parts of the Gulf region. Included in that evacuation were people who are living with HIV and AIDS. Many of them went to other parts of Louisiana, Alabama, Mississippi that were not impacted by the hurricane. Others went to neighboring States like Texas or Georgia, but the evacuees ended up in many places around the country. The challenge has been to find all of those patients who were enrolled and receiving care in the affected area and get them into care. Senator Carper. That is a pretty big challenge. Ms. Hopson. That is a big challenge, and one of the concerns that we have is that we have not found all of those patients. So that is a continuing challenge that we have. We are continually in contact with the States and with all of our grantees around the country to ask if they are still receiving patients who were displaced. Senator Carper. Any idea if they have found as many as half of them, three-quarters of them? Just roughly? Ms. Hopson. We do have that information. I just don't have it off the top of my head. Senator Carper. All right. Ms. Hopson. I can give you some specifics. We know that in Texas, there are over 800 evacuees who are receiving CARE Act services. Louisiana received 700 evacuees from New Orleans. We let the grantees know that they were able to have some flexibility so that Title I New Orleans dollars were able to be used by the Title II State. Also, Louisiana Medicaid provided funding to the Texas ADAP to purchase pharmaceuticals for Louisiana Medicaid-eligible clients. In Texas, they really did a yeoman's job of decreasing the complexity of people being eligible for ADAP and were able to very quickly get people enrolled in ADAP, and many of the pharmaceutical companies, as well, immediately stepped up to the plate and were able to provide some free medications for people who were evacuees. So again, there were lots of things that were done. We were limited, though, by the statute. There were people who were asking me constantly, well, can't you just waive this and waive that? And I said, no, I don't have the power to waive the statute. We still have to follow the law. Senator Carper. Excuse me for interrupting, but as we look toward reauthorizing the Act, and people especially like my colleague here, shouldn't we be involved along with folks on the HELP Committee? What ought we be doing to provide more flexibility, if that is appropriate? Ms. Hopson. Yes. Senator Carper. You can answer that for the record, but it is a timely question. Ms. Hopson. It is a great question. We have been having lots of discussions within the Department and I think I would like to provide that answer for the record. Senator Carper. Sure. That would be great. Let me go back, if I could, to Dr. Fenton. I don't think you have been asked enough questions yet, so I will ask you a few more. I understand CDC has suggested that HIV screening be conducted in maybe not all health care settings, but a whole lot of them, unless the patient declines. This seems like a laudable goal, but could you speak a little bit about how this would work on a practical level and how much it might cost to implement that kind of an approach? Finally, how would we pay for it? It is like a three-part question. Dr. Fenton. It is. To address the first question first, which is which settings and how is this going to be implemented, the real background to this is really to begin to have a systematic strategy to really reduce the undiagnosed fraction of HIV in the general population, and we know that certainly in the American population, approximately 75 percent of individuals attend their health care provider or are seen by a health care provider in the previous year. So this is a huge opportunity for us to really escalate the uptick of HIV testing in the population. In our revised screening guidelines, the objective is to involve as many health care settings in this process by routinizing HIV testing and removing the barriers to HIV testing in the health care setting. In this respect, we are looking at involving all different kinds of health care settings where individuals aged 13 to 64 would be seen for routine health care. Senator Carper. Do you have some idea how much something like this might cost, and finally, who might pay for it? How might we pay for it? Dr. Fenton. OK. I don't have the figures as to how much this might cost and I would like to provide that for the record? Senator Carper. All right. Who might pay for it? Dr. Fenton. We are looking at various strategies for paying for this. Certainly one area that we are looking at that we would be keen to pursue is exploring the ability for third- party payment for HIV rapid tests, or HIV tests, similar to other screening tests which are done in the population which are paid for by third-party payers. The objective would be to have HIV testing as being paid for in this manner. We also should remember that additional funds are being provided by the Administration through CDC to support the purchase of rapid tests and we will be working very closely with our partners at State and local government as well as other HHS agencies to ensure that rapid tests are provided in as many settings, both clinical and non-clinical settings, as possible. Senator Carper. All right. One last question for you, Dr. Fenton. I understand that CDC has stated that prevention counseling need not be conducted in conjunction with HIV testing. It seems like testing would be a logical point at which to give people information about how to reduce the risk of HIV infection. I am wondering if you can give us some more detail about CDC's thinking in this area. Dr. Fenton. Absolutely. In thinking about the future of HIV testing in the United States, it is important to unlink the testing which is being recommended in clinical settings from that which is being recommended in non-clinical or community settings. There are no plans afoot to separate prevention counseling in the non-clinical settings. However, in clinical settings, what we are looking at is streamlining the HIV testing process so it becomes shorter, more efficient, and therefore, we begin to remove some of the barriers to HIV testing in the clinical settings. Individuals who are diagnosed positive as a result of the HIV tests would still have intensive prevention counseling to enable them to access appropriate treatment and care and prevention services. So that part of the process counseling for HIV-positive individuals would not be lost. But it is crucial that if we are moving away from exceptionalization of HIV testing, that we really look at streamlining the HIV testing process, especially in clinical care settings, and removing the barriers, which are time constraints, concerns about stigmatization in providing HIV tests by health care providers, etc. Senator Carper. Dr. Crosse, would you care to comment on Dr. Fenton's response? Ms. Crosse. Senator, I don't believe that we have the information from the work that we have undertaken to be able to speak specifically to his remarks. If you would like us to review that, I would be happy to do that and provide information subsequently. Senator Carper. Thank you, ma'am. All right, Mr. Chairman. That is it for me. Thanks. Senator Coburn. I think the answer to your question lies in the chart to your right.\1\ A study released last August showed what the cost per infection prevented by the different intervention strategies, and to do HIV counseling with opt-in, one-on-one, the average cost is $110,000. --------------------------------------------------------------------------- \1\ The chart referred to appears in the Appendix on page 133. --------------------------------------------------------------------------- I find it very interesting that in 1996, the Ryan White CARE Act reauthorization contained a requirement that as a condition of Federal funding, all States require that a good faith effort be made to notify spouses of known HIV-infected patients that such spouse may have been exposed. We just heard testimony from Dr. Crosse that there are two States now that have to have the permission of the person who is infected, and the CDC has certified that all States are requiring with this requirement. How can CDC certify that if I am a spouse of somebody who is infected who doesn't want to tell me that I am infected that they are, in fact, complying with the Ryan White Act? How can the CDC take that position in those States that require that? You don't have to answer for the record. You can answer in written response, but it is very concerning to me because you hear Dr. Parham say she can't waive the law, and yet my big problem through the years with CDC seems to be that oftentimes what is expedient is waived and what isn't, isn't. So I would love for you to answer that in writing for us because you all have certified that, but we have had testimony today that is something different from that. Ms. Crosse. Mr. Chairman, if I could just add, in our review, we only examined the statutes in 12 of the States and so there may be additional States beyond those two---- Senator Coburn. Right. Ms. Crosse [continuing]. That have similar requirements. Senator Coburn. The two out of the 12, you had two where the trump card is if I am HIV infected and I don't want my wife to know, she can't know. The law says you have to not give people money who do that, and yet you certify they are all in compliance. Something isn't right there. But go back to the chart, which I think is very revealing, and I think what the CDC is trying to address with their specialized non-clinical setting testing and everything else is how do we spend money most effectively to take this large group of undiagnosed people, 300,000, and find out their status so that we don't enlarge the number of people who are unknown in their HIV status who are HIV-positive. But I think this chart is very revealing to us to know where to, in fact, spend our money most efficiently. Dr. Crosse made some mention about 340B testing in her reports, although they can't be sure because they don't have discounted net prices, rebate net prices. There is some concern that maybe efficiency of the present dollars in ADAP programs aren't as good as they should be because we are not getting a comparison of whether or not they are getting value. Based on what you have heard and based on what your plans are, what are HRSA's plans to do about holding accountable and within the 340B to get more bang for our buck in terms of the dollars spent by ADAP? Ms. Hopson. There are a number of things that we do currently. One, HRSA does require the ADAP, as a condition of their grant award, to participate in a cost-saving measure that is equal to or more economical than the 340B program. Now, the problem comes is that HHS cannot disclose the 340B-covered entities, such as ADAPs, what the prices are because of confidentiality agreements between the government and the drug companies. So there is that challenge that we have. Senator Coburn. But her point was that you are not working with a real number because the numbers they are reporting to you is not rebate-adjusted. Is that correct? Ms. Hopson. Yes, that is correct. Senator Coburn. So basically, whatever you are doing with it, it is not a real number. So is there something you all plan on doing to say, you have to give us rebate-adjusted pricing? Ms. Hopson. There is another program within HRSA, the Office of Pharmacy Affairs, and they are not part of my Bureau, so that is why I am turning around to make sure I get the right answer. I know what we are doing in the HIV/AIDS Bureau. But we are working with the Office of Pharmacy Affairs that manages the 340B program to make sure that the information that we get from our ADAPs is the information, the net price, essentially, of the drugs that we purchase through the ADAPs and that we give that information to the Office of Pharmacy Affairs who then can give us a range. They can't give us the exact price, but they can give us, within range, as to what price--are we paying a fair price close to the 340B price or not. There are a number of things that Dr. Duke, the HRSA Administrator, has put forward to the Department and has put in the 2007 budget request so that we can improve the ability of the Office of Pharmacy Affairs to report to us and work with us so that we can have the accurate prices. On our end, in the HIV/AIDS Bureau, we are working with our grantees, the ADAPs, so that they will report the net price to us so that we then have an accurate number to compare to the 340B prices. Senator Coburn. So their observation has already been addressed by HRSA. Ms. Hopson. Yes. Senator Coburn. The observation of GAO---- Ms. Hopson. We are in the process of--this is something we have proposed in the 2007 budget. We don't have that---- Senator Coburn. Dr. Crosse, would you respond to that? Ms. Crosse. Our understanding based on HRSA's response to our draft report was that the Office of Pharmacy Affairs was developing a system that would assist the ADAPs in determining for themselves whether or not they were obtaining economical prices in their drug purchasing, but HRSA's response indicated that it would be logistically difficult and require resources that they don't have to carry out the kind of oversight and monitoring that we recommend they do and that this would not require the sort of manual comparison they indicated in their comments, but could be carried out electronically and could be carried out for a subset of the drugs. We, for example, in our review looked at just 10 drugs that accounted for 73 percent of the expenditures by the ADAPs so that they could, likewise, examine either on some rotating basis or with some subset that account for a substantial portion of spending, particularly on the anti-retrovirals, what the actual prices finally are or are paid. But our understanding, our reading of their comments back to us was that they did not at this time intend to do that. Senator Coburn. I just want the panel to know, we are coming back to this, because every dollar wasted is somebody not treated. This is something that the law says and isn't being carried out. You can't waive it and I am going to be the enforcer. So just plan on about 4 months from now finding out what the response is, make sure it is in place, because we are going to have another hearing to ask about it. If Congress does not reauthorize the CARE Act by October 1, what will happen to the funding of States without names reporting or immature reporting systems? Dr. Hopson. Ms. Hopson. As you know, sir, because you were there in 2000, there is a requirement that by 2007, we must use HIV, not just AIDS, in the formula by which we distribute the Title I and Title II dollars. We are discussing that within the Department right now as to the options that we will use for those States that do not have that HIV data that is certified by the CDC, because we use data that is certified by CDC in order to make the funding decisions for Title I and Title II. Senator Coburn. So tell me again, what is going to actually happen? Ms. Hopson. We are having discussions on various options now within the Department---- Senator Coburn. So you haven't made a decision what is going to happen? Ms. Hopson. That is correct. Senator Coburn. OK. That is what I was wanting to get to. Is it important what the Ryan White CARE Act said in terms of the 2001 bill? Ms. Hopson. Absolutely. Senator Coburn. OK. Well, I have several other questions for all of you. I am not going to keep you here for that. I will submit the rest in terms of written format. I would very much appreciate your response in 2 weeks, if you can, and I know those have to be cleared, so I am patient. But this one issue on ADAP pricing and comparison, whether or not we are getting a good deal, the drug companies don't need to make any more money. They can afford to sell at a reasonable price to ADAPs if they can afford to sell to anybody. It is my concern that this be addressed very quickly because it is money going out of the door that shouldn't be going out of the door. Or, it may not be a problem at all, but the point is, we need to know whether it is. The GAO seems to think it may be, but we don't know. So I want to make sure that is addressed. I would also invite you to stay to hear our next panel, because I think they have information you all can use, and oftentimes government witnesses don't stay and they don't have the benefit of really getting the feedback that would be beneficial. Thank you all so much for your testimony and thank you for being here. Senator Coburn. Our next panel consists of Michael Weinstein, who is President of HIV Healthcare Foundation, the Nation's largest provider of HIV/AIDS medical care. Since 1986, Mr. Weinstein has been a leader in the fight against HIV and AIDS. As President and co-founder of AIDS Healthcare Foundation, he oversees a $140 million organization whose mission is to provide cutting-edge medicine and advocacy regardless of one's ability to pay. They currently serve 30,000 clients in the United States, Africa, Central America, and Asia. The Foundation now operates 14 outpatient AHF health care centers in California and Florida. They also operate seven pharmacies, a clinical research unit, a disease management program through the State of Florida, and the first capitated Medicaid managed care program for people with AIDS. Beth Scalco is Director of the HIV/AIDS program for the State of Louisiana's Office of Public Health. The HIV/AIDS program under her direction has the primary responsibility for overseeing Louisiana's response to the AIDS epidemic, including all prevention and care activities. Her office administers the Ryan White Title II program, including the ADAP program, the HOWPWA program, the Centers for Disease Control and Prevention surveillance cooperative agreements, and the State general funds for AIDS. She has been working in the field of HIV/AIDS since 1985. Welcome, both of you. Ms. Scalco, I think I will ask you to go first, since I introduced you second. TESTIMONY OF M. BETH SCALCO, DIRECTOR,\1\ HIV/AIDS PROGRAM, LOUISIANA OFFICE OF PUBLIC HEALTH, AND PAST CHAIR OF THE NATIONAL ALLIANCE OF STATE AND TERRITORIAL AIDS DIRECTORS (NASTAD) Ms. Scalco. Good afternoon, Mr. Chairman. My name is Beth Scalco and I am the Director of the HIV/AIDS program for the State of Louisiana. I am also the past Chair of the National Alliance of State and Territorial AIDS Directors (NASTAD). I want to thank you for inviting me to speak with you today. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Scalco appears in the Appendix on page 64. --------------------------------------------------------------------------- State AIDS directors appreciate the longstanding support of the U.S. Senate for the Ryan White CARE Act programs, and assuring that all persons with HIV/AIDS, regardless of their geographic location, have equal access to appropriate and high- quality HIV/AIDS services is our highest priority. I would like to share with you some views of my fellow State AIDS directors in addition to some views from the State of Louisiana. I have limited my comments to those that address increasing access to prevention services provided by State health departments, including testing and access to life-saving drugs provided by the AIDS Drug Assistance Program. As you said, Louisiana HIV/AIDS program administers the HIV/AIDS prevention and care programs funded by both State and Federal funds. HIV infections have penetrated both our metropolitan areas as well as our rural areas in our State. In 2004, the State of Louisiana had the 11th highest number of AIDS cases reported and the fifth highest AIDS incident rates in the Nation. There were a total of 25,846 cumulative cases of AIDS reported in Louisiana and there are currently 14,793 individuals living with HIV/AIDS in Louisiana as of March 2006. In 2005, we identified 967 new HIV/AIDS cases in Louisiana. We normally identify around 1,100 cases in Louisiana, and I am sad to say, I do not think that HIV infection decreased. I believe that is a result of the impact on our ability to test in the months following Hurricane Katrina. In the Federal fiscal year 2006, Louisiana received over $22 million in Ryan White CARE Act funding. We received $6 million for Title II base, $15 million for ADAP, and $950,000 for our emerging communities, which is Baton Rouge, Louisiana. Our Title I EMA, which is New Orleans, received $7.4 million. We received close to $5 million in HIV prevention cooperative agreement funds and $1.6 million for our surveillance cooperative agreement. The State of Louisiana contributes approximately $2.5 million specifically for HIV prevention activities in Louisiana. In addition, they contribute over $9 million for care and treatment of people who are HIV infected through the State's public hospital system. This is in spite of Louisiana's ongoing budget deficits both prior to the hurricane, and I, unfortunately, have to say, I do not believe that they will not be able to continue this contribution as a result of the hurricane. State public health agencies serve an essential and a unique role in the delivery of HIV/AIDS prevention, care, and treatment programs. The agencies are entrusted through the U.S. law as the central authorities of the Nation's Public Health System and as such bear the primary public sector responsibility for health. State Public Health responsibilities include disease surveillance, epidemiology, prevention programs, immunizations, emergency preparation, provision of primary health care services for the uninsured and the indigent, and overall planning and coordination, administration, and physical management of Public Health Services. The President's 2007 budget includes $93 million, of which $86 million is new funding, to increase testing in medical settings, make voluntary testing a routine part of medical care, and to create new testing guidelines, models, and best practices. The President's initiative will prioritize funding for regions with the highest number of new cases as well as focusing on incarcerated persons and injection drug users. State AIDS directors support the President's request for $86 million in new funding for domestic HIV prevention and believe that this funding should be allocated via the prevention and surveillance cooperative agreements with State and local health departments. State and local health departments already fund HIV testing in a variety of venues in communities and they are in the best position to maximize the potential of the President's testing initiative. However, testing alone will not prevent new infections. Funds must be increased to make up for 3 years of cuts, which have hampered the ability of State health departments to implement CDC's Advancing HIV Prevention Initiative. In addition, resources for surveillance are sorely needed, as the Federal Government shifts prioritization from AIDS to HIV case reporting and funding for core surveillance activities has eroded significantly in recent years. State AIDS directors support the delivery of HIV prevention services in primary care settings as a standard of care. Studies indicate that HIV-positive individuals who are aware of their status take steps to protect their partners from infection, with 70 percent reporting reductions in risky behaviors. Health departments use partner counseling and referral services as one tool to identify HIV-positive individuals and ensure their linkages to medical support and prevention services. Research has found PCRS to be a very cost-effective strategy for identifying HIV-infected persons who are unaware of their serostatus. State AIDS directors support the continuation of funding for PCRS through CDC cooperative agreements with States and the directly-funded cities. The State AIDS programs have been one of the largest implementors of HIV rapid testing programs. We have long supported the development and approval of rapid testing and worked collaboratively with Congress and the Administration to ensure rapid tests were considered for a CLIA waiver. In several jurisdictions and in certain settings, barriers to rapid testing exist. It is a complex testing technology. In addition, it is more costly to implement than traditional testing. The CARE Act is a safety net under other public programs, such as Medicaid and Medicare. The Ryan White programs must adapt to fill gaps particular to the individual State. ADAPs work closely with the State Medicaid programs and Medicare Part D to ensure that ADAPs remain the payer of last resort. Annually, ADAPs serve approximately 136,000 clients, or about 30 percent of the people living with HIV/AIDS estimated to be receiving care in the United States. In fiscal year 2005, States were dependent on State contributions to their ADAP programs and pharmaceutical discounts and rebates to sustain their ADAP programs, as the increase in Federal dollars for ADAPs was extremely limited. ADAPs receive the lowest prices in the country for anti- retroviral therapies. In 2003, NASTAD established the ADAP Prices Task Force to negotiate with the pharmaceutical industry on behalf of all ADAPs, and as a result of this highly successful public-private partnership, the task force achieved supplemental discounts and rebates beyond those mandated by the 340B program and price freezes that have resulted in over $300 million in savings over the past 3 years. Ten years after the advent of highly active anti-retroviral therapy, the lives of people living with HIV/AIDS have been greatly extended. Therefore, individuals are remaining on our ADAP programs for lifetimes. ADAPs across the country continue to encounter significant challenges in fiscal stability while adequately serving the growing number of people with HIV and AIDS. For 2007, State AIDS directors seek an increase of $197 million for ADAPs to maintain those that are currently enrolled and to meet the growing demand of new clients and to strengthen ADAPs' abilities across the Nation to provide the PHS standard of care and treatment. Senator Coburn. Could you summarize, please? You have gone past your 5 minutes. Ms. Scalco. Sure. I would like to summarize by saying that, first of all, State waiting lists for the ADAP programs are only one indicator of need, that many ADAPS have other restrictions in place, and to solely distribute money on the basis of a waiting list is not an equitable way to do it. I would also like to take one moment to address the issue of Hurricane Katrina and the State of Louisiana, and particularly since you asked the question about the flexibility provided by our Federal partners. What we found is that the flexibility was lacking and that, in fact, what occurred is that while we were trying to piece programs back together and provide services to clients, what basically was occurring is that we were also having to meet administrative requirements that could not be waived, which was not nearly as important as assuring that people had access to treatment and care. We also needed to have waivers of certain conditions of award and that has not been possible. The transfer of funding between Title I and Title II, which should have been an easy thing to do, actually could not be done without amending 20 contracts through the State of Louisiana's contract system. And so in that, I would say I would appreciate in the Ryan White CARE Act reauthorization if there is an emergency provision that would address this problem. Thank you. Senator Coburn. Thank you. Mr. Weinstein. TESTIMONY OF MICHAEL WEINSTEIN,\1\ PRESIDENT, AIDS HEALTHCARE FOUNDATION Mr. Weinstein. Senator Coburn, Senate staff and the audience, as President of the largest AIDS organization in the United States, I am deeply concerned about the lack of access to HIV medical care for half a million Americans. As we approach the 25th anniversary of the identification of the first cases of AIDS, I am troubled by our lack of progress in treating HIV and controlling the epidemic in this country. --------------------------------------------------------------------------- \1\ The prepared statement of Mr. Weinstein appears in the Appendix on page 76. --------------------------------------------------------------------------- Our No. 1 priority in all matters relating to AIDS should be protecting the public health. With half the people who are positive not in treatment, including many who do not even know their status, we cannot control the spread of this disease nor adequately help the people who have it. AIDS Healthcare Foundation's primary mission is the medical treatment of HIV in this country and across the globe, serving 32,000 patients. In several of the communities AHF serves, HIV patients are dangerously underserved. As an example, Alameda County, which includes the City of Oakland, is only spending 10 percent of its Ryan White CARE Act monies on primary medical care. The Magic Johnson Clinic, which we operate in Oakland, is largely unfunded and specialty referrals are almost impossible to obtain. Despite the fact that Alameda County has declared a state of emergency around HIV, much more money is being spent on social services than medicine. At our Magic Johnson Clinic in Jacksonville, Florida, the situation is similar. Ten years after the discovery of the miraculous drug cocktails that have made HIV a treatable illness, we are treating HIV as if it is a death sentence that it was in the 1980s. We reauthorized the Ryan White CARE Act 5 years ago without making the necessary adjustments to reflect the progress we have made in treating patients, and there are some who would have us do this again this year. We know what it takes to control this disease. We must identify most of the carriers and get them into treatment, and we must effectively educate the uninfected population. Despite billions of dollars a year in expenditures to combat AIDS, we are failing on all counts. One need merely look at the numerous countries, both rich and poor, that are succeeding where we have failed to understand why. We don't do enough tests. We don't provide enough money to treat. We are spending too much money on drugs. We are not putting sufficient responsibility on the infected person to protect their partners. Until we have treatment readily available to everyone who needs it, we will continue to have more and more AIDS cases. Until testing is taken out of the rarified atmosphere of an anonymous test site and integrated into mainstream medical care in hospitals, clinics, and doctors' offices, we will not identify many of the people who are positive. Until we tell the drug companies that the U.S. Government will not write a blank check for purchasing HIV drugs, we will continue to have waiting lists for the AIDS Drug Assistance Program. Until we are honest with people about the consequences of becoming infected by HIV, which is not a day at the beach, as the drug company ads portray it as, we will fail to fight AIDS effectively in America. The solutions are quite simple. If you want to improve access to care, require that the lion's share of Federal dollars be spent on treating the disease. We are doing this in Los Angeles. The result is an extensive network of outpatient clinics, both public and private, across the vast geography of Southern California. Alameda County would have the same diversity of treatment options if most of their money were not being spent on food, housing, transportation, case management, and everything else. If you want to find more positives, you need to test more people in a fast, convenient, and cost-effective manner. Routine testing in health care settings without onerous counseling requirements is the only way to go. If you want to make drugs more accessible to more patients, you cannot pay higher and higher prices for each new generation of drugs, including those that are developed at government expense, thus eating up most of the new money that Congress has appropriated. If we identify more people who are positive and get them into treatment, the number of new infections will go down. If it goes down below the number of deaths, then the number of people living with HIV will be less each year rather than more. We need to resolve to put the money where it is most needed to stop AIDS. Rural areas and cities with emerging epidemics must get a bigger piece of the pie. Distributing funds based on where the epidemic was 10 years ago will not help us fight it where it is found today. The people most hurt by this are people of color, who represent the overwhelming majority of new cases of AIDS. Public health and politics are a dangerous mix. Too many decisions about how to address AIDS have been made on the basis of how one constituency or another must be appeased. This has led to a piecemeal, half-hearted approach that has led us to where we are now. There is no more fundamental function of government than the protection of the public health. I strongly urge the Congress to reauthorize the Ryan White CARE Act in a fashion that will protect generations to come from this devastating illness, and I would ask you to take another look at other areas of AIDS spending, such as vaccines and research, where there is enormous waste of public resources. If these changes are adopted now, I am confident that in the United States--this has happened in a country like Uganda, that I returned from last week and I have visited eight times--we will have less AIDS down the road rather than more. Thank you. Senator Coburn. Thank you. Ms. Scalco, I may have heard you wrong, and I skimmed your testimony. Was it your testimony that rapid testing is more expensive than standard counseling testing and results? Is that your testimony? Ms. Scalco. Rapid testing is more expensive to implement than doing Orasure testing and it has to do with the cost of the kit and the cost of the controls and the cost of the other supplies related to rapid testing. Senator Coburn. As compared to an Orasure test? Ms. Scalco. Yes. Senator Coburn. OK, which can be, in fact, done very easily? Ms. Scalco. Yes. However, with the Orasure, you have to wait approximately 2 weeks for results. We are very much in favor of rapid testing. It has given us the ability to get results to people much quicker and it assists with people who don't return for their results. Senator Coburn. We know many thousands of people don't come back every year---- Ms. Scalco. Right. Senator Coburn [continuing]. Who test positive. Ms. Scalco. So, yes, we would like to implement more rapid testing. Senator Coburn. But you are looking at the cost of the test only. You are not looking at the cost of the test to identify. Ms. Scalco. Yes. We are looking at the costs of the actual test as being more expensive. Senator Coburn. But the cost to identify that somebody is HIV-positive, a rapid test is far less expensive than the other---- Ms. Scalco. That is correct. Senator Coburn. OK. I wanted to clarify that. Mr. Weinstein, we have known each other for quite some time. You just espoused in your testimony a true public health approach to HIV. My thought on this as I listened to the testimony from CDC, 10 years ago, I tried to get the CDC to do testing for newborn infants. It was blocked. The American College of Obstetricians and Gynecologists was against it. Gary Ackerman and myself, bipartisan, one Democrat liberal, one Republican conservative, were totally blocked by the political forces. So I take what you say very seriously, but my response is, how do we get other people embracing public health strategies instead of political strategies when it comes to HIV? How do you help me do that? Mr. Weinstein. Just in the last 2 weeks, we passed historic legislation in California to bring about names reporting for the first time. It took us a long time, but we built a coalition and in the end, it was unanimous. Senator Coburn. Why did that happen? Mr. Weinstein. It happened, first of all, I believe immodestly, because groups like us were willing to stand up and say it was necessary. I think also, when we enacted the code system, it was horrible. And then lastly, the threat of losing Ryan White CARE Act funds. But whatever it took, it happened. We have a bill in the legislature now to simplify testing. We are talking about routine testing. Let me tell you how it actually works in the field today. It takes longer to do a routine test because of the regulations of CDC and the State of California than it took previously to do the other test. It takes 40 minutes to do a test. Now, how many people can we test if we do that? Also, in this country, if you want to get a free test in most places, you are required to answer a long list of intimate sexually explicit questions to a total stranger. If you go to a doctor, you don't have to do it. But if you want to do it in a public setting, the price you have to pay is to answer questions about the most intimate aspects of your life. I don't think that is right. Also, it was said earlier by the CDC that in a doctor's office, we are going to uncouple counseling from testing. But in the public setting, we are not going to do it. Well, that is wrong, I would say, because 80 percent of the people we test, and we have the largest testing program in California, are repeat testers. No. 1, they have the information, and No. 2, the last word they hear in that counseling session is ``negative'' or ``positive.'' If a person is positive, they need intensive counseling not just on that occasion, but following it, as well, to make sure they get into care. We have to be practical. If we are actually going to test more people, we have to do it differently, and also, I would say, I am sure this will not be a surprise to you to hear, but what is enacted in Congress is not implemented in many cases. The reality is across this country that women are not informed that their husbands or boyfriends are infected with HIV. Most women who we treat, and we have a large women's program, have no known risk factor for HIV. I don't know how long we have been talking about it, but it is not happening. And I think, again, going back to your question about how we enacted names reporting, unless there is a concrete penalty for not doing it, it will never be done, and I think that is a terrible thing. Senator Coburn. Why is that? I mean, if this is a public health strategy we use in other areas, why is it that CDC won't move to a common sense public health strategy that works? I am not saying that they haven't made some movement. They have, and I compliment them on that. But I am the author of informed science about the effectiveness of condoms that passed this Congress in the year 2000 which still hasn't been implemented by the CDC saying people ought to know the level of protection they get from a condom. With HIV, it is wonderful. It is great. With many other diseases, it is not. But that is never a part of the counseling. The point being is how do we get to the point where we embrace public health strategies where we can save lives, where we can prevent, in fact? How do we move past the politics? In other words, you are out there on the activist side of this. Ms. Scalco is on the implementation side of it. How do we move to where we get policies that are efficient and effective, that save lives, move the ball forward, spend the money where it is going to give us the best return in terms of life and quality of life? How do we move to that? How do we build that? Mr. Weinstein. Well, I would argue that since we are fighting AIDS as a global effort, and I know there is always a tension between States' rights and Federal directives, but there are laws in California and elsewhere that prevent many of these things from being done, as you heard earlier. Therefore, I think that because you can't fight AIDS town by town and city by city and State by State, I think there ought to be a Federal standard that is enforced, at least in some of these areas. And I think that when it comes to partner notification, it shouldn't be voluntary, because if there is a group of sexually active people and they know that they have a risk, they are making that as an informed choice. But a woman who is not aware that her husband or a woman who is not aware that her boyfriend is using drugs or is bisexual is not able to make that choice. I think that is a societal obligation and I don't see any problem, really. Given the fact that the Federal Government is the primary funder, I don't see a problem with the Federal Government requiring in exchange for that funding that this be universal. Senator Coburn. If somebody is diagnosed with syphilis in one of your clinics, is there mandatory reporting of that? Mr. Weinstein. Yes. Senator Coburn. Is there partner notification? Mr. Weinstein. Ineffectively, but it is supposed to. It is not done effectively, but yes, there is. Senator Coburn. It is supposed to be, though? Mr. Weinstein. It is supposed to be. It is done to some extent, but not as fully as it should be. Senator Coburn. But it is supposed to be. Mr. Weinstein. Yes. Senator Coburn. And there are statutes and regulations to back that up. Mr. Weinstein. Yes. Senator Coburn. Would you consider HIV more deadly than syphilis? Mr. Weinstein. Oh, there is no question about that. Senator Coburn. So why would we not have the same policy for a disease that is more deadly? Mr. Weinstein. How I look at it is if you look back over 25 years and you look at the ineffective Federal response, you look at the stigma and discrimination that was even more intense then but still exists now, myself and many activists felt that the first order of business was privacy, protection, and rights. I think that what the problem is, that we had a revolution in treatment of HIV and when the disease goes from being a death sentence to being a manageable illness, things change. When you look back historically about how we used to handle breast cancer, when Betty Ford and Nancy Reagan came out publicly about it, all of a sudden, the paradigm shifted and now there is public discussion and advocacy. It is totally transformed. So, I mean, it takes a while to catch up to these technological changes, but I think guidance needs to be given, again, by the Federal Government, which is the most expert. The Centers for Disease Control is the most expert. They know what works. I think they should give that guidance. Senator Coburn. Thank you. Ms. Scalco, you all have an EMA in New Orleans. Were funds transferred from that EMA to help you with some of the programs that you had during the midst of this hurricane and the things that followed thereafter and the disruption in care and treatment for patients? Ms. Scalco. Yes. We ultimately were able to transfer funds through contractual arrangements so that the funding could follow clients who had evacuated to other parts of the State. Senator Coburn. Is Louisiana put at a disadvantage because under the former formula we are using former AIDS diagnosis instead of HIV? Would Louisiana benefit in terms of funding formulas if the basis was where the disease is now and not where it used to be? Ms. Scalco. We believe that we may benefit. We believe that we could have benefitted if that had been instituted earlier in the epidemic. I think right now, we need to see where other States stand in terms of their HIV infections. But we definitely---- Senator Coburn. We have run those numbers. You will benefit, I promise you. Ms. Scalco. Yes, we may benefit, and in actuality, we are serving people who are HIV infected and so we would like them counted in the formula distribution. Chairman Coburn. I have several other questions, but I am going to shorten our hearing because we have something on the floor at 4 o'clock. I want to thank you for your testimony. I am committed for us to getting the Ryan White CARE Act reauthorization. It doesn't have to be mine. It does need to address the public health aspects of this. It does need to address diagnosis, prevention, but also care and medical treatment of those who have it. We know this is a disease that can be controlled. We also know that with the early testing, we can markedly decrease the number of potential infections in the future coming from that one vector, and so it is important that we all figure out where we can find the most common ground and get this to happen before the end of this year. I appreciate your work, both of you, in terms of trying to get this done, and the others that have been here today. My commitment is to work to get that done. Thank you very much. The hearing is adjourned. 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