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Presidential Advisory Council on HIV/AIDS 750 17th St., NW, Ste. 600 Washington, DC 20503 PROGRESS REPORT Implementation of Advisory Council Recommendations July 8, 1996 I. Recommendations made on July 28, 1995 I.A. Leadership Recommendation I.A.1. The President himself must engage the American public through a National Summit that encompasses the scientific, medical, social, and political aspects of the AIDS epidemic. This summit, which should be held by the end of this year, should consider the impact of race, culture, poverty, disability, region, gender, sexual orientation, and age on our ability to develop an effective national AIDS strategy. Administration's Response The December 6, 1995, White House Conference on HIV/AIDS was a rapid response to an important recommendation. It was a truly historic event that has been followed through with continued dialogue and outreach to the HIV-affected communities across the country, in particular through the series of town meetings being held. Assessment of the Response The first White House Conference on HIV/AIDS was a prompt and substantive response to this recommendation. During the past year, the Administration■s commitment to fighting HIV/AIDS has been clearly more visible. Followup Action Recommended See Recommendation A.2 in Section II. Recommendation I.A.2. The President should then proceed with an address declaring the battle against HIV a national health priority and laying out his vision for the ending of this epidemic. Administration's Response At the White House Conference, the President addressed the American people about the high priority that the fight against AIDS has for this Administration■and the importance of the epidemic to American society in general. In addition, the President directed that a number of important followup steps occur to show the continued commitment of the Administration to addressing this epidemic. This included asking the Vice President to work with the pharmaceutical industry to promote greater private sector involvement in AIDS research; asking that a transgovernmental plan and budget for AIDS research be developed under the leadership of Dr. William Paul, Director, Office of AIDS Research (OAR), National Institutes of Health (NIH); and asking that the Centers for Disease Control and Prevention (CDC) host a national meeting on the interrelationship of substance abuse and HIV. The Vice President has held a meeting with the pharmaceutical industry and is now engaging in additional followup; Dr. Paul has presented the Federal plan to the White House; and the CDC meeting is scheduled for this summer. Assessment of the Response The President began this process with his speech at the White House Conference. That address provided a well-constructed blueprint for an appropriate national response to the HIV/AIDS epidemic. Followup Action Recommended The Council is awaiting the Administration's more detailed and comprehensive national strategy on AIDS. I.B. Services Recommendation I.B.1. The President should continue his support of the Ryan White CARE Act and should endeavor to prevent the Congress from attaching unnecessary funding restrictions. He should also continue to vigorously support funding levels for the Ryan White CARE Act that are responsive to the rising caseloads and costs of delivering comprehensive services to people with HIV/AIDS and make the CARE Act a budget priority. Administration's Response The President's support for the CARE Act has been consistent and clearly articulated to the public and Congress. The President spoke out several times against the divisive tactics and amendments offered by Senator Jesse Helms. Administration officials at all levels made clear to Congress the Administration's position opposing all negative and extraneous amendments. It is unfortunate that the Republicans' distraction with the fight over Medicaid and the budget delayed completion of action on the CARE Act reauthorization, a measure for which there was such strong bipartisan support, but we are pleased to see it finally enacted into law. The President continues to show strong leadership in support for increased funding for the CARE Act in the current fiscal year as well as FY 1997. Throughout the budget negotiations, funding increases for the CARE Act programs were a top priority. As a result of this persistence, CARE Act funding increased $105 million in FY 1996. This includes a budget amendment made by the President last month requesting an additional $52 million earmarked for the hard-pressed AIDS Drug Assistance Program (ADAP) under Title II. Assessment of the Response The Council commends the Administration's continued efforts to expand funding for the CARE Act. In particular, we are pleased with the Administration's leadership role in obtaining a $52 million emergency appropriation for ADAP and its strong advocacy for an additional $53 million in FY 1996. The President has also requested a $69 million increase for the CARE Act in his FY 1997 budget request. We also commend the President for his leadership in building bipartisan support for the Ryan White CARE Act renewal and funding increases. Followup Action Recommended While these funding increases are vital, the Council recognizes that they are modest relative to the critical need for CARE Act- funded services, especially in light of new drug developments. CARE Act programs will continue to play an essential role in ensuring access to these new therapies and must therefore receive substantial increases in funding in future years. Recommendation I.B.2. The President must maintain a strong commitment to the entitlement status of the Medicaid program, including a willingness to veto any legislation that inadequately funds or transforms Medicaid into a block grant. Administration's Response The President has fulfilled his commitment to protect Medicaid as an entitlement by vetoing legislation that would have gutted the Medicaid program. In his statement explaining his veto, the President mentioned the importance of Medicaid for people with AIDS as one of the reasons for opposing Republican efforts to make drastic cuts in and to block-grant the Medicaid program. Assessment of the Response The President's leadership was strong and effective, particularly his ability to create bipartisan support for Medicaid and Medicare. Followup Action Recommended We will continue to work with the Administration to turn back future challenges to Medicaid and Medicare. Recommendation I.B.3. The President must continue to demonstrate his strong support for the Housing Opportunities for Persons with AIDS (HOPWA) and other Federal housing programs that serve people living with AIDS. The President should make housing for people with AIDS (PWAs) a FY 1997 priority. Administration's Response The President has demonstrated his support for housing programs in the FY 1996 budget cycle. HOPWA has been protected from cuts, while many other housing programs have faced severe reductions. In the context of what is occurring with other housing programs, this is a tremendous victory. In the context of the rising need for housing services, it is recognized by the Administration that flat funding is insufficient. The Administration is examining ways to mitigate this in the context of the FY 1997 budget. Assessment of the Response Congress has imposed major cuts in many housing programs. AIDS housing programs have not been cut in this fiscal year, in large part due to the Administration's support of HOPWA. However, while flat funding is remarkable in the current fiscal climate, it is entirely inadequate in the overall context of the HIV/AIDS epidemic. Followup Action Recommended The Council strongly supports the proposals by Housing and Urban Development (HUD) Secretary Henry Cisneros to reprogram $15 million within the FY 1996 HUD budget to provide additional funding for HOPWA and to amend the President's FY 1997 budget to add an additional $50 million to funding for housing programs serving PWAs. The Council will work with the Administration on this effort. The Council recognizes the need to address the significance of housing for people with HIV/AIDS and the need to integrate housing services into a continuum of care. I.C. Prevention Recommendation I.C.1. The President should make HIV prevention an investment priority during budgetary decision making. Administration's Response The President's commitment to HIV prevention programs remains strong. While the Congress failed to grant his request for additional prevention funding in FY 1996, once again the President is seeking a $35 million increase in prevention spending in FY 1997. Assessment of the Response The Council commends the President for his commitment to HIV prevention funding, evidenced by his request for an increase in both FY 1996 and FY 1997. While HIV prevention efforts have essentially received flat funding for the past several years substantial increases are needed in order to adequately address prevention efforts. In the face of the current congressional budgetary and political realities, the Council acknowledges that adequate funding is unlikely. Nonetheless, we believe that this goal is imperative. Followup Action Recommended The Council urges that the President continue his advocacy for prevention, understanding its central role in ending the HIV/AIDS epidemic, by vigorously working for congressional passage of his requested FY 1997 increase. I.D. Research Recommendation I.D.1. The President should continue to show strong support for a coordinated Federal approach to HIV/AIDS research, including continued support for the Office of AIDS Research (OAR). Administration's Response Both the President and the Vice President have been active in support of a coordinated Federal approach to HIV/AIDS research. The President requested preparation of The Federal Biomedical and Behavioral Research Plan and Budget for HIV and AIDS, which is a transgovernmental plan and budget prepared under the leadership of Dr. William Paul, Director, OAR. The Vice President has been engaged in discussions with the pharmaceutical industry and others regarding a better public/private collaboration in various areas of HIV/AIDS research■from vaccine and microbicide development to clinical effectiveness trials. The Administration has staunchly supported its request for a consolidated budget for AIDS research at the NIH. House Republicans continue to be adamant in their opposition to providing the OAR with its full statutory authority (i.e., a consolidated budget and authority to shift funds during the fiscal year). Senior Administration officials at the White House, the Department of Health and Human Services (HHS), and the NIH continue to press our case for restoration of this important authority in FY 1996 and for a continuation of that authority in FY 1997 and beyond, through the NIH reauthorization bill. I.E. Combating Discrimination/Social Prejudice Recommendation I.E.1. In talking publicly about HIV, the President should vigorously speak out against HIV-related discrimination and condemn prejudice based on race/ethnicity and sexual orientation, which damage our efforts to combat AIDS. The President should strongly and visibly oppose any amendments to HIV-related legislation that are designed to divide the American people along lines of sexual orientation, substance use history, race/ethnicity, or other factors. Administration's Response The President has spoken out against HIV-related discrimination throughout his term. He was eloquent in his response to Senator Jesse Helms's divisive tactics during the Ryan White CARE Act debate. The President has most recently endorsed passage of the Employment Non-Discrimination Act, which would ban employment discrimination based on sexual orientation. All enforcement arms of the Administration have been working effectively and collaboratively in challenging HIV-related discrimination. The Justice Department and the Equal Employment Opportunity Commission (EEOC) are vigorously enforcing provisions of the Americans with Disabilities Act that prohibit discrimination against people with HIV/AIDS. The EEOC has received more than 900 charges alleging employment discrimination against people with HIV and AIDS and has resolved 789 charges, obtaining monetary benefits of over $6.1 million to the affected parties. The Health Care Financing Administration (HCFA) has taken action on nearly 20 complaints of denial of care by health care facilities or providers to persons with HIV/AIDS, and new efforts are being made to address discrimination in nursing homes. Assessment of the Response/Action To Be Taken The President is to be commended for his clear and vocal leadership in speaking against HIV-related discrimination. Strong antidiscrimination efforts and vigorous condemnation of prejudice-based discrimination must be continued. II. Recommendations made on December 8, 1995 II.A. Leadership Recommendation II.A.1. During his State of the Union Address, the President should renew his commitment to ending the AIDS epidemic and to committing our Nation's resources to preventing new infections, caring for people now living with HIV/AIDS, and finding a cure, a vaccine, and effective treatments for HIV. The President should, during this address, announce the immediate release of his updated national strategy on AIDS. Administration's Response During his State of the Union Address, the President focused on the health-related issue of greatest importance to people living with AIDS: the battle over Medicaid and Medicare. In that context, he renewed his pledge to protect Medicaid as an entitlement and to fight unreasonable cuts in funding. He mentioned people living with HIV/AIDS as a group that needed the protections Medicaid offered. The President has also mentioned the importance of Medicaid to people living with HIV/AIDS in other contexts as well. The National Strategy on HIV/AIDS is in final review. It is the Administration's hope to have a document ready for release in June. Assessment of the Response The President did mention AIDS in his State of the Union Address, although only in the context of health care. Followup Action Recommended It is important that the President continue to remind the Nation that much remains to be done in the battle against HIV/AIDS. It is essential that the President and his Administration strategize on how to systematically communicate, in all contexts, the impact of the HIV/AIDS pandemic on the Nation and the world. The President should continue to affirm his commitment to ending the AIDS epidemic and to committing the Nation's resources to preventing new infections, caring for people now living with HIV/AIDS, and finding a cure, a vaccine, and effective treatments for HIV. Recommendation II.A.2. To further accomplish the goals President Clinton outlined at the White House Conference on HIV/AIDS, the Clinton/Gore Administration should ensure that key Cabinet Secretaries initiate and maintain regular face- to-face meetings with HIV service providers, people living with HIV/AIDS, and their advocates to ensure consistent and ongoing communication and partnership with community members on the front lines of the AIDS epidemic. Administration's Response The Office of National AIDS Policy has initiated a series of regional town meetings featuring senior Administration officials and members of the Presidential Advisory Council on HIV and AIDS. The chief purpose of these meetings is to continue the dialogue with HIV service providers, people living with HIV/AIDS, and their advocates. Meetings have been held in Dallas/Fort Worth, New York, Newark, NJ, Miami/Fort Lauderdale, San Diego, and San Francisco. Further meetings are planned for Chicago, Cleveland, Los Angeles, and Durham, NC. In addition, Administration officials are continuing their ongoing dialogue with national and community leaders. For example, HUD Secretary Cisneros holds regularly scheduled meetings with AIDS housing advocates. HHS Secretary Shalala has had many such meetings. There is also considerable consultation between the HIV community and sub-cabinet officials. Assessment of the Response Progress has been made on this recommendation. Cabinet Secretaries and senior officials are actively involved in ongoing discussions with HIV service providers and persons affected by HIV/AIDS. The regional meetings being conducted are commendable. The meeting between Vice President Gore, Government scientists, and industry representatives was an outstanding beginning to the dialogue that must continue about HIV treatment, microbicides, and vaccines. Followup Action Recommended A mechanism should be put in place to ensure that suggestions and ideas from regional meetings are disseminated to interested and affected parties. Relevant and appropriate recommendations should be incorporated into the national strategy on AIDS. The Council urges all relevant Cabinet Secretaries to take a more proactive approach to regular face-to-face meetings with HIV service providers, people living with HIV/AIDS, and their advocates.II.B. Services Recommendation II.B.1. Continue to support and defend the entitlement status and funding for Medicaid and Medicare, and continue to oppose any efforts to restrict eligibility and services for people living with HIV/AIDS. Administration's Response The President has successfully fought to maintain the entitlement status of Medicaid; he has blocked attempts to make drastic cuts in Medicaid spending; he has opposed the block-granting of this program; he has supported a guaranteed package of benefits; and he has opposed attempts to remove the private right of action against inadequate State Medicaid programs. Assessment of the Response The continuing evolution of the variety of proposed changes makes our continued vigilance in following this issue essential. The Administration's strong opposition to the proposed changes that have come to date is acknowledged and supported by the Council. Followup Action Recommended The Council should continue monitoring changes in Medicaid and Medicare as they are proposed in legislation. Recommendation II.B.2. Direct that any waivers granted to States under the Medicaid program ensure access to a comprehensive continuum of care for people living with HIV/AIDS. To implement this policy, the President should direct the HCFA to establish national criteria by which to assess State waiver applications and to ensure that these criteria be consistent with current health care knowledge. These criteria also should be consistent with the provisions of the Americans with Disabilities Act (ADA), and State plans should be reviewed for this purpose by the HHS Office of Civil Rights. Administration's Response HCFA is currently reviewing all State Medicaid managed care waiver proposals to ensure continuity of care for Medicaid beneficiaries with HIV/AIDS, including education and outreach efforts during the managed care process, and procedures for disenrollment from HMO programs if continuity and quality cannot be provided through such arrangements. These general criteria have already been applied in several State waiver reviews (e.g., New York, California, and Florida). HCFA is now developing monitoring guidelines to evaluate and promote improvement in Medicaid managed care waiver programs serving people with HIV/AIDS, as well as guidelines for the content and coordination of home care services provided in managed care settings. During consideration of waiver applications, HCFA has worked closely with relevant community representatives with concerns about a specific State's proposal. In addition, all relevant agencies of HHS■such as the Office for Civil Rights and the Bureau of Primary Health Care at the Health Resources and Services Administration (HRSA)■have an opportunity to review State waiver applications. The HRSA AIDS Program Office will also review waivers with a special focus on HIV/AIDS issues and will, through its HIV/AIDS Managed Care Group, contribute to the development of the national monitoring guidelines being developed by HCFA. Assessment of the Response The Council acknowledges HCFA's work in establishing criteria that, while not yet in final form, have been used on a case-by- case basis in reviewing waiver applications. Followup Action Recommended We continue to desire that these criteria become "formalized" to ensure they are applied to all future waiver applications and that waivers approved include enforcement procedures to ensure that minimum standards of care are met. The Council will remain engaged in monitoring waivers being sought, with the goal that these waivers fully protect people with HIV/AIDS. Recommendation II.B.3. Direct HCFA to ensure that State Medicaid programs cover HIV testing and counseling. Administration's Response Medicaid may cover counseling and testing in the context of routine care for Medicaid clients. In addition, HCFA now leads a cross-cutting effort within HHS to provide outreach and information to Medicaid-eligible women regarding the potential benefits of HIV counseling and testing and, if appropriate, AZT treatment for pregnant women. HCFA has also sent policy guidance to State Medicaid directors that promotes full coverage and access for HIV counseling and testing services and AZT treatment pursuant to the results of AIDS Clinical Trials Group 076 protocol. Assessment of the Response The Council suggests this recommendation be incorporated into any reviews of standards of care and treatment that are developed over time. HCFA appears to be using all its available tools under current law to ensure that all Medicaid-eligible persons are offered HIV testing and counseling. The greatest need is to persuade Medicaid providers and physicians to offer testing and counseling as an element of routine preventive medicine. Followup Action Recommended The Council requests that HCFA (1) keep the Council regularly informed about the extent to which this goal is being achieved, and (2) propose new measures that would further this goal. Recommendation II.B.4. Direct HCFA to report to the Council, at its next meeting, possible strategies to address the need to ensure that all Food and Drug Administration (FDA)- approved drugs are covered under State Medicaid plans, even when prescribed for "off-label" indications. These strategies should address both policies and vigorous enforcement mechanisms. Administration's Response The Federal drug rebate law requires States to provide coverage for off-label uses of FDA-approved drugs, including those used in the treatment of HIV/AIDS. A policy guidance similar to that issued regarding AZT for pregnant women is being developed for State Medicaid directors to promote full coverage and access to the newly approved protease inhibitors. Assessment of the Response As new therapies become available for HIV, it will be imperative for HCFA to communicate the resulting new standards of care to States, thus ensuring HIV drug reimbursement in participating States. Followup Action Recommended The Council will continue to work with the Administration on this issue to ensure that States pay for all approved drugs if they have agreed to drug reimbursement. Recommendation II.B.5. The Administration should direct those Federal agencies that either finance or administer health care services (including but not necessarily limited to HCFA, the Department of Veterans' Affairs [VA], the Department of Defense, and the Department of Justice Bureau of Prisons) to develop oversight guidelines for HIV managed care programs. This will also require effective regulatory enforcement mechanisms. Administration's Response See response to Recommendation II.B.2. regarding HCFA's policies. While the VA provides guidance to its clinicians regarding standards of care for people with HIV, it does not restrict the discretion of the practicing physician to determine a treatment protocol for an individual patient. Most HIV-related care in the VA system is delivered by infectious disease specialists who serve as the primary care providers for people with HIV. The Office of National AIDS Policy has convened a working group of Federal agencies with programs affecting the incarcerated, including the Bureau of Prisons, with the express purpose of developing a standard of care for prisoners with HIV disease. Assessment of the Response This recommendation requires development of policies, procedures, and support to be used by community organizations, as managed care develops over time. Thus, the vast array of actions required to fully implement this recommendation is a work in process. This is very important to ensure that treatment, over time, is accessible, effective, complete, and timely. The Indian Health Service should be included as one of the agencies covered under this recommendation. Followup Action Recommended The Council must ensure that ongoing progress continues and that community organizations, which have been central in providing health care for persons with HIV/AIDS, remain an integral part of any managed care system and continue to receive appropriate support as the managed care environment develops. Recommendation II.B.6. The Administration should direct HRSA to develop a coordinated agency-wide approach that provides effective education, training, and technical assistance to HIV/AIDS providers and AIDS service organizations on health care management issues. Such an approach should include active participation by the private sector. Administration's Response HRSA has instituted several activities in response to the managed care movement. These include: * Establishment of the HRSA Managed Care Priority Group, which formed a partnership with American Association of Health Plans, formerly, Group Health Association of America, and jointly planned a national conference, April 1-2, 1996, to address managed care issues that relate to HRSA's mission and programs. * Formation of a subgroup of the HRSA AIDS Priority Committee/HRSA AIDS Coordinators to develop a strategy to address the issues of managed care and HIV/AIDS. * Implementation activities by the Bureau of Primary Health Care that have resulted in the development of a comprehensive managed care program that gives training, technical assistance, supplementary grant support, and access to senior executives in the managed care industry. The program includes training in managed care operations and procedures to health center staff, on-site technical assistance, network development, self-assessment tools, and collaborative initiatives with other Federal agencies, State and local governments, national organizations, private sector providers, and others involved in serving underserved populations. The Title III(b) programs (early intervention services for HIV/AIDS) are included in these activities. Recently, the Bureau of Primary Health Care has developed an agreement to train State health officials involved in the administration of CDC grants on managed care issues and has also initiated bureau-wide staff training in managed care. * Active involvement of the AIDS Education and Training Centers (AETC) program in providing HIV training to providers working in managed care settings. * Rapid dissemination of findings from five Special Projects of National Significance (SPNS) grants. These are grants to design and evaluate HIV capitated care approaches. Findings from these grants will be disseminated to HRSA grantees and other HIV providers through presentations, training, fax-out bulletins, and technical assistance to individual grantees. The SPNS grantees have participated in Titles I, II, and III(b) training sessions or meetings during the past 12 months. Assessment of the Response HRSA has been responsive in developing programs and plans for working with its grantees to understand the changing world of managed care and how they can continue to be essential care providers. Nevertheless, the vast array of actions necessary to fully implement this recommendation is a work in process. This is very important to ensure that treatment, over time, is accessible, effective, complete, and timely. Followup Action Recommended The Council must ensure that ongoing progress continues and that community organizations, which have been central to providing health care for persons with HIV/AIDS, remain an integral part of any managed care system. The Secretary of HHS needs to ensure that education, training, and technical assistance on managed care be made available to all grantees of the Ryan White CARE Act. It will also be important to ensure, over time, that adequate monitoring and reporting systems are developed to enable the Secretary to assess whether and to what extent all managed care systems, including comprehensive health centers, provide the full range of high-quality care and services needed by clients with HIV/AIDS. Recommendation II.B.7. Because complementary therapies are widely used, the President should direct all appropriate agencies to support investigation of the efficacy of complementary therapies and provide increased financial support for this effort. Therapies shown to have benefit should be reimbursed under Medicaid. Administration's Response The NIH Office of Alternative Medicine (OAM) has awarded a number of grants in the area of alternative therapies for AIDS. In addition, the recent report of the NIH AIDS Research Program Evaluation Working Group contains a specific recommendation that NIH should "strengthen the scientific base for the assessment of complementary and alternative therapies for HIV disease." Under the law, Medicaid can cover only FDA-approved treatments. There is a pending policy statement for Ryan White CARE Act Titles I and II that would permit CARE Act funds to be used for complementary therapies. Assessment of the Response Both the Council and the report of the NIH AIDS Research Program Evaluation Working Group confirm the importance of complementary therapies in the management of HIV disease. This area of research is only now beginning to receive the attention it deserves. Followup Action Recommended We expect HRSA to implement its proposal to allow alternative and complementary therapies to be reimbursed under the Ryan White CARE Act. HHS should convene a working group to assess mechanisms to obtain third-party coverage, including Medicare or Medicaid, for complementary therapies. This evolving area will require continued monitoring by the Council. Recommendation II.B.8. The President should continue to support full funding to a national network of AETCs, and direct HRSA to ensure that the work of the AETCs is coordinated with community providers and planning groups. Administration's Response The President supported $16.3 million for the national AETC program in FY 1996. The final appropriation for the AETCs was only at $12 million. The President has requested $16.3 million for the AETCs in his FY 1997 budget. It is a priority of the AETC program to establish close working relationships with community providers and planning groups and to include community input in development of training activities and information dissemination plans. This has been accomplished more successfully in the epicenters, where the 15 main grantees are located, than in less affected areas. The proposed inclusion of the AETC program in the reauthorized Ryan White CARE Act will help to strengthen the relationship with these community providers. Assessment of the Response The Council commends the President's leadership in restoring funding for AETCs even though Congress reduced the final allocation from $16.3 million to $12 million in FY 1996. While we agree that a closer working relationship has been developed by many AETC sites with local community providers and planning groups, other sites have been less successful. We recognize the important function the AETC program plays in training health care providers in delivering quality, state-of- the-art care. Followup Action Recommended We support the President's request in his FY 1997 budget to restore funding for AETCs to $16.3 million. The director of the AETC program should monitor the working relationship of each AETC with its associated planning councils, consortiums and other HIV coalitions in order to ensure more definitive and appropriate training efforts in all the regions. Recommendation II.B.9. The Administration should direct HRSA to review and report to the Council at its next meeting the effectiveness of the Bureau of Health Professions' education activities specific to HIV/AIDS. Administration's Response A written progress report on this recommendation will be provided prior to the September meeting of the Council. Assessment of the Response The continuing inability of many health care providers to recognize and diagnose HIV infection, particularly in women, and provide state-of-the-art therapeutics is directly related to the need for ongoing education on HIV infection. In light of the funding decreases to both the AETC program and to overall health professions education, the Council is concerned about the impact on the diagnosis and care of HIV-infected persons. Followup Action Recommended The Council requests that the AIDS Program Office and HRSA's Bureau of Health Professions work together to respond to these concerns. A substantive written response, with recommendations for action, should be made available to the Services Subcommittee 30 days prior to the next Council meeting. II.C. Prevention Recommendation II.C.1. The CDC and the President should direct the Secretary of HHS to produce an annual estimate of HIV incidence based on seroprevalence studies and to work to ensure a reasonable relationship between epidemiological trends and CDC prevention funding. This report should specifically examine the demographic characteristics and geographic distribution of populations that experience disproportionate increases in new infections. * The CDC should issue to the President an annual estimate of HIV incidence based on seroprevalence studies that provides a geographic and demographic analysis of the populations where there is a continuing disproportionate increase in new HIV infections. * The President should direct the Secretary of HHS to ensure that resources are allocated to accomplish this task. * The President should ensure that funding is adequate and responsive to the epidemiological trends, needs, and prevention infrastructure of affected communities. Administration's Response It should be noted that CDC's prevention programs have been flat- funded by the Congress, despite the President's efforts to obtain significant increases. Therefore, decisions to invest additional resources in one area often result in difficult decisions to cut back in others. CDC is working to derive annual HIV incidence estimates in selected subpopulations, including injection drug users (IDUs) and clients of sexually transmitted disease (STD) clinics. However, current methods have not succeeded in producing reliable HIV incidence estimates for the country as a whole. As part of the community planning process, State and local health departments are expected to document that programming for HIV prevention reflects the local epidemiology. Grant applications are being reviewed with this in mind, and States and localities not following this portion of the guidance will be provided technical assistance. When necessary, CDC can and will require revisions in State plans. Assessment of the Response The Council is pleased that the CDC has determined that HIV incidence estimates within subpopulations must play a central role in the development of HIV prevention and education programs. Followup Action Recommended The Council recommends that the CDC continue to pursue means to achieve reliable national incidence estimates using data from surveillance systems and special studies, as needed, and that the Council be periodically updated on the progress in this area. Furthermore, we recommend that the CDC report to the Council on its efforts to develop HIV seroincidence estimates, including adequacy, effectiveness, and efficiency of funding such efforts. Finally, the Council supports the requirement for State and local health departments to document that programming for HIV prevention reflects the local epidemiology. We urge strong enforcement of this policy as well as the provision of relevant technical assistance. Recommendation II.C.2. * The President should direct the CDC to develop a behavioral surveillance mechanism that will provide an analysis of patterns in risk-taking behavior. * The President should direct the CDC to join with the National Institute on Drug Abuse (NIDA) and other relevant agencies to institute surveillance methods for detecting patterns of risk-taking behaviors in populations that show a continuing disproportionate increase in AIDS cases. * He should direct the Secretary of HHS to coordinate the planning of an early warning system and ensure its ongoing use. Administration's Response CDC agrees with the Council's recommendation to develop a behavioral surveillance mechanism to monitor patterns of risk- taking behavior. In addition, behavioral surveillance can monitor the adoption of protective behaviors that decrease the risk of HIV transmission. CDC is in the process of integrating standard HIV data elements in ongoing behavioral surveillance mechanisms, coordinating surveillance approaches for HIV with those for other STDs, and continuing expanded surveillance of persons reported with HIV infection and AIDS. CDC will soon solicit proposals for behavioral surveillance of subpopulations at particular risk for HIV infection, to be initiated in FY 1997. While surveillance does not fall within the mission of the NIH, program staff of NIDA will consult with CDC program staff to develop a better method to detect patterns of risk behavior. In addition, the Substance Abuse and Mental Health Services Administration (SAMHSA) and CDC's National Center for Health Statistics (NCHS) are collaborating on an interagency agreement that would use SAMHSA's National Household Survey on Drug Abuse to collect new data. This includes incorporating NCHS's HIV/AIDS Risk Behaviors Module into the National Household Survey. CDC will also encourage local areas to use HIV surveillance or prevention funds for surveys of sexual behavior in the general population. As indicated above, State and local prevention partners are expected to direct their programs (and funds) in response to the epidemiology of the epidemic in their localities. Assessment of the Response The Council commends the Administration's efforts toward fulfilling this recommendation. It is our understanding that the Administration has made progress toward this goal. We acknow- ledge that developing an effective behavioral surveillance mechanism presents difficult scientific challenges. Furthermore, once developed, efficient dissemination of the findings as a part of an "early warning system"■although critical■will require extensive planning. Followup Action Recommended The Council requests that we be briefed at our next full Council meeting on the Administration's efforts to date and plans for future efforts in this area and that appropriate members of the Council be included in the ongoing development of this necessary prevention tool. Recommendation II.C.3. The Administration should pursue a comprehensive strategy to decrease HIV transmission related to injection drug use, which accounts for at least 50 percent of new HIV infections. In addition, high-risk sexual behavior while under the influence of drugs and/or alcohol accounts for another significant percentage of new cases of HIV disease. Strategies must explicitly address the sharing of injection drug use paraphernalia, as well as the high- risk sexual behavior associated with drug and/or alcohol use. Administration's Response The need for a comprehensive approach to substance abuse and HIV transmission was recognized by the President in his remarks at the White House Conference on HIV/AIDS on December 6, 1995. In that speech, he directed the CDC to convene a meeting designed to develop a cross-governmental strategy. This meeting is scheduled for this summer. In addition, the White House Office of National AIDS Policy has convened a working group of the Interdepartmental Task Force on HIV/AIDS to consider these issues. Assessment of the Response See Recommendation II.C.3a-c. Followup Action Recommended See Recommendation II.C.3a-c. Recommendation II.C.3.a. Increase access to effective substance abuse prevention and treatment research programs by: * Opposing congressional efforts to cut SAMHSA and other Federal funding for drug abuse treatment and prevention programs in FY 1996 appropriations. * Restoring budget requests for SAMHSA and other Federal funding for drug abuse treatment and prevention programs to at least the FY 1995 levels. * Supporting the continuation of specific funding for NIDA's AIDS demonstration projects. Administration's Response The President has fought for increased funding for substance abuse treatment and has opposed Congressional efforts to cut back dramatically on substance abuse funding. For FY 1997, the President has requested $1.272 billion for the Substance Abuse Performance Partnerships, the principal source of Federal funding for substance abuse treatment. This is $32 million above the FY 1995 spending level. The President's FY 1997 AIDS research budget request is contained in a consolidated account for the NIH OAR. The final level for projects proposed by NIDA will be determined by the Director of OAR in accordance with the priorities and objectives of the NIH Plan for HIV-Related Research. Assessment of the Response The Council commends the President for his support for expanded access to effective substance abuse prevention and treatment programs and the Administration's support of the Substance Abuse Performance Partnerships. Followup Action Recommended The Council recommends that the Administration actively support the reauthorization of SAMHSA programs and that the Director of the Office of National Drug Control Policy be engaged in communicating the importance of SAMHSA programs in our Nation's effort to reduce illicit drug use. Representatives of the Council would like the opportunity to meet with the Director of the Office of National Drug Control Policy. Recommendation II.C.3.b. Revise the Department of Justice Model Drug Paraphernalia Act, which serves as a model for State drug paraphernalia laws, to make it consistent with current reports, studies, and data relating to the access to sterile syringes as an effective intervention to counter HIV transmission among IDUs. Administration's Response CDC and a variety of Federal and nongovernmental agencies sponsored a "Consultation on Recommendations for Model Laws and Regulations Related to the Sale, Possession, and Distribution of Syringes," held at the Carter Presidential Center in Atlanta, Georgia, on Thursday and Friday, May 16-17, 1996. Leaders from the fields of public health, substance abuse treatment, pharmacy, medicine, ethics, and criminal justice participated. Sponsors included the Task Force for Child Survival and Development, the Kaiser Family Foundation, CDC, and the Georgetown/Johns Hopkins University Program on Law and Public Health. This meeting included a review of the Model Drug Paraphernalia Act. The Department of Justice will assess any changes in the model law based on the recommendations of the Secretary of HHS. Assessment of the Response We strongly commend the CDC for its leadership in convening this important meeting. We welcome the opportunity to engage in a dialogue with other public health, substance abuse treatment, pharmacy, medicine, ethics, and criminal justice professionals, as well as with State and Federal lawmakers to ensure that Federal and State laws regarding drug paraphernalia are consistent with current scientific knowledge. Followup Action Recommended The Council requests that it be briefed on what specific steps have been taken and those planned for the future. Recommendation II.C.3.c. The President should direct the Secretary of HHS to provide a recommendation (within 90 days) regarding the impact of needle-exchange programs on HIV infection and substance abuse. The recommendation should be based upon current reports, studies, and data on needle-exchange programs, and should include specific recommendations for programs and demonstration projects to implement needle exchange. The Secretary should develop and execute a plan to carry out the recommendations and indicate what programs and demonstration projects will be started or expanded. Administration's Response No action has been taken. Assessment of the Response The Council continues to have grave concerns that Federal policy regarding needle-exchange programs is not consistent with current knowledge and understanding regarding the impact of such programs on HIV prevention efforts. Followup Action Recommended Council representatives intend to meet with the Secretary of HHS and the Assistant to the President for Domestic Policy as soon as possible to explore steps to bring Federal policy in line with current scientific knowledge. Recommendation II.C.4. The President should reaffirm his support for community- based planning for prevention activities. Recommendation II.C.4.a. Direct the CDC to maintain HIV prevention programs independent of any consolidated grant programs, including the currently proposed Performance Partnerships Grants. Administration's Response CDC will continue to support community-based planning for HIV prevention efforts and will work to coordinate HIV prevention programs with other prevention services and activities serving the same populations. The Administration has decided to keep the HIV prevention programs separate from the new Performance Partnerships Grant structure. Assessment of the Response/Followup Action Recommended The Council is pleased that the Administration has decided to maintain the strategically important approach of community-based planning for HIV prevention efforts, as focused and distinct efforts from other health planning needs. We urge the Administration to continue this policy. The Council supports the Administration's efforts to find ways to increase the coordination of HIV prevention efforts with related health concerns and facilitate effective and efficient health planning by State and local health departments. Recommendation II.C.4.b. Direct the CDC to continue direct funding to community- based organizations. Administration's Response CDC has worked closely with community-based organizations over the past six years and views them as valuable partners in HIV prevention. CDC has extended the cooperative agreement for direct funding of HIV community-based organizations through March 1997. CDC will continue discussions with governmental and nongovernmental partners to determine the best ways to ensure that the HIV prevention needs of at-risk populations, currently addressed by community-based organizations, will continue to be met beyond April 1997. Assessment of the Response The Council supports the CDC decision to extend direct funding to community-based organizations through March 1997. We believe that this will allow for a natural transition and integration of these programs and organizations into the broad prevention efforts being developed in the HIV prevention planning process. Followup Action Recommended The Council recommends that this extension period be used to develop a strategic plan by which the communities, subpopulations, and programs that these organizations represent will continue to be served beyond 1997. The Council recommends that the direct funding of community-based organizations be maintained. Further, we recommend that the CDC clarify the relationships between directly funded community-based organizations and State/local health departments; develop clear guidance to ensure coordination between local planning groups, health departments, and community-based applicants for CDC funds; and provide support for program evaluation and accessible technical assistance. Recommendation II.C.4.c. Direct the CDC, with the assistance of existing national minority organizations and other appropriate partners, to structure its technical assistance programs to address the prevention program development and infrastructure needs of populations that are currently experiencing a continued disproportionate increase in new infections. Administration's Response CDC will continue to work through the National/Regional Minority Organizations (NRMOs) Grant Program to strengthen the capacity of existing NRMOs to work in partnership with CDC in the development of culturally competent HIV prevention programs for communities of color that are at increased risk for HIV infection. Beginning in FY 1994, activities for this program were refocused to concentrate on providing culturally competent and relevant technical assistance and training in organizational capacity building and programmatic development to organizations and agencies (primarily State and local health departments and minority community-based organizations) that offer HIV/STD prevention services to racial/ethnic minority populations. National organizations also provide tools and consultation to project areas to help assess technical assistance needs and priorities in support of HIV prevention community planning. Assessment of the Response The Council supports the CDC decision to continue its support of the NRMO Grant Program. Followup Action Recommended The Council requests that it be given an overview of what other partnerships the CDC has made in the effort to reach populations and subpopulations that are experiencing disproportionate increases in HIV infection rates (e.g., rural populations, young gay men, gay men of color, women, and IDUs). Additionally, we request that the CDC provide the Council with its assessment of the current NRMO technical assistance program and, if any changes or alterations are planned, ensure that the program is responsive to the current capacity-building and programmatic development needs of organizations serving the most highly impacted populations and subpopulations. Recommendation II.C.5. Direct the Director of the Indian Health Service (IHS) to develop a comprehensive AIDS prevention and care plan for Indian Country (within 90 days) with the input from consumers of IHS services. Administration's Response A review of the IHS AIDS prevention program is completed and will be available for the Council at its April meeting. Assessment of the Response We acknowledge the receipt of IHS's HIV/AIDS Prevention Program Report. Followup Action Recommended The Council requests an update on the implementation of the Summary of Findings and appendices contained in the IHS's HIV/AIDS Prevention Program Report, along with supporting documentation of consumers' input. II.D. Research Recommendation II.D.1. The Vice President's leadership and technological expertise should be sought to bring together the resources and expertise of various Government agencies, the private sector, community groups, and other nations in the effort to develop HIV vaccines and microbicides and to "reinvent" the Government's involvement in development of these products. Administration's Response On February 20, 1996, Vice President Gore met with representatives of the pharmaceutical industry regarding expanded collaboration between the public and private sectors on AIDS research. The meeting included a discussion of the need for greater industry and Government involvement in the development of microbicides. The Vice President has expressed interest in a continued role in furthering this area of research and development. Assessment of the Response The meeting between Vice President Gore, Government scientists, and industry representatives was seen as a productive and useful first step in the process of reinventing the partnership between Government and private industry in the development of HIV vaccines, microbicides, and other new therapies. Followup Action Recommended It is imperative that this dialogue continue. Another meeting between the Vice President and other concerned groups should be convened by September 1 in order to keep the momentum for this partnership thriving. Furthermore, it is essential that community groups be included in future discussions, and that the Council be informed of these meetings. Recommendation II.D.2. The priority for funding by the OAR for microbicide research and development, as well as such funding within CDC, must be increased substantially, with a concomitant increase of full-time equivalents (FTE's) allocated for this priority. Administration's Response NIH funding for research on microbicides has increased over the past several years and will continue to increase. The priority accorded to this important area of research has been determined through the OAR planning process, which included consultation with NIH and nongovernment scientists, clinicians, academicians, industry representatives, and AIDS community advocates. These experts reached a consensus on the scientific priorities included in the consolidated NIH Plan and Budget Request. OAR anticipates that this research will continue to receive high priority for funding. At CDC, the Epidemiology Branch, Division of HIV/AIDS Prevention (DHAP), in collaboration with the Division of Reproductive Health, the Division of STD, and the Women's Health Program Office, coordinated a meeting in mid-April to discuss policy, research, and program issues concerning microbicide research relative to CDC's mission of HIV prevention. This meeting was attended by CDC researchers, outside consultants, and representatives from NIH and FDA. Regarding ongoing research, the CDC HIV/AIDS Epidemiology Branch, in collaboration with the Division of Viral and Rickettsial Diseases, is currently conducting a three-year prospective study of HIV in female genital tract secretions. Studies are also being conducted within the Epidemiology Branch to examine women's interpretation of HIV prevention messages as a function of relevant beliefs and goals concerning close relationships and potential biases in message interpretation due to contextual framing information and the hierarchical presentation of message content. Assessment of the Response The Administration is certainly moving in the right direction regarding this area, although these concrete increases have not yet been seen. The President has used his leadership to emphasize the importance of this area to the public. Two meetings have been held (CDC, 4/15/96, with Patsy Fleming, Director, Office of National AIDS Policy, and others in attendance, and the International Working Group on Microbicides, in Virginia, 4/11/96). Followup Action Recommended The Administration should require each relevant agency and NIH institute to provide, on an annual basis, information on specific funding and FTE allocations being applied for microbicide research. Tracking of this information should include the specific types and nature of the research being conducted. Current efforts should be continued, and overall funding for microbicide research must significantly increase. Recommendation II.D.3. The Government should develop mechanisms to increase the pool of investigators in microbicide research and development, especially those involved in biomedical and behavioral aspects. Administration's Response Attracting new investigators into the field of AIDS research is a high priority for the NIH. Several mechanisms are already in place, such as the AIDS Loan Repayment Program, and others are under development. There are at present no special initiatives to increase investigators in any specific areas related to AIDS research, such as microbicides. Assessment of the Response While two recent meetings on microbicide research may have generated interest in this area by biomedical and behavioral researchers at the involved institutions, as yet there has been no evidence of specific mechanisms to increase the pool of investigators in this area. Followup Action Recommended The NIH, OAR, and CDC should issue Requests for Applications for training grants and for focused research projects related to microbicides. Federal agencies and institutes should track the monies being spent on training of potential investigators in the field of microbicide research. Recommendation II.D.4. In HIV/AIDS clinical research, the NIH must ensure the early and fundamental involvement of behavioral and social scientists in the process of initial study development, design, and implementation. Administration's Response The NIH has identified the issues of recruitment, retention, and adherence to clinical trial protocols and therapeutic regimens as important behavioral and social science research components of clinical research. These issues are critical to the outcome of these studies. The NIH is encouraging projects that link these important behavioral and clinical research issues. This is an important element of current NIH vaccine efficacy trials. Assessment of the Response This recommendation has not been implemented. The four recommendations listed in the Executive Summary of the NIH AIDS Research Program Evaluation Working Group Report (page 18) do not address this recommendation. However, NIH has identified the issue as an important component of clinical trial protocols and vaccine efficacy trials. Followup Action Recommended The Council will postpone recommendations for action until the report from the Behavioral, Social Science, and Prevention Area Review Panel of the NIH AIDS Research Program Evaluation Working Group is reviewed by the Council. Recommendation II.D.5. HHS should develop ongoing mechanisms to ensure the rapid translation of breakthrough research findings into clinical practice. Administration's Response The NIH has established a number of mechanisms to translate research findings to clinical practice. The NIH sponsors state- of-the-art and consensus conferences, coordinated through the NIH Office of Medical Applications of Research (OMAR), part of the Office of the Director of the NIH. A consensus meeting on behavioral research and HIV prevention is scheduled for this June. This is a critical tool for translation of science into practice. OAR is also currently planning a consensus conference with OMAR regarding the use of antiretroviral therapy in light of the many new advances in therapeutic research, including the new protease inhibitors recently approved by the FDA. In addition, the NIH supports ongoing programs as well as new initiatives in the field of research information dissemination, including: * Clinical Alerts to rapidly disseminate research findings to health care professionals, the media, and the public. * Clinical Alerts are available on-line on the MEDLARS system, provided to academic health science centers and hospitals, and transmitted via Internet. NIDA Community Alerts are designed to reach the drug abuse and drug abuse-related HIV/AIDS community with emerging issues of concern. * Computerized data bases, including those on the MEDLARS system (AIDSLINE, AIDSTRIALS, AIDSDRUGS, and DIRLINE), the toll-free (1-800-TRIALS-A) AIDS Clinical Trials Information Service (ACTIS), and the HIV-AIDS Treatment Information Service, provide the foundation for the global dissemination of information concerning basic research, clinical trials availability and results, and standards of care as well as other information of interest to HIV-infected individuals. * The National Library of Medicine (NLM) has provided awards to enable community-based organizations and public and health science libraries to design programs for improving access to AIDS information by targeted groups within their communities. * The NLM and OAR developed a "Guide to NIH HIV/AIDS Information Services," a comprehensive listing of NIH- supported information services that assist care and service providers and their patients. Dissemination of information is a Public Health Service-wide function. For example, HRSA, through its direct contact with hundreds of providers through the Ryan White CARE Act and the community health centers programs, is able to disseminate new findings rapidly. In addition, the AETCs play an important role in translating new research findings into practice. The CDC also works closely with community planning groups to provide them with information regarding the most effective behavioral intervention strategies. This has been identified as an important area of emphasis for additional technical assistance in the years ahead. Assessment of the Response Dissemination of information is a function of all agencies within the Public Health Service. However, in the area of behavioral and social science, there are no equivalent mechanisms for dissemination and translation of breakthrough research findings. Much of the behavioral and social science research findings are disseminated in the traditional manner, through journal publications. More rapid mechanisms for dissemination could facilitate community implementation of potentially more effective programs. Followup Action Recommended The Council will postpone action recommendations until the report from the Prevention Committee of the Working Group is reviewed by the Council. Recommendation II.D.6. A public health policy consensus panel should be convened by the Public Health Service by the end of April 1996 to assess the possible efficacy of available spermicides (e.g., nonoxynol-9) and other licensed products (e.g., chlorhexidine, benzalkonium chloride, diaphragms) to be used in "harm reduction" algorithms to decrease sexual transmission of HIV. The panel should include senior public health policy officials (CDC, FDA, HHS Secretary's Office), research agencies (NIH), community groups (women's health research advocates, commercial sex workers, interested foundations), academia, and industry. The meeting should also feature a review of the entire status of anti-HIV microbicide research. Administration's Response This recommendation is under active discussion. See the responses above under Recommendation II.D.2. regarding the CDC meeting as a potential precursor to the larger meeting suggested here. Assessment of the Response The Council is concerned that this recommendation has not been carried out in the timeframe we suggested. Followup Action Recommended The urgency of this issue would mandate that our recommendation must be accomplished as soon as possible. Recommendation II.D.7. The Council asks the FDA to comment by January 31, 1996, upon the proposed FDA regulations that require inclusion of women in all clinical trials of drugs for treatment of HIV/AIDS in which there is no known evidence of reproductive toxicity. When such toxicity has been documented, alternatives that allow the inclusion of women should be provided. Administration's Response Earlier this year, FDA Commissioner Dr. David Kessler, asked Dr. Ruth Merkatz, Senior Advisor for Women's Health, to chair a working group to develop these proposed regulations. A proposal has been drafted and is beginning the review process within the FDA. Assessment of the Response We acknowledge that the FDA hs a working group on this issue. Followup Action Recommended A status report on this recommendation should be provided to the Council 30 days prior to the next Council meeting. Recommendation II.D.8. The FDA must require a sponsor to file a gender accrual analysis in the annual Investigational New Drug (IND) report, as stated in the final version of the proposed regulations published in the Federal Register, Vol. 60, No. 184, at 46794. In addition, for the New Drug Application (NDA) and the product licensing application (PLA), the regulations must require sponsors to analyze clinical data by gender and assess potential differences, including reporting on side effects by gender. Administration's Response The FDA received 13 comments on this proposed rule to the regulations. The FDA is currently evaluating the comments and drafting the final rule. Assessment of the Response As of April 25, 1996, this had not been done. Followup Action Recommended A status report on this recommendation should be provided to the Council 30 days prior to the next Council meeting. Recommendation II.D.9. The Secretary of HHS should publish for public comment by March 1, 1996, the proposed regulations regarding participation of pregnant women in clinical trials, with the following revision: A pregnant woman's inability to obtain a written consent from the father of the fetus should not disqualify her from participation in a federally funded clinical trial. This fact should be so stated in the protocol consent form. Administration's Response Under current regulations, if a trial is for the health needs of the mother, the father's consent is not needed. Pending regulations address parental consent generally and are in final stages of review. Assessment of the Response Current policy (Code of Federal Regulations, Part 46.207) addresses this concern and does not preclude the inclusion of pregnant women in clinical trials. Followup Action Recommended This information should be widely disseminated. II.E. Combating Discrimination/Social Prejudice Recommendation II.E.1. The Administration should rescind mandatory HIV testing and/or discriminatory policies currently in place in the U.S. Foreign Service, the Peace Corps, the Job Corps, the State Department, and the military, when there is no compelling public health justification. Administration's Response On April 1, 1996, the Job Corps initiated a pilot program eliminating mandatory HIV testing for residential Job Corps applicants in Region VI. All applicants■residential and nonresidential■will be routinely counseled and offered voluntary HIV testing. After a three-month trial period, if successful, this program will be made national policy for the Job Corps. Assessment of the Response The progress by the Job Corps is encouraging and laudable. Unfortunately, the Council received no response from the Administration to our recommendation to eliminate policies of mandatory HIV testing and/or discrimination in the U.S. Foreign Service, the Peace Corps, the State Department, and the military absent a compelling public health justification for such policies. Followup Action Recommended The Council requests immediate clarification on the Administration's efforts to eliminate or justify mandatory testing and/or discrimination in the U.S. Foreign Service, the Peace Corps, the State Department, and the military. Recommendation II.E.2. The Secretary of HHS should instruct the CDC to (1) review its guidelines that arbitrarily restrict HIV- infected health care workers and that lead to discrimination against them, and (2) ensure that these guidelines are consistent with prevailing scientific and public health knowledge on the issue. Administration's Response The Secretary of HHS has asked for a review of these guidelines. Assessment of the Response The Council is pleased that the Secretary has asked for a review of these arbitrary guidelines. However, the fact that the review is only now in process makes clear that this review is long overdue, especially in light of the National Commission on AIDS recommendations and other scientific studies and reports issued in the last several years. Followup Action Recommended The Council seeks confirmation that the review will be completed and that all changes necessitated by this review will be implemented during the current calendar year. Recommendation II.E.3. The Administration should oppose any congressional efforts to require that otherwise qualified military service personnel who test positive for HIV be discharged, including a veto of the Department of Defense Reauthorization Act if such a provision is included. In his veto message, the Council recommends that the President state that the veto is, in part, due to the inclusion of this provision. Administration's Response The President and the Administration strongly opposed enactment of the so-called "Dornan Amendment." Through the coordinated efforts of the White House, the Department of Defense, the Department of Veterans Affairs, and the Department of Justice■along with the advocacy of many community groups■repeal of this provision was accomplished before any service member had to be discharged. The Administration will continue to oppose efforts to reimpose this provision. Assessment of the Response The Council strongly advised the President to veto for the second time the DoD Reauthorization Act because it still contained the Dornan Amendment. While we opposed his decision to sign the bill, we commend the Administration's vocal opposition to the Dornan Amendment, its bold decision not to defend the law in court, and its leadership in obtaining legislative repeal of this law. Followup Action Recommended Continued vigilance will be required as similar amendments have been introduced in Congress. Recommendation II.E.4. The Administration should direct the CDC, Immigration and Naturalization Service (INS), and Department of State to monitor and coordinate the HIV testing of immigrants to ensure informed consent, pre- and post-test counseling, and appropriate legal and health referrals and to ensure that waivers of the HIV exclusion are granted on a priority basis when permitted by statute. Also, when permitted by statute, the INS and the Executive Office of Immigration Review (EOIR) should grant stays of deportation, suspension of deportations, extended voluntary departure, deferred action, and asylum based on the social group category of HIV-positive individuals. Administration's Response The Office of National AIDS Policy has worked closely with the relevant agencies in the Federal Government to ensure waivers for those attending the Summer Olympics in Atlanta and to permit transit visas for those passing through the United States on their way to the International Conference on AIDS in Vancouver. The Office will also work with the CDC to ensure appropriate oversight of HIV testing of potential immigrants. While both EOIR and the INS are constrained by the need to approach and evaluate each application for asylum, stay or suspension of deportation, deferred action, or extended voluntary departure on its own legal and factual merits, the waiver process allows the flexibility to balance respect for individual rights with the need to protect the public health. Because stays of deportation, voluntary departure, and deferred action status are forms of relief granted by an INS district director at his or her prosecutorial discretion, the district director must consider each case on the basis of its individual facts and not on the basis of membership in a social group. Similarly, EOIR's immigration judges and its Bureau of Immigration Appeals are charged by regulation with independent adjudication of individual cases. Thus, it is not possible to render these types of immigration decisions based on social group category. The INS will, however, consider applications for stays of deportation, voluntary departure, and deferred action status submitted by HIV-positive individuals in a manner consistent with applications submitted by aliens seeking to remain in the United States for other medical reasons. This includes reviewing all applications for relief where an individual alleges that deportation may result in his or her being unable to obtain life- sustaining treatment. Finally, aliens with HIV who are seeking asylum or withholding of deportation may be able to qualify for recognition as members of a "particular social group" if the evidence in the individual case supports such a conclusion. (Courts have interpreted the phrase "particular social group" to mean a group of persons sharing a common, immutable characteristic that group members either cannot change or should not be required to change.) Withholding of deportation is available to persons whose life or freedom would be threatened on account of their membership in a particular social group. Aliens may be admitted on the basis of refugee status if they are able to document a well-founded fear of persecution on the basis of race, religion, nationality, membership in a particular social group, or political opinion and if they are able to satisfy the other elements of the statutory definition (the harm must emanate from the government of the refugee's country or an entity the government cannot or will not control, and the persecutor must seek to harm the asylum seeker specifically because of his or her membership in the social group). Finally, because asylum is a discretionary form of relief, the asylum seeker must demonstrate that he or she merits a favorable exercise of discretion. Humanitarian factors, such as an applicant's affliction with a serious medical condition, would generally weigh in the applicant's favor. In sum, although the INS and EOIR are required to adjudicate requests for asylum, stay or suspension of deportation, deferred action, or extended voluntary departure on their individual merits and cannot grant such discretionary relief in a blanket fashion, where appropriate they will consider HIV infection as a factor weighing in favor of discretionary relief from deportation. Additionally, where consistent with statute, the INS and EOIR will recognize HIV infection as a characteristic that, depending on the practices of the government in the home country, can define a particular social group for purposes of determining eligibility for asylum and withholding of deportation. Assessment of the Response The Council is pleased by the Administration's clarification of INS policies regarding the granting of asylum relief from deportation to HIV-positive immigrants. This clarification allows for a more compassionate and sensible approach. The Council remains concerned that informed consent, pre- and post-test counseling, and appropriate legal and health referrals for HIV-positive immigrants are not being monitored and coordinated by the INS. It is the INS that designates the doctors who conduct medical exams for immigration purposes. Followup Action Recommended Since the INS controls these "designated civil surgeons" and only the INS can instruct them to conduct appropriate health and legal service referrals to HIV-positive immigrants, the Council recommends that the INS take responsibility for the proper monitoring and coordination of all aspects of HIV testing, pre- and post-test counseling, and service referrals, using the CDC guidelines developed for these purposes. The Discrimination Subcommittee will continue to monitor this issue to get further clarification from INS.