Mr. Stephen Smith, Senior Advisor to the HRSA Administrator, covered the following areas in his report. HRSA observed the 15th anniversary of the Ryan White Comprehensive AIDS Resources Emergency Act (CARE Act) during its grantee conference in August 2006. The conference served as a time of remembrance, renewal and re-commitment. The grantees reflected on the significant amount of progress that has been made in treating the HIV/AIDS epidemic, such as collaborations with CDC on the HIV testing recommendations. The grantees also acknowledged that these efforts must continue to achieve greater progress in the future.

The pending bill on reauthorization of the CARE Act reflects the Administration’s themes, including HIV counting, core services, better coordination among CARE Act Titles, and improved accountability. These themes are consistent with the President’s principles of serving the neediest first and better targeting of resources. The CARE Act has not been re-authorized to date, but HRSA will continue to implement the current law and support the reauthorization process as opportunities arise. After the reauthorization bill is passed, HRSA will make diligent efforts to ensure that grantees have all necessary information and guidance to implement the new provisions.

HRSA is pleased that the President’s FY’07 budget request includes an additional $95 million for new activities under the domestic HIV initiative. The House and Senate marked up the President’s budget with different proposed budgets. HRSA and all other federal agencies are operating under a continuing resolution through November 17, 2006. HRSA will continue to monitor the current Congressional session on the HHS appropriation for FY’07, but significant changes from the President’s budget request are not anticipated.

HRSA is continuing its analysis of 2005 CARE Act data in preparation of completing a final report. Preliminary results of the data analysis showed that CARE Act-funded service providers served a total of 954,323 duplicated clients in 2005. Of these clients, >33% were women and >70% were persons of color. The >4.06 million visits for healthcare services that were reported in 2005 represented a 1% increase over the number of healthcare visits reported in 2004. CARE Act services currently reach >500,000 individuals.

HRSA will continue several ongoing activities and implement new initiatives in FY’07 to improve its ability to deliver HIV/AIDS care. Close collaborations with CDC on new HIV testing recommendations will be continued. Funding will be allocated to support a number of new initiatives under the Special Projects of National Significance (SPNS) grant program. Ten grants will be awarded under the SPNS jail-based initiative for grantees to implement and evaluate innovative methods for linking persons living with HIV/AIDS (PLWHA) who are incarcerated or recently released from local jails to primary medical care and ancillary services.

A new SPNS grant program totaling >$6.5 million will be implemented to support innovative oral healthcare for PLWHA. The SPNS Information Technology Networks of Care Initiative will award funds to support organizations that promote the enhancement and evaluation of existing electronic information network systems to serve PLWHA in underserved communities. The SPNS Case Management Initiative will identify case management models and services that are most important for improving access to and retaining patients in care.

The Minority AIDS Initiative (MAI) will fund five new projects from one to multiple years. The MAI activities will focus on (1) HIV care for women of color; (2) intervention strategies to help clinics retain patients in care; (3) an evaluation of MAI activities; (4) an assessment of the needs of tribal providers who serve American Indians/Alaska Natives in AIDS Education and Training Center (AETC) regions; and (5) a study on issues and barriers to increasing the capacity of health professions immigrants to provide HIV care in the United States.

HRSA established new resources to support its HIV/AIDS programs and activities. The TARGET Center is a new web site and help desk that will provide two major services. A centralized source will be available for CARE Act programs to obtain technical assistance. Grantees will be provided with a “virtual community” to learn about and share ideas. The National Perinatal HIV Consultation and Referral Service Hotline will provide three major services. Around-the-clock advice will be given on standard and rapid HIV testing in pregnancy. Consultation will be offered on the use of anti-retroviral therapy (ART) during pregnancy, labor and delivery, and the postpartum period. HIV-infected pregnant women will be linked to appropriate health care.

HRSA will undertake several efforts to improve the quality of its HIV/AIDS programs and activities. Client-level data and National Quality Center guidelines will be used to develop quality indicators for the HRSA HIV/AIDS Bureau (HAB) and HIV/AIDS care and services provided by grantees. Quality training, support and technical assistance will be provided to HAB staff and grantees. HRSA recently completed a quality initiative of AIDS Drug Assistance Program (ADAP) processes with eight Title II states. Most of the eight states showed significant improvements in the quality of ADAP outcomes. HRSA is now exploring strategies to widely disseminate the quality improvement models to all states.

HRSA will continue its global HIV/AIDS activities through the President’s Emergency Plan for AIDS Relief (PEPFAR). PEPFAR’s accomplishments to date include implementation of the HIVQUAL model in 142 hospital sites in Thailand and an expansion of the HIVQUAL model to Uganda, Namibia and Mozambique in FY’06. I-TECH implemented clinical mentoring in three new countries in 2006 and is currently providing clinical training in 25 countries. Training of rapid HIV testing in Namibia led to an increase in post-test counseling from 20% in 2005 to 66% in 2006. HRSA expects PEPFAR to continue to be supported as a $15 billion initiative over five years.

HRSA will continue to closely monitor Medicare Part D and the impact of the donut hole on clients who receive HIV/AIDS services under the CARE Act. The “donut hole” is the gap in coverage when no insurance for prescription drugs would be available. After total drug costs reach $2,250, a patient would pay an additional $2,850 out-of-pocket before coverage would continue under Medicare Part D. The donut hole will not affect ~70%-80% of Medicare beneficiaries living with HIV who qualify for low-income subsidies. Due to the high cost of ART, however, Medicare beneficiaries living with HIV who do not qualify for additional assistance would need to consider strategies to obtain lower drugs costs in the “catastrophic” coverage level.

HRSA informed grantees that ADAPs could assist with Medicare Part D costs and provide ART to clients affected by the donut hole. HRSA also advised grantees to encourage Medicare beneficiaries to contact state ADAPs to explore opportunities for assistance with the cost of ART. Medicare beneficiaries also have the option of considering Part D plans that have higher premiums, but provide partial coverage to compensate for or completely eliminate the donut hole. HRSA has not yet developed cost estimates of the impact of the donut hole on CARE Act grantees.

HRSA grantees in Alabama, Louisiana, Mississippi and Texas are still recovering from the devastation of Hurricanes Katrina and Rita. The most significant challenges of grantees in these states are tracking clients who were displaced, meeting CARE Act requirements and restrictions, and adhering to conditions of awards. HRSA will continue to closely collaborate with grantees in these states to overcome these barriers.

HRSA took several actions to improve its readiness to respond to emergencies. An Emergency Operations Center and “e-Room” were established to provide an electronic system to collect data from grantee project officers in all HRSA bureaus. The Office of Commissioned Corps Affairs (OCCA) was established in May 2006 to provide a centralized point for deployments and all other HRSA officer activities. OCCA will oversee implementation of the HHS Secretary’s vision for a transformed Commissioned Corps to ensure that the future force is prepared to meet the nation’s public health and emergency needs.

Mr. Smith thanked CHAC for its vital role in improving HIV/AIDS prevention, care and treatment throughout the nation and the world. He emphasized that the knowledge, experience and dedication of each CHAC member are invaluable to HRSA and HHS as future policies are established for HIV/AIDS care and treatment. He added that HRSA would continue to rely on CHAC’s expertise, guidance and recommendations to inform this process in the future.

On behalf of CHAC, Mr. Milan thanked HRSA for developing innovative strategies to assist CARE Act grantees. He was aware that legislative barriers and resource constraints adversely impact HRSA’s ability to administer its HIV/AIDS programs. Despite these challenges, however, funding for the new FY’07 projects illustrates HRSA’s diligent efforts and continued commitment to ensure that constituencies represented by CHAC are served.

Mr. Milan also commended HRSA for playing a critical role in ensuring that CHAC’s voice was heard during ongoing efforts to reauthorize the CARE Act. Most notably, CHAC’s proposed definitions for core medical services and other recommendations are being considered in current legislative drafts.

Other CHAC members joined Mr. Milan in applauding HRSA for allocating funds to implement and support the new FY’07 activities, particularly the MAI and SPNS initiatives. However, several members expressed concerns about certain aspects of some of HRSA’s HIV/AIDS activities.

• HRSA’s new jail-based initiative does not reflect coordination with a similar activity that CDC previously conducted. Lessons learned, experiences and important findings from CDC’s jail-based effort should be reviewed.
• The change in the CARE Act law will require HRSA to add HIV to the formula for distribution of Title I and II dollars in 2007. Clients who receive HIV/AIDS services under the CARE Act in states with no name-based reporting system will suffer adverse impacts as a result of this change. HSRA should provide technical assistance to help jurisdictions in converting to a name-based reporting system because some areas might require up to four years to make this transition.
• HRSA has not broadly communicated information on its new HIV/AIDS activities and resources. Most notably, many providers have no knowledge of HRSA’s National Perinatal HIV Consultation and Referral Service Hotline.
• HRSA should made stronger efforts to assist grantees in assuring continuity of care to clients who would be affected by the Medicare Part D donut hole.
• HRSA has not clearly described its efforts to collect client-level data. Most notably, CHAC has no knowledge of whether these data reflect capacity issues at various sites or if this activity is coordinated with the Centers for Medicare and Medicaid Services (CMS).

Mr. Smith, other HRSA staff, and Dr. Deborah Parham Hopson, the HAB Director and CHAC DFO for HRSA, provided additional details about HRSA’s HIV/AIDS activities in response to CHAC’s comments, questions and concerns.

• HRSA is currently collaborating with CDC to coordinate its new jail-based SPNS initiative.
• HSRA will continue to implement the 2000 CARE Act legislation in the absence of reauthorization. HRSA will adhere to the change in the legislation to add HIV to the formula for distribution of Title I and II dollars by 2007. Only HIV data from jurisdictions with HIV reporting systems will be used. Only name-based data that have been accepted and certified by CDC will be used. AIDS data will be accepted from states that do not have name-based HIV reporting systems. The change in the legislation will primarily affect the allocation of funds, but will not necessarily impact delivery of care to clients who receive services under the CARE Act.
• HRSA is conducting several activities in preparation for the change in the CARE Act legislation that must be implemented in 2007. In the absence of an FY’07 budget and reauthorization of the CARE Act, modeling is being performed to identify jurisdictions that will be affected. Communications with grantees about the change in the legislation were initiated in 2000 and will continue. Close collaborations with jurisdictions with no name-based reporting systems will continue. Assistance will continue to be provided to jurisdictions that lose CARE Act dollars each year to help these grantees to prioritize funds and assure continued delivery of essential services to patients. The House bill proposed a transition period for jurisdictions to convert to name-based reporting systems, but the Senate bill did not contain the same language.
• HRSA is identifying strategies for community health centers (CHCs) to provide care to persons with HIV. HRSA is aware that many care systems are currently at capacity and are unable to provide care to new patients. • HRSA recognizes that some states, territories and eligible metropolitan areas will receive less funds under Titles I and II in 2007 compared to 2006 based on the President’s FY’07 budget. Even with decreased funding, however, all jurisdictions will be held harmless in 2007 according to the law.
• HRSA is pleased that ADAP waiting lists were decreased from eight to four states: Alaska, Montana, South Carolina and West Virginia. HRSA will attempt to spread ADAP dollars in these four states to ensure continued delivery of services to Medicare beneficiaries living with HIV who would be impacted by the donut hole. However, many patients who are on ADAP waiting lists still receive medication through established relationships between ADAPs and Pharmacy Assistance Programs.
• HRSA took action on formal motions that CHAC passed during previous meetings. The HHS Secretary provided Congress with HRSA’s data runs for consideration in developing draft proposals of the CARE Act reauthorization. HRSA convened several consultations with grantees on the severity of need index and is now identifying a more quantitative strategy to analyze these data under Title I supplemental dollars.
• HRSA will use its established mailing lists of AETCs, CHCs, grantees, special interest groups and other organizations to broadly disseminate information on its HIV/AIDS activities and resources. Articles about HRSA’s National Perinatal HIV Consultation and Referral Service Hotline were recently published in peer-reviewed journals targeted to obstetricians/gynecologists and family practitioners.
• HRSA is conducting several activities to assess the capacity of grantees to report client-level data. At the next meeting, HRSA will provide CHAC with an overview of its ongoing efforts to collect client-level data from grantees.

Dr. Kevin Fenton, Director of the CDC National Center for HIV, Hepatitis, STD and TB Prevention (NCHHSTP) [proposed], reported that similar to HRSA, CDC has also taken several actions to assist jurisdictions in converting to name-based reporting systems. Since 1999, states and local jurisdictions have been strongly encouraged to undertake this effort.

Specific guidance and technical assistance have been provided to states and local jurisdictions, including methods to implement name-based reporting and strategies to assure data quality.

Legislative reviews were performed to assist states and local jurisdictions in examining barriers to converting to name-based reporting systems. New approaches are now being explored for CDC to more rapidly complete the data certification process. However, CDC is currently facing two major barriers to its ongoing role in providing assistance to states and local jurisdictions that still have not made the transition to a name-based reporting system: (1) addressing the backlog of HIV/AIDS cases reported over the past 25 years and (2) capturing new diagnosed HIV/AIDS cases.

Mr. Milan concluded the session by asking CHAC to provide him or Dr. McGuire with suggestions on resource needs for HIV/AIDS treatment and care for FY’07 and beyond that should be recommended to HRSA or the HHS Secretary. He confirmed that any suggestions proposed by the members would be presented and considered as potential formal motions during CHAC’s review of its business items on the following day.