Enactment of the new CARE Act is the culmination of a reauthorization process involving people working toward a common goal:  better health and well being for people living with HIV disease. The new legislation is a tribute to the consumers, advocates, providers, and congressional and other government officials who have worked to create a CARE Act that evolves with the epidemic. 

In Part I of this article, we describe six overarching themes reflected in the legislation. In Part II, we discuss changes in each of the CARE Act programs. 

The HIV/AIDS Bureau's role is to establish policies and administrative practices that respond to changes in the new legislation.  We will collaborate with grantees, consumers, and constituency groups to create a guide and a timeline for implementing programmatic changes in the coming months.

PART I:OVERVIEW OF THE NEW CARE
 ACT: OVERARCHING THEMES

The new legislation requires identification of affected populations based on HIV prevalence—the total number of individuals living with HIV disease—rather than on AIDS prevalence alone. These data provide a basis for planning, allocations, and grant-making based on the demographics of the entire epidemic.

There is also sharper focus in the legislation focus on the needs of HIV-positive individuals who know their sero-status, but who are not receiving care:

• A comprehensive planning process must embody an assessment of unmet needs among those not in care and contain timetables and goals for meeting their needs.
• Planning body membership is expanded to include representatives of substances users, homeless people, and individuals in corrections.  Additionally, planning councils are required to increase the participation of HIV-positive individuals who are not affiliated with CARE Act-funded organizations.
• Early intervention services (counseling and testing, outreach, and referrals) are now fundable under Titles I and II.  Both current CARE Act-funded sites, and providers designated as "key points of entry" may receive grants to provide these services.
• CARE Act providers are required to build relationships with entities providing "key points of entry" into HIV care.  These include providers of early intervention services, family planning clinics, substance abuse treatment providers, sexually transmitted disease clinics, community organ-izations, and correctional institutions. 
• The new legislation expands the list of territories eligible for funding and establishes a minimum award of $50,000.

2.  Quality management and health services

The new legislation stresses that all CARE Act-funded services should improve health outcomes and requires establishment of purposeful linkages between providers of social support services and health-related services. 

With the objective of enhancing access to the continuum of services through better coordination, CARE Act grantees are required to build re-lationships with other Federal and State agencies, including State Medicaid agencies, State Children's Health Insurance Pro-grams, providers of HIV prevention and substance abuse treatment services, and incarceration facilities.

(1) "Assist direct service medical providers in assuring that funded services adhere to established HIV clinical practices and Public Health Service guidelines;
(2) "Ensure that strategies for improvements to quality medical care include vital health-related supportive services in  achieving  appropriate  access  to adhe-rence to medical care; and
(3) "Ensure that available demographic, clinical, and health care utilization information is used to monitor the spectrum of HIV-related illnesses and trends in the local epidemic."

New resources are available to fund quality assurance activities.

3. Capacity developement

New duties for planning councils, States, and Care Corsortia include efforts to identify capacity and infrastructure needs in historically underserved communities unable to meet the needs of HIV-positive individuals.  Grantees will be expected to fund capacity development projects and create strategies to sustain these new providers and organizations.

In addition, new discretionary grant programs under Title III will fund capacity building—both for providers otherwise receiving CARE Act funds and for those who are not—for the purposes of providing HIV primary care.  Capacity building awards will address administrative and fiscal management, technical skills and competencies, as well as equipment, supplies, and minor facilities modifications. Grants will be made for up to a 3-year period at a total of $150,000. 

4.Targeting resources to meet the needs of  underserved communities and populations increasingly affected by the epidemic.

Throughout the new legislation, the Congress stresses the importance of identifying communities with emerging need. AIDS surveillance data are inadequate for identifying these communities, as they reveal HIV infection patterns from 10 years ago or more but tell nothing about infection trends today. The prevalence of HIV disease will be used for making formula and supplemental awards beginning in FY 2005 if certain provisions are met as determined by the Secretary and an Institute of Medicine study.  See Box 2. 

In addition, a new hold harmless provision for Titles I and II will protect grantees from significant losses and destabilization of HIV services.

One-third of the Title I supplemental grant will be based on severe need. There are two new supplemental awards under Title II:

(1)  A base award that funds communities that have reported between 500 and 1,999 AIDS cases over the past five years; and
(2)An ADAP supplemental award addressing the needs of States with limited or restricted drug formulas and eligibility requirements.

The bill also increases minimum allotments to States and Territories.

Other changes to target resources for underserved communities include the following:

• Preferential awards of new Title III funds to rural or underserved communities;
• Expansion of eligibility for the dental reimbursement program to include schools of dental hygiene and community dentistry programs;
• A requirement for all Titles for set-asides for services to women, infants, children, and youth proportional to their representation in the epidemic.

The Secretary is required to develop a plan for coordinating HIV services with corrections institutions and for the care of individuals upon release.  See Part II, General Provisions, Plan Regarding Release of Prisoners with HIV Disease.

5.Coordination and linkages

Coordination and linkages are key components of the new CARE Act. Congress recognized the importance of improving coordination among publicly-funded programs.  This is particularly relevant given "payer of last resort" requirements in the law.

Grantees and other publicly-funded programs—such as Medicaid, State Children's Health Insurance Programs, Maternal and Child Health Programs, Community Health Centers, and providers of services to the homeless and substance users—are required to collaborate in the assessment of need, planning, and allocation of CARE Act funds.  The new legislation expands planning body membership to include representatives and providers of services to substances users, homeless people, and individuals in corrections.

6.Participation of other Department of Health and Human Services agencies

Implementation of the new CARE Act requires the involvement of several U.S. Department of Health and Human Services Agencies in addition to the Health Resources and Services Administration.  The Centers for Disease Control and Prevention (CDC) will administer the partner notification and testing of newborns program.  Additionally, the CDC may receive increased appropriations for the purposes of data collection and evaluation assistance to CARE Act grantees.  The National Institutes of Health (NIH) will examine and report on enhancing clinical research linkages with HIV services sites.  And the CDC and NIH are to collaborate with the Food and Drug Administration (FDA) to help streamline the approval process for emerging rapid HIV tests. Finally, the Institute of Medicine is required to provided three studies: the first regarding the adequacy of available HIV surveillance data for grant making purposes; the second regarding the status of the financing and delivery of HIV services; the third regarding improved mechanisms for reducing perinatal transmission of HIV.  All of these activities are described in detail in Part II, General Provisions of this document.

PART II:THE NEW LEGISLATION, PROGRAM BY PROGRAM 

Planning Councils
Several changes have been made regarding the composition and functioning of Planning Councils in EMAs. 

Planning Council Membership

• The Congress amends the Act so that Planning Councils include providers of housing, homeless, and HIV prevention services, as well as "representatives of individuals who formerly were Federal, State, or local prisoners."*   
• Not less than 33 percent of a council must be comprised of individuals or the parents or caregivers of individuals receiving HIV-related services; a conflict of interest clause requires that these individuals are not affiliated with service providers.
• The council must reflect the demographics of individuals living with HIV disease. 

Planning

• Planning is to be based on the demographics of the HIV-positive population: the council must "determine the size and demographics of the population of individuals with HIV disease" and then "determine the needs of such population."  When and how Planning Councils move to a system based on HIV prevalence rather than AIDS prevalence is to be addressed in an Institute of Medicine study discussed in Part I,  Box 2, and Part II, General Provisions of this document.
• The Planning Council must ensure that HIV services are coordinated with providers of prevention and substance abuse treatment services. 
• The council must respond to "the capacity development needs resulting from disparities in the availability of HIV-related services in historically underserved communities."  
• Comprehensive plans must include strategies for bringing HIV-positive individuals into care, giving "particular attention to eliminating disparities in access and services among affected subpopulations and historically underserved communities, and include discrete goals, a timetable, and an appropriate allocation of funds."   

To support planning councils in implementing the CARE Act and its Amendments, the Federal government is to provide planning council training materials.

Meetings and Other Provisions

• Planning council meetings must be open to the public and records must be made available, unless doing so would constitute an invasion of personal privacy. 

Use of HIV Case Data in Formula Grants
Historically, one portion of Title I appropriations has been designated for "formula" awards and a second portion for "supplemental" awards.  Formula awards have been based on reported AIDS cases. If certain provisions are met, beginning in FY 2005 formula awards shall be calculated based on HIV prevalence.  See Part I, Box 2, and Part II, General Provisions in this document.

Hold Harmless
Hold harmless provisions call for a five-year protection period, commencing in the year that an EMA's formula award would decrease due to a reduction in AIDS prevalence (or, after FY 2005, HIV prevalence).  During the protection period, formula grants would be awarded based on a percentage of the base year grant—the year prior to the one in which the reduction first occurred—defined as follows:

Year 1:  98 percent of the base year grant
Year 2:  95 percent of the base year grant
Year 3:  92 percent of the base year grant
Year 4:  89 percent of the base year grant
Year 5 and subsequent years:  85 percent   of the base year grant

The provisions allow for two exceptions to the above formulation, regardless of the protection period year; if HIV prevalence data are used for making formula grants for FY 2005, the EMA's formula award for that year will not be less than 98 percent of its FY 2004 award; or, should the five-year protection period be interrupted by an increase in AIDS prevalence (or, after FY 2005, HIV prevalence), its losses in the subsequent year, should the decline recommence, would be limited to 2 percent.

Supplement Grants
One-third of each EMA's supplemental grant will now be based on severe need, which will be determined by several factors, in addition to those in the 1996 legislation:

• Current prevalence of HIV disease;
• Relative rates of increase in HIV disease;
• Increase in need for services; and
• Unmet need for services. 

Health-related Support Services
The CARE Act continues to authorize "ambulatory support services (including case management)," and it vigorously urges "outreach activities that are intended to identify individuals with HIV disease who know their HIV status and are not receiving HIV-related services." Support services are fundable under Title I "to the extent that such services facilitate, enhance, support, or sustain the delivery, continuity, or benefits of health services for individuals and families with HIV disease."

"Key Points of Entry"
The Congress gives considerable attention to access to care throughout the Amendments.  Providers receiving Title I funds must maintain "appropriate relationships with entities that constitute key points of access to the health care system."  See Part I.1 in this document.

Priority for Women, Infants, and Children
The proportion of an EMA's award used to address the needs of women, youth, children, and infants must be equal to the proportion of its total AIDS cases constituted by these populations.  A waiver is provided when EMAs can demonstrate that the needs of these populations are being met through other sources, such as State Children's Health Insurance Programs and Medicaid. This requirement will be implemented according to the prevalence of HIV disease among these populations, not just AIDS, as data become sufficient. 

Quality Management
All grantees are required to establish a quality management program that measures the extent to which providers are using the latest Public Health Service guidelines, and they must develop strategies for ensuring that services are consistent with the guidelines. See Part I.3 in this document for details.  Five percent of a grant or $3 million—which ever is less—may be used for these purposes.

Title II - Care Grant Program

HIV Care Consortia
Consortia service plans must be consistent with State comprehensive plans, with an enhanced focus on:

• Individuals with HIV/AIDS who are not receiving care;
• Disparities in access and health status; and
• The needs of historically underserved communities. 

Consortia should endeavor to include entities that participate in the Title I Planning Councils in their own planning processes.

Use of HIV Case Data in Making Grants and Creating Comprehensive Plans
Grants will be based on HIV prevalence, not AIDS prevalence, starting in FY 2005, if the Secretary of Health and Human Services has determined that such data are adequate for planning purposes.  Likewise, States and Territories must move toward planning based on HIV prevalence. See Part I Box I and Part II, General Provisions in this document.

State Comprehensive Plans
Grantees must target HIV-positive individuals who know their sero-status but who are not in care. Each State's comprehensive plan must include:

• Strategies that reach HIV-positive individuals not in care, giving particular attention to eliminating disparities in access and services among affected subpopulations and historically underserved communities. The plans should include discrete goals, a timetable, and an appropriate prioritization and allocation of funds. 
• Strategies that coordinate the provision of HIV care services with programs for HIV prevention and substance abuse prevention and treatment.

Priority for Women, Infants and Children
Grantees must ensure that the proportion of their award used to address the needs of women, youth, children, and infants is equal to the proportion of total AIDS cases constituted by these populations in their regions.  A waiver is provided when grantees can demonstrate that the needs of these populations are being met through other sources, such as State Children's Health Insurance Programs and Medicaid.  This requirement will be implemented based on the prevalence of HIV disease among these populations, not just AIDS prevelance, as data become sufficient.  

Health-related Support Services
The CARE Act continues to authorize "ambulatory support services (including case management)," and it vigorously urges "outreach activities that are intended to identify individuals with HIV disease who know their HIV status and are not receiving HIV-related services." Support services are fundable under Title II "to the extent that such services facilitate, enhance, support, or sustain the delivery, continuity, or benefits of health services for individuals and families with HIV disease."

Early Intervention Services
For the first time, Title I funds may be used to provide early intervention services for purposes of increasing access to primary care services.  The grantee must demonstrate  unmet need for these services, and that other sources of funds are insufficient. Early intervention services are  defined according to the Title III statute, both for eligible entities and "key points of entry" (see below).

"Key Points of Entry"
The Congress gives considerable attention to access to care throughout the Amendments.  Providers must maintain   "appropriate relationships with entities that constitute key points of access to the health care system."  See Part I.1 in this document.

Quality Management
Grantees must establish a quality management program that measures the extent to which providers are using the latest Public Health Service guidelines and ensures that services are consistent with the guidelines.  See Part I.3. of this document for details.  Five percent of the total grant or $3 million, which ever is less, may be used for these purposes.

AIDS Drug Assistance Program Funds (ADAP):  New Uses

Adherence
States may use a portion of their ADAP funds to "encourage, support, and enhance adherence to and compliance with treatment regimens, including related medical monitoring. States may normally use up to 5 percent of their award for these services, but if a State demonstrates that these services are essential and do not diminish access to medications, it may spend as much as 10 percent."

Health Insurance
States may likewise use a portion of their ADAP "earmark" to provide health insurance that covers costs of medications, so long as the costs of doing so do not exceed the costs of otherwise providing medications and coverage provides full access to primary care.

New ADAP Supplemental Grants

1. Severe Need
   Three percent of the ADAP "earmark" will be allocated for supplemental grants to States with a severe need for medications.  State's eligibility will be determined by the State's eligibility standards, the compre-hensiveness of the State's drug formulary, and the number of eligible people with income under 200 percent of the Federal poverty level.
   
   States must match any award at $0.25 for every $1.  Funds may be used only to purchase medications, and the State may not make its ADAP eligibility standards more strict than those in effect in January 2000.
    
2. "Emerging Communities"
   The Amendments make way for new supplemental Title II awards that fund services to "emerging communities" as follows:
• Cities with between 500 and 999 reported AIDS cases over the most recent five-year period shall collectively receive a minimum of $5 million, or 25 percent, of new Title II funds. 
• Cities with between 1,000 and 1,999 cases shall receive a comparable amount.  (Note:  To qualify as an EMA under Title I, 2,000 AIDS cases must have been reported over the previous five years.)  In 2005, this provision stipulates that HIV prevalence will provide the basis for defining eligibility.

States must demonstrate the existence of an emerging community, severe need, and how funds will be spent.  Among other provisions regarding eligibility, States must "demonstrate that the resources will be allocated in accordance with the local demographics including appropriate allocations for services for infants, children, women, and families with HIV disease."

Funds for these grants will become available in the first year that the total Title II appropriation, excluding the ADAP earmark, is increased by at least $20 million over the FY 2000 level.  Once the mechanism is triggered, funding will be at least $5 million per year for each set of emerging communities grants.

Increase in Minimum Title II Base Award
The Amendments raise existing minimum Title II base awards to the following levels:

• $200,000 for states with less than 90 living AIDS cases;
• $500,000 for States with 90 or more living AIDS cases;
• $50,000 for U.S. territories, including the Federated States of Micronesia and the Republic of Palau.

Hold Harmless
A State or territory may lose no more than 1 percent of its total award from the previous fiscal year, or 5 percent over the 5-year reauthorization period. 

Pregnancy and Perinatal Transmission of HIV
The Congress amends an existing grant program to include prevention and treatment services for pregnant women and newborns. The legislation instructs the Congress to appropriate at least $10 million and as much as $30 million in a given fiscal year.  No single grant is to exceed $4 million.

A portion of these new funds is set aside for:

• States with a mandatory testing requirement for all newborns or for newborns for whom the mother's HIV status is unknown; and
• States demonstrating the most significant reductions in the rate of new cases of perinatal HIV transmission.

The set-aside is 33 percent of the increase in FY 2001, 50 percent in FY 2002, 67 percent in FY 2003, and 75 percent in FY 2004 and FY 2005.

The remaining portion will be awarded to States not meeting the above provisions, based on:

• The extent of the reduction of perinatal HIV transmission and perinatal AIDS;
• The reduction of HIV and AIDS incidence among women of childbearing age;
• A higher acceptance rate of HIV testing among pregnant women; and
• The extent to which women and children are receiving HIV services.  

In additional efforts to reduce prenatal transmission, an Institute of Medicine (IOM) or comparable study will be conducted that will:

• Determine for the most recent fiscal year the number of  infants with HIV disease who were born in situations where the attending obstetrician did not know the HIV status of the mother;
• Determine for each State the barriers that discourage an obstetrician from routinely offering pregnant women HIV testing, and, in cases where the obstetrician does not know the HIV status of the mother, testing newborns; and
• Contain recommendations for each State for reducing the incidence of perinatal transmission.

The study is to be completed within 18 months of enactment of the CARE Act.  Results will be distributed to the Congress and to the States.  In FY 2004, the States will report their progress in implementing the IOM recommendations.

Grants for Partner Notification
States with comprehensive partner notification programs are now eligible for new grants, and those States with accurate HIV reporting systems will be given preference.  The Congress authorized $30 million for FY 2001, leaving the door open for larger program expenditures in FY 2002 and beyond. 

Title III - Early Intervention Services

Preference to Rural and Underserved Areas for New Funds
The Amendments direct that preference be given to rural and underserved areas when making grants with new Title III dollars.   

Planning and Development Grants
Two types of planning grants are now available and they may be awarded to organizations not otherwise receiving CARE Act funds. 

• The first will prepare organizations to provide early intervention services.  These grants are not to exceed $50,000, apply to only one fiscal year, and are not renewable. 
• The second provides capacity building in underserved communities.  These grants may not exceed $150,000 over a three-year period.

Strengthening of Partner Notification
New language strengthens the partner notification component of HIV counseling and testing.  The Congress calls for counseling that emphasizes the duty of infected individuals to disclose their status to their sexual partners and to those with whom they share hypodermic needles. Counseling should also advise infected individuals on the manner in which such disclosures can be made, and emphasize the continuing duty of the individuals to avoid any behaviors that will expose others to HIV.

Increase in the Administrative Cap
The administrative cap for Title III grants is raised from 7.5 percent to 10 percent; only Title III Administrative caps were changed in the Amendments.

Quality Management
Quality management provisions are included for each of Titles I, II, III, and IV.  See Part I.2 in this document.

Title IV

Access to Clinical Trials
Grantees are not required to enroll their clients in studies and clinical trials, but they must "provide individuals with information and education on opportunities to participate in HIV/AIDS-related clinical research."  The NIH is required to "examine the distribution and availability of ongoing and appropriate HIV/AIDS-related research projects to existing sites."  The report must be available to the Congress no later than 12 months after the Amendments are signed into law.

Quality Management
Title IV grantees, like other CARE Act programs, must implement quality management programs under the new CARE Act.  See Part I.2.  A related provision for Title IV specifically requires that the Secretary, "in consultation with grantees conduct a review of the administrative, program support, and direct service-related activities" to "ensure that eligible individuals have access to quality HIV-related health and support services."  The review must occur within the first 12 months after the date of the enactment.  Not later than 180 days after the 12-month period, the relationship between costs of services and access to care must be determined. Grantees must then comply with requirements stemming from the determination. 

AIDS Education and Training Centers

AIDS Education and Training Centers (AETCs) are required to target providers of prenatal and gynecological care.  Protocols for the medical care of women with HIV disease are to be developed. 

The AETC program is also required to disseminate HIV treatment information to health care providers and patients no later than 90 days after the date of the enactment. 

Dental Assistance Program

Two significant changes have been made in the dental assistance program.

1. Schools of dental hygiene are now eligible for the dental reimbursement program.
2. Competitive grants will be awarded to schools of dentistry and schools of dental hygiene to fund cooperative projects with community providers of dental services.

General Provisions

Studies by the Institute of Medicine (IOM)

1. HIV surveillance as a basis for making formula awards.  The Secretary is to request an IOM Study that will provide:
• A determination as to whether States' HIV reporting systems are sufficient to provide reliable information on the number of infections; 
• A determination as to whether the data is sufficient for making formula grants under Titles I and II;
• Recommendations for how States can improve their surveillance systems, where needed.

This study is to be completed within three years of enactment of the Amendments.

2. Health outcomes
   The second study concerns "appropriate epidemiological measures and their relationship to the financing and delivery of primary care and health-related support services."  The study must consider:
• The adequacy of health outcomes measures and data and the extent to which they could be used to measure the quality of services;
• The effectiveness and efficiency of service delivery  within the context of a changing health care and therapeutic environment, as well as the changing epidemiology of the epidemic.
• "Existing and needed epidemiological data and other analytic tools for resource planning and allocation decisions, specifically for estimating severity of need of a community and the relationship to the allocations process."
• "Other factors determined to be relevant to assessing an individual's or community's ability to gain and sustain access to quality HIV services."

This study must be completed within two years of enactment of the Amendments.

3. Perinatal Transmission
   A third and final IOM study is required under Title II and is discussed earlier in this document.  See Part II, Title II, Pregnancy and Perinatal Transmission.

Data Collection and the Centers for Disease Control and Prevention (CDC)
The Amendments authorize appropriations to the CDC for  collecting and providing data for CARE Act program planning and evaluation activities.  Technical assistance to CARE Act grantees is fundable under the provision.

Coordination among Federal Agencies
The Health Resources and Services Administration, the CDC, the Substance Abuse and Mental Health Services Administration, and the Health Care Financing Administration are required to coordinate planning, funding, and implementation of Federal HIV programs, in order to enhance the continuity of care and prevention services for individuals with HIV disease or those at risk.  The Secretary is required to report on the status of coordination efforts biennially.

Plan Regarding Release of Prisoners with HIV Disease
The Secretary is required to construct a plan for medical case management and provision of support services to individuals who were HIV-positive when released from incarceration.  The plan must be completed no later than two years after the date of the enactment of the Amendments.

Administrative Simplification Regarding Titles I and II
The Secretary and Title I and II grantees must establish the feasibility of a biennial application process.  A determination on the matter must be made within two years of enactment of the Amendments. Additionally, the grant-making timetable will be synchronized from Titles I and II. 

Development of Rapid HIV Test
The Amendments require that the NIH give increased attention to the "development of reliable and affordable tests for HIV disease that can rapidly be administered and results can rapidly be obtained."  

NIH, with the CDC and the FDA, must issue a report regarding the "premarket review and commercial distribution of rapid HIV tests," which is the standard FDA approval process.  The report must:

• Assess the public health need for such tests;
• Make recommendations regarding criteria for quickly evaluating new rapid testing technologies and products; and
• Determine whether the approval process is unnecessarily cumbersome.

The Amendments also require that the CDC establish or update guidelines regarding the use of a new rapid test for testing pregnant women in labor or in the late stages of pregnancy.

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