Detailed Information on the
Ryan White HIV/AIDS Assessment

Working toward client-level data reporting by Ryan White HIV/AIDS Program grantees beginning in 2009.

Implementing the 2006 reauthorization of the Ryan White HIV/AIDS Program and assuring that new provisions are being fulfilled appropriately.

Measure: Deaths of persons due to HIV infection.

Explanation:Reducing deaths of persons due to HIV infection with the identified targets is believed to be ambitious because it relies on a number of factors to accomplish, such as: 1) People continue to die from HIV/AIDS and its complications; 2) HIV's ability to mutate and become resistant to currently available drugs is a persistent threat; 3) Many patients do not benefit from or cannot tolerate complex combination regimens; 4) The long term side effects and complications associated with these therapies are not known; and 5) HIV and AIDS have disproportionately impacted racial and ethnic minorities in the United States and these populations continue to die at a rate significantly higher than Whites.

Measure: Number of racial/ethnic minorities and the number of women served by Ryan White -funded programs. (# of racial/ethnic minorities - # of women)

Explanation:Increased numbers of women and minorities are now being diagnosed as HIV positive. In addition, national HIV/AIDS prevalence data has indicated that these groups are (and continue to be) disproportionally affected by the HIV epidemic, relative to their representation in the general population. Understanding this, it is both appropriate and necessary that the Ryan White HIV/AIDS program measure its effectiveness in providing HIV treatment and care to these populations (women and minorities), who are so disproportionately impacted by the epidemic. A 2.5% increase of minorities and women served in Ryan White Program establishes a reasonable and ambitious target that is substantially higher than the percentage of racial/ethnic minorities represented in the epidemic. To establish a higher target would be irresponsible, not in accord with the epidemic, and target a real world threshold that can not be reached.

Measure: Ryan White Program-funded HIV primary medical care providers that have implemented a quality management program and meet two "core" standards included in the October 10, 2006 "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents."

Explanation:HAB is proposing to achieve a rate of 90 percent of Ryan White Program funded HIV primary care providers who will have implemented a quality management program and will meet two "core" standards, identified as a CD4 count and a viral load test. What establishes this as an ambitious goal is the need to greatly increase efforts by grantees and HAB project officers in developing, implementing and maintaining quality management programs and assuring that new patients receive a CD4 count and viral load test in light of the known barriers, such as: attrition rates of new patients, new patient retention problems, patients lost to follow up, patients who refuse blood work, and patients who refuse testing.

Measure: Number of AIDS Drug Assistance Program (ADAP) clients served through State ADAPs annually.

Explanation:The 2010 ADAP target has been revised downward due to the combined effect of the following factors: increased medical inflation including rising health insurance premiums, the addition of two new drug classes, the new PHS guidelines reflecting starting therapies earlier, and the increase of cost of laboratory testing associated with antiretroviral use, including resistance, tropism and HLA testing for patients. The 2009 target may also be revised downward in the future due to the same increased costs described above.

Measure: The number of persons who learn their serostatus from Ryan White Programs.

Explanation:This measure is ambitious because the new reauthorization language no longer emphasizes the early intervention services for Parts A and B, but places greater emphasis on a broad range of core medical services where these grantees must expend at least 75 percent of their Ryan White Program funds on.

Measure: Percentage of HIV positive pregnant women in Ryan White Programs who receive Anti Retroviral Medications.

Explanation:This measure is believed to be ambitious as the Ryan White Programs are already providing a substantial proportion of pregnant women i.e., 4,326 in 2005, with ARV therapy. Furthermore, the greater efforts needed to increase the proportion will include increased intervention efforts, e.g., more counseling by medical and support staff, more outreach efforts to keep pregnant women in care and to locate and bring pregnant women who have left care back into care, and possibly more family counseling to assure support of the pregnant woman and her use of ARV therapy.

Measure: Proportion of racial/ethnic minorities in CARE Act-funded programs served.

Explanation:This annual measure ensures that the Ryan White Program reaches traditionally underserved populations at a significantly and ambitious rate, i.e., a rate that is above the national representation of the populations in the AIDS epidemic.

Measure: Proportion of women in CARE Act-funded programs served.

Explanation:This annual measure is ambitious as it targets a proportion of women that exceeds the national number of women living with AIDS by helping to improve health outcomes in this portion of the population, while also increasing the probability that the Ryan White Program would increase the number of all women, including pregnant HIV positive women being enrolled into care. HIV and AIDS affect women in many ways. For example, women of color (especially African American women) are the hardest hit, younger women are more likely than older women to get HIV, and AIDS is a common killer, second only to cancer and heart disease for women. Even though more men than women have HIV, women are catching up. In fact, if new HIV infections continue at their current rate worldwide, women with HIV may soon outnumber men with HIV.

Measure: Number of CARE Act-funded primary medical care providers that will have implemented a quality management program.

Explanation:The incremental increase of 2.5 percentage points annually of providers implementing a quality management program is ambitious because of the presence of new programs each year that would require additional efforts to implement this measure and the efforts to assure that those programs who have not yet implemented such a program have the resources and ability to so. HAB considers a 2.5 annual percentage increase to be significant and ambitious. HAB has championed quality through its programs, emphasizing the importance of quality improvement by integrating requirements for quality management plans into contracts and program standards. HAB's emphasis on quality management programs for the Ryan White Program grantees helps ensure that standards of care are met and that quality care is delivered, with attention to increasing access to care and adherence to HIV medication regimens.

Measure: Proportion of new Ryan White Program HIV-infected clients who are tested for CD4 count and viral load. (Proportion tested for CD4 count - Proportion tested for Viral Load)

Explanation:This is considered ambitious because the measure is looking at new clients only - thus, grantees must continually strive to convince new clients to have these very important diagnostic tests done. Not only must they achieve the same percentage point from a year ago, but HAB is expecting them to achieve 1 percentage point higher, while trying to reduce the barriers that will keep them from achieving this measure, e.g., patient attrition, patients refusing blood work, and patients lost to follow-up.

Measure: Amount of savings by State ADAPs participating in cost-saving strategies on medications.

Explanation:

Is the program purpose clear?

Explanation: The purpose of the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White Program) is to address the unmet care and treatment needs of persons living with HIV/AIDS who are uninsured or underinsured and therefore unable to pay for HIV/AIDS health care and vital health-related supportive services. Ryan White Program funding pays for core primary health care and support services that enhance access to and retention in care and fills gaps in care not covered by other resources or payers. Ryan White Program services are intended to reduce the use of more costly emergency services and inpatient care, increase access to care for underserved populations, and improve the quality of life for those infected or affected by the epidemic. The Ryan White Program funds community based, non-profit, local and State programs that provide primary medical care and support services; healthcare provider training; and technical assistance to help funded programs address implementation and emerging HIV care need.

Evidence: 1. Authorized 1990-1995 (P.L. 101-381) under Title XXVI of the Public Health Service Act (PHS) 2. Reauthorized 1996-2000 (P.L. 104-146) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=104_cong_public_laws&docid=f:publ146.104.pdf 3. Reauthorized 2000-2005 (P.L. 106-345), http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_cong_public_laws&docid=f:publ345.106.pdf 4. Reauthorized 2007-2009 (P.L. 109-415) the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White Program) 5. House Committee Report, 109-695, Committee on Energy and Commerce, Purpose and Summary section, pages 2-14, September 28, 2006, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_reports&docid=f:hr695.109.pdf

Does the program address a specific and existing problem, interest, or need?

Explanation: As the payer of last resort, the Ryan White Program provides services to those persons who otherwise would not receive medical care for their HIV disease, including the poor, the uninsured, the underinsured, and the medically underserved. CDC estimates approximately 1,039,000 - 1,185,000 (mid-point 1,112,000) persons are living with HIV in the U.S. in 2003 (most recent data available) and 25 percent are unaware of their serostatus. Of this total number of people living with HIV, it is estimated that 20 percent have no health insurance and therefore most are dependent on Ryan White program to provide them HIV/AIDS treatment and care. In addition to this group, there are others living with HIV/AIDS who are underinsured or have public health insurance that does not cover all of their HIV/AIDS-related health care needs, and therefore are also in need of Ryan White CARE Act services. In 2005, the Ryan White Program provided medical care and related supportive services to an estimated 531,000 persons; 33 percent of those served were uninsured and 56 percent were underinsured. In addition, it has been documented that many patients who receive regular medical care for HIV do not get the dental care they need and that many of those reporting an unmet need for dental care, including Medicaid recipients whose state Medicaid program does not provide dental coverage, lack dental insurance. In 2004, the Ryan White Program's Community Dental Partnership Program served more than 3400 individuals; 31 percent were Black, and 14 percent Hispanic. Forty-six percent had no third-party payer coverage or other source of payment for dental care and nearly 800 students and residents gained clinical experience providing more than 21,000 hours of clinical care to HIV-positive patients in community settings. Another need of individuals with HIV/AIDS is the provision of quality health care from a provider knowledgeable and experienced in the treatment of persons with this disease. Various organizations support this and state that HIV/AIDS providers need to participate in continuing education regarding HIV treatment and medications to be able to provide up-to-date quality health care to their patients. HIV specialty training needs of providers who serve persons with HIV and AIDS are to a great extent met through the Ryan White Program's AIDS Education and Training Centers (AETCs). Supporting a network of 11 regional centers and more than 130 local performance sites, the AETCs conduct targeted, multi-disciplinary education and training programs for healthcare providers treating persons with HIV/AIDS. According to the HIV Medicine Association and the American Academy of HIV Medicine, "The CARE Act program plays a critical role in helping us meet the medical needs of our patients. Without the CARE Act, many of our patients would go without lifesaving therapies and care. Programs and services funded by the CARE Act attempt to fill the void in meaningful health care coverage that is left by the U.S. health care system, which relies on private insurers and targeted federal/state programs (e.g., Medicaid and Medicare) for financing health care."

Evidence: 1. CDC, Glynn M, Rhodes P. Estimating HIV Prevalence in the United States at the end of 2003. National HIV Prevention Conference; June 2005; Atlanta, GA. (http://www.aegis.com/conferences/NHIVPC/2005/T1-B1101.html) 2. IOM Report: Public Financing and Delivery of HIV/AIDS Care: Securing the Legacy of Ryan White (May 2004), page 7.(http://www.iom.edu/CMS/3793/4814/20147.aspx) 3. 2005 CARE Act Data Report for statistics for the Ryan White Program (http://hab.hrsa.gov/tools.htm) 4. CDC, HIV Prevention in the Third Decade: "Specific Populations. How are they Affected?" February 1, 2006.(http://www.cdc.gov/hiv/resources/reports/hiv3rddecade/chapter4.htm) 5. Strengthening the Ryan White CARE Act - Recommendations for the 2005 Reauthorization of the CARE Act from the American Academy of HIV Medicine and the HIV Medicine Association. (http://www.idsociety.org/Content/ContentGroups/HIVMA1/Presentations_and_Special_News_Features/RWCA_Final_Manuscript_030205.doc) 6. HIVdent Resources Community Based Dental Partnership Program (http://www.hivdent.org/resource/resourcenewsCBDP0405.htm) 7. HRSA/HAB Ryan White CARE Act - HIV/AIDS Dental Programs, July 2006 (http://hab.hrsa.gov/programs/DentalPrograms/) 8. AIDS Education and Training Centers National Resource Center (http://www.aidsetc.org/aidsetc?page=ab-00-00) 9. The HIV Cost and Services Utilization Study, Do People with HIV Get the Dental Care They Need? Results of the HCSUS Study, 2000. (http://www.rand.org/pubs/research_briefs/RB9067/index1.html) 10. PRNewswire, Dental Problems Go Unresolved in Many HIV Patients, April 2006. (http://www.aegis.com/news/PR/2001/PR010416.html) 11. Levi, J. et al., "Report of the December 10-11, 2002 Quality of Care - Closing the Gap Workshop," Department of Health Policy and the Forum for Collaborative HIV Research, George Washington University. (http://www.hivforum.org/publications/Quality%20of%20HIV%20Care%20-%20Closing%20the%20Gap%20-complete.pdf )

Is the program designed so that it is not redundant or duplicative of any other Federal, state, local or private effort?

Explanation: The Federal Ryan White Program is not redundant or duplicative of any other Federal, State, local or private effort. The program is unique in its design and application in the following ways: ?? As the payer of last resort, the Ryan White Program fills the gaps in care not covered by other resources, including other Federal programs, and public and private insurance; ?? Although both Medicaid and the Ryan White Program provide funds for medical care, Medicaid is an entitlement program and the Ryan White Program is not; ?? The Ryan White Program provides services to the uninsured and underinsured, including to those persons who do not have residency documentation; ?? The Ryan White Program provides for a local planning process that sets priorities for services, which includes determining the availability of other governmental and nongovernmental resources, including the State Medicaid plan under title XIX of the Social Security Act and the State Children's Health Insurance Program under title XXI of such Act to cover health care costs of eligible individuals and families with HIV/AIDS; ?? The successful and unique partnership arrangement in the design of the Ryan White Program between the Federal government and 1) local and State governments; 2) non-profit organizations; 3) health care providers; and 4) support service providers has helped to prevent redundant or duplicative activities; ?? All Ryan White funded programs in a State are required to collaboratively identify significant issues related to the needs of persons living with HIV and AIDS and to maximize coordination across CARE Act Titles. Under the new reauthorization, Section 2617(b)(5)(C), PART B consortia must provide a strategy to coordinate the provision of services with programs for HIV prevention (including outreach and early intervention) and for the prevention and treatment of substance abuse (including programs that provide comprehensive treatment services for such abuse);

Evidence: 1. Title XXVI of the PHS Act as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White Program) 2. HIV/AIDS Bureau website, (http://hab.hrsa.gov/programs.htm)

Is the program design free of major flaws that would limit the program's effectiveness or efficiency?

Explanation: The Ryan White Program is free of major design flaws. In 2003 and 2004 respectively, two Institute of Medicine (IOM) studies, "Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act" and "Public Financing and Delivery of HIV/AIDS Care: Securing the Legacy of Ryan White" were conducted that had major recommendations as follows: ?? Improve equity in funding allocation by pursuing more complete use of HIV data; ?? Distribute supplemental funds based on objective quantitative measurement of HIV/AIDS resource needs; ?? Adopt quality measures that include a standard set of clinical, process, outcome and area-level measures; ?? Ensure early and continuous access to a set of medical and ancillary services that meet the standard of care; ?? Facilitate the provision of services with a minimum administrative costs and duplication of efforts; ?? Ensure financing system and service delivery accountability for meeting established standards of treatment and health outcomes; ?? Promote the delivery of high-quality services. Through the Reauthorization, the Ryan White Program took into account the changing face of AIDS and the program's design and made recommendations for changes, many of which were incorporated into the reauthorized legislation as follows: ?? Use of HIV name-based and code-based data for formula funding distribution under Titles I and II rather than estimated living cases of AIDS; ?? Elimination of Grandfather clause for EMAs with under 2000 AIDS cases in the last five years that permitted certain EMAs to continue receiving funding when they did not meet the case count criteria; ?? Requirement for a minimum drug formulary under ADAP; ?? Establishment of 75 percent core medical services requirement under Parts A, B, and C; ?? Established a timeframe for obligation and expenditure of grant funds and a process for redistribution of these funds to areas of greatest need; ?? State designation of the agency to administer assistance, conduct assessments, receive notices with respect to all funding in state and grantee audits; ?? Established a 10 percent cap in program administrative expenses for Part D, which previously had none; ?? Establishment of clinical quality management requirements for programs under Parts A, B, and C; ?? Reporting of client-level data for improved management; ?? Codification of the Minority AIDS Initiative to assure to address the disproportionate impact of HIV/AIDS and disparities on minorities; and ?? Establishment of a severity of need index, in which Parts A and B grantees demonstrate the severe need for supplemental financial assistance to combat the HIV epidemic in their grant applications be implemented by fiscal year 2009. Since 2001, the Ryan White Program, at the grantee, provider and Bureau levels, has also been engaged in quality management activities through the Institute for Healthcare Improvement (IHI) Collaborative and other organized quality management initiatives.

Evidence: 1. Title XXVI of the PHS Act as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White Program) 2. IOM Report: Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act (November 2003) (http://www.iom.edu/CMS/3793/4819/16325.aspx) 3. IOM Report: Public Financing and Delivery of HIV/AIDS Care: Securing the Legacy of Ryan White (May 2004) (http://www.iom.edu/CMS/3793/4814/20147.aspx) 4. Ryan White HIV/AIDS 2006 Fall Update Assessment (https://max.omb.gov/app/part/prgoram/assessment/fall-updates?pid=1763&aid=6304 5. Quality management activities under the Institute for Healthcare Improvement (IHI) Collaborative can be found at: http://hab.hrsa.gov/special/qualitycare.htm and http://www.ihi.org/IHI/Topics/HIVAIDS/

Is the program design effectively targeted so that resources will address the program's purpose directly and will reach intended beneficiaries?

Explanation: The Ryan White Program is designed in a manner that targets resources to address the unmet care and treatment needs of persons living with HIV/AIDS who are uninsured or underinsured and therefore unable to pay for HIV/AIDS health care and vital health related supportive services. An estimated 89 percent of persons served through the Ryan White Program in 2005 were either uninsured or underinsured; 33 percent were uninsured and 56 percent were underinsured, clearly demonstrating that the program is effective in targeting and reaching its intended beneficiaries. The Administration realized the need to focus on life-saving and life-extending services and increased accountability, and to provide more flexibility to direct funding to areas of greatest need and assured that the 2006 reauthorization of the Ryan White Program addressed these issues. Parts A through F are each specifically designed to effectively target specific populations in need or a particular service delivery entity (e.g. dental care), thus assuring that intended beneficiaries are reached effectively through one or more service delivery mechanisms. The Ryan White HIV/AIDS Treatment Modernization Act of 2006 furthers this effective targeting of services by: 1. Providing more flexibility in directly funding communities and populations in areas of greatest need through new supplemental grants. 2. Targeting a larger percentage of funding to life-saving core medical services. 3. Assuring targeted populations have access to appropriate medications through ADAP. 4. Providing expanded resources for women, infants and children through universal testing of newborns and the provision of a wide range of family-centered care services for women and children with HIV/AIDS. 5. Codifying the Minority AIDS initiative to assure the provision of funding for activities to address the disproportionate impact of HIV/AIDS and disparities in access, treatment, care and outcome on racial and ethnic minorities. 6. Monitoring and redirecting unobligated balances allow for reallocating unexpended funds to the States most in need for Parts A and B. 7. Using HIV data to determine funding distribution, which more accurately reflects the burden of the disease than code-based data. HRSA/HAB recognizes that some Ryan White Program eligible individuals who need care are not enrolled in care for many reasons including: ?? Those who do not know they are HIV positive (approximately 278,000 persons); and ?? Those who know they are HIV positive but are not receiving care because they either: 1) choose not to be in care; or 2) do not know where or how to access care. HAB continues to make efforts to address these factors by continuing to fund HIV testing services with referral into the Ryan White Program if appropriate; collaborating with other Federal, State and local providers who conduct HIV testing to encourage them to refer clients who test positive to Ryan White Programs for treatment; and to assure that appropriate services are being provided in areas of greatest need, including where there are high rates of HIV infection, rural areas, and in communities with health disparities.

Evidence: 1. Title XXVI of the PHS Act as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White Program) 2. 2005 CARE Act Data Report for statistics on the Ryan White Program (http://hab.hrsa.gov/tools.htm)

Does the program have a limited number of specific long-term performance measures that focus on outcomes and meaningfully reflect the purpose of the program?

Explanation: HAB identified three specific, easily understood long-term program outcome goals that directly and meaningfully support the program's mission and purpose. Long-Term Measure I Deaths of persons due to HIV infection. Long-Term Measure II The number of racial/ethnic minorities and the number of women served by Ryan White -funded programs. Long-Term Measure III Ryan White Program-funded HIV primary medical care providers that have implemented a quality management program and meet two "core" standards included in the October 10, 2006 "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents."

Evidence: Do these measures meaningfully reflect the purpose of the program? YES. Please see the following explanations: Long-Term Measure I: The purpose of the Ryan White Program is to address the unmet care and treatment needs of persons living with HIV/AIDS who are uninsured or underinsured, measuring the program's progress in reducing the number of deaths due to HIV/AIDS allows the program to determine the effectiveness with which it delivers quality treatment and care to these underserved populations. Long-Term Measure II - YES As stated above, the purpose of the Ryan White HIV/AIDS Program is to address the unmet care and treatment needs of persons living with HIV/AIDS who are uninsured or underinsured, including populations and communities disproportionately impacted by HIV/AIDS. Increased numbers of women and minorities are now being diagnosed as HIV positive, and in addition, these groups tend to be disproportionally affected by the HIV epidemic, relative to their representation in the general population. Understanding this, it is both appropriate and necessary that the Ryan White HIV/AIDS program measure its effectiveness in providing HIV treatment and care to these populations (women and minorities), who are so disproportionately impacted by the epidemic. The following data from the Centers from Disease Control and Prevention (CDC)are cited as evidence of the disproportionate impact that HIV has had (and is having) on women and minorities within the United States. Women ?? Since 1985, the proportion of estimated AIDS cases diagnosed among women has more than tripled, from 8 percent in 1985 to 26 percent in 2005; and ?? Although Black and Hispanic women together represent only about one fourth of all US women, they account for more than three fourths of estimated AIDS cases to date among women; in 2005, Black and Hispanic women accounted for 83 percent of all cases diagnosed in women. Racial and Ethnic Minorities ?? Racial and ethnic minorities have been disproportionately affected by HIV/AIDS and represent 71% of new AIDS cases in 2005; ?? Although Blacks represent 12 percent of the US population, they accounted for 49% of HIV/AIDS cases in 2005; ?? Blacks accounted for 40% of the cumulative AIDS cases through 2003; ?? Blacks accounted for 37% of AIDS deaths through 2003; ?? Although Hispanics represent 13 percent of the US population, they accounted for 19% of HIV/AIDS cases in 2005; ?? Hispanics accounted for 15 percent of AIDS deaths from 2001 to 2005; ?? Children of color - especially Black children - continue to be disproportionately affected by AIDS; although only 16 percent of US children are Black, 66 percent of US children with a diagnosis of perinatally acquired AIDS in 2005 were Black; and ?? In 2004, teen girls represented 43% of AIDS cases reported among 13-19 year olds and Black teens represented 73% of reported cases, followed by Latino teens representing 14%; Long-term Measure III - YES The long-term effectiveness of the Ryan White HIV/AIDS program is directly impacted by the quality of care provided by the program's primary medical care providers. This long-term measure seeks to both determine if and ensure that Ryan White program providers are meeting the "core" standards of HIV/AIDS treatment and care established by the October 10, 2006 "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents."

Does the program have ambitious targets and timeframes for its long-term measures?

Explanation: The HIV/AIDS Bureau's (HAB) long-term performance measures have ambitious targets and timeframes that are expected to be achieved by 2014. 1. Long-Term Measure I Deaths of persons due to HIV infection. Baseline: 2003 - 4.7 per 100,000 persons Target: 2014 - 3.1 per 100,000 persons 2. Long-Term Measure II The number of racial/ethnic minorities and the number of women served by Ryan White -funded programs. Baseline: Minorities served: 2005 = 412,000 Target: 2014 - Increase by 2.5%; Minorities to be served: 422,300 Baseline: Women served: 2005 = 195,000 Target: 2014 - Increase by 2.5%; Women to be served: 199,875 3. Long-Term Measure III Ryan White Program-funded HIV primary medical care providers that have implemented a quality management program and meet two "core" standards included in the October 10, 2006 "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents." Baseline: 2005 - 63.7 percent Target: 2014 - 90 percent

Evidence: For Long-term Measure I Reducing deaths of persons due to HIV infection with the identified targets is ambitious. The rate of deaths due to HIV has been documented by the National Vital Statistics System, CDC, NCHS, as 5.3 per 100.000 in 1999, 5.2 per 100,000 in 2000, 5 per 100,000 in 2001, 4.9 per 100,000 in 2002, and 4.7 per 100,00 in 2003, with an average decrease in deaths of .15 persons per 100,000 annually. Accordingly, it would be expected that should this trend continue, by the year 2014, the death rate due to HIV should be approximately 3.1 persons per 100,000. The reduction of deaths due to HIV secondary to the advent of HAART appears to be leveling off and showing very modest decreases in recent years, and at some point remain stable and possibly even increase modestly. This is based on a number of factors: 1) People continue to die from HIV/AIDS and its complications; 2) HIV's ability to mutate and become resistant to currently available drugs is a persistent threat; 3) Many patients do not benefit from or cannot tolerate complex combination regimens; 4) The long term side effects and complications associated with these therapies are not known; and 5) HIV and AIDS have disproportionately impacted racial and ethnic minorities in the United States and these populations continue to die at a rate significantly higher than Whites. Therefore, in consideration of the five factors noted above, proposing to meet a target that would be consistent with the trend of reduction of deaths is very ambitious. For Long-Term Measure II: A 2.5 percent increase in the number of minorities and women served in the Ryan White Program establishes a reasonable and ambitious target given that 72% of persons served in 2005 through the Ryan White Program were racial/ethnic minorities and 33% of persons served were women. ?? To establish a higher racial/ethnic minorities target would not be in accord with the epidemic and would establish a threshold that could only be reached by discriminately enrolling minorities in the Ryan White Program and refusing services to other non-minority racial/ethnic groups. -We also need to be mindful that Ryan White Program funding resources have been level for the past four years for programs under Parts A, B (base), C, D and F, which may not speak directly to the issue of long term targeting for racial/ethnic minorities, but rather to the bigger issue of programs not being able to increase the number of clients they are serving. ?? The target for women represents the significant accomplishment made to date by Ryan White programs; a much higher proportion of overall HIV/AIDS care and treatment services are provided to women than the percentage of cases in women reported by CDC in 2005. The efforts of the Part D program targeted to women, children and youth, and the provisions under Parts A and B requiring services for these populations to be in proportion to the percentage in the epidemic have been successful in establishing a high threshold that cannot be increased without refusing services to other groups served by the Ryan White Program. For Long Term Measure III: The HIV/AIDS Bureau (HAB) is proposing to achieve a rate of 90 percent of Ryan White Program funded HIV primary care providers who will have implemented a quality management program and will meet two "core" standards, identified as a CD4 count and a viral load test for 90 percent of their new patients. What establishes this as an ambitious goal is the need to greatly increase efforts by grantees and HAB project officers in developing, implementing and maintaining quality management programs and assuring that an increased proportion of new patients receive a CD4 count and viral load test in light of the known barriers, such as: attrition rates of new patients, new patient retention problems, patients lost to follow up, patients who refuse blood work, and patients who refuse testing.

Does the program have a limited number of specific annual performance measures that can demonstrate progress toward achieving the program's long-term goals?

Explanation: The HIV/AIDS Bureau's (HAB) seven annual performance goals are stated in yearly increments (requiring annual performance results) that are discrete, quantifiable, and measurable. Each long-term performance goal is supported by two or three annual performance goals. The future cumulative effect of annual activities supports the long-term performance goals. Most importantly, these annual goals measure HAB's progress towards reaching the long-term goals. The Ryan White HIV/AIDS program's Annual Measures (listed according to the Long-term measures that they support) are as follows: LONG-TERM MEASURE I (Deaths of persons due to HIV infection) is supported by these annual measures: 1. Number of AIDS Drug Assistance Program (ADAP) clients served through State ADAPs annually. 2. Number of persons who learn their serostatus from Ryan White Programs. 3. Percentage of HIV positive pregnant women in Ryan White Programs who receive Anti Retroviral Medications. LONG-TERM MEASURE II (The number of racial/ethnic minorities and the number of women served by Ryan White -funded programs) is supported by these annual measures: 4. Proportion of racial/ethnic minorities in Ryan White-funded programs that exceed their representation in national AIDS prevalence data, as reported by the CDC. 5. Proportion of women in Ryan White-funded programs that exceed their representation in national AIDS prevalence data reported by the CDC. LONG-TERM MEASURE III (Ryan White Program-funded HIV primary medical care providers who will have implemented a quality management program and will meet two "core" standards included in the PHS Clinical Practices Guidelines for Treatment of Adults, Adolescents, and Pregnant Women) is supported by these annual measures: 6. Number of Ryan White-funded primary medical care providers that will have implemented a quality management program. 7. Proportion of new Ryan White Program HIV-infected clients who are tested for CD4 count and viral load.

Evidence: Do the Ryan White HIV/AIDS program's Annual Measures demonstrate progress toward achieving the program's long-term goals? YES. Please see the following explanations: Annual measures associated with LONG-TERM MEASURE I: Achieving success in reducing the number of deaths of persons due to HIV infection is dependent on the following: 1) INCREASING the number of persons served in the AIDS Drug Assistance Program who receive life extending medications; 2) INCREASING the number of persons learning their serostatus and being able to enroll in medical care when they learn they are HIV positive; and 3) INCREASING the percentage of pregnant women receiving antiretrovirals, thus increasing the health and longevity of the mothers as well as reducing the likelihood the child will be born HIV positive. Each of these annual measures supports the decline in deaths due to HIV infection, thus directly addressing and working towards the goal of reducing deaths of persons due to HIV infection. Annual measures associated with LONG-TERM MEASURE II: By serving a proportion of racial/ethnic minorities and women that EXCEEDS their representation in national AIDS prevalence data (as reported by CDC) the Ryan White HIV/AIDS Program demonstrates its effectiveness in actively identifying and enrolling those people who (data indicates) have the greatest unmet care and treatment needs. This directly addresses and works toward the goal of increasing the number of racial/ethnic minorities and the number of women served by the Ryan White-funded programs. Annual measures associated with LONG-TERM MEASURE III: In order to determine if the program is making progress toward its long-term goal of increasing the number of Ryan White Program-funded HIV primary medical care providers who implement a quality management program and meet two "core" standards of care (as established in 2006), the program will annually monitor: 1) the number of Ryan White-funded primary medical care providers that have implemented a quality management program; and 2) the proportion of new Ryan White Program HIV-infected clients who are tested for CD4 count and viral load- the testing for which constitutes standards of care as established by the 2006 PHS Clinical Practices Guidelines for Treatment of Adults, Adolescents, and Pregnant Women with HIV.

Does the program have baselines and ambitious targets for its annual measures?

Explanation: The HIV/AIDS Bureau's (HAB) annual performance measures are set relative to an established baseline, have clear time frames and targets, and challenge program managers to continuously improve program performance. There are seven annual measures which support the three long-term performance measures. Four of the annual measures have specific incremental increases built into the measures. Three Annual Measures associated with Long Term Measure I: 1. Number of AIDS Drug Assistance Program (ADAP) clients served through State ADAPs annually. Baseline: 2005 - 143,339 Target: Increase the number of clients served annually through ADAP. Year Target 2009 145,038 2008 144,239 2007 143,339 2. Number of persons who learn their serostatus from Ryan White Programs. Baseline: 2005 -572,397 Target: Sustain the number of persons at no less than 572,397 Year Target 2009 572,397 2008 572,397 2007 572,397 3. Percentage of HIV positive pregnant women in Ryan White Programs who receive Anti Retroviral Medications. Baseline: 2005 - 85.3 percent Target: Increase by 1 percentage point annually Year Target 2009 89.3% 2008 88.3% 2007 87.3% Two Annual Measures associated with Long Term Measure II: 1. Proportion of racial/ethnic minorities in Ryan White-funded programs served. Baseline: 2005 - 72 percent Target: Increase by 5 percentage points above CDC data annually Year Target 2009 5 percentage points above CDC data 2008 5 percentage points above CDC data 2007 5 percentage points above CDC data 2. Proportion of women in Ryan White-funded programs served. Baseline: 2005 - 33 percent Target: Increase by 5 percentage points above CDC data annually Year Target 2009 5 percentage points above CDC data 2008 5 percentage points above CDC data 2007 5 percentage points above CDC data Two Annual Measures associated with Long Term Measure III: 1. Percent of Ryan White Program-funded primary medical care providers that will have implemented a quality management program. Baseline: 2005 - 85.7 percent Target: Increase by 2.5 percentage points annually Year Target 2009 95.5% 2008 93% 2007 90.5% 2. Proportion of new Ryan White Program HIV-infected clients who are tested for CD4 count and viral load. Baseline: 2005 --CD4 - 83.2 percent; Viral Load - 79.3 percent Target: Increase number tested for CD4 count and for viral load by 1 percentage point annually. Year Target 2009 CD4-87.2%, Viral Load - 83.2% 2008 CD4-86.2%, Viral Load - 82.3% 2007 CD4-85.2%, Viral Load - 81.3%

Evidence: For the Three Annual Measures associated with Long Term Measure I: 1. Number of AIDS Drug Assistance Program (ADAP) clients served through State ADAPs annually. What makes this measure ambitious is that grantees will increase the number of persons receiving ADAP in light of the high cost of medications and rising costs of drugs. Compounding that fact, the new legislation requires that each State ADAP provide all classes of HIV/AIDS drugs on their formularies will certainly increase the cost of medications per client. 2. Number of persons who learn their serostatus from Ryan White Programs. This measure is ambitious because the new reauthorization language no longer emphasizes the early intervention services for Parts A and B, but places greater emphasis on a broad range of core medical services where these grantees must expend at least 75 percent of their Ryan White Program funds on. Furthermore, outreach is a support service; and with the reduction of funding for support services, outreach will probably be reduced or eliminated by grantees. 3. Percentage of HIV positive pregnant women in Ryan White Programs who receive Anti Retroviral Medications. This measure is ambitious as the Ryan White Programs are already providing a substantial proportion of pregnant women i.e., 4,326 in 2005, with ARV therapy and increasing the percentage will require substantial efforts and resources. Furthermore, the greater efforts needed to increase the proportion will include increased intervention efforts, e.g., more counseling by medical and support staff. For the Two Annual Measures associated with Long Term Measure II: 1. Proportion of racial/ethnic minorities in Ryan White-funded programs served. This annual measure ensures that the Ryan White Program reaches traditionally underserved populations at a significantly and ambitious rate, i.e., a rate that is above the national representation of the populations in the AIDS epidemic. 2. Proportion of women in Ryan White-funded programs served. This annual measure is ambitious as it targets a proportion of women that exceeds the national number of women living with AIDS by helping to improve health outcomes in this portion of the population, while also increasing the probability that the Ryan White Program would increase the number of all women, including pregnant HIV positive women being enrolled into care. Two Annual Measures associated with Long Term Measure III: 1. Percent of Ryan White Program-funded primary medical care providers that will have implemented a quality management program. A 2.5 annual percentage increase is significant and ambitious. HAB has championed quality through its programs, emphasizing the importance of quality improvement by integrating requirements for quality management plans into contracts and program standards. 2. Proportion of new Ryan White Program HIV-infected clients who are tested for CD4 count and viral load. This is ambitious because the measure is looking at new clients only - thus, grantees must continually strive to convince new clients to have these very important diagnostic tests done. Grantees are expected to achieve 1 percentage point higher for the proportion of new clients tested, while trying to reduce the barriers that will keep them from achieving this measure. Additional Evidence: 1. Shackman, BR, et al, The Lifetime Cost of Current Human Immunodeficiency Virus Care in the United States, Medical Care, v44, n11, November 2006 2. Hoffman, JM, et al, Projecting Future Drug Expenditures - 2006, American Journal of Health Systems Pharmacy, v63, January 15, 2006 3. "HIV/AIDS and Women" (http://www.cdc.gov/hiv/topics/women/index.htm)

Do all partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) commit to and work toward the annual and/or long-term goals of the program?

Explanation: HAB's partners support the overall goals of the program and measure and report on their performance as it relates to accomplishing those goals. This requirement is communicated clearly to the grantees in several ways: 1) in all grant application guidance documents; 2) in conference calls; 3) through letters; 4) in project officer calls to individual grantees; and 5) at meetings, such as the All Grantee Meeting. Submission of a CARE Act Data Report (CADR) is a grant award reporting requirement. All Ryan White Program Grantees must submit a CADR detailing the number of clients served, client characteristics, and services delivered. Acceptance of this grant award indicates the grantee's assurance that it will comply with data requirements of the CADR, and that it will mandate such compliance by each of its contractors and subcontractors. CADRs are due annually on March 15. If a Grantee fails to submit the CADR as required, the Notice of Grant Award may be withheld until the Grantee complies with the requirement. The annual and long term goals are measured utilizing grantee/subgrantee data provided on an annual basis through the CADR. HAB's program-level goals (PART and GPRA measures) and performance expectations are clearly stated in the annual program application guidance. Additionally, HRSA's Office of Performance Review works collaboratively with HAB and their grantees to measure program performance, analyze the factors impacting performance, and identify effective strategies and partnerships to improve program performance, with a particular focus on outcomes.

Evidence: 1. Title I FY 2006 -HIV Emergency Relief Grant Program Application Guidance, section x 2. Title II - FY 2006 Ryan White Title II Formula Application Guidance, section x 3. Title III: FY 2006 Categorical Grant Program to provide outpatient Early Intervention Services with Respect to HIV Disease Program Guidance, section x 4. Title III FY 2006 Capacity Building Grant Program Application Guidance, section x 5. Title IV FY 2006 Grants for Coordinated HIV Services and Access to Research for Women, Infant, Children, and Youth Program Guidance, section x 6. 2005 CARE Act Data Report for statistics for the Ryan White Program (http://hab.hrsa.gov/tools.htm) 7. DHHS/HRSA Performance Review Protocol (http://www.hrsa.gov/about/perplan/ )

Are independent evaluations of sufficient scope and quality conducted on a regular basis or as needed to support program improvements and evaluate effectiveness and relevance to the problem, interest, or need?

Explanation: The HIV/AIDS Bureau (HAB) is regularly evaluated by independent agencies such as the Institute of Medicine (IOM), the HHS Office of Inspector General (OIG), and the General Accounting Office (GAO): INSTITUTE OF MEDICINE (IOM) REPORTS The IOM conducted two evaluations examining State surveillance systems and the prevalence of HIV and the relationship between epidemiological measures and health care for certain individuals with HIV disease; this report, Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act, was released November 7, 2003. OFFICE OF INSPECTOR GENERAL (OIG) EVALUATIONS Numerous OIG evaluations, audits, and reports that have been submitted and/or are pending regarding the Ryan White programs. In the past 5 years, these evaluations, audits, and reports have focused on looking at barriers to HIV testing, monitoring of Ryan White programmatic performance, grantees' monitoring of subgrantees, and monitoring of the AIDS Drug Assistance Program. GENERAL ACCOUNTING OFFICE (GAO) AUDITS In addition, GAO has conducted several specific audits of grantees and subgrantees under the Ryan White Program. The findings of these audits are directly shared with grantees, with HRSA's Grants Management Office, and with HAB programs to ensure remedial action is taken where needed. These audits are noted under the Evidence/Data section for this question. (Is this true also of GAO reports/audits, that they are directly shared with grantees, with HRSA's Grant Management Office etc.?)

Evidence: As you will see by the following lists, HIV/AIDS Bureau's programs have been the focus for numerous evaluations, audits, and reports focusing on Federal, State, and local programmatic monitoring and services provided by grantees in the past 5 years. Section 4.5 provides additional detail on some of these independent evaluations and audits. HHS OIG AUDITS 1. Monitoring of Ryan White CARE Act Title I and Title II Grantees (0EI-02-01-00640) (March 2004) (http://oig.hhs.gov/oei/reports/oei-02-01-00640.pdf) 2. Reducing Obstetrician Barriers to Offering HIV Testing (OEI-05-01-00260)(April 2002) (http://oig.hhs.gov/oei/reports/oei-05-01-00260.pdf) 3. The Ryan White CARE Act Title I and Title II Grantees' Monitoring of Subgrantees (OEI-02-01-00641) (March 2004) (http://oig.hhs.gov/oei/reports/oei-02-01-00641.pdf) 4. Monitoring of the CARE Act AIDS Drug Assistance Program (OEI-02-01-00642) (April 2004) 5. Review of 340B Drug Pricing Program (OEI-05-0200073)(July 2006) (http://oig.hhs.gov/oei/reports/oei-05-02-00073.pdf) GAO AUDITS 1. Ryan White CARE Act: Improved Oversight Needed to Ensure AIDS Drug Assistance Programs Obtain Best Prices for Drugs, GAO-06-646 (April 2006) (http://www.gao.gov/new.items/d06646.pdf) 2. HIV/AIDS: Changes Needed to Improve the Distribution of Ryan White CARE Act and Housing Funds, GAO-06-332 (February 2006) (http://www.gao.gov/new.items/d06332.pdf) 3. GAO study entitled Report on HIV/AIDS: Use of Ryan White CARE Act and Other Assistance Grant Funds [GAO/HEHS-00-54] (March 2000) (http://www.gao.gov/new.items/he00054.pdf ) IOM REPORTS 1. IOM Report: Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act (November 2003) http://www.iom.edu/CMS/3793/4819/16325.aspx 2. IOM Report: Public Financing and Delivery of HIV/AIDS Care: Securing the Legacy of Ryan White (May 2004)http://www.iom.edu/CMS/3793/4814/20147.aspx

Are Budget requests explicitly tied to accomplishment of the annual and long-term performance goals, and are the resource needs presented in a complete and transparent manner in the program's budget?

Explanation: The program does not adequately define the relationship between annual and long-term performance targets and resources. The program does not provide an integrated budget and performance presentation that makes clear the impact of funding on expected performance or provide evidence on how the funding requested (including funding increases, when requested) will enable the program to meet its performance goals.

Evidence: The Health Resources and Services Administration Fiscal Year 2008 Justification of Estimates for Appropriation Committees, which includes the budget justification for the Ryan White CARE Act (and each of its Titles/Parts).

Has the program taken meaningful steps to correct its strategic planning deficiencies?

Explanation: The Ryan White Program has no current strategic planning deficiencies. When such deficiencies are identified there is a mechanism to address them both programmatically and through program management. The Ryan White Program has performance measures with baselines and targets. These are the program's GPRA measures. GPRA measures and the Ryan White Program accomplishments are reported as part of the annual budget process. In addition, in 2006, HAB's vision, mission, goals and strategies were updated to further align HAB's vision and mission with HRSA's and to enhance and reinforce program goals and strategies within the framework of reauthorization and the key principles that guided that process.

Evidence: 1.HRSA performance Budget, Fiscal Year 2008, Performance Budget Submission to the Office of Management and Budget 2.Strategic Plan FY 2005 - 2010, (http://www.hrsa.gov/about/strategicplan.htm) 3.HAB Internal Vision, Mission, Goal, and Strategies Document, October 2006

Does the agency regularly collect timely and credible performance information, including information from key program partners, and use it to manage the program and improve performance?

Explanation: The HIV/AIDS Bureau (HAB) regularly collects timely and credible performance information from Ryan White program grantees and sub-grantees (HIV/AIDS service providers). There are three ways in which performance related information is collected: 1. The CARE Act Data Reporting (CADR) system - In existence since 2002, the CADR is the principal grantee/provider based data system utilized by HAB to receive performance and program data from over 2,460 service providers that receive funds from Ryan White Program Grantees. All Ryan White service providers are required to submit a CADR to HRSA in March of each year. The CADR collects data from service providers regarding: a) characteristics of provider organizations; b) the number and demographic characteristics of clients served; and c) the types of services provided and the number of clients receiving these services, as well as the number of client visits by type of service. These data serve three major purposes: a) enabling HRSA to collect unduplicated, aggregate-level data from service providers for monitoring and reporting; b) reducing the reporting burden for grantees and service providers who are funded through multiple Ryan White Program providers; c) and better serving both HRSA and Ryan White Program grantees as a source of data for planning and evaluation across all Ryan White Parts. The annual Data & Evaluation report uses data reported by grantees using the standardized CARE Act Data Report (CADR) system, with 2003 being the first year that these standardized data were available. Under the CADR system, all providers, even those with multiple funding, complete one CADR and report on all clients served regardless of funding sources. This provides HRSA with a comprehensive understanding of how Ryan White funds are being used to deliver health care services to families living with and affected by HIV disease. 2. The Office of Performance Review (OPR) - HRSA's OPR serves as the agency's focal point for reviewing and enhancing the performance of HRSA supported programs. The OPR conducts performance reviews of over 500 HRSA grants annually and since 2004 OPR has reviewed over 1200 HRSA grants. The purpose of conducting these reviews is to analyze the key factors associated with successful performance of HRSA programs. These reviews also assist grantees in their efforts to perform successfully and achieve the best possible results. At the completion of these reviews, grantees receive a comprehensive analysis of the key systems and processes impacting performance on their stated goals and objectives; are provided with a report of key findings, including strengths and areas of improvement and a set of recommendations for performance enhancement; and receive HRSA supported technical assistance, when necessary, to improve performance. In 2006, OPR conducted nine pilot State Strategic Partnership Reviews, which are designed to examine the individual and collective effectiveness of HRSA funded State programs, facilitate State level collaboration in addressing priority health needs, and provide direct feedback to the agency about the impact of HRSA policies on State program implementation and performance by focusing on one to two key State level, cross-program performance measures. The pilot included reviews of AIDS Drug Assistant Program (ADAP) grantees. 3. HAB collects data directly through various means, including through program-specific site visits to provide technical assistance to grantees and subgrantees and to monitor compliance issues; telephone calls between program project officers and grantees; and through written requests from the program to the grantees.

Evidence: 1. 2005 CADR Report for statistics for the Ryan White Program (http://hab.hrsa.gov/tools.htm) 2. DHHS/HRSA Performance Review Protocol (http://www.hrsa.gov/about/perplan/) 3. Sample Program Site Visit Reports

Are Federal managers and program partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) held accountable for cost, schedule and performance results?

Explanation: The Associate Administrator for HAB has a performance contract with the HRSA Administrator that links to the performance results set by the program. Each Division Director within HAB also has a performance contract with the Associate Administrator for HAB that links to the performance results by their respective programs. Program officials assume responsibility by continually monitoring grantees budgets, financial status reports, data and performance of services to subgrantees and clients. Grantees are also held accountable for cost, schedule and performance results. This is monitored through several methods as follows: 1. New and continuing grant applicants are required to prepare a detailed budget as part of the application consistent with instructions in the funding opportunity announcement and application instructions that is submitted to HRSA. Grantees are directed by HRSA as to what costs are acceptable and allowable and what costs are prohibited, and limitations on any cost categories, such as administrative expenses. As appropriate, grantees are also notified by HRSA of any cost sharing or matching requirements for their programs, which must be reflected in their application. In addition, the HRSA Grants Management Officer is responsible for the business management and other non-programmatic aspects of an award. 2. Grantees are periodically visited by a team of expert consultants to assess performance, through HRSA's Office of Performance Review (OPR). HRSA's Performance Plan is designed to complement and support the budget justification material for the Agency's annual budget request and is an integral part of the overall HRSA budget. The OPR serves as the agency's focal point for reviewing and enhancing the performance of HRSA funded programs within communities and States. Through performance reviews, OPR works collaboratively with grantees and other HRSA components to measure program performance, analyze the factors impacting performance, and identify effective strategies and partnerships to improve program performance. If grantees are found to be non-compliant, have financial instability or inadequate management systems, inexperienced in handling Federal funds, or demonstrate poor programmatic performance during any of the mechanisms discussed above, decisions are made by HAB regarding continued funding, appropriateness of funding levels, transfer of funds from one category to another, placement of the grantee on the Departmental Alert List, or other actions. Examples of situations and actions that have been taken include: 1. A community health center fired their infectious disease specialist and several HIV program coordinators. A diagnostic, compliance site visit was scheduled to coincide with a diagnostic visit from the Bureau of Primary Health Care. Major Part C findings were: 1) inability to document use of funds for HIV care and 2) clinical care which did not meet PHS guidelines. TA was provided on site and the grantee was referred to the Southeastern AETC (SEAETC) for assistance and training. The grantee was given a 1-year project period with a requirement to re-compete and scored low by the objective review committee. Ultimately, the grant was not renewed. 2. A faith-based organization was awarded a Part C and a Part D grant, but problems in administering the program, providing care, and recruiting and retaining consumers was discovered. A site visit yielded promises of correction and the project officer monitored the grantee closely. Ultimately, the grantee was placed on draw-down restriction for HAB funds; the Office of Performance Review conducted a site visit; the Division of Field Investigations (DFI) was alerted and conducted a site visit with HAB project officers; and the grant was transferred in mid-budget year to another clinical site that provides HIV care in the area.

Evidence: 1. Program Managers performance contracts 2. Sample of FY 2006 HAB Application Guidance Documents, section 3. DHHS/HRSA Grant Policy Statement, section (ftp://ftp.hrsa.gov/grants/hhsgrantspolicystatement.pdf) 4. DHHS/HRSA Performance Review Protocol (http://www.hrsa.gov/about/perplan/) 5. Sample of Site Visit Reports 6. OIG Report: "Use of the Departmental Alert List by HRSA," May 2006 (OEI-02- 03-00011) http://www.oig.hhs.gov/oei/reports/oei-02-03-00011.pdf

Are funds (Federal and partners') obligated in a timely manner, spent for the intended purpose and accurately reported?

Explanation: Agency and program requirements are in place to assure timely obligation and expenditure of grant funds by Ryan White Program grantees. The Ryan White Program works with HRSA's Office of Financial Accountability and Management, Division of Grants Management Operations to assure that grants are administered in accordance with planned schedules and spend for intended purposes. HRSA/HAB has obligated its funding by quarter fairly consistently over the years. The majority of funds are obligated within the first two quarters. Under Part A grantees are required to submit a final budget 90 days after they receive their final notice of grant award for the year. Under Part B grantees are required to obligate 75 percent of their grant funds will within 120 days of receipt of the notice of grant award. Each grantee is required to submit a financial status report 150 days after receipt of the grant. Under Part B, it is the program's policy to consider ADAP funds obligated by the State upon receipt of the grant award if the State has demonstrated a commitment to spend the funds for ADAP purposes. For Parts C and D, grantees must propose their allocation of funds at the time the application is submitted. If revisions are required, they are due within 30 day of the notice of grant award. Grantees report on funds spent and funds remaining unobligated within 90 days of the end of the budget period. Grantees either request carryover of unobligated funds into the next budget period or funds are offset and used for one-time awards within the Ryan White Program . Grantee and subgrantee have audit requirements as established by HRSA grants management, in accordance with OMB circular A-133. Office of Inspector General audits are also conducted on a regular basis and HRSA/HAB works with OIG and its grants management staff to assure timely follow-up with grantees when audit irregularities arise. HAB monitors grantee expenditures to ensure compliance with legislation, regulation and policies. Grantees monitor their subgrantee budgets and expenditures, as required in the Program Guidance. Grantees must submit financial data for all grant funds, including those paid to subgrantees and contractors, in financial reports to HRSA and HAB. As a result, grantees establish and implement reporting schedules to their subgrantees and contracts on budget expenditures and services provided that assures the grantee is able to meet their reporting requirements to HRSA. There are a few cases when grantees or subgrantees do not use their funds according to statute. Most of these cases stem from subgrantees improperly managing resources, and the grantee of record identifies the problem and reports it to HRSA/HAB. A problem may also be found with a grantee through a site visit, audit, or as reported to HAB by the grantee. At that time remedial action would be taken, such as: the provision of technical assistance to the grantee, subgrantee and/or contractor on financial management and accountability; closer monitoring of the grantee by the HAB project officer is instituted; funds may be required to be returned to the grantee of record or to HRSA; or legal action may be taken. The fiscal year 2007 appropriations law specifies that funds under Parts A and B of the Ryan White Program are available for obligation by the Secretary for three years. In addition the legislation allows the Secretary to reallocate unobligated balances based on need.

Evidence: 1. Estimated obligations by quarter in apportionments for FYs 2005-2006 2. Actual obligations by quarter for FYs 2005-2006 NOTE: All grantees expending above $500,000 in Federal funds provide Single Audit Act reports. 3. DHHS/HRSA Grant Policy Statement, section (ftp://ftp.hrsa.gov/grants/hhsgrantspolicystatement.pdf 4. OMB Circular A-133, (http://www.whitehouse.gov/omb/circulars/a133/a133.html)

Does the program have procedures (e.g. competitive sourcing/cost comparisons, IT improvements, appropriate incentives) to measure and achieve efficiencies and cost effectiveness in program execution?

Explanation: The Ryan White Program has an efficiency measure with baseline and targets that centers on cost saving of our ADAP programs: Amount of savings by State ADAPs participating in cost-saving strategies on medications. Baseline: 2005 - $275 million Target: Increase by 1 percent over previous year's results Year Target Result 2005 $146.3 M $275 M 2006 $278 M 2007 $281 M 2008 $284 M This challenges the Ryan White Program ADAPs to contain costs at the same time they are asked to expand access to medications over time. As a result, ADAPs have taken a number of steps to stretch dollars. These include changing the system used to purchase/distribute drugs, seeking larger price discounts or rebates on drugs (e.g., through participation in the Section 340B Drug Discount Program), third party reimbursement, and direct negotiations with pharmaceutical companies. The Ryan White Program achieves other kinds of efficiencies and cost-effectiveness through: CARE Act Data Report (CADR) - the incorporation of all Ryan White Program grantees and their service providers, services, and activities into one post-award annual standardized aggregate data reporting mechanism that is integrated for electronic reporting through the HRSA Electronic Handbook. Electronic Handbook (EHB) - HRSA's Grants Management web site for performing the daily work of planning, making, and administering grants is the EHB, which is accessible to HRSA staff involved in grants management and allows interaction and performance of most job functions of monitoring grants online. Grants.gov - HRSA no longer accepts applications for grant opportunities on paper. Applicants submitting new, competing, and some non-competing applications submit their applications electronically through Grants.gov. Performance Review (OPR) - HAB's grantee monitoring is conducted through HRSA's OPR which serves as the agency's focal point for reviewing and enhancing the performance of HRSA funded programs within communities and States. Unified Financial Management System (UFMS) - HAB has fully implemented and utilizes the UFMS to achieve greater economies of scale, eliminate duplication and provide better service delivery. Contracts - HAB has two multi-year contracts to provide: 1) Logistics Assistance; and 2) Technical Assistance. The contracts were awarded through a full and open competition. By utilizing one source for logistics and one source for technical assistance, the Bureau readily has resources in place when such services are needed, such as for the planning and implementation of meetings or when immediate and specialized TA is needed to assist a grantee. This arrangement has demonstrated to be efficient and cost effective. Indefinite Delivery/Indefinite Quantity Contracts (IDIQ) - This type of contract allows for increased administrative efficiencies within the Bureau. HAB has the option of contracting for its evaluation needs using task orders through the IDIQ process. The IDIQ is limited to contractors who have satisfied the technical merit and already been awarded contracts under a specific task, such as program evaluation. IDIQ administrative procedures and actual award processes significantly simplify and streamline full and open competitions.

Evidence: 1. All HAB post-award grantee data reporting systems are now operable and linked to the HRSA Electronic Handbook; 2. ADAP Quarterly Report for 2006 3. 2005 CADR Report - HRSA/HAB's information technology efforts center around standardizing data collection, so that HAB may measure number of people served, the number of health-related visits, or the types of drugs prescribed to HIV+ clients (http://hab.hrsa.gov/tools.htm) 4. Unified Financial Management System Website (http://www.hhs.gov/ufms/) 5. Federal Acquisition Regulations - for contracts requirements - (http://www.acquisition.gov/far/) (see Subpart 6.1??Full and Open Competition) 6. Electronic Handbook Website (https://grants.hrsa.gov/webexternal/home.asp ) 7. HRSA Performance Review Website (http://www.hrsa.gov/performancereview) 8. Copies of current Technical Assistance and Logistics Contracts

Does the program collaborate and coordinate effectively with related programs?

Explanation: The Ryan White Program both coordinates and collaborates effectively with other Federal programs, such as the Office of the Secretary of HHS, the Centers for Disease Control and Prevention (CDC), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Center for Medicaid and Medicare Service, (CMS), the Department of Housing and Urban Development (HUD), the National Institutes of Health (NIH), the Department of Veteran's Affairs (DVA), and the Department of Justice (DOJ), as well as other Bureaus within HRSA, such as the Bureau of Primary Health Care. The Ryan White Program coordinates and collaborates with national AIDS organizations through a partnership that includes organizations such as: the National Association of People with AIDS, the National Minority AIDS Council, National Alliance of State and Territorial AIDS Directors, the Communities Advocating Emergency AIDS Relief Coalition, the AIDS Alliance of Children, Youth and Families, and the AIDS Action Foundation. The Ryan White Program grantees are required to create, encourage, and maintain linkages to other entities, such as the Part A Planning Bodies that work with State and Local Ryan White Program funded grantees, Medicaid programs, HIV prevention providers and maternal and child health agencies to establish HIV service priorities, direct funds for services, identify gaps in care, assess shifts in the local HIV epidemic, and develop a comprehensive service strategy. The Part B programs are required to coordinate with State, local, and Ryan White Program grantees to develop a statewide coordinated statement of need. Part D programs are required to develop a comprehensive family oriented system of care, which many times requires the collaboration of a lead grantee with numerous subgrantees and/or contractors to assure appropriate and wide range service provision. Some examples of coordination and collaboration efforts of the Ryan White Program follow: 1. Case Management Workgroup - HRSA/CDC/CMS/SAMHSA/NIH and HUD: A HRSA/HAB and CDC funded project to examine the benefits and barriers that affect collaboration among HIV/AIDS case managers; to identify methods for strengthening linkages between HIV/AIDS case management programs; and to develop recommendations regarding collaboration and coordination among federally funded HIV/AIDS case management programs. 2. 4TC Initiative - HRSA/CDC/OPA and SAMHSA - Collaborative training effort that coordinates activities between 4 national training programs, i.e., HRSA/HAB's AETCs, CDC's Prevention and Training Centers, OPA's Regional Training Centers and SAMHSA's Addiction Technology Transfer Centers. 3. Severity of Need Index (SONI) - HRSA/CMS/CDC and SAMHSA: Project to develop a SONI for the distribution of Ryan White Program funds for Parts A - D. 4. Housing Opportunities for Persons with AIDS (HOPWA) - HUD/HRSA and the Office of the Secretary: Collaborative efforts: 1) for joint funding and shared oversight of comprehensive systems of care specifically targeted toward homeless persons; 2) to ensure HRSA clients have equitable access to these entitlement and insurance resources; and 3) to address the needs of homeless people with HIV. 5. Provider Information Sharing - HIV, substance abuse and mental health professionals/ DVA clinicians and Ryan White Program providers - Various training, coordination and resource-sharing efforts to enhance information-sharing among HIV, primary care, mental health and substance abuse providers. 6.SPNS Initiative - Enhancing Linkages to HIV Primary Care in Jail Settings - State and local health departments/Jails/ Correctional Institutions/other SPNS grantees/Ryan White Program providers: HRSA and CDC funded grants to support organizations to implement demonstration projects that identify HIV-infected individuals in jails and assist them in securing HIV primary care and social support services when transitioning back to the community.

Evidence: 1. 2003 - 2004 Report to Congress on Coordination of Federal HIV Programs 2. HAB Internal Listing of Coordinated Efforts 3. HAB Website - Special Initiatives (http://hab.hrsa.gov/specialprojects.htm)

Does the program use strong financial management practices?

Explanation: In its 2006 audit, HHS received a material control weakness for its financial management systems and reporting. Specifically, HHS had trouble producing timely and reliable financial statements. Substantial manual procedures, significant adjustments to balances, and numerous accounting entries outside HHS's general ledger system were necessary. HRSA contributes to this material internal control weakness. In FY 2006, HRSA replaced its existing accounting system with the Unified Financial Management System (UFMS), which should improve compliance with the Federal Financial Management Improvement Act (FFMIA). However, auditors found difficulties with the UFMS conversion process. It is expected that these errors will go away in FY 2007 when the conversion process is complete. In addition to the material weaknesses identified in the HHS audit, internal control weaknesses in HRSA led to the re-obligation of prior year funds, which may not be in compliance with accounting requirements.

Evidence: Since 2003, HRSA has been included in a consolidated HHS audit. In a 2006 audit of HHS, Price Waterhouse Coopers found a material weakness in HHS financial management systems and reporting. HHS's financial management systems are not FFMIA compliant. In particular, the 2006 audit found that HHS continues to experience significant challenges in resolving issues related to the UFMS conversion and implementation. Despite the implementation of UFMS, HHS recorded more than 1,000 manual entries during the year, more than of $10 billion to correct conversion balances, correct opening balances, and record financial transactions in order to complete the financial reporting process. In addition, the 2006 audit found HHS has not completed the implementation of the UFMS reports module. HHS completes the reports module in 2007 and expects that the need for manual entries will disappear once the UFMS conversion process is complete. The Inspector General of HHS is in the process of investigating potential violations of accounting requirements at HRSA.

Has the program taken meaningful steps to address its management deficiencies?

Explanation: HRSA has recently taken steps to address identified internal control deficiencies. HRSA is centralizing the control of prior year funds within the office of the HRSA CFO. HRSA's program offices will no longer have funds control authority for prior year funds. Instead, the Division of Financial Management, Budget Execution Branch maintains the funds control for all prior year funds.

Evidence: Under this new procedure, a program office wishing to use prior year funds must obtain a funds availability signature (or electronic approval) from a trained budget analyst in the Budget Execution Branch who would have the knowledge to make determinations about the legitimate use of prior year funds and who would also have the support of attorneys in the HHS Office of General Counsel when an unusual circumstance might call for legal advice. The UFMS accounting system is also structured to support this new approach, because in the UFMS system HRSA will assign the funds control role for available prior year funds only to specific users in the Budget Execution Branch.

Does the program have oversight practices that provide sufficient knowledge of grantee activities?

Explanation: HRSA has established effective oversight activities for its Part A and Part B grantees. During the 2002 PART, the program's need for mechanisms to identify problems or make corrective actions prior to the mismanagement of resources by grantees or sub-grantees was identified and thus became a focus of the resulting PART Improvement Plan. In addition, OIG audit/evaluations conducted in 2004 and 2006 on oversight of Ryan White Program funds by Parts A and B grantees and their sub-grantees and the ADAP raised the issue of the adequacy of HRSA's oversight of the performance of these entities. In response to both the OMB PART 2002 and the OIG evaluations, HAB conducted a number of assessments and implemented needed actions that provided corrective actions to address identified problems and issues as follows: ?? Developed the following efficiency measure: "Increase by 2 percent annually the amount of savings by State ADAP participation in cost-savings strategies on medications," which was included in the Bureau's GPRA plan. ?? Inserted language in Part A and B guidance documents related to oversight responsibilities by grantees of subgrantees. In addition, the Office of Performance Review (OPR) also while conducting its assessment will review the grantee audits and provider reports. OPR's Performance Review Protocol has 'prompting questions' that are asked during all visits to grantees; two questions are specific to this issue and state: "How has the grantee performed in the oversight of funds and contracted services and it its overall fiduciary responsibilities? Are funds disbursed in a timely manner?" ?? Provided additional training to Project Officers to assure increased grantee budget and performance monitoring. ?? Conducted an evaluation, "Improving the Monitoring of Ryan White CARE Act Title I and Title II Sub-Grantee Performance," with a resulting consensus document identifying TA areas, including fiscal accountability. When was this conducted? Was this conducted in response to the GAO and OIG reports specifically? What where the findings? ?? Held a series of consultations with grantees resulting in: 1) Training and TA to assist grantees improve monitoring of sub-grantee performance; 2) Feedback from grantees on the training and TA; and 3) Evaluation of the effectiveness of Training and TA and recommendations for future needs. ?? Conducted a policy study on the ADAP, "Allocating Scarce Resources in AIDS Drug Assistance Programs: Ethical Considerations." ?? Held a National Partners Meeting to discuss the ADAP Ethics Discussion Paper that was used as an internal document to develop TA activities for grantees that have ADAP waiting lists, 2004. ?? Held a National Technical Assistance conference call on fiscal accountability and OIG audit findings from Part A and B grantees in 2006. ?? HAB has established a process of site visits and reverse site visits with challenged grantees including Norfolk Virginia EMA and Puerto Rico, San Juan EMA in the most recent year. These activities are above and beyond the oversight activities conducted by HAB, Office of Performance Review and Grants Management Office in HRSA.

Evidence: 1. Ryan White CARE Act: Improved Oversight Needed to Ensure AIDS Drug Assistance Programs Obtain Best Prices for Drugs, GAO-06-646 (April 2006) (http://www.gao.gov/new.items/d06646.pdf) 2. Monitoring of Ryan White CARE Act Title I and Title II Grantees (0EI-02-01-00640) (March 2004) (http://oig.hhs.gov/oei/reports/oei-02-01-00640.pdf) 3. The Ryan White CARE Act Title I and Title II Grantees' Monitoring of Subgrantees (OEI-02-01-00641) (March 2004) (http://oig.hhs.gov/oei/reports/oei-02-01-00641.pdf) 4. Review of 340B Drug Pricing Program (OEI-05-0200073)(July 2006) (http://oig.hhs.gov/oei/reports/oei-05-02-00073.pdf) 5. Ryan White HIV/AIDS 2006 Fall Update Assessment (PART Improvement Plan) (https://max.omb.gov/app/part/prgoram/assessment/fall-updates?pid=1763&aid=6304) and interim reports. 6. Consultation on Technical Assistance to Improve Subgrantee Monitoring, Final Report, REDA International, December, 2006 7. "Allocating Scarce Resources in AIDS Drug Assistance Programs: Ethical Considerations," 2003, HRSA 8. "Examination of Fiscal Management and the Allocation of CARE Act Resources," May, 2005, HRSA 9. Memorandum to the Director, Office of Financial Policy and Oversight; Subject: 2006 Unimplemented Office of the Inspector General and General Accounting Office Information Request, November 30, 2006 10. Memorandum to the Director, Office of Financial Policy and Oversight; Subject: Draft Compendium of Unimplemented Office of the Inspector General Recommendations Request, March 16, 2007. 11. Memorandum to the Director, Office of Financial Policy and Oversight; Subject: Follow-up Comments on the Government Accountability Office Report: RYAN WHITE CARE ACT: Improved Oversight Needed to Ensure AIDS Drug Assistance Programs Obtain Best Prices for Drugs, March 22, 2007. 12. DHHS, HRSA; "Performance Review Protocol." December 2004

Does the program collect grantee performance data on an annual basis and make it available to the public in a transparent and meaningful manner?

Explanation: All Ryan White Programs collect performance and program data from Grantees and their service providers on an annual basis, with the exception of the Ryan White CARE Act's AIDS Drug Assistance Program (ADAP) which submits data on a quarterly basis. All data are analyzed and published each calendar year. These data are available to the public on the HAB website and hard copies can be obtained through the HRSA Information Center. In addition, a profile of the HIV/AIDS epidemic, Ryan White Programs, and recipients of program services in each State also are available on the HAB website.

Evidence: 1. HAB Program Data Reports and Presentations (http://hab.hrsa.gov/reports/data2a.htm) 2. HRSA Information Center Website (http://www.ask.hrsa.gov/)

Are grants awarded based on a clear competitive process that includes a qualified assessment of merit?

Explanation: 100 percent of the competitive grants awarded by the Ryan White Program are reviewed, ranked, and awarded according to the competitive process established by the centralized HRSA Division of Independent Review (DIR). This review includes the use of an objective review panel comprised of non-HRSA staff. The review criteria are taken directly from the program application guidance. There are no earmarks for competitive grants and all awards are subject to peer review. The HRSA Preview is a comprehensive description of discretionary grant programs and cooperative agreements scheduled for award. The Preview includes grant program descriptions and information on 1) eligibility and application deadlines; 2) estimated number of awards and funding priorities; 3) projected award dates and application kit availability; and 4) program contacts and more. The Preview contains almost all of HRSA's grant offerings. Additional funding opportunities made available after its publication for the upcoming or current fiscal year will appear in the Federal Register and on the HRSA home page. After award decisions are made, HRSA informs all applicants of the results of their application review prior to the start date of the grant. Expected award announcement dates and program contacts are listed in the HRSA Grants Preview program summaries linked from http://www.hrsa.gov/grants/. Current HRSA grantees, listed by program and by State, can be found at GranteeFind.hrsa.gov.

Evidence: 1. DHHS/HRSA Grant Policy Statement (ftp://ftp.hrsa.gov/grants/hhsgrantspolicystatement.pdf) 2. Sample Part C & Part D 2006 Program Guidance

Does the program have oversight practices that provide sufficient knowledge of grantee activities?

Explanation: The HIV/AIDS Bureau (HAB) conducts numerous oversight practices that provide sufficient knowledge of their grantees' activities. These oversight practices as administered by HAB include: 1. Grant applications, that provide detailed information about the proposed project for funding, including, but not limited to: current and past progress of grantee in serving persons affected by HIV; anticipated number of clients to be served; services to be provided; types of providers who will be funded; total funding requested; and detailed budget specifying amount of funds by services; 2. Site Visits by OPR and as needed by program staff persons and/or consultants; 3. Grantee Submission of Conditions of Award responses; 4. Grantee Submission of Data reports through the CARE Act Data Reporting system; 5. Ongoing monitoring of programmatic activities by HAB Project Officers; 6. Submission of financial status reports (FSR) by grantees 90 days prior to end of project period; 7. Submission of carryover requests by grantees to utilize unobligated funding with a detailed explanation for not using funds during project period and a detailed plan for use of the funds during the next project period. If during any of these oversight mechanisms noted above, deficiencies are found, HAB can and will take action by: 1. Providing technical assistance; 2. Placing a grantee on draw-down restrictions; 3. Referring a grantee to the local or regional AETC for training and possible continued oversight; 4. Conducting a targeted site visit; 5. Suspending an award; 6. Transferring an award; or 7. Terminating an award.

Evidence: 1.Sample Titles III and IV, Dental and AETC grant applications, section 2.DHHS/HRSA Performance Review Protocol (http://www.hrsa.gov/about/perplan/) 3.Sample of Site Visit Reports for Titles III and IV, Dental and AETC grantees 4.Sample CADR document to demonstrate types of data requested 5.Sample FSR for Titles III and IV, Dental and AETC grantees

Does the program collect grantee performance data on an annual basis and make it available to the public in a transparent and meaningful manner?

Explanation: All Ryan White Programs collect performance and program data from Grantees and their service providers on an annual basis, with the exception of the Ryan White program's AIDS Drug Assistance Program (ADAP) which submits data on a quarterly basis. All data are analyzed and published each calendar year. These data are available to the public on the HAB website and hard copies can be obtained through the HRSA Information Center. In addition, a profile of the HIV/AIDS epidemic, Ryan White Programs, and recipients of program services in each State also are available on the HAB website.

Evidence: 1. HAB Program Data Reports and Presentations (http://hab.hrsa.gov/reports/data2a.htm) 2. HRSA Information Center Website (http://www.ask.hrsa.gov/)

Has the program demonstrated adequate progress in achieving its long-term performance goals?

Explanation: The HIV/AIDS Bureau's (HAB) long-term performance goals are all showing progress toward meeting the 2014 targets. Long-Term Measure I: Deaths of persons due to HIV infection. 2014 Target - 3.1 per 100,000 persons Year Actual 2003 4.7 2002 4.9 2001 5.0 2000 5.2 1999 5.3 As the above actual data indicates, the program has demonstrated clear progress toward achieving its long-term performance target. Long-Term Measure II: Number of racial/ethnic minorities and the number of women served by Ryan White -funded programs. 2014 Target: Minorities to be served: 422,300 Women to be served: 199,875 Year Actual Actual R/E Minorities Women 2005 412,000 - 195,000 2004 DNA - 189,193 2003 DNA - 193,943 2002 DNA - 191,833 (Measure first adopted in 2002) 2000 369,300 - 160,000 (Baseline) Due to the aggregate nature of the CARE Act Data Report (CADR) data and the way the racial/ethnic questions were phrased, the proportion of racial/ethnic minorities served by the Ryan White Program could not be calculated consistent with CDC data for 2002 - 2004. HAB obtained clearance under the Paperwork Reduction Act to change the 2005 CADR data collection questions on race and ethnicity to remedy this problem that is consistent with the way CDC collects and reports it's their data. As the above data indicates, the program has demonstrated clear progress toward achieving this measure's long-term performance target. Long-Term Measure III: Ryan White Program-funded HIV primary medical care providers will have implemented a quality management program and will meet two "core" standards included in the PHS Clinical Practices Guidelines for Treatment of Adults, Adolescents, and Pregnant Women. 2014 Target - 90 percent of all Ryan White-funded HIV primary care providers Year Actual 2005 63.8% of all Ryan White-funded HIV primary care providers had implemented a QM program and had met two "core" standards included in the October 10, 2006 "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents." Of these, at least 80% of the providers' new HIV-Positive clients had had a CD4 count and at least 75% of their HIV-positive clients had a viral load. 2002 50% (baseline estimate) This long-term measure was defined as a developmental measure in the 2002 PART. 2005 was the first year actual data were available to report, therefore there is no additional historical data and no surrogate data are available. The first year of data availabe for this measure indicates that the program is making progress toward achieving its long-term performance target.

Evidence: 1. FY 2008 Performance Budget - Congressional Justification version (ftp://ftp.hrsa.gov/about/budgetjustification08.pdf, Pages 344 - 354) 2. 2005 CADR Report for statistics for the Ryan White Program (http://hab.hrsa.gov/tools.htm) 3. National Vital Statistics System (NVSS), CDC, NCHS. Resident death data are based on information from death certificates filed in the 50 States and the District of Columbia (http://wonder.cdc.gov/scripts/broker.exe).

Does the program (including program partners) achieve its annual performance goals?

Explanation: The HIV/AIDS Bureau (HAB) has achieved its annual goals as described below. 1a. Number of AIDS Drug Assistance Program (ADAP) clients served through State ADAPs annually. Target: Increase the number of AIDS Drug Assistance Program (ADAP) clients served through State ADAPs annually. Year Actual 2005 143,339 2004 142,653 2003 143,711 2002 136,345 2001 136,875 2000 128,078 The program has demonstrated success in increasing the number of people served through the States' AIDS Drug Assistance Program between 2000 and 2005. As the numbers above indicate the ADAP program did experience a slight drop between 2003 and 2004 in the numbers of people served, however this can be attributed to an increase in the average cost of medications in 2004, due largely to the introduction of a new medication, Fuzeon (approved by FDA in March 2003). For example, the average cost per year of medications for ADAP clients was $11,283 in 2002. Fuzeon costs about $20,000 per client per year, and in 2003 the HIV/AIDS Bureau determined that approximately 4,000 ADAP clients would potentially benefit from the new medication, resulting in a projected cost to ADAP of $80 million. As a result of this increase demand for resources, State ADAP organizations began to institute medication waiting lists. The Ryan White Program has also demonstrated effectiveness in meeting its targets for another of its ADAP-related measures: 1b. Number of ADAP clients receiving HIV/AIDS medications through State ADAPs during at least one month of the year. Target: Increase the number of ADAP clients receiving HIV/AIDS medications through State ADAPs during at least one month of the year by at least 4 percent. Year Target Result 2004 89,731 89,933 2003 84,331 86,280 2002 81,178 (Baseline) 2. Number of persons who learn their serostatus from Ryan White Programs. Target: Sustain the number of persons who learn their serostatus from Ryan White Programs. Year Actual 2005 572,397 2004 553,569 2003 450,928 2001 387,061 2000 352,283 3. Proportion of racial/ethnic minorities in Ryan White-funded programs served. Target: Exceed by 5 percentage points their representation in national AIDS prevalence data reported by the CDC, annually. Year CDC Actual 2005 64.1% 72% 2001 62.7% 69.1% Due to the aggregate nature of the CADR data and the way the racial/ethnicity questions are currently phrased, the proportion of racial/ethnic minorities served by the Ryan White Programs could not be calculated for 2002 - 2004. 4. Proportion of women in Ryan White -funded programs served. Target: Exceed by 5 percentage points their representation in national AIDS prevalence data reported by the CDC, annually. Year CDC Actual 2005 24% 33% 2004 23% 33% 2003 21.8% 36% 2002 21.5% 34.1% 2000 20.6% 33.3% 5. Percentage of Ryan White Program-funded primary medical care providers that will have implemented a quality management program. Target: Increase by 2.5 percentage points annually Year Actual 2005 85.7 2002 50% (estimated baseline) This measure required data collection revisions to the CADR and OMB clearance. The CADR was revised to include this data element and 2005 was the first year actual data were available to report.

Evidence: 1.FY 2008 Performance Budget - Congressional Justification version (ftp://ftp.hrsa.gov/about/budgetjustification08.pdf, Pages 344 - 354) 2.2005 CADR Report for statistics for the Ryan White Program 3.HIV/AIDS Surveillance Reports, as follows: ??2005 Edition, Volume 17 ??2004 Edition, Volume 16 ??2003 Edition, Volume 15 ??2002 Edition, Volume 14 ??Year-end 2001 Edition, Vol.13, No.2 ??Year-end 2000 Edition, Vol.12, No.2

Does the program demonstrate improved efficiencies or cost effectiveness in achieving program goals each year?

Explanation: The historical data associated with the Ryan White Program's efficiency measure demonstrate the program's improved efficiencies or increased cost-effectiveness. The Ryan White Program's efficiency measure, baseline, target and historical data are: Amount of savings by State ADAPs participating in cost-saving strategies on medications. Target: Increase by 1 percent over previous year's results Year Target Result 2005 $146.3 M $275 M 2004 $94.3 M $143.5 M 2003 $77.5 M $92.5 M The State ADAPs utilize various cost savings strategies, including: seeking larger price discounts or rebates on drugs (e.g., through participation in the Section 340B Drug Discount Program), and direct negotiations with pharmaceutical companies. In addition to the savings demonstrated above, the Ryan White HIV/AIDS program has achieved efficiencies and cost-effectiveness through: CARE Act Data Report (CADR) - the incorporation of all Ryan White Program grantees and their service providers, services, and activities into one post-award annual standardized aggregate data reporting mechanism that is integrated for electronic reporting through the HRSA Electronic Handbook. Electronic Handbook (EHB) - HRSA's Grants Management web site for performing the daily work of planning, making, and administering grants is the EHB, which is accessible to HRSA staff involved in grants management and allows interaction and performance of most job functions of monitoring grants online. Grants.gov - HRSA no longer accepts applications for grant opportunities on paper. Applicants submitting new, competing, and some non-competing applications submit their applications electronically through Grants.gov. Performance Review (OPR) - HAB's grantee monitoring is conducted through HRSA's OPR which serves as the agency's focal point for reviewing and enhancing the performance of HRSA funded programs within communities and States. Unified Financial Management System (UFMS) - HAB has fully implemented and utilizes the UFMS to achieve greater economies of scale, eliminate duplication and provide better service delivery.

Evidence: 1. HRSA Performance Budget, Fiscal Year 2008, Performance Budget Submission to Office of Management and Budget. 2. 2005 ADAP Quarterly Reports

Does the performance of this program compare favorably to other programs, including government, private, etc., with similar purpose and goals?

Explanation: No other program, public or private or at the Federal, State, or local level is comparable to the Ryan White Program. As stated previously in the answer to question 1.3, the Ryan White Program is unique in that it: 1) is not an entitlement program; 2) is the payer of last resort; 3) provides services to the uninsured and underinsured, including to persons without residency documentation; 4) provides for a local planning process that sets priorities for services; 5) has a unique multi-title structure that assures comprehensive medical care and enhanced support services necessary for the complex treatment of HIV and AIDS; 6) has a unique partnership arrangement between Federal, State and local entities; 7) only serves persons infected and affected by HIV and AIDS; 8) utilizes HIV testing in its clinical programs as a part of its coordinated approach to medical treatment and assures that any person testing positive is referred immediately into a clinical program; 9) requires its funded programs in States to collaboratively identify significant issues related to the needs of persons living with HIV and AIDS and to maximize coordination across CARE Act Titles; and 10) provides an array of coordinated and comprehensive services.

Evidence: 1. Title XXVI of the PHS Act as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White Program) 2. HIV/AIDS Bureau website, (http://hab.hrsa.gov/programs.htm)

Do independent evaluations of sufficient scope and quality indicate that the program is effective and achieving results?

Explanation: The following two studies, one from the Institute of Medicine (IOM) and the other from the General Accounting Office (GAO), both of which were independent and of sufficient scope, have concluded that the HIV/AIDS Bureau's Ryan White CARE Act (RWCA) program has been effective and is achieving results. The Institute of Medicine (IOM): In the report entitled Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act (November 2003), the IOM review found that: 1. The RWCA has provided lifesaving care to millions of persons who otherwise would not have access to adequate services; 2. The RWCA has helped develop an infrastructure for providing high-quality care that would not exist in the absence of the Act; 3. The Health Resources and Services Administration (HRSA), the agency that administers the RWCA, has been assertive and innovative in promoting quality-management and -improvement programs throughout the country. The Government Accountability Office (GAO): The GAO performed a study entitled Report on HIV/AIDS: Use of Ryan White CARE Act and Other Assistance Grant Funds (GAO/HEHS-00-54), to (1) audit and evaluate Federal HIV/AIDS programs and services, and (2) to identify the characteristics of persons served by Ryan White CARE Act programs, and the availability of CARE Act funds in rural areas. The GAO study found that: 1. Funds provided by the CARE Act serve vulnerable groups in higher proportions than their representation in the AIDS population; 2. The CARE Act funds are also serving persons living in rural areas; 3. The CARE Act's AIDS Drug Assistance services are reaching the rural AIDS population in proportion to the AIDS cases in rural areas; 4. Most CARE Act funds go to medical treatment and medications; 5. CARE Act funds support both health care and support services such as case management, housing, transportation, and nutrition services; while CDC support prevention activities and HOP WA funds support housing- related expenses and social services for low income people with HIV/AIDS;

Evidence: 1. IOM Report: Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act (November 2003) (http://www.iom.edu/CMS/3793/4819/1635.aspx ) 2. GAO study entitled Report on HIV/AIDS: Use of Ryan White CARE Act and Other Assistance Grant Funds [GAO/HEHS-00-54] (March 2000) (http://www.gao.gov/new.items/he00054.pdf )