Detailed Information on the
Hansen's Disease Services Programs Assessment

Expanding efforts to train private sector physicians in the diagnosis and treatment of Hansen's disease.

Implementing viable recommendations of a recent Research Advisory Panel of national and international experts regarding the NHDP's research activities

Expanding efforts to train private sector physicians in the diagnosis and treatment of Hansen's disease.

Exploring feasibility and scope of an independent evaluation.

Measure: Level of Hansen's disease-related disability and deformity among patients treated and managed by the NHDP (Percentage of patients at grades 1 and 2).

Explanation:The program seeks to prevent an increase of the percentage of Hansen's disease patients with grades 1 or 2 disability/deformity. Disability/deformity is measured based on the World Health Organization scale, which ranges from 0-2. Patients graded at 0 have protective sensation and no visible deformities. Patients graded at 1 have loss of protective sensation and no visible deformity. Patients graded at 2 have visible deformities secondary to muscle paralysis and loss of protective sensation. In 2003, 47 percent of patients had grades 1 or 2 disability/deformity. Hansen's disease is a life-long chronic condition which left untreated and unmanaged will usually progress to severe deformity. As this deformity is generally irreversible, the target is ambitious because only through good case management and patient compliance will deterioration to a higher grade of disability/deformity be prevented.

Measure: Development in the armadillo of an animal model for the full spectrum of clinical complexities of human Hansen's disease, as measured by the number of armadillo-specific biological response modifiers/cell markers developed, characterized, and function validated experimentally with armadillo cells.

Explanation:The development of the armadillo, the only other species besides man to naturally acquire Hansen's disease, as an animal model for the full spectrum of clinical complexities of human Hansen's disease will allow for potential advances in scientific knowledge related to questions associated with pathogenesis, early diagnosis, vaccine development, and transmission of Hansen's disease. The measure tracks the development of six protective biological response modifiers (BRM) and six white blood cell subtype markers (CM) that are important in host resistance to Hansen's disease.

Measure: Number of private sector physicians who have received training from NHDP.

Explanation:Early diagnosis and treatment helps reduce Hansen's disease-related disability and deformity. This can only be achieved if there are enough healthcare providers in the U.S. with knowledge of the disease and the support provided by NHDP though its function as an outpatient clinic, training, and education center and referral center for Hansen's disease patients requiring orthopedic surgery and/or advanced management of Hansen's disease-related complications.

Measure: Cost per patient served in Hansen's disease outpatient clinics.

Explanation:Hansen's Disease outpatient clinics support treatment protocols for multi-drug therapy, diagnostic studies, consultant ancillary medical services, clinical laboratory analysis, hand and foot rehabilitation, leprosy surveillance, and patient transportation for indigent patients. The program's goal is for increases in the cost per patient served in the outpatient clinics to be at or below the medical inflation rate (currently estimated at 4.8% by the Bureau of Labor Statistics).

Is the program purpose clear?

Explanation: The National Hansen's Disease (HD) Programs (NHDP) seeks to prevent and manage Hansen's disease (leprosy) through clinical, rehabilitative, research, and training activities. The program provides medical care to any patient living in the United States and Puerto Rico for Hansen's disease related conditions, training to health professionals, and scientific research on Hansen's disease. The program also provides long-term care to 28 patients who have historically resided in institutional care treatment facilities. The NHDP is administered by the Health Resources and Services Administration (HRSA) at the Department of Health and Human Services (HHS).

Evidence: Section 320 of the Public Health Service Act describes the purpose of the program as: 1) to provide short-term care and treatment, including outpatient care, for Hansen's disease and related complications to any person determined to be in need of such care and treatment; 2) conduct training in the diagnosis and management of Hansen's disease and related complications; and 3) conduct and promote the coordination of research, investigations, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of Hansen's disease. P.L. 107-78 provides for long-term care for certain Hansen's disease patients.

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

Explanation: The program addresses diagnosis, treatment, education, and research of Hansen's disease. Hansen's disease is an infectious disease caused by bacterium that affects skin, peripheral nerves, and in some cases eyes. If left untreated, Hansen's disease causes nerve damage, which can result in loss of sensitivity and muscle control, the crippling of hands and feet, and blindness. There are approximately 3,300 persons in the United States with active disease requiring drug treatment and management and 100 to 200 new cases reported annually. (While the disease is communicable, it is unlikely to affect a large portion of the U.S. population. Most specialists agree that more than 95% of the world's population has a natural immunity to the disease.) Hansen's disease can be effectively treated and rendered non-communicable by antibiotics that kill nearly all the bacilli. (However, after treatment, Hansen's Disease bacteria remain latent and can reactivate later.) Early diagnosis and treatment is important and can prevent many of the complications associated with the disease. Lack of experience with this disease by U.S. physicians, because of its infrequent occurrence in the population, leads to lack of recognition and delay in diagnosis. The stigma associated with Hansen's disease can prevent patients from receiving care in mainstream medicine. Little is known about the transmission of Hansen's disease, and it is difficult to diagnose. Research could improve the early diagnosis of the disease and understanding of transmission, causes of nerve damage, and immunity to Hansen's disease.

Evidence: Hansen's disease is described at the NHDP website: http://bphc.hrsa.gov/nhdp and in "Hansen's Disease, A Guide to Management in the United States." The National Hansen's Disease registry lists 6,000 individuals who have ever had Hansen's disease in the US. Currently there are approximately 3,300 people living with Hansen's disease in the US individuals living who have been diagnosed with Hansen's disease. "A Summary of Hansen's Disease in the United States-2004" (March 1, 2005) reports 131 new cases of Hansen's disease in 2004. The skin manifestations of early Hansen's disease often resembles other skin diseases, making the differential diagnosis difficult. In Measuring Leprosy Stigma - a Preliminary Review of the Leprosy Literature, van Brakel reports that: "People have left their families and even spouses and children, fearing the repercussions of the fact they had leprosy. In addition stigma may affect leprosy control. People who fear the consequences of the diagnosis of leprosy may delay in presenting themselves to the health services, and thus have an increased risk of disability and continue to be potential source of infection in the community." Another example of stigmatization is community protests that blocked the creation of a leprosy clinic in a HRSA Community Health Center clinic in Alviso, California in 1987 (Jose Mercury News, May 28, 1987). In "More than Drugs Needed to Eradicate Leprosy," Fox describes the need for Hansen's disease research (American Society for Microbiology News, Volume 67, Number 3).

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

Explanation: NHDP is the only dedicated provider of expert Hansen's disease treatment services in the U.S. NHDP is also the only source of continuing education for providers dealing with the identification and treatment of Hansen's disease in the US. NHDP is the largest, most comprehensive laboratory in the world that conducts research on Hansen's disease. It has multidisciplinary expertise in immunology, epidemiology, microbiology, molecular biology, and pathology.

Evidence: The lack of other duplicative efforts is demonstrated by the fact that in 2003, the program underwent a competitive sourcing evaluation and no bids were submitted. In 2005, the NHDP clinic centered in Baton Rouge and its 11 outreach Ambulatory Care Clinics provided care to 3031 patients. Physicians in the private sector saw 311 patients under close consultation with NHDP. There are two other labs in the United States that perform research on Hansen's disease; however, these labs are not as comprehensive as NHDP and their research is dependent on resources provided by the program. Mainstream labs are reluctant to do Hansen's disease research because of extraordinary obstacles. The bacterium that causes Hansen's disease cannot be cultured in the lab and grows so slowly that it takes one to two years to complete an experiment. Available animal models (genetically deficient mice and feral armadillos from the U.S. Gulf Coast) poorly represent human Hansen's disease and are difficult to obtain. Researchers from eleven universities worldwide submitted testimonials to NHDP in 2006 concerning the importance of the program as the only provider of the HD bacillus as a research reagent.

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

Explanation: The program is designed to meet its objective of preventing and managing Hansen's disease and there is no evidence that another program model would be more effective. The provision of Hansen's disease services through the federal workforce was found to be cost-effective. The current NHDP model of providing outpatient care (with the exception of a small population of long term care patients to whom the Federal government promised services) is an effective method of providing treatment services. Patients become noninfectious after taking only a few doses of antibiotic drugs, and therefore there is no longer a need for isolation. The program provides much of its outpatient services through competitive contracts, which allows NHDP to define the deliverables and to hold the contractors accountable. Training provided by NHDP helps increase awareness of Hansen's disease among physicians to encourage earlier diagnosis. Research focuses on the development of molecular tools to track and block transmission; application of biotechnology to develop simple lab techniques for case detection and diagnosis of pre-clinical disease; identification of host resistance mechanisms for potential use in vaccines development; and provision of Hansen's disease bacilli to the world's leprosy researchers.

Evidence: An October 25, 2004, Health and Human Services memo reports on the results of a cost comparison competitive sourcing study of the National Hansen's Disease Programs, which found that it was more cost effective to retain the NHDP services as a federally staffed program than to contract out all the services. The ability to treat Hansen's disease through outpatient care is discussed on the program's website and in the booklet "Diagnosis and Treatment of Hansen's Disease in the United States." NHDP contracts with providers include lists of services expected. Comprehensive program training reached 91 health providers in 2005. Research findings led to rehabilitation techniques developed for the care of insensitive limbs of Hansen's disease patients (Repetitive Stress on Insensitive Feet: The Pathology and Management of Plantar Ulceration in Naturopathic Feet).

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

Explanation: The program is designed to reach all persons in the United States diagnosed with Hansen's disease. The program has located its clinics in areas with the highest levels of Hansen's disease prevalence. Training and outreach consists of comprehensive seminar programs, and registration is limited so that only those who are interested and may benefit from the training in diagnosis and treatment of Hansen's disease attend. The basic research conducted by the program advances understanding of the complex pathogenesis of Hansen's disease, the unique biology of its causative bacillus and the diagnosis, treatment, transmission, and prevention of Hansen's disease in the U.S. and around the world. In addition, the world-wide Hansen's research effort is bolstered by the collaborative expertise of NHDP scientists and the program's provision of the bacterium that causes Hansen's disease. NHDP research findings are published or presented in peer-reviewed journals and meetings.

Evidence: NHDP clinics are located in Arizona, California, Florida, Illinois, Louisiana, Massachusetts, New York, Puerto Rico, Texas, and Washington. Patients seen in these clinics comprise approximately 95% of Hansen's disease patients in the United States. The program's outreach and training seminars participant lists include members of the health professions field who have a direct interest in Hansen's disease. The program also provides viable bacteria of Hansen's disease to 20 investigators worldwide. Eleven research institutes submitted testimonials to the program on the importance of NHDP as the only laboratory that can create the bacteria that causes Hansen's disease. An example of program research is "Application of viability-staining method for Mycobacterium leprae derived from the athymic (nu/nu) mouse foot pad" (Lahiti et al, Journal of Medical Microbiology, 54).

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: NHDP has two long-term performance measures that reflect the program's purpose of preventing and managing Hansen's disease. The first measures the program's efforts to control Hansen's disease-related disability and deformity that stems from nerve destruction and subsequent loss of sensation. The second measures the advances in scientific knowledge related to the early diagnosis, treatment, and prevention of Hansen's disease by tracking the development of the armadillo, the only other species besides man to naturally acquire Hansen's disease, as an animal model for the full spectrum of clinical complexities of human Hansen's disease. Once this animal model exists, potential advances in scientific knowledge related to questions associated with pathogenesis, early diagnosis, vaccine development, and transmission of Hansen's disease can be further explored.

Evidence: The program's two long-term performance measures are: (1) Level of Hansen's disease-related disability and deformity among patients treated and managed by the NHDP, and (2) Development in the armadillo of an animal model for the full spectrum of clinical complexities of human Hansen's disease, as measured by the number of armadillo-specific biological response modifiers/cell markers developed, characterized, and function validated experimentally with armadillo cells.

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

Explanation: NHDP has ambitious targets and timeframes for both of its long-term measures. The program's target is: no increase in the level of disability/deformity in the Hansen's disease population by 2013. Hansen's disease is a life-long chronic condition which left untreated and unmanaged will usually progress to severe deformity. As this deformity is generally irreversible, the target is ambitious because only through good case management and patient compliance will deterioration to a higher grade of disability/deformity be prevented. The program's target for its research measure reflects its goal of advancing scientific knowledge related to Hansen's disease. This measure and the five-year timeframe are ambitious because it takes advantage of breakthroughs in genomic and molecular biology and currently, no such model for human leprosy exists. Tracking the development of the animal model for the full spectrum of clinical complexities of human Hansen's disease is ambitious because to date, almost no armadillo research reagents have been available. Once this animal model exists, potential advances in scientific knowledge related to questions associated with pathogenesis, early diagnosis, vaccine development, and transmission of Hansen's disease can be further explored.

Evidence: The program seeks to prevent an increase, relative to 2002 levels, of the percentage of Hansen's disease patients with grades 1 or 2 disability/deformity by 2013. Disability/deformity is measured based on the World Health Organization scale, which ranges from 0-2. Patients graded at 0 have protective sensation and no visible deformities. Patients graded at 1 have loss of protective sensation and no visible deformity. Patients graded at 2 have visible deformities secondary to muscle paralysis and loss of protective sensation. In 2002, 50 percent of patients had grades 1 or 2 disability/deformity. The program also seeks to produce a tractable animal model (armadillo) that manifests the full spectrum of human Hansen's disease by 2013.

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 program has three annual measures that demonstrate progress toward achieving the program's long-term goals of managing and preventing Hansen's disease. The first measure is the same as the long-term measure of program's efforts to control Hansen's disease-related disability and deformity. The second measures the number of private sector physicians, trained by the NHDP, who are capable of diagnosing and/or managing a case of Hansen's disease. Increasing knowledge about Hansen's disease in the U.S. medical community should lead to earlier diagnosis and intervention, resulting in a decrease in Hansen's disease-related disabilities. The third measures the progress in developing reagents that will permit development of the armadillo as an animal model for human Hansen's disease. This model will allow for experimentation on vaccine protection and understanding the pathogenic mechanisms that cause nerve damage and methods to prevent it.

Evidence: The measures are (1) Level of Hansen's disease-related disability and deformity among patients treated and managed by the NHDP, (2) The number of private sector physicians who have received training from NHDP, (3) Development in the armadillo of an animal model for the full spectrum of clinical complexities of human Hansen's disease, as measured by the number of armadillo-specific biological response modifiers/cell markers developed, characterized, and function validated experimentally with armadillo cells.

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

Explanation: The program has ambitious baselines and targets for its annual measures. As two of the program's annual measures are the same as its long term measures (1)level of Hansen's disease-related disability and deformity among patients treated and managed by the NHDP, and 2) development in the armadillo of an animal model for the full spectrum of clinical complexities of human Hansen's disease, as measured by the number of armadillo-specific biological response modifiers/cell markers developed, characterized, and function validated experimentally with armadillo cells), the level of ambition is discussed in Question 2.2. Regarding the annual measure of the number of private sector physicians who have received training from NHDP, the targets are ambitious as they reflect the anticipated impact of a national promotion effort targeted at physicians whose practice may include individuals with Hansen's disease (e.g., dermatologists).

Evidence: In 2008, the program seeks to maintain the percentage of Hansen's disease patients with mild to severe levels of disability/deformity; train 45 physicians; and to identify, produce, characterize and validate three biological response modifiers and three white blood cell subtype markers.

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: NHDP requires contractors to commit to the performance of specific activities that exhibit an effort toward meeting the annual and long term goals of the program. Expectations of the required work items are clearly identified in the scope of each contract, as are potential consequences for not adequately performing. The work performed is monitored by the program through a database which tracks the results of the disability risk categories.

Evidence: NHDP collaborates through a contractual relationship with ambulatory care clinics and other health service providers for treatment and rehabilitative services. Contractors' Request for Proposal's Statements of Work include descriptions of work and require reporting of data that the program uses to track overall performance.

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: There are no comprehensive individual evaluations performed of NHDP that provide information on the effectiveness of the program. However, to date the program has undertaken a number of evaluation activities of a more limited scope related to the program's cost-effectiveness and research activities.

Evidence: Comprehensive evaluations are needed to help determine the impact of the program. However, to date, evaluations of a more limited scope have been conducted to inform specific elements of program performance. The program's cost-effectiveness was evaluated in the recent competitive sourcing evaluation. The 11 NHDP Ambulatory Care Clinics have been fully accredited as outpatient clinics (eight by the Joint Commission on Accreditation of Healthcare Organizations, three by state or local bodies). Research has been evaluated through a peer-review process and by a National Institutes of Health Expert Panel. A blue-ribbon panel of scientists will review and evaluate progress and future direction of research goals in a Hansen's disease Research Advisory Panel meeting on August 14, 2006.

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: Budgets are not explicitly tied to accomplishments of annual and long-term goals. The relationship between annual and long-term targets and budget resources is not clear. The program also does not budget for the full cost of the program.

Evidence: The budget justifications for Hansen's disease activities are included in the Health Resources Administration Fiscal Year 2007 Justification of Estimates for Appropriation Committees.

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

Explanation: The program has recently developed meaningful long-term outcome measures that reflect the purpose of the program.

Evidence: Long-term performance measures are described in Question 2.1.

If applicable, does the program assess and compare the potential benefits of efforts within the program and (if relevant) to other efforts in other programs that have similar goals?

Explanation: NHDP is not redundant or duplicative of any other Federal, state, local, or private effort in the U.S. in providing a comprehensive basic research program on Hansen's disease. NDHP's existing research goals were found to be consistent with the recommendations of an National Institute of Health-sponsored expert panel that met in 1999 to recommend future leprosy research goals. Moreover, NHDP staff participated in a World Health Organization (WHO) Scientific Working Group in 2002 to present findings and participate in formulating a Leprosy Eradication Program and again in 2003 to organize the WHO-linked Consortium Initiative to Develop Epidemiological Assays for Leprosy.

Evidence: Question 1.3 described how NHDP provides a unique service. National Institute of Health Panel's recommended research goals are published in "More than Drugs Needed to Eradicate Leprosy," American Society for Microbiology News, Volume 67, Number 3.

Does the program use a prioritization process to guide budget requests and funding decisions?

Explanation: Funds are allocated by program managers based on assessments of the research approach and progress. Research proposals are peer-reviewed by the NHDP Research Committee and given a scientific merit score of 1-5. These peer-reviewed assessments are used to make funding decisions.

Evidence: The NHDP Research Committee scored 19 proposals between 2001 and 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: NHDP regularly collects performance data, including data from program partners, relating to program goals. For example, the program regularly collects data on the status of patients and research that it uses to set baselines and targets for program goals. NHDP uses this data to allocate resources, such as when it reduced the number of physicians on staff to reflect a decrease in patient load. NHDP also uses this data to manage its contractors, such as when it took deductions from a nursing contract for not meeting performance levels.

Evidence: NHDP collects data through a variety of mechanisms. NHDP uses a Quality Assurance Surveillance Plan to set annual targets for performance, such as number of patient physicals and time preparing tissue culture. The program monitors its progress against these targets through quarterly Most Efficient Organization Performance Workload Data reports. The program monitors activities performed by contractors, who provide health services, through standardized progress reports. Through these reports, the program receives data on patient visits and diagnoses and is able to monitor performance against contract requirements.

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 program holds managers accountable for achieving program results in performance contracts. NHDP contractors are also held accountable for costs, schedule, and performance results. For example, the program has reduced payments from a nursing contract invoice for not meeting the performance levels required in the contract. The nursing contractor did not provide the required number of staff. A show-cause notice was issued and the contractor submitted a plan for correcting the deficient performance.

Evidence: Performance Evaluation Plans of program managers includes goals such as developing reagents for early diagnosis, developing a DNA fingerprint model of M. leprae, and training dermatologists. Contracts have written performance standards, which are reviewed monthly upon invoice certification. If performance falls below any of the acceptable levels, payment is reduced as prescribed in the contract.

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

Explanation: NHDP obligates funds in accordance with annual plans and has a limited amount of unobligated balances at the end of the fiscal year. NHDP annual procurement plans and spending plans are established at the beginning of each fiscal year and monitored throughout the year to ensure adherence. Program awards are reported in the Federal Procurement Data System-Next Generation (FPDS-NG), which is monitored by requisition status in the PRISM electronic purchasing system.

Evidence: The program's FY 2005 actual spending was aligned with its annual spending plan. The program had less that $200,000 in unobligated balances at the end of FY 2005. The CORE and GovNet reporting systems verify expenditure of funds and year-end closeout status for program areas.

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: In 2003, the program underwent a competitive sourcing evaluation. The program has an efficiency measure of the cost per patient served. The program's goal is for increases in the cost per patient served in the outpatient clinics to be at or below the medical inflation rate. The increasing costs of medical care and the ongoing need for outpatient care of Hansen's disease require the program to have continued medical expenditures. To control this cost so that is at least equal to the average increase (inflation) of medical costs in the nation is an ambitious target because referral patients seen at NHDP often have serious complications requiring varying complex management regimens not employed at the ACP clinics.

Evidence: An October 25, 2004, Health and Human Services memo reports on the results of a cost comparison competitive sourcing study of NHDP, which found that it was more cost effective to retain the NHDP services as a federally staffed program than to contract out all the services. The program's efficiency measure is: maintaining annual costs per patient receiving outpatient care through the NHDP at or below the medical inflation rate.

Does the program collaborate and coordinate effectively with related programs?

Explanation: NHDP collaborates with the Food and Drug Administration (FDA) Drug Shortage Program as well as Novartis (the pharmaceutical company) to distribute the anti-leprosy drug clofazimine. At the request of FDA, NHDP agreed to manage an investigational new drug (IND) distribution that makes the drug available in the United States. Research of Hansen's disease is a small and specialized field. NHDP collaborates with 31 researchers worldwide on the study of Hansen's disease. Finally, the program is developing an inter-agency agreement with the Bureau of Primary Health Care Health Disparities Collaborative for diabetes. The program will apply its expertise in treatment of the Hansen's disease insensitive foot to the more prevalent insensitive diabetic foot by providing multilingual training and education to Community Health Centers on the prevention and care of the diabetic insensitive foot.

Evidence: Novartis teleconference meeting minutes discuss the collaboration with the NHDP to manage the investigational new drug clofazimine. NHDP is part of a National Institute of Allergy and Infectious Diseases funded contract, #Y1-AI-2004-01, "Tuberculosis Drug Screening," a highly coordinated program to facilitate the search for new anti-tuberculosis drugs. The NHDP is part of a National Institute of Allergy and Infectious Diseases funded contract, #Y1-AI-2646-04, "Maintenance of an Armadillo Colony," a unique program to provide enormous numbers of armadillo-derived Hansen's disease bacilli for distribution to researchers. In 2006, eleven research institutes submitted testimonials to the program on the importance of NHDP collaboration.

Does the program use strong financial management practices?

Explanation: In 2005, HHS received a material control weakness for its financial systems and processes. HRSA contributes to the material internal control weakness identified in the 2005 HHS audit. HHS is in the process of resolving these weaknesses by replacing existing accounting systems within HHS with the Unified Financial Management System (UFMS). UFMS is scheduled to be operational for HRSA in October 2006.

Evidence: Since 2003, HRSA has been not been included in a consolidated HHS audit. In a 2005 audit of HHS, Ernest and Young found a material weakness in HHS financial systems and processes. In particular, the audit found: Documentation regarding significant accounting events, recording of non-routine transactions and post-closing adjustments, as well as correction and other adjustments made in connection with data conversion issues, must be strengthened. Processes to prepare financial statements need improvement. Financial systems are not FFMIA compliant. Weaknesses were identified in Department/Operating Division Periodic Analysis, Oversight, and Reconciliations. In addition, the audit found PSC's DFP CORE accounting system, which supports the activities of HRSA, did not facilitate the preparation of timely financial statements and did not have an efficient mechanism in place to compile accounting statements.

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

Explanation: HRSA is in the process of switching over to the UFMS to improve its financial management. The UFMS will improve funds control and monitoring and provide real-time data.

Evidence: HHS documents indicate that HRSA will adopt the UFMS system in 2006.

For R&D programs other than competitive grants programs, does the program allocate funds and use management processes that maintain program quality?

Explanation: Funds are allocated by program managers based on assessments of the research approach and progress. Research proposals are peer-reviewed by the NHDP Research Committee and given a scientific merit score of 1-5. These peer-reviewed assessments are used to make funding decisions.

Evidence: The NHDP Research Committee scored 19 proposals between 2001 and 2006.

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

Explanation: The program is on track to meet its long-term goals. In 2006, it developed the first reagent needed to fully develop an armadillo model. In 2003, the number of Hansen's disease patients with mild and severe levels of disability/deformity slightly decreased.

Evidence: In 2003, the percentage of Hansen's disease patients with Grades 1 and 2 levels of deformity decreased from 50% to 47%. In 2006, the program developed the first of 12 reagents needed to produce a tractable animal model (armadillo) that manifests the full spectrum of human Hansen's disease.

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

Explanation: The program achieved two of its three annual goals

Evidence: In 2006, the program achieved its annual goal of developing the first reagent needed to develop an armadillo model. It also achieved its goal of having the level of deformity/disability in the Hansen's disease population not increase. Due to Hurricane Katrina, two conferences were cancelled, so the program did not meet its goal of the number of private sector physicians trained.

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

Explanation: In 2003, the program underwent a competitive sourcing evaluation which found that it was more cost effective to retain the NHDP services as a federally staffed program than to contract out all the services. The program recently developed an efficiency measure that reflects the average cost of care of all outpatient services offered through the NHDP program. The program does not have historical data on this measure. The program does have historical data on the average cost of care provided by ambulatory care clinics (a portion of the medical services offered through the program). These data indicate that the growth in patient care costs was below the medical inflation rate in 2003 and 2005, but exceeded it in 2004.

Evidence: An October 25, 2004, Health and Human Services memo reports on the results of a cost comparison competitive sourcing study of the National Hansen's Disease Programs. Average patient care costs at ambulatory care clinics fell by 2 percent in 2003, rose by 5 percent in 2004, and rose by 0 percent in 2005.

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

Explanation: There are no other programs with a similar purpose or goals.

Evidence: Question 1.3 explains how the program is not duplicative of any other government or private effort.

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

Explanation: While a number of evaluation activities of a limited scope have been conduction on components of NHDP, to date there are no comprehensive individual evaluations that provide information on the effectiveness of the program.

Evidence: Comprehensive evaluations are needed to help determine the effect of the program.