Document of The World Bank FOR OFFICIAL USE ONLY Report No: PAD3185 PROGRAM APPRAISAL DOCUMENT ON A PROPOSED LOAN IN THE AMOUNT OF US$400 MILLION TO THE REPUBLIC OF INDIA FOR A PROGRAM TOWARDS ELIMINATION OF TUBERCULOSIS February 26, 2019 Health, Nutrition & Population Global Practice South Asia Region This document has a restricted distribution and may be used by recipients only in the performance of their official duties. Its contents may not otherwise be disclosed without World Bank authorization. CURRENCY EQUIVALENTS Exchange Rate Effective December 31, 2018 Currency Unit = US$ INR 69.78 = US$1 FISCAL YEAR April 1 - March 31 Regional Vice President: Hartwig Schafer Practice Group Vice President: Annette Dixon Country Director: Junaid Kamal Ahmad Practice Manager: Rekha Menon Task Team Leader(s): Ronald Upenyu Mutasa i ABBREVIATIONS AND ACRONYMS ACSM Advocacy, Communication and Social Mobilization AIDS Acquired Immuno-Deficiency Syndrome AIC Airborne Infection Control BMGF Bill and Melinda Gates Foundation BMWM Bio-Medical Waste Management CA Chartered Accountant CAAA Controller of Aid, Accounts, and Audit CAG Comptroller and Auditor General CIEs Central Level Internal Evaluations CMSS Central Medical Services Society CPF Country Partnership Framework CPP Central Procurement Portal CTD Central TB Division CTF Common Treatment Facility CVC Central Vigilance Commission DALY Disability-Adjusted Life Year DBT Direct Benefit Transfer DDG Deputy Director-General DLI Disbursement-Linked Indicator DLR Disbursement-Linked Result DOHFW Departments of Health and Family Welfare DOTS Directly Observed Treatment, Short-Course DR-TB Drug-Resistant TB DST Drug Susceptibility Test EHS Environmental Health & Safety ESSA Environmental and Social Systems Assessment FM Financial Management FMR Financial Monitoring Report FPIC Free and Prior Informed Consultation FSA Fiduciary System Assessment GAC Governance and Anti-Corruption GDP Gross Domestic Product GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria GFR General Financial Rules GOI Government of India GPS Global Positioning System GST Goods and Services Tax HDI Human Development Index HCF Health-Care Facilities HIV Human Immune-Deficiency Virus IBRD International Bank of Reconstruction and Development ICT Information and Communications Technology ii IC Infection Control IDA International Development Association IEC Information, Education, and Communication IFSA Integrated Fiduciary System Assessment INR Indian National Rupee INT Institutional Integrity IRL Intermediate Reference Laboratories IRR Internal Rate of Return ISM Implementation Support Mission IT Information Technology IVA Independent Verification Agency JEET Journey of Enhancing Targeted Interventions JICA Japan International Cooperation Agency JMM Joint Monitoring Mission LTA Long-Term Agreement MDR-TB Multidrug Resistant TB MOHFW Ministry of Health and Family Welfare NCD Noncommunicable Diseases NGO Non-Governmental Organization NHM National Health Mission NPV Net Present Value NPY Nikshay Poshan Yojana NSP National Strategic Plan OPRC Operational Procurement Review Committee PAD Project Appraisal Document PAP Program Action Plan PDO Program Development Objective PFMS Public Financial Management System PforR Program for Results PIP Program Implementation Plan PP Public Private PPE Private Provider Engagement PPM Public-Private Mix PPSA Private Provider Support Agency PTETB Program Towards Elimination of TB RNTCP Revised National TB Control Program ROP Record of Proceedings SC Scheduled Castes ST Scheduled Tribes TA Technical Assistance TB Tuberculosis TSU Technical Support Unit WHO World Health Organization XDR-TB Extensively Drug-Resistant TB iii BASIC INFORMATION Is this a regionally tagged project? Financing Instrument No Program-for-Results Financing Bank/IFC Collaboration Does this operation have an IPF component? No No Proposed Program Development Objective(s) To improve the coverage and quality of TB control interventions in the private and public sector in targeted states of India Organizations Borrower: Republic of India Implementing Agency: Ministry of Health and Family Welfare COST & FINANCING SUMMARY (USD Millions) Government program Cost 8,300.00 Total Operation Cost 1,334.00 Total Program Cost 1,334.00 Total Financing 1,334.00 Financing Gap 0.00 Financing (USD Millions) Counterpart Funding 934.00 Borrower 934.00 International Bank for Reconstruction and Development (IBRD) 400.00 Expected Disbursements (USD Millions) Fiscal Year1 2019 2020 2021 2022 2023 2024 Absolute 40.00 70.00 80.00 80.00 70.00 60.00 Cumulative 40.00 110.00 190.00 270.00 340.00 400.00 INSTITUTIONAL DATA Practice Area (Lead) Health, Nutrition & Population 1 Refers to World Bank fiscal year and figures provided are indicative. iv The World Bank Program Towards Elimination of Tuberculosis (P167523) Contributing Practice Areas Climate Change and Disaster Screening Yes PRI_PUB_DATA_TBL Private Capital Mobilized No Gender Tag Does the program plan to undertake any of the following? a. Analysis to identify Project-relevant gaps between males and females, especially in light of country gaps identified through SCD and CPF Yes b. Specific action(s) to address the gender gaps identified in (a) and/or to improve women or men's empowerment Yes c. Include Indicators in results framework to monitor outcomes from actions identified in (b) Yes SYSTEMATIC OPERATIONS RISK-RATING TOOL (SORT) Risk Category Rating 1. Political and Governance ⚫ Moderate 2. Macroeconomic ⚫ Low 3. Sector Strategies and Policies ⚫ Low 4. Technical Design of Project or Program ⚫ Substantial 5. Institutional Capacity for Implementation and Sustainability ⚫ Substantial 6. Fiduciary Fiduciary rating from IRT: ⚫ Substantial ⚫ Substantial as of 26-Nov-2018 7. Environment and Social Environmental Risk rating from Specialist: ⚫ Moderate as of 19-Nov-2018 ⚫ Moderate Social Risk rating from Specialist: ⚫ Moderate as of 19-Nov-2018 8. Stakeholders ⚫ Moderate 9. Other ⚫ Low v The World Bank Program Towards Elimination of Tuberculosis (P167523) 10. Overall ⚫ Substantial COMPLIANCE Policy Does the program depart from the CPF in content or in other significant respects? [ ] Yes [✔] No Does the program require any waivers of Bank policies? [ ] Yes [✔] No Safeguard Policies Triggered Safeguard Policies Yes No Projects on International Waterways OP/BP 7.50 ✔ Projects in Disputed Areas OP/BP 7.60 ✔ Legal Covenants Sections and Description Technical Support Unit (TSU): The Borrower shall establish and maintain a Technical Support Unit (TSU) under the Central TB Division (CTD) within 24 months of the Effective date; the unit shall be provided with competent, experienced, and qualified staff, in sufficient numbers and under terms of reference acceptable to the Bank, and be responsible for providing expert advice on strategic purchasing, private sector engagement, and direct benefit transfer management [Schedule 2, Section I (a)] Sections and Description State Technical Support Units (STSUs): The Borrower shall cause each of the Program States to establish, within 24 months of the Effective Date, and maintain throughout Program implementation, State Technical Support Units (STSUs), each of which shall be provided with competent, experienced, and qualified staff, in sufficient numbers and under terms of reference acceptable to the Bank [Schedule 2, Section I (b)] . Sections and Description Program Action Plan: The Borrower shall implement the Program Action Plan agreed with the Bank, in a manner and substance satisfactory to the Bank [Schedule 2, Section I (c)]. Sections and Description Verification: The Borrower shall undertake a verification process, in accordance with the terms of reference agreed with the Bank, to certify the fulfillment of the Disbursement Linked Results (DLRs), and furnish to the Bank corresponding verification report(s), in form and substance agreed with the Bank [Schedule 2, Section III (B)]. Sections and Description The Borrower shall cause each Program State to prepare and submit for approval to CTD annual Program implementation plans, which contain, inter alia, implementation arrangements, activities to be undertaken to achieve the DLIs and as per the Program Action Plan, financial and procurement arrangements at the state level and modalities of the performance-based mechanism under the Program [Schedule 2, Section I (B)]. Conditions Not Applicable. vi The World Bank Program Towards Elimination of Tuberculosis (P167523) TASK TEAM Bank Staff Name Role Specialization Unit Team Leader(ADM Ronald Upenyu Mutasa Public Health and TB Control GHN06 Responsible) Procurement Specialist(ADM Sreenivas Devarakonda Procurement GGOPZ Responsible) Financial Management Tanya Gupta Financial Management GGOIS Specialist(ADM Responsible) Social Specialist(ADM Sangeeta Kumari Social Development GSU06 Responsible) Operations and Project Ajay Ram Dass Team Member GHN19 Management Ambrish Shahi Team Member Direct Benefit Transfer GSP06 Anupam Joshi Environmental Specialist Environment GEN06 Di Dong Team Member Health Financing and TB GHN05 Di Qiu Team Member Finance CMD Hiroshi Tsubota Team Member Finance AFCW2 Health Financing and TB Jorge A. Coarasa Team Member SACIN Control Jose F. Molina Team Member Finance FABBK Maria E. Gracheva Team Member Project Operations GHNGE Martin M. Serrano Counsel Legal LEGES Raadhika Gupta Counsel Legal LEGES Sharlene Jehanbux Environmental Specialist Environment GEN06 Chichgar Son Nam Nguyen Team Member Health Systems and PforR GHN01 Suresh Kunhi Mohammed Team Member Public Health GHN06 Operations and Project Tanusree Talukdar Team Member SACIN Management Victor Manuel Ordonez Team Member Finance WFACS Conde Extended Team Name Title Organization Location Guy Stallworthy Private Sector Consultant BMGF United States vii The World Bank Program Towards Elimination of Tuberculosis (P167523) Seattle,United Puneet Dewan STC- Technical Adviser World Bank States Ranjan B. Verma Social Development Consultant World Bank India Sameer Kumta Senior Program Officer BMGF United States viii The World Bank Program Towards Elimination of Tuberculosis (P167523) TABLE OF CONTENTS I. STRATEGIC CONTEXT ............................................................................................................... 1 A. Country Context .................................................................................................................. 1 B. Sectoral (or Multi-Sectoral) and Institutional Context........................................................ 1 C. Relationship to the CPF and Rationale for Use of Instrument ............................................ 4 II. PROGRAM DESCRIPTION ......................................................................................................... 6 A. Government Program ......................................................................................................... 6 B. PforR Program Scope .......................................................................................................... 6 C. Program Development Objective(s) (PDO) and PDO Level Results Indicators ................. 15 D. Disbursement Linked Indicators and Verification Protocols ............................................ 15 III. PROGRAM IMPLEMENTATION .............................................................................................. 18 A. Institutional and Implementation Arrangements ............................................................. 18 B. Results Monitoring and Evaluation ................................................................................... 20 C. Disbursement Arrangements ............................................................................................ 21 D. Capacity Building ............................................................................................................... 21 IV. ASSESSMENT SUMMARY ....................................................................................................... 22 A. Technical (including program economic evaluation)........................................................ 22 B. Fiduciary ............................................................................................................................ 24 C. Environmental and Social .................................................................................................. 28 D. Risk Assessment ................................................................................................................ 33 ANNEX 1. RESULTS FRAMEWORK MATRIX ................................................................................... 35 ANNEX 2. DISBURSEMENT LINKED INDICATORS, DISBURSEMENT ARRANGEMENTS AND VERIFICATION PROTOCOLS ........................................................................................................... 40 ANNEX 3. PROGRAM ACTION PLAN .............................................................................................. 50 ANNEX 4. IMPLEMENTATION SUPPORT PLAN .............................................................................. 55 ix I. STRATEGIC CONTEXT A. Country Context 1. India continues to be the world’s fastest growing major economy . Growth has accelerated in the last two quarters to reach 8.2 percent in the first quarter of FY18/2019. This growth was supported by a revival in industrial activity, strong private consumption, and a rise in exports of goods and services. At the same time, the external situation has become less favorable. The current account balance has widened on the account of an increasing trade deficit (on the back of strong import demand and higher oil prices) from 0.7 percent of GDP in FY16/17 to 1.9 percent in FY17/18. Meanwhile, external headwinds—monetary policy ‘normalization’ in the US coupled with recent stress in some Emerging Market Economies—have triggered portfolio outflows from April 2018 onwards, putting additional pressure on the balance of payments. Going forward, growth is projected to reach 7.3 percent in FY18/19 and to firm up thereafter at around 7.5 percent, primarily on account of robust private and public consumption expenditure, a rise in exports of goods and services, and a gradual increase in investments. However, the current account deficit is also projected to remain elevated in FY18/19. 2. Since the 2000s, India has made remarkable progress in reducing absolute poverty. Between FY2011/12 and 2015, poverty declined from 21.6 percent to an estimated 13.4 percent at the international poverty line (2011 PPP US$1.90 per person per day), continuing the earlier trend of robust reduction in poverty. Aided by robust economic growth, more than 90 million people escaped extreme poverty and improved their living standards during this period. Despite this success, poverty remains widespread in India. In 2015, with the latest estimates, 176 million Indians were living in extreme poverty while 659 million, or half the population, were below the higher poverty line commonly used for lower middle-income countries (2011 PPP US$3.20 per person per day). Recent trends in the construction sector and rural wages, a major source of employment for the poorer households, suggest that the pace of poverty eradication may have slowed. India is still marked by disparities between urban and rural areas, as well as structural inequalities by gender, tribe, and caste. Addressing these inequalities will require increasing access, quality, and utilization of human development services, including health care. B. Sectoral (or Multi-Sectoral) and Institutional Context Health Outcomes and Health Financing 3. Despite substantial improvements in health outcomes since 1990, India still faces tremendous challenges in health care access, quality, and utilization. Between 1990 and 2016, infant mortality rates fell by half, deliveries in health facilities tripled, and maternal mortality ratios fell by more than 60 percent. However, overall progress in health remains slower than in countries of comparable income, and variations persist within and among states. Quality of care is a significant and complex challenge. India’s demographic and epidemiological transition calls for an aggressive response to persisting communicable diseases and a burgeoning burden of non- communicable diseases (NCDs). 4. India’s steadily increasing health expenditures are dominated by regressive out-of-pocket payments by households. Between 2013 and 2015, total health expenditures per capita grew by more than 10 percent per year–a higher rate than the country’s GDP growth (Figure 1). Despite this rapid increase, India’s health expenditures are relatively low at India Rupees (INR) 3,800 (US$56) per person, compared to US$233 per person in other lower middle-income countries 2 . In addition, there is a weak correlation between per capita health expenditures and outcomes across states. Despite increases in health expenditures through central level schemes, including tuberculosis (TB) control, the private sector continues to dominate the provision of health services in India. Out-of-pocket expenditures—accounting for 63 percent of India’s total health expenditure—are driven by 2 National Health Accounts (NHA) 2014-2015 1 outpatient care costs, diagnostics, and drugs, which disproportionately affect poor households3. Figure 1: Trends and Composition of Health Expenditures TB control in India 5. TB is a prime example of a persisting communicable disease challenge for India. TB kills approximately 480,000 people every year in India. The country still contributes almost 25 percent of the global TB burden and this proportion has remained constant for more than 20 years. While the coverage of TB interventions by the public sector expanded rapidly from 1993 to 2012 under the Revised National TB Control Program (RNTCP), such coverage has plateaued, and TB treatment outcomes have stagnated over the past five years. 6. Drug-resistant TB (DR-TB) is a major public health threat to India and potentially to the world. TB is one of the world's top anti-microbial resistant pathogens, mostly due to poor management of TB patients. Resistance to first-line drugs is known as multi-drug-resistant TB (MDR-TB). Inappropriate management of MDR-TB can lead to a highly lethal form of TB called extensively drug-resistant TB (XDR-TB). Resistant forms of TB require more expensive drugs with higher levels of toxicity, case fatality, and treatment failure rates. Unfortunately, India has the world’s highest burden of MDR-TB, with 37,000 cases or 24 percent of the world’s total in 2016. India’s health systems are ill-equipped to adequately respond to DR-TB, with DR-TB outcomes lagging global and regional trends. These resistant forms of TB threaten to erode India's health and development gains. 7. Many TB cases remain undiagnosed and/or inadequately treated. Despite increases in total new TB cases reported to the RNTCP (notified cases), India still accounts for approximately one third of the world’s three million people with TB each year who are not diagnosed, treated, or officially registered by a national TB program. Most of these people are in their economic prime. In India, unnotified cases are either undiagnosed4 or inadequately diagnosed and treated in the private sector. As such, delayed diagnosis and incomplete treatment are the greatest challenges to TB control in India—particularly among private providers, who are ill- equipped or unmotivated to sustain patients on prolonged, complex, and costly regimens. 8. TB is a disease of poverty. TB predominantly affects the poor and marginalized. It entrenches poverty through health and economic shocks to households least able to cope. A systematic review of studies in low- and middle-income countries shows that the total cost of TB ranges from 5 percent to 40 percent of a TB 3 Gupta I, Chowdhury S, Prinja S, Trivedi M (2016) Out-of-Pocket Spending on Out-Patient Care in India: Assessment and Options Based on Results from a District Level Survey. PLoS ONE 11 (11): e0166775. doi:10.1371/journal. pone.0166775 4 Undiagnosed TB represents a major public health failure given that an undiagnosed person with TB can infect 10-15 people. (Stop TB Partnership, 2015). 2 patient’s annual household income. This share can even be higher than 200 percent for poorer households and patients with MDR-TB. A staggering 70 percent of patients in these countries took loans for TB treatment. India is no exception in this regard. 9. A combination of household and health system factors account for India’s persistently high levels of TB. They include: i. Poor coordination in TB care: The TB burden is exacerbated by fragmented health care provision through diverse providers, including an unregulated private sector accounting for more than half of TB cases treated in India. Convoluted patient pathways, especially in the private sector, prolong the times between onset of symptoms, diagnosis, and initiation of treatment5. ii. Quality gaps: Evidence points to quality gaps in TB diagnosis and treatment in both public and private sector, with varying levels of adherence to India Standards of TB Care6. A standardized patient study among providers in two cities found only: (i) 35 percent compliance with care standards; (ii) 31 percent of interactions with an order of microbiological testing; and (iii) 5 percent of cases with a prescription of anti-TB drugs.7 iii. Delayed care-seeking and leakages in care cascade: Many patients delay seeking care and do not adhere to treatment due to various behavioral and socio-economic factors. Transportation costs are a well-known barrier to TB care. High out-of-pocket costs related to TB treatment as discussed above also reduce treatment adherence. While under-nutrition is a major risk factors for TB, emerging evidence shows that it also contributes to unfavorable treatment outcomes. iv. Diagnostic laboratory network limitations: In 2017, an external Diagnostic Laboratory Assessment revealed substantial deficiencies. To diagnose the estimated 2.8 million cases of TB and 150,000 cases of MDR-TB a year, laboratory capacity must be expanded by (i) further decentralizing molecular testing to Health Blocks; (ii) improving specimen referral and transport systems; (ii) engaging private providers and laboratories; (iii) deploying a centralized laboratory information system; and (iv) enhanced monitoring and evaluation, quality assurance and supportive supervision. v. Institutional capacity constraints at central and state levels: There is a mismatch between the skills mix envisioned by the National Strategic Plan (NSP) 2017-25 and the current staffing situation of the RNCTP, including high vacancy rates in some high burden TB states. Key areas for further institutional strengthening include private sector contracting, Direct Benefit Transfer (DBT) for TB patients, information systems and performance-based management system between CTD and states. 10. Evidence suggests that strategic engagement with the private sector could be a game changer for TB control in India. Around 80 percent of people with TB make first contact with the health system through private providers8. In recognition of the roles of the private sector, the RNTCP has articulated guidelines and schemes for private sector engagement since 1999. However, most activities were only confined to pilots in Maharashtra and Gujarat states in the earlier years of the RNTCP. Several reviews of this period pointed to the lack of attention to private sector engagement. However, in 2012, the GOI: (i) approved the NSP 2012-17, which endorsed contracting Private Provider Interface Agencies to engage private providers; (ii) made TB a notifiable disease and passed a regulation to mandate TB notifications by private providers; and (iii) introduced the Nikshay information system on a large scale to enable TB case notifications by all providers. Following these policy actions, the GOI appointed dedicated Public Private Mix (PPM) Coordinators and worked with partners— 5 Das et al., (2015). Use of Standardized Patients to Assess Quality of TB Care: A Polit Cross-Sectional Study. Lancet Infectious Diseases, November 2015. 6 Studies found low adherence to case specific checklists of TB care, inappropriate treatment and overuse of unnecessary treatment such as steroids and anti-biotics. See McDowell, A. Pai, M. 2016. “Treatment as diagnosis and diagnosis as treatment: empirical management of presumptive tuberculosis in India” IJTLD 20(4) 7 World Health Partners (WHP), World Vision India, Lepra, Mamta, Alert, Karnataka Health Promotion Trust (KHPT) and Maharashtra Janvikas Kendra (MVK). 8 Ministry of Health and Family Welfare, National Strategic Plan for Tuberculosis Elimination, 2017-25 3 USAID, the Global Fund to Fight AIDS, TB and Malaria (Global Fund), and the Bill and Melinda Gates Foundation (BMGF)—to test and roll out implementation models to engage the private sector in TB control. RNCTP data show that while public sector notifications have plateaued since 2012, recent efforts to engage private providers, while falling short of ambitious targets, have yielded promising results (Figure 2). Figure 2: TB Notification in Public and Private Sectors (2012-18) Total (Plan) Total (Actual) Private (Plan) Private (Actual) Public (Plan) Public (Actual) 4,000,000 3,500,000 3,000,000 2,500,000 TB Notifications 2,000,000 1,500,000 1,000,000 500,000 - 2012 2013 2014 2015 2016 2017 2018* 2019 2020 2021 Source: Ministry of Health and Family Welfare 11. Determined to eliminate TB, India has launched a robust response with the National Strategic Plan (NSP) for Tuberculosis Elimination 2017-25. The GOI’s NSP 2017-25 embraces evidence-based interventions, new technologies, bold innovations and major institutional reforms (please see section III below for further analysis), with the aim to achieve End TB goals by 2025, five years ahead of the global timeline of 2030. The comprehensive scope of NSP is matched by an impressive budget of US$8.3 billion. The transformative nature of India’s NSP and the scale of its ambitions are thus unprecedented among countries with high burdens of TB. The GOI’s actions speak louder than words – it already doubled the annual budget for TB within a span of one year, from US$252 million in FY2016 to US$525 million in FY2017. The Bank’s proposed support builds on this bold vision and supports the NSP’s out-of-the box innovations which are game changers in TB control. These include: (i) contracting of private provider interface agencies; (ii) expanding direct benefits transfer for patients; (iii) expansion of ICT services; and (iv) strengthening DR-TB services. C. Relationship to the CPF and Rationale for Use of Instrument 12. The proposed operation builds on 20 years of successful partnership in TB control between the World Bank and the GOI. The Bank has a strong track record of supporting the GOI in TB control with three IDA projects since 1998. All of them were rated as Satisfactory for outcomes upon completion. The Bank’s support has contributed to the scaling up of (i) Directly Observed Treatment, Short-Course (DOTS) to nationwide (1998- 2006); (ii) services to poor and high-risk groups, including tribal households, HIV patients, and children; initiation of MDR-TB services (2006-2012); and (iii) universal access to diagnostics and quality TB care (2012-2017). 13. The proposed Program is consistent with the World Bank Group’s Country Partnership Strategy FY18- 4 22; Report No. 126667-IN, July 25, 2018 discussed at the Board on September 20, 2018. By supporting India to tackle an infectious disease with substantial health and economic impacts as well as negative externalities, the Program directly aligns with the objectives of the CPF FY18-22 and contributes to Focus Area 3: Investing in Human Capital, one of the three “Whats” of the CPF. To achieve this objective, it will apply all of the four “Hows” of the CPF by: (i) leveraging the private sector through engaging private providers in TB control; (ii) strengthening public sector institutions; (iii) engaging a Federal India by working with both the CTD and states; and (iv) contributing to the “Lighthouse India” learning initiative by connecting practical know-how and innovations in TB elimination among states for the benefit of India and the wider world (Figure 3). The proposed Program will support government driven learning and will be coordinated with partners to systematically distill lessons from innovations at state and central levels. Figure 3: PTETB Implementation and Links to the CPF 14. The proposed Program also contributes to the attainment of the Sustainable Development Goal 3 and the Health, Nutrition and Population Global Practice goal of ending preventable deaths and disability through Universal Health Coverage (UHC). The relationship between health and wealth is well-established, with better health resulting in enhanced cognitive development and increased human capital9,10. Besides affecting health, TB leads to income loss and forces people deeper into poverty. The Program will contribute to India’s efforts to achieve UHC goals by promoting effective coverage of TB through the private and public sectors and patient support mechanisms. 15. The Program-for-Results (PforR) is the most suitable instrument for the operation. This is because the PforR: (i) allows the operation to be firmly anchored in the GOI’s NSP for TB elimination ; (ii) focuses on results rather than inputs, which allows the flexibility to innovate and learn from different pathways for achieving the 9 Mirvis D.M. and D.E. Bloom. 2008. Population health and economic development in the United States. Journal of the American Medical Association. 300(1): 93-95. Grantham-McGregor et al 2007. 10 Grantham-McGregor, S., Cheung, Y. B., Cueto, S., Glewwe, P., Richter, L., Strupp, B., International Child Development Steering Group (2007). Developmental potential in the first 5 years for children in developing countries. Lancet (London, England), 369(9555), 60-70. 5 results, i.e. private sector engagement; (iii) uses country systems, with attention to system strengthening, which enhances development impact and sustainability; and (iv) is an instrument with which India already has had significant experience at both national and state levels. II. PROGRAM DESCRIPTION A. Government Program 16. The ambitious NSP 2017-25 constitutes the government program. The NSP lays out the GOI’s strategic approaches and priority interventions to eliminate TB. The US$8.3 billion NSP 2017-25 is organized around four pillars (Figure 4), as follows: Figure 4: Vision, Goal, and Strategic Pillars of India’s National Strategic Plan for TB Control VISION: TB-Free India with zero deaths, disease and poverty due to TB GOAL: To achieve a rapid decline in burden of TB, morbidity, and mortality, while working towards elimination of TB in India by 2025 Detect Treat Prevent Build • Improved diagnostics • Reduced losses in cascade • Scale-up airborne infection • Restructure TB program • Private provider of care with support control in high-risk settings • Build high-level political engagement systems • Expand treatment of latent commitment • Universal screening for • Free anti-TB drugs for public TB infection in contacts and drug-resistant TB and private TB cases high-risk individuals • Systematic screening of • Enhanced TB regimens • Address social determinants high-risk populations • Patient-friendly adherence of TB among high-risk monitoring communities and families • Elimination of catastrophic costs with social support Source: Ministry of Health and Family Welfare 17. The NSP 2017-2025 is technically robust, comprehensive and bold: NSP rightly emphasizes early case- finding and effective treatment to interrupt transmission as key to TB control. It strives to better serve at least 1.5 million patients in the public system per year and, at the same time, to detect and improve the management of millions more in the private sector. To this end, NSP encompasses several new technologies, innovative implementation approaches and bold institutional reforms. First, the country adopts a more effective treatment regimen for drug-susceptible TB and shorter regimens for DR-TB in a bid to improve TB outcomes. Second, molecular testing will be further decentralized at the Health Block level. Third, based on the promising pilot results, the NSP will scale up engagement with private providers and provide them with incentives for TB notification and proper treatment. Fourth, notified TB patients will receive cash transfers, home visits, counseling and preventive interventions for treatment adherence. Fifth, Nikshay information system will be strengthened and other information technology will be leveraged to facilitate the scale up of such new interventions targeting both providers and patients. Finally, institutional strengthening will be prioritized in the NSP, with (i) improving staffing level and mix at all levels to match the focus and ambition of the NSP; and (ii) establishment of a TB control board to strengthen stewardship of resources and RNTCP oversight. B. PforR Program Scope 18. The proposed Program Towards Elimination of TB (PTETB) is a well-defined subset of the government program. The PTETB was carved out of the NSP by: (i) result area; (ii) geographical area with the selection of priority states; and (iii) timeframe. Within the above-mentioned four NSP pillars (Figure 4), the Program focuses on four result areas: (i) scaling up private sector engagement; (ii) rolling out TB patient management and support interventions; (iii) strengthening diagnostics and management of DR-TB; and (iv) strengthening RNTCP institutional capacity and information systems. These results areas are inter-linked and mutually reinforcing. 6 The four result areas represent transformative changes required for service delivery to meet the ambitions and targets of the NSP. Figure 5 outlines the relationship between NSP and PTETB. Figure 5: NSP vs. PTETB PILLAR NSP EXISTING TB PROGRAM EMPHASIS ("p") NSP RESULTS AREA (RA) INCLUDED IN PTETB ("P") Public sector case finding (RA 1) Private provider engagment Detect Systematic screning of high risk populations (RA 2) DBT incentives Basic microscopy (RA 3) Expanded DR-TB detection, public and private DST for DR-TB detection (RA 1) Private provider engagement, via PPSA Free TB drugs for all patients (RA 2) DBT incentives Treat (RA 2+4) Patient social & nutritional support via DBT Adherence support and monitoring (RA 4) Patient tracking via ICT Prevent (RA 3) Scaling up airborne infection control in high-risk Expand treatment of Latent TB infection settings High level political commitment (RA 1-4) Restructure TB program Build Strengthened HR for TB services (RA 1) Private provider engagement, technical support Abbreviations: NSP=National Strategic Plan for TB Control 2017-2025. DST=Drug susceptibility testing. DR-TB=Drug resistant TB. DBT=direct benefits transfer. PPSA=Private provider support agency. ICT=Information and communication technology. HR=Human resources 19. Considering (i) the estimated TB burden and (ii) the gap between private notifications and estimated TB burden, the GOI selected nine states for the participation in the Program: Uttar Pradesh, Maharashtra, Bihar, Rajasthan, Madhya Pradesh, Karnataka, West Bengal, Assam, and Tamil Nadu. Together, these nine states account for: - 60 percent of the public-sector notification in the country; - 62 percent of the existing gap in private sector notification (based on NSP targets); and - 70 percent of all private TB treatment nationwide (or 12 out of 19 million patient-months of anti-TB treatment distributed via private chemists) 20. Success in these nine states is critical for India to meet its NSP targets. The GOI’s prioritization of these states will enable intensified implementation of high impact TB interventions at scale. In addition, these nine states will provide a platform for peer learning and for generating important lessons and evidence for the rest of the country. All the remaining 26 states and Union Territories will benefit from cross-cutting system interventions under the Program, mainly improvements to the Nikshay information system. In terms of timeframe, the Program is a time-slice of the NSP (i.e., five years out of seven remaining NSP years). 21. The total Program cost of US$1.334 billion accounts for 74 percent of total government expenditures on TB in the nine targeted states (including state-level expenditures and CTD expenditures relevant for activities in the nine states), or 16 percent of the US$8.3 billion in funding required by India’s NSP 2017 to 2025 Program expenditures categories are detailed in Table 1. Excluded from the Program are expenditures related to major 7 civil works, high value procurement11, procurement under the Global Drug Facility, hiring and maintenance of vehicles, and miscellaneous office operations. Expenditures on drug and material procurement will be at the CTD level, whereas other expenditures will be predominately at state level. The exact distribution may vary depending on the specific implementation arrangements in each state. Table 1: Program Expenditure Requirements by Expenditure Categories Central- State- Total level level percent Amount Category Amount Amount Total (US$ (US$ (US$ Amount million) million) million) Supplies and Materials - Procurement of Anti TB Drugs, 836 1 837 equipment, and laboratory materials 63 percent Private sector support (PPM, NGO, PP support) 20 204 224 17 percent Salaries and Benefits 13 120 133 10 percent Honoraria 0 95 95 7 percent Training 4 13 17 1 percent Supervision and monitoring 3 12 15 1 percent Patient support and transportation 0 13 13 1 percent Total 860 474 1,334 100 percent 22. IBRD financing is US$400 million or 30 percent of the total Program cost estimate of US$1.334 billion. The GOI will finance the remaining 70 percent (Table 2). Table 2: Program Financing Source Amount (US$ million) percent of Total IBRD 400 30 Government 934 70 Total Program Financing 1,334 100 23. The full GOI request for IBRD financing for the period 2019 to 2025 is US$500 million; the remaining US$100 million requested by GOI will be considered by the World Bank by March 2022. 24. As mentioned above, the Program will support four result areas which are inter-linked and mutually reinforcing. Below is a detailed description of these Results Areas. 25. Result Area 1: Scaling-up Private Provider Engagement (US$176 Million): The aim is to scale up private sector engagement to ensure timely diagnosis and notification and effective management of TB among patients in line with Standards of TB Care in India. The array of private providers in India relevant to TB control includes: Rural Health Practitioners 12 , chemists and pharmacies, laboratories, qualified AYUSH providers, qualified allopathic Bachelor of Medicine General Practitioners, and specialists (such as pulmonologists). Until recently, the RNTCP’s engagement with them has been sporadic and small-scale. The NSP envisages an initial doubling of the number of patients detected and treated, with most of the increase coming from engagement of such 11 This refers to contracts valued at or above Operational Procurement Review Committee (OPRC) thresholds (i.e., US$75 million for works; US$50 million for goods and non-consulting services; and US$20 million for consultant services). 12 Also known as Rural Medical Practitioners, Less Than Fully Qualified Practitioners and quacks. 8 private healthcare providers. Approaches to engaging such a wide range of providers naturally differ: (i) high- volume specialists may merit assignment of dedicated staff to assist with TB patient notification and treatment support; (ii) doctors in solo practice are critical for decentralized case finding and management but require efficient engagement models given their large numbers; (iii) chemists and labs can provide specific TB services if their costs are covered; and (iv) informal providers can play a role in early referrals. 26. Strategic Rationale and Theory of Change: TB control efforts have been limited to public sector health services so far despite the fact that the majority of outpatient care is delivered by private providers. In urban areas, more than 80 percent of those ultimately diagnosed as TB cases start their health care journey with a private provider. However, it is well-documented that private providers often do not meet TB care standards. Delayed diagnosis, case mismanagement, inadequate patient counselling, high cost of care and negligible treatment adherence support all contribute to increases in drug resistance, TB recurrence, high mortality and catastrophic expenditures among private sector TB patients. Engaging the private sector for timely and accurate diagnosis, notification, and good patient management in line with the Standards of TB Care is a critical pathway for India’s successful achievement of NSP objectives. Evidence from earlier pilots confirmed the efficacy of engaging with private providers. For example, in Patna, Bihar (a city with more than 6 million people and one of the sites of the Gates Foundation-supported program) private provider engagement increased total TB case notification more than four-fold between 2013 and 2017 (Figure 6). The treatment success rate among privately- notified patients was also increased to 74 percent (not shown). Figure 6: Results from Private Sector TB Pilot 27. Built on years of pilots and more recent large-scale demonstrations, the GOI’s new approach to scaling up private provider engagement is summarized in Figure 7 13. Depending on the context, three different basic models will be used: (i) RNTCP field staff directly engaging private providers to elicit notifications and support patients; (ii) contracting of intermediary agencies to manage all aspects of private provider engagement and patient support; and (iii) a hybrid model in which RNTCP field staff engage the private providers and contract local NGOs for supportive functions, such as sputum transport or patient support. All models will be supported by Nikshay case-based information system which will enable large scale monitoring, strategic purchasing, direct electronic payments to patients and providers and new adherence support technologies. Digital systems for 13NSP will also support other approaches to engage private sector such as (i) use of health insurance schemes to scale-up private sector engagement; (ii) engaging private sector professional associations; and (iii) strengthening pre-service medical education related to TB. However, they are not priorities in the Program 9 recording and reporting will facilitate trust, accountability, and rapid-cycle performance management. The mix of incentives and engagement models will create an ecosystem for private sector engagement. The nine targeted states vary considerably in the strength of their TB programs, in their general public administration, and in their experience with contracting private providers. While all of them are expected to deploy all the strategic elements, the mix of engagement models will vary between states. Figure 7: Pathways to scale in the current and planned approach to private provider engagement Hundreds of thousands of providers (chemists, labs, GPs, informal providers, hospitals) Engagement Models ~ 2 million patients Provider-Patient RNTCP engages RNTCP engages Contracted Private Providers Private Providers Intermediaries and supports engage Private patients Contracted NGOs Providers and support patients support patients Digitally-Enabled Strategic Purchasing Nikshay 2.0 and National Call Centre to facilitate notification; linked to PFMS for DBT to patients Systems Support and providers, vouchers management for diagnostics and drugs, and adherence technologies; with job aids for frontline workers and their supervisors; and powerful analytics and dashboards for accountability and transparency Regulatory Enforcement Penalties for failure to comply with Mandatory Notification and Schedule H-1 28. However, each approach has its own strengths and weakness, which are summarized below (Table 3). Table 3: Strengths and weaknesses in current pathways to scale for private provider engagement Strategy Details Potential Challenges Direct RNTCP Deployment of several hundred • Most comfortable approach Not yet able to ensure engagement contractual PPM Coordinators, in for RNTCP treatment adherence addition to thousands of other • Demonstrated ability to or quality of care field staff increase notifications Contracting • Contract NGOs for support Demonstrated ability to increase • Limited capacity for intermediaries roles: sputum transport, lab case-finding and assure large-scale technicians, adherence support successful treatment outcomes contracting • Issue more substantial • Few NGOs with contracts for end-to-end PPSA skills and (here-to-fore donor-funded) experience at scale Digitally-enabled • User-friendly digital case-based • Efficiency at scale • Design and mass purchasing registry • Transparency implementation of of private • 99DOTS adherence monitoring • Data and analytics for complex data services • Call Centers to support management systems notifications, treatment support • Attractive to PPs because • DBT/PFMS payments to reliable, impersonal patients, providers and • Facilitates rapid testing and treatment supporters adoption of adaptations • Potentially, vouchers for private • Accountability for public diagnostics and drugs funds 10 Strategy Details Potential Challenges Regulatory • Mandatory notification decrees, Increases motivation for • Inconsistent enforcement with penalties for non- providers to notify enforcement compliance • Drug Controller General enforcement of Schedule H1 29. In light of the RNTCP’s limited experience in engaging private providers, Technical Support Units (TSUs) will be established in the CTD and in each of the nine states to support strategic purchasing, private sector engagement, and DBT management under the Program. The CTD will set a minimum skills mix expected for a TSU and work with states to contract or develop such teams 14 . However, there will be flexibility in TSU configurations. For example, states with active Public Private Partnership Units will have the option to strengthen such units so that they can perform the TSU roles. 30. Four DLIs will be used to incentivize this results area. Prior result #1.0 will be about revision of national guidelines for engagement with private providers. DLI# 1.1 and DLI# 1.2 are related to results in TB notifications, management, and treatment outcomes by private providers. DLI# 1.3 will be about institutional strengthening to support private sector engagement. The GOI will provide incentives to private providers who notify TB patients. 31. Result Area 2: Rolling out TB Patient Management and Support Interventions (US$60 Million): TB control outcomes depend on whether TB patients seek care early and adhere to treatment. Thus, the GOI is rolling out TB patient support as one of its strategic interventions to eliminate TB. 32. Strategic Rationale and Theory of Change: Providing treatment enablers in the form of financial incentives and nutritional support can increase treatment adherence and treatment success rates. They are therefore recommended interventions under the WHO End TB Strategy. In this context, the GOI is rolling out a Direct Benefit Transfer (DBT) scheme to t to provide financial incentives to TB patients called Nikshay Poshan Yojana (NPY). The GOI will also support the incentives for private providers to notify TB and the incentive for tribal patients (Table 4). Table 4: Direct Benefit Transfer Schemes for TB Patients and Providers S.No. Scheme Name Amount to be paid Scheme Description 1. Nikshay – TB notification INR 500 (US$7.23) upon Private providers are enrolled in the incentive for Private Sector notification and again upon Nikshay data base and notify TB cases Providers treatment completion or manage and subsequently report to the RNTCP. 2. Nikshay Poshan Yojana – INR 3000 (US$43.44) Beneficiaries are TB patients under Private and public-sector the RNTCP who are eligible for patients with drug susceptible nutritional support in three TB (Nutritional Support) installments of INR 1000 each. 3. Nikshay – Tribal patients INR 750 (US$10.86) Beneficiaries are tribal TB patients treated under the RNTCP. 33. To implement NPY, RNTCP will use Nikshay, the web-based TB case monitoring system. This information system has already been deployed across India but still needs further strengthening to facilitate electronic 14The WHO, BMGF and the Global Fund will continue to provide technical support at CTD and state level while TSUs are being established. 11 payments to beneficiaries, including integration with the GOI’s Public Financial Management System (PFMS). 34. Three DLIs will be used to incentivize this results area. Prior result #2.0 will be about the development of information systems modules in Nikshay 2.0 to enable implementation of the DBT schemes. DLI#2.1 will be about rolling out digital payment and certification systems at district level for processing DBT payments to patients and private providers. DLI#2.2 will be about the proportion of patients receiving DBT through Nikshay. 35. Result Area 3: Strengthening Detection, Treatment, and Monitoring of Drug-Resistant TB (US$70 Million): The aim is to scale-up DR-TB interventions in India to aggressively respond to the complex and costly DR-TB challenge. 36. Strategic Rationale and Theory of Change: As mentioned above, India has the largest absolute burden of DR-TB in the world. While standard daily-dosed anti-TB drugs cost approximately US$50 per 6-month regimen, drug costs for rifampicin-resistant TB and variants are 30-60 times more expensive. A recently completed national anti-TB drug resistance survey found that roughly 25 percent of pulmonary TB patients in Indian public facilities have some forms of anti-TB drug resistance, and that 6 percent of all TB cases had MDR-TB. Progress against NSP 2017-25 targets on drug-resistant TB targets has lagged (Figure 8). Figure 8: Progress against key DR-TB Indicators (end 2017) vs Targets in the NSP-TB Source: Ministry of Health and Family Welfare 37. The proposed Program will address DR-TB control by tackling various bottlenecks simultaneously. First, the Program will support universal Drug Susceptibility Testing (DST), the gateway to additional testing and appropriate treatment. In the past, DST was prioritized for patients seeking care in the public sector, but not for those in the private sector. Developing robust sputum transportation to the growing number of public laboratories with molecular diagnostics capabilities for at least rifampicin susceptibility testing will be a key activity supported by the Program to facilitate DST. Second, the Program will track progress in detection of additional drug resistance and completion of treatment because poor treatment outcomes in DR-TB have been associated with fluoroquinolone resistance and poor adherence15. Third, an underappreciated component of DR-TB control involves improving airborne infection control in high-risk settings. The Program will support this important activity in DR-TB centers in the targeted states. 15Parmar MM, Sachdeva KS, Dewan PK, Rade K, Nair SA, Pant R, et al. (2018) Unacceptable treatment outcomes and associated factors among India's initial cohorts of multidrug-resistant tuberculosis (MDR-TB) patients under the revised national TB control programme (2007–2011): Evidence leading to policy enhancement. PLoS ONE 13(4): e0193903. https://doi.org/10.1371/journal.pone.0193903 12 38. Attention to DR-TB control has synergy with private provider engagement under the first Results Area. Private provider engagement has been shown to promote screening for DR-TB. The RNTCP’s experiences in Mumbai and Patna are instructive. With private sector engagement, private providers in Mumbai could detect more than 3,500 or 30 percent, of MDR-TB cases citywide. Similarly, the Patna private provider engagement initiative detected nearly 800 MDR-TB cases—75 percent of the total in the district over the project period16. 39. Under this Results Area, DLI#3.1 will incentivize rifampicin susceptibility testing for TB patients. 40. Result Area 4: Strengthening RNTCP Institutional Capacity and Information Systems (US$93 Million): The transformative nature of India’s NSP and the scale of its ambition are unprecedented among countries with high burdens of TB. The Program will help the GOI build the institutional capacities required to succeed. 41. Strategic Rationale and Theory of Change: The RNTCP institutional capacity and information systems have been evolving with the expanding TB program. However, the staffing levels and skills mix are yet to match NSP goals at central and state levels, particularly in the nine states supported by the Program. The Program will therefore support the MOHFW to develop and implement a human resource plan to meet the needs of the NSP. 42. The transition to Nikshay 2.0 in September 2018 brought a paradigm shift to a comprehensive information system that tracks each patient through their entire TB episode. In addition to supporting TB patient management and adherence monitoring, it is also used for TB drug inventory management, DBT for providers and patients, and public finance management. Nikshay 2.0 is in the process of system stabilization and roll-out. However, there are still concerns about: (i) data quality (including authenticity and duplication of notified cases); (ii) use of data for decision making at all levels; (iii) private sector interface; and (iv) supply chain management features (including forecasting). The Program will support Nikshay 2.0 strengthening and data integrity. This includes development of modules for DBT schemes and private sector notification. 43. To hold state and districts accountable for results, the MOHFW will develop and roll out a performance- based management mechanism between the CTD and states (a.k.a. “state compact”), taking into account not only state performances but also their level of development and implementation capacity. A guideline will be developed in the first year of the Program to guide the implementation of this mechanism. It will include a performance-based management matrix or scorecard reflecting Program priorities, (notably private provider engagement, patient support, and data quality). Based on the state and district teams’ performances as measured by the matrix/scorecard, the CTD will pay team-based incentives for state and district teams in the targeted states. The Program will also support annual State and National TB forums, which are venues for vertical integration of social accountability, civic engagement, stakeholder consultations, and peer learning at different levels. Both performance-based mechanism and TB Forums represent innovative approaches in the management and governance of RNTP. 44. Three DLIs will be used to incentivize this results area. The prior result #4.0 will be about a Nikshay mechanism for deduplication (of patients and providers) and reconciliation of different provider types. DLI#4.1 will be about human resource for health in TB. DLI#4.2 will be about the development and roll-out a performance-based management scheme between the central government and states. The amounts included under the DLI#4.2 only serve as incentives under the Program. These amounts will not match the exact amount of performance-based management incentives paid by CTD to states. 45. The Program’s Theory of Change is illustrated below in Figure 9. 16Papinini et al. Effective service delivery for TB patients seeing care from the private sector in Patna. 2018. Publication pending; available on request. 13 Figure 9: Theory of Change EXPECTED EXPECTED OUTPUTS AND INTERMEDIATE CHALLENGES INPUTS/Activities OUTCOMES/ RESULTS PDO INDICATORS −Non-standardized TB −Identify and provide Cross- Scaled-up Public Private Engagement (RA1) Number of private notifications, services in the private incentives to TB patients in Cutting/Institutional − Increased number of TB cases diagnosed and put on net of any decrease in public sector the public and private treatment notifications (DLI 1.1). −Poor quality TB sectors − Improved enforcement − Increased number of public-private agencies services -convoluted −Monitor TB notification of India TB standards of contracted Treatment success rate of private patient pathways and patient management care − Increased proportion of TB private providers receiving sector notified TB patients (DLI −Delayed household by private providers − Revision and approval of incentives through DBT 1.2). care seeking for TB −Strengthen central and revised National screening and care state institutional capacity Guidelines for −Limited diagnostic to engage private providers Partnerships under Rolling out Patient Support Interventions (RA2) capacity in private and −Strengthen diagnostic RNTCP (Prior Result 1.0) − Proportion of TB patients receiving financial support Proportion of notified TB public sectors services in public sector – − Development of modules through DBT (DLI 2.2). patients with known Rifampicin- −Weak drug-resistant include TB sample in Nikshay 2.0 for all 4 − Proportion of districts implementing digital signature susceptibility status (DLI 3.1) programmatic & transportation DBT schemes (Prior certificate-based approval process for DBT payments clinical management −Strategically purchase TB Result 2.0) (DLI 2.1) Proportion of privately notified capacity services from private − Implement HR Plan to pulmonary TB patients that have −Human resources gaps providers improve CTD and state Improved Detection, Treatment and Monitoring of microbiological confirmation (clinical and −Expand drug-susceptibility capacity DR-TB (RA3) programmatic) testing and monitoring − TB Forums established at −High Out-of-Pocket −Develop human resources State and National Levels − Proportion of TB patients with known rifampicin Expenditures for TB plan to match scope and − Performance-based susceptibility status − Strengthened sputum transportation systems in priority states RNTCP institutional capacity to Affected Households ambition of NSP management between achieve select NSP objectives −Develop information CTD and states strengthened (private sector, DR- systems to strengthen TB implemented (DLI 4.2) TB and patient support) program and patient management Strengthened Prog Management Capacity & −Establish technical support Information Systems (RA4) units at central and state − Technical Support Unit (TSU) integrated at state level levels and CTD level to support activities related to Private Sector Engagement (DLI 1.3). − Improved staffing at CTD and state levels (DLI 4.1) − Nikshay information system enhanced and supporting DBT schemes (DLI4.0) Text highlighted in BOLD and ITALICS denote the expected outputs and expected outcomes that are included in DLIs 14 C. Program Development Objective(s) (PDO) and PDO Level Results Indicators 46. The PDO is to improve the coverage and quality of TB control interventions in the private and public sector in targeted states of India. 47. Program Key Results Indicators Coverage of TB interventions: • The number of private notifications, net of any decrease in public notifications in targeted states (Annual) • Proportion of TB patients receiving financial support via Nikshay Poshan Yojana in targeted states (Annual, by category of DBT scheme) (i) Proportion of TB patients notified by public providers receiving 1st Nikshay Poshan Yojana payment in targeted states (ii) Proportion of TB patients notified by private providers receiving 1st Nikshay Poshan Yojana payment in targeted states Quality of TB interventions • Treatment success rate of TB patients notified by private providers in targeted states (Annually, cohort of patients notified in prior calendar year) • Proportion of notified TB patients tested for rifampicin susceptibility in targeted states D. Disbursement Linked Indicators and Verification Protocols 48. To advance progress toward priority outcomes of the NSP 2017-25, the development of the Program DLIs (Table 5) followed these principles: i. Maximizing the use of existing indicators in the government’s NSP; ii. Corresponding to priority areas of the NSP, especially major bottlenecks along the results chain and providing incentives for removing them; iii. Stimulating performance at different levels of the RNTCP; iv. Making full use of and strengthening the GOI’s routine information system, Nikshsay; and v. Balancing ambition (“stretch”) and feasibility (“realism”) Table 5: Disbursement Linked Indicators DLI DLI Indicator Scaling-up Rolling out Strengthening Strengthening Private TB Patient Detection, RNTCP Institutional Provider Management Treatment Capacity and Engagement Support and Information Interventions Management Systems Drug - Resistant TB 1.1 Number of private notifications,   net of any decrease in public notifications in targeted states (Annual) 1.2 Treatment success rate of TB  patients notified by private providers in targeted states 1.3 Establishment of Technical   15 DLI DLI Indicator Scaling-up Rolling out Strengthening Strengthening Private TB Patient Detection, RNTCP Institutional Provider Management Treatment Capacity and Engagement Support and Information Interventions Management Systems Drug - Resistant TB Support Units (TSUs) in CTD and targeted states to support activities related to private sector, DBT, PFMS, and multi sectoral engagement as per agreed TOR 2.1 Proportion of districts  implementing Digital Signature Certificate (DSC) based approval process for DBT payment in targeted states 2.2 Proportion of TB patients receiving financial support via Nikshay Poshan Yojana in targeted states (Annual). DLI 2.2.1 Proportion of TB patients notified by public  providers receiving 1st Nikshay Poshan Yojana payment in targeted states. DLI 2.2.2 Proportion of private sector notified TB patients receiving 1st Nikshay Poshan   Yojana payment in targeted states. 3.1 Proportion of notified TB  patients tested for Rifampicin susceptibility in targeted states 4.1 Staffing capacity of the RNTCP strengthened: DLI 4.1.1: Development and approval of a multi-year RNTCP Human Resource Plan at CTD  and state level to match the scale and ambition of the NSP. DLI 4.1.2: Reduction of the staffing gap identified by the Human Resource plan for CTD  and the targeted states. 4.2 Development and  implementation of a 16 DLI DLI Indicator Scaling-up Rolling out Strengthening Strengthening Private TB Patient Detection, RNTCP Institutional Provider Management Treatment Capacity and Engagement Support and Information Interventions Management Systems Drug - Resistant TB performance-based management mechanism between the center and the targeted states. 49. In addition to the above DLIs, the Program will support three prior results (see Table 6 below) that are critical reforms and outputs to form the foundation for Program implementation and success. Prior Results are expected to be achieved by the time the Program becomes effective. However, some of these results might be achieved within the first year of implementation. Table 6: Prior Results Prior Prior Result Indicator Private TB Drug - Program Result sector Patient Resistant TB Management engagement Support & Capacity & surveillance Institutional Strengthening 1.0 Revision and approval of the National  Guidelines for Partnerships under RNTCP 2.0 Development of Nikshay modules for all 4   DBT schemes (Nikshay Poshan Yojana, Tribal TB Patients, Private Providers and Treatment Supporters) 4.0 Nikshay mechanisms developed for (i)   deduplication (of patients and providers) and reconciliation of different provider types; and (ii) reconciliation of direct benefit transfer payments through Nikshay versus the public financial management portal for Nikshay Poshan Yojana. 50. The achievement of prior results and DLIs would trigger World Bank disbursements. The verification protocols for prior results and DLIs are detailed in Annex 3. There will be two Independent Verification Agencies (IVAs): one to verify DLIs related to IT systems development and functionality (given the special nature of IT systems, Ernst and Young has been selected to play this role) and one to verify programmatic DLIs (WHO has been selected to play this role). CTD will achieve recurrent DLIs by June 30th of each year. Verification of the DLIs will be undertaken subsequently by the IVAs. Lessons Learned and Reflected in the Program Design 51. India’s own experiences and lessons from elsewhere informed the Program design. Program design benefitted from lessons from RTNTP’s various pilots, India HIV/AIDS Program; China TB Program’s experiences 17 with incentives at different levels; and World Bank and other partners’17 experiences in PforR, TB control, private provider engagement, and DBT. They include: a. Engaging private providers improves TB outcomes. Pilots to engage private providers in India and elsewhere have demonstrated that it is possible to work effectively with private providers of all kinds to substantially increase case detection and treatment outcomes comparable with those in the public sector. However, engaging private sector should not be at the expense of public services. Relentless efforts are needed to ensure TB services in the public sector are continuously maintained and improved while private sector engagement is scaled up. b. Flexibility, innovation, and adaptation are critical to successfully engage private providers. Perhaps this is the single most important lesson in engaging private providers for TB, both in India and elsewhere18. While there are common themes, there is no single operational model. Health markets differ significantly from one setting to another, and successful implementation requires adjustment of approaches over time. A potential solution lies in output-based contracting approaches that encourage flexibility for contractors to manage their inputs and tactics—if defined results and quality standards are met. Engagement of more than one implementing organization on the same terms can create healthy competition to drive performance. Also, it is important to respect private providers’ need to attract and retain patients. Earlier approaches, in which private providers were simply instructed to refer presumptive TB patients to public providers, were unsuccessful c. The availability of timely, insightful, and well-communicated data has been critical. Patient- and provider-specific data can be used to make rapid-cycle adjustments to program implementation and hold implementers accountable for results. Use of information technology greatly enhances engagement with private providers in notification, monitoring, and referrals. d. Constraints to strategic contracting in the RNTCP should not be underestimated. Private sector engagement in TB control has been embraced by GOI leadership and reflected in policies and strategies. However, both capacity and buy-in for contracting by lower-level operational managers remains low. Continued dialogue, guidance, tools, and capacity building for strategic contracting are needed to facilitate private sector engagement at the frontline. e. Political commitment has been critical. The Prime Minister’s personal commitment to TB eradication has created unprecedented pressure to perform throughout the system and resulted in increases in RNTP resources. Continued commitment, advocacy, and resources will be required to realize this new and expanded vision. f. Use of evidence to inform interventions: The success of India’s HIV program is to a significant extent thanks to an evidence-based approach which enabled the government to: (i) focus on areas of greatest HIV burden; (ii) respond to different target groups and states with different HIV transmission dynamics differently; (iii) formulate strategic purchasing for HIV services; and (iv) mobilize best technical resources to address the country’s HIV challenges. These lessons are important for the RNTCP. III. PROGRAM IMPLEMENTATION A. Institutional and Implementation Arrangements 52. The MOHFW is the implementer of the proposed Program and the CTD provides stewardship for Program implementation. At the central level, the MOHFW’s CTD is the primary responsible agency for policy 17 Partner experiences includes Global Fund’s ongoing JEET Program and Bill and Melinda Gates Foundation’s Universal Access to TB Care Pilots in Mumbai, Patna and Meshana. 18 WHO (2018) Engaging private health care providers in TB care and prevention: a landscape analysis. 18 development, technical oversight, quality assurance, monitoring and evaluation, and capacity-building for the RNTCP. RNTCP services and systems are highly-standardized, and anti-TB medicines are procured centrally by MOHFW to ensure quality and uniformity of treatment. 53. Table 7 summarizes the TB Program governance structure under the CTD: Table 7: Governance and Leadership Structure of the TB Program Level Administrative Head Technical Head General Health System Central Secretary – Health and Family Welfare, Deputy Director Additional Secretary (Health), Joint General-TB Secretary in charge of TB State Principal Secretary- Health and Family State TB Officer Director- Health Welfare and Mission Director- NHM Services District District Collector/Deputy Commissioner District TB Officer District Health Officer/Chief Medical Officer/Civil Surgeon 54. The Deputy Director General (TB) of MOHFW is the technical head of the TB program. Administratively, a Joint Secretary is responsible for the program, reporting to the Additional Secretary (Health). The Additional Secretary (Health) in turn reports to the Secretary of Health and Family Welfare. Several committees and research institutes provide technical guidance to the CTD. 55. At the state level, RNTCP administrative and financial management structures are merged with those of the NHM. The MOHFW and each state and union territory have entered a memorandum of understanding for implementation of the NHM, which includes the RNTCP. The State TB Officer in the State TB Cell is part of the NHM State Program Management Unit, reporting to the Director of Health Services and the Director of the NHM in the state. The State TB officer—with team support—oversees district level program implementation, reviews staff training, undertakes minor procurement, prepares technical and financial reports, ensures quality control, and monitors program indicators. 56. At the district or municipal level in large cities, the District Health Officer/Chief Medical Officer or an equivalent functionary in the district is responsible for all medical and public health activities, including TB control. The District TB Officer at the District TB Center manages the RNTCP and coordinates with other programs and departments. The District TB Officer is assisted by a Medical Officer and supervisors of TB/HIV coordination, PPM, and advocacy, communication and social mobilization (ACSM), as well as other staff. The RNTCP now has service delivery and administrative structures in 632 districts in 35 states and union territories 57. At the sub-district level, the TB Unit manages day-to-day RNTCP services. Planned alignment of TB Units with the block-level administrative structures of the NHM (Block Program Management Units) will mean that the responsibilities of the Block Medical Officer will include the RNTCP (along with other health programs and services), with a Medical Officer (TB Control) or Program Officer focusing on TB services, and a Senior Treatment Supervisor and Senior TB Laboratory Supervisor providing support. There are currently 2,700 TB Units, for average coverage of one TB Unit per 500,000 population. With 5,900 sub-district administrative units in the country, such an alignment will more than double the number of TB Units. Each TB Unit will then serve 200,000 population—100,000 in tribal, desert, remote and hilly regions. The subsequent increase in Senior Treatment Supervisors will enhance the supervisory and management capacity, notably to handle MDR-TB services and expanded public-private engagement. 19 58. Central Government-State Relationship: The RNTCP is a centrally driven program. Historically, TB implementation has been conceptualized and designed at the central level using a ‘one size fits all’ approach with rigid control of inputs. This is not optimal for a diverse country as well as an epidemic that has wide geographic variations in terms of levels, patterns and trends and driving factors. Within this context, the RNTCP will greatly benefit from state and district level innovations driven by local context and TB epidemic dynamics. The main instrument for Program planning is the Program Implementation Plan (PIP), which will be developed and approved annually at state and central levels. As discussed above, a performance-based management mechanism will also be developed to stimulate the performance of state and district teams. The performance matrix that is being developed by CTD includes measures to assess the extent to which states execute PIP. 59. Institutional Strengthening: As discussed above, the Program will support the strengthening of existing RNTP structures as well as putting in place new arrangements (e.g. TSUs, State and National TB Forums) to enhance program planning, evaluation, and reporting capacity at various levels. The CTD will further strengthen implementation of annual State and National TB Forums, which provide an opportunity to: (i) review implementation progress; (ii) distill key lessons and resolutions at different levels; (iii) amplify citizen voice and social accountability in TB control; and (iv) provide a platform for multi-sectoral engagement. Scaling Up Private Provider Engagement 60. To date, the CTD has not directly engaged intermediaries, other than by coordinating with donor-funded projects. Under the Program, CTD will conduct strategic purchasing of Private Provider Support Agencies, private drugs and diagnostics from distributors, and lab services from large laboratory networks that operate across multiple states. While implementation models will vary from place to place, there will be a significant increase in the contracting of intermediaries, either for specific functions such as sputum transportation or adherence support, or for the full end-to-end model that has been demonstrated so successfully in Patna and Mumbai. 61. All levels of the RNTCP have important roles to play in private provider engagement (PPE). The CTD will (i) develop National Partnership Guidelines for PEE (a prior result) to guide the PPE implementation. And (ii) convene the National Technical Working Group on PPE to advise the Program and provide technical support in PPE. As discussed, TSUs will be established in both the CTD and targeted states to support the design and management of such contracts, which will then be executed through the state NHMs. The Program will build on the technical support being provided to states under Global Fund and BMGF supported pilots. The Global Fund program will provide interim capacity building support in some of the states in years 1 and 2. Partnership to support the Program 62. Collaboration with other development partners will be maximized to effectively support the GOI in Program implementation. In addition to financing independent verification of the Program, the BMGF will provide technical assistance in PPE and DBT. WHO will provide specialized technical support to the Program as well as serve as the IVA for programmatic DLIs. The Program will benefit from the experience of private sector pilots supported by the BMGF and Global Fund. In addition, United States government agencies (i.e., USAID and the CDC) are also financing DR-TB innovations and use of technology to strengthen patient adherence to treatment. The World Bank team will thus work closely with all relevant development partners under the Program. B. Results Monitoring and Evaluation 63. The CTD has more than twenty years of experience implementing World Bank supported operations, 20 including one DLI-based TB project with satisfactory outcomes. The CTD will report on DLI achievement and provide evidence to the World Bank in line with the agreed verification protocol. The CTD will commission the WHO and Ernst and Young to undertake independent verification of results as per protocols accepted by the World Bank. 64. Since 2012, the RNTCP has developed and continuously improved Nikshay - a robust information system based on individual patient records for (i) notification and monitoring of TB patients and (ii) routine program monitoring. Under the NSP 2017-25, the CTD is taking the system to the next level as Nikshay 2.0 to accommodate new activities in private sector engagement, DR-TB, and patient support. Data quality and use of data for decision making will be critical for successful implementation of the NSP 2017-25. To complement HIMIS data, the Program will commission surveys as well as independent verification of data. Low-cost, just-in time and practical implementation research will be carried out under the Program to inform decision making and contribute to the “Lighthouse India” initiatives. C. Disbursement Arrangements 65. Guiding principles for disbursement under the Program: a. The GOT will pre-finance Program expenditures using its own budget19. b. The CTD will prepare technical reports to document the achievement of DLIs. The technical reports will be verified by IVAs (WHO and Ernst and Young) as per terms of reference agreed with the World Bank. The CTD will then communicate the achievement of DLIs and corresponding DLI values to the World Bank along with the supporting documents. For time-bound DLIs, achievement of the DLIs must happen before the deadlines specified in the DLI matrix. c. For a non-scalable DLIs, the World Bank will disburse the DLI value only upon full achievement of its targets. For a scalable DLI, the World Bank will disburse against the level of DLI achievement as per the DLI formula. d. The World Bank will issue an official letter to the CTD endorsing the achievement of the DLIs and disbursement values. e. The CTD will submit the disbursement claim of the DLI values to the Controller of Aid, Accounts, and Audit (CAAA) in the GOI. f. The CAAA will submit the disbursement claim to the World Bank, and the funds will be disbursed by the World Bank to the GOI under IBRD loan terms. The GOI will release funds to the CTD as per agreed financing norms between the Ministry of Finance and the MOHFW. 66. In the last year of the Program (2024), the CTD will coordinate with the World Bank and reconcile the audited Program expenditures (incurred under identified budget lines) with the DLI amounts disbursed by the World Bank. Any shortfall in the Program expenditure in relation to the DLI disbursement will be adjusted by the World Bank from the final DLI claim. D. Capacity Building 67. Human Resource for RNTP: As discussed earlier, RNTCP capacity has been evolving over time and become much stronger at higher levels. However, the staffing levels and skills mix are yet to match the NSP ambitions. The Program will support this critical area, with a DLI to incentivize the development and implementation of the staffing plan. Capacity building for new areas (PPE, DBT) will be prioritized under the Program. 19A forecast of disbursements will be developed at the time of Program effectiveness to inform GOI budgeting and planning processes. 21 68. Implementation capacity building: As Program implementation requires additional capacity and skills at the CTD, states and districts levels, the GOI will develop a detailed multi-year capacity building plan. The CTD and states will execute capacity building activities annually according to the plan with the technical support of the Bank and key partners. 69. Learning and Adaptation Mechanisms: The Program will support learning at various levels of implementation. The Program will support central and state level TB fora which will provide platforms within and across states for multi-stakeholder technical and implementation reviews, documentation of best practices and showcasing of innovations related to the results areas of the Program. TSUs at central and state levels will pay a pivotal role in operationalizing TB fora. In line with this, TSUs will support State TB Offices to develop and execute systematic learning and knowledge dissemination plans. At the national level, the Bank and other partners will support the CTD to commission operations research and evaluations of the DBT schemes, private sector engagement and DR-TB. The operations research will inform policy and programmatic decisions of the RNTCP. This includes mid-course adjustments to Program interventions. Learning under the Program will contribute to the broader “Lighthouse India” learning initiative by connecting practical know-how and innovations among the Indian states and between the GOI and high-burden TB countries. In addition to the above, the Program will leverage quarterly technical review meetings convened by WHO for states and CTD officials to identify and resolve implementation bottlenecks across various areas of the NSP. IV. ASSESSMENT SUMMARY A. Technical (including Program economic evaluation) 70. The fundamental approach of the Program is to target private provider engagement and patient support in parallel with strengthening public sector TB services. There is no alternate pathway to TB control in India that does not involve PPE and patient support. Even future diagnostic tools and treatment regimens will need such systems to reach poor patients with subsidized services. India’s PPE approach under the Program is technically sound because it has been demonstrated to be cost-effective at scale by the GOI evaluation of the pilots which covered 5 percent of India’s population. Experience elsewhere (including those from the China’s TB program) points to the same direction. 71. Toward this end, there are several game changers in the Program design. These include: (i) contracting of private provider interface agencies; (ii) expanding direct benefits transfer for patients; (iii) expansion of ICT services; and (iv) strengthening DR-TB services. First, a key mechanism to augment PPE capacity is through contracting interface (or intermediate) agencies by the TSUs. Second, DBT is crucial to incentivize patients for treatment adherence. Third, Nikshay and the call center system are force multipliers, enabling a limited number of public sector staff and contracted partners to efficiently support hundreds of thousands of private providers. Fourth, DR-TB is a special market failure that requires public provision, and public provision of DR-TB testing and treatment is a useful lever for private engagement. The large numbers of DR-TB cases detected when private providers are engaged require expansion of service delivery infrastructure. The program includes activities and incentives to address each of these expected challenges. 72. The selection of the nine states for the Program is strategically justified by (i) the burden of TB, (ii) the dominant nature of private health provision, and (iii) current gap in private sector notifications in such states. In aggregate, the nine states represent 12 of 19 million patient months of anti-TB treatment distributed via private chemists, or 70 percent of all private TB treatment nationwide. Remaining states will still benefit from 22 Program support for cross-cutting system strengthening such as Nikshay, but success in these nine states will contribute substantively towards national achievement of NSP 2017-25 goals. 73. Adequate institutional arrangements and governance structures are in place for Program implementation. There is strong emphasis on capacity development in new thematic areas such as private provider engagement and DBT. TSUs will be established to strengthen the implementation capacity of states and CTD to scale up private sector engagement. Mechanisms for central and state implementers to collaborate with each other, as well as to coordinate with other country stakeholders and external development partners, are well-established and will be further enhanced under the Program. The MOHFW has moderate to high technical and management capacity to undertake Program activities. This will be augmented by technical support by other development partners, including the World Bank. Program Expenditure Framework 74. The comprehensive NSP 2017-25 is costed at US$8.3 billion. Over the past four years, the GOI’s central level budget for TB increased at an average nominal rate of 31 percent annually (26 percent in real terms, net of inflation). In 2018 alone, it increased by 70 percent. As per NSP, further nominal increase is expected at around 12 percent during the Program. Given India’s high GDP growth rate (between 6.4 percent-8.2 percent in the past 5 years, and a projection of 7.8 percent in 2019) and the GOI’s high commitment to TB, funding sustainability and predictability is not a major risk to the Program. However, to meet DLI targets on private sector engagement and DBT, budget and expenditures in related categories (i.e., private sector support, honorarium, patient support and transportation) would need to grow more rapidly than (i) historical rates and (ii) other expenditure categories during Program implementation. 75. The expenditure needs projection used actual FY2017-18 expenditures by budget line in the CTD and nine targeted states as the baseline, assuming the annual expenditure growths for each budget line to be proportional to the yearly targets of relevant DLIs. 76. Budget outturn in the past three years shows reasonably well-functioning budget allocation and execution, ranging from 87 percent to 150 percent. For FY18, utilization is 150 percent of the original budget due to increased donor commitments, leading to a substantial increase in the Externally Aided Component. Program Economic Evaluation 77. A detailed economic analysis demonstrated the Program’s positive development impact. Within the Program period of 2019-2024, if all DLI targets are met, the Program will at least prevent 308,350 deaths and save 591,286 DALYs. When long-term benefits are considered, the Program will gain over 4.16 million DALYs over a 20-year period (Table 8). Assuming the monetary value of 1 DALY equaling per capita GDP of India, the benefits of the Program is around US$5.45 billion. Cost per DALY averted through the Program is US$274. Applying India’s GDP per capita as the threshold for cost-effectiveness as recommended by the WHO, the Program is highly cost-effective. The Program’s estimated Net Present Value (NPV) is largely positive (US$3.79 billion), with an estimated Internal Rate of Return (IRR) around 54 percent, and benefit-to-cost ratio of 5.58. In sensitivity analysis with different GDP growth rates and inflation, the Program still has reasonably good returns. 23 Table 8: Estimated Program Health Benefit Total Total Result areas Health benefits 2019-20 2020-21 2021-22 2022-23 2023-24 (2019- (2025-38) 24) Private Estimated 10,131 25,971 47,571 70,380 96,531 250,582 Sector deaths averted Engagement Estimated 9,827 33,968 76,366 121,984 201,219 443,365 2,829,468 in TB Control DALYs gained Estimated 7,604 12,272 14,204 12,382 11,306 57,768 deaths averted MDR-TB Estimated 7,376 18,701 31,104 41,132 49,607 147,921 736,175 DALYs gained Estimated 17,735 38,242 61,774 82,762 107,836 308,350 deaths averted Total Estimated 17,203 52,670 107,470 163,117 250,827 591,286 3,565,643 DALYs gained 78. In addition to the direct health benefits, the Program is likely to bring additional economic benefits. First, the economic loss to TB in 2016 was around 1 percent of India’s GDP. By reducing the future TB disease burden, the program will bring future economic return. Second, more than half of TB costs are due to income loss, and the Program will improve economic productivity of TB patients. Third, as TB disproportionally affects the poor; the Program is pro-poor and will contribute to poverty reduction in India. 79. The Program’s rationale for public investment is strong. According to the Copenhagen Consensus, engaging private sector for TB management has higher return to investment (179.4 to 1) than most public health interventions (including nutrition, hygiene and cervical cancer screening interventions) and many non-health public interventions (such as e-marketing for farmers and supporting startup incubators)20. While 70 percent of TB patients seek care in the private sector, TB detection, case notification, service quality, and treatment success in the private sector are far behind the public sector, partly due to the lack of incentive and support for the private providers to provide quality TB services. By strategically investing public resources in private sector (performance-based incentives and support to private providers), as well as in government capacity to manage private sector (private contracting, surveillance, and management), this Program is investing in areas with high returns for the GOI. 80. The World Bank’s added value in this Program will center around its experience in implementation support and research in TB control, as well as its expertise in results-based approaches, private sector engagement and DBT in general. Given its global footprint, the World Bank can also facilitate the sharing of (i) relevant lessons from elsewhere with India and (ii) best practices generated from this Program’s innovative approaches with global health and social protection communities. B. Fiduciary Fiduciary Assessment 81. The PforR Program will rely on country systems for financial management, procurement, and Governance 20Indian states are testing a new way of setting development priorities. https://www.economist.com/asia/2018/06/14/indian- states-are-testing-a-new-way-of-setting-development- priorities?fsrc=rsspercent7Casi&mc_cid=edcb4313d9&mc_eid=beb0742f0e. 24 and Anti-Corruption (GAC) at various implementing levels. The country systems have their own inherent strengths and weaknesses which are detailed in the full Integrated Fiduciary Systems Assessment (IFSA) 21 disclosed as a separate document. The conclusion of the IFSA is that the Program’s fiduciary systems at the various levels of implementation provide reasonable assurance that the financing proceeds will be used for intended purposes with due attention to the principles of economy, efficiency, effectiveness, transparency, and accountability. During the IFSA, certain areas of improvement have been identified, and recommendations made as part of the PAP and risk mitigation matrix. Program Fiduciary Systems 82. The RNTCP has implementation structures embedded within the NHM responsible for programmatic and fiduciary management in the nine states. Funds are routed from the center to the State Treasuries and then onward to the implementing agencies’ respective Bank accounts. The planning process is lengthy, and the budget release are often delayed until mid-year, and there are concerns over delays in fund releases from the Treasury to the NHM; and some states have also reported the need for regular follow-up for release of the state share to the Centrally Sponsored Scheme (CSS). However, resources are not a constraint for Program implementation due to opening balances available with the implementing agencies, and the provision to avail temporary loans from NHM funds. 83. The books of accounts are maintained at the central, state, and district levels with varying levels of automation. In three of the nine states, such books are also maintained at the sub-district level. PFMS is used sporadically across the states to track the utilization of funds and to make DBT payments (linked to Nikshay). Building on ongoing CTD reforms, PFMS implementation will therefore be scaled up and mainstreamed for Program expenditure reporting. This will require hands-on training of staff at different levels. 84. The internal control framework at national and state levels are embodied in the Budget Manual, Financial Rules, and Treasury Code, as well as in the Store Purchase and Works Manuals and other related employee rules. To improve Program fiduciary monitoring and oversight, the CTD Financial Management cell will hold periodic review meetings with Financial Management officials from the state and district TB cells every six months. 85. The Central Medical Services Society (CMSS), under administrative control of the MOHFW, will carry out major Program procurements (i.e., drugs and equipment) using the NIC e-procurement system. The CTD procurement cell carries out some procurements of services, e.g. selected media and laboratory services. Such procurements by CMSS and CTD are carried out in accordance with the GOI’s 2017 General Financial Rules (GFR). 86. Annual requirements for TB drugs and diagnostics will be assessed (based on last year’s consumption, remaining stocks, expected deliveries against ongoing contracts and other relevant factors) and consolidated for economy of scale by the CTD. The indents including relevant technical specifications and consignee list with consignee wise quantity requirements will be send by the CTD to the CMSS for procurement. The bid notices and bidding documents are published on the CMSS website and Central Procurement Portal (CPP), both of which offer free access. An abridged advertisement is published in the newspapers for information of the bidding community. The time allowed for preparation of bids is three weeks. In the future, the bidding documents under the Program will contain a clause requiring compliance with Bank’s Guidelines on Preventing and Combating 21IFSA was conducted at the national level for the CTD and CMSS; and in sample seven out of the nine selected states. Procurement assessment was limited to CMSS and CTD as 90percent of program procurement is expected to be done by CMSS & CTD. The procurement at states are minimal. 25 Fraud and Corruption (July 2015) and the eligibility clause. 87. The evaluation of technical bids is done by Technical Evaluation Committee (TEC) consisting of CMSS officers, a TB Program Officer, and one external expert, usually from a hospital. TEC examines the availability of bid security and other documents, conducts technical evaluation, and verifies the qualification criteria. The TEC report is approved by the CMSS sub-committee consisting of the DG&CEO (Chairman), OSD, Internal Finance Department (IFD) of Ministry, Director (EPW) of Ministry and Director of Program Division (RNTCP). After approval by the sub-committee, financial bids are opened only from technically responsive bidders. A summary statement of the financial bids is prepared and uploaded on the portal. The commercial evaluation is done by a committee called Price Bid Evaluation Committee (PBEC) who committee determine the reasonableness of prices and prepares a Bid Evaluation Report (Commercial) and submits it to the same CMSS sub-committee. This committee recommends the bids to the CMSS governing body for approval. The Governing Body of CMSS consists of 16 members with AS&DG as the Chairman. The quorum is any five members. Once the Governing Body accords approval, long term agreements (LTAs) are signed. The time from opening of bids to the signing of LTA takes between three and eight months. There have been notable improvements in the procurement lead time over the past 10 months. 88. To maintain uninterrupted supplies, the CMSS finalizes LTA with a minimum of two suppliers, for the tendered product (e.g. drug) with 70 percent of the orders given to the lowest bidder (a.k.a L1 bidder) and the balance of 30 percent to the next lowest bidder who agrees to match the price of the L1 bidder. Accordingly, L1 and matched bidder shall pay a security deposit at the rate of 5 percent of the total value of the goods. Subsequently, the CMSS issues Purchase Orders against the LTAs. The consignee list along with the quantities for each warehouse are mentioned in the Purchase Order. 89. Upon arrival of drugs from the suppliers at CMSS warehouses, the inspection and quality testing of medicines starts. Quality testing is done through empaneled laboratories meeting the qualification criteria. Empanelment was undertaken through an advertised tendering process in the past. However, during the current fiscal year, this system has not been followed and only government laboratories have been empaneled. Delays by government laboratories in submitting test reports have been documented. This is a problem which needs to be addressed and monitored during implementation. 90. Medicines are quarantined until the clearance by the Quality Control Department based on the laboratory reports. The 20 CMSS warehouses have the responsibility of delivering medicines and medical supplies to the respective state warehouses and Government Medical Stores Depots (GMSD), using the “e-Aushadhi” information system. The state warehouses and GMSDS further distributes the medicines to the respective health centers, TUs, PHI and end users. The inventory control system needs to be further strengthened. 91. Supply chain management of drugs from the CMSS warehouse to the state’s warehouses, GMSDS, TUs and PHI is monitored by CTD through the Nikshay information system. The CTD also carries out random testing of the drugs across the country through third party agencies and accredited testing laboratories. 92. Currently any procurement complaint is received and addressed by the same staff who handle procurement, which is a conflict of interest. Under the Program, an electronic complaint handling portal (as part of Grievance Redressal System) will be developed by December 30, 2019 which will be handled by an independent team for all complains related to CMSS purchases. This will include monitoring and publishing information on complaints received, percentage of complaints addressed, and time taken to resolve complaints. 93. The CMSS is a lean organization with limited staff carrying out multiple tasks. Delays in evaluation of bids, 26 requirement of multi-stage approvals which might delay the finalization of procurement decisions, delays in obtaining test reports from nominated laboratories, substandard quality of drugs, and stock out of drugs are key risks to the program. These risks are addressed as part of the PAP. It is also recommended that the CMSS provide periodic reports on advance, utilization and available balances to CTD quarterly to improve accounting, reporting, and transparency. 94. The State Health Societies statutory audit is done by private Chartered Accountants in a timely manner. Every state has an Audit Committee that meets two to three times a year to discuss the audit plan, findings, and compliance. A private Chartered Accountant (CAG empaneled) is appointed to conduct an annual audit, the report of which is endorsed by the CAG. Additionally, the expenditures incurred at the central level by CTD will be audited by the CAG. All nine states’ TB Program audit reports (issued by CA firms), CMSS entity audit reports (issued by CAG) and central level expenditure audit report (issued by CAG) will be submitted within nine months of closing each financial year. The external audit scope will include: (i) reviewing contracts to ensure that contracts are not awarded to sanctioned firms; (ii) assessing their effectiveness and internal control; (iii) ensuring no High Value Contracts over the OPRC under the program without approval. 95. The Program is not expected to require large contracts valued at or above Operational Procurement Review Committee (OPRC) thresholds (i.e., US$75 million for works, US$50 million for goods and non-consulting services, and US$20 million for consultant services). Governance and accountability systems 96. CTD and CMSS operations fall under purview of the Central Vigilance Commission (CVC), Comptroller and Auditor General (CAG), as well as the Right to Information Act of Government of India. Although GAC implementation on the ground varies from state to state, overall existing systems provide a good foundation for improving program transparency and accountability. In general, the line department oversight is fulfilled by a Chief Vigilance Officer, and Vigilance Committees are also established at district levels with varying degrees of effectiveness. The GOI is fully committed to ensuring that the Program is not affected by fraud and corruption and has agreed that it will also be governed by the “Guidelines on Preventing and Combating Fraud and Corruption (July 2015)22.” The CTD, the GOI, and CMSS have agreed to report to the Bank any credible and material allegations of fraud and/or corruption related to the Program as part of the overall program reporting requirements. The Bank will inform the recipient and the CTD about any allegations that it receives. The Bank’s right to investigate allegations regarding the Program's activities and expenditures, and the related access to required persons, information, and documents will be observed in accordance with the standard arrangements for this purpose between the GOI and the Institutional Integrity (INT) unit of the Bank. 97. Risks and Mitigation Measures: Based on the assessment and identification of risks, overall fiduciary risk rating is considered Substantial and mitigation actions have been agreed to and detailed in the PAP (Annex 3). 98. In addition to the above-mentioned risks mitigated through actions documented in the PAP, fiduciary performance will be monitored during Program implementation, through the following indicators: a. Funds transferred in a timely manner (measured in days); b. Timely preparation of annual financial statements within three months from end of FY; c. PFMS rolled out across states; Available at 22 https://policies.worldbank.org/sites/ppf3/PPFDocuments/Forms/DispPage.aspx?docid=3682&ver=current 27 d. Periodic Financial Reporting submitted by CMSS; e. Timely submission of audit reports within six months from end of FY; f. Average length of procurement Processes (including contracts awarded within initial bid validity); g. Time taken for supply of drugs to reach the CMSS warehouse from suppliers; h. Time taken for quality testing of drugs; and i. Percentage of procurement complaints addressed 99. The above indicators will be monitored every six months by CTD and reports will be shared with the Bank. C. Environmental and Social 100. The Environmental and Social Systems Assessment (ESSA) was carried out in line with World Bank policies and procedures for PforR financing for the identified Program. The ESSA provides a comprehensive review of relevant environmental and social management systems and procedures in India pertaining to detection and treatment of TB care23. The ESSA also identifies the extent to which the country systems are consistent with the World Bank’s PforR Policy and Directive, and recommends necessary actions to address potential gaps, as well as opportunities to enhance performance during program implementation. The Program’s overall environmental and social risk rating is Moderate and can be effectively mitigated within the existing environmental and social management systems. All risks/effects analyzed, and mitigation suggested by ESSA are applicable to both public and private sectors. 101. The ESSA relied primarily on a desk review of relevant documents and was complemented by field visits to health care facilities, DR-TB and antiretroviral treatment centers, Common Bio-Medical Waste Treatment Facilities (CBMWTFs), IRLs, and private laboratories. Consultations, interviews, and discussions were also held with key program stakeholders, experts, government officials, and community groups24. 102. Environmental Benefits: the Program is likely to introduce positive environmental, health, and safety provisions for healthcare and lab workers in high-risk settings (DR-TB Centres, ART Facilities and TB Containment Labs) by (i) reducing the risk of contracting TB and other infectious diseases, (ii) providing training in personal protective equipment for health workers, and (iii) strengthening the servicing and decommissioning of key lab safety equipment. At the same time, the Program will strengthen environmental systems for better management of medical waste, infection control, and accident management at facility level. Under Results Area 3, the PTETB will also have a dedicated focus on implementation of airborne infection control (AIC) measures as an integral component of Environment Health and Safety. 103. Environmental Impacts and Risks include: (i) infection control associated with TB services, including safe handling of clinical and infectious waste, sputum, sharps (slides) generated from diagnosis and treatment services; (ii) high risk settings requiring high adherence to AIC measures and use of personal protective equipment to ensure health workers’ health and safety, patient and public safety; (iii) adequate disposal of all waste streams including bio-medical waste, solid wastes (e-waste, plastics and pharmaceuticals), and liquid waste (chemical reagents, effluents) streams so that there is no contamination to soil and water bodies 23 The ESSA was disclosed both in-country on MoH&FW website (December 14, 2018) and World Bank external website (December 17, 2018). 24 These included CTD officials in charge of environmental and social aspects, state TB officers, development partners during the program preparation in Delhi, Lucknow, Mumbai, Pune, Hyderabad, Udaipur, and NGOs and academia currently engaged in the RNTCP 28 associated with their disposal; (iv) ensuring that all key lab safety equipment would need to be serviced and kept in good working condition; and (v) preventing risks to public and worker exposure to infectious diseases through improved management of airborne infection control and medical waste handling practices. These risks are well defined, site-specific and easily mitigated. However, with inadequate attention and poor management, these issues can pose greater risk to worker and public health and safety. 104. While the Program will not include large scale construction, there may be minor renovations works required for upgradation of diagnostic facilities and implementation of AIC measures in existing HCF premises. Environmental impacts by such small works are envisaged to be moderate and temporary or site-specific and can be mitigated within the current systems for environmental management. There are no anticipated adverse impacts to natural habitats, physical cultural property, natural resources. 105. Consultations and information disclosure: In addition to meetings with RNTP stakeholders as discussed above, a free and prior informed consultation with tribal communities was carried out in tribal blocks of Pune and Udaipur districts belonging to Schedule-V areas under the constitution of India. Following preparation of the draft ESSA, a national level multi-stakeholder consultation workshop was conducted in Delhi on November 28, 2018. Participants concurred with the ESSA findings and mitigation measures. In addition, participants had the following suggestions to strengthen environmental and social performance under the Program: i. States require flexibility for planning and implementing Tribal Strategy. The State incentive grants can be utilized for showcasing innovations in this area. ii. To operationalize TB forums at State and district level, and support State TB cells, it would be useful to engage a professional agency/institution. iii. Creation of specialized unit in NTI Bangalore that can cater to servicing and maintenance of key lab equipment’s (bio-safety cabinets, Air Handling units, and centrifuge). This would cater to the 64 IRLs in India. iv. Hiring of State officers/experts to supervise, monitor and strengthen Bio-Medical Waste Management (BMWM) and AIC. v. Hiring of State social experts to supervise and monitor the implementation of social safeguards activities, including citizen engagement, ACSM, gender, tribal health issues. vi. Mainstreaming AIC capacity and responsibilities to plan and implement with IC officers of medical colleges and district IC committees so that technical capacity and knowledge remains institutionalized. vii. Creation of easy to understand guidance handbook for environment health and safety management for STOs and DTOs to include key aspects of BMWM, IC and AIC. viii. Developing abbreviated guidelines for planning and retrofitting DR-TB centers to conform with national guidelines on AIC, IC, and BMWM. This includes guidance on consumables (protective gear, chemicals, vendors, suppliers). ix. Bio-medical engineers at the district level posted under NHM can be utilized to provide support for RNTCP lab network at the DMC and TU level. Table 9: Applicability of the ESSA Core Principles Core Principle 1: Environmental and social management procedures and processes promote environmental and social sustainability in the program design, avoid, minimize, or mitigate against adverse impact, and promote informed decision-making - Applicable 29 Summary Findings: To better manage Program’s environmental effects, mitigation measures include, among others: (i) strengthening environment health and safety monitoring capacity in CTD and states on bio-medical waste management and airborne infection control; (ii) developing accreditation criteria for C&DST labs to include enhanced EHS and biosafety criteria; (iii) update biomedical waste trainings to include management of all wastes including e-waste and hazardous wastes; (iv) ensuring emergency response mechanisms such as fire detection, and accident reporting and response mechanisms to be functional at all HCFs and Labs; (v) strengthening AIC and general infection control capacity at facility level; (vi) developing guidance for State and District TB officers on EHS as part of national guidelines/ regulations. Screening for all environmental risks and impacts will be conducted by the healthcare facility in charge, with guidance from DTO. Core Principle 2: Avoid, minimize, or mitigate the program’s advers e impacts on natural habitats and physical cultural resources –Not applicable Core Principle 3: Protect public and worker safety against the potential risks - Applicable Summary Findings: TB diagnosis and treatment exposes healthcare and lab workers to risks associated with exposure to TB, hazardous materials, infections, as well biosafety, and would require mitigations These include, among others: (i) improving occupational health and safety practices at healthcare facilities through infrastructure design, AIC, infection control, protocols for addressing accidental spills; (ii) providing protective clothing and personal safety equipment, as required; (iii) ensuring safe storage, segregation, transport and disposal of biomedical and hazardous wastes; (iv) implementing good practices with regards to cleanliness, hygiene and general waste management; (v) ensuring worker and public health and safety focusing on emergency response and fire safety; (vi) conducting maintenance of critical lab safety equipment; (vii) training for workers in sputum collection transport on biosafety and use of spill kits and (viii) having qualified biomedical engineers and technical staff available to service, maintain and conduct safety testing on critical lab equipment in the IRLs. Core Principle 4: Land acquisition and resettlement - avoids or minimizes displacement, and affected people - Not Applicable Summary Findings: There is no land acquisition or resettlement, as Program’s civil works is limited to minor renova tions within the existing footprint of the facilities. Screening will be conducted in facilities where any repair, renovation and/or expansion is proposed under the Program by the facility- in-charge with guidance from DTO. The resettlement to be avoided includes involuntary displacement of people who are illegally occupying areas within the grounds of the health facilities. Core Principle 5: Due consideration to cultural appropriateness of, and equitable access to, program benefits giving special attention to rights and interests of Indigenous People and vulnerable groups- Applicable Summary Findings: In recent years, some of the tribal areas have been reporting a high incidence of not only drug sensitive but also drug resistant TB cases. The NSP 2017-25 also recognizes limited progress in a special action plan for tribal populations. Improving access and coverage requires not only screening and treatment activities but also adopting culturally appropriate ACSM and communication approaches. The Program provides for special incentives in the tribal and difficult to reach areas for transportation to patients and sputum sample transportation to enhance access. Core Principle 6: Avoid exacerbating social conflict - Not Applicable Summary Findings: While there are some areas affected by social conflicts in the 9 targeted states, including left wing extremist (LWE) issues, the Program interventions do not exacerbate any social conflicts. It will strike to improve the overall health of the population and reach vulnerable pockets with TB interventions. Exclusion of any groups in terms of caste, religion, and/ or geography by the Program is not expected. 106. Considering the nature of the Program, OP 7.50 International Waterways or OP 7.60 Disputed Territories are not applicable. Assessment of Environment Systems 107. The provisions of the existing environmental legal and regulatory framework are adequate but require enabling institutional and technical capacity for compliance. While the provisions of the Biomedical Waste 30 Management & Handling Rules (as amended on March 2018), Infection Management and Environment Policy Framework (IMPS) are being implemented, provisions of other relevant environmental acts such as hazardous, solid, plastic and e-waste rules applicable to RNTCP require additional capacity building efforts. Currently BMW, IC, AIC is being managed by different committes and technical specialists; and coordination needs to be strengthened at both facility level and state levels. Efforts are also required to improve the monitoring of the management of different kinds of wastes, including liquid waste and effluents from labs and TB treatment facilities. National and RNTCP Program guidelines are adequate for addressing the following risks (i) patient and worker safety, (ii) biosafety, (iii) air borne infection control, (iv) packaging and transport of infectious sputum samples and (v) surveillance and screening of TB workers. However, there is scope for strengthening the existing RNTCP technical and operational guidelines to include EHS aspects and ensure full coverage of activities under the NSP, through careful planning, capacity building and institutional coordination to achieve sustainable outcomes. 108. Capacity to manage environment health and safety has been instilled into the RNTCP institutional framework at the national level but requires more dedicated support at state and district levels to strengthen implementation of EHS activities. Although there are comprehensive national guidelines covering institutional, administrative and infrastructure needs, AIC implementation has been limited to a few pilot centers, and each health facility is responsible for how they implement the guidelines, with different capacity resulting in varied practice. AIC is critical to ensuring worker safety in high risk settings. The program results framework supports preparation of AIC action plans in DR-TB Centres. 109. The ESSA recommended measures to strengthen environment health and safety performance through the programme implementation plan, this includes: (i) hiring of environmental experts in the targeted states as part of the RNTCP HR plan; (ii) strengthening accreditation criteria for private sector C&DST labs to include EHS and biosafety criteria consistent with national regulations; (iii) preparing and implementing health and biosafety advisory for workers involved in sputum collection and transport; (iv) updating of BMW trainings to include most relevant rules and regulations, e-waste and hazardous wastes, liquid waste and implementing a training program for all RNTCP staff; (v) building capacity and technical expertise (biomedical engineers) for maintenance and safety testing of critical lab equipment such as biosafety cabinets, centrifuge and air handling units and (vi) strengthening of AIC capacity at the state and facility level along with better institutional coordination with the public works department that usually undertakes the construction work. The ESSA leads to one PAP action for environment to develop SOPs/ protocols for servicing and decommissioning of key lab safety equipment to ensure health and safety of lab workers. 110. Assessment of social systems: As discussed above, the Program does not involve any land acquisition, resettlement, or any major construction. It will only support minor renovation within the existing footprint of the facilities. Screening will be conducted by the health care facility in-charge with guidance from DTO to rule out any adverse social impact by any civil works. Both health facility in charges as well as DTOs will be training by the social safeguard officer at the State TB Cell. The legislative framework to ensure social sustainability and the interest of marginalized and vulnerable populations, including SC and ST populations, is already aligned with World Bank’s safeguard policies. The targeted states account for 51.5 million tribal population (49 percent of the India’ tribal population) and have both scheduled V and Scheduled VI areas as defined under the Constitution of India with special legislative and judicial provision including customary rights in scheduled-VI areas. The NSP 2017-25 also recognizes that there has been limited progress in special action plans for tribal populations while some of them have been reporting a high incidence of not only drug sensitive but also DR-TB cases. It is therefore important to strengthen the TB control activities in these difficult areas. To extend the incentives designed for tribal populations and for tribal areas, the CTD shall follow the designated tribal areas (tribal districts and blocks and scheduled areas) as per Ministry of Tribal Affairs, as well as strengthen data 31 collection and monitoring of the tribal population transport reimbursement and other incentives. The key social risk emerges from capacity gaps to deal with tribal issues, ACSM, and the program’s gender responsiveness. The risks identified will be mitigated by: (i) updating /preparing and implementing a coherent social and behavior change communication (SBCC) strategy and action plane; (b) strengthening data collection and monitoring of tribal population transport reimbursements and annual CTD report to capture coverage and trends in DBT for tribal populations, (c) developing and adopting a framework for TB among women which will include specific programmatic interventions (such as outreach strategies to enable early reporting) towards addressing socio- cultural barriers; and (d) updating ‘Partnership guidelines,’ ‘Technical and Operational Guidelines for TB Control in India’ and monitoring mechanisms and tools such as CIE and State Level Internal Evaluation (SIE) to include specific interventions such as outreach in tribal and hilly areas, ACSM (with revised financial norms), gender responsiveness and SBCC. The Program has moderate social risk rating. 111. Gender: Women and girls make up nearly one million of the estimated 2.8 million TB cases in India each year; TB is the fifth leading cause of death among women in the country, accounting for nearly 5 percent of fatalities in women aged 30–69. Although more men are affected by TB, women experience the disease differently and suffer from more stigma. The rapid assessment of gender and TB in India reveals the differential aspects of TB among women. This includes women delaying seeking care for TB because of a high household work burden; low awareness, mobility, poor access to resources, and limited decision-making power. In addition, women face stigma when seeking care in the public sector and disproportionately seek care in the private sector. These factors considerably influence TB case detection and adherence to treatment. A gender framework for TB to address socio-cultural barriers to TB care for both women and men will be developed and adopted in year 2 of the Program and is an agreed action in the PAP. In addition, the scaling up of private provider engagement for timely diagnosis and effective management of TB patients will include outreach to women. An intermediate result indicator to track the treatment success rate of female TB patients notified by private providers in targeted states has been included in the results framework. 112. Citizen Engagement: The CTD will enhance citizen engagement in the TB response. This includes creating/strengthening TB forums at district, state and national levels to (i) review implementation progress; (ii) distill key lessons and resolutions at different levels; (iii) amplify citizen voice and social accountability in TB control; and (iv) provide a platform for multi-sectoral engagement. The scope of community engagement will include: (i) providing patient support services through community participation - including awareness creation and stigma reduction, screening for TB and TB-related morbidity, referring for diagnosis of TB and related diseases, providing treatment adherence support, linking social support to patients, and helping address equity and non-discrimination issues; and (ii) informing and empowering communities as well as institutionalizing accountability platform by creating feedback mechanisms on TB services at all levels using community monitoring tools. The scope of community engagement is much wider than the current terms of reference developed for the state and district TB forums. The key Program action is to strengthen the community empowerment and accountability mechanism. 113. Grievance Redress Mechanism: The RNTCP National Call Centre "Nikshay Sampark” is a major grievance redress mechanism for the Program. It answers queries on services available and grievances related to various aspects of Program implementation. All grievances registered by Call Centre Executives is escalated to the Centre In-charge and Team Lead for further processing, using a standardized format from the official email of Nikshay Sampark (nikshay.sampark@rntcp.org). All emails from the team lead (or nodal point) will be marked to the respective District TB Officer (DTO) and State TB Officer (STO) where the patient/caller is residing or currently/registered. The prime responsibility of resolution of grievances is with the DTO. All grievances are supposed to be acted upon within 7 days of reporting and should be resolved maximum within 1 month. Once the response has been received from STO/ DTO, the call center then contacts the patient/ person on the 32 response and record whether the grievance has been resolved and whether the patient/ person is satisfied with the response. A separate list of all grievances is shared with the CTD on weekly basis along with updated (final) resolution status. The RNTCP will have a proper Grievance Redressal Policy, which should be like a Standard Operating Procedure with defined escalation matrix. 114. Communities and individuals who believe that they are adversely affected as a result of a Bank supported PforR operation, as defined by the applicable policy and procedures, may submit complaints to the existing program grievance redress mechanism or the WB’s Grievance Redress Service (GRS). The GRS ensures that complaints received are promptly reviewed in order to address pertinent concerns. Affected communities and individuals may submit their complaint to the WB’s independent Inspection Panel which determines whether harm occurred, or could occur, as a result of WB non-compliance with its policies and procedures. Complaints may be submitted at any time after concerns have been brought directly to the World Bank's attention, and Bank Management has been given an opportunity to respond. For information on how to submit complaints to the World Bank’s corporate Grievance Redress Service (GRS), please visit http://www.worldbank.org/GRS. For information on how to submit complaints to the World Bank Inspection Panel, please visit www.inspectionpanel.org. The ESSA concludes that the program has a moderate environmental and social risk. 115. The key environmental risks also emerge from: (i) lack of dedicated capacity at state level to plan and monitor BMW, IC and AIC activities; (ii) a shortage of dedicated biomedical engineers to support lab safety; (iii) inadequate management of infection control associated with TB related diagnostic and treatment services; and (iv) inadequate management of the incremental increases in biomedical and other wastes generated through Program supported activities. There are no high impact activities associated with the PforR boundaries such construction of large buildings, central bio-medical waste treatment facilities, and effluent treatment plants (these activities are not eligible for including under the Program). 116. The key social risk emerges from capacity gaps to deal with tribal issues, ACSM, communication, and the Program being gender responsive. Engagement with private sector requires revisiting the strategies for ACSM, SBCC and other emerging needs. In addition, the Program not having adequate and dedicated human resources for addressing social risks at national and state level presents additional challenges. The Program activities do not anticipate any land acquisition and/or resettlement. D. Risk Assessment 117. Based on the integrated risk assessment, the overall risk of the Program is considered Substantial. 118. Technical design risk is Substantial. As discussed above, The NSP 2017-25 is robust and prioritizes high impact interventions. Government financing for TB control has been increasing significantly and there is continued commitment at the highest levels of the GOI. In this context, the Program supports the GOI to scale- up newest interventions of the NSP 2017-25. These interventions (private sector engagement and patient support through DBT) are built on successful pilots in India as well as the global evidence. However, GOI has limited experience in directly engaging the private sector for TB control. There are significant inherent risks to engage the private sector at the scale envisaged by the Program. The main risk being the GOI’s lack of strategic purchasing capacity at state and national levels. Such interventions are therefore high-risk, high-reward activities which can be game changers for India to achieve NSP 2017-25 goals. Risk mitigation measures identified which include setting up of TSUs at national and state levels are robust and the team will systematically review the risks, undertake process evaluations to identify implementation bottlenecks and 33 introduce mid-course corrections as needed. 119. Environmental and social risk is Moderate. The MOHFW is familiar with World Bank safeguard policies, and no major environmental or social risks or impacts are envisaged due to the absence of major civil works and the overall positive social impacts of the Program. There are no high impact activities in Program boundaries such as construction of large buildings, bio-medical waste treatment facilities, and effluent treatment plants. The key environmental risks emerge from: (i) lack of dedicated capacity at state level to plan and monitor BMW, IC and AIC activities; (ii) shortages of laboratory staff and dedicated biomedical engineers to monitor laboratory safety; (iii) management of infection control associated with TB related diagnostic and treatment services; and (iv) management of the increased biomedical and other waste generated through the Program supported activities. These risks are managed utilizing country systems for environment health and safety management, supported by capacity strengthening activities recommended as part of the ESSA. 120. Stakeholder risk is Moderate, owing mainly to the relatively non-controversial nature of the Program objectives and design and the robust collaboration in TB control between the MOHFW and development partners, including the private sector and civil society. The MOHFW recently established a National Technical Advisory Group on private sector engagement for TB control that will actively provide advice and support to strengthen the MOHFW’s engagement with the private sector during the implementation of the Pro gram. 121. Institutional Capacity for Implementation and Sustainability Risks is Substantial. Although the CTD team has considerable experience implementing a Bank-supported project, the CTD has limited technical capacity to manage the implementation of some novel interventions proposed under the Program—specifically, the envisaged rapid scale-up of the private sector engagement and the DBT. The CTD will need rapid scale-up of staff capacity in these technical areas to guarantee high quality implementation at scale. r Capacity building activities for key CTD and state level stakeholders will be continued during implementation phase. The MOHFW will develop a human resource plan and implement it as part of the PAP monitored under the Program. 122. Fiduciary risk is Substantial. Main risks include: (i) inadequate staff at the CMSS; (ii) delays in bid evaluation; (iii) absence of a unified accounting system; and (iv) weak financial management monitoring at the CTD level. Risk mitigation measures have been identified and included in the Results Framework and the Program Action Plan. 123. In addition, the Program was screened for climate and disaster risks. The following hazards are applicable to the geographic areas covered under the Program: extreme temperature, extreme precipitation and flooding, drought, sea level rise, and storm surge. The impact of these hazards in the short to medium term is assessed as “moderate”. The use of updated sputum transportation systems which help minimize the need for patients to travel large distances to seek care. Transport incentives will be provided by the GOI under a separate initiative to vulnerable populations to connect them to TB centers and this will be an important resilience measure if these areas are impacted by climate/disaster events. The minor renovations supported by the Program will support climate-friendly technologies such as use of renewable energy and energy saving appliances. In implementing these measures, improvements will be made to ensure that healthcare infrastructure is climate smart. This means introducing low-carbon technologies and increasing the resilience of health facilities to impacts of climate change. Climate and disaster related information will be used in decisions around allocation of TB resources and supply chains (supply of drugs, equipment etc.) so that there is no impact on service delivery. 34 The World Bank Program Towards Elimination of Tuberculosis (P167523) ANNEX 1. RESULTS FRAMEWORK MATRIX Program Development Objective (PDO): To improve the coverage and quality of Tuberculosis control interventions in the private and public sector in targeted states of India. Data Responsi Frequen Source/ bility for Annual Target Values cy Methodo Data NSP DLI Indicators Unit Baseline logy Collection YR1 YR2 YR3 YR4 YR5 PDO Level Results Indicators PDO Indicator 1- DLI 1.1: Number of private notifications, net of Number 263,549 400,000 480,000 576,000 691,200 800,000 Annual NIKSHAY CTD any decrease in public notifications in targeted states (Annual) PDO Indicator 2- DLI 2.2: Proportion of TB patients receiving financial support via Nikshay Poshan Yojana in targeted states (Annual, by category of DBT scheme) PDO Indicator 2.1- DLI 2.2.1: Proportion of TB patients notified by 30 40 50 60 70 public providers receiving 1st Nikshay percent 11 percent Annual NIKSHAY CTD percent percent percent percent percent Poshan Yojana payment in targeted states (Annual) PDO Indicator 2.2- DLI 2.2.2: Proportion of TB patients notified by 10 20 30 50 60 private providers receiving 1st Nikshay percent 0 Annual NIKSHAY CTD percent percent percent percent percent Poshan Yojana payment in targeted states (Annual) PDO Indicator 3- DLI 3.1: Proportion of notified TB patients tested 35 45 50 55 60 percent 29 percent Annual NIKSHAY CTD for Rifampicin susceptibility in targeted percent percent percent percent percent states (Annual) 35 The World Bank Program Towards Elimination of Tuberculosis (P167523) PDO Indicator 4-DLI 1.2: Treatment success rate of TB patients 20 35 50 60 70 notified by private providers in targeted percent 9 percent Annual NIKSHAY CTD percent percent percent percent percent states (Annual, patients notified in prior calendar year) Intermediate Results Area 1: Scaling Up Private Provider Engagement Intermediate Results Indicator 1: Proportion of privately notified 0 10 20 30 40 45 Pulmonary TB patients that have percent Annual NIKSHAY CTD percent percent percent percent percent percent microbiological confirmation in targeted states Mechanis 10 TSUs m to establis Intermediate Results Indicator 2-DLI 1.3: contract hed at Establishment of Technical Support Units TSUs CTD and CTD (TSUs) in CTD and targeted states to Text No TSUs develope state N/A N/A N/A administr CTD support activities related to private d and levels ative data sector, DBT, PFMS, and multi sectoral approved by engagement as per agreed TOR by the MOH&F MOH&FW W Intermediate Results Indicator 3: CTD Proportion of Blocks with molecular 15 percent 18 21 24 27 30 Cumulat percent administr CTD diagnostic services operational in (681/4461) percent percent percent percent percent ive ative data targeted states Intermediate Results Indicator 4: GOI annual expenditure on strategic RNTCP Amount 208 286 420 548 760 purchasing under NGO/Private Provider 197 Million Annual expenditu CTD (INR) Million Million Million Million Million budget head in targeted states (INR per re data year) Intermediate Results Area 2: Rolling-out TB Patient Management and Support Interventions Intermediate Results Indicator 5: Percentage of beneficiaries out of total 70 72 75 80 85 percent 68 percent Annual NIKSHAY CTD notified TB Patients seeded in Nikshay percent percent percent percent percent within 3 months of notification. 36 The World Bank Program Towards Elimination of Tuberculosis (P167523) a) Aadhaar b) Verified bank account 40 45 50 60 70 percent 33 percent Annual NIKSHAY CTD percent percent percent percent percent Framework Intermediate Results Indicator 6: Gender developed CTD responsive framework for RNTCP Text N/A & approved N/A N/A N/A N/A administr CTD developed by CTD & approved by by ative data MOH&FW MOH&FW Intermediate results Indicator 7 Proportion of TB patients notified by private providers for whom at least one 15 25 35 50 60 DBT incentive payment was made to percent 0 Annual NIKSHAY CTD percent percent percent percent percent their private providers. (Reported data for TB patients disaggregated by gender) Intermediate Results Indicator 8: Proportion of beneficiaries receiving 24 32 40 48 56 financial support (2nd payments of percent 0 Annual NIKSHAY CTD percent percent percent percent percent Nikshay Poshan Yojana) through DBT in targeted states Intermediate Result Indicator 9: Treatment success rate of female TB 0 15 30 40 50 60 percent Annual NIKSHAY CTD patients notified in targeted states in the percent percent percent percent percent percent private sector. Intermediate Results Area 3: Strengthening Detection, Treatment and Monitoring of Drug-Resistant TB Intermediate Results Indicator 10: CTD Proportion of DRTB centers in the 40 45 50 60 70 percent 34 percent Annual administr CTD targeted states with the action plan for percent percent percent percent percent ative data AIC Intermediate Results Indicator 11: Proportion of notified rifampicin-resistant TB cases with second-line drug- 40 50 55 60 65 Lab percent 32 percent Annual CTD susceptibility testing results documented percent percent percent percent percent Register within 3 months of DR-TB treatment initiation 37 The World Bank Program Towards Elimination of Tuberculosis (P167523) Intermediate Results Indicator 12: 48 52 55 60 65 Treatment success rate among MDR/RR- percent 46 percent Annual NIKSHAY CTD percent percent percent percent percent TB patients (treatment cohort) Intermediate Results Area 4: Strengthening RNTCP Institutional Capacity and Information Systems Intermediate Results Indicator 13: Annual surveillance system analysis published; including data quality by Annual Annual Annual Annual Annual Analysis district, annual state/CTD surveillance Text N/A analysis analysis analysis analysis analysis Annual CTD Reports system evaluation, and estimates for published published published published published potential under-notification and duplication Intermediate Results Indicator 14: Number of targeted states replacing CTD paper TB registers with e-TB Nikshay Cumulat Number 0 3 5 8 8 8 administr CTD adopted real-time monitoring of ive ative data notification and quality of care in at least 50 percent of districts Intermediate Results Indicator 15-DLI Mechanism 4.2: Development and implementation of Implement Implement Implement CTD developed Implement Cumulat a performance-based management Text N/A ation in 8 ation in 8 ation in 8 administr CTD and ation in 5 ive mechanism between the center and the States States States ative data approved States targeted states Intermediate Results Indicator 16: CTD Number of targeted states adopted and Cumulat Number 0 2 6 8 9 9 administr CTD transitioned from paper-based to ive ative data electronic SOE generated from PFMS Intermediate Results Indicator 17: Number of Annual TB Forum at state and national level conducted to: (i) promote CTD 8 8 8 citizen engagement; (ii) foster learning Number 0 3 5 Annual administr CTD within and between states; and (iii) to ative data provide a multisectoral platform for TB control 38 The World Bank Program Towards Elimination of Tuberculosis (P167523) Addendum: Definitions of Selected Intermediate Results Results Framework Indicator Numerator Denominator Notes Intermediate Results Indicator 1: Proportion of Number of privately-notified pulmonary TB Number of privately- IGRA or TST results do not count privately notified pulmonary TB patients that patients in reporting cohort with test result notified pulmonary TB have microbiological confirmation in targeted (molecular or bacteriological) confirming patients states TB. Intermediate Results Indicator 3: Proportion of Number of health blocks with RNTCP Number of health blocks Metric for decentralization of molecular Blocks with molecular diagnostic services CBNAAT operational in house at end of diagnostics. Transport schemes to send specimens operational in targeted states calendar year. to another block for molecular testing do not count. Intermediate Results Indicator 5: Percentage of Number of patients with Aaadhar entry Number of notified TB Date of Aadhar entry and date of bank account beneficiaries out of total notified TB Patients date/Bank Account verification date within patients verification in Nikshay will be used for analysis with seeded in Nikshay within 3 months of 3 months of treatment initiation notification. - Aadhaar and - Verified bank account Intermediate Results Indicator 8: Proportion of Number of TB patients notified in the first 6 Number of TB patients Cohort is limited to TB patients notified in the first beneficiaries receiving financial support (2nd months of each calendar year with 2 notified in the first 6 6 months of each calendar year because payments payments of Nikshay Poshan Yojana) through documented payments of NPY by the end of months of the calendar require time to be made and recorded. In addition DBT in targeted states the same reporting year in the targeted year in the targeted states to total number, data should be stratified by public states. and private notifications. Intermediate Result Indicator 9: Female TB patients notified by private All women notified by Baseline is zero because the limited available data Treatment success rate of female TB patients providers in the targeted states whose private providers in the is not fully disaggregated. The target for women is notified in targeted states in the private sector. treatment is successful (annual). targeted states (annual). lower given the low baseline. However, the Program seeks to reduce the treatment success rate between men and women. Intermediate Results Indicator 10: Proportion Number of DRTB centers with budgeted Number of DRTB centers This includes nodal and district DR-TB centers of DRTB centers in the targeted states with the action plan for AIC in the targeted states budgeted action plan for AIC Intermediate Results Indicator 11: Proportion Number of notified DR-TB patients (with at Number of notified DR-TB Cohort is limited to DR-TB patients notified in first of notified rifampicin-resistant TB cases with least rifampicin resistance) in the first 6 patients (with at least 6 months of each calendar year, given the time lag second-line drug-susceptibility testing results months of each calendar year, who have rifampicin resistance) in of DST, and the need to collect data for the documented within 3 months of DR-TB result for at least fluoroquinolone the first 6 months of the indicator by the end of the calendar year. treatment initiation resistance, documented within 3 months of calendar year. DR-TB treatment initiation. . 39 The World Bank Program Towards Elimination of Tuberculosis (P167523) . ANNEX 2. Disbursement Linked Indicators, Disbursement Arrangements and Verification Protocols . DISBURSEMENT-LINKED RESULTS DISBURSEMENT LINKED DLI BASELINE INDICATORS RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED BY FY2019/20 (YEAR 1) IN FY2020/21 (YEAR 2) IN FY2021/22 (YEAR 3) IN FY2022/23 (YEAR 4) IN FY2023/24 (YEAR 5) 1.0 Revision and approval of National CTD has revised and National Guidelines adopted National Guidelines for for partnership 2014 Guidelines for partnerships under partnerships under in existence RNTCP (Prior Result) RNTCP≠ Allocated Amounts USD 16,000,000 1.1 Number of private notifications, net of any decrease in public 263,549 400,000 480,000 576,000 691,200 800,000 notifications in (2017) Program States (Annual) USD 130 per USD 130 per USD 130 per USD 130 per USD 130 per additional patient additional patient additional patient additional patient additional patient notified by private notified by private notified by private notified by private notified by private sector net of any sector net of any sector net of any sector net of any sector net of any Allocated Amounts decrease in public decrease in public decrease in public decrease in public notifications decrease in public notifications notifications notifications compared to the notifications compared to the compared to the compared to the previous calendar compared to the previous calendar previous calendar previous calendar year previous calendar year year year year 1.2 Treatment success rate of TB patients notified by private 9 percent providers in Program 20 percent 35 percent 50 percent 60 percent 70 percent (2017) States (Annual, cohort of patients notified in prior calendar year) 40 The World Bank Program Towards Elimination of Tuberculosis (P167523) DISBURSEMENT-LINKED RESULTS DISBURSEMENT LINKED DLI BASELINE INDICATORS RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED BY FY2019/20 (YEAR 1) IN FY2020/21 (YEAR 2) IN FY2021/22 (YEAR 3) IN FY2022/23 (YEAR 4) IN FY2023/24 (YEAR 5) USD 114,754 per USD 114,754 per USD 114,754 per USD 114,754 per USD 114,754 per every 0.1 percentage every 0.1 percentage every 0.1 percentage every 0.1 percentage every 0.1 percentage Allocated Amounts point increase from point increase from point increase from point increase from point increase from the previous the previous calendar the previous the previous the previous calendar year year calendar year calendar year calendar year 1.3 Establishment of a TSU in CTD and STSUs in Program States to support activities MOHFW has related to private developed and sector, direct benefit 1 TSU established at approved the No TSU/STSU in place CTD and 9 STSUs at transfer, public mechanism to state level by MOHFW financial management contract TSU and system, and multi- STSUs± sectorial engagement as per agreed terms of reference USD 1,500,000 for Allocated Amounts USD 5,000,000 each TSU/STSU established 2.0 Development of Modules for all four Nikshay modules for all schemes (Nikshay four direct benefit Poshan Yojana, Tribal transfer schemes TB Patients Scheme, (Nikshay Poshan Only Nikshay Poshan Private Providers Yojana, Tribal TB Yojana existing in Scheme and Patients Scheme, Nikshay (Sept 2018) Treatment Private Providers Supporters Scheme) Scheme and Treatment functional in Nikshay. Supporters Scheme) Modules include (Prior Result) payment processing 41 The World Bank Program Towards Elimination of Tuberculosis (P167523) DISBURSEMENT-LINKED RESULTS DISBURSEMENT LINKED DLI BASELINE INDICATORS RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED BY FY2019/20 (YEAR 1) IN FY2020/21 (YEAR 2) IN FY2021/22 (YEAR 3) IN FY2022/23 (YEAR 4) IN FY2023/24 (YEAR 5) and confirmation of payment. USD 2,500,000 for Allocated Amounts each module 2.1 Proportion of districts implementing digital signature certificate-based 0 percent 20 percent 40 percent 60 percent 80 percent approval process for direct benefit transfer payment in Program States USD 62,500 per every USD 62,500 per every USD 62,500 per every USD 62,500 per every 1 percentage point 1 percentage point 1 percentage point 1 percentage point Allocated Amounts increase from the increase from the increase from the increase from the previous calendar previous calendar previous calendar previous calendar year year year year 2.2.1 Proportion of TB patients notified by public providers 11 percent (Aug receiving the 1st 30 percent 40 percent 50 percent 60 percent 70 percent 2018) Nikshay Poshan Yojana payment in Program States (Annual) USD 389,831 per USD 389,831 per USD 389,831 per USD 389,831 per USD 389,831 per every 1 percentage every 1 percentage every 1 percentage every 1 percentage every 1 percentage Allocated Amounts point increase from point increase from point increase from point increase from point increase from the previous the previous calendar the previous the previous the previous calendar year year calendar year calendar year calendar year 2.2.2 Proportion of TB patients notified by 0 percent 10 percent 20 percent 30 percent 50 percent 60 percent private providers 42 The World Bank Program Towards Elimination of Tuberculosis (P167523) DISBURSEMENT-LINKED RESULTS DISBURSEMENT LINKED DLI BASELINE INDICATORS RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED BY FY2019/20 (YEAR 1) IN FY2020/21 (YEAR 2) IN FY2021/22 (YEAR 3) IN FY2022/23 (YEAR 4) IN FY2023/24 (YEAR 5) receiving the 1st Nikshay Poshan Yojana payment in Program States (Annual) USD 366,667 per USD 366,667 per USD 366,667 per USD 366,667 per USD 366,667 per every 1 percentage every 1 percentage every 1 percentage every 1 percentage every 1 percentage Allocated Amounts point increase from point increase from point increase from point increase from point increase from the previous the previous calendar the previous the previous the previous calendar year year calendar year calendar year calendar year 3.1 Proportion of notified TB patients tested for rifampicin 30 percent 35 percent 45 percent 50 percent 55 percent 60 percent susceptibility in Program States (Annual) USD 233,333 per USD 233,333 per USD 233,333 per USD 233,333 per USD 233,333 per every 0.1 percentage every 0.1 percentage every 0.1 percentage every 0.1 percentage every 0.1 percentage Allocated Amounts point increase from point increase from point increase from point increase from point increase from the previous the previous calendar the previous the previous the previous calendar year year calendar year calendar year calendar year 4.0 Nikshay (i) CTD has mechanisms developed developed Nikshay features and manuals for (i) deduplication (of for deduplication; patients and providers) and Only manual and reconciliation of (ii) CTD has run the mechanism for different provider first system-wide deduplication of types; and (ii) round of patient patients and deduplication to reconciliation of direct providers in existence ensure that all TB benefit transfer notifications payments through represent distinct Nikshay versus the episodes for each public financial patient as unique≠ 43 The World Bank Program Towards Elimination of Tuberculosis (P167523) DISBURSEMENT-LINKED RESULTS DISBURSEMENT LINKED DLI BASELINE INDICATORS RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED BY FY2019/20 (YEAR 1) IN FY2020/21 (YEAR 2) IN FY2021/22 (YEAR 3) IN FY2022/23 (YEAR 4) IN FY2023/24 (YEAR 5) management portal for Nikshay Poshan Yojana (Prior Result) Allocated Amounts USD 14,000,000 4.1.1 Development and approval of a multi- MOHFW has year RNTCP Human developed and No human resource Resource Plan at CTD adopted RNTCP plan in existence and state levels Human Resources covering the Program Plan± States Allocated Amounts USD 10,000,000 4.1.2 Reduction of the staffing gap identified by the RNTCP Human 0 percent 25 percent 50 percent 60 percent 70 percent Resource Plan for CTD and the Program States USD 571,429 per USD 571,429 per every 1 percentage every 1 percentage USD 571,429 per USD 571,429 per point reduction from point reduction from every 1 percentage every 1 percentage Allocated Amounts the previous calendar the previous point increase from point increase from year, up to a calendar year, up to the previous the previous maximum of USD a maximum of USD calendar year calendar year 19,600,000 19,600,000 4.2 Development and implementation of a Five (5) Program Eight (8) Program Eight (8) Program Eight (8) Program performance-based No performance- CTD has developed States have States have States have States have and approved a management based mechanism in implemented the implemented the implemented the implemented the performance-based mechanism between existence performance-based performance-based performance-based performance-based mechanism± the CTD and the mechanism in year 2 mechanism in year 3 mechanism in year 4 mechanism in year 5 Program States 44 The World Bank Program Towards Elimination of Tuberculosis (P167523) DISBURSEMENT-LINKED RESULTS DISBURSEMENT LINKED DLI BASELINE INDICATORS RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED RESULTS TO BE ACHIEVED BY FY2019/20 (YEAR 1) IN FY2020/21 (YEAR 2) IN FY2021/22 (YEAR 3) IN FY2022/23 (YEAR 4) IN FY2023/24 (YEAR 5) USD 689,655 for each USD 689,655 for each USD 689,655 for each USD 689,655 for each Program State in Program State in Program State in Program State in Allocated Amounts USD 9,000,000 which the which the which the which the mechanism mechanism is mechanism is mechanism is is implemented implemented implemented implemented ≠ These DLRs must be met not later than three (3) months after the Effective Date. ± These DLRs must be met not later than nine (9) months after the Effective Date. 45 The World Bank Program Towards Elimination of Tuberculosis (P167523) Verification Protocol Table: Disbursement Linked Indicators Protocol to evaluate achievement of the DLI and data/result verification Verification DLI Definition/Description of achievement Data source/agency entity Procedure Scaling Up Private Provider Engagement 1.0 Revision and approval of National Final documents and MOH&FW circular RNTCP WHO Draft guidelines will be shared with World Bank for Guidelines for Partnerships under or other proof of formal adoption comments before finalization. IVA will review final RNTCP submitted to IVA. Guidelines to documents and confirm achievement. include output-based contracting of intermediary organizations. 1.1 Number of private notifications, net Increase in the number of new TB case RNTCP from Nikshay WHO IVA will (i) review NIKSHAY data using data quality of any decrease in public notifications notifications of all types by private healthcare assurance tool and (ii) contact a random subset of in targeted states (Annual) providers during each calendar year relative to patients to verify, using an independent call center and the previous year, minus any reduction in the home visits. number of new TB case notifications of all types by public providers relative to the For (ii), the IVA will specify sample size and sampling previous year (targeted states). technique acceptable to the Bank in their inception report. 1.2 Treatment success rate of TB patients Numerator: number of new DS TB patients RNTCP from Nikshay WHO notified by private providers in notified by private providers in the prior annual targeted states (annual, patients cohort with treatment success (cure or notified in prior calendar year) completion) recorded in Nikshay (targeted states) Denominator: number of new DS TB patients notified by private providers in the prior annual cohort (targeted states)25 1.3 Establishment of Technical Support Contracts and other proof of TSUs RNTCP WHO IVA will review contracts and qualifications of key Units (TSU) in CTD and targeted states establishment submitted to IVA individuals to verify that capacity corresponds to support activities related to private with functions and capabilities specified in terms sector, DBT, PFMS, and multi-sectorial of reference engagement as per agreed TOR 25 Results achieved in FY2019/20 (Year 1) will be for the cohort of DS TB patients notified by private providers in the year 2018/19 (July 1, 2018 to June 30, 2019). 46 The World Bank Program Towards Elimination of Tuberculosis (P167523) Protocol to evaluate achievement of the DLI and data/result verification Verification DLI Definition/Description of achievement Data source/agency entity Procedure Rolling out TB Patient Management and Support Interventions 2.0 Development of Nikshay modules for Modules for 4 schemes (Nikshay Poshan RNTCP IVA 2 IVA will conduct desk review of availability and all 4 DBT schemes (Nikshay Poshan Yojana, Tribal TB Patients, Private Providers functionality of modules in Nikshay web software and Yojana, Tribal TB Patients, Private and Treatment Supporters) functional in comment on their ability to deploy payments under the Nikshay. Modules include processing for four schemes. Providers and Treatment Supporters) payment and confirmation of payment. 2.1 Proportion of districts implementing Numerator: Number of districts in targeted RNTCP WHO IVA will (i) conduct a desk review of programmatic digital signature certificate (DSC) states which implement end-to-end Digital guidance to States and from States to districts to move based approval for DBT payment Payments. from manual to full digital payment approval systems Denominator: Total number of TB districts in (ii) visit a random subset of districts to verify. targeted states For (ii), the IVA will specify sample size and sampling technique acceptable to the Bank in their inception report. 2.2 Proportion of TB patients receiving financial support through DBT: IVA will (i) review Nikshay/PFMS data using data quality 2.2.1 Proportion of TB patients notified by Numerator: Number of patients for whom at RNTCP from Nikshay WHO assurance tool and (ii) contact a random subset of public providers receiving first Nikshay least one DBT payment is confirmed paid by / PFMS patients to verify, using an independent Call Centre and Poshan Yojana payment in targeted PFMS in the last calendar year in targeted field visits. states (annual) states Denominator: Number of patients eligible for For (ii) IVA will specify sample size and sampling 2.2.2 Proportion of TB patients notified by DBT disbursements (who have not RNTCP from Nikshay WHO technique acceptable to the Bank in their inception private providers receiving first “surrendered” their benefit) in the last / PFMS report. Nikshay Poshan Yojana payment in calendar year in targeted states targeted states (annual) 47 The World Bank Program Towards Elimination of Tuberculosis (P167523) Protocol to evaluate achievement of the DLI and data/result verification Verification DLI Definition/Description of achievement Data source/agency entity Procedure Strengthening Detection, Treatment and Monitoring of Drug-Resistant TB 3.1 Proportion of notified TB patients Numerator: Number of notified (public and RNTCP from Nikshay WHO IVA will (i) review NIKSHAY data using data quality tested for RIfampicin susceptibility in private) TB patients tested for Rifampicin assurance tool (ii) visit a random subset of laboratories targeted states (annual) susceptibility (including CBNAAT result of MTB to verify, by checking primary laboratory records. not detected) in the last calendar year target For (ii), the IVA will specify sample size and sampling states technique acceptable to Bank in their inception report. Denominator: Total number of notified (public and private) TB patients in the last calendar year targeted states Strengthening RNTCP Institutional Capacity and Information Systems 4.0 Nikshay mechanisms developed for (i) Operational combination of software features RNTCP IVA 2 The IVA will (i) review the software algorithm and deduplication (of patients and to ensure that all TB notifications represent operational guidance for ensuring that patients may providers) and reconciliation of distinct episodes for distinct patients only be notified once for a given episode of TB, that Private Providers are consistently identified and different provider types; and (ii) procedures for local resolution of potential duplicates reconciliation of direct benefit transfer are in place; (ii) verify if Nikshay can actually carry out payments through Nikshay versus the said deduplication; and (iii) run scripts at the back end public financial management portal for of Nikshay software to ensure that deduplication is Nikshay Poshan Yojana. taking place. 4.1 Staffing capacity of the RNTCP strengthened: 4.1.1 Development and approval of a multi- RNTCP Human Resources Plan formally RNTCP WHO IVA will confirm approval of plan and its dissemination year RNTCP Human Resource Plan at approved by MOH&FW, with no objection from to target states, and comment on extent to which the CTD and state levels covering the the World Bank, with due focus on staff for plan adequately addresses priority issues. Program states. private sector engagement, DBT, DR-TB and information systems. 4.1.2 Reduction of the staffing gap identified Numerator: number of vacancies in the staffing RNTCP WHO IVA will (i) review data on filled posts (“in place”) from by the human resource plan for CTD gap identified by the HR plan for CTD and CTD and targeted states and compare with approved and targeted states targeted states filled at the end of last calendar RNTCP HR plan, and (ii) review proofs of year contracts/letter of deputation for such posts. Denominator: Total vacancies identified by the HR plan for CTD and targeted states 48 The World Bank Program Towards Elimination of Tuberculosis (P167523) Protocol to evaluate achievement of the DLI and data/result verification Verification DLI Definition/Description of achievement Data source/agency entity Procedure 4.2 Development and implementation of Development of guidelines and issuance of RNTCP WHO IVA will review the Guidelines and Circular. a performance-based management MOH&FW Circular or other proof of approval mechanism between the center and sent to IVA. IVA will review annual report on the the targeted states implementation of the mechanism and proof of Number of targeted states in which at least 75 recognition/reward. percent of eligible teams were recognized/rewarded in the past year as per the guidelines 49 The World Bank Program Towards Elimination of Tuberculosis (P167523) ANNEX 3. PROGRAM ACTION PLAN Action Description DLI Responsibility Recurrent Frequency Due Date Completion Measurement Annual surveillance system analysis CTD Yes Annual June 30, 2020 Annual Surveillance published; including data quality by district, System Analysis annual state/CTD surveillance system June 30, 2021 Report Approved by evaluation, and estimates for potential the Bank June 30, 2022 under-notification and duplication June 30, 2023 June 30, 2024 GOI and World Bank agree to a multi-year CTD Yes September 30, Capacity Building capacity building plan 2019 (initial plan) Plan Approved by MOH&FW AS Capacity building plan executed annually Yearly Execution Central, State and District TB Forum States and CTD Yes Annual December 31, Government strengthened to improve learning and 2019 (CTD shares approval of the accountability. final TORs with the revised TORs for Bank for review State and national and clearance) TB Fora Annual Fora in Central, State and District TB forum Program States strengthened per the TOR agreed to with and at CTD by the the World Bank. following: June 30, 2020 June 30, 2021 June 30, 2022 June 30, 2023 June 30, 2024 50 The World Bank Program Towards Elimination of Tuberculosis (P167523) Action Description DLI Responsibility Recurrent Frequency Due Date Completion Measurement CTD Strengthens Data Collection and CTD Yes Continuous Data Collection and Monitoring of Tribal Population Transport Monitoring Plan for Reimbursement. Tribal Populations - Annual CTD report which capture coverage Annual TB Report and trends in DBT for tribal populations with data on DBT for Tribal Populations Development and adoption of framework CTD No June 30, 2019 Framework for TB for TB and gender in a manner and Among Women substance satisfactory to the Bank. This will Adopted by CTD for include: Program Management a) Analysis of context specific, socio- Purposes cultural norms and overlapping health concerns (such as Gender specific malnutrition, exposure to fumes, data for TB etc.) that are likely to amplify the monitoring incidence of TB amongst women reported by CTD in disaggregated by caste and annual reports. geography in participating states. b) Monitoring of gender related interventions by adding them in the Central Level Internal Evaluation Format, and State Level Internal Evaluation Format that are being used by the RNTCP. The CTD formulates and adopts health and CTD No June 30, 2019 Health and Safety safety guidelines for staff/workers involved Guidelines for in the transport of sputum Sputum Transportation Published on RNTCP 51 The World Bank Program Towards Elimination of Tuberculosis (P167523) Action Description DLI Responsibility Recurrent Frequency Due Date Completion Measurement website and disseminated to State TB Offices for implementation Servicing Standard Operating Procedures of CTD No June 30, 2019 Standard operating key lab equipment procedures for lab equipment (BSC, AHU, centrifuge, autoclaves) [ only published on RNCTP where there is health and safety implications websites and for workers] disseminated to states Process evaluation of the implementation CTD No June 30, 2021 Process Evaluation and effect of DBT on adherence to TB Report treatment and success rate. June 30, 2023 Operating Procedures for Grievance CTD No December 31, Approved Redressal developed and adopted by CTD in 2019 Grievance Redressal a manner and substance satisfactory to the Policy Bank. Strengthen the capacity of Central Medical CMSS No September 30, a) Filling the five Services Society (CMSS) to manage the 2019 vacant staff procurement and supply chain management positions and for drugs and equipment in line with maintain full staff increased workload emanating from the strength thereafter; Program. (b) Expanding number of laboratories to conduct post destination quality assurance (presently five labs); and (c) enhancing 52 The World Bank Program Towards Elimination of Tuberculosis (P167523) Action Description DLI Responsibility Recurrent Frequency Due Date Completion Measurement CMSS/Supplier interface and overall procurement efficiency Decentralize data entry on TB drug stock in CTD No September 30, Nikshay Aushadi the Nikshay Aushadhi software at TU level. 2019 data entry decentralized to TU levels in targeted states. Ensure proper testing by empaneled CMSS & CTD Yes Annual Drug quality testing independent Quality Assurance Lab and report monitor the time taken by the labs Implementation of PFMS to monitor and CTD and states Yes Annual September 30, Expenditure reports track real time fund utilization, including 2019 produced from preparation of expenditure reports from PFMS PFMS, in a manner and substance (initial report) satisfactory to the Bank. Yearly Execution Regular FM review by CTD of the state and CTD and States Yes Every 6 September 30, FM review district TB cells, pursuant to scope, protocols months 2019, completed and standards agreed with the Bank. (initial review) Execution every 6 months Scale-up RNTCP call center from 50 to 100 CTD NO June 30, 2019 Contract effective seats and staff in place for 100 seat call centers. 53 The World Bank Program Towards Elimination of Tuberculosis (P167523) Action Description DLI Responsibility Recurrent Frequency Due Date Completion Measurement Updated supervision and monitoring CTD NO December 30, Updated guidelines to include integration of routine 2019 supervision and assessment and improvement of data monitoring completeness and quality in a manner and guidelines to substance satisfactory to the Bank. include integration of routine assessment and improvement of data completeness and quality Beneficiary Satisfaction Survey as the TOR CTD YES Every six September 30, Beneficiary agreed with the World Bank. months 2019 (First survey) satisfaction survey report. Strengthen RNTCP Guidelines to include CTD No One time December 31, Standard operating protocols/standard operating procedures for 2019 procedures for lab standardization in servicing and equipment replacing/decommissioning key lab safety published on RNTCP equipment website and disseminated to states. Update the Tribal Action Plan in a manner CTD No One time December 31, Updated Tribal and substance satisfactory to the Bank 2019 Action Plan approved at CTD and disseminated to states. Recommendations documented in section IV not included in the PAP do not significantly impact implementation and/or achievement of the PDO. Implementation of such recommendations will be monitored through standard implementation support and supervision missions. 54 The World Bank Program Towards Elimination of Tuberculosis (P167523) ANNEX 4. IMPLEMENTATION SUPPORT PLAN 1. The success of the Program will depend on a detailed implementation plan supported by a framework for implementation. This framework/plan for the Program is based on: (a) needs assessment for TA; (b) development of an operational plan to achieve results; (c) development of a system of open and regular communication between different stakeholders to maximize coordination; (d) learning from implementation through knowledge exchanges and operational research; (e) regular and systematic review missions, technical consultations, and monitoring. The World Bank will ensure that timely support is provided to the Program to ensure that implementation progress is not hindered, and results are achieved. The World Bank will leverage its technical partnership with key partners to mobilize relevant technical and implementation support for the Program. Focus of Implementation Support Time Focus Skills Needed Resource Estimate Partner Role • Implementation and technical support to CTD and states on private sector, DR-TB • Experts in private sector and DBT contracting, TB control, BMGF Specialists • Fiduciary monitoring Technical; quality of care, and and Consultant First twelve capacity fiduciary; information systems, health on private sector months • Systems to monitor institutional; systems WHO and Global safeguards Env & social • Operations officer Fund Experts on • Systems for reporting • Fiduciary specialists; Env & TB Control on Results Framework social safeguards specialists & DLIs Institutional arrangements • TB program performance review • Experts in private sector with emphasis on BMGF Specialists contracting, TB control, private sector, Direct and Consultants Technical; quality of care, and Benefit Transfer and on private sector fiduciary; information systems, health 12-48 months DR-TB WHO and Global institutional; systems • Monitoring of Fund Experts on Env & social • Operations officer fiduciary and TB Control • Fiduciary specialists; Env & safeguards areas social safeguards specialists • Institutional arrangements Other Role of Partners in Program Implementation Name Institution/Country Role Bill and Melinda Gates Foundation USA & India Technical & IVA WHO Switzerland and India IVA and Technical Support 55