FOR OFFICIAL USE ONLY Report No: RES48374 INTERNATIONAL BANK FOR RECONSTRUCTION AND DEVELOPMENT RESTRUCTURING PAPER ON A PROPOSED PROGRAM RESTRUCTURING OF ROMANIA HEALTH PROGRAM FOR RESULTS APPROVED ON SEPTEMBER 17, 2019 TO ROMANIA Health, Nutrition & Population Global Practice Europe And Central Asia Region Regional Vice President: Anna M. Bjerde Country Director: Gallina Andronova Vincelette Regional Director: Fadia M. Saadah Practice Manager: Tania Dmytraczenko Task Team Leader(s): Dorothee Chen, Adanna Deborah Ugochi Chukwuma The World Bank Romania Health Program for Results (P169927) ABBREVIATIONS AND ACRONYMS DLI Disbursement-Linked Indicator DLR Disbursement-Linked Result PDO Program Development Objective PforR Program-for-Results The World Bank Romania Health Program for Results (P169927) DATA SHEET (Romania Health Program for Results - P169927) BASIC DATA Project ID Financing Instrument IPF Component P169927 Program-for-Results Financing No Approval Date Current Closing Date 17-Sep-2019 31-Dec-2023 Organizations Borrower Responsible Agency Romania Ministry of Health Program Development Objective(s) The Program Development Objective (PDO) is to increase the coverage of primary health care for underserved populations and improve the efficiency of health spending by addressing underlying institutional challenges. OPS_TABLE_PDO_CURRENTPDO Summary Status of Financing (US$, Millions) Net Approval Effectiveness Closing Ln/Cr/TF Signing Date Commitment Disbursed Undisbursed Date Date Date IBRD-90050 17-Sep-2019 23-Sep-2019 12-Jan-2021 31-Dec-2023 557.20 87.16 473.62 Policy Waiver(s) Does the Program require any waivers of Bank policies applicable to Program-for-Results operations? No Page 1 of 36 The World Bank Romania Health Program for Results (P169927) I. PROGRAM STATUS AND RATIONALE FOR RESTRUCTURING A. Program Status 1. The Romania Health Program-for-Results (PforR) was approved on September 17, 2019, the Loan Agreement was signed on September 23, 2019, and the Project became effective on January 12, 2021. Delays in the ratification and effectiveness were due to a change in Government in November 2019 and the COVID-19 outbreak, which led to changes in Government’s approach to some health sector reforms and the need to prioritize actions to respond to the public health emergency. The project has been restructured once (July 2020) to ensure alignment between the PforR activities with the views and objectives of the new Government and to support non-pharmaceutical interventions and reforms to strengthen the health care system in response to the public health emergency caused by COVID-19. 2. The Program Development Objective (PDO) is to increase the coverage of primary health care for underserved populations and improve the efficiency of health spending by addressing underlying institutional challenges. Both progress towards achievement of PDO and overall implementation progress have been rated Moderately Satisfactory since June 2020. 3. As of September 30, 2021, there has been no disbursement under the operation. However, the World Bank confirmed on September 27, 2021 that disbursement-linked results (DLRs) 4.1 and 7.1 have been achieved and the achievement of said results has been verified in accordance with the provisions of the Project’s verification protocol. As such, disbursements totaling EUR 75 million are expected in October 2021. B. Rationale for Restructuring 4. This restructuring proposes to correct two points of oversight in the restructuring paper (RP) published on July 30, 2020, namely:  Revision of the amounts allocated for achievement of disbursement-linked indicators (DLIs) in the DLI Matrix to reflect USD equivalencies (as the default currency for this table). In the first restructuring, the values entered into the DLI Matrix under Annex 1 (page 15 of the RP published on July 30, 2020) were mistakenly made in EUR, despite USD being the default for this table. As the loan is denominated in EUR and includes DLR allocations in EUR, the proposed change is to ensure consistency between project documents and the Financing Agreement.  Revision of the Program Action Plan under Annex 2 (page 30 of the RP published on July 30, 2020), namely deletion of an action that is no longer relevant as it was associated with the original DLI 4 that was changed during the first restructuring, as cited in the RP published on July 30, 2020 (paragraph 10 (d)). II. DESCRIPTION OF PROPOSED CHANGES 5. Adjustments to the DLI Matrix. The DLI Matrix has been revised to update the USD equivalencies for EUR allocations and is summarized below (Table 1) in both USD and EUR. The World Bank Romania Health Program for Results (P169927) Table 1: Summary of Allocations by DLI, EUR and USD Equivalent DLIs Total Allocated Amount (EUR) Total Allocated Amount (USD Equivalent) 1. Alignment of the minimum Sub-total 75,000,000 83,580,000 PHC package for the uninsured Year 1 - - population with the basic PHC Year 2 20,000,000 22,288,000 package for the insured Year 3 20,000,000 22,288,000 population Year 4 35,000,000 39,004,000 Sub-total 90,000,000 100,296,000 2. Number of underserved Year 1 - - communities receiving public Year 2 15,000,000 16,716,000 community health care in Year 3 25,000,000 27,860,000 collaboration with PHC providers Year 4 50,000,000 55,720,000 Sub-total 75,000,000 83,580,000 Year 1 - - 3. Share of the NHIH budget Year 2 20,000,000 22,288,000 allocated to primary health care Year 3 20,000,000 22,288,000 Year 4 35,000,000 39,004,000 Sub-total 50,000,000 55,720,000 4. Strengthening of PHC to Year 1 50,000,000 55,720,000 respond to the COVID-19 Year 2 - - outbreak Year 3 - - Year 4 - - 5. Scope and effectiveness of Sub-total 50,000,000 55,720,000 PHC traced through the share of Year 1 - - diabetes medication initiated by Year 2 - - PHC providers and proportion of Year 3 20,000,000 22,288,000 adults (40+) receiving annual medical check up Year 4 30,000,000 33,432,000 Sub-total 50,000,000 55,720,000 6. Efficiency of NHIH expenditure Year 1 - - improved through data-driven Year 2 25,000,000 27,860,000 decision-making process Year 3 - - Year 4 25,000,000 27,860,000 Sub-total 60,000,000 66,864,000 7. Efficiency of expenditure Year 1 25,000,000 27,860,000 improved through Year 2 - - implementation of centralized Year 3 35,000,000 39,004,000 procurement Year 4 - - Sub-total 50,000,000 55,720,000 Year 1 - - 8. Pharmaceutical measures Year 2 30,000,000 33,432,000 revised for better efficiency Year 3 - - Year 4 20,000,000 22,288,000 TOTAL 500,000,000 557,200,000 6. Adjustments in the Program Action Plan. The following action has been removed from the Program Action Plan given that (as of the first restructuring) it is no longer relevant to the Program: “strengthen the capacity to adapt, prevent and react to extreme weather events by developing/updating/revising internal procedures and guidelines at PHC.” The World Bank Romania Health Program for Results (P169927) III. SUMMARY OF CHANGES Changed Not Changed Change in Results Framework ✔ Reallocation between and/or Change in DLI ✔ Change in Implementing Agency ✔ Change in Program's Development Objectives ✔ Change in Program Scope ✔ Change in Loan Closing Date(s) ✔ Change in Cancellations Proposed ✔ Change in Disbursements Arrangements ✔ Change in Disbursement Estimates ✔ Change in Systematic Operations Risk-Rating Tool ✔ (SORT) Change in Safeguard Policies Triggered ✔ Change in Legal Covenants ✔ Change in Institutional Arrangements ✔ Change in Technical Method ✔ Change in Fiduciary ✔ Change in Environmental and Social Aspects ✔ Change in Implementation Schedule ✔ Other Change(s) ✔ IV. DETAILED CHANGE(S) OPS_DETAILEDCHANGES_COMPONENTS_TABLE OPS_DETAILEDCHANGES_EA_TABLE The World Bank Romania Health Program for Results (P169927) . The World Bank Romania Health Program for Results (P169927) ANNEX 1: RESULTS FRAMEWORK . . Results framework Program Development Objectives(s) The Program Development Objective (PDO) is to increase the coverage of primary health care for underserved populations and improve the efficiency of health spending by addressing underlying institutional challenges. Program Development Objective Indicators by Objectives/ Outcomes RESULT_FRAME_TBL_PDO Indicator Name DLI Baseline Intermediate Targets End Target 1 2 3 To increase the coverage of primary health care for underserved populations Number of the uninsured in Romania who are registered with family physicians and entitled to 0.00 0.00 0.00 500,000.00 2,000,000.00 receive the minimum PHC package, which is aligned with the basic PHC package (Number) Percentage of adults (40 years old and above) receiving annual medical check-ups from family 1.00 1.00 1.00 10.00 20.00 physicians (disaggregated by gender) (Percentage) To improve the efficiency of health spending Page 6 of 36 The World Bank Romania Health Program for Results (P169927) RESULT_FRAME_TBL_PDO Indicator Name DLI Baseline Intermediate Targets End Target 1 2 3 Percentage of National Health Insurance House’s annual budget 6.50 6.50 8.00 10.00 allocated to PHC (Percentage, Custom) (Percentage) Proportion of supplies and devices for emergency medical services (in 0.00 30.00 50.00 value) procured under framework agreements (Percentage) PDO Table SPACE Intermediate Results Indicators by Result Areas RESULT_FRAME_TBL_IO Indicator Name DLI Baseline Intermediate Targets End Target 1 2 3 Improving coverage for underserved population Number of underserved communities covered by 0.00 0.00 0.00 100.00 300.00 community health care in collaboration with PHC (Number) Difference between the counties 48.6% with the highest and lowest Highest coverage: 100% coverages of children who have 0.47 0.45 0.43 0.41 Lowest coverage: 51.4% received one dose of measles vaccination at 12 months old (Text) Percentage of uninsured who are Not applicable because they 0.60 0.90 aware they are entitled to receive are not entitled yet Page 7 of 36 The World Bank Romania Health Program for Results (P169927) RESULT_FRAME_TBL_IO Indicator Name DLI Baseline Intermediate Targets End Target 1 2 3 an improved PHC benefit package (aligned with the basic benefits package for the insured) (Text) Number of community health care workers (community health nurses 0.00 0.00 1,500.00 2,000.00 2,000.00 and Roma health mediators) trained (Number) Percentage of women living in communities covered by community health care receiving at 0.00 0.00 0.00 40.00 70.00 least one annual visit from a community health care provider (Percentage) Hospital-centric health system rebalanced towards effective primary care Percentage of metformin prescriptions initiated at the PHC 0.00 0.00 10.00 20.00 30.00 level (Percentage) Number of communication tools applied for universal access to PHC 0.00 3.00 6.00 9.00 12.00 and framework contract modification (Number) Number of public expenditure 0.00 1.00 1.00 3.00 reviews conducted (Number) Improving fiscal efficiency by addressing cristical cost drivers Percentage change in claims 0.00 0.00 detected as unacceptable Page 8 of 36 The World Bank Romania Health Program for Results (P169927) RESULT_FRAME_TBL_IO Indicator Name DLI Baseline Intermediate Targets End Target 1 2 3 (unnecessary care, non-optimized laboratory tests, intentional or unintentional errors, …) (Percentage) PHC claims (Percentage) 0.00 0.00 10.00 20.00 20.00 Hospital claims (Percentage) 0.00 0.00 5.00 10.00 20.00 Laboratory tests (Percentage) 0.00 0.00 10.00 20.00 30.00 Percentage of healthcare providers that automatically share data to 0.00 0.00 the central EHR (Percentage) PHC practices (Percentage) 0.00 0.00 0.00 30.00 90.00 Hospitals (Percentage) 0.00 0.00 0.00 10.00 60.00 Community health care information system upgraded to share data No No No Yes Yes with the EHR (Yes/No) Annual international price comparisons for all medicines with No No Yes Yes Yes registered shortages in Romania (Yes/No) Managed Entry Agreement signed for 50% of newly assessed patented drugs with conditional entry 0.00 0.00 0.00 30.00 50.00 decision through HTA methodology (Percentage) Page 9 of 36 The World Bank Romania Health Program for Results (P169927) RESULT_FRAME_TBL_IO Indicator Name DLI Baseline Intermediate Targets End Target 1 2 3 Clawback tax regulation revised to improve access to cost-effective Clawback tax not revised Clawback tax revised Clawback tax revised drugs (Text) List of drugs reimbursed by HNIH not revised using Revision of the list of drugs List of drugs reimbursed by List of drugs reimbursed by updated HTA methodology / No reimbursed by NHIH (Text) NHIH revised NHIH revised HTA Methodology not updated IO Table SPACE Disbursement Linked Indicators Matrix DLI IN01042823 ACTION Alignment of the minimum PHC package for the uninsured population with the basic PHC package for the insured DLI 1 population Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome Yes Text 75,000,000.00 0.00 Period Value Allocated Amount (USD) Formula About 2 million uninsured do not have access to the Baseline basic PHC package Prior Results 0.00 Year 1 0.00 Page 10 of 36 The World Bank Romania Health Program for Results (P169927) Health Reform Law 95/2006 amended to provide at free to the uninsured population a minimun PHC Year 2 20,000,000.00 package aligned with the the basic PHC package for the insured population Annual Budget Law and Medium Expenditure Framework reflect the amended Health Reform Law Year 3 95/2006 to finance the minimum PHC package for 20,000,000.00 the uninsured population as aligned with the basic PHC package for the insured population At least 2 million uninsured persons registered with PHC providers (family physicians) to receive the Year 4 35,000,000.00 See Formula under Description of DLI minimum PHC package as aligned with the basic PHC package for the insured population Action: This DLI has been Revised. See below. DLI IN01045132 ACTION Alignment of the minimum PHC package for the uninsured population with the basic PHC package for the insured DLI 1 population Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome Yes Text 83,580,000.00 0.00 Period Value Allocated Amount (USD) Formula About 2 million uninsured do not have access to the Baseline basic PHC package Prior Results 0.00 Year 1 0.00 Health Reform Law 95/2006 amended to provide at Year 2 22,288,000.00 free to the uninsured population a minimun PHC Page 11 of 36 The World Bank Romania Health Program for Results (P169927) package aligned with the the basic PHC package for the insured population Annual Budget Law and Medium Expenditure Framework reflect the amended Health Reform Law Year 3 95/2006 to finance the minimum PHC package for 22,288,000.00 the uninsured population as aligned with the basic PHC package for the insured population At least 2 million uninsured persons registered with PHC providers (family physicians) to receive the Year 4 39,004,000.00 See Formula under Description of DLI minimum PHC package as aligned with the basic PHC package for the insured population Rationale: The value of the total financing allocated to the DLI has been revised to correct an error - the original figures were in EUR (not USD). Revised allocations reflect estimated USD equivalencies of EUR allocations. DLI IN01042824 ACTION DLI 2 Number of underserved communities receiving public community health care in collaboration with PHC providers Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome Yes Text 90,000,000.00 0.00 Period Value Allocated Amount (USD) Formula Community health services not in collaboration with Baseline PHC services Prior Results 0.00 Year 1 0.00 Methodological guidelines and household Year 2 monitoring instruments for community health care, 15,000,000.00 and template agreements for collaboration between Page 12 of 36 The World Bank Romania Health Program for Results (P169927) community health care and PHC developed and adopted by the MoH Progress report on the first year of implementation of the new community healthcare tools in at least Year 3 25,000,000.00 100 underserved communities providing public community health care in collaboration with PHC 300 underserved communities providing public Year 4 community health in collaboration with PHC 50,000,000.00 See Formula under Description of DLI providers Action: This DLI has been Revised. See below. DLI IN01045133 ACTION DLI 2 Number of underserved communities receiving public community health care in collaboration with PHC providers Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome Yes Text 100,296,000.00 0.00 Period Value Allocated Amount (USD) Formula Community health services not in collaboration with Baseline PHC services Prior Results 0.00 Year 1 0.00 Methodological guidelines and household monitoring instruments for community health care, Year 2 and template agreements for collaboration between 16,716,000.00 community health care and PHC developed and adopted by the MoH Progress report on the first year of implementation Year 3 27,860,000.00 of the new community healthcare tools in at least Page 13 of 36 The World Bank Romania Health Program for Results (P169927) 100 underserved communities providing public community health care in collaboration with PHC 300 underserved communities providing public Year 4 community health in collaboration with PHC 55,720,000.00 See Formula under Description of DLI providers Rationale: The value of the total financing allocated to the DLI has been revised to correct an error - the original figures were in EUR (not USD). Revised allocations reflect estimated USD equivalencies of EUR allocations. DLI IN01042825 ACTION DLI 3 Share of the NHIH budget allocated to primary health care Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Output Yes Text 75,000,000.00 0.00 Period Value Allocated Amount (USD) Formula a) Share of the NHIH budget allocated to family medicine is 6.5%; b)Provider payment mechanisms Baseline for PHC providers limits effectiveness of PHC provision; c) Limited scope of PHC Prior Results 0.00 Year 1 0.00 Framework contract is modified to increase the effectiveness of PHC through a) Revised provider Year 2 20,000,000.00 payment mechanisms; and b) Expanded scope of services allowed at PHC Share of the NHIH budget allocated to PHC is at Year 3 20,000,000.00 least 8% Page 14 of 36 The World Bank Romania Health Program for Results (P169927) Year 4 Share of the NHIF budget allocated to PHC is 10% 35,000,000.00 See Formula under Description of DLI Action: This DLI has been Revised. See below. DLI IN01045134 ACTION DLI 3 Share of the NHIH budget allocated to primary health care Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Output Yes Text 83,580,000.00 0.00 Period Value Allocated Amount (USD) Formula a) Share of the NHIH budget allocated to family medicine is 6.5%; b)Provider payment mechanisms Baseline for PHC providers limits effectiveness of PHC provision; c) Limited scope of PHC Prior Results 0.00 Year 1 0.00 Framework contract is modified to increase the effectiveness of PHC through a) Revised provider Year 2 22,288,000.00 payment mechanisms; and b) Expanded scope of services allowed at PHC Share of the NHIH budget allocated to PHC is at Year 3 22,288,000.00 least 8% Year 4 Share of the NHIF budget allocated to PHC is 10% 39,004,000.00 See Formula under Description of DLI Rationale: The value of the total financing allocated to the DLI has been revised to correct an error - the original figures were in EUR (not USD). Revised allocations reflect estimated USD equivalencies of EUR allocations. Page 15 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01042826 ACTION DLI 4 Strengthening of PHC to respond to the COVID-19 outbreak Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Process Yes Text 50,000,000.00 0.00 Period Value Allocated Amount (USD) Formula Baseline Limited scope of PHC services Prior Results 0.00 Regulations adopted to: (i) introduce in the benefits package for the uninsured population COVID-19- related services delivered at all levels of care including PHC; (ii) introduce remote consultations Year 1 50,000,000.00 and prescriptions in the scope of services delivered by PHC providers; (iii) expand prescribing rights for PHC providers; and (iv) remove hourly caps on the number of consultations Year 2 0.00 Year 3 0.00 Year 4 0.00 Action: This DLI has been Revised. See below. Page 16 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01045184 ACTION DLI 4 Strengthening of PHC to respond to the COVID-19 outbreak Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Process Yes Text 55,720,000.00 0.00 Period Value Allocated Amount (USD) Formula Baseline Limited scope of PHC services Prior Results 0.00 Regulations adopted to: (i) introduce in the benefits package for the uninsured population COVID-19- related services delivered at all levels of care including PHC; (ii) introduce remote consultations Year 1 55,720,000.00 and prescriptions in the scope of services delivered by PHC providers; (iii) expand prescribing rights for PHC providers; and (iv) remove hourly caps on the number of consultations Year 2 0.00 Year 3 0.00 Year 4 0.00 Rationale: The value of the total financing allocated to the DLI has been revised to correct an error - the original figures were in EUR (not USD). Revised allocations reflect estimated USD equivalencies of EUR allocations. Page 17 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01042827 ACTION Scope and effectiveness of PHC traced through the share of diabetes medication initiated by PHC providers and proportion DLI 5 of adults (40+) receiving annual medical check up Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome Yes Text 50,000,000.00 0.00 Period Value Allocated Amount (USD) Formula a) Initiation of diabetes medication at the PHC level Baseline is 0%; b) Number of adults (40+) receiving annual medical check-ups is 1% Prior Results 0.00 Year 1 0.00 Year 2 0.00 a) 10% of metformin prescription (a commonly used diabetes medication) initiated by PHC providers; EUR 10 million for a) and EUR 10 million Year 3 20,000,000.00 b)10% of adults (40+) receiving annual medical for b) check ups by PHC providers a) 20% of metformin prescription (a commonly used diabetes medication) initiated by PHC providers; b) Year 4 30,000,000.00 See Formula under Description of DLI 20% of adults (40+) receiving annual medical check ups by PHC providers Action: This DLI has been Revised. See below. Page 18 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01045135 ACTION Scope and effectiveness of PHC traced through the share of diabetes medication initiated by PHC providers and proportion DLI 5 of adults (40+) receiving annual medical check up Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome Yes Text 55,720,000.00 0.00 Period Value Allocated Amount (USD) Formula a) Initiation of diabetes medication at the PHC level Baseline is 0%; b) Number of adults (40+) receiving annual medical check-ups is 1% Prior Results 0.00 Year 1 0.00 Year 2 0.00 a) 10% of metformin prescription (a commonly used diabetes medication) initiated by PHC providers; EUR 10 million for a) and EUR 10 million Year 3 22,288,000.00 b)10% of adults (40+) receiving annual medical for b) check ups by PHC providers a) 20% of metformin prescription (a commonly used diabetes medication) initiated by PHC providers; b) Year 4 33,432,000.00 See Formula under Description of DLI 20% of adults (40+) receiving annual medical check ups by PHC providers Rationale: The value of the total financing allocated to the DLI has been revised to correct an error - the original figures were in EUR (not USD). Revised allocations reflect estimated USD equivalencies of EUR allocations. Page 19 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01042828 ACTION DLI 6 Efficiency of NHIH expenditure improved through data-driven decision making process Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome No Text 50,000,000.00 0.00 Period Value Allocated Amount (USD) Formula 0% (current level of avoiding unnecessary Baseline expenditures used as baseline) Prior Results 0.00 Year 1 0.00 a) Health Data Management Strategy approved by MoH, and institutional arrangements implemented as defined in the said Strategy; b) Integrated Year 2 management system in NHIH upgraded to allow 25,000,000.00 improved detection of inefficient spending on claims management in PHC and hospital care, and laboratory tests. Year 3 0.00 a) An inter-operable system connects data between PHC providers, NHIH and MoH, to provide regular data cross-checks and inefficient spending data Year 4 analytics; b).Efficiency of health spending increased 25,000,000.00 by avoiding inefficient NHIH expenditures in an amount equivalent to 2.5% of total projected annual NHIH expenditures Action: This DLI has been Revised. See below. Page 20 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01045185 ACTION DLI 6 Efficiency of NHIH expenditure improved through data-driven decision making process Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome No Text 55,720,000.00 0.00 Period Value Allocated Amount (USD) Formula 0% (current level of avoiding unnecessary Baseline expenditures used as baseline) Prior Results 0.00 Year 1 0.00 a) Health Data Management Strategy approved by MoH, and institutional arrangements implemented as defined in the said Strategy; b) Integrated Year 2 management system in NHIH upgraded to allow 27,860,000.00 improved detection of inefficient spending on claims management in PHC and hospital care, and laboratory tests. Year 3 0.00 a) An inter-operable system connects data between PHC providers, NHIH and MoH, to provide regular data cross-checks and inefficient spending data Year 4 analytics; b).Efficiency of health spending increased 27,860,000.00 by avoiding inefficient NHIH expenditures in an amount equivalent to 2.5% of total projected annual NHIH expenditures Rationale: The value of the total financing allocated to the DLI has been revised to correct an error - the original figures were in EUR (not USD). Revised allocations reflect estimated USD equivalencies of EUR allocations. Page 21 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01042829 ACTION DLI 7 Efficiency of expenditure improved through implementation of centralized procurement Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome No Text 60,000,000.00 0.00 Period Value Allocated Amount (USD) Formula National Office for Centralized Procurement (ONAC) Baseline not operational and not mandated to work in health sector Prior Results 0.00 Framework agreements between ONAC and Year 1 suppliers signed for 10 priority products to address 25,000,000.00 the COVID-19 outbreak Year 2 0.00 Framework Agreements between the designated procurement agencies and suppliers signed for Year 3 minimum of 60 medical supplies and devices for 35,000,000.00 publicly owned hospitals and emergency medical services Year 4 0.00 Action: This DLI has been Revised. See below. Page 22 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01045231 ACTION DLI 7 Efficiency of expenditure improved through implementation of centralized procurement Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome No Text 66,864,000.00 0.00 Period Value Allocated Amount (USD) Formula National Office for Centralized Procurement (ONAC) Baseline not operational and not mandated to work in health sector Prior Results 0.00 Framework agreements between ONAC and Year 1 suppliers signed for 10 priority products to address 27,860,000.00 the COVID-19 outbreak Year 2 0.00 Framework Agreements between the designated procurement agencies and suppliers signed for Year 3 minimum of 60 medical supplies and devices for 39,004,000.00 publicly owned hospitals and emergency medical services Year 4 0.00 Rationale: The value of the total financing allocated to the DLI has been revised to correct an error - the original figures were in EUR (not USD). Revised allocations reflect estimated USD equivalencies of EUR allocations. Page 23 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01042830 ACTION DLI 8 Pharmaceutical measures revised for better efficiency Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome No Text 50,000,000.00 0.00 Period Value Allocated Amount (USD) Formula Shortcoming of existing pharmaceutical policy: a) External reference pricing for pharmaceutical carried out sporadically b) List of drugs reimbursed Baseline based on outdated health technology assessment (HTA) methodology c) Great potential to expand use of Management Entry Agreements (MEA) Prior Results 0.00 Year 1 0.00 (a) New HTA methodology for inclusion of new drugs to the list of drugs approved; (b) Annual Year 2 recalculated prices for medication published on the 30,000,000.00 MoH website and annual list of reference prices published on the NHIH website. Year 3 0.00 MEA signed by NHIH and market authorization holders for 50% of newly assessed patented drugs Year 4 20,000,000.00 with the conditional entry decision using the new HTA methodology Action: This DLI has been Revised. See below. Page 24 of 36 The World Bank Romania Health Program for Results (P169927) DLI IN01045232 ACTION DLI 8 Pharmaceutical measures revised for better efficiency Type of DLI Scalability Unit of Measure Total Allocated Amount (USD) As % of Total Financing Amount Outcome No Text 55,720,000.00 0.00 Period Value Allocated Amount (USD) Formula Shortcoming of existing pharmaceutical policy: a) External reference pricing for pharmaceutical carried out sporadically b) List of drugs reimbursed based on Baseline outdated health technology assessment (HTA) methodology c) Great potential to expand use of Management Entry Agreements (MEA) Prior Results 0.00 Year 1 0.00 (a) New HTA methodology for inclusion of new drugs to the list of drugs approved; (b) Annual recalculated Year 2 prices for medication published on the MoH website 33,432,000.00 and annual list of reference prices published on the NHIH website. Year 3 0.00 MEA signed by NHIH and market authorization holders for 50% of newly assessed patented drugs Year 4 22,288,000.00 with the conditional entry decision using the new HTA methodology Rationale: The value of the total financing allocated to the DLI has been revised to correct an error - the original figures were in EUR (not USD). Revised allocations reflect estimated USD equivalencies of EUR allocations. Page 25 of 36 The World Bank Romania Health Program for Results (P169927) Page 26 of 36 The World Bank Romania Health Program for Results (P169927) ANNEX 2: PROGRAM ACTION PLAN . . PAP_CHANGE_TBL Action Completion Description Source DLI# Responsibility Timing Measurement Action Sufficient Fiduciary Systems MoPF Recurrent Continuous Program funding No Change allocation of consistent with Program funding annual in the budget and workplans. timely remittance of financing to implementing entities Strengthen the Environmental and Social MoH Other First 2 years of Analysis of MoH No Change enforcement of Systems Program internal the existing implementatio regulations norms regulations for n for implementing medical waste the procedures management to for reactive and handle, collect, preventive record, store, identified decontaminate, priorities for transport and medical waste disposal of waste management by confirmed developing/updat ing/revising internal procedures and guidelines at PHC Strengthen the Environmental and Social MoH Other First 2 years of Analysis of MoH Marked for capacity to adapt, Systems Program internal Deletion prevent and react implementatio regulations/norm to extreme n s for weather events implementing the by procedures for developing/updat reactive and ing/revising preventive internal identified procedures and priorities for guidelines at PHC adaptation to climate change effects confirmed Develop and Environmental and Social MoH, NIPH, CSO, Other Second and Findings on the No Change implement Systems other third years of level of public existing Program awareness communication implementatio regarding access tools, as may be n to basic services relevant, to package for increase public uninsured Page 27 of 36 The World Bank Romania Health Program for Results (P169927) awareness of Program initiatives in consultation with the World Bank Strengthening a Technical MoH Due Date 31-Dec-2020 A ministerial No Change unit of the MoH order will be to ensure issued to specify integration at the the unit staffing, institutional level job descriptions of strategic and planning for qualifications, primary and overall community institutional health care mandate, and services operational budget. Determining the Technical MoH, NHIH, Due Date 30-Jun-2021 Benefit package No Change benefit package MoPF for PHC for PHC, including determined and the currently incorporated in uninsured the Health Care Law 95/2006. Conducting public Technical MoPF Other At least 2 times PER conducted No Change expenditure during and results review based on Program analyzed and defined scope of period used for decision work making Maintain records Environmental and Social NHIH, MoH, Recurrent Yearly Reporting by No Change of and track the Systems MoSPJ community number of health workers on patients, on a the number of sample basis, patients who whom have been community referred by health workers community have referred to health workers to acquire IDs for acquire an ID for their registration their registration with family with family physicians physicians Adequate Fiduciary Systems MoH Recurrent Continuous Timely No Change arrangements preparation and and technical audit of Program capacity to financial prepare Program statements. financial statements and have them timely audited Technical Fiduciary Systems MoH/MoPF/ON Other First year of Report on No Change Page 28 of 36 The World Bank Romania Health Program for Results (P169927) assistance for the AC Program completed review establishment of implementatio and centralized n implementation procurement of of report's medical supplies recommendation – including s – included in systems and annual progress staffing report Technical Fiduciary Systems MoH/MoPF/ON Due Date 30-Dec-2022 Report on system No Change assistance for the AC functionalities establishment and roll-out data, and maintenance including of electronic information on platforms for capacity building collation of of actual and procurement potential users – needs of included in implementing annual progress entities to report. support timely centralized procurement Conducting Technical MoH Other Year 2 of Training No Change training of Program conducted and community implementatio evaluation report nurses and Roma n from training mediators on participants public community available. health care in collaboration with PHC providers . Page 29 of 36 The World Bank Romania Health Program for Results (P169927) ANNEX 3: VERIFICATION PROTOCOL TABLE—DISBURSEMENT LINKED INDICATORS DLI_TBL_VERIFICATION Alignment of the minimum PHC package for the uninsured population with the basic PHC DLI 1 package for the insured population This DLI aims to support the shift from input-based to results-based financing, facilitating improvements in the efficiency and predictability of expenditures in the Romanian health system, while addressing demand-side financial barriers to health care access. Year 2: The Health Reform Law 95/2006 will be amended to provide the minimum PHC package for free to the uninsured with the same services as the basic PHC package for the insured population. With regard to prescriptions and referrals, the minimum PHC package for the uninsured population will include simple prescriptions and referrals; reimbursement of drugs and outpatient specialist consultations, laboratory services and imaging services will not be Description included. Year 3: Annual budget law and medium expenditure framework will reflect the amended Health Reform Law 95/2006 to finance the coverage of the minimum PHC package for the uninsured with the same services as the basic PHC package for the insured population. Year 4: Two million uninsured people will be registered with family physician to receive the minimum PHC package with the same services as the basic PHC package for the insured population. Formula: EUR 35 million divided by 2 million multiplied by actual number of uninsured registered with PHC providers (family physicians) to receive the aligned minimum PHC package, up to a maximum amount of EUR 35 million. Year 2: Official Gazette from MoH and MoPF Year 3: Official Gazette from MoH and NHIH Data source/ Agency Year 4: NHIH reports on the number of people registered with family physicians for the aligned minimum PHC package Verification Entity Independent Verification Entity (IVA) Year 2: the IVA will confirm that the amendment of the law grants free access to the minimum PHC package to the uninsured with the same services as the basic PHC package for the insured population as described above. Year 3: the IVA will confirm that budget allocation for projected expenditure for the Procedure minimum PHC package for the uninsured with the same services as the basic PHC package for the insured population to be transferred to NHIH is approved by the budget Law and reflected in the medium expenditure framework. Year 4: the IVA will confirm that the NHIH reports include 2 million uninsured people that are registered and there is claim of PHC services among this group. DLI_TBL_VERIFICATION Number of underserved communities receiving public community health care in collaboration DLI 2 with PHC providers This DLI aims to improve the effectiveness of community health services and leverage partnerships between public provision of community health care and largely private family physicians to address supply-side barriers to PHC in underserved communities. Description Year 2: The MoH will develop and adopt methodological guidelines and household monitoring instruments for community health care, and template agreements for collaboration between community health care and PHC providers. The methodological guidelines and template agreements will specify the scope of work of community health nurses, Roma health mediators, Page 30 of 36 The World Bank Romania Health Program for Results (P169927) and family physicians in the continuum of care between community healthcare and PHC, the technical standards for each procedure, and mechanisms for collaboration (between community healthcare and PHC) and supervision by the DPHAs. The household monitoring instrument will also include standardized evaluation of health risks for each household in the geographical area of each community nurse. Year 3: The MoH will issue a Progress report on the first year of implementation of the new community healthcare tools in at least 100 underserved communities providing public community health care in collaboration with PHC. The agreements for collaboration between community healthcare and PHC providers will be signed. Community health nurses will be hired, trained, and supported by the MoH to provide health promotion services based on the standards defined by the MoH, to provide services according to the guidelines to at least 100 local authorities that meet the criteria of underserved communities defined in the PAD, and facilitate linkages to PHC per the collaboration agreement signed. In communities with up to 700 self-identifying Roma, a Roma health mediator will also be hired (at the request of the community), trained, and supported by the MoH and local authority to ensure registration of vulnerable groups to receive PHC services. Year 4: Formula: EUR 50 million divided by 200 multiplied by the number of additional communities (above the initial 100) providing public community healthcare in collaboration with PHC, up to a maximum amount of EUR 50 million. Year 2: Ministerial order/MoH, Year 3: MoH's report based on the existing electronic system for Data source/ Agency community health care (AMCMSR), Year 4: Existing electronic system for community health care (AMCMSR) from MoH Verification Entity IVA Year 2 (Development of standards): Methodological guidelines and household monitoring instruments for community health care, and template agreements for collaboration between community health care and PHC providers developed and adopted by the MoH. The IVA will confirm the issuance of Ministerial order. Year 3: (100 communities) The IVA will confirm, using the existing electronic system for community health care (AMCMSR), the number of localities that have community services in place and reporting, including for each locality: a) the number of community health nurses and Roma health mediators working in the area; b) the number of agreements for collaboration signed; c) summary reports on the number of services delivered (household visits, communication with PHC providers and referrals to PHC providers) per month; and d) supervision reports prepared by the Procedure DPHA. The verification protocol will include spot checks/surveys to be conducted with technical support to confirm the results achieved to complement and validate system generated data. Year 4 (300 communities): The IVA will confirm, using the existing electronic system for community health care (AMCMSR), the number of localities that have community services in place and reporting, including for each locality: a) the number of community health nurses and Roma health mediators working in the area; b) the number of agreements for collaboration signed; c) summary reports on the number of services delivered (household visits, communication with PHC providers and referrals to PHC providers) per month; and d) supervision reports prepared by the DPHA. The verification protocol will include spot checks/surveys to be conducted with technical support to confirm the results achieved to complement and validate system generated data. Page 31 of 36 The World Bank Romania Health Program for Results (P169927) DLI_TBL_VERIFICATION DLI 3 Share of the NHIH budget allocated to primary health care This DLI aims to support efforts by the Ministry of Health to reorient the health system towards primary health care, by adjusting the incentives for service provision through revision of clinical guidelines and provider payment mechanisms and increasing overall funding for primary health care. Negotiations between the NHIH and the family physician’s association will continue as currently is the case, and the framework contract will then be approved by the NHIH Board and MoH. Year 2: Milestone a): Provider payment mechanisms for family physicians will be modified to incentivize an increase in the scope and supply of primary health care services. Specifically, capitation methods will also be adjusted for gender, the threshold on the volume of services reimbursed through fee-for-services will be increased, performance-based payment mechanisms for attaining service coverage targets and quality will be introduced, and family physicians will be reimbursed for services introduced through the revision of clinical guidelines (e.g., initiation and coordination for chronic diseases care). Milestone b): Relevant regulations will be modified by the Ministry of Health in consultation with physician associations to expand the scope of services in Description primary health care to include initiation and coordination of care for diabetes mellitus and cervical cancer and other such as chronic obstructive pulmonary diseases, psychiatric conditions, and chronic pain, including prescription of related medication and the required diagnostic tests. These normative changes will be translated to regulation through the framework contract. Year 3: The share of the NHIH budget allocated to family medicine is at least 8%. Numerator: annual NHIH budget for service delivery allocated to family medicine. Denominator: total NHIH budget for service delivery allocated to goods and services and transfers in the same year as for the numerator. Year 4: The share of the NHIH budget allocated to family medicine is 10% by Year 4. Numerator: annual NHIH budget for service delivery allocated to family medicine. Denominator: total NHIH budget for service delivery allocated to goods and services and transfers in the same year as the numerator. Formula: EUR 17.5 million multiplied by percentage points of the share of NHIH budget above 8% allocated to family medicine, up to a maximum amount of EUR 35 million (percentage points of the share of NHIH budget should be rounded to the first decimal digit (e.g., 9.7%)). Year 2: Official Gazette from MoH and NHIH, Year 3: Official Gazette/NHIH, Year 4: Official Data source/ Agency Gazette/NHIH Verification Entity IVA Year 2: The IVA will confirm that the revised framework contract reflects changes in provider payment mechanisms and reimbursement for expanded scope of PHC as described in the PAD. Year 3: The IVA will assess the official gazette documenting legislation on the budget for NHIH to Procedure confirm that the allocated amount for family medicine is at least 8% of the total NHIH budget. Year 4: The IVA will assess the official gazette documenting legislation on the budget for NHIH to confirm that the allocated amount for family medicine is 10% of the total NHIH budget. DLI_TBL_VERIFICATION DLI 4 Strengthening of PHC to respond to the COVID-19 outbreak This Disbursement-Linked Indicator aims to strengthen PHC to respond to the COVID-19 outbreak, including the capacity of PHC providers to deliver COVID-19 services to uninsured populations and Description to deliver regular PHC services efficiently during the outbreak. Year 1: The Government will adopt regulations to: (i) introduce in the benefits package for the Page 32 of 36 The World Bank Romania Health Program for Results (P169927) uninsured population COVID-19-related services delivered at all levels of care including PHC; (ii) introduce remote consultations and prescriptions in the scope of services delivered by PHC providers; (iii) expand prescribing rights for PHC providers; and (iv) remove hourly caps on the number of consultations. All these measures will be valid during the state of alert declared during the epidemic. Data source/ Agency Year 1: Official Gazette Verification Entity IVA Year 1 (regulations passed/scheme established): The IVA will confirm that government regulations (i) introducing in the benefits package for the uninsured population COVID-19-related Procedure services delivered at all levels of care including PHC; (ii) introducing remote consultations and prescriptions in the scope of services delivered by PHC providers; (iii) expanding prescribing rights for PHC providers; and (iv) removing hourly caps on the number of consultations have been issued. Scope and effectiveness of PHC traced through the share of diabetes medication initiated by PHC DLI 5 providers and proportion of adults (40+) receiving annual medical check up Year 4: Formula: EUR 15 million divided by 10 and multiplied by (percentage of metformin prescription initiated by PHC providers minus 10 percentage points ) up to EUR 15 million for (a) and EUR 15 million divided by 10 and multiplied by (percentage adults (40+) receiving annual medical check-ups minus 10 percentage points) up to EUR 15 million for (b). This DLI serves as a tracer indicator for increased scope and improved effectiveness of PHC services. Years 3 and 4: the total allocation of EUR 50 M is divided equally between result related to metformin (EUR 25 M) and annual check up (EUR 25 M); Year 3: a) Due to the expansion of the scope of primary health care, the percentage of metformin prescriptions for Diabetes Mellitus Type 2 initiated by family physicians will increase to 10%. Numerator: number of metformin regimen initiation by family Description medicine physicians in a given 12 months period. Denominator: total number of metformin regimen initiations in the same 12 months as for the numerator. b) The NHIH will revisit the scope of preventive check-ups for asymptomatic adults, ensuring its focus on most cost-effective preventive interventions and revise the framework contract accordingly. The result will be estimated based on the following: Numerator: number of adults (40+) receiving annual medical check-ups as defined in the PAD during a given year (if a person receives both preventive check-up and case management during the same year, it will only be counted once). Denominator: number of adults (40+) registered with family physicians to receive basic package during the same year as for the numerator. Year 4: a) same as for Year 3, but the target is 20%; b) same as for Year 3, but the target is 20%. Year 3: Existing e-prescription system/NHIH system reports Year 4: Existing e-prescription Data source/ Agency system/NHIH system reports Verification Entity IVA Years 3 and year 4: The IVA will confirm that the existing system reports include the numerator, the denominator and the share as defined. The IVA will also confirm that mechanisms for reviewing and checking reported data in the system are in place (such as outliers, unexplained Procedure changes in patterns, mismatching) and actions are taken to address the identified inconsistencies based on related evidence. Page 33 of 36 The World Bank Romania Health Program for Results (P169927) DLI 6 Efficiency of NHIH expenditure improved through data-driven decision making process This DLI will support efforts to build IT systems that will enable improved legal, financial, organizational and data analytics capacity to improve policy decisions for identifying and reducing inefficient health expenditure and promoting performance management in service provision. “Inefficient health expenditures" means spending that is detectable by data analytics as non- optimal. For instance, unnecessary care (referrals, visits, laboratory tests, etc.), non-adherence to best practices, duplication of services, non-optimized laboratory tests, non-optimal use of infrastructure and medical equipment, low workforce productivity, detectable high cost centers such as high readmissions, over-prescribing centers, etc., and errors, including coding, claimed services not connectable to medical conditions, and frauds. Year 2: a) A Health Data Management Strategy is developed and aims at increasing the stewardship role of the Ministry of Health in overseeing the efficient, reliable, complete, and timely collection and reporting of data for decision-making via centralized systems. A stakeholders' agreement in the form of a policy paper will define as a minimum: (i) a single vision of IT domain in health, including consolidation and coordination of current systems and projects already underway at NHIH and MoH, (ii) overall future architecture of health data management and eHealth systems and their interaction, (iii) institutional arrangements on improved data governance and responsibilities for the implementation of the Strategy, and (iv) action plan, including sources of investments and sustainable systems' development and maintenance. b) System reports from integrated NHIH management system showing the detected cases of inefficient spending in healthcare claims (PHC claims, hospitals claims, and separately laboratory tests). Description Year 4: a) The advanced methodology and algorithms for identifying inefficient spending are expanded by using data analytics and cross-check on the connected data among NHIH, MoH and providers. An inter-operable system that connects data among NHIH, MoH, and providers (based on Government Cloud support) is established to allow: - integration of key central systems (expanded national EHR, key registries such as HR registry, NHIH core systems, ePrescription, eReferrals), providers' systems (PHC, hospitals, pharmacies, laboratories) and community care information system; - interaction between the systems based on interoperability standards, and data and registers models according to the EU recommendations; - Integrated Health Management Information System (HMIS) as a Business Intelligence (BI) and data analytics tool that allows consolidation of administrative and financial data, implements data cross-checks and smart analytics aimed at reducing losses caused by inefficient spending and provides analytical reporting on healthcare system resources (human resources, facilities, etc.) and key performance indicators (KPIs). - The National Health Data Observatory as a data warehouse and data reporting/analytics tool that identifies health data consumers, data sets and data sources, consolidates public health data sets and registries, provides key national healthcare system indicators, including key national reporting indicators to EU, WHO... (NOTE: The HMIS and Observatory can be implemented as one technical system, but with distinctive features). b) The MoH, NHIH and IPH will use improved methodology and algorithms to utilize new tools and information available, including blended methods of monitoring and evaluation (automatic with the combination of manual/classic audit), improvements of the definition of data sets to be provided by providers, legal consolidation of data on healthcare systems resources, etc. To improve legal, financial, organizational and data analytics capacity to make better policies and decisions, thus increasing the efficiency of the Page 34 of 36 The World Bank Romania Health Program for Results (P169927) healthcare system by avoiding unnecessary NHIH expenditures. Year 2: a) Official Gazette and collaboration protocols/MoH documenting: (i) the adoption of Health Data Management Strategy, (ii) implementation of the institutional arrangements in accordance with the Strategy (establishment of a Strategy implementation unit, and agreed institutional responsibilities of the MoH, NHIH, IPH and other stakeholders), (iii) establishment of standardization and software certification mechanisms. b) System reports from integrated NHIH management system showing the detected cases of inefficient spending in healthcare claims (PHC claims, hospitals claims, and separately laboratory tests). Data source/ Agency Year 4: a) System reports from central registries, National EHR, NHIH core systems, ePrescription, eReferrals, community health care information system, HMIS and Health Data Observatory that show system utilization and data exchange between systems/MoH, NHIH and IPH. b) The report on calculated NHIH expenditure reduction due to improved data management in the last 12 months. Projected NHIH expenditure (based on trend from the period 2014-2020) will be compared with actual NHIH expenditure to estimate expenditures avoided by reducing losses (MoH and NHIH). Verification Entity IVA Year 2: a) The IVA will confirm the Official Gazette and collaboration protocols include i) the adoption of Health Data Management Strategy, (ii) implementation of the institutional arrangements in accordance with the Strategy (establishment of a Strategy implementation unit, and agreed institutional responsibilities of the MoH, NHIH, PHI and other stakeholders), (iii) establishment of standardization and software certification mechanisms. b) The IVA will confirm that system reports from the integrated NHIH management system show detection of cases of inefficient spending in health care claims and laboratory tests. Procedure Year 4: a) The MoH, NHIH and IPH will provide system reports from central registries, National EHR, NHIH core systems, ePrescription, eReferrals, community health care information system, HMIS and Health Data Observatory. The IVA will confirm the reports include: (i) level of systems implementation, (ii) level of systems usage, (iii) mapping of data exchange between the systems, and (iv) effectiveness of systems' support to business processes. b) The IVA will confirm that the methodology for projecting expenditures and calculating expenditure reduction as an outcome of improved data management is used by NHIH. DLI 7 Efficiency of expenditure improved through implementation of centralized procurement This Disbursement-Linked Indicator aims to facilitate coordination between relevant agencies to address barriers to centralized procurement in the health sector. Year 1: The National Office for Centralized Procurement will conclude framework agreements with suppliers for 10 priority products to address the COVID-19 outbreak, using technical specifications Description provided by the Ministry of Interior. Year 3: The designated centralized procurement agencies will conclude framework agreements for at least 60 medical supplies and devices for publicly owned hospitals contracted with the NHIH and emergency medical services, using technical specifications provided by the Ministry of Health and the Ministry of Interior as needed. Year 1: E-procurement system/ONAC Data source/ Agency Year 3: E-procurement system/designated centralized procurement agencies Page 35 of 36 The World Bank Romania Health Program for Results (P169927) Verification Entity IVA Year 1: The IVA will confirm that the snapshots provided by ONAC include signed framework agreements for 10 priority products to address the COVID-19 outbreak. Procedure Year 3: The IVA will confirm that the snapshots provided by the designated centralized procurement agencies include signed framework agreements for 60 medical supplies and devices for publicly owned hospitals and for emergency medical services. DLI 8 Pharmaceutical measures revised for better efficiency This DLI aims to support changes in pharmaceutical policy to ensure regular implementation of price referencing, improvement of the health technology assessment methodology, and the increase in implementation of managed entry agreements facilitating access to medicines while ensuring efficiency gains. Year 2: (a) The National Agency for Medicines and Medical Devices will revise the health technology assessment methodology for inclusion of new drugs on the positive list to incorporate cost-effectiveness of medication in Romania; (b) To improve transparency and accountability, the pricing process for medicines will be completed annually and published on the Ministry of Health website, while the list of reference prices calculated based on the prices set by the Ministry of Health will be published on the National Health Insurance House web page. The total allocation of EUR 30 M is divided equally between results related to HTA (EUR 15 M) and drug pricing (EUR 15 Description M). Year 4: The Ministry of Health will increase the number of MEA signed for drugs with conditioned entry into the list of medicines reimbursed from the National Health Insurance House. Cumulative of 50% of newly listed patented drugs with conditional entry decision will be introduced in the positive list through the revised health technology assessment methodology and reimbursed by the National Health Insurance House subject to concluded MEAs. Numerator: newly-listed patented drugs with conditional entry decision, introduced in the positive list through the revised health technology assessment methodology and reimbursed by the National Health Insurance House, for which MEA have been concluded between the NHIH and market authorization holders; Denominator: all newly-listed patented drugs with conditional entry decision introduced in the positive list through the revised health technology assessment methodology and reimbursed by the National Health Insurance House; Time period: Cumulative as of the year 2. Year 2: (a) Official Gazette/MoH/NHIH (HTA); (b) websites of MoH and NHIH (drug pricing) Data source/ Agency Year 4: Contracts, NHIH Verification Entity IVA Year 2: (a) The IVA will confirm that the official gazette reflects legislation documenting the adoption of the new HTA methodology; (b) the IVA will confirm that the MoH website includes the description of pricing process for medication and NHIH website includes the list of reference prices Procedure endorsed by independent experts in this field. Year 4: The IVA will confirm the registration numbers of contracts for newly listed patented drugs subject to MEA, the list of newly assessed patented drugs with the conditional entry, and the share as defined above. Page 36 of 36