Establishing national hospital costing systems: insights from the qualitative assessment of cost surveillance pilot in Indian hospitals.

OBJECTIVE: The Indian Government launched Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY), the world's largest health insurance scheme, in 2018. To reform pricing and gather evidence on healthcare costs, a hospital cost-surveillance pilot was initiated among PM-JAY empanelled hospitals. We analysed the process and challenges from both healthcare providers and payer agency's perspectives and offer recommendations for implementing similar systems in lower- and middle-income countries. DESIGN: We employed an open-ended, descriptive and qualitative study design using in-depth interviews (IDI) as the data collection strategy. SETTINGS: The interviews were conducted in both virtual and face-to-face modes depending on the convenience of the participants. The IDIs for the National Health Authority (NHA) officials and all providers in Kerala were conducted virtually, while face-to-face interviews were conducted and in Haryana and Chhattisgarh. PARTICIPANTS: Staff from 21 hospitals in three states (Haryana, Chhattisgarh and Kerala), including officials from State Health Agency (n=5) and NHA (n=3) were interviewed. RESULTS: The findings highlight significant challenges in reporting cost data at the hospital level. These include a shortage of trained staff, leading to difficulties in collecting comprehensive and high-quality data. Additionally, the data collection process is resource-intensive and time-consuming, putting strain on limited capacity. Operational issues with transaction management system, such as speed, user-friendliness and frequent page expirations, also pose obstacles. Finally, current patient records data has gaps, in terms of quantity and quality, to be directly put to use for pricing. CONCLUSION: Accurate cost data is vital for health policy decisions. Capacity building across healthcare levels is needed for precise cost collection. Integration into digital infrastructure is key to avoid burdening providers and ensure quality data capture.

Health care cost accounting in the Indian hospital sector.

Setting reimbursement rates in national insurance schemes requires robust cost data. Collecting provider-generated cost accounting information is a potential mechanism for improving the cost evidence. To inform strategies for obtaining cost data to set reimbursement rates, this analysis aims to describe the role of cost accounting in public and private health sectors in India and describe the importance, perceived barriers and facilitators to improving cost accounting systems. In-depth interviews were conducted with 11 key informants. The interview tool guide was informed by a review of published and grey literature and government websites. The interviews were recorded as both audio and video and transcribed. A thematic coding framework was developed for the analysis. Multiple discussions were held to add, delete, classify or merge the themes. The themes identified were as follows: the status of cost accounting in the Indian hospital sector, legal and regulatory requirements for cost reporting, challenges to implementing cost accounting and recommendations for improving cost reporting by health care providers. The findings indicate that the sector lacks maturity in cost accounting due to a lack of understanding of its benefits, limited capacity and weak enforcement of cost reporting regulations. Providers recognize the value of cost analysis for investment decisions but have mixed opinions on the willingness to gather and report cost information, citing resource constraints and a lack of trust in payers. Additionally, heterogeneity among providers will require tailored approaches in developing cost accounting reporting frameworks and regulations. Health care cost accounting systems in India are rudimentary with a few exceptions, raising questions about how to source these data sustainably. Strengthening cost accounting systems in India will require standardized data formats, integrated into existing data management systems, that both meet the needs of policy makers and are acceptable to hospital providers.

National hospital costing systems matter for universal healthcare: the India PM-JAY experience.

India envisions achieving universal health coverage to provide its people with access to affordable quality health services. A breakthrough effort in this direction has been the launch of the world's largest health assurance scheme Ayushman Bharat Pradhan Mantri Jan Arogya Yojana, the implementation of which resides with the National Health Authority. Appropriate provider payment systems and reimbursement rates are an important element for the success of PM-JAY, which in turn relies on robust cost evidence to support pricing decisions. Since the launch of PM-JAY, the health benefits package and provider payment rates have undergone a series of revisions. At the outset, there was a relative lack of cost data. Later revisions relied on health facility costing studies, and now there is an initiative to establish a national hospital costing system relying on provider-generated data. Lessons from PM-JAY experience show that the success of such cost systems to ensure regular and routine generation of evidence is contingent on integrating with existing billing or patient information systems or management information systems, which digitise similar information on resource consumption without any additional data entry effort. Therefore, there is a need to focus on building sustainable mechanisms for setting up systems for generating accurate cost data rather than relying on resource-intensive studies for cost data collection.

Protocol for estimating the willingness-to-pay-based value for a quality-adjusted life year to aid health technology assessment in India: a cross-sectional study.

INTRODUCTION: To ensure that the evidence generated by health technology assessment (HTA) is translated to policy, it is important to generate a threshold value against which the outcomes of HTA studies can be compared. In this context, the present study delineates the methods that will be deployed to estimate such a value for India. METHODS AND ANALYSIS: The proposed study will deploy a multistage sampling approach considering economic and health status for selection of states, followed by selection of districts based on Multidimensional Poverty Index (MPI) and identification of primary sampling units (PSUs) using the 30-cluster approach. Further, households within PSU will be identified using systematic random sampling and block randomisation based on gender will be done to select respondent from the household. A total of 5410 respondents will be interviewed for the study. The interview schedule will comprise of three sections including background questionnaire to elicit socioeconomic and demographic characteristics, followed by assessment of health gains, and willingness to pay (WTP). To assess the health gains and corresponding WTP, the respondent will be presented with hypothetical health states. Using time trade off method, the respondent will indicate the amount of time he/she is willing to give up at the end of life to avoid morbidities in the hypothetical health condition. Further, respondents will be interviewed about their WTP for treatment of respective hypothetical conditions using contingent valuation technique. These estimates of health gains and corresponding WTP will then be combined to ascertain the value of WTP per quality-adjusted life year. ETHICS AND DISSEMINATION: The ethical approval has been obtained from the Institutional Ethics Committee (IEC) of Postgraduate Institute of Medical Education and Research, Chandigarh, India. The study outcomes will be made available for general use and interpretation of HTA studies commissioned by India's central HTA Agency.

Development of a Health Technology Assessment Quality Appraisal Checklist (HTA-QAC) for India.

OBJECTIVE: We aim to develop a comprehensive checklist for evaluating Health Technology Assessment (HTA) studies commissioned in India. The primary objective of this work is to capture all vital aspects of an HTA study in terms of conduct, reporting and quality. METHODOLOGY: The development of a quality appraisal checklist included 3 steps. First, a targeted review of the literature was done to gather information on existing HTA checklists. After reviewing these checklists, an initial draft of the HTA quality appraisal checklist (HTA-QAC) for India was prepared with discussion amongst the authors. Second, the draft checklist was reviewed by the members of the Technical Appraisal Committee (TAC) and their feedback was incorporated. Subsequently, the revised checklist was presented at a virtual meeting of the TAC. Finally, a pilot phase was undertaken to apply HTA-QAC for the approved HTA study reports. Three rounds of virtual discussions were held with the researchers who were involved in the conduct of these HTA studies to resolve any discordance in opinion or develop solutions for the problems in the use of the HTA-QAC followed by a further revision of the checklist. RESULTS: The HTA-QAC is divided into two parts: a self-reporting section to be completed by the author, and the other to be completed by the reviewer. The reviewer checklist has two sections: one to review the report and the other to review the model. The author section is in a self-reporting format, which includes details of basic study information, the rationale for the study, policy relevance, study description, study methods, reporting of model parameters, and results. The reviewer section of the checklist focuses on the quality aspect of the conducted study. The domains included in the report review include details on study methodology, results, discussion, and conclusion. The second part of the reviewer section of HTA-QAC constitutes a review of the model in terms of model assumptions, functionality, model inputs, calculations, uncertainty analysis, model output, and model validation. CONCLUSION: We recommend a standardised process of quality appraisal to ensure the high quality of HTA evidence for policy use in the Indian context. The proposed HTA-QAC will help authors to ensure standardised reporting, as well as allow reviewers to assess the quality of analysis.

Establishing a Health Technology Assessment Evidence Ecosystem in India's Pradhan Mantri Jan Arogya Yojana.

The introduction of the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) scheme in India was a significant step toward universal health coverage. The PM-JAY scheme has made notable progress since its inception, including increasing the number of people covered and expanding the range of services provided under the health benefit package (HBP). The creation of the Health Financing and Technology Assessment (HeFTA) unit within the National Health Authority (NHA) further enhanced evidence-based decision-making processes. We outline the journey of HeFTA and highlight significant cost savings to the PM-JAY as a result of health technology assessment (HTA). Our paper also discusses the application of HTA evidence for decisions related to inclusions or exclusions in HBP, framing standard treatment guidelines as well as other policies. We recommend that future financing reforms for strategic purchasing should strengthen strategic purchasing arrangements and adopt value-based pricing (VBP). Integrating HTA and VBP is a progressive approach toward health care financing reforms for large government-funded schemes like the PM-JAY.

COVID-19 management: The vaccination drive in India.

Objective: We undertook the study to present a comprehensive overview of COVID-19 related measures, largely centred around the development of vaccination related policies, their implementation and challenges faced in the vaccination drive in India. Methods: A targeted review of literature was conducted to collect relevant data from official government documents, national as well as international databases, media reports and published research articles. The data were summarized to assess Indian government's vaccination campaign and its outcomes as a response to COVID-19 pandemic. Results: The five-point strategy adopted by government of India was "COVID appropriate behaviour, test, track, treat and vaccinate". With respect to vaccination, there have been periodic shifts in the policies in terms of eligible beneficiaries, procurement, and distribution plans, import and export strategy, involvement of private sector and use of technology. The government utilized technology for facilitating vaccination for the beneficiaries and monitoring vaccination coverage. Conclusion: The monopoly of central government in vaccine procurement resulted in bulk orders at low price rates. However, the implementation of liberalized policy led to differential pricing and delayed achievement of set targets. The population preference for free vaccines and low profit margins for the private sector due to price caps resulted in a limited contribution of the dominant private health sector of the country. A wavering pattern was observed in the vaccination coverage, which was related majorly to vaccine availability and hesitancy. The campaign will require consistent monitoring for timely identification of bottlenecks for the lifesaving initiative.

Health-Related Quality of Life Among Liver Disorder Patients in Northern India.

Objective: The present study aims to determine the health-related quality of life (HRQoL) among liver disorder patients being treated in tertiary care hospital in north India and exploration of factors affecting HRQoL. Methodology: The HRQoL was assessed among 230 patients visiting either the outpatient department (OPD) or those admitted in high dependency unit (HDU) or liver intensive care unit (ICU) using direct measuring tools such as Euro QoL five-dimension questionnaire (EQ-5D) and EQ visual analog scale. Multivariate regression was used to explore the factors influencing HRQoL. Results: Mean EQ-5D scores among chronic hepatitis and compensated cirrhosis patients were 0.639 ± 0.062 and 0.562 ± 0.048, respectively. Among those who were admitted in the ICU or HDU, mean EQ-5D score was 0.295 ± 0.031. At discharge, this score improved significantly to 0.445 ± 0.055 (P < 0.001). The multivariate results implied that HRQoL was significantly better among patients with lower literacy level (P = 0.018) and those treated in OPD settings (P < 0.001). Conclusion: HRQoL is impaired among patients suffering from liver disorders specifically those admitted in ICU. Further, there is a need to generate more evidence to explore the impact of determinants and treatment-associated costs on the HRQoL.

Cost-effectiveness of Post-Mastectomy Radiotherapy (PMRT) for breast cancer in India: An economic modelling study.

Background: The role of post-mastectomy radiotherapy (PMRT) for breast cancer is controversial when 3-or-less lymph nodes are metastatic. Apart from local control, survival and toxicity, cost also plays an important role in decision-making. Methods: A Markov model was designed to assess cost, health outcomes and cost-effectiveness of different radiotherapy techniques for management of PMRT patients. Thirty-nine scenarios were modelled based on type of radiotherapy, laterality, pathologic nodal burden, and dose fractionation. We considered a societal perspective, lifetime horizon and a 3% discount rate. The data on quality of life (QoL) was derived using the cancer database on cost and QoL. Published data on cost of services delivered in India were used. Findings: Post-mastectomy radiotherapy results in incremental quality adjusted life years (QALYs) that ranged from -0.1 to 0.38 across different scenarios. The change in cost ranged from estimated median savings of USD 62 (95% confidence intervals: -168 to -47) to incurring an incremental cost of USD 728 (650-811) across different levels of nodal burden, breast laterality and dose fractionation. For women with node-negative disease, disease-specific systemic therapy remains to be the preferred strategy. For women with node-positive disease, two-dimensional radiotherapy (2DRT) with hypofractionation is the most cost-effective strategy. However, a CT based planning is preferred when maximum heart distance (MHD) >1cm, irregular chest wall contour and inter-field separation >18cm. Interpretation: PMRT is cost-effective for all node-positive patients. With similar toxicity and effectiveness profile compared with conventional fractionation, moderate hypofractionation significantly reduces the cost of treatment and should be the standard of care. Conventional techniques for PMRT are cost-effective over newer modalities which provide minimal additional benefit, at high cost. Funding: The funding to collect primary data for study was provided by Department of Health Research, Ministry of Health and Family Welfare, New Delhi, wide letter number F. No. T.11011/02/2017-HR/3100291.

National Methodological Guidelines to Conduct Budget Impact Analysis for Health Technology Assessment in India.

OBJECTIVE: Our paper aims to present Budget Impact Analysis (BIA) guidelines for health technology assessment (HTA) in India. METHODOLOGY: A Systematic Literature Review (SLR) was conducted to retrieve information on existing BIA guidelines internationally. The initial set of principles for India were put together based on an interactive process between authors, taking into consideration the existing evidence on BIA and features of Indian healthcare system. These were reviewed by Technical Appraisal Committee (TAC) of Health Technology Assessment in India (HTAIn) for their inputs. Three rounds of consultations were held before finalising the guidelines. Finally, user feedback on the draft guidelines was obtained from the policy makers and programme managers involved in the budgeting decisions. RESULTS: We recommend a payer's perspective, which will include both a multi-payer (depicting the current situation in India) and a single-payer scenario (which reflects a futuristic universal health care situation). A time horizon of 1-4 years is recommended. For estimation of eligible population, a top-down approach is considered appropriate. The future and current mix of interventions should be analysed for different utilisation and coverage patterns. We do not recommend discounting; however, inflation adjustments should be performed. The presentation of results should include total and disaggregated results, segregated year-wise throughout the chosen time horizon, as well as segregated by the type of resources. Deterministic sensitivity analysis and scenario analysis are recommended to address uncertainty. CONCLUSION: Our recommendations, which are tailored for the Indian healthcare and financing context, aim to promote consistency and transparency in the conduct as well as reporting of the BIA. BIA should be used along with evidence from economic evaluation for decision making, and not as a substitute to evidence on value for money.

Systematic Literature Review of Guidelines on Budget Impact Analysis for Health Technology Assessment.

OBJECTIVES: The objective of this systematic review was to review the recommendations for the conduct of a budget impact analysis in national or organisational guidelines globally. METHODS: We searched several databases including MELDINE, EMBASE, The Cochrane Library, National Guideline Clearinghouse, HTA Database (International Network of Agencies for Health Technology Assessment), Econlit and IDEAS Database (RePEc, Research Papers in Economics). The OVID platform was used to run the search in all databases simultaneously. In addition, a search of the grey literature was also conducted. The timeframe was set from 2000 to 2020 with language of publication restricted to English. RESULTS: A total of 13 publications were selected. All the countries where financing of health is predominantly tax funded with public provisioning recommend a healthcare payer (government) perspective. However, countries where a healthcare payer includes a mix of federal government, communities, hospital authorities and patient communities recommend a complementary analysis with a wider societal perspective. While four guidelines prefer a simple cost calculator for costing, the rest rely on a decision modelling approach. None of the guidelines recommend discounting except the Polish guidelines, which recommend discounting at 5%. Only two countries, Belgium and Poland, mention that indirect costs, if significant, should be included in addition to direct costs. CONCLUSIONS: The comparative cross-country analysis shows that a standard set of recommendations cannot be directly useful for all as there are contextual differences. Thus, budget impact analysis guidelines must be carefully contextualised in the policy environment of a country so as to reflect the dynamics of health systems.

Cost-effectiveness and budget impact analysis of facility-based screening and treatment of hepatitis C in Punjab state of India.

OBJECTIVE: Despite treatment availability, chronic hepatitis C virus (HCV) public health burden is rising in India due to lack of timely diagnosis. Therefore, we aim to assess incremental cost per quality-adjusted life year (QALY) for one-time universal screening followed by treatment of people infected with HCV as compared with a no screening policy in Punjab, India. STUDY DESIGN: Decision tree integrated with Markov model was developed to simulate disease progression. A societal perspective and a 3% annual discount rate were considered to assess incremental cost per QALY gained. In addition, budgetary impact was also assessed with a payer's perspective and time horizon of 5 years. STUDY SETTING: Screening services were assumed to be delivered as a facility-based intervention where active screening for HCV cases would be performed at 22 district hospitals in the state of Punjab, which will act as integrated testing as well as treatment sites for HCV. INTERVENTION: Two intervention scenarios were compared with no universal screening and treatment (routine care). Scenario I-screening with ELISA followed by confirmatory HCV-RNA quantification and treatment. Scenario II-screening with rapid diagnostic test (RDT) kit followed by confirmatory HCV-RNA quantification and treatment. PRIMARY AND SECONDARY OUTCOME MEASURES: Lifetime costs; life years and QALY gained; and incremental cost-effectiveness ratio for each of the above-mentioned intervention scenario as compared with the routine care. RESULTS: Screening with ELISA and RDT, respectively, results in a gain of 0.028 (0.008 to 0.06) and 0.027 (0.008 to 0.061) QALY per person with costs decreased by -1810 Indian rupees (-3376 to -867) and -1812 Indian rupees (-3468 to -850) when compared with no screening. One-time universal screening of all those ≥18 years at a base coverage of 30%, with ELISA and RDT, would cost 8.5 and 8.3 times more, respectively, when compared with screening the age group of the cohort 40-45 years old. CONCLUSION: One-time universal screening followed by HCV treatment is a dominant strategy as compared with no screening. However, budget impact of screening of all ≥18-year-old people seems unsustainable. Thus, in view of findings from both cost-effectiveness and budget impact, we recommend beginning with screening the age cohort with RDT around mean age of disease presentation, that is, 40-45 years, instead of all ≥18-year-old people.

Real-world cost-effectiveness of pan-genotypic Sofosbuvir-Velpatasvir combination versus genotype dependent directly acting anti-viral drugs for treatment of hepatitis C patients in the universal coverage scheme of Punjab state in India.

BACKGROUND: We undertook this study to assess the incremental cost per quality adjusted life year (QALY) gained with the use of pan-genotypic sofosbuvir (SOF) + velpatasvir (VEL) for HCV patients, as compared to the current treatment regimen under the universal free treatment scheme in Punjab state. METHODOLOGY: A Markov model depicting natural history of HCV was developed to simulate the progression of disease. Three scenarios were compared: I (Current Regimen)-use of SOF + daclatasvir (DCV) for non-cirrhotic patients and ledipasvir (LDV) or DCV with SOF ± ribavirin (RBV) according to the genotype for cirrhotic patients; II-use of SOF + DCV for non-cirrhotic patients and use of SOF+VEL for compensated cirrhotic patients (with RBV in decompensated cirrhosis patients) and III-use of SOF+VEL for both non-cirrhotic and compensated cirrhotic patients (with RBV in decompensated cirrhosis patients). The lifetime costs, life-years and QALYs were assessed for each scenario, using a societal perspective. All the future costs and health outcomes were discounted at an annual rate of 3%. Finally, the incremental cost per QALY gained was computed for each of scenario II and III, as compared to scenario I and for scenario III as compared to II. In addition, we evaluated the lifetime costs and QALYs among HCV patients for each of scenario I, II and III against the counterfactual of 'no universal free treatment scheme' scenario which involves patients purchasing care in routine setting of from public and private sector. RESULTS: Each of the scenarios I, II and III dominate over the no universal free treatment scheme scenario, i.e. have greater QALYs and lesser costs. The use of SOF+VEL only for cirrhotic patients (scenario II) increases QALYs by 0.28 (0.03 to 0.71) per person, and decreases the cost by ₹ 5,946 (₹ 1,198 to ₹ 14,174) per patient, when compared to scenario I. Compared to scenario I, scenario III leads to an increase in QALYs by 0.44 (0.14 to 1.01) per person, and is cost-neutral. While the mean cost difference between scenario III and I is-₹ 2,676 per patient, it ranges from a cost saving of ₹ 14,835 to incurring an extra cost of ₹ 3,456 per patient. For scenario III as compared II, QALYs increase by 0.16 (0.03 to 0.36) per person as well as costs by ₹ 3,086 per patient which ranges from a cost saving of ₹ 1,264 to incurring an extra cost of ₹ 6,344. Shift to scenario II and III increases the program budget by 5.5% and 60% respectively. CONCLUSION: Overall, the use of SOF+VEL is highly recommended for the treatment of HCV infection. In comparison to the current practice (scenario I), scenario II is a dominant option. Scenario III is cost-effective as compared to scenario II at a threshold of one-time GDP per capita. If budget is an important constraint, velpatasvir should be given to HCV infected cirrhotic patients. However, if no budget constraint, universal use of velpatasvir for HCV treatment is recommended.