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Showing posts with label health care. Show all posts
Showing posts with label health care. Show all posts

Thursday, September 30, 2021

Distribution of self-reported health in India: The role of income and geography

by Ila Patnaik, Renuka Sane, Ajay Shah and S. V. Subramaniam.

In health research, we study the causes and consequences of health at the individual level. This requires measurement of the health status of individuals. One simple path lies in asking a person: "Are you feeling well today?". This `self-reported health' (SRH) is a measure that is easy to implement, and has limitations in that psychological factors are present. A significant global literature has emerged, which draws on this measure to explore the causes and consequences of health.

The CMIE CPHS is an important new dataset which has longitudinal data for about 170,000 households, measured three times a year. They measure SRH for each individual in each wave. This measurement of SRH, alongside a rich array of household characteristics, makes possible many interesting research projects. In a new paper, Distribution of self-reported health in India: The role of income and geography, we discern some new facts and phenomena about health in India, through this data.

We use data for calendar 2018 and 2019, which works out to 3.5 million observation of a person in a wave. These years were chosen in order to obtain a baseline description of health in India, while avoiding the pandemic of 2020 and the possible impact of demonetisation in 2017.

What do we find? On average, ill health is observed in 3.25% of the records. On average, people in India are unwell for about 12 days a year. There is a U-shaped curve in age, with higher ill health rates for the young and the old.

We get a nice map of the variation of the ill-health rate across the country. This is interesting, in and of itself, as it shows us something about health care requirements. However, some of this variation reflects geographical heterogeneity in income and age structure.

We estimate logit models which explore correlations between standard socio-economic measures and the ill-health rate. The important sources of variation turn out to be age, income and location.

We then focus on an approximately modal person. Model-based predictions for the ill-health probability are constructed for this individual. This yields a map of the predicted ill-health rate --  


 

This shows the variation of ill-health in the 102 `homogeneous regions' (HRs), after controlling for income, age structure and other standard socioeconomic characteristics. It is an interesting and new map. These results do not conform with the standard stereotypes of north vs. south. Epidemiological research is required in understanding what is at work in each of the difficult HRs. Major gains in the health of the people could potentially be obtained by focusing on these hot spots and finding the right public health interventions.

We then ask: are rich people healthier than poor people? As the rich fare better on nutrition, housing quality, knowledge and access to health care, we expect there would be such a correlation. This is indeed the case in the overall aggregate data. However, there is strong geographical variation in this correlation. Ill health and poverty are positively correlated in only half of the country. There are even HRs where the relationship is reverse -- where poor people report better health than the rich. Further, the two maps (the map of ill health of the modal person, and the map of the places where ill health is not positively correlated with income) show different patterns. They are distinct phenomena that invite further exploration.

Friday, July 03, 2020

Legal and regulatory framework for laboratory testing in India: A case study for Covid-19

By Harleen Kaur, Ameya Paleja, and Siddhartha Srivastava.

Testing is central to understanding the spread of the SARS-CoV-2 virus at an individual & population level and designing suitable interventions (Shah, 2020). As of June 23, 2020, India has the fourth-largest number of SARS-CoV-2 cases worldwide. This is despite having conducted only 119 tests per million people. In comparison, the United States and Russia, countries with more cases than India have conducted 1518 and 2074 tests per million respectively. While India has somewhat improved its testing rate since the early stages of the SARS-CoV-2 pandemic (21 per million on April 24), we are still unable to test in adequate numbers. In this blog, we study the reasons behind insufficient testing rates in India by reviewing the legal environment for regulating medical testing.

The Indian diagnostics industry is dominated by the private sector. The legal framework for regulation of private labs is set up under the Clinical Establishments Act, 2010. The issues of non-standardisation of service quality and supplier-induced demands are prevalent in the industry (Competition Commission of India, 2018). Therefore, these labs have been functioning under market-led and self-imposed norms. The government did not depend on this regulatory framework during the SARS-CoV-2 pandemic. Instead, it granted unchecked discretionary power to the Indian Council of Medical Research (ICMR) to regulate the testing strategy. Under the regulatory framework set up by the ICMR, the private lab network is not being utilised optimally for SARS-CoV-2 testing. For instance, the private sector accounts for about 70% of the health care market in India. As of June 22, 2020, only 27% of all labs approved for SARS-CoV-2 testing in India are private labs. In this article, we argue that; i) the private labs are governed by a weak regulatory framework that has allowed market failure to persist in the diagnostics sector in India, and ii) the testing strategy mandated by the ICMR for SARS-CoV-2 pandemic has led to poor outcomes with respect to the participation of private labs. Hence, there is an immediate requirement for reviewing the powers of ICMR for managing the testing strategy and a long term requirement for rethinking the present regulatory framework for labs.

Concerns about market failure in the field of medical testing

A market failure occurs when the free market is unable to obtain efficient economic outcomes. Of the four types of market failures, viz; externalities, asymmetric information, market power, and public goods, the diagnostics sector in India is seen to be affected primarily by information asymmetry. Information asymmetry or information inequality occurs when one party such as a physician possesses much greater information than the other, a patient (Arrow, 1963). During a pandemic, testing becomes a crucial part of a nation's public health strategy and hence, the public goods element of market failure also comes into play. For instance, testing data is a public good in as much as it is useful to understand the spread of the disease in an area that helps the government to design public health policies, and sharing of such data by the government affects behavioral changes in individuals.

As a result of information asymmetry, the field of medical testing in India faces the recurring issue of quality control and standardisation of services. For instance, practices such as hiring unqualified professionals, using sub-standard equipment, and proxy digital signatures have become prevalent in the industry in the absence of effective regulation. In extreme cases, there have been instances of private labs disbursing 300-400 diagnostic reports within a matter of hours, often without conducting any testing at all.

The free market does not solve the issues of market failure on its own and requires state intervention. This can be done through effective regulation of the market either by itself or through State coercion. We now study the existing regulatory framework for labs in India and its limitations.

Regulation of diagnostic labs

Health care is a state subject under the Indian Constitution. This means that in the usual course of events, states have exclusive powers to make laws concerning different aspects of health care such as diagnostic laboratories. Article 249 of the Constitution provides exceptional powers to the union government to make laws on state subjects in the national interest. For such matters, the states retain the power to accept or reject the union law. The Clinical Establishment Act has been passed by the union government under this provision and 11 states have enacted it as of now. However, there are two difficulties with the law which have created a gap between aspiration and outcome. First, under our constitutional arrangement the Clinical Establishments Act is only applicable to those states that choose to adopt it, and only 11 states have adopted this law. Second, the law has serious difficulties in design and implementation.

In the 11 states where the Act is present and implemented, the regulatory function is limited to granting registration to labs and maintaining a register of clinical establishments. The labs interact with the regulatory authority only at the time of registration when they submit evidence of having complied with the prescribed standards for registration to the regulatory authority. Once a permanent registration is granted, there is no mechanism to review the functioning of the labs or provide grievance redressal to patients under the Act. If a person starts a lab without registration, the maximum punishment under the law is a monetary penalty of rupees five lakhs.

Other than the Clinical Establishments Act, private labs have to comply with the standard regulatory requirements under the state Shops and Establishments Act (relating to hours of work, cleanliness, holidays, etc.) and obtain registration under the provisions of the Biomedical Waste Management Rules, 2016. Additionally, diagnostic kits and reagents used by labs are defined as 'drugs' under the Drugs and Cosmetics Act, 1940, and therefore have to be approved by the Central Drugs Standard Control Organisation (CDSCO).

We see that there is effectively no legal framework for regulating private labs in India. The labs only comply with allied regulatory requirements such as disposal requirements for biomedical waste and approval of diagnostic kits under the Drugs and Cosmetics Act. Given this regime, two mechanisms namely accreditation and public procurement have sought to fill the regulatory void in the diagnostics industry.

Alternative methods of regulation

In the absence of an overarching law that assures the quality of clinical establishments, private labs have turned to voluntary accreditation for establishing credibility in the vast diagnostics market. Accreditation of labs is not mandatory in India. The National Accreditation Board for Testing and Calibration Laboratories (NABL), an autonomous body under the Quality Council of India, prescribes accreditation criteria for various kinds of labs. Of the estimated 100,000-110,000 labs present in India, around 4000 have NABL accreditation. Some labs prefer obtaining certifications from international accreditation bodies in addition to obtaining NABL accreditation. Accreditation helps in assuring the quality of labs to the public as well as the government.

The second method to ensure quality standards and avoid market failure is public procurement. The government has dealt with the absence of a regulatory framework in the past by using contractual mandates to avail the services of private labs. The standards expected from these labs are contractually specified by the government while entering into public-private partnership (PPP) agreements for diagnostics. For instance, the union government under the National Health Mission (NHM) has a Free Diagnostics Services Initiative which contains detailed requirements from diagnostic/pathology labs. NABL accreditation is one of the common requirements for private labs to participate in such government programmes.

To compensate for weak regulation under the Clinical Establishments Act, voluntary accreditation by the NABL and public procurement through PPP agreements have acted as alternative strategies for regulation. These alternatives help in reducing information asymmetry and assuring the quality of services to the public and could have played an important part in the regulation of the labs for SARS-CoV-2. Yet, we find that the government strategy for medical labs for SARS-CoV-2 is based on a command-and-control approach under ICMR.

Regulation of medical labs for SARS-CoV-2

Under the existing regulatory framework, private labs did not have to follow any criteria or adhere to any standards before starting a new/novel test, such as the SARS-CoV-2 test. This means that patients would have been able to get SARS-CoV-2 tests done in any private lab offering the test using reagents/test kits approved by the CDSCO and having a valid bio-waste and other local licenses.

The lack of a regulatory framework led to confusion regarding the role of private labs in the response to the SARS-CoV-2 pandemic. As a result, the government set up an emergency regulatory framework for the SARS-CoV-2 crisis using provisions of the Epidemic Diseases Act, 1987, and the Disaster Management Act, 2005. Using these laws, it appointed the Indian Council of Medical Research (ICMR) as the apex decision-making body for India's diagnostic testing strategy through the MoHFW (see notifications here and here).

The Epidemics Act authorises the state governments to take exceptional measures and prescribe regulations to contain the spread of a dangerous epidemic disease. It lists a set of basic subjects for which regulations may be made such as travel restrictions, examination and quarantine of suspected cases, and inspections of any ship or vessel leaving or arriving at any port of call. The role of the union government under this law is limited to managing epidemic diseases at ports.

The Disaster Management Act contains an administrative framework for disaster management. Section 6 of the Act sets up the National Disaster Management Authority (NDMA) as a nodal body for disaster management. Any directions issued by the NDMA and the union government must be followed by the Union Ministries, State Governments and State Disaster Management Authorities. The SARS-CoV-2 pandemic has been notified as a disaster under this Act. Under this, the government has passed various directives on different aspects of the SARS-CoV-2 response using the umbrella clauses of this legislation such as section 6(2)(i) (The NDMA may lay down the policies, plans and guidelines for disaster management) and Section 10(2)(l) (The National Executive Committee may lay down guidelines or give directions to union ministries, state governments and state authorities for responding to the disaster) have been invoked to respond to the SARS-CoV-2 crisis.

Using the powers granted to it by the government, the ICMR has placed severe restrictions on private labs to test for SARS-CoV-2. These restrictions include requiring approvals from ICMR for lab facilities, commercial testing kits, and cost-capping for testing. We now study the ICMR decisions on testing strategy in detail to understand its role in the testing outcomes for SARS-CoV-2.

The role of the ICMR

The ICMR has been responsible for the regulation of public labs under a 2012 scheme called the Viral Research and Diagnostic Laboratories (VRDL) network under the MoHFW. The scheme was initiated to increase government capacity for the timely detection of emerging/re-emerging viral diseases. The VRDL labs were exclusively responsible for testing in the initial phase of the SARS-CoV-2 pandemic in India.

The initial advisories issued by the ICMR contained no mention of private labs and focused only on directing public labs to undertake SARS-CoV-2 testing. At the time, some state governments explicitly banned private labs from testing as per their regulations issued under section 2 of the Epidemic Diseases Act, 1897. For instance, the Delhi Epidemic Diseases COVID-19 Regulations, 2020 and the Bihar Epidemic Diseases COVID-19 Regulations, 2020 contain the following provision on testing of potential SARS-CoV-2 cases by private laboratories:

"No private laboratory has been authorised to take samples for COVID-19 in the State. All such samples will be collected as per the guidelines of the Government of India..."

Subsequently, the ICMR issued guidelines for private labs to undertake SARS-CoV-2 testing on March 21, 2020. Since then, the ICMR has been responsible for approving private labs to test for SARS-CoV-2. The ICMR conducts checks on the capability of private labs to test for SARS-CoV-2 and updates the list of approved private labs regularly. It also issues detailed guidelines for other aspects of testing such as procurement of reagents, evaluation of commercial testing kits, etc. In doing so, it has usurped the regulatory functions of existing statutory regulators such as the CDSCO, as well as voluntary bodies like the NABL. For instance, while diagnostic kits for SARS-CoV-2 are considered "drugs" and should be approved by the CDSCO, they also require validation by the ICMR. Similarly, NABL approved private labs are required to get a mandatory clearance from ICMR for SARS-CoV-2 testing. This means that while NABL has accredited 278 labs for RT PCR RNA testing for SARS-CoV-2, the ICMR has approved 258 of these labs for testing as of June 21, 2020. The ICMR does not document the rationale or process of performing these regulatory functions. The Epidemics Act and the Disaster Management Act do not require the ICMR to adhere to minimum standards of accountability, transparency, and public engagement. The invocation of these laws to empower the ICMR means that there is no coherent or intellectually defensible framework for reviewing the ICMR's actions during the pandemic except that the basic rule of law principles are followed by it.

Building state capacity for regulation is a gradual process that requires backing by a comprehensive legal framework (Roy et al, 2018). ICMR was abruptly thrust into a role for which it did not have the required organisational or procedural capacity. Hence, it compensated for the lack of a regulatory framework by issuing strict command and control orders. We see that after being appointed as the government regulator for the testing strategy for SARS-CoV-2, the ICMR barred all private labs from testing unless approved by it. Given that the labs are already approved by NABL, the rationale for re-approval for testing of private labs by ICMR was never shared. Additionally, ICMR started regulation of reagents, test-kits and costs of tests. This has had an adverse impact on the testing outcomes as seen below.

Implications of regulation of private labs by ICMR

ICMR has been responsible for advising on the SARS-CoV-2 testing strategy for the country. The restrictive policies by the ICMR have led to the inaccessibility of the tests for a vast population. As a result, various courts in India are being involved to challenge such policies.

In April, the Supreme court heard the issue of cost-capping of lab testing for SARS-CoV-2 by ICMR and ordered that the tests shall be free for persons falling under government schemes such as Ayushman Bharat or any other category of economically weaker section of the society as notified by the government. The ICMR cost-cap of INR 4500 per test for private labs was not examined by the court in this petition, but it emphasised on the need for affordable tests to the population.

The Delhi high court reviewed the cost fixed by ICMR for the procurement of rapid testing kits in April. It held that the costs at which ICMR procured the kits had an unduly high profit-margin for the vendors and ordered the cost per kits to be reduced from INR 600 to INR 400. Furthermore, the kits procured by ICMR were later found to be faulty. The court criticised the government and ICMR for low testing of SARS-CoV-2 cases in another order dated June 18, 2020. It ordered the government to review ICMR policies on labs such as the protocol for sample collection, approval of labs, data sharing by labs, and costs per test through an existing government committee.

The Gujarat high court is monitoring the state response to SARS-CoV-2 under a suo-motu writ petition. Under this petition, in an order dated May 29, 2020, the court modified the ICMR guidelines on testing for different categories of patients as it found the patient categories to be non-exhaustive. The court has also decided to review the rationale behind the ICMR SARS-CoV-2 testing strategy.

The ICMR has been criticised for its advisories on the evolving SARS-CoV-2 testing strategy by experts. For instance, its restrictions on the usage of RT-PCR and rapid antigen testing are seen to be unreasonable as the testing capacity has been increasing over time. Additionally, the issue of lack of transparency in sharing testing data and its regulatory procedure makes ICMR decisions difficult to understand and implement.

The ICMR policies regarding the testing strategy for SARS-CoV-2 are restrictive for private labs. This is indicative of a trust-deficit between ICMR and the labs. The ICMR regulatory strategy to reduce this trust-deficit is to micromanage every aspect of testing sought to be done by the private labs. This has led to lower participation of such labs in testing for SARS-CoV-2 and issues of unavailability of tests to the public.

Conclusion

The bulk of the health care services in India are provided by the private sector despite the presence of public health care facilities (Hooda, 2015). Recognising the growth and demand of the private sector, the policy framework in health has gradually shifted from the government providing health care services to being a financier of these services (Patnaik et. al, 2018). Recently, the Indian government conceded before the Supreme Court that the testing capacity of the public sector for SARS-CoV-2 is insufficient.

In this article, we studied the regulatory framework with respect to medical laboratories in India. We find that in the regular course of events, the Clinical Establishment Act, 2010, and the rules thereunder are responsible for such regulation. Issues with the adoption and implementation of this Act leave the sector effectively unregulated. Despite the presence of some alternative methods of regulation, the regulatory gap in the diagnostic sector persists. Therefore, there is a need for a comprehensive law to deal with the market failure of information asymmetry and public goods. However, the enactment of such a law is a long-term deliberative process and should not be attempted in the face of a pandemic.

For SARS-CoV-2 testing, the government has deviated from the existing course of minimal intervention in regulating private labs to regulating every aspect of testing through the ICMR. Government laboratories set up under the VRDL framework were initially the exclusive bodies allowed to test for SARS-CoV-2. While private labs have now been allowed to test for SARS-CoV-2, they are still heavily regulated by the ICMR. The rationale for this approach has not been provided. We believe such an approach is unsuitable for managing the SARS-CoV-2 pandemic. Using the broad powers given to it, the ICMR has reduced the capacity for testing in India by introducing prescriptive testing guidelines, licensing requirements, and cost-capping. This has resulted in non-utilisation of a bulk of the testing capacity for SARS-CoV-2 in India so far. Therefore, we suggest that the power given to the ICMR for SARS-CoV-2 regulation be minimised by specifically disallowing any duplication of regulatory functions already being performed by bodies such as CDSCO and NABL. Further, for the powers delegated to ICMR for regulating the testing strategy, due process requirements such as documenting the rationale, public consultation, sharing of public data should be mandated by the government to increase the accountability of ICMR.

References and further reading:

Arrow, 1963: Kenneth J. Arrow, Uncertainty and the welfare economics of medical care The American Economic Review, December 1963.

Nandraj, 2012: Sunil Nandraj, Unregulated and Unaccountable: Private Health Providers, Economic and Political Weekly, January, 2012.

Srinivasan, 2013: Sandhya Srinivasan, Clinical Establishments Act, 2010 Regulation and the Medical Profession, Economic and Political Weekly, 19 January, 2013.

Hooda, 2015: Shailendra Kumar Hooda, Private Sector in Health Care Delivery Market in India: Structure, Growth and Implications, Institute for Studies in Industrial Development, Working Paper 185, December, 2015.

Patnaik et. al, 2018: Ila Patnaik, Shubho Roy, and Ajay Shah, The rise of government funded health insurance in India, NIPFP Working Paper Series, No. 231, 21 May 2018.

Roy et al, 2018: Shubho Roy, Ajay Shah, B. N. Srikrishna, and Somasekhar Sundaresan, Building State capacity for regulation in India NIPFP Working Paper Series, No. 237, 3 August, 2018.

Competition Commission of India, 2018, Policy Note: Making markets work for affordable health care, Competition Commission of India, October, 2018.

Kelkar and Shah, 2019: Vijay Kelkar and Ajay Shah, In service of the Republic: The Art and Science of Economic Policy, Penguin Allen lane, December 2019.

Shah, 2020: Ajay Shah, More testing: From concept to implementation, The Leap Blog, 06 April, 2020.


Ameya Paleja is a molecular biologist and science blogger based in Hyderabad. Harleen and Siddhartha are researchers at NIPFP. The authors are thankful to Ajay Shah, Renuka Sane, Amrita Agarwal, Smriti Parsheera, Shubho Roy, Anand Prakash, Arjun Sinha, and three anonymous referees for their valuable comments.

Wednesday, June 24, 2020

Skepticism about measurement: Hospital beds edition

by Shubho Roy.

The Covid 19 pandemic has motivated many studies based on data about the disease and the response. However, measurement in India is often weak. There is a need for greater caution before using such data. In this article, we look closely at one such issue: estimating health care capacity based on hospital beds.

The health care infrastructure response to Covid 19 has been to ramp up the number of hospital beds. However, severe and critical care patients in India may often need ventilators and ICU beds. There are no measures available about the number of ventilators or ICU beds in India. Researchers have taken to guesswork in order to address this gap. How reasonable are these estimates?

Extrapolation from the count of hospital beds

It makes sense to use hospital beds as a standardised measure of hospital capacity. Infrastructure, equipment and manpower standards for hospitals have been built on a per bed basis. The number of nurses, doctors, equipment, and even floor space is a function of the number of beds in the hospital. For example, according to the Indian government, a hospital should ideally have 80 to 85 sq m of plinth area per bed; there should be a toilet for every six beds; and one operation theatre for every 50 beds in the general ward. This makes estimating the availability of health facilities easier. Count the number of hospital beds in a country, and you have a sense of the overall health care capacity. Both the World Health Organization and the World Bank track the number of hospital beds per 1000 population as a measure of health care capacity.

Estimates

If we work within such quantification of hospital capacity based on the number of beds, how many ventilators and ICU beds might be present in India? The central government formulated the IPH Standards in 2012, to improve capacity in government health services (run mostly by the state governments). The standards for district-hospitals (at pg.5) requires 300 district-hospital beds per million population. IPH standards for district-hospitals states that five to ten per cent of the total beds in a district-hospital should be ICU beds (See page 25) and each ICU bed should have a ventilator (amongst other equipment). If the entire country were to be up to IPHS standards, there should be 416,189 district hospital beds and between 41,618 to 20,809 ventilators in the country (in the government system).

In reality, the numbers will probably be lower than the standards. Experts have tried to estimate the availability of hospital beds, ICUs and ventilators for the present epidemic. Rajagopalan and Choutagunta have estimated the availability of hospital beds (both in government and private sector) in various Indian states. Singh et al. use a 2008 paper by Yeolekar and Mehta, which estimates that there are around 5-8% ICU beds in government hospitals. Singh et al. assume that around 50% of the ICU beds have a ventilator. This gives them a range of 35,699 to 57,119 ventilators for the entire country (in the government system). Similarly, Kapoor et al. estimate that there should be around 35,699 ICU beds and 17,850 ventilators for the country.

For U.P., they estimate 3,813 ICU beds and 1,907 ventilators.

The ground reality in Uttar Pradesh

How do the government aspirations and expert estimates stack up against the ground reality? In 2019, India’s supreme audit institution (the CAG), carried out a performance audit of Hospital Management in Uttar Pradesh. U.P. has 75 districts and 174 district hospitals (in 2018). The CAG covered seven districts (out of 75) for its audit of 16 government hospitals. In addition, three out of 11 district-hospitals of Lucknow were audited (See Table 45 at pg. 93). The seven districts which were fully covered by the audit (for district-hospitals) are distributed across the five administrative regions of U.P. The CAG found that the reality was far away from the aspiration or estimates.

The seven districts have a population of 25.9 million. As per IPH standards, they should have 7,700 district-hospital beds. The CAG found 2,275 beds, a shortfall of over 70%. If the districts follow IPH standards, there should be 385 to 770 ICU beds for the ideal 7,700 district-hospital beds. Even if IPH standards were maintained on a base of 2,275 beds, there should have been 113 to 228 ICU beds in the sampled district hospitals. The CAG found that ` 10 out of the 11 district hospitals had no ICU beds’. Only the Gorakhpur district hospital had 13 ICU beds (3% of its total beds). In short, of the seven districts examined by the CAG, there were 13 ICU beds, all located in one district.

Even where there were ICU beds, the CAG found shortages of equipment considered essential for an ICU bed (as per IPH standards). The CAG noted:

audit observed that only six High-end Monitors were available against the requirement of 14, seven Infusion pumps were available against the requirement of 14, while Ventilators, Ultrasound for invasive procedures and Arterial Blood Gas (ABG) analysis machine were not available at all in D.H. Lucknow. Similarly, in D.H. Gorakhpur, there were no Ventilators, Infusion Pumps, Ultrasound for invasive procedures and ABG analysis machine.

(pg. 34 of the CAG Report)

In the seven districts where the CAG audited district hospitals, the CAG found no ventilators. Even in the district-hospitals in Lucknow (outside the seven districts), 2% of the beds were ICU, and there were no ventilators.

The CAG report only covers seven districts out of U.P.’s 75 districts. U.P. is one of India’s poorest states. The government of U.P. also operates some super-speciality hospitals where facilities might be better, but they will be few. These seven districts constitute 11% of U.P.’s population. While the findings may not be representative of India, they are not inconsequential. The gap between central government standards, expert estimations, and reality is vast. Table 1 shows the gap between these numbers for the 11 districts of U.P.

Target and reality gap between hospital beds, ICUs and ventilators
Measurement approach Hospital Beds ICU Beds Ventilators
IPH standards 7,700 385 - 770 385 - 770
Expert estimation (from UP numbers) 8,339 419 210
If existing beds maintained ICU ratio 2,275 113 - 228 113 - 228
CAG findings (Reality) 2,275 13 0

Goodhart’s law

Why is there such a large discrepancy between the IPH standards, expert estimates and the reality observed by the CAG? We may conjecture that Goodhart’s Law is at work. Goodhart’s law states: “When a measure becomes a target, it ceases to be a good measure”.

For too long, the academic and policy literature, in India, has emphasised one metric: the number of beds available in government hospitals. Press articles regularly criticize the government for India’s low bed to population ratio (See here, here and here). An easy way out for politicians and officials is to look good in such measurement, while skimping on other elements of health care. Between 2014-2018 the Central Government spent Rupees 8.5 billion for the country out of which Rupees 1.5 billion was spent in U.P., under the National Health Mission, to upgrade facilities in state government hospitals. The result was a rapid expansion in the number of beds (the measure which health policy makers are sensitive to), and not much else.

This problem is not limited to hospital beds. It extends to other parts of the health sector. The central government operates a detailed database called the Health Management Information System. As an example, Smriti Sharma shows that there are significant discrepancies in the database. Numbers which portray the system in poor light are under-reported while the numbers which show the health system positively are inflated.

Using the hospital bed measure to estimate the availability of health care capacity is misleading. Even when the government sets up new facilities, measurement is being done on the basis of new beds. Till April 11, the government had set aside 100,000 hospital beds and 11,500 ICU beds in 586 hospitals. On May 15, the Maharashtra government planned to set aside another 100,000 beds, just in Mumbai with an additional 1,000 ICU beds. In thinking about the situation in health care, this is not enough information. We need to know the facilities and personnel that will be available for these beds.

A general philosophy in India is to be very careful about using data. Researchers need to gain confidence in the quality of the measurement process. This is particularly critical where the agency which performs a function is also the source of data about the same function. When the underlying data is weak, no amount of cleverness in statistics can rescue the distortion of our view of what is going on.

References

Assessing Healthcare Capacity in India. Shruti Rajagopalan and Abishek Choutagunta, Mercatus Working Paper, Mercatus Center at George Mason University, Arlington, VA, April 2020.

Covid 19 in India: State-wise estimates of current hospital beds, intensive care unit (ICU) beds and ventilators, Geetanjali Kapoor, Aditi Sriram, Jyoti Joshi, Arindam Nandi, and Ramanan Laxminarayan, Center for Disease Dynamics, Economics and Policy, Princeton University April 2020.

Covid 19 | Is India’s health infrastructure equipped to handle an epidemic?, Prachi Singh, Shamika Ravi and Sikim Chakraborty, Up Front, Brookings, March 24, 2020.

Covid-19 in India in the coming months: The puzzles faced by leaders of health care organisations, Ajay Shah, The Leap Blog, June 2020.

Hospital Management in Uttar Pradesh, Comptroller and Auditor General of India, 2019.

Problems of the Health Management Information System (HMIS): the experience of Haryana., Smriti Sharma, The Leap Blog, June 2016.

Prudent public health intervention strategies to control the coronavirus disease 2019 transmission in India: A mathematical model-based approach., Sandip Mandal, Tarun Bhatnagar, Nimalan Arinaminpathy, and Anup Agarwal Indian Journal of Medical Research. 2020 10.4103/ijmr.IJMR_504_20.

 

The author is a researcher at the University of Chicago and would like to thank Renuka Sane and Rajeswari Sengupta for their valuable inputs.

Monday, June 15, 2020

Covid-19 in India in the coming months: The puzzles faced by leaders of health care organisations

by Ajay Shah.

Peering into the next six months

How might the pandemic play out in India in coming months? There are newspaper reports about some important statistical evidence from ICMR about the spread of Covid-19 in 70 districts of India (caveat). Based on antibody testing, it appears that about a third of the people in containment zones in some large cities had antibodies in late April. We can cautiously expect significant progress towards herd immunity, in containment zones, by today, i.e. mid-June. Recent stories from Dharavi in Bombay are consistent with such an argument (while also being a testimony to the public health capability of the municipal authorities).

In most of India, however, the picture is quite different. E.g. while about a third of the people in the containment zones in Bombay had antibodies in end-April, the fraction of persons in Bombay as a whole who had antibodies is small. In most of India, the bulk of the epidemic lies in the future.

There is a public health problem (how to slow down the spread of the disease) and there is a health care problem (how to care for the people who get sick). In this article, we focus on the health care problem. For the leadership of health care organisations in most of India, this is an extremely important moment, when they need to plan for this coming surge. In this article, we think about the pandemic from their point of view. A given facility might appear to be relatively unruffled today, but it is important to envision the coming surge of demand for health care, and to lay the groundwork for faring better at the peak of the pandemic in the catchment of the facility. What are the issues, and what are the potential actions that can be taken?

About 70 per cent of health care in India is in the private sector. In this article, we place ourselves in the shoes of the leaders of health care organisations of all kinds, but we have an accent on private organisations as this is where the bulk of the action will lie.

Equipment

Oxygen therapy is a key element. There has been a lot of talk, internationally, about ventilators. However, from the viewpoint of both efficacy and cost, ventilators are a poor solution. The skill required of health care workers, to use a ventilator, is substantial and this will limit scale up. It is more useful to develop a strategy that involves oxygen cylinders and oxygen concentrators. The former is associated with the problem of managing the supply chain for oxygen cylinders. All hospital beds should be equipped with oxygen ports.

In many hospitals, there is a need to introduce physical isolation and establish a dedicated wing in which Covid-19 patients will be treated.

Beds in the ICU are a scarce resource. It is useful to establish `step down beds', where patients exiting the ICU can be safely placed, when they require a high standard of care but no longer require to be in the ICU. This will improve the extent to which the ICU is available to the patients who need it most.

Internal management

The medical community in each city needs to debate and agree on the clinical protocols that will be put into play, that are feasible and cost-effective under their local conditions. This will reduce fumbling and recrimination in the surge. Conversations and documents around rules of triaging will help.

Economies of scale and cost reductions can be obtained by establishing `eICUs', where a central command centre has skilled staff which monitors the data coming in from a remote ICU. This is a more feasible path to scaling up ICU capacity, particularly in places when the skilled staff in ICUs is hard to find.

When the surge comes, the management processes of the hospital will be tested. Every element of the process requires analysis from the viewpoint of coping with a surge environment. Enhancing non-medical staff and processes, ahead of time, will help cope with the surge.

Health care workers

A key problem concerns health care workers (HCWs), who face the risk of high dose exposure to the virus. While some HCW are driven to serve the community, many may retreat from work when the surge gathers momentum. At precisely the time when the most capacity is required, the capacity could degrade, thus increasing the chances of an organisational rout.

The leadership needs to undertake many measures which will be fair to HCW and reinforce their commitment to hold the ranks:

  1. It is penny wise, pound foolish, to skimp on the quality and quantity of PPE. If a few ward boys get sick, word of this will leak to other ward boys. For ward boys to feel safe, their training and consumables have to be of high quality.
  2. HCW and their families need to be reassured that there will be ample effort on giving them treatment if required.
  3. PPE and training is required not just in the ICU but also for the primary care providers, who are the first point of contact for patients when they reach the facility.
  4. Periodic antibody testing for all HCW will be particularly useful: (a) In assessing the extent to which infection and immunity has come about, (b) Generate metrics of the class of situations where new infections are coming about and feed back to process improvements, and (c) Increase the confidence of HCW as a stream of process improvements are visible, and when it is seen that the infection rate and severity of the disease is low.

Community initiatives

These elements (equipment, management, HCW) constitute a reasonable work plan to gear up for the surge. But many or most hospitals today are beset with difficulties. In the best of time, their management bandwidth was limited. Covid-19 has induced a financial crisis with a decline in non-Covid revenues, and the Indian financial system is not able to engage effectively with most hospitals. The thin capabilities have been adversely affected by the retreat of HCW. The puzzle lies in finding the energy and resources to actually pull off a significant amount of preparatory work.

There are many problems which are hard to address at the level of one hospital. Consider a city like Nagpur. There is significant value in constructing a Coalition of hospitals and of the local business community, which can work towards many initiatives -- without any government involvement -- which will reduce the damage caused to the city from the epidemic. Examples of such collaborative initiatives are :

  1. Nagpur requires facts, through random sampling, about the state of infection and antibodies in Nagpur. The weekly or monthly construction of these facts is vital for health care organisations to know the planning horizon that they face, before the surge. The citizenry requires these facts to make decisions about the economic and social activities that are safe. The Indian state does not produce this information. Better planning by health care organisations is good for them and for the citizenry and economy of Nagpur. It would be valuable if such a work program can be put together by the Coalition.
  2. The Coalition can collaborate with the medical testing industry to establish capacity, and negotiate bulk rates.
  3. The Coalition can establish a process of discussion and drafting of appropriate clinical protocols which can then by used by all HCW in the city.
  4. When an individual requires health care or a bed, there is chaos during the surge, with patients running around across multiple facilities looking for spare capacity. The Coalition should establish a shared information system and call centre for patients to use. This will reduce the operational overheads and queues outside facilities. This will increase bed utilisation and improve the allocation of facilities based on the condition of the patient.
  5. The Coalition can pool resources to do bulk buying and inventory management on medical supplies such as PPE or oxygen cylinders, and dynamically respond to the shortages of consumables that are discovered at future dates.
  6. There has been significant friction between health care organisations and the government. The Coalition could be more effective in addressing inappropriate behaviour of various arms of the Indian state. The Coalition is a natural locus for addressing bad behaviour by some health care actors, and can head off such problems so as reduce the probability of the state getting involved.
  7. The Coalition can be more effective in overcoming the frictions faced by hospitals in empanelment with the various government sponsored health insurance schemes (GSHIS) and address frictions associated with dealing with health insurance companies.
  8. Some health care organisations may falter in their commitment to stay in this fight. The Coalition will be valuable in exerting peer pressure, and in helping transmit management knowledge to some organisations who are sitting on the fence.

To the extent that the health care problem in a city like Nagpur is worked out well, individuals will feel more safe, and will get back to working and consuming, thus bolstering the economy. If the health care system gets crushed, there will be greater reticence on the part of the citizenry to spend or work, and the economy will be more adversely affected. Supply chains will get disrupted if there is a lockdown in the future in Nagpur. There is thus ample self interest which should drive the business community, and the health care community, to come together, and expend financial and management resources on building such a Coalition.

There are severe financial problems in many health care organisations today, as the traditional revenue stream has dried up as a consequence of fearful households. The leadership of many health care organisations is firefighting a financial crisis, which is exerting a tax upon their management bandwidth, at a time when they should primarily be working on laying the groundwork for the surge. The Indian financial system works poorly and is not able to perform its role, of efficiently supplying capital. There is a need for owners to bring in equity capital to alleviate this problem. It is also in the self interest of business interests in a given city, to offer loans to health care organisations, so as to diminish the organisational rout of health care organisations in the surge, which would adversely impact upon the economy of the city.

Conclusion

The bulk of the discussions surrounding Covid-19 in India are focused on public policy. But state capacity in India is low, and we should have low expectations for what the state can do. As the de-lockdown progresses, the pandemic will accelerate. We are now at the last barricade: Health care.

How things work out in 2020 will now be shaped by the sagacity and leadership qualities of the senior managers of health care organisations across the country. There are about 10,000 important hospitals in India, and about 50,000 key persons who make up the leadership of these hospitals. All eyes are on the actions of these 50,000 people, which will have an impact upon millions of lives. Seldom has so much depended on so few.

In this article, we have shown some areas of planning and preparedness that are required in health care organisations. All large hospitals in the country, private or public, need to plan for the surge. A key theme we have emphasised is negotiation and collaboration between private persons. The Indian state is generally not able to usefully intermediate in the interactions between private persons. A key feature of the way forward lies in organising communities, in privately negotiated local solutions. It is in the best interests of the citizenry and the health care community of (say) Nagpur to take their future in their own hands, to plan their best way forward.