Regulatory Policies for Urban Health

By Prasanna Saligram

Regulation in Health Sector

With the private markets becoming significant, regulation of health services has gained importance

(Bloom et. al. 2009). The definition of regulation in the narrowest sense comprises of statutory

action to constrain market entrepreneurship (Maynard, 1982) but in a broader sense encompasses

all mechanisms both by state and non-state actors that seek to modify the individual and

organizational activity in the health sector (Saltman et al 2002). The objectives of Regulation are two

fold - one to correct for market failures (Bloom et. al. 2009) through health sector management

mechanisms like regulation of quality; efficiency; provider behaviour; payers and regulation of

pharmaceuticals; prevention of quality skimping (Saltman et. al. 2002) and two to promote social

and economic policy objectives like equity and justice; health and safety; patients’ rights and

entitlements and public disclosure for informed citizens (Saltman et. al. 2002). Regulatory

instruments for the domain of provision of health services are directed towards High costs of care;

better quality of care; ethical conduct of providers and equal availability of health care (Roberts et.

al. 2004)

Indian Health System and Regulatory scenario

Indian health system is a mixed health system where the public health systems are weak and under-

resourced (Nandkumar et al 2004) and the private sector is very heterogeneous and exploitative

(Sheikh K et al 2010). Both the public and private operate in a weakly regulated environment (Peters

and Muraleedharan 2008). The boundaries between the public and private providers are also

blurred (Mills and Brugha 2002). This results in unethical, irrational practices sometimes leading to

outright criminal negligence. A recent study on the regulatory architecture in two states of Madhya

Pradesh and Delhi revealed significant gaps in the policy designs for regulation for each of the

domains. On the costs of care there were no established price schedules or reference prices defined

for treatments and procedures and absence of anti-trust laws for restriction of unrestricted profit

mongering (Sheikh K et. al. 2013). On the regulation of quality of care and provider conduct huge

gaps exist in the design of regulatory architecture like the absence of standard treatment guidelines;

lack of practice of evidence based medicine and health care users’ survey; the government was not

bringing its power, as a high volume purchaser, to bear by enforcing performance based incentives;

self regulation measures like accreditation is in its infancy and largely inadequate and other

mechanisms like benchmarking, peer review, performance indicators, public disclosure, triple loop

learning are non-existent; enforced self-regulation measures like, making accreditation as a pre-

condition for empanelment for government schemes, is largely absent (Saligram PS et. al. 2013 in

press). Even where policies exist, there are lacunae in implementation. Implementation is hampered

by inadequate financing and staff capacities; lack of separation between the regulatory activities and

the developmental activities of the public sector resulting in former getting less autonomy and

attention; frequent contestation by the professional bodies (Sheikh K et. al. 2013). The urban health

scenario is further complicated by the presence of multiple agencies like the municipal and urban

local bodies responsible for the health of the urban populations. Most of the ULBs suffer from funds

scarcity and there are not enough incentives to implement regulations for better public health (Das

Gupta M et. al. 2009).

Proposed Regulatory Architecture for Urban services

Design

As mentioned in the previous sections there are serious gaps in the design of regulatory policies in

the country. The following is the architecture that could be proposed to regulate the costs, quality,

conduct and distribution of providers. Since no one regulatory approach would work, there has to be

a combination of approaches. Braithwaite and colleagues (2005) advocate for a Responsive

regulation Pyramid in which the approaches are arranged in a hierarchical order from the voluntary

to the command-and-control approaches as shown in Table 1 striking a balance between the

compliance and adherence. As can be seen from the table considerable gaps exist in the regulatory

policies at each level and for each domain of health services. These regulatory instruments have to

be put in place to shore up the regulatory scenario as a prerequisite to ensuring efficient and quality

services under the proposed National Urban Health Mission.

Implementation

In addition to the deficiencies in the design architecture, the regulatory scenario is also plagued by

the lacunae in the implementation of the policies. This section presents the institutional mechanisms

needed for the implementation of regulatory policies. The following are some of the principles on

which the regulation has to be located.

The regulatory agency shall be an autonomous agency with suitable checks and balances

The regulatory agency shall be separated from the health directorate but having health

directorate’s representation in order that there is no conflation between the developmental

and regulatory functions.

The Regulatory agency shall be responsible for ensuring standards of both the public and

private facilities.

The regulatory agency shall be strengthened with substantial funds, dedicated staff and

infrastructure both for its routine functions and also for such items as capacity building and

standards setting.

The whole regulatory architecture shall be centred around the issue of patients’ rights and

entitlements.

Convergence of the various agencies responsible for the delivery of health services in urban

areas. This means that the facilitation and monitoring of the other agencies like sanitary and

food safety departments which shall have close connections for the health of the urban

populations (Das Gupta M et. al. 2009)

The process of regulation could be a potential for harassment, corruption and red tape

coupled with the slow judiciary existing in the nation. Hence it becomes very important that

reasonable standards with the involvement of all stakeholders are set; information

disseminated; facilitating compliance and minimizing the scope for corruption (Das Gupta M

et. al. 2009). The setting of standards shall also take into account the diversity existing

among the providers and accordingly modulated else it might lead to a situation where

some of the small time rational providers (who might be the only access to the people)

might be crowded out.

Figure 1 provides a draft outline of the sort of regulatory mechanism that could be put in place.

References

Braithwaite, J., Healy, J., Dwan, K., (2005). ‘The Governance of Health Safety and Quality’. Commonwealth

of Australia, 2005

Das Gupta M et. al. (2009). ‘How might India’s Public Health Systems be strengthened?’, Policy Research Working Paper, No. 5140, World Bank, Washington DC. Grol, R(2001). ‘Improving the quality of medical care’. JAMA,Vol 286, No 20, November 2001 pp 2578-2585 Jost, TS (1988). ‘Necessary and proper role of Regulation to assure the quality of health care’. Hein Online,

25 Hous. L. Rev. 525 1988.

Maynard, A. (1982). The Regulation of Public and Private Health Care Markets. A Public/Private Mix for Health: the Relevance and Effects of Change. London. Mills, A & Brugha, R (2002), 'What can be done about the private health sector in low-income countries?', Bulletin of the World Health Organization, 80, 01: 325-330 Ministry of Health and Family Welfare (2013). National Urban Health Mission, Framework for Implementation. New Delhi. 2013 Nandakumar, A. K., Bhawalkar, M., Tien, M., Ramos, R., & De, S. (2004). Synthesis of Findings from NHA Studies in Countries.Health (San Francisco). Nishtar, S (2010).’The mixed health systems syndrome’. Bulletin of the World Health Organization. 88(1):

74-75

Peters, D.H. & Muraleedharan, V.R., 2008. Regulating India's health services: to what end? What future? Social Science & Medicine (1982), 66(10), 2133-44.

Roberts, M Hsiao, W Berman, P & Reich, M (2004). ‘Getting Health Reform Right’.Oxford University Press.

New York

Saligram, PS Sheikh, K & Hort, K (2013). Weak at the top and the bottom: Applying the responsive

regulation pyramid to assess quality of care regulations in India

Saltman RB, Busse R, Mossalios E (eds). ‘Regulating entrepreneurial behaviour in European health care

systems’. European Observatory on Health Care Systems. Open University Press available online at

www.euro.who.int/__data/assets/pdf_file/0006/98430/E74487.pdf accessed on 23.04.2013

Scrivens E (2002). Accreditation and regulation of quality in health services. Chapter 4 in Saltman RB,

Busse R, Mossalios E (eds). ‘Regulating entrepreneurial behaviour in European health care systems’.

European Observatory on Health Care Systems. Open University Press available online at

www.euro.who.int/__data/assets/pdf_file/0006/98430/E74487.pdf accessed on 23.04.2013

Sheikh, K Saligram, PS & Prasad, LE (2013). ‘Mapping the regulatory architecture for Health Care Delivery

in LMIC Mixed Health Systems’. Working paper series, Nossal Institute for Global Health, Health Policy and

Health Finance Knowledge Hub, No. 26, pp1-28, April 2013

Table 1: The Regulatory instruments for the Health sector

Regulatory level

Domain of Regulation

Text book approaches to regulation Policies Availability in India

Voluntary

Costs of Care Display the schedule of charges Not followed uniformly, available in Karnataka1

Quality of Care Continuing Medical Education (CME)2 CME organized in a limited way by the Indian Medical Association

Clinical Guidelines2 Standard Treatment Guidelines for some specific treatments by National Rural Health Mission3

Evidence Based Medicine2 Absent Health care users’ survey4 Absent

Conduct of providers Open disclosure4 Absent

Accessibility of care Patients’ charter Not present uniformly across the country

Market Mechanisms

Costs of Care Anti-trust laws Absent

Prevention of unbridled profit mongering Absent Quality of Care Performance based incentives5 Largely absent

Purchasing arrangements5 Purchasing arrangements under the Public-private partnership rubric (PPP). Some Human Resource and staffing conditionalities for empanelment of the private providers

Conduct of Providers Provider Payment Mechanisms5 Largely on Fee-for-service basis.

Contract Management6 Absent

Accessibility of care Permission for new hospitals based on need and after due inspections

Not followed uniformly. Delhi state has this7

Self Regulation

Costs of care -- --

Quality of Care Accreditation8 Accreditation on a voluntary basis

1 Karnataka Private Medical Establishments Act, 2009

2 Grol 2011

3 Ministry of Health and Family Welfare, 2005

4 Braithwaite et. al. 2005

5 Jost 1998

6 High Level Expert Group (HLEG) 2011

7 Government of Delhi, Directorate of health and family welfare, Hospital Cell

8 Scrivens 2002

Benchmarking5 Absent

Peer review5 Absent

Performance indicators5 Absent

Triple loop learning4 Absent Conduct of providers Ethical Guidelines Ethical guidelines evolved by the Medical Councils as a form of

peer regulation. Accessibility of care Public disclosure4 Absent

Meta Regulation

Costs of Care Setting of prices for treatments Largely absent

Price schedules Largely absent

Quality of Care Enforced self-regulation4. Eg. Accredited facility for government schemes.

Absent

Enforced quality improvement4. Eg. Renewal of License on CME credits

Absent

Prescription Audits4 Absent

Conduct of Providers Medical Audits4 Absent

Accessibility of Care Patient Grievance Redressal Mechanisms with Ombudsperson4

Absent

Community based Monitoring and Planning of health services

Communitization component of the National Rural Health Mission

Command and Control

Costs of Care Revocation of license for failure of disclosure of prices4 Absent

Quality of Care Licensing of practitioners Licensing of practitioners through the medical councils9

Licensing of Facilities Clinical Establishment Act and state level acts in limited states10

Conduct of Providers Consumer laws Consumer Protection Act for Medical Negligence Accessibility of Care Public Health Acts Largely absent, but present in 2 states of Tamil Nadu11 and

Assam12 9 Indian Medical Council Act, 1947 and other council acts

10 Clinical Establishments Act, 2010 and state acts

11 Tamil Nadu Public Health Act, 1939

12 Ministry of Health and Family Welfare, Government of Assam, (2010). 'Assam Public Health Act'.

MINISTRY OF HEALTH AND

FAMILY WELFARE

DIRECTORATE OF HEALTH AND

FAMILY WELFARE

REGULATORY AUTHORITY

PATIENTS’ EMPOWERMENT

Public Health Act

Patients’ rights and entitlements

Health Services Charter / Patients’

charter

Grievance Redressal Mechanism

Ombudsperson

Mahila Arogya Samitis / Rogi Kalyan

Samitis1

Ward Action for Health (Ward planning

and Monitoring)

Report Cards

Public disclosure about clinical facilities

QUALITY ASSURANCE TEAM1

Setting of standards periodically

Accreditation of both private and

public facilities

CME, EBM, STG etc.,

IPHS Standards setting for urban

facilities

Clinical Establishments Act

Enforced Self Regulatory policies

Medical and Prescription Audits

1. NUHM Framework document

MINISTRY OF HEALTH AND

FAMILY WELFARE

DIRECTORATE OF HEALTH AND

FAMILY WELFARE

REGULATORY AUTHORITY

PROJECT MANAGEMENT UNIT

Contract Management

Monitoring and Evaluation

HMIS

Empanelment of providers

based on predetermined

criteria

Provider Payment Mechanisms

Performance based incentives

Negotiation and setting of

price lists

Monitoring of the price lists

Monitoring of other agencies’

work like sanitation and food

HEALTH PERSONNEL

REGULATION

Education

Registration and

licensing

Deregistration and

sanctions

Renewals of

registrations