It was in the year 2015 that reports of unwarranted hysterectomies in Kalburgi district of Karnataka began to appear in several media. A number of private hospitals in Kalburgi wilfully provided unscientific misinformation and instilled fear of cancer and pushed thousands of poor Dalit women to undergo medically unwarranted hysterectomies.

Two subsequent detailed enquiries, one by the department of health and family welfare and another by the Karnataka State Women’s Commission, squarely indicted the deliberate misconduct by private hospitals. The National Human Rights Commission took suo moto cognizance of the issue and issued a notice to the state government.

After all this, when the district and state administration moved to take action, they found that the Karnataka Private Medical Establishments (KPME) Act 2007 — the only existing piece of legislation in Karnataka which applies to the private health sector — had no provisions to hold private hospitals accountable for such malpractice and violations of patients’ rights!

Undoubtedly, this was a big wake up call, a reminder of the need to bring in some accountability and regulation of the private healthcare sector that accounts for almost 75% of medical expenditure by patients in the country.

It has been estimated that lack of regulation and the resultant dominance of the private medical sector has led to catastrophic healthcare expenses that is pushing 6 crore people every year into poverty and destitution!

A burgeoning free-for-all playing field

In India, the share of private medical establishments has enormously grown and they range from small clinics and dispensaries, nursing homes, general hospitals/poly clinics to corporate hospitals. In addition there are other allied services which are procured from the private sectors such as diagnostics, drugs & medicines.

That the private sector has been able to grow to this extent and gain profits is due to the fact that there is hardly any regulation governing their registration, financial turnover or the fees they charge patients. Plus, there is very little scope for grievance redressal.

The legal/ regulatory framework in health care is grossly inadequate and whatever little exists is fragmented and piecemeal with poor implementation. While there is some mechanism to hold the government health staff accountable (weak and inadequate as it is) there is really none to hold the private practitioners accountable.

In Karnataka, the KPME Act came into being to register private hospitals and monitor their functioning in terms of their adherence to certain minimum standards, to get them to display rates of services provided in their hospital, maintain and report crucial data related to the National health programmes. Clearly, however, in the present form, the KPME Act is weak in both content and form.

Drawbacks of the existing legislation

The KPME Act as its stands does not contain provisions related to certain key areas requiring regulation. For example,

• It does not safeguard or protect  the rights of patients who seek care in private hospitals.
• It has no grievance redressal mechanism to address issues of health/patients’ rights violations, unethical practices or medical malpractice and misconduct by hospitals.
• It does not provide a rational, scientific formula for arriving at the costs of procedures, tests and consultations. It does not cap the costs of health services in the private sector which has been one of the main causes of catastrophic out of pocket expenses.
• The Act does not have a separate, dedicated architecture or resources for its implementation, which was one of the main reasons for its poor enforcement.
• Significantly, it includes representatives of the Indian Medical Association (IMA) within the registration body. Given that a sizable membership of the IMA is from the private sector, having the IMA as part of the regulatory body is a conflict of interest.

Amendments

In view of the above, the government’s move to amend the Act to make it “citizen-centric” and to “protect the welfare and ensure safety of citizens” in private hospitals was seen as a progressive one.

In July 2016, the government appointed an expert committee headed by Justice (Retd) Vikramjit Sen was to recommend amendments to the Act.  The amendments were to focus on strengthening regulation of private hospitals.

The government’s proposal also suggested obtaining “first-hand information from persons that have faced hardship or have any sort of grievances against the present-day functioning of Private Medical Establishments in the State, to be able to incorporate deterrent provisions in the amended Act and to ensure that citizens do not endure these grievances in the future”.

But again, this committee was dominated by pro-private elements like the Indian Medical Association, the AYUSH doctors’ association, private research agencies and public-private partnerships. The committee to make the Act citizen-centric had only one member representing citizens’ groups.

On April 28, the committee held its last meeting to finalize its recommendations to the government. The ‘expert’ committee decided:

• To include government hospitals also under the Act
• Not to have a separate authority to oversee the enforcement of the Act
• Have IMA as part of the registration body/ enforcement body
• Not to have a separate grievance redressal mechanism for patient rights violations
• Not to cap costs of health services in the private sector or provide a scientific rational formula for arriving at costs of services

There was no guaranteed protection of key patient rights and violations of the same were not justiciable, meaning that cases of such violation could not be tried in a court of law.

The government retained some of these recommendations and rejected some. The draft presented in the Assembly decided to continue to focus only on private hospitals as before and includes a charter of patient rights.

It was decided that costs of healthcare would be regulated by setting up expert committees under the Act with representation from private medical establishments to categorise the various private medical establishments, draw up standards for each category and arrive at cost of procedures based on that .

It is not that the government will decide unilaterally on the costs but the Bill provides for a fair process to arrive at costs scientifically. There are also district level grievance redressal committees (with representation from private medical establishments) headed by the Zilla Panchayat (ZP) CEO with the powers of a civil court.

The Act also says private hospitals cannot withhold dead bodies until payment of dues and cannot demand advance payment in medical emergencies. All these are ‘citizen-centric’ moves even as they ensure adequate space for private hospitals to have their say, particularly in regulation of costs and in grievance redressal.

A few loopholes

From a citizens’ perspective, several concerns persist, particularly about the grievance redressal mechanism and related issues.  For example the Bill provides for a district level grievance redressal committee headed by the ZP CEO, but

• This committee is not exclusive to patient rights violations and will hear grievances from both patients and medical establishments related to registration issues.
• The Bill does not specify who will head the committee in urban areas (the ZP CEO is in charge of only rural areas)
• The Appellate body at the state level has three senior officers from the department (the Health Commissioner, Director of Health services and AYUSH services) but no citizen/patient representatives.
• While the district level body has powers of the civil court, the Bill does not specify the powers of the Appellate body
• Both at the district level and the state level, it is senior government officers who are heading the grievance redressal bodies. Given that they have several other responsibilities, one is not sure about how much attention grievances will receive. In fact one of the problems with the previous Act was precisely that it did not have dedicated full-time officers for its implementation.

Is the KPME Act draconian?

It is important to understand that the Act in its present form is not draconian as it is made out to be by private hospitals. In fact the KPME Amendments Bill 2017 provides for much less protection to patients as compared to the West Bengal Clinical Establishments (Registration, Regulation and Transparency) Act, 2017  which was passed recently after the chief minister Mamata Banerjee herself took on private medical institutions upon charges of malpractice and fleecing of patients.

The West Bengal act provides for a separate regulatory commission to oversee its implementation and “ensuring accountability and transparency in dealing with patients by clinical establishments in providing patient care services, to advise the Government on measures to be adopted for enhancing and augmenting the performance of clinical establishments in the State”.

According to that Act as well, all private clinical establishments must follow 24 conditions, which include

• Not resorting to any unethical or unfair trade practices, including unfair pricing for different services
• Treating accident, acid attack and rape victims even if they cannot pay for treatment immediately. The hospital would have the right to recover the cost of treatment “in due course”.
• Releasing the body of a patient even if the bill for treatment has not been paid.
• Maintaining grievance cells for patients and their kin to accept complaints about treatment, billing and staff behaviour.
• Setting up a help desk each to ensure proper communication with patients.
• Implementing the e-prescription system, maintaining medical records electronically and providing a copy each of all medical records and treatment details at the time of a patient’s discharge.
• Following “fixed rates and charges, including the package rates for investigation, bed charges, operating theatre procedures, intensive care, ventilation, implants, consultation and similar tests and procedures.” Any additional treatment or procedure shall not attract additional charges “over and above the fixed rates and charges, including the package rates”.
• Providing proper estimates of cost of treatment “not covered in fixed rates and charges, including the package rates”. The final bill cannot exceed the estimate by more than a percentage fixed by the government.
• “Endeavouring” to set up fair-price medicine shops and diagnostic centres, if it has more than 100 beds.
• Providing “completely free treatment” to 20 per cent of the patients in the outpatient departments and 10 per cent of admitted patients if the hospital has taken land or other help from the government.

It also has stringent penalties upto Rs 10 lakh, including compensation for victims of medical negligence. Clearly, therefore,  the need for strict regulation and monitoring of the private medical sector has been felt in other states as well.

The intense and vitriolic opposition to the Karnataka Bill by the private hospital lobbies is unjustified especially in the light of large-scale violations of patient rights and complete lack of their accountability. On June 20th, the Assembly debated the issue for nearly five hours and decided to refer the Bill to the Joint Select Committee with a timeframe to revert within one month.

Will the people’s representatives succumb to pressure from vested interests and shove the Bill into cold storage or will they rise above it to stand for the last person standing in society?

[The article is co-authored by Vijayakumar Seethappa, Vinay Sreenivasa, Akhila Vasan and E. Premdas Pinto. Vijay and Akhila are activists with the Karnataka Janaarogya Chaluvali. Vinay is with the Alternative Law Forum and Premdas works with the Center for Health and Social Justice, New Delhi]