11 December, 2017

Medico-Legal Newsletter
December 2017, New Delhi

KPME ACT, 2007
In the year 2007, the Karnataka government introduced the KPME Act to register private hospitals and monitor their functioning in terms of their adherence to certain minimum standards, to mandate them to display rates of services provided in their hospital, maintain and report crucial data related to the National health programmes.
The KPME Act, 2007 as its stands does not contain provisions related to certain key areas requiring regulation. Such as:
  • 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 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 objects and reasons for the Bill are to reconstitute the registration and grievances Redressal authority and to specify the patient’s charter and private medical establishment’s charter in the schedule to the private medical establishment Act.
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, which were to focus on strengthening regulation of private hospitals.

According to the government, this latest amendment will pave way for the Karnataka government fixing the rates for each class of treatment, and will provide grievance Redressal systems. It also aims to put a stop to the practice of demanding advance payment in case of emergency treatment, and not releasing dead bodies to relatives till all dues have been settled. The State Government had incorporated penal provisions in the Amendment Bill to the Karnataka Private Medical Establishments (KPME) Act, 2007 to regulate the functioning of the private hospitals, including the treatment cost, Grievances Redressal Committees and imprisonment of doctors if a patient dies due to their medical negligence.

Initially the main amendments to the Act included:
  • All private hospitals only to follow rates fixed by Government for consultation, investigations, bed charges, OT procedures, intensive care, ventilation, implants and additional treatments including the package rates unless explained to and consented to by a patient. Every private medical establishment shall provide proper estimate for treatment not covered in fixed rate to the patient or attendant and final bill cannot exceed estimate.  Any private medical establishment or person found overcharging the patients or their kin will have to pay a penalty of Rs 25,000 to Rs 5 lakh and face imprisonment of six months to five years. Similarly, the fine and term of imprisonment for non-adherence to the rules regarding maintenance of clinical records, and payments has been increased from 6 months and Rs. 2,000 to three years and Rs.1,00,000.
  • It also makes it mandatory to provide lifesaving or stabilising emergency measures without insisting on advance payment. Additionally, it adds that every PME should display prominently the Patient's Charter and Private Medical Establishment's Charter and that in the event of death, the body of the deceased should be released immediately without insisting on payment of dues.
  • A Private Medical Diagnostic Laboratory must be located outside 200 meters radius of a Government Hospital.
  • A District Grievance Redressal Committee, headed by the Chief Officer of the Zilla Panchayat and including the Superintendent of police, a representative of private hospital, district surgeon, public prosecutor and woman representative nominated by the government as its members to be set up. The Committee on receiving a complaint from a patient may inspect the private hospital to check that the Act is being implemented.
On 21st November, 2017, the Karnataka Assembly has passed the KPME Bill after dropping controversial clauses and it broadly includes the following:
  • Earlier, the bill had proposed six months to three years jail term and hefty penalty for medical negligence on the part of doctors. The bill now removes imprisonment provisions in case of violation of certain sections of the Act.
  • It also provides for emergency treatment as per the need without insisting on payment of advance from patient or representative of the patient in specified cases and enhancing certain monetary penalties leviable under certain sections.
  • The bill also empowers the state government to fix uniform package rates for treatment and procedures under it’s health assurance schemes, specify the patients charter and private medical establishment’s charter. It provides for levy of monetary penalty in case of non-compliance to the patients charter or private medical establishments charter.
  • The complaints pertaining to negligence, non-adherence to standard protocols for treatment, procedures and prescription audit shall be referred to the Karnataka Medical Council for inquiry.
  • Medical establishments should hand over body of deceased patients to this representative without insisting on prior payment of the dues. 

The said amendments had been termed as "draconian” by many. The main area of concern for the doctors are that:
  1. The Government hospitals have been kept out of the purview of the Bill;
  2. If the Bill is passed, then the new rules will enable the government to regulate functioning of private hospitals in all aspects;
  3. Jail terms and increase in fines for doctors for charging prices higher than those prescribed by the government and price control in medical procedures;
  4. The other provision of the proposed Bill was to set up a Grievance Redressal committee chaired by a Zila Parishad CO and which may have any doctor from any specialty including from AYUSH who will be presiding over a medical case of which they may not have adequate knowledge; and
  5. Doctor is not allowed to even have a lawyer to represent him/her against the Committee whereas the patient is provided free legal support to pursue the case.
  1. Include government hospitals also under the Act; 
  2. Not to have a separate authority to oversee the enforcement of the Act; 
  3. Have IMA as part of the registration body/ enforcement body; 
  4. Not to have a separate grievance Redressal mechanism for patient rights violations;
  5. Not to cap costs of health services in the private sector or provide a scientific rational formula for arriving at costs of services

According to the government, the amendment in the Act would benefit as:
  1. Overpricing is a common phenomenon where for a stent which costs Rs. 50,000, private hospitals charge Rs. 2 lakhs. And most of the time, the patients are unaware of it. The situation is so grave that even the Insurance companies have blacklisted 337 hospitals for inflating bills.
  2. If the Bill is passed, then the new rules will enable the government to regulate functioning of private hospitals in all aspects.

From a citizens’ perspective, several concerns persisted, 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; and
  • 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.

The proposed amendments to the Karnataka Private Medical Establishments Act – including regulating fee and service charges at private hospitals – are not against doctors. Rather, they will facilitate a better doctor-patient relationship. 
  1. Firstly, there is a distinction between private hospitals and medical professionals. Many doctors and nurses employed in private hospitals have been under pressure to do procedures and tests that violate patient rights and their own professional ethics. This could range from unnecessary investigations, compulsorily putting patients in the intensive care unit, prolonged and unnecessary use of the ventilator, recommending irrational repetition of tests and unnecessary procedures, including surgeries.
    The doctors and other medical professionals currently do not have access to a system that protects their professional ethics. The KPME offers a process to regulate medical establishments, prevent them from taking advantage of patients. A doctor, who is also simultaneously the owner of the medical establishment, would be held accountable for wilfully violating a rule laid down under the new medical code. The KPMEA thus offers a system to protect private health professionals who want to practice in an ethical manner.
  2. Secondly, the district grievance committee will perform the role of a civil court and will not have the chief executive officer of the zilla panchayat as its member (as has been widely quoted by PHANA). It will have the additional deputy commissioner or special deputy commissioner as chairperson, with the district surgeon, district superintendent of police, one IMA member and one woman, with the last being decided by the state. Non-formal members and IMA will not constitute more than one-third of this body. The role of this body is to respond to complaints at the district level. The complaints received will be reviewed and a recommendation sent to the manager of the establishment with a copy to the Karnataka Medical Council or the Ayush Medical Council. It will also inform the registration authority, comprised of the deputy commissioner, the district health officer, the district AYUSH officer and two members from recognised association, which can also register a private medical establishment. This decentralisation of registration will increase the convenience for those looking to set up establishments at the level of the district.
  3. The third point, which is important, is that there will be an expert group that – with inputs from private medical establishments – will decide on uniform rates for procedures across the state. For instance, if the cost for cataract extract or lens implant procedure to the establishment is Rs 20,000, then the cost of that medical procedure throughout the state cannot exceed Rs 30,000-35,000, as decided by the expert committee. However, based on the facilities offered by the hospital – and this would include the quality of implanted lens – the rates can vary depending on the hospital. A charity hospital may charge an additional Rs 10,000 as consultant fees or room rates while a corporate hospital may
Patients will have some degree of choice in that they can opt for the same procedure with lower room rates or choose more high-end facilities at higher rates. The rates, since they are fixed, can be informed to the patient in advance so that suitable arrangements can be made. Additionally, private medical establishments cannot withhold emergency treatment pending advance payment and cannot refuse to hand over a deceased patient’s body to the relatives unless bills are settled. Again this is not an issue between the health professional and the patient as much as it is between a medical establishment and a patient. It reflects establishment policies rather than the motivation behind the doctor’s decision. The doctor may be inclined to treat a patient in an emergency and waive off costs for a poor patient. But the establishment may not allow her to take that decision.

These are the major amendments to the Bill. It poses fundamental questions before healthcare professionals working in private medical establishments, compelling them to decide if they want to be viewed as independent professionals or as part of
profit-driven medical establishment. It should also be noted that many of the schemes and benefits accrued by private hospitals go predominantly to three or four large corporates within Bangalore. Over 77% of the pre-authorisation amount approved by the Suvarna Arogya Suraksha Trust was cornered by hospitals in Bangalore Districts such as Bellary, Bidar, Gulbarga and Raichur, on the other hand, accounted for an almost insignificant proportion of that amount, even as Koppal and Yadgir do not even figure in this.

In Bangalore, super speciality hospitals such as Narayana Hrudayalaya, Sagar Hospitals, Vydehi Hospital and BGS Global Hospital have been the top four hospitals in terms of the number of pre-authorisation approved cases and the amount. In fact, these hospitals accounted for 40% of the treated cases and almost 43% of the approved amount. It is also won’t be a big stretch to say that these corporates are at the fore of the resistance against amendments to the KPME.

It is crucial to understand that the amendments are not targeting health professionals as is being articulated by vested interests. On the contrary, they facilitate a better doctor-patient relationship in factoring in the needs of patients who access services in critical situations. The amendments constitute a step forward for ethical and compassionate healthcare.

With back to back cases of alleged medical negligence in the city, the delay in implementation of the Clinical Establishments Act — a Central law to regulate hospitals, nursing homes, clinics and diagnostic centres passed by Parliament in 2010 and notified two years later — is again in focus. A few states have adopted the rules, even as the Delhi government has formed a committee to deliberate upon the concerns raised by the medical community. Currently, Delhi's hospitals are governed by the Delhi Nursing Home Registration Act and there is no law to regulate diagnostic labs, however, the members of the committee are working on the law and it will be notified soon.
The Act was initially brought to effect in only four states — Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim — and all UTs, except Delhi, since March 1, 2012. Later, Uttar Pradesh, Uttarakhand, Rajasthan, Bihar, Jharkhand and Assam also adopted it. The Act permits health authorities to conduct inspections and penalise or cancel licences of hospitals that are found to be fleecing patients, either by prescribing needless tests and procedures
, or overcharging.
Read here

The West Bengal health department has suspended a doctor for alleging in Facebook posts that the government was suppressing facts relating to the dengue menace in the state.

Arunachal Dutta Choudhury's post on Facebook amounts to "misinterpretation in the public and is derogatory to the hospital administration," the suspension order issued by the state health department read.

He claimed in the posts that 500 people were admitted
at the hospital and wrote about his struggle to diagnose the patients many of whom were lying on the floor. According to the health department, there have been 19 deaths in state-run hospitals since January and over 18,000 cases were reported in various government clinical establishments. The senior physician also wrote about pressure from health department bosses to cover up the lack of manpower and shortcomings in infrastructure. He wrote that at the instruction of higher-ups, doctors like him were not even mentioning in a death certificate that the patient died of dengue.
Read more


On the night of 12.08.2002, the patient named Devinder Kaur was admitted to the said hospital when she felt pain in her abdominal region and was shifted to ICU till 16.08.2002. As she was the CGHS patient, the Hospital Authorities asked the Complainant not to worry about the expenses.
However on 21.08.2002, due to her condition, she was again shifted to ICU and was kept on ventilator. Later, on 27.08.2002, she was shifted to Ward and a Tracheotomy was conducted but the patient started showing symptoms of madness. The Complainant’s main grievance is that in the morning of 29.08.2002 when the patient was having tea and biscuits, she was offered a tablet and after taking that tablet, she was shifted to ICU in the state of cardiac arrest. She was not passing Urine
andit was later found that the catheter was not properly adjusted. The total Hospital Bill charged was about Rs.1,32,720/-. Thereafter, she was shifted to Apollo Hospital, wherein on 14.12.2002 she took her last breath.
Later, the husband of the deceased patient filed a case for medical negligence against the Hospital and the Doctors claiming compensation of Rs.20 lakhs.

The Doctors vehemently defended their case and denied all the allegations and stated that the patient was the case of long-standing diabetes mellitus with neuropathy, hypertension and stress fracture of D 11-L 1. She was referred and treated by to Physicians, Surgeons, Gastroenterologist, Neurosurgeons and Chest physicians as and when required. The Cardiorespiratory arrests were the result of poorly treated diabetes mellitus and obesity and its related complications. It was also submitted the medical record and discharge summary of Apollo Hospital were not filed.

The State Commission referred the matter to the expert committee and the Committee in its report clearly opined that the treatment given to the deceased was proper and there was no negligence on part of doctors. This report was relied upon by the Commission and moreover, this report was not challenged by the Complainant.
The Commission observed that the Complainant made allegations without proofs. There was no iota of evidence to prove the allegations that wrong medicine was administered or there was maladjustment of catheter and Complainant has made a bald allegation that a minor difficulty of pain in the left abdominal region led to the loss of life.
It was also observed that almost 6 Doctors from different
specialties treated her and she was recovering well, however, later she developed anoxia and encephalopathy in third cardio-respiratory arrest. Moreover, there was no record of any medical treatment for the period of 105 days after her discharge from Opponent Hospital.
The Commission dismissed the case holding that the loss of companionship to the Complainant is unquantifiable in terms of money, however, the law does not act on emotions, but on proofs as in the instant case, almost all the Specialists were involved and they were trying to save the life of the Deceased.
Read here

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