THE KARNATAKA PRIVATE MEDICAL ESTABLISHMENTS (AMENDMENT) ACT, 2017
(Received the assent of Governor on the 04th day of January, 2018)
KARNATAKA ACT NO. 01 OF 2018
(First Published in the Karnataka Gazette Extra-ordinary on the 06th day of January, 2018)
An Act further to amend the Karnataka Private Medical Establishments Act, 2007. Whereas it is expedient further to amend the Karnataka Private Medical
Establishments Act, 2007 (Karnataka Act 21 of 2007) for the purposes hereinafter appearing;
Be it enacted by the Karnataka State Legislature in the sixty-eighth year of the Republic of India, as follows:-
1. Short title and commencement.-(1) This Act may be called the Karnataka Private Medical Establishments (Amendment) Act, 2017.
(2) It shall come into force on such date as the State Government may, by notification, appoint and different dates may be appointed for different provisions of this Act.
2. Amendment of section 2.- In section 2 of the Karnataka Private Medical Establishments Act, 2007 (Karnataka Act 21 of 2007) (hereinafter referred to as the Principal Act) ,-
(i) after clause (f), the following shall be inserted, namely:-
“(f-1) “Grievance” means any complaint in respect of non-compliance to the Patient’s Charter or Private Medical Establishment's Charter;”
(ii) for clause (h) the following shall be substituted, namely:-
"(h)" Inspection Committee" means the Inspection Committee constituted under section 7;";
(iii) in clause (l) after the words "Acupressure treatments" the words "and any other manner of treatment as may be prescribed” shall be inserted;
(iv) after clause (m) the following shall be inserted, namely:-
“(m1) Patient’s Charter and Private Medical Establishment's Charter" means the rights and responsibilities of the patient and the Private Medical Establishments specified in the schedule;
(m2) “prescribed” means prescribed by rules made by the State Government under this Act;
(v) in clause (n),-
(a) after the word "polyclinic" the words "Dental Clinic or Dental Polyclinic" shall be inserted; and
(b) after the words "voluntary or private medical establishments" the words "as may be notified by the State Government by notification" shall be inserted.
(vi) after clause (r) the following shall be inserted, namely:- "(s)"schedule" means schedule appended to this Act.”
3. Substitution of expressions.- For the expressions “Registration Authority” or “Registration Authorities” wherever they occur in the Principal Act, the expressions “Registration and Grievance Redressal Authority” or “Registration and Grievance Redressal Authorities” shall be substituted respectively.
4. Amendment of section 3.- In section 3 of the Principal Act, in the proviso after the words "till the disposal of the application" the words "and shall comply with the provisions of this Act" shall be inserted.
5. Substitution of section 4.- For section 4 of the Principal Act, the following shall be substituted, namely:-
“4. Registration and Grievance Redressal Authority.- There shall be a Registration and Grievance Redressal Authority in each district consisting of the following members nominated in such manner with such qualification as may be prescribed, namely:-
(a) The Deputy Commissioner of the District Chairman
(b) District Health and Family Welfare Officer Member
Secretary
(c) District AYUSH Officer Member
(d) One member each from Indian Medical
Association and one more association Members
(e) One woman representative when the Authority is
dealing with a grievance redressal. Member
’’
6. Amendment of section 6.- After section 6 of the Principal Act, the following proviso shall be inserted, namely:-
"Provided that no new Private Clinical Laboratory shall be permitted within a radius of 200 meters from the Government Hospital or from the Hospital promoted or managed by a society or trust or autonomous organization owned or controlled by the State Government or Central Government or Local Bodies with effect from the date of commencement of the Karnataka Private Medical Establishments (Amendment) Act, 2017."
7. Amendment of section 7.- In section 7 of the Principal Act,-
(i) for sub-section (1) the following shall be substituted, namely:-
"(1) On receipt of an application under section 5 the Registration and Grievance Redressal Authority may having regard to the provisions of section 6 and after such enquiry as may be necessary, by an Inspection Committee, either grant registration subject to the conditions as may be prescribed or reject the application within ninety days from the date of receipt of the complete application in all respects:
Provided further that in case of any delay beyond ninety days the registration shall be deemed to have been granted.”
(ii) after sub-section (3), the following shall be inserted, namely:-
"(4) For purpose of sub-section (1), the Registration and Grievance Redressal Authority may constitute the Inspection Committee consisting of such members as may be prescribed.
(5) On receipt of application for renewal of registration, the Registration and Grievance Redressal Authority may having regard to the provisions of section 6 and after such enquiry as may be necessary by the Inspection Committee constituted under sub- section (4) either grant renewal subject to the condition as may be prescribed or reject the application within ninety days from the date of receipt of the complete application in all respect; in case of any delay beyond ninety days the renewal shall be deemed to have been granted.
(6) The Registration and Grievance Redressal Authority shall not reject the application for registration or renewal without giving an opportunity of being heard to the applicant and without recording the reasons for such rejection.
(7) The Registration and Grievance Redressal Authority, on its own or based on any written complaint, may cause inspection or direct the Inspection Committee constituted under sub-section (4) to inspect, at a reasonable time, any private medical establishment, to satisfy itself that the conditions of registration are being duly observed and complied with.
(8) In case the Registration and Grievance Redressal Authority finds that the private medical establishment is not being run in accordance with the conditions of registration, the Authority shall direct the establishment to remedy the same within the reasonable time as may be specified in the order.”
8. Substitution of section 8.- For section 8 the Principal Act, the following shall be substituted, namely:-
"8. Functions of the Registration and Grievance Redressal Authority.- (1) The Registration and Grievance Redressal Authority on receiving a complaint regarding non- compliance to the Patient’s Charter or Private Medical Establishment's Charter shall enquire into the complaint:
Provided that the complaints pertaining to negligence, non-adherence to standard protocols for treatments, procedures and prescription audit shall be referred to the Karnataka Medical Council for enquiry and report within sixty days to the Authority.”
(2) The Registration and Grievance Redressal Authority shall, while investigating or enquiring any matter under this section, have the powers of a civil court trying a suit under the Code of Civil procedure 1908, and in particular in respect of the following matters, namely:-
(i) summoning and enforcing the attendance of any person and examining him on oath;
(ii) discovery and production of any documents and witness;
(iii) receiving any evidence on affidavits;
(iv) requisitioning for any public record or copy thereof from any court or office; and
(v) any other matter which may be prescribed.
(3) The Registration and Grievance Redressal Authority shall, to remedy the Grievance, hear the aggrieved person and the other party and shall dispose of the complaint by a summary trial within ninety days from the date of complaint.
9. Amendment of section 9.-In section 9 of the Principal Act,-
(i) in sub-section (1) after the words "standards", the words "of staffing pattern and infrastructure, etc.," shall be inserted; and
(ii) after sub-section (2) the following shall be inserted, namely:-
“Provided that the number of representatives of private medical establishments shall not exceed one-thirds of the total members.”
10. Insertion of new section 9A.- After section 9 of the Principal Act, the following shall be inserted, namely:-
"9A. Functions of the Experts Committees and other Committees.-(1) The Expert Committee constituted under section 9 shall also discharge the following functions, namely:-
(a) study and recommend classification of the Private Medical Establishments on objective basis for the purpose of clause (b);
(b) recommend minimum standards of infrastructure, staffing pattern and staff qualification;
(c) recommend standard protocols for treatments and procedures, and prescription audit;
(d) make recommendations for fixation of uniform package rates for each procedure and treatment covered under any of the health care assurance scheme of the Government for private medical establishments; and
(e) any other functions as may be prescribed by the State Government.
(2) The State Government, on the recommendation of the Expert Committee, and after previous publication, calling for objections from the persons likely to be affected and considering the same shall fix and notify the following, namely:-
(a) classification of Private Medical Establishments;
(b) minimum standards of infrastructure, staffing pattern and qualification of staff;
(c) standard protocols for treatments, procedures and prescription audit; and
(d) uniform package rates for each procedure and treatment covered under any of the health care assurance scheme of the Government for private medical establishments.
(3) Other ad-hoc Committees.- (a) The State Government may also constitute such number of ad-hoc committees with such number of members as may be prescribed;
(b) The ad-hoc committee shall perform such work as may be prescribed and shall submit its report to the State Government for its consideration;
(4) The Expert Committee constituted under section 9 or the ad-hoc committee constituted in this sub-section shall follow such procedure, as may be, prescribed in discharge of its functions; and
(5) The non-official Members of the Expert or ad-hoc Committee shall be eligible for Travelling Allowance and Daily Allowance or any other allowances, as may be, prescribed by the State Government."
11. Substitution of section 10.- For section 10 of the Principal Act, the following shall be substituted, namely:-
“10. Schedule of charges and establishment details to be notified.- (1) Every Private Medical Establishment for the information of patients and general public shall notify and make available the schedule of charges for consultation fee, investigations, medical treatments, procedures, hospital charges and other services, and establishment details, as may be prescribed, in each of the manners specified below:-
(i) display schedule of charges and establishment details in the prescribed manner on a public website to be provided by the Government;
(ii) display schedule of charges and establishment details in the prescribed manner on its own website, if any;
(iii) display consultation fee, rates of major and largely used investigations, procedures, treatments and other services, and hospital charges on the notice board of the establishment at a conspicuous place at the reception; and
(iv) schedule of charges in form of booklets or brochures, which is readily available to patients and public at the establishment at all times:
Provided that in the event of any discrepancy in the schedule of charges notified as per the above detailed manners, the least amount shall be considered to be effective.
(2) For the services provided, the Private Medical Establishment shall collect from the patient or his relative or attendant an amount not more than the charges notified as per sub-section (1), after providing an itemized bill.
(3) For the services provided to a patient belonging to eligible household under the National Food Security Act, 2013 (Central Act 20 of 2013) and referred under any of the health assurance schemes of the Government, no charges shall be collected from the patient.
(4) For the services provided to a patient not belonging to eligible household under the National Food Security Act, 2013 (Central Act 20 of 2013) but referred under any of the health assurance schemes of the Government, the charges over and above the amount reimbursable from the Government as per the scheme norms shall be collected subject to the rates notified under sub-section (1), after providing an itemized bill.
(5) In case of any investigation or treatment or procedure being necessary over and above the standard protocol prescribed under clause (c) of sub-section (2) of section 9A for any patient covered under sub-section (2) or (3) or (4), the concerned private medical establishment can undertake the same after explaining the need to the patient or his representative and obtaining his consent, and charge additional amount, subject to the rates notified as under sub-section (1) after providing an itemized bill.
(6) Every Private Medical Establishment shall provide proper estimates for treatments and charges to the patient or attendant of the patient during initiation or due course of treatment and final bill shall not exceed the estimates."
12. Amendment of section 11.- In section 11 of the Principal Act,-
(i) in clause (i) after the words, "it at the establishment" the words "in the event of such emergencies, without insisting on advance payment" shall be inserted; and
(ii) after clause (iv) the following shall be inserted, namely:-
"(v) display the Patient’s Charter and Private Medical Establishment's Charter in such place easily visible to the public;
(vi) handover in the event of the death of a patient, the body of the deceased immediately, without insisting on prior payment of the dues:
Provided that in case the patient was admitted under any of the health care assurance schemes the private medical establishment shall claim the amount as per the scheme norms from the Government in accordance with clause (d) of sub-section (2) of section 9A.
Provided further that the due amount in accordance with sub-section (2) of section 10 or balance due amount in accordance with sub-section (4) or (5) of section 10 may be recovered from representatives of the deceased in due course as per law.
(vii) provide the Grievance Redressal Mechanism at Private Medical Establishment Level in such manner as may be prescribed."
13. Insertion of new section 11A and 11B.-After section 11 of the Principal Act, the following shall be inserted, namely:-
"11A. Patient’s Charter and Private Medical Establishment's Charter.- (1) Every patient or authorized family member and Private Medical Establishment shall have the rights and duties specified in the Patient’s and Private Medical Establishment's Charter as contained in the Schedule to the Act.
(2) Every patient or authorized family member and Private Medical Establishment shall have right to make complaint to the Registration and Grievance Redressal Authority in respect of violation of any of the provisions of sub-section (1) or rules made under the Act in such manner as may be prescribed.
11B. Power of State Government to amend the schedule.- (1) The State Government may, by notification, add, amend or omit any of the entries in the Schedule.
(2) Every notification issued by the State Government under this section shall be laid before both houses of the State Legislature."
14. Amendment of section 12.- In section 12 of the Principal Act, after sub-section (3), the following shall be inserted, namely:-
"Provided that no such information shall be disclosed to any other person."
15. Amendment of section 15.- In section 15 of the Principal Act,-
(i) in the heading for the word “Suspension” the words “Penalty or suspension” shall be substituted;
(ii) the sub-sections(1), (2) and (3) shall be renumbered as sub-sections (5), (6) and
(7) thereof and before sub-section (5) as so renumbered the following sub-sections shall be inserted, namely:-
"(1) In case of any private medical establishment failing to comply with any of the directions given by the Registration and Grievance Redressal Authority under sub-section
(8) of section 7, the Authority may impose a penalty not exceeding fifty thousand rupees and extend the time for compliance or proceed to cancel the registration of the establishment, after giving the establishment an opportunity of being heard.
(2) In case of a complaint from a patient regarding over-charging the Registration and Grievance Redressal Authority after holding enquiry under sub-section (3) of section 8 finds that the Private Medical Establishment has violated the provisions of sub-section (2),
(4) or (5) of section 10 the Registration and Grievance Redressal Authority shall impose a penalty equivalent to one and half times of the overcharged amount, after giving the establishment an opportunity of being heard. Out of the penalty amount an amount equal to the over-charged amount shall be paid to the patient and the balance shall be deposited with the Arogya Raksha Samithi of the district for taking up public health activities:
Provided that in case of such over-charging by a particular private establishment the Registration and Grievance Redressal Authority after holding such enquiry under sub- section (3) of section 8 finds that the Private Medical Establishments has violated the provisions of section 10 for the third time within a calendar year, the Registration and Grievance Redressal Authority shall make a written complaint to the concerned Court for taking up cognizance of the offence and subsequent prosecution. On conviction, the concerned private medical establishment shall be liable for a penalty which may be extend to three-times of the amount over charged or rupees one lakh, whichever is higher.
(3) In case of a complaint from a patient regarding any matter in the Patient’s Charter or Private Establishments Charter, other than the over-charging the Registration and Grievance Redressal Authority having found that the Private Medical Establishments has violated the provisions of section 11A shall impose a penalty of rupees ten thousand for the first non-compliance and rupees twenty five thousand for the second non-compliance during a calendar year on the concerned private medical establishment, after giving the establishment an opportunity of being heard. Fifty percent of the penalty amount shall be paid to the patient and the balance fifty percent shall be deposited with the Arogya Rakshana Samithi of the district for taking up public health activities:
Provided that in case of such complaint against a particular private establishment for the third time within a calendar year, the Registration and Grievance Redressal Authority shall make a written complaint to the concerned Court for taking up cognizance of the offence and subsequent prosecution. On conviction, the concerned private medical establishment be liable for a penalty which may be extend to fifty thousand rupees.”
(iii) in sub-section (5) as renumbered in the proviso after the words "Private Medical Establishment" the words "and also ensure that arrangements are made within reasonable time for uninterrupted health care to the inpatients." shall be inserted.
16. Amendment of section 16.- In section 16 of the Principal Act,-
(i) for the words "There shall be an Appellate Authority" the words "There shall be an Appellate Authority over the Registration and Grievance Redressel Authority" shall be substituted; and
(ii) for clause (c) the following shall be substituted, namely:-
"(c) The Director of AYUSH (Ayurveda, Unani, Siddha, Homeopathy, Nature cure and Yoga): Member
(d) One Clinician with Post Graduation in General Medicine nominated by the State Government: - Member
(e) Director of Medical Education: - Member.”
17. Amendment of section 19.- In Section 19 of the Principal Act,-
(i) in sub-section (1), for the words “ten thousand” the words “one lakh” shall be substituted;
(ii) in sub-section (4),-
(a) the words “with imprisonment for term which may extend to six months and” and “with imprisonment for a term which may extend to one year and” shall be omitted;
(b) for the words “with a fine which may extend to two thousand rupees” the words “with a fine which may extend to “twenty five thousand rupees” shall be substituted;
(c) for the words “with a fine which may extend to five thousand rupees” the words “with a fine which may extend to “fifty thousand rupees” shall be substituted; and
(i) in sub-section (5) for the words “five thousand rupees” the words “one lakh rupees” shall be substituted.
(iv) After sub-section (5), the following shall be inserted, namely.-
“(6) Notwithstanding anything contained in this Act, whoever makes any false and frivolous or vexatious complaint under this Act shall be punishable by the Registration and Grievance Redressal Authority with a fine which may extend to ten thousand rupees.”
18. Insertion of new section 19A and 19B.- After section 19 of the Principal Act, the following new sections shall be inserted, namely:-
“19A. Cognizance of offence.- No court shall take cognizance of offence under this Act except on a written complaint by the Registration and Grievance Redressal Authority or any officer authorised in this behalf by the Registration and Grievance Redressal Authority:
Provided that nothing in this section shall prevent the aggrieved person to approach the competent court after exhausting the remedies available under this Act and in case the Registration and Grievance Redressal Authority or the authorised officer fails to make written complaint within thirty days from the date of application to make a complaint.
19B. Jurisdiction of Magistrates.- No magistrate shall try an offence under this Act unless he is a Judicial magistrate of first class."
19. Insertion of schedule.- After section 28 of the Principal Act, the following schedule shall be inserted, namely:-
"SCHEDULE
(see clause (s) of section 2 and section 11B) PATIENT'S CHARTER AND ESTABLISHMENT CHARTER
I. PATIENT’S CHARTER
A. PATIENT’S RIGHTS:
(1) Care.- Every Patient shall have,-
(i) a right to receive treatment irrespective of the type of primary and associated illnesses, socio-economic status, age, gender, sexual orientation, religion, caste, cultural preferences, linguistic and geographical origins or political affiliations;
(ii) right to receive treatment in cases listed at sub-section (i) of section 11 without being asked for advance payment;
(iii) right to be heard of his medical problem and concerns;
(iv) expectation from the doctor to write the prescription legibly and explain him on the details on dosage, dos and don’ts and generic options for the medicines;
(v) to be provided with information and access on whom to contact in case of an emergency;
(vi) right to be treated as per the standard protocol prescribed under clause (c) of sub-section (2) of section 9A;
(vii) right to know the information regarding the schedule of charges in the manner prescribed under sub-section (1) of section 10
(viii) right to be charged not more than the rates notified under sub-section (1) of section 10; and
(ix) right to receive clinical records in accordance with sub-section (3) of section 12.
(2) Confidentiality and Dignity.- (a) Every Patient shall have,-
(i) right to personal dignity and to receive care without any form of stigma and discrimination;
(ii) privacy during examination and treatment;
(iii) protection from physical abuse and neglect;
(iv) provision for spiritual and cultural preferences; and
(v) right to confidentiality about their medical condition.
(b) In the event of death of a patient, his family members shall have the right to receive the dead body immediately without being asked for prior payment of the dues in accordance with clause (vi) of section 11.
(3) Information.- Every Patient or his authorised family member shall have right to,-
(i) information to be provided to him which are meant to be and in a language of the patient’s preference and in a manner that is effortless to understand,-
(ii) receive complete information on the medical problem, prescription, treatment and procedure details;
(iii) a documented procedure for his informed consent to enable him to make an informed decision about his care to be practiced with utmost diligence and transparency;
(iv) be educated on risks, benefits, expected treatment outcomes and possible complications to enable him to make informed decisions and involve him in the care planning and delivery process;
(v) request information on the names, dosages and adverse effects of the medication that they are treated with;
(vi) request access and receive a copy of his clinical records;
(vii) complete information on the expected cost of treatment presented as an itemised structure of the various expenses and charges;
(viii) information on hospital rules and regulations; and
(ix) information on organ donation.
(4) Preferences.- Every Patient shall have right to,-
(i) seek a second opinion on his medical condition; and
(ii) get his treatment options, so that he can select what works best for him.
(5) Right to redress.- Every Patient shall have right to,-
(i) justice through an authority dedicated for this purpose by the healthcare provider organization or with Government Grievance Redressal authorities;
(ii) a fair and prompt hearing of his concern; and
(iii) appeal to a higher authority in the private medical establishment and insist in writing on the outcome of the complaint.
B. PATIENTS’ RESPONSIBILITIES.-
(1) Honesty in Disclosure.- Every Patient shall be honest with the treating Doctor in disclosing family or medical history.
(2) Treatment Compliance.- Every patient shall,-
(i) be punctual for appointments;
(ii) do the best to comply with the doctor’s treatment plan;
(iii) have realistic expectations from the doctor and his treatment;
(iv) inform and bring to the doctor’s notice if it has been difficult to understand any part of the treatment or of the existence of challenges in complying with the treatment; and
(v) display intent to participate intelligently in medical care by actively involving in the prescribed do-at-home activities.
(3) Intent for Health Promotion.- Every patient shall do everything in capacity to maintain healthy habits and routines that contribute to good health and take responsibility for health.
(4) Transparency and Honesty.- Every patient shall,-
(i) make a sincere effort to understand therapies which include the medicines prescribed and their associated adverse effects and other compliances for effective treatment outcomes;
(ii) not ask for surreptitious bills and false certificates, and/or advocate forcefully by unlawful means to provide with one;
(iii) in the event of not being happy, shall inform and discuss with doctor; and
(iv) report fraud and wrong-doing.
(5) Conduct.- Every patient shall,-
(i) respect the doctors and medical staff caring and treating;
(ii) abide by the Hospital or facility rules;
(iii) bear the agreed expenses of the treatment that is explained to in advance and pay bills on time in accordance with section 10; and
(iv) not involve in abusing, assaulting or causing harm to the Doctor or staff of Hospital. (any contravention may attract penalty under the Karnataka Prohibition of Violence Against Medicare Service Personnel and Damage to Property in Medicare Service Institutions Act, 2009 (Karnataka Act 01 of 2009))
II. PRIVATE MEDICAL ESTABLISHMENT’S CHARTER:-
(1) Transparency and Honesty.-Every Private Medical Establishment shall,-
(i) provide a printed schedule of fee for office visits, procedures, testing and surgery and provide itemized bills; and
(ii) inform the doctor's qualifications to perform the proposed diagnostic measures or treatments.
(2) Patient Friendly.-Every Private Medical Establishment shall,-
(i) schedule appointments in such a manner that it may allow patient the necessary time to interact and examine him with minimal waiting times and listen to his problems and concerns without interruptions or distractions; and
(ii) encourage patient to bring a friend or relative into the examining room with him.
shall,-
(3) Effective Communication for Patient Education.- Every Doctor shall,-
(i) explain the patient prognosis, further diagnostic activity and treatment in simple terms such that it facilitates easy understanding to him;
(ii) prescribe an Information, Therapy and discuss with the patient diagnostic treatment and medication options, to enable him to make well-informed of decisions; and
(iii) not proceed until the patient is satisfied and convinced that he understands the benefits and risks of each alternative and he has his agreement on a particular course of action.
(4) Implementation of the patient charter.- Every Private Medical Establishment
(i) publish the patient charter in Kannada and English;
(ii) display the patient charter prominently and at multiple locations in the healthcare provider setting; and
(iii) implement the patient charter in its true spirit in everyday medical practice."
|
