THE PRIVATE HEALTHCARE FACILITIES & SERVICES ACT …



THE PRIVATE HEALTHCARE FACILITIES & SERVICES ACT 1998 AND REGULATIONS 2006

MEMORANDUM TO THE

MINISTER OF HEALTH MALAYSIA

SUBMITTED BY

MALAYSIAN MEDICAL ASSOCIATION

AND

MALAYSIAN DENTAL ASSOCIATION

JULY 13TH 2006

PREAMBLE

1. Introduction

The Malaysian Medical Association and the Malaysian Dental Association welcome the implementation of the Private Healthcare Facilities and Services Act (PHFSA) 1998 and its Regulations 2006.

In principle, the Associations agree that there is a need for legislation to regulate healthcare facilities and services in the country, especially to prevent the setting up of such facilities by untrained and unqualified persons, and the provision of services which may be below the accepted standards of medical care.

In this respect, we agree that there is a need to set standards with regard to facilities and services, and understand and support the spirit of the law, with its primary objective of ensuring a good standard of medical care which is the rightful expectation and entitlement of the public.

The Associations are also thankful that Part XV of the Act on Managed Care Organisation, as well as Part XIV relating to the role of Medical Advisory Committees on the Board of Management of Private Healthcare Facilities, will be enforced by the Act and Regulations.

2. Feedback and concerns

The Associations, over the past few weeks, however, have carefully studied the Act and the Regulations, with useful feedback from the wide cross-section of registered medical and dental practitioners who are members of the Associations. We have observed that there are certain stipulations and requirements in both the Act and Regulations which are too exacting and often ambiguous and which may adversely affect the provision of health care to the people in Malaysia specifically and the practice of medicine generally.

We are concerned that these may in the end be counter-productive and negate the primary objectives and spirit of the Act and Regulations.

One particularly serious implication in the Act and Regulations is the possibility that practitioners, who in general strive to provide a genuine professional service and care to their patients, may, on the slightest failure to comply with the stringent requirements spelt out throughout the Act and Regulations, be fined heavily, imprisoned or both.

This may lead to defensive medical practice in our country and reluctance and fear on the part of practitioners to commence private general practice or specialist practice.

3. Existing Safeguards

The MMA is aware that there are many existing safeguards in place to ensure the good and ethical practice of Medicine. These include the Medical Act 1971 which regulates the registration and practice of medical practitioners including the requirement for all medical practitioners to have an Annual Practising Certificate (APC), and the Code of Professional Conduct and various Guidelines issued by the Malaysian Medical Council. In addition, the professional bodies in the country have also come up with several Clinical Practice Guidelines and Standards of Practice for various specialties to ensure that the practice of medicine is up to date and evidence-based.

However, we do admit that there are certain shortcomings in the administration and provision of private healthcare facilities and services which need to be addressed and streamlined.

4. Major concerns

Some of the over-riding concerns regarding the Act and its Regulations include

• That the Act seems to bring about a “criminalization” of medical and dental practice in the country. We hope that the Honourable Minister will seriously review and revise the severe penalties for offences committed under the Act.

• That the processes and procedures for registration are cumbersome and time consuming, which may result in delays and unnecessary complications. We hope that the forms can be simplified, and facilitated by making on-line registration and submission of statistical returns possible.

• That there are many requirements for documentation and written policies, which may not be applicable to all practices. We hope that exceptions will be made for different types of practices, particularly dental and solo medical practitioners.

• That the numerous requirements for standards will add to the cost of running a clinic and this may lead to increased cost for the patients. We hope that the Honourable Minister will ensure that in the enforcement of the Act, the functional and service aspects of the facility will be the main consideration, rather than the nitty-gritty details.

5. Proposal for changes

Details of the Associations’ concerns and proposals for changes are listed systematically, following the Act and Regulations, in the accompanying document.

6. Action taken by MMA/MDA to ensure compliance by members

The MMA and MDA would like to assure the Honourable Minister that we on our part are doing everything possible to facilitate compliance to the Act and its Regulations by our members. Some of our actions include

• Road-shows to explain to our members the implications and implementation of the Act.

• Practical help for our members in fulfilling the requirements for registration, for example assistance with filling the forms and their submission, working with MOX and other agencies to ensure timely supply of proper oxygen cylinders and other equipment for resuscitation to clinics, etc.

• Making available refresher courses on Basic Life Support for our members.

7. Appeal to the Honourable Minister

The MMA and MDA would like to implore the Honourable Minister of Health to kindly consider the above broad principles and submissions and invoke his powers, as provided for in the Act and Regulations, to amend, exempt or delete various sections in the Act and Regulations, as provided for in Part XVII Section 103(1) and Part XIX section 121(1) of the Act.

The MMA and MDA submit this memorandum to the Honourable Minister of Health with a request to make a short oral presentation to highlight some parts of the memorandum to allow the Minister to seek any clarifications directly from the MMA/MDA delegation at this time, and if possible to give us some responses to our feedback at the same time.

We will be happy to work with Ministry of Health officers in the practical aspects of making the requested changes a reality, to ensure the timely and appropriate implementation of this important legislation.

We shall be grateful for a favourable response at your earliest convenience.

THE PRIVATE HEALTHCARE FACILITIES & SERVICES ACT 1998 AND REGULATIONS 2006

DISCUSSION AND PROPOSALS FOR CHANGES

A. REGISTRATION OF CLINICS

PHFSA 1998: PART II: CONTROL OF PRIVATE HELTHCARE FACILITIES & SERVICES

3. No person shall establish or maintain any of the following private healthcare facilities or services without approval being granted under paragraph 12(a) or operate or provide any such facilities or services without a license granted under paragraph 19(a)

4.(1) No person shall establish, maintain, operate or provide a private medical clinic or private dental clinic unless it is registered under section 27.

(2) Notwithstanding subsection (1), a private medical clinic or ….. which forms part of the premises of a licensed private healthcare facility and to which the clinic is organisationally, administratively and physically linked shall not be required to be registered separately but shall comply with such standards and requirements as shall be prescribed.

PHFSA 1998: PART V: REGISTRATION OF A PRIVATE MEDICAL CLINIC

Separate Registration for Private Medical Clinics

30. Separate registration shall be required for ---

(a) a private medical clinic and a private dental clinic which are physically, administratively or organizationally linked to each other;

(b) a private medical clinic which is not physically, administratively and organisationally linked to another licensed or registered private healthcare facility;

(d) a private medical clinic which is not physically linked but is organisationally or administratively linked to a registered private medical clinic, or to a licensed healthcare facility or service;

(f) a private medical clinic or private dental clinic which is under an individual medical practitioner or dental practitioner, as the case may be, sharing manpower, facilities or services, in the same premises but which are not administratively nor organisationally linked to each other.

(g) any other forms of organisation or administration of private medical clinic or private dental clinic as the Director General may determine.

Discussion:

a. First Schedule: Application for Registration 6.1 Variant of Clinic in respect of section 30 of the PHFSA 1998, requires indication of physical, organisational and administrative linkage of private medical clinics.

b. Specialist clinics which are located within private hospitals are physically linked to the private hospital as well as organisationally and administratively, for reasons considered below:

(i) Clinic: rented on session basis, whole clinic on rental, or clinic space owned by doctor (title held)

(ii) Physically linked: clinic within the hospital complex, same entrance-exit, clinic linked to all service areas of hospital

(iii) Organisational: admitting rights, using lab and imaging facilities, using hospital pharmacy, on hospital on-call roster. (Refer Part III Section 11. (4) of the Regulations, cited below)

(iv) Administrative: subject to standards and practice rules laid down by the hospital, contract signed, stipulated clinic operating hours, security cover, member of hospital committees (OT, Infection Control, etc.)

c. Part III Regulations 2006: Organisation and Management of Private Healthcare Facilities and Services, under Plan of Organisation, states:

11. (4) All registered medical practitioners privileged to practise in the private healthcare facilities or services shall be considered as part of the organisation.

MMA/MDA proposal:

a. Any specialist clinic within a private hospital (healthcare facility or service) should not be required to be separately registered. However, the option for separate registration should be allowed for those who wish to do so.

b. Clinics physically located in the premises of a healthcare facility are to be considered organisationally and administratively linked to the healthcare facility.

c. Private medical clinics closed down and reopened within the same locality should not be required to be registered again.

d. We request that the enforcement of the Act should be deferred for one year from Nov 2006 to allow time for the details of the Act and Regulations and their implications to be fully complied to by medical practitioners.

B. First Schedule: Application for Registration to establish Private Medical Clinic

A. Information on Private Clinic

B. Information on Applicant:

8. (k) Reference from two referees as to the character and fitness.

8. (l) Statutory Declaration that he has not been convicted of any offence involving fraud or dishonesty and is not an undischarged bankrupt.

C. Information on Partnership or Body Corporate or Society

D. Information on Person in Charge (if different from applicant)

E. Other Information

12.1 Details of staff employed, engaged or privileged to practice in the private medical clinic or private dental clinic.

12.2 Present or proposed clinic layouts

(a) to be drawn to scale (not smaller than 1:100, which include plans, drawings and specifications and each document to be titled and numbered for identification

(b) Specifications shall show but not limited to the followings:

(i) Internal dimensions of each compartment;

(ii) The purpose or use of each compartment;

(iii)The position and width of doors, windows, entrances and exits;

(iv)The location and types of benches, beds or couch, fixtures and major equipment;

(v)Location and type of lighting, electrical points, air-conditioning, if any, fire fighting equipment, if any, and the like

12.3 Details of any Managed Care Organisation having any contract or arrangement with the private medical clinic.

Discussion:

a. Reference from referees and statutory declaration are felt to be excessive. Registered medical practitioners are subject to the Medical Act 1971 and are fully registered and have been issued Annual Practising Certificate.

b. Information (MCO, etc) may not be available to specialists in clinics in private hospitals as the contracts by MCOs are made directly with the healthcare facility management.

C. PHFSA 1998: Part V of the REGISTRATION OF PRIVATE MEDICAL CLINIC

27. Upon receiving and having considered the application, the Director General may register the private medical clinic or private dental clinic with or without such terms or conditions as he may deem necessary and issue a certificate of registration upon payment of the prescribed fee

Discussion:

1. It is not clear what is meant by “with or without such terms or conditions as he may deem necessary”, since the application is believed to have been scrutinized, processed and formally approved before issuance of the certificate.

2. We envisage that the MOH may have difficulty in the timely processing of the registration of clinics, given the large workload. Even without this Act, the MOH already has difficulty in issuing APCs and Hospital Licenses in time.

D. PHFSA 1998: Part IV LICENCE TO OPERATE OR PROVIDE PRIVATE HEALTHCARE FACILITY OR SERVCE OTHER THAN A PRIVATE MEDICAL CLINIC

19. Upon receiving and having considered the report under section 16 and after giving it due consideration the Director General shall have the discretion ---

(b) to refuse the application for licence with or without assigning any reason for such refusal”

Discussion

It does seem irregular that a license can be refused without any reason.

E. PHFSA 1998: CONTROL OF PRIVATE HEALTHCARE FACILITIES AND SERVICES

5. (1) A person who contravenes section 3 or section 4 commits an offence and shall be liable, on conviction ---

(a) in the case of an individual person ---

(i) to a fine not exceeding three hundred thousand ringgit or to imprisonment for a term not exceeding six years or to both; and

(ii) for a continuing offence, to a fine not exceeding one thousand ringgit for every day or part of a day during which the offence continues after conviction;

Discussion

The fine and imprisonment imposed are very stiff and obviously are so prescribed to serve as a deterrent. However, they are considered too severe and are probably not consistent with the seriousness of the crime.

F. PHFSA 1998: Part XIX SAVINGS AND TRANSITIONAL PROVISIONS

122. A person who immediately before the date of commencement of this Act was maintaining or operating a private medical clinic or dental clinic may continue to maintain, provide or operate the private medical clinic or private dental clinic without registration under this Act if within the first six months of the date of commencement of this Act an application for registration is made under this Act.

Discussion

There are various issues pertaining to the Regulations 2006 which need to be addressed as stated above.

G. REGULATIONS 2006: Part IX: GENERAL PROVISIONS FOR STANDARDS OF PRIVATE MEDICAL CLINICS

Location of private medical clinic

34. (1) A private medical clinic or private dental clinic shall be located free from undue noise or, if the private medical clinic or private dental clinic is located in a noisy area, the holder of a certificate of registration or a person in charge of a private medical clinic or private dental clinic shall take adequate measures to ensure that the noise is minimized to the extent that no disturbance is caused to its patients.

(2) The location of any private medical clinic or private dental clinic shall not be exposed to excessive smoke, foul odours or dust.

Discussion

a. This is a difficult regulation to comply with as clinics have to be located in areas of patient requirements and accessibility.

b. The regulation implies that if a workshop or factory is built after the clinic is in operation, the onus is for the holder of the certificate to “take adequate measures to ensure that the noise is minimized”.

H. REGULATIONS FOR PHFS 2006: PART III: ORGANISATION AND MANAGEMENT OF PRIVATE HEALTHCARE FACILITIES OR SERVICES

Person in charge of Private healthcare facility or service

12. A person in charge of a licensed private healthcare facility or service shall hold such qualification, have undergone such training and possess such experience as stipulated in the Fourth Schedule.

Fourth Schedule: Qualifications, Training and Experience of Person in Charge:

Facility – Private Hospital

Person in charge – Registered medical practitioner

Qualification – (a) Degree in Medicine from local universities or from other universities recognised by the Government of Malaysia, and

b) registered with the Malaysian Medical Council

Training – At least two years’ training in any specialty provided by the healthcare facility or service

Experience – (a) Has served in a post in public service or has been granted reduction, exemption or postponement of service under section 42 of the Medical Act; and

(b) at least two years experience in hospital management.

REGULATIONS FOR PRIVATE MEDICAL CLINIC AND PRIVATE DENTAL CLINIC: Part III

Person in charge of Private Medical clinic or private dental clinic

8. A person in charge of a registered private medical clinic or registered private dental clinic shall hold such qualifications, have undergone such training and possess such experience as stipulated in the Third Schedule.

Third Schedule: Qualifications, Training and Experience of Person in Charge:

Facility – Private Medical Clinic

a) General outpatient

Person in charge– Registered medical practitioner

Qualification – Degree in Medicine from local or recognised university; registered with MMC

Experience - has served in public service or postponement under section 42 of the Medical Act 1971

b) Specialised Outpatient

Person in charge – Registered medical practitioner

Qualification – Degree in medicine from local or recognised university; postgraduate qualification recognised by the Government; registered with the MMC

Experience - has served in a post in public service or postponement under section 42 of the Medical Act 1971

c) Private Dental Clinic

Person in charge – Registered dental practitioner

Qualification – degree in dentistry from local or recognised university

Experience – has served in a post in public service or postponement under section 49 of the Dental Act 1971.

Discussion

There are private hospitals where the person in charge is not a registered medical practitioner. There are also private medical clinics which are run by persons not qualified and therefore not registered with the MMC.

I. REGULATIONS 2006: PART IV: POLICY

17 (1) A private medical clinic or a private dental clinic shall, upon request prior to the initiation of care or treatment, inform the patient ---

(a) of the estimated charges for services based upon an average patient with a diagnosis similar to the tentative or preliminary diagnosis of the patient; and

(b) of the anticipated charges for services that is routine, usual and customary.

17. (2) Billing procedure: Patient has right to be informed of the billing procedure.

17. (3) Patient has right to obtain itemised billing for the whole course of treatment.

(4) Any person who contravenes this regulation commits an offence and shall be liable on conviction to a fine not exceeding ten thousand ringgit or imprisonment for a term not exceeding three months or to both.

Discussion

a. The manner in which this will need to be implemented poses problems. The consultation will take longer at the expense of other waiting patients.

b. It can be easily denied by the patient as having been discussed or that he did not understand the explanations. Patient may refuse if asked to sign consent for the charges.

J. Patient’s rights

18 (1) The holder of a certificate of registration or a person in charge of a private medical clinic or private dental clinic shall take reasonable steps to ensure that a patient is ---

(a) provided with information about the nature of his medical condition proposed treatment, investigation or procedure and the likely cost of the treatment, investigation or procedure;

(b) treated with strict regard to decency; and

(c) provided with medical report within a reasonable time upon request by the patient and upon payment of a reasonable fee.

(2) Any person who contravenes this regulation commits an offence and shall be liable on conviction to a fine not exceeding ten thousand ringgit or imprisonment for a term not exceeding three months or to both.

Discussion

a. 18 (1) (b) is vague and if the implication is ethical behaviour then the contravention should be subjected to disciplinary procedures as per the Medical Act and Code of Professional Conduct.

b. There is no provision in the Medical Act 1971 for fines or imprisonment for ethical or disciplinary infringements.

c. The punishment is too severe for any contravention in this Part.

K. REGULATIONS 2006: PART V: REGISTERS, ROSTERS AND RETURNS

Statistical returns

25. (1) The holder of a certificate of registration or a person in charge of a private medical clinic or private dental clinic shall forward to the Director General the following details;

a) statistical information of International Classification of Disease Ten (ICD-10) at every three month intervals; and

b) any other information deemed necessary at any time by the Director General.

Patient’s Medical Record Register

21. (1) The holder of a certificate of registration or a person in charge of a private medical clinic or private dental clinic shall keep and maintain a Patient’s Medical Record Register to record the movement of patient’s medical record.

Discussion

a. The need for obtaining statistics on diseases treated in private medical clinics is accepted as important and timely.

b. “Any other information” is vague, and unless clarified it would be difficult to be able to produce “any other information” at short notice.

c. Statistical returns are most conveniently conveyed on-line to the Director General rather than through hard copies which can be very cumbersome and occupying space when received by MOH.

d. The requirement for a Patient’s Medical Record Register is cumbersome and does not apply to a solo medical practice.

L. REGULATIONS 2006: PART VI: GRIEVANCE MECHANISM

Patient grievance mechanism plan

26. The holder of a certificate of registration or a person in charge of a private medical clinic or private dental clinic shall provide a patient grievance mechanism plan which shall include a method by which each patient will be made aware of his rights to air his grievances and the grievances procedures.

Discussion

a) It is not practical to provide common grievance mechanism plan as the grievance situation may not be always the same. However, the practitioner is normally aware of steps to take should a patient be aggrieved.

b) This provision may lead to public becoming frivolously litigious.

M. REGULATIONS 2006: PART IX: GENERAL PROVISIONS FOR STANDARDS OF PRIVAE MEDICAL CLINIC or PRIVATE DENTAL CLINIC

Emergency power supply

50. Adequate emergency electrical generating equipment with automatic transfer in case of interruption of normal power supply to essential equipment, rooms and areas shall be provided in a private medical clinic or private dental clinic.

Discussion

Only clinics which have operating facilities/theatres/delivery suites should be required to have electrical emergency generating systems.

Clinics would normally have simple contingency measures to handle emergency power failure.

N. REGULATIONS 2006 PART IX: GENERAL PROVISIONS FOR STANDARDS OF PRIVATE MEDICAL CLINICS or PRIVATE DENTAL CLINICS

Section 34 to Section 55

• Location (noise, excessive smoke, foul odours)

• Vector Control (rodents and insects)

• Stairways and ramps

• Doors

• Floor finishes

• Wall surfaces

• Ceilings

• Signage and Labelling system

• Waiting area

• Janitor’s closet

• Storage

• Plumbing

• Toilet

• Water supply

• Electrical sockets

• Lighting

• Emergency power supply

• Ventilation

• Sewage and Sewerage system

• Refuse

• Hazardous waste disposal

Section 56 to Section 72

* Organisation of Housekeeping Services (cleaning methods, equipment and supplies, germicides, storage, dry dusting and sweeping)

• Soiled linen handling

• Hand washing

• Linen storage room or area

• Laundry

• Communication system

• Transport arrangements (to other facilities for consultation)

• Maintenance, repair (safety of patients)

• Staffing

REGULATIONS 2006: PART XII STANDARDS FOR OUTPATIENT FACILITIES AND SERVICES

Sections 89 to 91

Section 90 (3)

• Waiting room or area

• Reception area/admitting facilities

• Administrative office or area

• Public and staff toilet

• Public telephone and drinking facilities

• Utility Room

90. (4) Notwithstanding sub-regulation 90. (3), in case of small outpatient department, general and administrative facilities may be combined with inpatient or emergency department general administrative facilities within a private healthcare facility or service.

Discussion

a. The absolute compliance of all these “extra” fittings, rooms, facilities and services should be viewed or evaluated from the functional and service aspects and not on strict dimensions of space and allocation. Many of them are also primarily construction infra-structure and would have been approved by the respective city/town councils.

b. Clinics are rarely ‘custom’ planned, designed and constructed and are usually rented from shop-house lots or shopping mall lots.

c. Clinics are established with various space constraints and to fit in all these requirements may need much larger space and larger premises, beyond the financial capability of medical practitioners just starting private medical practice.

d. By the government laying down numerous restrictions and making it difficult for doctors to establish clinics and adding to the cost of running a clinic; it may in fact be indirectly denying provision of essential healthcare for the public.

O. PHFS 1998 PART VI : RESPONSIBILITIES OF A LICENSEE, HOLDER OF CERTIFICATE OF REGISTRATION AND PERSON IN CHARGE

Emergency treatment and services

38(1) Every licensed and registered private healthcare facility or service shall at all times be capable of instituting and making available essential life saving measures and implementing emergency procedures on any person requiring such treatment or services.

38(2) The nature and scope of such emergency measures , procedures and services shall be as prescribed. (This is in Eighth Schedule of the Regulations)

REGULATIONS 2006: PRIVATE HEALTHCARE FACILITIES & SERVICES: Eighth Schedule

Basic Emergency Services

Each private healthcare facility or service shall, unless otherwise specified by standards set for that private healthcare facility or service, provide at a minimum the following services and equipment, for both adult and paediatric, as applicable to the type of healthcare facility or service, level of care of such facility or service and scope and capability of the healthcare facility or services to provide emergency care.

Private healthcare facilities & services

• An emergency call system

• Oxygen

• Ventilation assistance equipment – airways, manual breathing bag

• ECG monitoring and cardiac defibrillator

• IV Therapy supplies necessary for the level of service to stabilise the patient as specified by the person in charge

• Laryngoscope and endotracheal tubes

• Suction equipment

• Indwelling urinary catheters

• Drugs and other emergency medical equipment and supplies to stabilise the patient as specified by the person in charge

• In the case of private hospitals, private ambulatory centres, and private maternity homes, basic obstetric supplies necessary for the level of service to stabilise the patient as specified by the person in charge.

REGULATIONS 2006 Part X Special requirements for Emergency Care Services (private medical clinics)

Basic emergency care services

75 (1) All private medical clinics or private dental clinics shall have a well-defined care system for providing basic outpatient emergency care services to any occasional emergency patient who comes or is brought to the private medical clinics…

(2) The nature and scope of such emergency care services shall be in accordance with a private medical clinic’s capabilities.

(8) Equipment and services shall be provided to render emergency resuscitative and life-support procedures pending transfer of the critically ill or injured to other healthcare facilities or services.

75 (9) For the purpose of sub-regulation (8), the minimum capability provided, unless specified otherwise, shall include equipment, apparatus, materials, pharmaceuticals, substances or any other things deemed necessary to stabilise or resuscitate a patient as listed in the Fifth Schedule

REGULATIONS 2006: FIFTH SCHEDULE : Basic Emergency Services, Equipment, Apparatus, Materials and Pharmaceuticals

Private Medical Clinic

• An emergency call system (also dental clinic)

• Oxygen

• Ventilation assistance equipment, airways, etc (also dental clinic)

• IV therapy supplies for the level of service to stabilise the patient as specified by the person in charge

• ECG

• Laryngoscope and endotracheal tubes

• Suction equipment (also dental clinic)

• Indwelling urinary catheters

• Drugs and other emergency medical equipment and supplies, necessary for the level of services to stabilise the patient as specified by the person in charge. (also dental clinic).

Discussion

a. The use of some of these equipment and apparatus require special training and skills. We agree that all doctors should have basic resuscitation skills (BLS) but the requirement for laryngoscope and endotracheal tubes is not reasonable as intubation is not a skill that is taught to all medical practitioners, and in the hands of an unskilled practitioner can be very dangerous.

b. It is estimated that a very ill/dying patient comes to a clinic on the average about 1-2 in 10 years. It is very rare for patients to have actually died in the clinic over a period of time.

c. It is felt that this requirement will give rise to possible frivolous complaints by patients and/or legal suits based on these very stringent requirements.

d. This will lead to “defensive medical practice,” and to higher indemnity subscriptions for medical practitioners.

P. BOARD OF VISITORS

PHFSA 1998 Part XVII Power of Minister Section 104 Board of Visitors

104 (1) The Minister may appoint a Board of Visitors for each private hospital.

Discussion

It is agreed that a Board of Visitors to periodically visit a private hospital will help to establish a line of communication between the public and the hospital management.

 

 Q. SOCIAL OR WELFARE CONTRIBUTION

PHFSA ACT 1998: PART XVII: POWER OF MINISTER

105. (1) The Minister may prescribe the type of social or welfare contributions or the quantum of social or welfare contribution that shall be provided, and the manner in which it shall be provided, by any private healthcare facility or service.

REGULATIONS 2006: MISCELLANEOUS

105. (1) The holder of a certificate of registration or a person in charge of a private medical clinic or private dental clinic shall ensure that each private medical clinic or private dental clinic submit details of the type or nature and manner of social or welfare contribution provided or to be provided.

(2) The social and welfare contributions referred to in sub-regulation (1) may be one or a combination of types of contribution as listed in the Sixth Schedule.

The Sixth Schedule stipulates the type of social or welfare contribution and manner of discharging obligations:

- Discount or exemption for charge or fee;

- Provision for emergency care for poor patients

- Public education

- Providing donations to associations and organisations

- Providing assistance to non-governmental or charitable organisations

- Organising blood donation campaigns

The clinics are required to submit yearly returns on the type of programmes or activities or donation provided, the cost to the facility or service and where applicable, the beneficiaries.

Discussion

This section presupposes that private medical clinics and other private healthcare facilities and services do not make social or welfare contributions and that practitioners do not contribute to community healthcare services. This is grossly inaccurate.

R. FEE SCHEDULE

PHFSA 1998: PART XVII: POWER OF MINISTER

106 (1) The Minister may make regulations prescribing a fee schedule for any or all private healthcare facilities or services or health related facilities or services.

(2) The Minister may, from time to time, after consulting the DG, amend the fee schedule by order published in the Gazette.

(3) A private healthcare facility or service for which a fee schedule has been prescribed under this section shall comply with such fee schedule.

(4) A private healthcare facility or service which fails to comply with any fee schedule prescribed under this section commits an offence.

Discussion

a. The Act specifies that the Minister may make regulations prescribing a fee schedule for any or all private healthcare facilities or services or health related facilities or services.

b. Yet, the fee schedule is only for doctor’s professional fees. The coverage of procedures/treatments is also not complete.

c. Hospital charges (facilities) and nursing care, catering, etc (services) are not included in the Fee Schedule.

REGULATIONS 2006: PRIVATE MEDICAL CLINICS: PART XIV MISCELLANEOUS (Chapter 4)

Fee Schedule

108. (1) The fees to be charged for any facility or service provided by any private medical clinic ….shall be as stipulated in the Seventh Schedule.

(2) Subject to sub-regulation (1), all private medical clinics … shall have a written policy on the quantum of fees to be charged.

PART A - MEDICAL FEE

Note: 1.

• All charges shown are the maximum chargeable charges unless specified otherwise.

• When two procedures are performed through the same incision, the fee chargeable for the lesser procedure should not exceed 50% of the fee charged for the lesser procedure.

• When a repeat procedure is required, consequent to the first procedure, the fee chargeable for the second procedure should not exceed 50% of the first and when a third repeat procedure is required, the fee chargeable for the third procedure should not exceed 25% of the fee charged for the first procedure.

• For procedures under local anesthetic (LA), when administered by the operating practitioner, a charge not exceeding 20% of the procedure charge may be levied.

• Fee for monitored anesthesia care make up 80% of the anesthetic fee for such procedure.

• Surgeon includes all categories of specialist except for anesthetist.

Discussion

a. The term “unless specified otherwise” leaves a dubious opening. Does this mean fees can be negotiated, as the “maximum” may be exceeded if the patient agrees with the doctor justifying higher charge?

b. Can discounts be allowed?

c. Practitioners should be allowed to charge a mutually agreed amount above the maximum in the Schedule based on the expected complexity or difficulty of a procedure and with the consent of the patient.

S. PHFSA 1998 PART XV MANAGED CARE ORGANISATION

83 (1) The licensee of a private healthcare facility or service or the holder of a certificate of registration shall not enter into a contract or make any arrangement with any managed care organisation that results in –

(c) the contravention of any provisions of this Act and the regulations made under this Act;

(d) the contravention of the code of ethics of any professional regulatory body of the medical, dental, nursing or midwifery profession or any other healthcare professional regulatory body;

(e) the contravention of any other written law.

Discussion

a. Currently, insurance firms which are called “third party payers” act to provide managed care to corporate bodies. Many of them demand private healthcare facilities and providers to give discounts (10%, 20%) on the MMA fee schedule, and those facilities or providers not agreeing to their proposals of discounted fees are ‘black listed’ and taken off their list of preferred facilities and providers.

b. It is also known that these insurance firms have private direct contract with preferred providers. This arrangement may be construed as ‘fee splitting’. The definition of Fee splitting in the PHFSA 1998 is:

• “Means any form of kickbacks or arrangements made between practitioners, healthcare facilities, organisation or individuals as an inducement to refer or to receive a patient to or from another practitioner, healthcare facility, organisation or individual.”

c. The term “maximum fees unless specified otherwise” needs to be defined. Whether the “specified otherwise” is related to specifications set out by the Ministry, the MCOs or the private healthcare facilities needs to be explained.

T. REGULATIONS 2006: PART VII: PATIENT’S MEDICAL RECORDS

Private Healthcare facility & services

44. (1) A patient’s medical record is the property of a private healthcare facility or service.

Private Medical Clinic

30 (1) A patient’s medical record is the property of a private medical clinic.

Retention of patient’s medical record

31 (1) for Private Medical Clinics

45 (1) for Private Healthcare Facilities & Services

…all original patients’ medical records or documents relating to such records shall be preserved at least for the period specified under any written law pertaining to limitation period.

32. (4) Nothing in this regulation shall be construed so as to limit the right of a healthcare professional or counsel to inspect the patient’s medical record.

Discussion

a. The term “property”’ needs to be defined as property can be a right through possession, location, intellectual, assignment or legal.

b. Section 44(1), may be interpreted by private healthcare facilities’ administrators to mean that all private specialist clinic notes (even those belonging to ‘private’ patients) be centrally stored and secured in the Hospital Records Department. The private patient notes are confidential between the private patient and the practitioner and this privacy and confidentiality may be breached by this section.

c. The “Good Medical Practice” of the Malaysian Medical Council states:

“It is well to remember that while the clinical notes and records physically reside with the doctor and the hospital, the information therein contained belongs, morally and ethically to the patient and to regulatory authorities. ..”

U. PHFSA 1998 Part XVII POWER OF MINISTER: VALID CONSENT

107. (gg) to prescribe the requirements to be satisfied for obtaining a valid consent for any anaesthetic procedure, surgical operation or procedure, diagnostic procedure, diagnostic procedure or medical procedure or treatment, the method of obtaining such consent, the conditions under which such consent may be dispensed with and for specifying the age at which a valid consent for any anaesthetic procedure, surgical operation or procedure, diagnostic procedure or medical procedure or treatment to be performed on a patient.

Discussion

a. Separate anaesthetic consent is required

b. There is no mention of “implied consent” which is a traditionally practised norm.

c. There is no mention of “informed consent”.

d. There is no mention if a witness needs to sign in the consent which is required to be “in writing”.

REGULATIONS 2006: PART VIII: CONSENT

Valid consent

47 (1) A licensee or a person in charge of a private healthcare facility or service shall obtain or cause to be obtained valid consent from a patient before any procedure or surgery is carried out on the patient.

(2) The valid consent under sub-regulation (1) shall be obtained from ---

a) the patient;

b) if the patient is mentally or physically disabled, the spouse, parent or next of kin; or

c) if the patient is unmarried and below eighteen years of age, the parent or guardian.

d. Consent obtained or caused to be obtained under this regulation shall be in writing.

e. Any person who contravenes this regulation commits an offence and shall be liable on conviction to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding three months or to both.

Discussion

a. The legal age of consent in Malaysia is 18 years, but the age for consent for marriage is 16 years. In Islamic law, the age of consent for marriage is lower.-

b. This would mean that if a patient below the legal age of consent, like age 16 or below, is married, then that person can give “legal consent”.

c. Further, no mention is made about implied consent as it is not possible to take consent for any diagnostic procedure as stipulated in Section 107 (gg) of the Act 1998 above. Diagnostic procedures where consent is implied would be taking plain X-rays or drawing blood for tests. This is normal clinical practice.

V. FEE FOR REGISTRATION

REGULATIONS 2006. FEES FOR REGISTRATION: SECOND SCHEDULE

Private Medical Clinics

• Registration (Processing Fees) RM 500

• Registration (Issuance of Certificate) RM 1000

• Transfer, assignment, otherwise disposal RM 300

• Variations of terms or conditions

or amendments to certificate RM 150

• Duplicate Copy RM 200

• Search on or extracts from Clinics Register RM 50

Maternity Homes (as an example)

• Licence to Operate (processing) RM 900 + RM 5 per bed

• Issuance Fees (certificate)

Less than 25 beds RM 2000

More than 45 beds RM 4000

• Approval to Establish (processing) RM 1500

Renewal Fees (beds) RM 2000-4000

Discussion/Proposal

The fee payable at every stage of intended registration and type of facility is exorbitant and should be revised

W. PHFSA 1998: PART XIV : BOARD OF MANAGEMENT AND ADVISORY COMMITTEE

Board of Management

77.(1) The licensee of a private hospital, private maternity home, private ambulatory care centre, private hospice, or any other private healthcare facility or service as the Minister may specify, shall establish a Board of Management of whom two members shall be from the Medical Advisory Committee established under paragraph 78(b)

Medical Advisory Committee

78 (b) where the facility or service is a private hospital…., there is established a Medical Advisory Committee whose members shall be registered medical practitioners representing all medical practitioners practising in the facility or service to advise the Board of Management…on all aspects relating to medical practice.

Discussion

The specialists in private healthcare facilities and service sometimes face employment and service problems with the Board of Management and these are often not discussed. The specialists’ representation though the Medical Advisory Committee in the Board is considered an important avenue for them to voice their opinions at the higher level.

X. PHFSA 1998: PART XVI: ENFORCEMENT

Appointment of inspectors

87. (1) The Director General may appoint such number of persons to be Inspectors as he deems necessary for the purposes of this Act.

(2) An Inspector may exercise all or any of the powers vested in him under this Part.

Power of Inspector to enter and inspect

88. (1) An inspector shall have the power to enter and inspect at any time any licensed or registered private healthcare facility or service which he suspects or has reason to believe to be used as a private healthcare facility or any other premises in or from which private healthcare services are provided without a license or a certificate of registration.….without a license or a certificate of registration.

Discussion

The powers vested on the Inspectors are vast and voracious

FURTHER GENERAL DISCUSSIONS

Y. CONVICTIONS AND PUNISHMENTS

• The fines and imprisonment, or both, for many of the infringements or non-compliance appear to be on a “free-scale” and draconian.

• If indeed these are based on established scales according to seriousness of guilt, then majority of the infringements appear extremely serious.

• When a registered medical practitioner is found guilty and fined, imprisoned, or both, he will face further disciplinary procedures under PART IV Disciplinary Proceedings of the Medical Act 1971 in Section 29 (2) of the Act, which states:

“The Council may exercise disciplinary jurisdiction over any registered person who –

(a)has been convicted in Malaysia or elsewhere of any offence punishable with imprisonment (whether in itself only or in addition to or in lieu of a fine)”

• Such practitioner, if found guilty as charged under the Medical Act section 29 (2) (a) may have his name struck off or suspended from the Register on conviction to a fine, imprisonment, or both.

For example:

Part IV Regulations: For failure to discuss charges with patient:

“Any person who contravenes this regulation commits an offence and shall be liable on conviction to a fine not exceeding ten thousand ringgit or imprisonment for a term not exceeding three months or to both.”

Part VIII Regulations 2006: For failure to control infection:

“Any person who contravenes this regulation commits an offence and shall be liable on conviction to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding three months or both.”

Part X Regulations 2006: For failure to have emergency car services or equipment, apparatus, materials, pharmaceuticals …listed in Fifth Schedule:

“Any person who contravenes sub-regulation (1), (4) (8) or (9) commits an offence and shall be liable on conviction to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding three months or to both.”

“Where no penalty is expressly provided for an offence under these Regulations, a person who commits such offence shall be liable on conviction to fine not exceeding five thousand ringgit or to an imprisonment for a term not exceeding one month or to both.”

SUPPLEMENTARY SUBMISSION BY THE

MALAYSIAN DENTAL ASSOCIATION

The Malaysian Dental Association supports the points raised in the Memorandum submitted by the Malaysian Medical Association with whom we have worked together.

In addition we would like to submit the following supplementary items which affects mainly Dental Clinics.

1 Part V Regulation 25: Statistical Returns

Patients attending dental clinic are generally healthy individuals. Also dental practitioners are not familiar with the International Classification of Disease Ten (ICD-10).

WE WOULD LIKE TO APPEAL TO BE EXEMPTED FROM THIS REGULATION.

2. Part VI Regulation 26: Greivance Mechanism

The vast majority of dental clinics are solo practitioners where compliance with the procedures set out are going to be difficult.

WE SUGGEST THAT THE GRIEVANCE OF THE PATIENTS BE DIRECTED TO THE MALAYSIAN DENTAL ASSOCIATION FOR INVESTIGATION AND MEDIATION BEFORE BEING DIRECTED TO THE DIRECTOR GENERAL.

3.Part VIII Regulation 33: Infection Control

Again the vast majority of Dental Clinics are solo practitioners dealing with healthy individuals. The number of staff employed is small in number. It will be very difficult for these dental clinics to comply with the provisions of Regulation 33.

We, however, support the use of autoclaves or equivalent equipment for infection control of equipments and materials in dental clinic.

WE SUGGEST THAT DENTAL CLINICS BE EXEMPTED FROM THE PROVISIONS OF REGULATION 33 AND THAT ALL DENTAL CLINICS BE EQUIPPED WITH AUTOCLAVES OR EQUIVALENT EQUIPMENTS.

4. Part X Regulation 75

Most dental clinics and practitioners are not equipped and prepared to deal with emergencies. Such events are not common in dental clinics of general practitioners.

WE APPEAL TO THE MINISTER TO EXEMPT DENTAL CLINICS FROM THIS REGULATION.

5. Part XI Regulation 81 and 82

The range of drugs stored and prescribed in a dental clinic is very small and there is no need for the facilities provided for in regulations 81 and 82.

WE WOULD LIKE TO APPEAL FOR THE DENTAL CLINICS TO BE EXEMPTED FROM PROVISIONS OF REGULATIONS 81 AND 82

Part XIII:Special requirements for radiological services.

Currently many dental clinics are performing endodontic and minor surgery to remove buried and impacted teeth without the assistance of Xrays. This is not satisfactory.

WE RECOMMEND THAT PROVISION FOR ALL DENTAL CLINICS TO HAVE XRAY EQUIPMENT BE INCLUDED.

End of Submission

-----------------------

MMA/MDA proposal:

a. Sections 8 (k), 8(l) should be reviewed.

b. Section 12.2 Details of clinic’s layouts should be limited to functionality rather than dimensions of doors, windows, entrances, etc.

MMA/MDA proposal:

a. To review the above “terms and conditions” in the certificate.

b. In recognition of the fact that there may be considerable administrative time lapse between application, inspection and issuance of (final) certificate, a Letter of Acknowledgement should be issued on acknowledged receipt of the application.

c. This Letter of Acknowledgement should be considered for all intents and purposes as a temporary certificate until the final certificate is issued.

This is to facilitate practitioners to rent space, commence internal construction, purchase equipment, employ staff and generally be prepared , according to specifications, before certificate of registration is issued as in Form B.

d. On-line registration should be made more user-friendly and practical.

MMA/MDA proposal:

a. Grounds for refusal should be revealed.

b. The Inspection Report ( Part IV, Section 16), particularly the adverse comments, or shortcomings, should be revealed to applicant.

c. An appeal mechanism should be instituted within this section without having to appeal to the Minister as provided for in Part XVII of the Act Power of Minister Section 101.

d. Re-submission of application for re-inspection after remedy of shortcomings should be allowed.

MMA/MDA proposal:

The punishments should be reviewed and adjusted to be consistent with the scale of punishments relative to seriousness of such crimes.

MMA/MDA proposal:

a. The time limit should be extended for one (1) year after November 2006 to allow the existing clinic to remedy deficiencies, if any.

b. Existing clinics should not be subjected to the requirements of new clinics as it may not be possible to accommodate all the standards stipulated in the Regulations without actually rendering massive renovations of existing clinics at the expense of closing down the clinic during such renovation.

MMA/MDA proposal:

Section 34 (1) and (2) should be reviewed.

MMA/MDA proposal:

The regulations should be enforced forthwith for both private healthcare facilities and private clinics.

MMA/MDA proposal:

a. To review section 17(1)(a) and 17 (1)(b)

b. The penalty is too severe. The quantum of the fine should be reduced and the imprisonment deleted.

c. A pamphlet with the fees to be charged may be made available for perusal by the patient and should suffice. It can be in four languages.

MMA/MDA proposal:

Sections 18 (1) (b) and 18 (2) should be reviewed.

MMA/MDA proposal:

These statistical returns should be transmitted through on-line links and should be imposed initially on medical clinics or dental clinics which have such facilities.

MMA/MDA proposal

Section 26 needs to be reviewed and its necessity in Regulations to be re-considered.

MMA/MDA proposal

The need for all medical clinics to be so equipped is considered too stringent. Section 50 above should be reviewed.

MMA/MDA proposal:

a. Some of the requirements, like public telephone and drinking facilities are superfluous in view of present day habits where cellular phones and drinking water bottles are so commonly carried by most members of the public.

b. Many of the requirements in this Part on General Provisions for clinics should be reviewed.

eg. Plumbing

45 (3 ) – Hands-free faucet shall be on all hand washing facilities….

Toilet

46 ( 1 )The private medical clinic shall provide

(b) each hand washing facility shall include soap , hand washing appliance and sanitary hand drying facility

(d) water-spray at each water closet

Water supply

47 ( 2 ) There shall be sufficient water supply at all times…..

House keeping

55 ( 2 ) Person in charge shall be appointed to supervise…………….

56 . Written Procedures There shall be specific written procedures for appropriate cleaning of all service areas

59 . Germicides …………………….

the selection of germicides shall be under the supervision of a person appointed under 55 ( 2 )

61. Dry dusting and sweeping

No dry dusting and sweeping in any room or area of any private medical clinic or private dental clinic are allowed

Maintenance

Written policies and procedures

71 ( 1 ) There shall be written policies and procedures for an organized maintenance programme to keep the entire private medical clinic in good repair………

MMA/MDA proposal:

a. Only clinics run by practitioners who have declared themselves trained, experienced and prepared to provide emergency care should be equipped with these special resuscitation items.

b. The requirement for general medical clinics/ or specialty clinics should be only for basic emergency assistance and immediate transfer to a hospital.

c. The Fifth Schedule in the Regulations should be reviewed.

MMA/MDA proposal:

The Board should be appointed primarily by the Hospital management and the Minister kept informed of the composition. Alternatively, the Minister may appoint not more than one-third of the members in the Board of Visitors. The privileges and functions of the Board to be determined by the Minister in Section 104(2) should ensure that members of the Board do not abuse their privilege, and conditions to this effect should be built into the terms.

MMA/MDA proposal:

This whole section should be reviewed and made into a simple reminder of the practitioners’ duty to the community rather than a prescribed and mandated activity with possible punitive implications.

MMA/MDA proposal:

a. Hospital charges should be included to make the Fee Schedule complete.

b. Discounts on the fee schedule should not be permitted as this will open to various “fee splitting” possibilities through undisclosed private arrangements between third party payers, private healthcare facilities executives and even with practitioners.

c. Practitioners should be allowed to charge reasonable fees for procedures not listed in the Fee Schedule.

d. Fees which are mutually agreed between doctor and patient, should be allowed even if they do not comply with the fee schedule.

MMA/MDA proposal

In view of the continued absence of registration and regulation of insurance firms acting as MCOs and Third Party Payers, and until the proposed MCO Bill is passed, Part XV of the PHFSA 1998 on Managed Care Organisation should be enforced forthwith.

MMA/MDA proposal:

a. The position stated in the Good Medical Practice should be adopted.

b. The limitation period for preservation of patients’ medical records should be specified for children and adults (7 years for adults and 18+5 years for children).

MMA/MDA proposal:

a. The above points need to be taken into consideration and section 47(2) should be reviewed.

b. There is a place for implied consent and this should be built in into the Act.

MMA/MDA proposal:

a. Sections 77 and 78 of the Act should be implemented forthwith, although these are not addressed in the Regulations.

b. Further, section 78 (b) should be expanded to cover the requirement that the MAC should be elected from amongst all medical practitioners in that facility or service.

MMA/MDA proposal:

It is hoped that the powers of enforcement and inspection are not executed without respect or dignity and the Inspector is a medical practitioner from the Ministry of Health rather than a non-doctor.

MMA/MDA proposal:

a. The entire lot of convictions and punishments meted out for contraventions in the Regulations should be reviewed.

b. The part on imprisonment in all these punishments should be removed so that a practitioner found liable on conviction under the Private Healthcare Facilities and Services Act 1998 is not further charged under Section 29 (2)(a) of the Medical Act 1971.

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