BLOEMFONTEIN PROTOCOLS

PREAMBLE

Realising that the legal and ethical considerations of the practise of medicine and related professions, had not yet been addressed with regard to the advent of Managed Healthcare, the Oranjemed IPA arranged a symposium: Managed Healthcare: Ethics and the Law.

The raison d'être of this two-day symposium was to draw the relevant role players together with a view to identifying possible legal and ethical problems and then to draw up the so-called Bloemfontein Protocols, which would act as a guideline for further consultation with and input to various statutory bodies, various organisations representing doctors, managed healthcare companies, patients, etc., with a view to identifying hiatuses in the current legal and ethical codes and if necessary, to see to it that these hiatuses were addressed, if necessary through formal legislation.

The symposium identified, inter alia the following problems:

1. That the present ethical rules and codes of conduct which guided and regulated

professional service providers, did not make provision for or did not adequately

address situations which may arise with the implementation of managed healthcare.

2. That accountability, while still being recognised as the final responsibility of the

individual service providers, would possibly be modified by the implementation

of managed healthcare contracts, and needed to be addressed.

3. That the confidentiality of clinical information with respect to patients, was under

threat by the requirements of managed healthcare and that this would potentially

impact upon all the role players, but specifically on the liability of the service

provider and the wishes of the patients.

4. That, while the consent signed by a patient, giving a medical aid, the medical

management company or similar kind of organisation, the right to obtain clinical

information regarding himself/herself (and by extension, information regarding

his/her family) maybe construed as prima facie evidence that such consent had

indeed been given, that the symposium had serious reservations that the patient

(or his/her family) was in most cases totally uninformed and therefore unaware

of the implications of such consent and the impact thereon, upon the confiden-

tiality of his/her relationship with his/her service provider.

Uninformed consent means - no consent.

5. That, pursuant to point 4, Article 16 of the Ethical Code of the Interim Medical and

Dental Council was insufficient as a guideline.

6. That the freedom of choice by patients may in certain circumstances, under

managed healthcare contracts, be limited and constrained.

This applies to the service provider and health care institutions, e.g. hospitals or

clinics.

7. That while the service provider was still ultimately responsible and accountable

for the diagnosis and treatment of a patient's condition, various financial and

administrative constraints were being introduced by various medical aids, medical

management companies and related organisations which could possibly, through

financial and other penalties, impact upon the freedom of choice of both the

patient and the provider, with regard to certain diagnostic, curative, preventative

or rehabilitative procedures.

This in fact means, that the managed healthcare organisations make the rules, but

that the service provider has to carry the responsibility.

8. That the gate-keeping role; that particularly the general practitioners might be

called upon to fulfil; may in fact force them to assume risks and clinical responsi-

bilities that they were unwilling or unqualified to bear and may in fact create

irreconcilable conflicts between the needs of the patients and the requirements

of such a gate-keeping role.

9. That it was unacceptable that any medical aid, medical management company

or similar organisation place any constraint upon either a patient or a service

provider to discuss openly and frankly the benefits, constraints and potential

effects of any contract, between any of the above organisations and the patient

and/or service provider.

10. That the introduction of managed healthcare plans will place an increasing

burden upon the service provider with regard to his loyalty to the needs of the

patient, the needs of all the patients in the system, his own legitimate needs and

the economic and administrative needs of the managed healthcare plan.

Therefore, a wedge is created between the doctor and his patient.

11. That patients are in general totally uninformed about the implications of their

current medical aid contracts but also more specifically, any managed healthcare

contracts and have little or no realisation of how the contracts effect them or

their rights.

It is unlikely that patients realise that medical data contains sensitive diagnostic

information.

12. That the current Managed Care and Medical Schemes' Act does not provide any

statutory requirements for managed care per se nor for certain forms of contractual payment such as capitation.

Medical aids expect that the service provider meddles with the contract between the

patient and his medical aid.

Caution must be taken against under-servicing.

Disputes should rather be avoided than dealt with.

13. That there is a singular lack of professional, statutory or other standards that

regulate the performance, security or confidentiality of medical data, by the

purveyors of electronic transfer and storage of data.

14. That managed healtcare may in fact be in contravention of one of the basic

principles of the recorded rights of patients i.e. that every patient has the right to

be cared for by a physician (service provider), whom he/she knows to be free to

make clinical and ethical judgements, without outside interference but that the

constraints of managed healtcare may in fact be more far-reaching than this.

15. That the dissemination of health information may not in the first instance be

used to the benefit of the patient or the health care professional.

Is this not just another middleman that has to be paid for by the patient’s

medical aid’s premium?

16. That in South African Law the protection of data including particularly medical

data is at best, deficient.

17. That consent by a patient to the transfer of data from the health care professional's

practice to another agency, i.e. a medical aid or a managed healthcare company

or similar group is at present implied or inferred, but that there is no clear

definition or guidelines by the courts or the Interim Medical and Dental Council

with regard to the scope, intent or usage of such information, which is at the

present entirely discretionary and may be a cause of legal problems for the service

provider.

18. That the patients and providers may be unwillingly to accept the implication that

refusal to release confidential data implied a willingness to self-fund the inter-

vention or the disease process.

19. That the service provider has the right to provide input into managed healthcare

contracts, making use of discretionary legal opinion where necessary, which

will provide for and protect his and his professional relationship with his patient.

20. That elements of managed healthcare, such as the release of information, pre-

authorisation, quality and utilisation review, the use of generic drugs and the

responsibility, should any constraints be applied to the service provider, need

to be negotiated by all parties concerned, including patient groups, in order to

avoid future litigation and indeed a failure of the whole process and also to

prevent what is currently occurring in the United States, where laws are needed

to be promulgated, to address the problems created by managed healthcare.

21. That service providers have a right to protect their own legal rights and to par-

ticipate in any decisions that they will be held accountable for, particularly the

right to act in the interests of their patients and to retain their professional

autonomy.

22. That the successful implementation of managed healthcare, needs the identifica-

tion of common goals by all the role players, including the patients and providers,

in order to introduce joint and acceptable strategies.

Presently it seems to be planned one-sidely.

23. That no contract should be signed by any service provider or service provider

group acting for individual service providers, until there has been a full disclosure

of all the relevant and pertinent documentation regarding such a managed health-

care contract.

24. That it is probably impossible from both the patients' and the providers' perspec-

tive, to safely introduce managed healthcare contracts, before the questions

raised, particularly the questions of accountability, confidentiality and the

affects of constraints included in any managed healthcare contract, are examined,

identified, more clearly defined and where necessary, statutorily regulated.

THE BLOEMFONTEIN PROTOCOLS

Emanating from the above points, the following protocols were decided upon:

1. THE INTERIM MEDICAL AND DENTAL COUNCIL

That given the stated willingness by the learned Council to address the issues involved with the input from the widest possible spectrum of role players, that Council be requested to:

1.1 Examine the inherent vagueness of Ethical Rule 16 and give consideration to

defining it more clearly, with the object of providing greater clarity and guidance

for both patients and the professions, particularly where the tenets of any managed healthcare or other contract, conflict with the rule.

1.2 Give urgent attention to the proposed managed healthcare contracts, with a view

to identifying any conflicts between the existing ethical codes and regulations

and the said contracts in order to formulate precise and clearly delineated ethical

codes and guidelines for the protection of the public and the guidance of the

profession in this new dispensation.

1.3 Give particular consideration to the modification of existing codes of conduct

and where necessary, the institution of new codes, which will address inter alia,

but not exclusively, the accountability of service providers, how consent, including stated, implied or presumed, would affect the liability of the service providers.

1.4 Identify clearly which issues were ethical and non-ethical.

1.5 Set up a permanent group which could evaluate all contracts presented to service

providers or groups of service providers in order to evaluate them with regard

to ethical and professional acceptability.

1.6 Examine generally all the aspects of managed healthcare and related issues, with

a view to determine the ethical correctness of the process, and if necessary, recom-

mending legislation.

2. REGISTRAR OF MEDICAL SCHEMES

In concert with the Representative Association of Medical Schemes, individual medical aids and benefit funds and managed healthcare companies, and with input of all role players is requested to:

2.1 Examine with great urgency the setting-up of a statutory body which will lay down ethical codes and regulations which will be binding on all forms and types of medical care organisations including medical aids, medical benefit societies, medical manage-ment companies and related or similar organisations with the express intention to ensure that such codes and regulations take full cognisance of and relate, pari passu, to the ethical codes that pertain to and regulate the service providers as drawn up by the Interim Medical and Dental Council, modified from time to time, having as its goal that of obviating any conflict between the two sets of ethical codes.

2.2 Make every effort, including the proposal of legislation, to ensure that any medical care organisation (see above) is required to fully inform every member or potential member (patient) of his/her full rights under the contract, but more particularly, what services are not available and what constraints will be in place with regard to the choice of service provider, a scope of the service provider's practise, how it is limited and what the effects and penalties of such limitations may have upon the member or his family and what responsibility the managed care organisation will carry, should the implementation of its limitation in the contract have a deleterious affect upon the patient's obtaining of healthcare or treatment or the patient's health.

2.3 To examine ways by which any clause in respect of consent may be explained to the patient with particular guard to the confidentiality of information.

2.4 Promote legislation which would regulate all forms of third party payments and related systems of payments, with due regard to the rights and benefits of patients and the ethics and rights of service providers and the needs of the third party payors including both paragraph 2.2 (vide infra) and the suggestions as set out in his formal presentation.

2.5 To address as a matter of urgency and as an interim measure, the inconsistancy of

current contracts which are being constantly amended and which place new con-

straints and make new demands upon both patients and providers.

2.6 Use his knowledge, experience and expertise of his department, to identify potential problems in the managed healthcare field, and more particularly in the contracts pertaining thereto, in order to make recommendations to the various relevant authorities including government as well as the various role players, including the various organisations that represent doctors and patients.

2.7 Identify what information will be required for the business purposes of managed

healthcare companies, which will be compatible with the rights of both patients

and the service providers. It was particularly felt that the rule that an account

only contain a description of a procedure and not the diagnosis, be retained.

2.8 Examine the proposed system of coding so as to retain the confidentiality of the

patient.

3. THAT THE VARIOUS MEDICAL CARE ORGANISATIONS, INCLUDING MEDICAL AIDS, MEDICAL BENEFIT SOCIETIES, MANAGED HEALTHCARE COMPANIES AND RELATED OR SIMILAR ORGANISATIONS BE URGENTLY REQUESTED:

3.1 To take full cognisance of the reservations and potential problems relating to

managed healthcare, ethics and the law, as identified at the symposium and that

they individually/or as a group address such problems with the input of the relevant

role-players, including the representative organisations of the service providers and patients.

3.2 To devise acceptable, practical and effective systems, whereby the patients

belonging to their organisations are fully and clearly informed as to their rights

with regard to any consent clauses, and what they entail, precisely how the

practices of service providers who they may consult under the rules of the

managed healthcare contract may potentially be circumscribed or constrained

and what their options are, should their healthcare providers require diagnostic

or treatment modalities which are out-with the managed healthcare programme.

3.3 To include in their contracts either a willingness to accept accountability for any constraints which they may place upon the diagnostic or treatment modalities

of service providers and what the extent of their accountability, will be or in the

event that they do not accept any such accountability that any such disclaimer, is

prominently brought to the attention of both their clients and the service providers.

3.4 Define what information they require to run their organisations effectively and

to ensure that the delivery of such information is compatible with the confiden-

tiality requirements of the patients, the ethical rules of the Interim Medical and

Dental Council and the professional relationship between the patient and the

service provider and the rules governing that relationship.

3.5 That they ensure that any future amendments to their organisation's rules remain

within the original frameworks of the ethical codes laid down.

3.6 To ensure that all contracts are the result of bi-lateral negotiations between the

relevant parties, including, where applicable, representative associations of service providers and patients and that such contracts will in every case address the ethical and legal issues of healthcare, as identified in this document, in order to protect the rights of all the co-signees.

3.7 To take cognisance of the fact that many patients are not proficient in either the

language of the contract or in the terminology of the contract and that many

patients are unsophisticated, so that special consideration is given to this potential

problem in order to ensure that all patients are fully and clearly informed.

4. THAT THE PURVEYORS OF INFORMATION TRANSPORT SERVICES BE ASKED AND REQUIRED:

4.1 To draw up acceptable codes of conduct including ethical rules, assurances of

confidentiality and the acceptance of responsibility of data in their care.

4.2 To set up procedures which will ensure the ethical, secure and confidential treatment of data.

4.3 To give clear indications as to the ownership of data and information, during the various stages of their operations.

4.4 That they, together with other role players set up accreditation standards and an

accreditation body for the future control of electronic transportation of medical

data.

5. SERVICE PROVIDERS THROUGH THERE VARIOUS REPRESENTATIVE ORGANISATIONS INCLUDING IPAs, THE VARIOUS IPA UMBRELLA BODIES, THE SAMDP, THE MEDICAL ASSOCIATION OF SOUTH AFRICA AND OTHER SIMILAR OR RELATED BODIES:

5.1 Further identify what, in relation to the implementation of managed healthcare and the contracts pertaining thereto, they require from the Interim Medical and Dental Council, the medical care organisations and the legal fraternity, in order to ensure that such managed healthcare contracts comply with the relevant ethical and legal provisos.

5.2 That they come up with consensus opinion on their requirements in these managed healthcare contracts, including, but not limited to the confidentiality of information, their gate-keeping role and its responsibilities, pre-authorisation, the limiting of their diagnostic and treatment modalities by such contracts, including the use of limited drug lists, quality review, etc. and to take such an opinion to the relevant statutory bodies and managed healthcare organisations concerned.

5.3 That they define the limits of culpability which they are prepared to accept in the event that their delivery of healthcare is limited or circumscribed by a managed healthcare contract.

5.4 That they agree, on a consensus basis, that where such a contract limits or precludes them from instituting any diagnostic, curative, preventative or rehabilitative procedures, that they inform their patients of the salient facts, giving them the various options, or where required referring to the organisations which have contracted them as their third party payors.

6. PATIENT REPRESENTATIVE BODIES WHERE ASKED AND REQUIRED:

6.1 To identify themselves with a view to giving input into the various matters raised.

6.2 To give specific input on the question of confidentiality of their medical data,

particularly with due regard to the requirements of a managed healthcare programme.

6.3 To make recommendations with regard to the limits that may be placed upon their chosen healthcare providers in respect of diagnostic, curative, preventative and rehabilitative procedures.

6.4 To identify their requirements and needs within the managed healthcare system.

6.5 To make any proposals for legislation which would protect their interests in the

managed healthcare system.

THE COMMITTEE

Consensus opinion amongst the delegates to the symposium was that a committee should be formed in order to ensure that the Bloemfontein Protocols, as enunciated above, were carried forward and be implemented and that all the role players who had attended the conference and relevant role players who had not, were informed of the protocols and the various responsibilities as set out therein.

The committee was specifically tasked with seeing that the goals as set out in the Bloemfontein Protocols were attained.

The committee would be under the patronage of the Oranjemed Independent Practitioners' Association, who would also, if required, provide the secretariat and support services for the committee.

The following personages were elected onto the committee:

Prof. F van Oosten - University of Pretoria, Faculty of Law (Chairman)

Dr WJ Herholdt - Oranjemed IPA

Mrs I Wilken - Consumer Council

Dr K Letlape - SAMDP

Dr A Rothberg - Southern JV

It was felt, for the purposes of efficiency, this committee would be kept at this number, but that it would have the right to co-opt other persons on an ad hoc basis.

The modus operandi and the name of the committee would be decided by the committee itself.

The only requirement, apart from its stated task, would be, that it would make an interim report to all the delegates to the conference and where required other role players, within two months.

ADDENDUM

The following were the speakers and chairmen at the symposium:

Mr N Barendrecht - Safsure

Dr JJ de K Botha - Schering- Plough

Rev M Chabaku - Speaker of the Free State Provincial Legislature

Dr M Chetty - Greater Durban Practitioners' Association

Mr H Cooper - Q EDI

Dr WJ Herholdt - Oranjemed Independent Practitioners' Association

Mr K Hollis - Medscheme

Dr B Gampel - Hosmed

Mr L Kelbrick - MacRobert de Villiers, Lunnon & Tindell - Attorneys

Mr D Kolver - Registrar of Medical Schemes

Dr K Letlape - South African Medical and Dental Practitioners

Mr R Magennis - Medscheme

Mr N Prinsloo - Registrar, Interim Medical and Dental Council

Dr A Rothberg - Medical Director, Southern JV

Dr E Snyman - Vice-chairman, National Association of Independent Practitioners'

Associations

Dr A van der Merwe - National Association of Private Hospitals

Mrs S van der Merwe - Oranjemed IPA

Prof. F van Oosten - Professor in Criminal and Medical Law, University of Pretoria

Dr G Veliotes - Medical Association of South Africa

Dr A A Visser - Oranjemed Practitioners' Association

Mrs I Wilken - Consumer Council

SPONSORS AND EXHIBITORS

The organisers of this symposium are proud and grateful to list the following companies, who willingly and unstintingly, rendered financial and other assistance to this symposium. Without their contribution this symposium could not have been held and a debt of gratitude is acknowledged:

Astra Pharmaceuticals Ciba Geigy

Boehringer Ingelheim Janssen Pharmaceutica

Lederle Laboratories Lennon

3M Pharmaceuticals Medpro Pharmaceutica

Parke-Med Pfizer

SAD Ethicals Sandoz

Servier Laboratories Smith Kline Beecham

Triomed UCB

Zeneca

Drawn-up by Dr AA Visser

ORANJEMED INDEPENDENT PRACTITIONERS' ASSOCIATION