Proposed Regulations on the publication of reference price lists
Submissions by interested parties on the regulations relating to the obtaining of information and the processes of determination and publication of reference price lists proposed under National Health Act are invited by the 28th February 2007. These proposed regulations are contained within Regulation Gazette, no. 29443 published on the 1st December 2006. These regulations are relevant to healthcare funders and healthcare providers and include provisions for the calling, by the Director-General of Health, for information relating to health financing, the pricing of health services, business practices within or involving health establishments, health agencies, health workers and health care providers. Click here to download Gazette no. 29443 The regulations also make provision for the inclusion of information pertaining to overhead costs, activity times for procedures, equipment, labour costs, costs relating to the maintenance of premises, etc. The proposed regulations call for the DG of Health, in determining a reference price list, to take into account aspects including the need for private health establishments to have reasonable return on investment; the need for health care providers to earn a reasonable income; the need for certainty, sustainability and stability within the sector; the need to improve and maintain efficiency and quality in the delivery of health care services; the need to eliminate perverse incentives, unethical business practices and unprofessional conduct from the private health care industry; and the legal obligations of medical schemes in terms of the Medical Schemes Act.
Amendments to regulations relating to a transparent pricing system for medicines and scheduled substances
In terms of the Medicines and Related Substances Act, this gazette (no. 29443) also includes amendments to regulations made by the Minister of Health relating to the transparent pricing system. These include the amendment of term definitions previously used, including those of ‘dispense’ and ‘logistical services’, as well as the substitution of regulation ten, referring to the appropriate dispensing fee to be charged by pharmacists. The draft Methodology for International Benchmarking of Medicine Prices in South Africa is also included in this gazette. It elaborates the views of the Pricing committee and the Department of Health in this regard and explains in what context various definitions will be used as well as to what level benchmarking will be applied to the different categories of medicines and scheduled substances. Deadline for comments was the 19th March 2007. The gazette also lists information which should be published by manufacturers and importers of medicines and scheduled substances before taking an increase in the SEP.
Inquiry by the South African Human Rights Commission
The South African Human Rights Commission (SAHRC) has announced a public inquiry into the right to have access to health care service Government Gazette No 29611 of 16 February 2007. The SAHRC is a national institution established to entrench constitutional democracy through the promotion and protection of human rights. It states in its introduction and rationale for the inquiry that apart from high profile court judgments, investigations and annual surveys that pronounce on the ills of the sector, the SAHRC has received many complaints with regard to poor service delivery in the health care system in all the provinces. These information sources point to the lamentable state of many hospitals in the country, the shortage of trained health care workers, lack of drugs in clinics, long waiting periods for treatment, poor infrastructure, disregard for patient’s rights, the shortage of ambulance services and poor hospital management. The SAHRC has also visited various health facilities in the Northern Cape, North West Province and Mpumalanga, the Eastern Cape and Western Cape where it found that conditions in many clinics and hospitals were unacceptable. The SAHRC has powers in terms of section 184(2) of he constitution to investigate and report on the observance of human rights and to take steps to secure appropriate redress where human rights have been violated. The Commission will call for submissions from the public and interested parties including institutions, organizations and individuals on any matters referred to in its terms of reference. The closing date for submissions was the 30 March 2007. The Commission may invite specific individuals, organizations, institutions and any other parties to make documentary and/or oral submissions and testimony to the public inquiry. Such testimony may be given under oath or affirmation.
Tax Guide on the Deduction of Medical Expenses
'This guide is based on the legislation as at 25 July 2006, including the amendments effected by section 25(1)(a) of the Revenue Laws Amendment Act, Act 31 of 2005 which are applicable in respect of any year of assessment commencing on or after 1 March 2006. The Pharmaceutical Stakeholders Forum (PSF) launched an urgent court interdict in Tshwane today, to prevent the department of health from implementing the new dispensing fee structure on January 1. This guide is based on the legislation as at 25 July 2006, including the amendments effected by section 25(1)(a) of the Revenue Laws Amendment Act, Act 31 of 2005 which are applicable in respect of any year of assessment commencing on or after 1 March 2006.' Click here to download the Tax Guide on the Deduction of Medical Expenses
New Regulations on Human Tissue
Published for Public Comment On 05 January 2007, the Department of Health published for public comment two sets of regulations under the National Health Act 2003. These are Regulations on Artificial Fertilisation and Related Matters and Regulations Regarding The Use Of Human DNA, RNA, Cultured Cells, Stem Cells, Blastomeres, Polar Bodies, Embryos, Embryonic Tissue And Small Tissue Biopsies For Diagnostic Testing, Health Research And Therapeutics. The period given for comment in both cases is three months from the date of publication of the relevant notice. The first set of Regulations published in Government Gazette No29527 of 05 January 2005 deals with artificial fertilisation and related matters. These regulations may be of interest to medical schemes because in terms of the regulations to the Medical Schemes Act, female infertility is a prescribed minimum benefit condition in the following terms CODE: 902M DIAGNOSIS: INFERTILITY TREATMENT: MEDICAL AND SURGICAL MANAGEMENT The regulations cover a number of issues relating to artificial fertilisation, including record keeping, informed consent, a definition of ‘deceased’ as somatic death, serious genetic conditions, restrictions on the donation of gametes, prerequisites for the removal or withdrawal of gametes, gamete donor files and the destruction of gametes, requisites for artificial fertilisation and embryo transfer etc. It is not practical to full reproduce them in this communiqué, even aside from issues of copyright. An indication is given below of some of the content of these draft Regulations. In the Regulations "artificial fertilisation" is defined as - “conception resulting from artificial insemination or in vitro fertilisation of a woman; "artificial insemination" means the placing of male gametes (sperm) into the female reproductive tract by means other than copulation” The regulations stipulate that no person, except a competent person, may remove or withdraw a gamete or cause a gamete to be removed or withdrawn, from the body of a gamete donor for the purpose of artificial fertilisation. A ‘competent person’ is defined as -
(a) a gynaecologist with training in reproductive endocrinology, particularly in the use of ovulation-inducing agents and the hormonal control of the menstrual cycle; (b) a gynaecologist with training in pelvic reparative (infertility) surgery and laparoscopic and ultrasound-guided oocyte retrieval techniques; (c) an ultrasonographer with specialised training in gynaecologic sonography who provides the monitoring of follicular development; (d) an expert in male reproduction (andrology) with special training in semenology; (e) an expert in male reproductive surgery; (f) an expert in the organisation and maintenance of a basic or clinical embryology laboratory as well as tissue culture techniques; (g) an expert in gamete and embryo cryopreservation techniques; or (h) an expert in gamete biology and experience in microoperative techniques; The Regulations provide that a person from whose body a gamete has been removed or withdrawn may be reimbursed for any reasonable expenses incurred by him or her in order to donate a gamete as contemplated in section 60(4)(a) of the Act.
The draft regulations also provide that -
- Artificial fertilisation or embryo transfer must only be effected at an authorised or prescribed institution.
- No more than three zygotes or embryos may be transferred to the recipient during an embryo transfer procedure, unless there is a specific medical indication to the contrary
- A competent person must destroy a zygote or embryo, which she or he has in storage as soon as the recipient for whom that zygote or embryo has been effected conceives or as soon as it is decided not to go ahead with the embryo transfer into that recipient subject to certain exceptions.
- An artificial fertilisation or embryo transfer may only be effected after the competent person has -
- (a) notified the Director-General in writing of the name or names of the authorised or prescribed institution where she or he intends to perform such artificial fertilisation or embryo transfer; and (b) in her or his possession a written approval of such intended artificial fertilisation or embryo transfer.
- Gametes removed from a person younger than 18 years of age may generally not be used for purposes of artificial fertilisation
- The Director General must establish an electronic data bank into which all information regarding gamete(s) and embryo(s) donations are stored.
- Regulations on Stem Cells, Therapeutic Cloning and Biotechnology The second set of Regulations was published in Government Gazette No 29526 of 05 January 2007. Once again these regulations are too comprehensive to be reproduced in full in this communiqué. Interested members are advised to obtain a copy of the Gazette. The Regulations cover issues such as harvesting of human biological material from deceased persons and from the living, preimplantation and prenatal testing for sex selection, research relating to the use of gametes, embryos, foetuses, cultured cells and stem cells, ownership of excess embryos, umbilical cord blood, aborted foetuses before harvesting of stem cells, therapeutic cloning etc. Medical schemes are likely to have an interest in these regulations from the point of view of being increasingly required to fund biotechnology based health services as the new technologies develop. These regulations define a competent person as – a) in the case of the intravenous withdrawal of blood, a person registered in terms of the Health Professions Act, 1974 (Act No. 56 of 1974) as a medical practitioner or the Nursing Act, 2005 Act No. 33 of 2005) as a nurse, or in the case of intra-arterial withdrawal of blood, a medical practitioner registered as a specialist in the procedure; (b) in the case of a finger prick for the withdrawal of a drop of blood for testing purposes, a person mentioned in paragraph (a) or any person who has been trained to perform such a procedure; (c) in the case of a developing blastocyst, an expert in organisation and maintenance of a basic or clinical embryology laboratory as well as tissue culture techniques; (d) in the case of a gamete removal or withdrawal, a gynaecologist with training in reproductive endocrinology, particularly in use of ovulation-inducing agents and the hormonal control of the menstrual cycle; or (e) in the case of collection of cells from the inside of the cheek (buccal swab), any person who has been trained to perform such a procedure or the person himself/herself who provides the sample for genetic testing; The Regulations provide that no person, except a registered medical practitioner or dentist, may harvest biological material for genetic testing, health research or therapeutic purposes. Biological material for genetic testing, health research or therapeutic purposes may only be harvested in - (i) a hospital or an authorised institution; (ii) prescribed institution; or (iii) for ancestry analysis, a research institution such as a museum. A person may not remove any biological material from the body of another living person for the purpose of genetic testing, health research or therapeutics, unless it is done - (a) with the informed consent of the person from whom such biological material is removed; or (b) where the person is younger that 18 years for the medical treatment of such person - (i) an informed consent by a child over the age of 12 years, provided the child is of sufficient maturity and has the mental capacity to understand the benefits, risks, social and other implications of the procedure; (ii) an informed consent of a parent, guardian or care giver where the child is younger than 12 years or the child is over 12 years but has no sufficient maturity or the mental capacity to understand the benefits, risks, social and other implications of the procedure; (iii) consent by head of the health establishment in the case of an emergency; (iv) consent by the Minister if the parent, guardian orcaregiver of the child- (aa) unreasonably refuses to give consent or assist the child in giving consent; (bb) is incapable of giving consent or cannot assist the child in giving consent; (cc) cannot be readily traceable; or (dd) is deceased. DNA, RNA, cultured cells, amniocytes, stem cells, gametes, polar bodies, lastomeres and small tissue biopsies including single cells from developing blastocysts, may be removed or withdrawn from living persons and used for the following specific medical and dental purposes – (a) DNA, RNA and chromosome-based genetic testing including: (i) diagnostic tests; (ii) testing for genetic carrier status; (iii) antenatal diagnosis; (iv) voluntary presymptomatic, predictive or susceptibility testing, screening tests, drug response or toxicity tests,identity or paternity testing; (v) tests that are performed post-natally; (vi) preimplantation DNA tests to be carried out on a polar body of an ovum, in order to ensure that an ovum that does not carry a mutation that causes a serious genetic condition can be selected for in vitro fertilisation; (vii) preimplantation DNA tests following the removal of a polar body or one or two blastomeres of a developing embryo can be carried out for the purpose of ensuring implantation of an embryo, without a mutation that causes a serious genetic condition. These regulations are of a fairly scientific and technical nature but they will impact on medical scheme benefits sooner rather than later and members are urged to consider their potential impact on schemes if not for purposes of making comment on the draft regulations then for purposes of benefit design.
Benefit Design - A Policy Response to cirucular 8
The Council for Medical Schemes has proposed certain policies for a new benefit framework in Circular 8 entitled ‘Consultation on a Revised Benefit Structure for Medical Schemes. In the Circular it is proposed that in addition to prescribed minimum benefits, schemes must offer to all of their members benefits that are common across all options within the scheme. This is to increase community rating within the scheme so that all members pay the same contribution for the same benefits and to eliminate practices that amount to risk rating through the use of options within medical schemes. BHF has developed a policy document which discusses in some depth the proposals of Circular 8 and the medical schemes industry policy position on these proposals at present. Read the document name on the Communiques page.
National Credit Act
The National Credit Act (NCA) No 34 of 2005 is designed to achieve a number of objectives most of which are to benefit and protect the consumer. It regulates consumer credit and seeks to ensure fair and non-discriminatory access to consumer credit and improved standards of consumer information. It also seeks to promote responsible granting of credit and provides for debt re-organisation in cases of over-indebtedness. Those credit providers who provide credit recklessly can find their agreements with consumers suspended and the credit provider’s rights under the agreement or under any law in respect of that agreement are unenforceable. Some agreements may be unlawful in terms of the NCA.
A critical analysis of the National Credit Act in the context of medical schemes and Practical guidelines on contracting issues involving the National Credit Act
- The Head of Health Service and Legislation at BHF, Debbie Pearmain, compiled an evaluation of the NCA legislation in order to assess the impact and cost implications of this legislation to medical schemes and Practical guidelines on contracting issues involving the National Credit Act.
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Summary of the National Credit Act
- Medical schemes as credit providers:
- Medical schemes will not be affected unless they charge interest on loans to members or savings accounts in debit
- Medical schemes as credit consumers:
- Contracts between schemes and providers could be affected if there are penalty clauses for late payment, provisions for interest on overdue payments etc
- Contracts with credit providers who are not registered with the NCR are invalid
- Click here to view the National Credit Act and Regulations
- National Credit Act 34 of 2005
- Regulations
Considerations for Medical Schemes Road Accident Benefit Scheme
“Strategy for The Restructuring of the Road Accident Fund As Compulsory Social Insurance in Relation to the Comprehensive Social Security System”
Gazette No 29017 of 08 September 2006 - published for public comment In June 2006 Cabinet approved in principle a plan for the Road Accident Fund (RAF) to be replaced by a Road Accident Scheme. Although Cabinet approved the plan to restructure the RAF in principle, it still needs to go through a process of public participation. According to the Department of Transport, it will only be implemented in the 2008/2009 financial year. It is stated in the document that three pillars represent the components of the Comprehensive Social Security System (CSSS). The first pillar provides basic universal protection; this includes grants and free healthcare. The second pillar provides for compulsory contributory cover for individuals in a position to contribute to the protection of specific risks such as road accidents. The third pillar provides discretionary protection based on preferences and willingness to pay. The Road Accident Benefit Scheme will form part of the CSSS as a form of contributory social insurance (Pillar 2) with a scheduled framework of benefits.Attachment Size Tax Guidelines 120.28 KB BHF Submission on the Medical Schemes Amendment Bill 377 KB Gazette no. 29443.pdf 1.53 MB