May 2014

CERTIFICATE OF NEED

The sections of the National Health Act regarding the requirement of a certificate of need by health establishments were implemented on 1 April 2014. “Health establishments” included for example medical and dental practices. Certificates of need were required to:

• Establish, construct, modify or acquire a health establishment or health agency;
• Increase the number of beds in or acquire prescribed health technology at a health establishment or health agency; or
• Provide prescribed health services.

The technology and health services would be prescribed by Regulation. Certificates of need would be valid for a prescribed period, which might not exceed 20 years and would be issued by the Director-General of Health. A decision of the Director-General could be appealed to the Minister of Health. The Director-General had to take the following matters into account when issuing or renewing a certificate of need:

• The need to ensure consistency of health services development in terms of national, provincial and municipal planning;
• The need to promote an equitable distribution and rationalisation of health services and health care resources and to correct inequities based on racial, gender, economic and geographical factors;
• The need to promote an appropriate mix of public and private health services;
• The demographics and epidemiological characteristics of the population to be served;
• The potential advantages and disadvantages for existing public and private health services and for any affected communities;
• The need to protect or advance persons or categories of persons designated in terms of the Employment Equity Act within the emerging small, medium and micro-enterprise sector;
• The potential benefits of research and development with respect to the improvement of health service delivery;
• The need to ensure that ownership of facilities did not create perverse incentives for health service providers and health workers;
• The quality of health services rendered by the applicant in the past, if applicable;
• The probability of the financial sustainability of the health establishment or health agency;
• The need to ensure the availability and appropriate utilisation of human resources and health technology;
• Whether the private health establishment was for profit or not; and
• Compliance with the requirements of a certificate or non-compliance, if applicable.

There were no Regulations in place to support these provisions. The Act made provision for Regulations to be issued by the Minister in respect of:

• The requirements for the issuing or renewal of a certificate of need;
• The requirements for a certificate of need for health establishments and health agencies existing at as well as those coming into being after the time of commencement of the relevant sections of the National Health Act;
• Any other relevant matter relating to the granting of a certificate of need; and
• The inspection and administration of health establishments and health agencies.

The Regulations had to:

• Ensure the equitable distribution and rationalisation of health, with special regard to vulnerable groups such as woman, older persons, children and people with disabilities;
• Prescribe the formats and procedures to be used in applications for the issuing and renewal of certificates of need and the information that had to be submitted with such applications;
• Ensure and promote access to health services and the optimal utilisation of health care resources, with special regard to vulnerable groups such as woman, older persons, children and people with disabilities;
• Ensure compliance with the provisions of the National Health Act and national operational norms and standards for the delivery of health services;
• Seek to avoid or prohibit business practices or perverse incentives, which adversely affected the costs or quality of health services or the access of users to health services;
• Avoid or prohibit practices, schemes or arrangements by health care providers or health establishments that directly or indirectly conflicted with, violated or undermined good ethical and professional practice; and
• Ensure that the quality of health services provided by health establishments and health agencies conformed to the prescribed norms and standards.

The Regulations could also prescribe the fees payable in respect of the applications for the issuing and renewal of certificates of need.

Existing health establishments had to obtain certificates of need within 24 months. Health establishments that operated without such certificates would commit an offence for which the penalties were a fine and/or imprisonment for a maximum of 5 years.

HPCSA VERDICTS

The HPCSA has made the following verdicts regarding matters of professional conduct by registered practitioners during the period January to March 2014:

CATEGORIES OF COMPLAINTS	TYPES OF COMPLAINTS	PENALTIES
CLAIMING FOR SERVICES NOT RENDERED / INACCURATE ACCOUNTS	Claiming for procedures and/or medicine from patients / medical schemes that were not performed / dispensed Irregular claims and incorrect tariff codes	Suspension from practice for periods ranging from 6 months to 3 years of which the operation was suspended for variable periods Fines of R5 000 or R10 000 often together with a suspension from practice of which the operation was suspended for variable periods Admission of Guilt Fines ranging from R8 000 to R20 000 Caution and reprimand
FAILURE TO PROVIDE ADEQUATE CARE	Failure to recognise and act on complications subsequent to an operation Failure to provide adequate (post-operative) care Failure to care for critically ill patient, follow up on test results and attend to patient in ICU Failure to assess and/or examine patient adequately Failure to consider differential diagnosis in pre-operative assessment, abandonment of patient in care of other attendants, prohibition on transport of patient by ambulance and failure to follow patient up at another hospital	Fines ranging between R7 500 and R35 000 Admission of Guilt Fines of R10 000 Suspension from practice for 12 months of which the operation was suspended for 3 years
FAILURE TO OBTAIN INFORMED CONSENT	Failure to obtain informed financial consent for care and procedures to be performed Treatment of minor children without consent of parent Quotation to patient was for routine procedure and did not indicate that additional charges could apply to unscheduled / emergency procedure	Fines of R5 000 Admission of Guilt Fines ranging from R5 000 to R10 000 Caution
DISPENSED INAPPROPRIATE MEDICATION	Dispensing of inappropriate medication for children under the age of 12 years Dispensed expired medicine	R100 000 or 10 years, of which the operation of 50% was suspended for 5 years Admission of Guilt Fine of R5 000
BREACHING PATIENT CONFIDENTIALITY	Divulging of confidential patient information without written consent from patient Breached patient confidentiality by faxing test results to patient’s workplace	Admission of Guilt Fines of R10 000
MULTIPLE PROFESSIONAL CONDUCT MATTERS	Breached confidential relationship Statements in letter to prosecutor not based on sufficient information Did not state limitations and/or potential bias of findings Deserted patients – did not continue with therapy Omission of registered profession on letterhead Entered into multiple relationships with patients e.g. marital and family therapist	Suspended from practice for 2 years of which the operation was suspended for 3 years and practitioner had to attend Ethics course and submit proof of compliance
OVERSERVICING	Over-servicing	Fine of R50 000 and suspended 12 months from practice of which the operation was suspended for 3 years
SPLIT-BILLING AND PRE-PAYMENT OF FEES	Split-billing Split-billing (which included charging of an administrative fee) and collected fees upfront	Fine of R10 000 and suspension from practice for 2 years of which the operation was suspended for 3 years Admission of Guilt Fine of R10 000
UNREGISTERED PRACTITIONERS	Locum not registered at HPCSA Employed unregistered person and allowed unregistered locum to sign documents on practitioner’s behalf Allowed patient to be treated unknown person	Fines ranging from R5 000 to R15 000 R20 000 fine and suspension from practice for 12 months of which operation was suspended for 5 years
UNLICENSED RESEARCH	Conducted unlicensed research and did not obtain consent of hospital manager	Caution and reprimand
PATIENT COMMUNICATION	Failure to communicate with patient in a polite and professional manner Communicated to patient in disrespectful / rude manner or which amounted to verbal abuse	Suspension from practice for 12 months of which the operation was suspended for 3 years Admission of Guilt Fines ranging from R5 000 to R20 000
SEXUAL HARASSMENT	Sexual and verbal harassment	Fine of R50 000 and suspended from practice for 2 years of which the operation was suspended for 5 years and to be subjected to CPD audit
SCOPE OF PRACTICE	Misrepresented registered profession and acted outside scope of practice	Suspended from practice for 6 months of which operation was suspended for 12 months and had to attend Ethics course on scope of practice
POST MORTEM	Performed inadequate / incomplete post mortem resulting in incorrect cause of death	Caution and reprimand
CORRESPONDENCE FORM HPCSA	Did not respond to correspondence form HPCSA	Admission of Guilt Fine of R10 000

COMPETITION COMMISSION INQUIRY

The Health Inquiry into the Private Health Care Sector that was envisaged by the Competition Commission would probe the private health care sector holistically to determine the factors that restricted, prevented or distorted competition and underpinned increases in private health care prices and expenditure. Should there be features that would adversely affect competition, the Panel could make recommendations that could include new or amended policy, regulation or deregulation and an investigation of an alleged prohibited practice by a particular firm in terms of the Competition Act. The decision to initiate such an investigation would be made by the Competition Commission.

The chairperson of the Panel of the Inquiry, the former Chief Justice Sandile Ngcobo, advised that the market inquiry would be investigative and inquisitorial in nature and not accusatorial. No one was accused of anti-competitive conduct. The focus would be on how the market as a whole functioned. The Inquiry Panel would gather evidence and insights into private health care through public hearings, review of secondary material, information requests, consultations and summons, as required. The provisions of the
Competition Act relating to confidential information would be applicable to the Market Inquiry. Persons submitting information to the Inquiry were entitled to claim confidentiality, which claims had to be accompanied by statements explaining why the information had to be kept confidential. Claims of confidentiality that were disputed would be determined by the Competition Tribunal. All valid claims of confidentiality would be protected from disclosure under the provisions of the Act.

Administrative Guidelines, which were aimed at facilitating the gathering of information and the conduct of the Inquiry, as well as a Statement of Issues, which would assist persons who would like to submit information to focus on the issues relevant to the Inquiry, would be published. The draft Guidelines and Statement of Issues were published on 30 May 2014 for comment. It was envisaged that the Inquiry would officially commence on 1 August 2014 and be concluded by November 2015.

The timelines for the Inquiry were as follows:

IMPORTANT DATES	EVENTS
1/8/2014	Publish final Statement of Issues and Administrative Guidelines and Call for Submissions on subject matter of Inquiry
1/8/2014-30/10/2014	Receive submissions
1/11/2014-31/1/2015	Analysis of information
1/3/2015-30/4/2015	Public hearings
1/5/2015-31/7/2015	Analysis and targeted public hearings and information requests
October 2015	Publish provisional findings and recommendations

DISPENSING FEE REVISED

OLD DISPENSING FEES		DISPENSING FEES WITH EFFECT FROM 3 APRIL 2014
Single Exit Price (SEP)	Maximum Dispensing Fee (Excl of VAT)	Single Exit Price (SEP)	Maximum Dispensing Fee (Excl of VAT)
=R90	30% of SEP	=R103	30% of SEP
>R90	R27	>R103	R30.90

A notice had to be clearly displayed in the dispensing practice, informing the members of the public of the maximum fee structure of that practice to determine the dispensing fee. Invoices that indicated the dispensing fee and single exit price (SEP) in respect of each medicine had to be provided.

MOBILE RADIOLOGY SERVICES

The Health Professions Council of SA (HPCSA) has warned practitioners about suspicious mobile radiology practices. Apparently certain companies have purchased X-ray equipment for purposes of performing mobile radiology services. These companies were unable to obtain licences from the Radiation Control Directorate of the National Department of Health as they were not adequately qualified and trained to operate such machines. Hence they apparently made lucrative offers to practitioners in order to use their HPCSA numbers, thereby securing licences from Radiation Control. The Professional Board for Radiography and Clinical Technology was concerned about the possible unethical and unprofessional relationship that might emanate between the health care practitioners and the companies providing the services. Practitioners were advised to desist from giving or selling their HPCSA registration numbers or practice code numbers obtained from the Board of Healthcare Funders of SA (BHF) to others. Practitioners had to be cognisant of the fact that they were liable for all professional acts performed or taking place in their presence or absence when their professional numbers were used. Practitioners were requested to report any unethical practices to the HPCSA for further investigation.

MEDICAL SCHEME DEVELOPMENTS

The Registrar of Medical Schemes has confirmed mergers between Discovery Health Medical Scheme and Afrox Medical Aid Society (Afrox) as well as between Discovery Health Medical Scheme and PG Bison Medical Aid Society (PG Bison) from 1 May 2014.

Hosmed Medical Scheme was also recently placed under provisional curatorship as a result of governance concerns at the scheme. The Council for Medical Schemes has given the assurance that the claimspaying ability of Hosmed was not affected as a result of the appointment of the provisional curator