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Purpose

The purpose of these Regulations is to give effect to the purposes of the Act as set out in section 2 by exempting the following categories of agreements or practices from the application of sections 4(1)(a), 4(1)(b)(i) and 5(1) of the Act, in respect of Prescribed Minimum Benefits (PMBs) and non- Prescribed Minimum Benefits (non-PMBs) –

    1. the collective determination of healthcare services tariffs;
    2. the collective determination of standardized diagnosis, procedure, medical device and treatment codes; and
    3. the collective determination of quality measurements/metrics, medicines formularies and treatment protocols/guidelines.

with the purpose of contributing to affordability of quality healthcare services across both PMBs and non-PMBs, contributing to reducing costs and contributing to the prevention of overutilization of healthcare services.

Category of agreements or practices exempted

Subject to regulations 9, 10, 11 and 16, the Minister hereby exempts the following categories of agreements or practices in the healthcare sector from the application of sections 4(1)(a), 4(1)(b)(i) and 5(1) of the Act in respect of both PMBs and non-PMBs:

    1. Collective determination of healthcare services tariffs; or
    2. Collective determination of standardized diagnosis, procedure, medical device and treatment codes; or
    3. the collective determination of quality measurements/metrics, medicines formularies and treatment protocols/guidelines.

The framework for collective determination of tariffs

The following process shall be adopted for the collective determination of tariffs:

Appointment of Tariffs Governing Body (TGB)

    1. The National Department of Health (NDoH), in consultation with the CMS, shall establish and oversee a healthcare services tariffs governing body (“Tariffs Governing Body” / “TGB”).
    2. The TGB will be chaired by a Chief Tariffs Manager, who shall be a senior official of the National Department of Health appointed by the Director-General of Health.
    3. The Director-General of Health will appoint no more than eight additional members of the TGB through a public nomination process, which members shall:
      1. be fit and proper persons;
      2. have no conflict of interest; and
      3. whose qualifications, skills and experience include tariff determination methods and practice.The Director-General of Health will appoint no more than eight additional members of the TGB through a public nomination process, which members shall:
    4. The TGB shall, inter alia:
      1. issue terms of reference, guidelines and rules for tariff determination and agreements contemplated in sub-regulation 8;
      2. consult with the NDoH Coding Committee and NDoH Health Technology Assessment (HTA) Committee respectively;
      3. establish rules for tariff determination in cases where MLNF members are:
        1. unable to reach an agreement on tariffs; or
        2. unable to reach an agreement on the process to determine the tariffs; or
        3. deviate from the determined tariffs;
      4. collaborate with the CMS on the review of PMBs;
      5. conduct a price-cost assessment to validate the tariffs determined by the MLNF; and
      6. perform any other functions reasonably necessary to meet the purpose of this Regulation as agreed by the Director-General of Health.The Multilateral Negotiating Forum (MLNF)
    5. The Director-General of Health shall appoint members of the MLNF following a nomination process, which will include representatives from the government, associations representing healthcare practitioners (HCPs), healthcare funders, civil society, patient and consumer rights organisations, and any other regulatory body within the healthcare sector.
    6. The MLNF shall be responsible for, inter alia,:
      1. collectively determine the maximum tariffs for PMBs and non-PMBs for healthcare services;
      2. in the absence of codes as developed by the NDoH Coding Committee, collectively recommend standardized codes to the NDoH Coding Committee;
      3. collectively recommend quality measurements/metrics, to the Office of Health Standards Compliance (OHSC) and recommend medicines formularies and treatment protocols/guidelines to the NDoH; and
      4. in the absence of HTAs as developed by the NDoH HTA Committee, collectively source relevant evidence on applicable HTAs from other contexts for presentation to the NDoH HTA Committee.
    7. The MLNF shall agree on the process to be followed to determine the tariffs.
    8. For the purposes of this regulation, the MLNF tariff determination process will not apply to services provided by health establishments with practice codes 47 Drug & Alcohol Rehab, 49 Sub-Acute Facilities, 55 Mental Health Institutions, 56 Provincial Hospitals, 57 Private Hospitals (‘A’ – Status), 58 Private Hospitals (‘B’ – Status), 59 Private Rehab Hospital (Acute), 76 Unattached operating theatres / Day clinics, 77 Approved Unattached Operating Theatre Units / Day clinics and 79 Hospices. Tariffs for health establishments with practice codes 47, 49, 55, 56, 57, 58, 59, 76, 77 and 79 shall continue to be determined through bilateral negotiations between funders and the respective health establishments.
    9. Decisions by the MLNF shall be taken by consensus.
    10. In the event that MLNF members are unable to make a determination on tariffs or deviate from the determined tariffs, the TGB shall have the authority to make a final determination of the tariffs and may request claim line data, cost structures or other data relevant to confirming the veracity of proposed tariffs.Tariffs Determination Process
    11. All tariffs proposal submissions to the MLNF must be made through the CMS for validation and archiving.
    12. Stakeholders must submit to the CMS any data and/or supporting evidence they intend to rely on during tariffs determination, in advance, to facilitate a fairer and more transparent process. This should include claim line data, cost structures or other data relevant to confirming the veracity of the proposed tariffs.
    13. The CMS shall provide aggregated cost and pricing data to the MLNF.
    14. All interested parties shall have an opportunity to make submissions to the CMS on the tariff determination process.
    15. The CMS must, to the extent possible, provide a data repository/warehouse for all submitted information and analytical support essential for the MLNF tariff determination process.Validation
    16. Prior to the implementation of the determined tariffs, such tariffs shall be validated by the MLNF and the TGB respectively, as follows:
      1. the MLNF shall ensure that the determined tariffs are cost-based; and
      2. the TGB shall conduct a price-cost assessment within a maximum period of 60 business days to validate the determined tariffs.Publishing
    17. The NDoH, CMS, relevant health sector statutory bodies, healthcare funder associations, and healthcare professionals shall publish the tariffs determined by the MLNF for easy access by consumers, patients and other interested stakeholders.Bilateral Negotiations
    18. Funders and healthcare professionals may engage in bilateral negotiations only for the purpose of concluding an agreement on reductions, but not increases, on the tariffs for PMBs and non-PMBs as determined by the MLNF process.
    19. Outcomes of bilateral negotiations must be documented in written contracts, not limited to risk, quality, and outcomes metrics.
    20. These contracts must be submitted to the TGB and lodged with the CMS for monitoring.

Requirements for agreements made in terms of these Regulations

The agreements and practices made in terms of these Regulations must:

    1. Be legally enforceable;
    2. Include a provision stating that the TGB has the authority to report on, monitor and enforce the tariffs determined by the MLNF;
    3. Include a provision granting the TGB the power to make a final determination if MLNF members are unable to determine tariffs or deviate from the tariffs; and
    4. State that the tariffs determined by the MLNF are binding on all parties to the agreement.

Exclusions

These Regulations exclude:

    1. Collusive tendering;
    2. Market allocation;
    3. Agreements or practices by health establishments with practice codes 47 Drug & Alcohol Rehab, 49 Sub-Acute Facilities, 55 Mental Health Institutions, 56 Provincial Hospitals, 57 Private Hospitals (‘A’ – Status), 58 Private Hospitals (‘B’ – Status), 59 Private Rehab Hospital (Acute), 76 Unattached operating theatres /Day clinics, 77 Approved Unattached Operating Theatre Units / Day clinics and 79 Hospices; and
    4. Tariffs and codes for medicines.

HDP and SMME Participation

HDP Firms and SMMEs at all levels of the value chain must be afforded an opportunity to opt-in to agreements and/or practices entered into in terms of these Regulations.

Scope of the exemption

    1. The scope of these Regulations is limited only to agreements and/or practices specified under regulation 8.
    2. These Regulations apply to health funders (medical schemes, administrators and managed care companies), and all health professionals registered in terms of the Health Professions Act (Act No. 56 of 1974), or the Nursing Act, 2005 (Act No. 33 of 2005), Allied Health Professions Act, 63 of 1982, or the Dental Technicians Act, 1979 (Act No. 19 of 1979); and the agreements and/or practices exempted in these Regulations can vary on a per healthcare sub-sector or clinical discipline basis.
    3. The agreements and/or practices exempted in these Regulations include the exchange of information strictly necessary for the purposes of the conclusion and implementation of the agreements and/or practices. After consultation with the NDoH, the CMS may appoint an independent facilitator to, inter alia, facilitate the sharing of competitively sensitive information by individual firms, and the

Monitoring

The CMS and/or the MLNF must supply the Commission, the DTIC and the NDoH with the record of determined tariffs, the minutes of meetings held, correspondence related to the exempted agreements and practices, exchanges of competitively sensitive information strictly necessary for the purposes of the conclusion and implementation of the agreements or practices, and all agreements or practices entered into in terms of these Regulations on a quarterly basis. Such submission must be made to the following:

    1. Submissions to the Commission should be sent to exemption.conditions@compcom.co.za.
    2. Submissions to the DTIC should be sent to exemption.conditions@thedtic.gov.za.
    3. Submissions to the NDoH should be sent to nhi.info@health.gov.za

Firms who participate in any agreements or practices falling within the scope of these exemptions must keep accurate written records of meetings held, correspondence related to the exempted agreements and practices, exchanges of competitively sensitive information strictly necessary for the purposes of the conclusion and implementation of the agreements or practices, and all agreements or practices entered into in terms of these Regulations.

The Commission and/or CMS may, at any time, request from all participants of the exemption the record of determined tariffs, the minutes of meetings held, correspondence related to the exempted agreements and practices, exchanges of competitively sensitive information strictly necessary for the purposes of the conclusion and implementation of the agreements or practices, and all agreements or practices entered into in terms of these Regulations.

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Freedom of Religion SA (FOR SA)

TEMPLATE PROVIDED BY FOR SA

I strongly oppose the Prevention and Combating of Hate Crimes and Hate Speech Bill [B9B – 2018], which I believe to be unconstitutional and unnecessary, for the following reasons:

  1. The Bill violates our constitutional rights as religious persons to express our religious beliefs without fear of punishment or persecution (section 15, read with section 16). Increasingly, around the world but also in South Africa, various holy scriptures (particularly on contentious issues) are regarded as “politically incorrect” or “offensive”, allegedly causing emotional and/or social harm.
  2. I specifically oppose the Bill’s:
    1. wide definition of “harm” (in Clause 1);
    2. the failure to define “hatred” (in Clause 1); and
    3. definition of, and creation of, the crime of “hate speech” (in Clause 4).
  3. The creation of the crime of “hate speech” for saying / distributing something which could possibly be construed as “harmful”, will have certain unintended consequences, namely the criminalisation of good / well-meaning people who will be prosecuted for saying what they sincerely believe (according to their holy texts) and sent to jail.
  4. There are already sufficient existing laws dealing with “hate speech”.
  5. For all of the reasons given, I ask:
    1. For the scrapping of the “hate speech” sections from the Bill altogether;
    2. Alternatively, should the “hate speech” provisions remain part of the Bill, we ask:
      1. That “harm” be defined as: “gross emotional and psychological detriment that objectively and severely undermines the human dignity of the targeted group”; and
      2. That “hatred” be defined as: “strong and deeply-felt emotions of enmity, ill-will, detestation, malevolence and vilification against members of an identifiable group, that implies that members of that group are to be despised, scorned, denied respect and subjected to ill-treatment based on their group affiliation”.
    3. That Clause 4(2)(d) (the “religious exemption clause”) be strengthened as follows to protect:
      “expression of any religious conviction, tenet, belief, teaching, doctrine or writings, by a religious organisation or an individual, in public or in private, to the extent that such expression does not actively support, instigate, exhort, or call for extreme detestation, vilification, enmity, ill-will and malevolence that constitutes incitement to cause gross emotional and psychological harm that severely undermines the dignity of the targeted group, based on race, ethnicity, gender, religion or sexual orientation”.