# summary

- Link: https://dearsouthafrica.co.za/healthcare-block-exemptions/summary/
- Published: 2025-02-25T15:10:03+02:00
- Author: dearSA

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[Purpose](https://dearsouthafrica.co.za/healthcare-block-exemptions/summary/#1738150189952-44103674-e29d4f67-c652)

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.  a. the collective determination of healthcare services tariffs;
     b. the collective determination of standardized diagnosis, procedure, medical device
        and treatment codes; and
     c. 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](https://dearsouthafrica.co.za/healthcare-block-exemptions/summary/#1738150189975-5d0623dc-47dc4f67-c652)

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

[The framework for collective determination of tariffs](https://dearsouthafrica.co.za/healthcare-block-exemptions/summary/#1738150854013-bb98f5fb-7d094f67-c652)

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

**_Appointment of Tariffs Governing Body (TGB)_**

 1.  a.  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”).
     b.  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.
     c.  The Director-General of Health will appoint no more than eight additional members
         of the TGB through a public nomination process, which members shall:
     d.   a. be fit and proper persons;
          b. have no conflict of interest; and
          c. 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:
     e.  The TGB shall, inter alia:
     f.   a. issue terms of reference, guidelines and rules for tariff determination and 
             agreements contemplated in sub-regulation 8;
          b. consult with the NDoH Coding Committee and NDoH Health Technology Assessment(
             HTA) Committee respectively;
          c. establish rules for tariff determination in cases where MLNF members are:
          d.  a. unable to reach an agreement on tariffs; or
              b. unable to reach an agreement on the process to determine the tariffs; or
              c. deviate from the determined tariffs;
          e. collaborate with the CMS on the review of PMBs;
          f. conduct a price-cost assessment to validate the tariffs determined by the MLNF;
             and
          g. 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)_**
     g.  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.
     h.  The MLNF shall be responsible for, inter alia,:
     i.   a. collectively determine the maximum tariffs for PMBs and non-PMBs for healthcare
             services;
          b. in the absence of codes as developed by the NDoH Coding Committee, collectively
             recommend standardized codes to the NDoH Coding Committee;
          c. 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
          d. 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.
     j.  The MLNF shall agree on the process to be followed to determine the tariffs.
     k.  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.
     l.  Decisions by the MLNF shall be taken by consensus.
     m.  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_**
     n.  All tariffs proposal submissions to the MLNF must be made through the CMS for
         validation and archiving.
     o.  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.
     p.  The CMS shall provide aggregated cost and pricing data to the MLNF.
     q.  All interested parties shall have an opportunity to make submissions to the CMS
         on the tariff determination process.
     r.  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_**
     s.  Prior to the implementation of the determined tariffs, such tariffs shall be 
         validated by the MLNF and the TGB respectively, as follows:
     t.   a. the MLNF shall ensure that the determined tariffs are cost-based; and
          b. the TGB shall conduct a price-cost assessment within a maximum period of 60 
             business days to validate the determined tariffs.**_Publishing_**
     u.  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_**
     v.  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.
     w.  Outcomes of bilateral negotiations must be documented in written contracts, not
         limited to risk, quality, and outcomes metrics.
     x.  These contracts must be submitted to the TGB and lodged with the CMS for monitoring.

[Requirements for agreements made in terms of these Regulations](https://dearsouthafrica.co.za/healthcare-block-exemptions/summary/#1738151172108-10076802-4d004f67-c652)

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

 1.  a. Be legally enforceable;
     b. Include a provision stating that the TGB has the authority to report on, monitor
        and enforce the tariffs determined by the MLNF;
     c. 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
     d. State that the tariffs determined by the MLNF are binding on all parties to the
        agreement.

[Exclusions](https://dearsouthafrica.co.za/healthcare-block-exemptions/summary/#1738151231288-dfdfde22-26f04f67-c652)

**These Regulations exclude:**

 1.  a. Collusive tendering;
     b. Market allocation;
     c. 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
     d. 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](https://dearsouthafrica.co.za/healthcare-block-exemptions/summary/#1738151253752-ee477515-a6464f67-c652)

 1.  a. The scope of these Regulations is limited only to agreements and/or practices 
        specified under regulation 8.
     b. 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.
     c. 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](https://dearsouthafrica.co.za/healthcare-block-exemptions/summary/#1740579458083-1891d4e9-e49a)

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.  a. Submissions to the Commission should be sent to exemption.conditions@compcom.co.
        za.
     b. Submissions to the DTIC should be sent to exemption.conditions@thedtic.gov.za.
     c. 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.

[ Have your say](https://dearsouthafrica.co.za/healthcare-block-exemptions/)

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### STATEMENTS AND MEDIA RELEASES

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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:
 3.  a. wide definition of “harm” (in Clause 1);
     b. the failure to define “hatred” (in Clause 1); and
     c. definition of, and creation of, the crime of “hate speech” (in Clause 4).
 4. 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.
 5. There are already sufficient existing laws dealing with “hate speech”.
 6. For all of the reasons given, I ask:
 7.  a. For the scrapping of the “hate speech” sections from the Bill altogether;
     b. Alternatively, should the “hate speech” provisions remain part of the Bill, we
        ask:
     c.  a. That “harm” be defined as: “gross emotional and psychological detriment that 
            objectively and severely undermines the human dignity of the targeted group”;
            and
         b. 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”.
     d. 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”._
