Key words: Affordability, Clinical appropriateness, Cost effectiveness, Prescribed Minimum Benefit Condition, Prescribed Minimum Benefit Level of Care.

INTRODUCTION

Prescribed Minimum Benefit  (PMB) is defined by the Council of Medical Schemes as “a set of defined benefits to ensure that all medical scheme members have access to certain minimum health services, regardless of the benefit option they have selected”[1]. PMB is developed in South Africa in terms of Medical Schemes Act 131 of 1998, section 29 (1)(o) which provides that: The Registrar shall not register a medical scheme… and no medical scheme shall carry on any business, unless provision is made in its rules for inter alia, The scope and level of minimum benefits that are to be available to beneficiaries as may be prescribed. The Regulations to the Medical Schemes Act (herein referred to as “The Regulations”) Annexure “A” provide with a list of PMB conditions (Categories of Diagnosis and Treatment) and Regulation 8 obliges medical schemes to pay in full any benefit option that is offered by a medical scheme, without co-payment or the use of deductibles, the diagnosis, treatment and care costs of these PMB conditions. The PMB is therefore a protective measure for members of medical schemes in South Africa and it makes healthcare affordable for people.

PMB AND THE OBLIGATION TO FUND

The initial process in the determination to fund a patient in terms of Regulation 8 will be to ensure if the person has been diagnosed with a PMB condition. The next step would be the determination if the treatment for the patient falls under PMB level of care or not.  Should the treatment fail to be classified as a PMB level of care, it means therefore, that such treatment may not be funded in terms of Regulation 8. This means that a patient may have a PMB condition, but the treatment administered to them may not be funded due to the fact that they are not being construed to be a PMB level of care.

Regardless of funding the obligation in terms of Regulation 8, Regulation 15I(c), provides an exception to funding treatment that is not listed as a PMB level of care in the Regulations Annexure “A”. Regulation 15I(c) provides that, “If managed health care entails the use of a formulary or restricted list of drugs, provision must be made for appropriate substitution of drugs where a formulary drug has been ineffective or causes or would cause adverse reaction in a beneficiary, without penalty to that beneficiary.” This means that the patient must be funded of the substitute treatment if the PMB treatment is proved to be inappropriate and ineffective to the patient.

The above means that, funding of a PMB treatment should be effected if certain attributes of the treatment to the PMB condition are satisfied. Failure to satisfy this condition means that funding cannot be effected in terms of Regulation 8 or Regulation 15I(c). Attributes of clinical appropriateness, effectiveness, cost-effectiveness and affordability of the treatment are crucial in determining funding.

 Clinical appropriateness and effectiveness:

This concept denotes that, the treatment to be administered to the patient must be appropriate in addressing the needs of the patient. Effectiveness refers to the treatment’s ability to achieve desired results or outcomes for the patient. If the treatment could not achieve desired results in any way, that treatment will be considered to be clinicaly inappropriate and ineffective hence cannot be funded in terms of Regulation 8.

Cost-effectiveness and Affordability:

This refers to the value for money regarding the treatment for the PMB condition. A treatment that is cheaper is considered affordable than the one that calls for more money. However, a treatment that is cheaper but not achieving, much of the desires of the patient is not cost-effective.

Clinical efficacy:

This is a measure of how well a treatment succeeds in achieving its aim on the patient. This refers to how efficient the treatment is to the patient. This is a treatment that exposes the patient to lesser risks of other infections.

Evidence-based medicine:

Regulation 15 defines “evidence-based medicine” as the conscientious, explicit and judicious use of current best evidence in making decisions about the care of beneficiaries whereby individual clinical experience is integrated with the best available external clinical evidence from systematic research.

Regulation 15G, states that “If managed health care entails limiting coverage of specific diseases such limitations or a restricted list of diseases must be developed on the basis of evidence-based medicine, taking into account considerations of cost-effectiveness and affordability; and that the medical scheme and the managed health care organisation must provide such limitation or restricted list to health care providers, beneficiaries and members of the public, upon request.”

Regulation 15I provides that “If managed health care entails the use of a formulary or restricted list of drugs such formulary or restricted list must be developed on the basis of evidence-based medicine, taking into account considerations of cost effectiveness and affordability the medical scheme and the managed health care organisation must provide such formulary or restricted list to health care providers, beneficiaries and members of the public upon request and provision must be made for appropriate substitution of drugs where a formulary drug has been ineffective or causes or would cause adverse reaction in a beneficiary, without penalty to that beneficiary.”

LIMITATION TO FUNDING OF A PMB CONDITION

Regulation 8(5) provides that when a formulary includes a drug that is clinically appropriate and effective for the treatment of a prescribed minimum benefit condition suffered by a beneficiary, and that beneficiary knowingly declines the formulary drug and opts to use another drug instead, the scheme may impose a co-payment on the relevant member.

This provision means that a patient who has a PMB condition and there is an established PMB level of care for him/her which is clinically appropriate and effective  for him/her and the patient elects to go for another option, the medical scheme shall employ their discretion to fund or not to fund the patient’s option. In other words, the medical scheme is no under obligation to fund a patient who opt for another treatment in place of a PMB level of care which is clinically effective.

EYE PMBs AS SEEN THROUGH RECENT CASELAW

1. R v D and Another

This case was an appeal case brought in terms of section 48(1) of the Medical Schemes Act. The patient was appealing the decision of the Registrar to decline full funding of Eylea® intra-vitreal therapy.

The Appeals Committee of the Council for Medical Schemes ruled in her favour and ordered The Respondent to fund Eylea® intra-vitreal therapy in full retrospectively from the date that it initially refused to do so within 14 days of receipt of the Ruling.

The Appeals Committee considered a number of aspects. It stated that “A PMB level of care treatment that is clinically inappropriate to a member should be totally stripped of its PMB level of care status, instead of members being forced to use it.” Thus, Regulation 15D (a)(i) which refers to “clinical necessity”, “appropriateness”, “efficacious” and” efficiency”, should indeed have been be given effect to in this matter, by both Respondents. In terms of Regulation 8(5), the Appeals Committee considered that the use of Eylea® intra-vitreal therapy was clinically appropriate regardless of the fact that it was not a PMB level of care. This was so because the treatment that was considered to be PMB level of care was inappropriate  for her. Once the PMB level of care treatment is inappropriate for the patient, it cannot be considered.

2. C v D and Another

This case was an appeal case brought in terms of section 48(1) of the Medical Schemes Act. The Appellant, who is a member of the First Respondent’s Medical Health Scheme, suffers from uncontrolled glaucoma in his right eye. He applied to the First Respondent to authorise funding for procedure to be performed on his right eye to decrease the high pressure thereon, and thus manage his condition as conservative therapy had failed. The First Respondent, upon application by the Appellant, declined to authorise funding for the use by the Appellant of Xen-stent, on the basis that Xen-stent was being clinically evaluated by the First Respondent’s Clinical Policy Unit and therefore not funded by the First Respondent. The Appeals Committee ordered the first Respondent to fund Xen-stent in full, retrospectively from the date that it declined to do so and to do so within 14 days.

The Appeals Committee construed that Regulation 15H(c) can only be invoked when there is a two-pronged test to be met before it may be applied to Appellant on this matter.  The criteria of the test:

1. Is the patient’s PMB condition a PMB level of care?
2. Is the PMB level of care offer clinically effective, cost effective, efficient and affordable to the particular patient?

The answer to the two tests should be in the affirmative for the application of an exception to funding in terms of Regulation 15H(c). Satisfying only the first question does not guarantee application of an exception. This exception protects patients who would have to be subjected to levels of care that are considered clinically appropriate and efficient generally but fails to be efficient to the health needs of particular patients. Forcing a level of care that has been proved to be efficient but is not being efficient to particular patient defeats the whole purpose of having PMBs, that is to protect the patients.

3. D v B and Another

This was an appeal  brought in terms of in terms of section 50(3) of the Medical Schemes Act 131 of 1998 (“the Act”) against the ruling of the Appeals Committee of the Council for Medical Schemes (“Appeals Committee”).

The Appeal Board noted the Appellant’s decision to decline funding was irrational and defying the principles and objectives of a managed healthcare system. The Appellant was therefore compelled to fund a protocol which was cheaper, affordable and clinically effective and not harmful to the First Respondent. It was stated in the Ruling that,  the objective or guiding principle of managed health care system is to achieve appropriateness, cost effectiveness and affordability of health care.

Although the Appellant noted that there could be significant differences that might exist between Public and Private sector practices of establishing PMBs, the wanted interpretation of the PMB to follow the predominant Public Hospital practice. The court however could not adopt the Appellant’s interpretation. Instead, it was stated that , funding of PMBs in public health institutions should not necessarily always be the same from funding of PMBs in private health institutions.

It was stated that, determining a PMB level of care should strictly not be in terms of state public practice. PMB level of care is influenced by issues like budgetary processes or constraints, delayed bureaucratic tendering/procurement processes, skills shortage, human resource training priorities, administrative challenges, and adverse reaction to the treatment. This means that it is possible that a condition may fail to qualify as a PMB level of care in a public health institution, but it would be considered as a PMB level of care in a private institution since private health institutions are generally not affected by above mentioned conditions.

It was held that, for a medical scheme to narrowly, simplistically and religiously adopt prevailing state hospital practice in determining PMB level of care will be subjecting its members to incorrect decision making and the whole process would be prone to abuse by the same medical scheme.

The question though, to fund , or not to fund, remains elusive in the current regulatory framework.

[1] https://www.medicalschemes.com/medical_schemes_pmb/