Rare Diseases SA
What’s in a Ruling? Nothing binding… apparently.
Many years ago, a groundbreaking Council for Medical Schemes (CMS) ruling was made.
This was a pioneering victory, and naively, our rare disease community believed it would be the only one that would be necessary. Because one should be enough, right?
It appears that the Medical Schemes disagree as they have left us debating the same arguments, issues and merits for years to come.
Here is that first, pioneering ruling - in black and white, for further discussion.
From our layman understanding, it was pretty clear that Gaucher disease is deemed a Prescribed Minimum Benefit (PMB) condition under code 901K and that Enzyme Replacement Therapy (ERT) for this condition should be funded in full where clinically appropriate.
Therefore, in our view - if a doctor determines that the treatment is clinically appropriate based on the disease specific treatment guidelines, it should be paid for in full and without question by the Medical Scheme.
Since 2002, we have had several more cases with the same merits, ie. a “life-threatening congenital abnormality of carbohydrate, lipid, protein, and amino-acid metabolism” requiring a form of ERT as part of the “medical management” under code 901K - all of which have gone through the same process, in an attempt bythe Medical Schemes to overturn the ruling.
All such attempts have been unsuccessful and every ruling issued has been in line with the first 2002 ruling.
It is important to note that a Section 50 Appeal (the 2002 ruling) takes the following process, based on the SMSs website:
The Appeal Board shall have the powers which the High Court has to summon witnesses, to cause an oath or affirmation to be administered by them, to examine them, and to call for the production of books, documents and objects.
It goes without saying that a ruling, at this level, should be deemed a binding decision, made clear to all Medical Schemes via the circular, which should be upheld and honoured by these Schemes.
However, 20 years later, we have had four patients with THIS EXACT condition with whom we have had to revisit the CMS, to obtain yet another ruling. Currently we have patients with other conditions (falling under the same disease classification 901K code) that have been denied treatment by the following Medical Schemes:
Momentum - 1 patient
BestMed - 1 patient
Discovery Health - 1 patient
GEMS - 1 patient
What are some of the reasons provided by these schemes in support of their denial of treatment for these patients?
The disease is not considered life-threatening enough. RDSA: the patient needs to be in an emergency setting for the Medical Schemes to consider them worthy of treatment?
Funding these diseases negatively impacts the Medical Schemes affordability (RDSA: bottom line) and places them at financial risk. From an RDSA perspective, unless the treatment alone places the Medical Scheme reserves below the 25% liquidity threshold, then the affordability is relative. It is important to note that we have often asked Medical Schemes how they determine affordability - and they have told us it is a complex process which remains part of their Intellectual Property (IP) and is confidential to their Actuarial and Risk teams.
Medical Schemes are convinced that there are no patients in state hospitals that are being funded by these facilities. We have even been asked to obtain procurement documentation from a state hospital as proof that patients are accessing treatment in these facilities - We as a lay community with no access to a hospitals procurement files! The fact that we regularly meet with, advocate for, and assist these patients at their clinics and treatment days is apparently, not considered proof enough!
The price of the drugs simply needs to decrease (another complex issue to be addressed in future blog). However, it is essential to note that Single Exit Pricing (SEP) regulation prohibits any drug manufacturer from offering discounts in South Africa. Whether we agree with this or not is a moot point - since these are the current legislated laws of the land and so there can be no wiggle room.
How many other rulings have been issued aside from this one? Many.
I will share a few below which we have personally been involved in:
For Mucopolysaccharidosis II (Hunters Disease)
For Gaucher disease
During IS vs GEMS, the Medical Scheme filed a Section 50 Appeal, which was subsequently withdrawn mid-process.
This case was appealed by the Medical Scheme, with the Scheme subsequently withdrawing during the Appeal Hearing.
Elsabe Klink from Elsabe Klink & Associates wrote an opinion piece on the Gaucher ruling CL vs Bonitas in Healthcare in 2015 in chapter 10 (Legislation: Medical Schemes and the complaints process), with the following comments:
A PMB cannot be conflated with an Emergency condition.
Cost concerns relate to the incidence of the condition in a Medical Scheme.
Previous decisions of the Appeals Committee and the Appeal Board are taken into consideration (as they should be), when making new rulings.
And lastly, a comment on the "state level of care" argument, which is very pertinent:
Taking into consideration all of the above, is it really fair to continually subject Medical Scheme members to this process each and every time? An unnecessary process that wastes time and resources, and more importantly, places the health of vulnerable patients at further risk?
If you agree that Medical Schemes are continuing to exploit this process as a means to delay paying for high cost medicines, - please assist us by signing our Petition at Change.Org. In this petition we are motivating for the Minister of Health, as the Constitutionally appointed custodian of all healthcare related matters within South Africa, to provide oversight and support to the CMS to: 1) Effectively and efficiently fulfil it’s responsibilities to Medical Scheme members with disputes related to the conduct and decisions of their Medical Scheme, and 2) Ensure that the necessary resources are provided to CMS to ensure it is able to fulfil its mandate (with teeth).
Alone we whisper, Together we Roar!
Written by Kelly du Plessis, Founder and CEO of Rare Diseases South Africa