Scheme ‘no’ to autoimmune guidance

SA’s medical scheme industry regulator has rejected a call from an advocacy group for patients with autoimmune diseases to issue guidance on funding expensive specialised treatments, saying each case had to be assessed on its own merits. The Autoimmune Alliance of SA has been lobbying the Council for Medical Schemes to clarify the extent to which funders must cover biologics.

SA’s medical scheme industry regulator has rejected a call from an advocacy group for patients with autoimmune diseases to issue guidance on funding expensive specialised treatments, saying each case had to be assessed on its own merits.

The Autoimmune Alliance of SA (AASA) has been lobbying the Council for Medical Schemes (CMS) to clarify the extent to which funders must cover biologics, saying patients should not have to repeat battles previously won by other people in a similar position.

At issue is the application of regulations to the Medical Schemes Act setting out schemes’ obligations to cover the cost of chronic conditions that are defined as prescribed minimum benefits (PMBs). Schemes must cover PMB conditions, but this duty is limited to the standard of care offered in the state sector, which often does not include expensive treatments such as biologics and immunotherapy drugs.

Regulations 15H (c) and 15I (c) of the act contain provisions that enable patients to apply for an exception to these rules if they have failed to respond to conventional, PMB-level treatment.

These applications are regularly rejected by medical schemes, but overturned when patients complain to the CMS, according to AASA founder Catherine McCormack.

“(We) cannot issue a blanket ruling binding all medical schemes to fund biologics in terms of regulation 15I (c) because each case must be considered on its own clinical merits,” the CMS said. “The regulations are also clear about instances were appropriate exceptions (or) substitutions must be considered.

“Biologics are generally not regarded as the standard of care for these conditions, however, the CMS endeavours to adjudicate complaints on a case-bycase basis guided by the clinical merits, evidence-based medicine, cost effectiveness and affordability. The CMS’s reluctance to issue a blanket directive for funding of biologics is driven by the need to maintain compliance with the act and regulations,” it said.

The CMS said it had previously invited McCormack to a meeting with several medical schemes to discuss the issue and had advised schemes to streamline their processes so they could respond to funding requests as quickly as possible.

It defended its record in handling complaints against medical schemes from patients with autoimmune diseases, saying it had promptly finalised the 52 complaints received since May 2021. “Suggestions that the CMS (is) failing patients (is) a complete distortion and obfuscation of facts,” it said, responding to McCormack’s remarks to Business Day earlier this month in which she said the regulator was not doing enough to protect medical scheme members’ interests.

“Over the past two years we have significantly reduced the turnaround time for resolution of complaints and kept a resolution rate of more than 90%. While we respect the organisation’s advocacy role in fighting for its patients and members, the CMS is a creature of statute governed by law and thus cannot exercise powers beyond the scope of its mandate,’ it said.

McCormack said no-one was asking for a blanket statement on biologics, but for consistency when there was no clinical debate about the need for the drugs.

“In these cases (where clinical merits are undisputed) the CMS always rules the same way, because (it) always interprets the regulations in the same way. It makes no sense to require the member to spend seven months getting to the end of a predictable ruling and appeal period,” she said.

The government and medical schemes had the power to change the prices paid for biologics, she added.

“To the people that rely on them to function, they are a link to life. To the rest, they are a drain on resources,” she said.

WE CANNOT ISSUE A BLANKET RULING … TO FUND BIOLOGICS … EACH CASE MUST| BE CONSIDERED ON ITS OWN CLINICAL MERITS