Clinics Are Flouting CQC Registration Requirements

Using botulinum toxin to treat axillary hyperhidrosis or excessive sweating in the armpits (and on other areas of the face and body) is nothing new.

In fact the market leading brand, Botox® has been approved in the UK for use in treating severe hyperhidrosis of the axillae since July 2001.

What is perhaps newer is the growth in the number of private providers of this treatment through doctor and nurse-led medical aesthetic clinics, the length and breadth of the UK. In fact, if a clinic is offering wrinkle-relaxing treatments using the drug, then it’s very likely that they are also offering a service to treat excessive sweating with botulinum toxin too.

However, unlike the use of Botox®, and other BoNTA brands including Dysport®, Azzalure®, Bocouture® and Xeomin® for cosmetic facial wrinkle reduction, which is largely unregulated (aside from some self-regulated accreditation schemes), the use of botulinum toxins for treating hyperhidrosis is subject to statutory regulation.

This is because the condition of hyperhidrosis is classed as a disorder which must be diagnosed and then it can be treated. It is further defined as such by the NHS. This makes it a ‘regulated activity’ with the Care Quality Commission (CQC) in England (with similar requirements in Wales, Scotland and Northern Ireland).

Consulting Room surveyed 27 clinics based in England, of which 15 were already registered with the CQC, yet all 27 were offering botulinum toxin treatments for hyperhidrosis to the public. That means that based on this small sample, 44% were not registered with the CQC but were carrying out a regulated activity. Worrying, isn’t it?

When it came to how clinics were promoting this treatment, 67% marketed it as ‘treatment for excessive sweating’, 26% as ‘treatment for hyperhidrosis’ and 3% each for ‘treatment for sweating’ and ‘sweat reduction treatment’.

A representative from the CQC confirmed the need for regulatory compliance. They stated;

“As you will probably know, any person (provider) that carries on or provides a regulated activity (in England) must be registered with CQC.

Treatment of hyperhidrosis that is carried out by a health care professional is within the CQC scope of registration because it would constitute the regulated activity of TDDI (Treatment of Disease, Disorder or Injury).”

Similarly, they noted;

“The regulated activity of ‘surgical procedures’ explicitly excludes the subcutaneous injection of a substance or substances for the purpose of enhancing a person`s appearance. However, if a condition or disorder is being treated with Botox®, (such as hyperhidrosis), then this type of treatment would not meet the explicit exemption set out in the activity of surgical procedures.”

Thus, the treatment of hyperhidrosis with botulinum toxin (or other methods) could fall within the regulated activities of both TDDI and surgical procedures (in some cases).

Yet many clinicians, and sadly it seems some CQC inspectors themselves, are blissfully unaware of this fact. Our small survey sample certainly highlighted that to be true amongst clinics.

This means that both the industry and the regulators are currently equally responsible for the number of providers who are happily offering this treatment to the public without any regulatory audit in place to check their standards of practice.

Dr. Philip Dobson from LCS Healthcare Ltd who helps organisations through the CQC registration process told us;

“Hyperhidrosis is a medical condition and as such should fall under CQC registration when treated by a healthcare professional – the method of treatment is of secondary importance, but Botox® most certainly meets the requirement.

I have registered a number of clients with the CQC using hyperhidrosis under TDDI but almost without exception the nature of the condition has to be explained to the CQC inspector to ensure that they understand why it should be registered.

This falls under the same umbrella as treating acne using IPL or skin peels and treating migraine with Botox® or even a doctor running a slimming clinic where advice or treatment (of any sort) is provided! All should be registered, but as you know the CQC don’t really understand their own regulations!”

It’s not surprising then to hear that many clinics don’t realise that there is a regulatory requirement if the regulator themselves are not wholly sure, and are certainly not actively pursuing providers for compliance.

Similarly, this need is not flagged up by medical indemnity insurers; so could clinics be forgiven for their ignorance of this issue?

Eddie Hooker, CEO of Hamilton Fraser Insurance Ltd explained their policies;

“Botox® for hyperhidrosis treatment is automatically included within our cover at no additional premium or terms. We do not ask for additional training or qualifications. We would automatically expect clinics to comply with correct procedures and protocols when offering these treatments.

Should it transpire at the time of a claim that they have failed to carry out the procedure under the correct procedures or standards, then the policy terms may well be breached, and the practitioner may not benefit from the full protection under their policy. We have never experienced a claim for hyperhidrosis in over 15 years.

As a general note, our policy is written in such a way that requires all practitioners to follow legislative requirements and industry protocols, otherwise the policy may not respond.”

No one is suggesting that those currently un-CQC-registered clinics, that are providing botulinum toxin treatment for hyperhidrosis are offering a sub-standard service, compared to those that are already audited by the regulator. But in a time of heightened exposure to the regulation, or lack of, of the UK aesthetic and cosmetic surgery industry, this seems like yet another oversight which needs correcting for the benefit of good practice and patient safety.

Alongside the many clinics also offering botulinum toxin treatment for migraine headaches, who are also not CQC registered, this certainly gives the industry a need to pause for thought.

If we can’t get our own house in order, even with the involvement of quango regulators like the CQC, how can we be so critical of the unregulated non-medics operating in the industry dishing out cosmetic injectables. The post-Keogh teams have a lot to think about if they want to make sure this industry is properly regulated.

Meanwhile, if you offer BoNTA for excessive sweating you may wish to re-evaluate your regulatory status and the impact this may be having on your current insurance cover