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Confidence to Thrive is a podcast built for practitioners and healthcare entrepreneurs who are doing something that matters - building innovative practices in functional medicine, aesthetics, integrative healthcare and mental health, while navigating the regulatory complexity that comes with it.
Confidence To Thrive - a podcast for ambitious healthcare practitioners and entrepreneurs
Episode 20 - CQC or not CQC? Answering the question of registration with Dionne Simons, Designated Medical
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Do You Need CQC Registration? Guidance for Functional and Private Practice Clinicians
In this episode of Confidence to Thrive, Owlicity director Christopher Cloke-Brown speaks with Dionne Simons, head of operations at Designated Medical, on the question of when functional medicine practitioners need CQC registration and why the issue goes beyond whether you prescribe.
Dionne explains that many “exemptions” only apply when you are clearly working under another provider’s CQC registration with defined practising privileges, governance, and contractual terms, and that simply renting a room in a CQC-registered clinic does not usually provide cover, including for digital consultations.
She warns that assessing, diagnosing, monitoring, interpreting tests, or creating personalised protocols for disease and disorder (e.g., Lyme disease, autoimmune conditions, chronic fatigue, hormone disorders, cancer) can constitute regulated activity.
The discussion covers current CQC application timelines, common form rejections, interview expectations, the need for governance documents upfront, and enforcement risks including closure, prosecution, fines, reputational damage, and possible GMC notification.
Episode time stamps
- 01:29 Introducing Dionne Simons
- 03:13 Why CQC guidance feels grey
- 04:12 Exemptions explained
- 06:22 The potential pitfall of virtual care
- 06:57 Why prescribing is not the test
- 09:35 Lifestyle vs treating disease
- 12:36 The CQC process and timelines
- 14:21 What to expect during application and interview process
- 16:56 The value of investing in ongoing compliance
- 17:42 The cost of enforcement and risk to reputation
- 23:18 The reality of the NHS to private practice shift
Follow Dionne Simons and Designated Medical
Dionne Simons - https://designatedmedical.com/team/dionne-simons
Designated Medical - https://designatedmedical.com
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This podcast was brought to you by Owlicity Insurance Advisors who support your business ambitions. Owlicity advises practitioners, owners, and entrepreneurs of healthcare practises on mitigating risks so your business can thrive.
Learn more about how Owlicity can support here: Owlicity.co.uk
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You're listening to Confidence to Thrive, the podcast for ambitious healthcare practitioners and entrepreneurs, brought to you by Our Listing Advisors. Welcome to Confidence to Thrive, the podcast helping growing practitioners and healthcare entrepreneurs navigate the challenges and risks of regulation while building brands that matter. Every episode, we tackle a different issue facing healthcare practitioners or entrepreneurs, or we interview a guest who is working on the leading edge of private healthcare building something that matters in their sector or profession.
SPEAKER_03Today's episode, Christopher Cloak Prown, Director of Towelicity, speaks to Dion Simons, head of operations at designated medical, about the question of CQC registration. Dion leads the private practice division, overseeing medical PA, practice management, billing and CQC compliance teams, and to help practitioners better understand whether they need CQC registration and help work through the process. Let's join Christopher and Dion.
SPEAKER_01Dion, thank you for making time to come on Confidence to Thrive, a podcast for ambitious healthcare professionals. Certainly, one question we get asked a lot, and especially from people doing more sort of alternative integrative functional medicine, is do I have to be CQC registered? And it's really some of our practitioners don't prescribe. A lot of them try not to, some of them succeed in not prescribing. I think we always feel that the CQC, the CQC or not CQC situation is a lot deeper than just do I prescribe or not.
SPEAKER_00Yeah, definitely.
SPEAKER_01So it would be great to start off if you can give us a little bit about yourself and your background, and then we can dive in and try and clarify some of these questions for practitioners.
SPEAKER_00Sure, of course. Thank you for having me, Chris. So my name is Dion, and yes, I am a specialist in CQC compliance and registration. My background is I have been working in private healthcare, high-level medical operations for the last 20 years. So I have, I would say I've probably done a little bit of everything, started off as a medical secretary in the NHS and progressed from there to practice management into private healthcare. And I've undertaken many roles within various different healthcare providers, from one-man band GPs all the way up to large hospitals and huge departments. So I've got a bit of experience across most services and specialisms. I've worked with functional medicine specialists for many years and GPs. That's my main kind of focus. That's the one I really love. But we obviously at Designated help a range of specialists. So we hear these questions all the time. Everything that you're saying, I hear pretty much every day. And I think there is also a vagueness around the CQC because the guidance is obviously very black and white, and it can be interpreted in many ways, which we see all of the time, and that can sometimes cause confusion. And I think we also have specialists who contact the CQC and sometimes don't feel like they get a straight answer. So we can try and help fill those gaps, hopefully, today.
SPEAKER_01That's great. Thanks, Dion. And yes, it's interesting. So we it slightly amuses us, we're a regulated business doing insurance. And our regulator, if you phone up with our regulator of advice, they say it's open to your interpretation. But oddly enough, they know exactly when you've done it wrong.
SPEAKER_00That's it. That's exactly what the CQC do. They say you send us which policies you think are relevant, and but then they'll tell you that those policies are not relevant. So yeah, it's a real gray area, and I know it can be really tough to navigate, but I think if you break it down, you can definitely figure out the most important parts.
SPEAKER_01And just to stick with that for a minute, certainly our experience is I think a lot of the regulation is having it straight in your own mind, what you're doing and why. That helps remove some of the grayness if you have a clear vision of your own. And that's where people like yourselves, I'm sure, can help form you crystallize that that view. Yeah.
SPEAKER_00Absolutely, I completely agree.
SPEAKER_01So just we have mentioned the exemptions, and uh to me that is the absolute crux. That's sort of the end of what we hear. So just to be really technical for a minute, we looked all this up. So we are referring to section 3, 1, A, and B of Schedule 2 of the Health and Social Care Act 2008 brackets regulated activities. So for anybody who wants to go there themselves, I'm sure many people have found it. But that lists out, I can't remember, but it's quite a few, isn't it? Is A to K or so exemptions. We were talking just before we came on the podcast, weren't we? To say, for if you if I am a GMC registered GP and I read certainly the first paragraph of that, I go, hey, I'm exempt. Then I get into that whole list of exceptions. And I think where the niggling thought at the back of our head with most of our clients is always, by the time you really get going, you've probably tripped over one of those exemptions. Yeah.
SPEAKER_00I completely agree. I think the exemptions for me, I think just cause huge confusion because what it's actually saying is you're not exempt unless you have a license. It just doesn't read that way. So what the exemptions say is that you don't need a license. If you're basically practicing under somebody else's practicing privileges or CQC license, and that's all the same thing. So if you are working from a clinic already and they have a license and you are covered under their license, fabulous, you're exempt. That's quite rare. There are some clinics out there that will offer you that. You will know if you're being offered that, it would be part of your contract. There would be lots of specifics that you would have to undertake. So, for example, you would be working to their governance schedule. So their policies and procedures, they would provide you with a policy pack that you need to adhere to, they would get signatures so that you understand. And you're basically working by their rules. So it's really clear if you have that in place or not. And most people don't have that in play for what they want to do. So I can give you an example. We had a GP recently who is working from a CQC regulated clinic. He has started his own clinic and he was offering virtual consultations from that location. He felt that he was covered by their license, but he wasn't. And there are a lot of people out there that fall into the same trap. Digital consultations are still seen as the same thing. You still need to have a license, and the license needs to be registered to you, or if you're under somebody else's license, it needs to be very specific to the services that you're delivering. So I think for most people, I think you just need to take it back to the basics. And you touched on this earlier that a lot of functional medicine specialists, for example, will say, Well, I'm not prescribing, so therefore I'm exempt. That's not actually true. You can be not prescribing and still be offering a regulated activity. So what you really need to think about, and the question that you need to answer is what are you actually doing? Not what do you call yourself. You might be an integrative or functional medicine or longevity specialist. But if you are treating, assessing, diagnosing, monitoring any type of medical condition, then you are treating disease and disorder. So therefore, it's a regulated activity. And I think a lot of functional medicine specialists will have, let's say, on their website, that they are treating patients with Lyme disease, autoimmune conditions, chronic fatigue, hormone disorders, and even cancer. Now, all of those things fall into a category of disease and treatment. So if you are assessing your patients based on those types of diseases that I've mentioned, then you're really in the gray area and you probably do need a CQC license. Unfortunately, I don't think it's that clear on the CQC website. And I think most people interpret the exemptions as they want to see them because it helps them maybe feel that they're not in that category where it's needed. The CQC are really clamping down on this type of thing and they can take enforcement. So you really don't want to fall on the wrong side of them.
SPEAKER_01No, thank you, Dion. And so that makes a lot of sense on many levels. And actually, again, just relating it back to our own regulated activities. We have this idea of an appointed representative. So I don't have to be regulated by the regulator, I can go to another regulated entity, and basically they become my regulator, which sounds very much like your CQC description. Exactly. I think that's a really important point. Just because somebody offers you a room in the CQC premises, it doesn't mean that they're umbrella in your regulation.
SPEAKER_00No, we've met clients like that recently, and it really does put them in a hole. So you really do need to be checking your contract and asking specific questions. Am I covered by your CQC registration? Are you giving me practicing privileges? It's really simple, it's just one or two questions, and you'll know exactly where you're at.
SPEAKER_01Yeah. And the other really interesting thing you were talking about is, and this is to me, a big debate in that sort of integrated functional lifestyle longevity, all the different flavors, world, is there is a big difference and a big step to us between some people just offer a fairly generic health lifestyle. I'm afraid maybe too dismissively say it's the advice your mum would give you drink, sleep more, eat more properly, and so on, which is all great and all very good advice, and advice I should definitely take myself. There's a big step between that and where you are offering these advices specifically to try to tackle a number of these chronic conditions that you named fibromyalgia, Lyme disease, cancer, diabetes, yeah, general weight loss, general fatigue. There's a whole range, and most practitioners, at least to a degree on their website, hold themselves out as, as you say, diagnosing and treating those diseases. And that's a very fine line. And that's where we get that's where we start to worry. So it's really interesting that you picked up on that because to me that's absolutely the line that you need to think about really quite hard.
SPEAKER_00Yeah, I think if you look at what you're doing, if you're assessing a patient, so you're taking a medical history, you are taking, I don't know, height, weight measurements, blood pressure, those things are all part of a clinical assessment. So that in itself is already some form of treatment. You're interpreting investigations, maybe clients come to you, they might have their bloods elsewhere, but they come to you and you're interpreting those bloods or scans. You are treating an aspect of their care. We have people who say, Well, I'm just creating protocols for insulin resistance and also improving autoimmune. Unfortunately, that protocol is part of treatment. So you really have to break it down and look at what you're actually doing and what you're offering. And like you said, if you are just talking about sleep, taking an over-the-counter supplement and changing your diet, that's very different. But if you're doing more than that and you are creating personalized protocols and you are dealing with any of the things that we've mentioned, then you are managing a disease or a disorder and you are moving much closer to regulated healthcare. So I think if you're confused, if you're not sure, if you think you are on the line, it's always best to check with a professional. Designated, we are here, we offer a free 30-minute consultation call where you can ask us any of these questions. And I'm sure there's many other of our competitors out there who would be more than happy to talk you through whether you need a license or not. But it's something that you shouldn't ignore, especially if you're nervous that you're nearing that line.
SPEAKER_01That's brilliant. Thanks, Dion. So I think where we've got to is your practitioners are probably closer to or over that line than they might imagine. So now they're facing the awful prospect of a CQC process, Dion. So maybe you can outlay some of those fears and what what is it, how big is it, how much time does it take, how you know how how painful is it?
SPEAKER_00It's not as bad as you think. I think there's this big fear around the CQC. And look, it's definitely a difficult process. It's not simple, but it shouldn't be because at the end of the day, they are regulating care across the whole of the UK. So they need to have stringent pathways and processes. So we understand that and we're happy to work with that. The time frame does vary. So I can give you an example of last year, you were looking at around nine months' wait, which is pretty long. I think the year before that, it was almost going into 12 months. However, the CQC have been making lots of improvements to the way that they work over the last 18 months. And we're currently seeing the waiting list at around three months. So their KPI is they want to be hitting no one waits longer than 10 weeks, or around the eight to 10 week mark, they think that they're picking up most applications. And they were definitely doing that at the start of the year. We see that as the year develops, obviously, you go into summer, people are on holiday, it does tend to get a bit slower. And towards the end of the year, you see that waiting period getting a little bit longer. But at the moment, they're doing really well. So I would say from submission date to when you get an interview with an inspector, it's about three months. Part of the process is obviously the application forms. I would say that they are the hardest part. The forms themselves can take several hours to complete. And the framework has changed recently. So they've just added in a new application form. So you have to fill in a form for a registered manager application and a second form for a new location, and then you also now have to fill in a third form, which is an online provider form if you are purely digital and online. Now, some of these forms are 30 pages long. So that's the hard part. They need to be perfect. They go through think some form of AI or machine first, which if it thinks that something's missing, a digit from your phone number, or you haven't put your job title in, or you are a missus and you've left it blank, then they will reject it. So we do see a high level of rejections on that first submission. And then once they are happy with it, which can be third, fourth, sometimes sixth or seventh time round, then they will accept it. And that's your waiting time. That's when the clock starts. We obviously work with our clients to ensure that they get those applications through first time. So that's one of the things that working with a consultancy can help with. And then obviously there's the interview stage, which depending on how good you are at your job, can be difficult or can be a breeze. As long as you understand what's expected of you and you can evidence that, then you'll be fine. The one thing I always say to people is that the CQC are not looking for perfection, they just need to see evidence that you're going to be providing safe, effective, and well-governed care. So that's the biggest mistake is I think that people just want to present that they're perfect. And the CQC know that that's not the case. There's going to be learning, there's going to be changes to your policies that you'll make probably in the first few months, maybe in the first year. And they understand that. So as long as you can show them that you are demonstrating that you're going to build a safe service, then you should be absolutely fine. I think one of the biggest changes at the moment is that they are expecting you to have all of your governance and policies and procedures ready straight away. And that can be a sticking point for some people. But again, if you're not able to create these yourselves, then you've got designated or others who can help you create those policies and get everything done within the time scale that's needed.
SPEAKER_01That's great. Thanks, Dion. And just as a general comment, it's just something that we notice in all practitioners starting healthcare businesses. It's one of those things, it's like starting any business. You need to invest in it to get it going. And especially when you're a regulated business, then I'm afraid we've had to do that ourselves. We're a regulated business and you have to invest in putting that regulation in place.
SPEAKER_00100%. And I think if you can do that from the beginning, that it actually makes compliance ongoing a lot easier. They are going to come back and inspect the service. You need to be making sure that you're doing all the things that you've put into your policies. So I think if you can start on a really strong footing, then you're actually and invest that time, you're going to make life much easier for yourselves going forward.
SPEAKER_01That's right. So one thing we hate to do is to sell on fear. But the flip side is I think people do need to understand the risks that they take. When we chatted to Andrea James of Keystone Law about registration and the risks of a GMC process for doctors, in particular doctors, the comment she made that absolutely rings in my mind is that the CQC are far more gung-ho about prosecuting people than the GMC. So if you are not CQC registered and you're deemed to be offering regulated services, what are the risks? What can happen?
SPEAKER_00Obviously, nobody likes to talk about enforcement and this type of thing, but you're right, the practitioners do need to understand the risks. Right now, the CQC, as I said, have changed the way that they work. They're revamping everything and they are enforcing their powers. So depending on the circumstances, there's many things that could happen. Obviously, the first is that they would stop you operating immediately. They would investigate and potentially pursue prosecution. So you could be prosecuted, they can also use fines against you. And some of these fines can be pretty hefty. Obviously, then that leads to reputational damage, commercial risk to your business. Insurers may then have concerns. You may find it difficult to then move forward and get insurance for other clinics that you work at. Patients would obviously question your suitability if they've read in the papers or there's rumors that you were struck off of the CQC register or that you were practicing without a license. All of these things can cause huge damage to a reputation that you've spent a long time building. So I like to say to people, the kind of prosecution and the fines are the least of your worries because you've built the last 10 years, you're building your clinical business, and that's just going to be taken away from you in one go. So I do think that people need to be aware that this is happening. People are also reporting more issues than ever before. Prior to this, there weren't many people that would actually ring in or call in about a service that they believed were working without a license. That happens all of the time now. And also it's really easy for the CQC to check these things with websites and Google, with phone numbers and addresses. It's super easy for them to find the clinics that are not working within the regulations. So you do need to be really careful.
SPEAKER_01So it sounds to me, it's, I know most doctors are very fearful of GMC processes, and it's rightly very stressful for them because of that sort of cliff risk. You can get struck off and then you can't apply what you trained for seven years to do. And it sounds that people should think of CQC in the same mindset. It's the cliff risk is you get closed down and you're not in business anymore.
SPEAKER_00Yeah. And it will be made public. There, there would be, it would be somewhere, people will be able to read and see that information. So although technically you're not being struck off, the GMC may also be contacted. So there is also that worry as well. They have a duty of care. And if you're a GMC doctor and you're, let's say you have a clinic with no license, then they may feel that it's their duty to report you to the GMC. And I can imagine that there's a high case of that. So yeah, you really do need to consider everything. And to be honest, it's just not worth it because the CQC is not that difficult. If they if you apply and they reject you, there's usually a good reason. And those rejections are given in detail and you are able to go away and fix it and reapply. So there really is no reason to pursue that avenue of actually it's easier just to work without a license and going through that process. Because I honestly don't think it is easier. And I think the amount of stress that it would cause you every day, thinking, are the CQC going to rock up today and take away everything? It's just not worth it.
SPEAKER_01So I was going to say you mentioned. The designated offer, a free 30-minute call. And it sounds like that free 30-minute call is uh well worth it. So could you just let everybody know, where can they find you to make to book a call?
SPEAKER_00So we the designated medical, you can book via our website. There's also an email address on there. You can get in touch with us anytime. We are a team of experts who love to help. Even if you don't want to move forward with the services, we'll at least be able to tell you what you need to do or not do. And if it is that you don't need a license, fantastic. At least you know that and you have factual evidence of that rather than just assuming. So, yeah, we're happy to help. We do a 30-minute sort of discovery call where we can talk through. And I guess one of the other things as well that happens a lot with new businesses who are seeking a CQC license is they've never done this before. They might not have been in private practice. We see a lot of NHS doctors moving into private care. They don't know how private care works. So actually, working with a company such as Designated, you also get a little bit of hand holding, you get expert advice on how to set up your business, and they can help you with so much more than compliance. So I definitely think if you are considering it, then it's a good option.
SPEAKER_01It's something we notice actually as a general comment, and again, we have this confidence to thrive podcasting. Confidence to thrive is one of our strap lines because we're all for our clients thriving. But it is quite a step, especially for people who have spent their entire life in the NHS, which is geared to taking everything away from you. So all you need to do is the medical part. The unfortunate thing about private healthcare is it is a business at the end of the day, and you have all those other business things to worry about. You have to worry about sales and marketing and accounting and bookkeeping and regulation, and in fact, all things that designator can help with as well.
SPEAKER_00Yeah, absolutely.
SPEAKER_01But it's yeah, I would say worth the conversation because it's it's interesting. And then just as I've said, and not to put people off, but I think again, if you are going into private practice, you are going into the business, you need to think about the turnover and all things, I'm sure designation can help with the sort of investment and turnovers and what you need to make. It always rings in my mind. One of our clients is was a very large, successful weight loss surgery business, and they're pivoting rapidly into uh into weight loss drugs and men's and women's health and so on, as you can imagine. But the guy who founded that was always he was a complete marmite character because he was an NHS doctor who set up a very successful private practice. And he basically said, if you are going to set up private practice, don't mess around. You need to go, you need to have the intention to make quite a lot of money because there's quite a lot of expenses along the way.
SPEAKER_00Yeah, yeah, and that's actually really good advice. It isn't something that you should just fall into because you think it's easy. I think there are obviously costs associated with that, and there's a lot of work that comes with it. But again, working with designated or somebody similar, we can help with figuring out the costs, making them as low as possible. We this is where we excel. We've done this for many years, we've run lots of different practices. So working with an expert and getting that initial advice is a really good investment in the beginning because it could actually save you a lot of time and a lot of money. For example, we've seen people who are applying for the CQC license and they may have already bought a building, they are paying rent, and they've then got a nine-month wait to get their license, which we absolutely wouldn't advise. And if they had come to us first, we would have helped them navigate the best way of doing those things. So it can definitely, it might be a small investment, but it can definitely save you costs in the long run. And I think the other thing just to mention is that a lot of NHS-based practitioners will also confuse the NHS with private, and they'll think, gosh, NHS CQC is a nightmare. I don't even want to think about that. But actually, in private healthcare, it is simpler. You're not dealing with big hospital-like models. So, therefore, the governance is really simple. It is definitely something that needs to be seriously thought about, but it's much easier to manage than in the NHS. So they also shouldn't let that put them off.
SPEAKER_01Perfect. That sounds like a great positive note to finish on. So thank you ever so much for your time.
SPEAKER_00You're welcome. Thanks for having me.
SPEAKER_04Thank you for listening to Confidence to Thrive. Before you go, please rate, review, and subscribe to Confidence to Thrive on your preferred podcast platform and help us spread our message to others who are making a difference in private healthcare. This podcast was brought to you by Ourlicity, insurance advisors who support your business ambitions. Our City advises practitioners, owners, and entrepreneurs of healthcare practices on mitigating risks so your business can thrive. Learn more about how Aurlicity can support you by finding the link in the show notes or visiting ourlicity.co.uk.