Orthodontic and third-party agreements: risks and concerns.

In recent times, there has been a growing number of companies on the internet offering orthodontics like braces, aligners, and other products that people can use at home. While the convenience is very appealing for patients, the same can’t be said about the risks and concerns that come with partnering with foreign-based aligner companies. With the recent demise of two overseas aligner providers, some dentists have not been able to continue patient care in the middle of a course of orthodontic treatment. This has resulted in patient complaints against dentists, who had no part in the companies’ collapse but are left to manage the fallout and develop a re-treatment plan with another aligner provider.

Another recent development is that patients are asking dentists to place attachments for “at-home, do-it-yourself” aligner treatment. Seeing that this is a complex issue, the ADAVB has approached their advisors at Meridian Lawyers to make general comments about the pitfalls for dentists undertaking either of these two types of treatment. Their advice is that the provision of aligners and/or attachments may make the dentist liable for any adverse treatment outcomes and possibly affect a dentist’s professional indemnity (PI) cover.

The ADAVB recommends that any member undertaking orthodontic treatment with third-party aligner providers familiarise themselves with the risks and ensure that they are not exposing themselves to additional liability, which may place them in a precarious position when defending a claim.

Major concerns 

Treatment plans by aligner companies are often computer-generated offshore with some input from a technician. Blindly following these plans may result in a compromised outcome and potentially irreversible damage. Orthodontists often make changes before a satisfactory plan is reached and may even further modify plans during treatment, depending on the progress. As the clinician, you’re responsible for the treatment and any adverse outcomes, not the aligner company that generated the treatment plan.

As a result, any claims by patients would most likely be against the dentist or the clinic. Contractual and duty of care considerations need to be taken into account. Even if the contract says the aligner company will cover your liability, that can’t be enforced. By Australian law, the dentist cannot delegate liability for treatment performed to another party. So, in the end, the problem comes back to bite the dentist.

Fault by association

A claim against the aligner provider would necessitate chasing shelf and overseas companies, making it almost

impossible for the patient. The patient will turn to the only person they can reach and direct the blame to – their dentist. It should be noted that at present, there are two class action claims in courts overseas against aligner providers, but these may take years to play out, and it’s unknown if they will be successful.

An insurer is not privy to the contracts dentists sign or warranties offered by aligner companies. This means warranties deflect back to the dentist and may not be covered under a professional indemnity policy. In Australia, health service providers cannot give warranties, so that part of the company’s “promise” is worthless unless it relates specifically to the aligners themselves (breakages, replacements, etc), not treatment outcomes. 

The issue with consent

Informed consent is potentially lacking as most dentists are utilising documents supplied by the aligner company, which in many cases, are not comprehensive enough to satisfy the Australian Code of Conduct requirements.

Less experienced dentists are often targeted to promote this type of orthodontic treatment as an easy treatment option to provide to patients. Patients seeking aligner treatment usually have high expectations, and it can be challenging to achieve the desired result using aligners only. 

Unaligned with Australian laws

While there is a high demand for DIY aligners, dentists should be mindful that undertaking treatments designed by a foreign company can bring more damage than good, especially as they don’t usually meet the standards set by

Australian authorities. Some examples of these breaches include:

> Against regulatory guidelines: advertising may not be compliant with Ahpra’s Code of Conduct because the company is based abroad.

> Products may not be TGA approved (as required in any PI policy): there is a high risk that the insurer may reject a claim when these devices are being used.

> Australian Privacy Principles (APPs) may be broken by sending confidential patient information overseas: if there is a breach of privacy, the insurer can deny cover as the policy wording indicates the dentists must abide by the APPs in how they store patient information. Foreign companies are not bound by the APPs, so a dentist must weigh the risks and inform the patient about the potential breach of confidentiality before undertaking treatment. In saying that, the risk

remains that an indemnity claim could still be denied.

> Companies may offer incentives or discounts, equipment, etc: these all need transparent disclosure under Ahpra’s regulatory framework. If you don’t disclose these on all advertising and patient material, you could be in breach of Ahpra

or TGA’s advertising standards and guidelines.

A professional indemnity policy is a contract between you and your insurer, and part of that contract is that you will abide by all regulatory requirements, and the issues mentioned above may expose you to a regulatory finding of

unsatisfactory professional conduct.

The ADAVB recognises that there are a lot of hidden issues that members are not familiar with. It’s strongly recommended that you consider your practice before agreeing to take on such treatments. ADAVB has provided some links to follow if you would like more information. You can also speak to your Account Manager or contact Guild Insurance at 1800 810 213 to review your policy for coverage and exclusions.

Australian Health Practitioner Regulation Agency (Ahpra) – Guidelines for advertising
Therapeutic Goods Administration – The Therapeutic Goods Advertising Code:  tga.gov.au/about-tga/legislation/legislationand- legislative-instruments/therapeutic-goodsadvertising- code

 

Office of the Australian Information Commissioner (OAIC) – Australian Privacy Principles: oaic.gov.au/privacy/australian-privacy-principles

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    Importance of Informed Consent

    All health practitioners would be well aware of their requirements to obtain informed consent from their patients before assessment or treatment takes place.  However, Guild Insurance’s vast experience in managing claims made against health practitioners has highlighted that many practitioners don’t meet all their informed consent requirements.

    What is informed consent?

    There is an explanation about informed consent in the Code of Conduct for each of the professions regulated by AHPRA.  In this document, informed consent is defined as ‘a person’s voluntary decision about healthcare that is made with knowledge and understanding of the benefits and risks involved’.  This statement highlights the difference between consent and informed consent.  If a patient hasn’t been made aware of the benefits and risks, their consent isn’t informed.

    Informed consent isn’t just required for treatment. Depending on the nature of the healthcare being provided, informed consent should also be obtained for assessment. 

    Informed consent and insurance claims

    Informed consent can feature in insurance claims against practitioners in a couple of ways.

    It’s not uncommon when a patient is unhappy following treatment for them to allege they weren’t made aware of the risks when they consented to treatment.  Quite often they will allege the treatment was negligent and has resulted in harm or suffering.  They then add that had they been informed of the possible risks, they wouldn’t have consented.

    In other cases, patients may not make any allegation about consent, their complaint might solely focus on the clinical outcome, yet when their claim is being managed it’s found that they didn’t give their informed consent prior to treatment being provided.  When this occurs, it makes it challenging for Guild to prove that the practitioner has treated appropriately and met their requirements.

    The informed consent conversation

    Informed consent requires a conversation between the treating practitioner and the patient.  This conversation needs to occur prior to assessment and treatment. 

    The conversation must:

    • detail the recommended assessment and treatment as well as alternate treatment options
    • include the expected benefits of that treatment
    • provide information about the risks of the treatment
    • allow time for the patient to ask questions
    • be held in language which can be understood by the patient which means practitioners should avoid technical clinical language.
    • take place in a private area where the patient will feel comfortable being open and honest about their health situation.
    • be tailored to that individual patient and their unique clinical needs

    Recording informed consent

    It’s imperative that practitioners make a note in the clinical record regarding the patient providing their informed consent.  This needs to be more than ‘IC given’.  The record needs to show what treatment options and risks were discussed as well as any questions asked by the patient.  The record should also show what the patient consented to as well as what they didn’t consent to where relevant.

    The informed consent form

    One area which leads to some confusion about informed consent is how to use an informed consent form.  Having a patient sign a form is seen as a quick and simplified way of having a patient provide their informed consent and keeping a record of that.  However, they are unfortunately too often used inappropriately. 

    Signed forms aren’t a requirement.  While recording consent is required, this doesn’t need to be done using a form.  Notes in the clinical record are sufficient.  However, signed forms do provide additional evidence if there is an allegation that informed consent wasn’t given.

    Forms can’t be used to replace the informed consent conversation.  A patient can not read a form and gain the same level of understanding as they would from a conversation with the practitioner.  Nor can they ask questions of the form. 

    A form should only be signed after the conversation with the practitioner has been had and the patient understands what it is they’re consenting to.  Patients are occasionally asked to sign consent forms at reception before they’ve seen the practitioner.  As there has been no assessment or discussion about treatment at this stage, this can’t be considered informed consent as the patient hasn’t been informed.

    Some practices combine new patient forms with the consent form.  This isn’t ideal as the two forms serve different purposes.  Also, having them on the one form encourages patients to sign the consent form at reception before they’ve seen the practitioner.  Therefore, they should be divided into two separate forms.

    Informed consent is not a one-off event

    Practitioners regularly ask how often their patients need to give informed consent.  There is no set time frame for when informed consent conversations or signed forms need to be repeated.  The requirement is that when a patient is receiving any assessment or treatment, they need to have given their informed consent to this.  Therefore, informed consent should be an ongoing process; it’s a continual conversation with patients during consultations.  And when there is any change in the treatment being provided, or if the patient has returned following a period of absence, informed consent needs to be revisited.  A general ‘consent to all treatment’ for the life of the therapeutic relationship is not appropriate.

    Informed financial consent

    As well as consenting to assessment and treatment, patients should also give their informed financial consent.  This means they need to be provided with information about the expected cost of treatment before this treatment commences.

    In summary…

    There is no one right way to undertake an informed consent conversation and process.  Practitioners must adapt what’s discussed for the patient they’re treating and that patient’s unique circumstances.  However, what must occur in all cases is that the patient is informed of and understands the proposed treatment, alternate treatment options and the risks involved.  Only with this information can they give their informed consent.  The practitioner must also be sure to make a record of this informed consent discussion in the clinical record.

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  •

    Managing patient expectations in dentistry

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    It’s well recognised that patients don’t necessarily complain simply based on their clinical outcome. Most dentists will have heard of or seen situations where a patient has experienced an outcome which wasn’t ideal yet wasn’t particularly poor, however the patient has been quite annoyed with the outcome and has lodged a complaint.  On the other hand, there are many cases of patients who have experienced quite poor outcomes yet have chosen to not complain.

    There are many reasons why the above may occur, some which are easier to identify than others. All patients are different and human behaviour isn’t always predictable.  Good communication and the relationship between the patient and dentist will greatly influence the likelihood of a complaint.  One other very important factor is the expectations of patients.

    Patient expectations

    Many patients will go into dental appointments with some level of expectation regarding their likely outcome. They may have a very clear and detailed outcome in mind or it may be more broad and open.  Most importantly, some of these expectations will be realistic, however others won’t be.

    Unrealistic patient expectations pose very real challenges for dentists. If a patient undergoes treatment which they have unrealistic expectations about, it’s unlikely those expectations are going to be met simply due to them being unrealistic.  If a patient’s expectations haven’t been met, it’s likely the patient is going to be unhappy or dissatisfied with the treatment.  Those unhappy and dissatisfied patients are the ones more likely to complain about the treatment and expect further corrective treatment or compensation.  It’s therefore vital that dentists do all they can to help the patient fully understand treatment and the likely and possible treatment outcomes before treatment begins.

    Creating realistic expectations

    A key step in making sure a patient has realistic outcomes regarding treatment is to have an open and honest conversation with them. This will not only provide the patient with further information about their treatment, but will also give the dentist a clearer understanding of the patient’s expectations.  A dentist’s clinical skills are vital to what they do, however effective communication goes a long way in providing positive outcomes.

    To assist a patient to have realistic expectations, dentists must ensure they explain the treatment and outcomes using simple, clear terms. Technical clinical language should be avoided as many patients won’t understand this.  Dentists should also consider how they tailor their language and the information for each individual patient.  For example, a person with language or literacy challenges may need information presented in a more detailed manner than other patients.  Dentists should also consider using diagrams, pictures or models to assist with understanding where appropriate.

    When discussing treatment with a patient, it’s important that dentists don’t make assumptions about what the patient will or won’t understand. It’s easy for dentists to become so familiar with what they do and know that they sometimes forget how foreign that knowledge can be to other people.  Patients will have varying degrees of knowledge and experience regarding dental treatment.  Therefore, what they understand about their treatment will also vary.

    When a patient attends a dental clinic and requests a particular form of treatment, this is an occasion when a dentist should be especially mindful of the patient’s expected outcome. When a patient has requested a form of treatment, the patient has clearly formed a decision around what treatment they need to get the outcome they desire.  What they’re requesting and expecting may be reasonable and realistic, however in some cases it may not be.  When presented with this situation, dentists need to be sure they don’t rush into providing the patient with the requested treatment.  As with all patients, there needs to be a thorough assessment and diagnosis process.  Then the patient is to be provided with their treatment options, as well as the risks and benefits of those options.  There may be treatment options which are more suitable for that patient which the patient isn’t aware of.  The patient also needs to be made aware of the likely treatment outcomes for each of those treatment options.

    The dentist needs to be sure the patient has all required information before consenting to treatment and this includes understanding the likely outcomes. A patient requesting particular treatment doesn’t alter this required process.  And dentists need to remember that they’re always responsible for the treatment they’ve provided, regardless of whether it was requested by a patient.

    In summary…

    Dentists should be doing all they realistically can to improve the outcomes for their patients and reduce the likelihood of poor outcomes and complaints. An important step in this process is making sure patients have realistic expectations regarding treatment outcomes.  Dentists have a very important role in using their clinical knowledge in conjunction with practical terminology to assist patients to develop realistic expectations.  Dentists need to remember this is of great benefit to both themselves and their patients.

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    Guild Insurance Limited ABN 55 004 538 863, AFS Licence No. 233 791. Guild Insurance supports your Association through the payment of referral fees for certain products or services you take out with them. This article contains information of a general nature only, and is not intended to constitute the provision of advice.
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    Are you prepared for a power outage?

    Are you prepared for a power outage?

    Power outages are unfortunately becoming a somewhat common occurrence in parts of Australia. The threat of heatwaves, and therefore higher than usual demands on power, means that power outages are a real threat to many businesses over summer.

    Insurance protection during a power outage

    It’s important that all businesses understand their insurance cover in case of events which impact the running of the business, such as a power outage. Guild Insurance will provide cover when the power outage is unplanned, and this is defined as when there is less than 48 hours’ notice that the outage will occur. Cover will be provided for the cost of hiring a generator. And the really beneficial part about this cover is that there’s no waiting period with Guild Insurance. So if the power is out for only 2 hours, the policy will still respond and provide cover for that short period.

    Planning for an outage

    Sometimes there is no notice that a power outage is to occur. And even when notice is given, there may not be enough time to allow a business to adequately prepare for the outage. Therefore it’s vital that all businesses have a plan in place, sometimes referred to as a business continuity plan, for what they’ll do if a power outage was to affect their business.

    Some factors to consider when making this plan include:

    • Is there a business nearby which provides generators for backup power?
    • Can the business continue running from another site or location?
    • Is there another location where items, such as refrigerated stock, can be stored so they don’t perish or become damaged?
    • Where will emergency contact details (e.g. power company, insurer, clients) be stored away from the business in case the business can’t be accessed?
    • What are the implications for both the business and clients if the business doesn’t operate for a period of time?

    Remember, planning during an outage is too late. Don’t think this won’t happen to you, have a plan just in case.

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