Under the Knife: 2023 Reforms to the Cosmetic Surgery Industry Part 2.1
Part 2.1 – Guidelines for performing cosmetic surgery.
The Australian cosmetic surgery industry is growing at a rapid rate, with more than $1 billion spent each year over 500,000 procedures – making cosmetic surgery more popular per capita than in the US. According to new research released by the Australasian College of Cosmetic Surgery and Medicine, almost seven million Australians – or 38% of the adult population – are considering having cosmetic surgery performed in the next 10 years.
However, the 2023 cosmetic surgery reform package announced by the Medical Board of Australia (MBA) and the Australian Health Practitioner Regulation Agency (AHPRA) promises to significantly disrupt the largely unregulated industry, and provided practitioners only three months to review practice procedures and audit any advertising materials in advance of its 1 July 2023 commencement.
As discussed in part 1 of this series, the new practice and advertisement guidelines were introduced in response to a 2022 Independent review of the regulation of medical practitioners who perform cosmetic surgery. The review outlined various concerns regarding the lack of universal standards for education, training and qualifications within the sector and the associated risks to patients who undergo cosmetic surgery and procedures. These guidelines were also accompanied by a new set of accreditation standards introduced by the Australian Medical Council Limited (AMC) for the MBA to accredit education and training providers, and new laws to ensue only qualified doctors who have completed the appropriate accredited surgical training can use the title “surgeon”.
In this second instalment of Under the Knife, the Regulatory and Advertisement Lawyer team at BlackBay Lawyers explores the updated Guidelines for registered medical practitioners who perform cosmetic surgery and procedures, identifying the changes to standards of practice and outlining how practitioners and business owners can successfully operate within the context of the 2023 reforms.
Background: Performing cosmetic surgery and procedures
Medical practitioners registered under the Health Practitioner National Law (the National Law) who perform cosmetic surgery and procedures have previously been subject to the October 2016 Guidelines for registered medical practitioners who perform cosmetic medical and surgical procedures. The guidelines were developed to complement Good medical practice: A code of conduct for doctors in Australia (Good Medical Practice) and provide specific standards for practitioners within the cosmetic surgery industry.
The 2016 guidelines included a set of standards applicable to cosmetic “medical or surgical procedures”, including (but not limited to) the assessment of patients, consent, training and experience and financial arrangements.
The new guidelines, effective from 1 July 2023, improve upon and clarify the existing guidelines in order to provide better protection for patients and address the unique challenges posed by the Australian cosmetic surgery consumer landscape in 2023. They similarly apply to medical practitioners registered under the National Law and are intended to be read in conjunction with Good Medical Practice.
The new guidelines are drafted in two sections to provide specific guidance for:
Cosmetic surgery – including cutting beneath the skin. Examples include breast augmentations, rhinoplasty, surgical face lifts and liposuction; and
Non-surgical cosmetic procedures – which do not involve cutting beneath the skin but may involve piercing the skin. Examples include injectables such as Botulinum toxin (Botox), dermal fillers, thread lifts, fat freezing, laser hair removal and chemical peels.
Importantly, the guidelines do not apply to gender affirmation surgery or reconstructive surgery, being surgery that restores form, function, and normality of appearance. The guidelines only apply to plastic surgery when it is performed solely for cosmetic or aesthetic reasons.
Keep reading to learn more about the most relevant updates and the changes to the 2016 standards for medical practitioners:
The updated guidelines – Cosmetic Surgery
The patient should be referred for evaluation to an independent psychologist psychiatrist or general practitioner (excluding general practitioners who provide cosmetic procedures) if there are indications that the patient has significant underlying psychological problems which may make them an unsuitable candidate for the procedure.
A medical practitioner should decline to perform a cosmetic procedure if they believe that it is not in the best interests of the patient.
All patients seeking cosmetic surgery must have an independent referral, preferably from their usual general practitioner.
Patients should be asked if another practitioner has declined to prove them cosmetic surgery.
The medical practitioner performing the surgery must assess the patient for underlying psychological conditions such as body dysmorphic disorder (BDD), using a validated psychological screening tool to screen for BDD.
If screening indicates that a patient has significant underlying psychological issues which make them an unsuitable candidate, they must be referred for evaluation to an independent psychologist, psychiatrist or general practitioner.
A medical practitioner must decline to perform the surgery if they believe that it is not in the best interests of the patient.
As described above, one of the most relevant changes to the practice guidelines is that patients seeking cosmetic surgery must have an independent referral from a general or specialist practitioner. The purpose of this reform is to support continuity of care and patient safety, given it necessarily involves general practitioners assessing a prospective patient’s physical and mental health. This referral step also provides a further opportunity for a patient to discuss their motivations for undergoing cosmetic surgery. However, both practitioners and patients should note that this requirement only applies to cosmetic surgery – and not procedures as defined above.
The new guidelines also impose positive obligations on practitioners to screen for underlying psychological conditions, with particular reference to BDD and appropriate screening tools. Now, practitioners must assess, refer or decline as directed by the guidelines.
Patient consultation type and timing
The 2023 reforms improve upon the existing guidelines concerning patient consultations by providing the following additional guidance:
· A patient seeking cosmetic surgery must have at least two pre-operative consultations;
· A patient must not be requested to sign consent forms at their first consultation;
· A patient cannot consent to cosmetic surgery until they have had an in-person consultation.
These requirements are in addition to earlier guidelines, which also required a cooling-off period of at least seven days. However, practitioners should note that this cooling off period now commences to run after the patient has had the second consultation and in which informed consent has been given.
Additional Responsibilities – patients under the age of 18
The guidelines concerning additional responsibilities when providing cosmetic surgery for patients under the age of 18 remain largely similar to the 2016 guidelines, save for the following small differences:
The MBA expects that medical practitioners are familiar with relevant legislation of the jurisdiction in relation to restrictions on cosmetic surgery for patients under the age of 18.
There must be a cooling off period before the informed consent and the procedure being performed:
Medical practitioners must know and comply with relevant legislation of the jurisdiction in relation to restrictions on cosmetic surgery for patients under the age of 18.
There must be a cooling-off period of at least three months between the provision of informed consent and the surgery being performed.
Informed consent – including informed financial consent
The medical practitioner who will perform the procedure must provide the patient with enough information for them to make an informed decision about whether to have a procedure. The practitioner should provide written information in plain language.
The medical practitioner who will perform the procedure must provide the patient with enough information to enable them to make an informed decision about whether to have a procedure. The practitioner should provide written information in plain language. Practitioners should take all practical steps to provide information in a language understood by a patient. Information must not glamorise surgery, minimise the complexity of surgery, overstate results or imply patients can achieve unrealistic outcomes. For any cosmetic surgery that includes an implantable device, the patient must be given the Therapeutic Goods Administration (TGA) approved patient information leaflet (PIL) (before the surgery) and the patient implant card (PIC) (after the surgery) for the device.
In addition, the consent guidelines have been expanded to include information about:
Where the surgery will be performed;
The range of possible outcomes – in the short and long term;
The medical practitioner’s registration type, as opposed to their qualifications and experience;
Whether the practitioner has an endorsement for cosmetic surgery applicable to the practitioner’sregistration (when such endorsement is available); and
Whether other practitioners will be involved in the surgery.
Practitioners will now also have to disclose information relating to the costs of:
Any implants or other devices;
Other medical practitioners, including assistant surgeon and anaesthetist fees;
Possible costs for allied health or other care required post-operatively; and
Advising the patient that cosmetic surgery is not covered by Medicare.
Further, as explored in the first instalment of this series, consent must be requested for any photographs or videos a practitioner proposes to take of a patient. For more information concerning patient consent to use of their images, such the requirement that they be given an opportunity to view the images before consenting to their use in advertising, click here.
If the medical practitioner who performed the procedure is not personally available to provide post-procedure care, they must have formal alternative arrangements in place. These arrangements should be made in advance where possible, and made known to the patient, other treating practitioners and the relevant facility or hospital.
When a patient may need sedation, anaesthesia and/or analgesia for a procedure, the medical practitioner who is performing the procedure must ensure that there are trained staff, facilities and equipment to deal with any emergencies, including resuscitation of the patient. There should be protocols in place for managing complications and emergencies that may arise during the procedure or in the immediate post-procedure phase.
If the medical practitioner who performed the surgery is not personally available to provide post-operative care, they must have formal alternative arrangements in place, including a nominated delegate who is a suitably qualified medical practitioner. These arrangements must be made in advance, documented, and made known to the patient, other treating practitioners and the relevant facility or hospital.
When a medical practitioner performs cosmetic surgery in a location that is not their primary place of practice, the medical practitioner who performed the surgery must be available at that location for at least 24 hours after the patient’s surgery. Ongoing post-operative care in these locations can be delegated after the first 24 hours.
When a patient may need sedation, anaesthesia and/or analgesia for cosmetic surgery, the medical practitioner who will perform the surgery must comply with the Australian and New Zealand College of Anaesthetists’ (ANZCA) guidance on procedural sedation and ensure that there are trained staff, facilities and equipment to deal with any emergencies, including resuscitation of the patient.
There must be protocols in place for managing complications and emergencies that may arise during the surgery or in the immediate post-operative phase.
It is preferable that the medical practitioner who will perform the surgery has admitting rights to an appropriate hospital in the event that post-operative admission is required. If the practitioner does not have admitting rights, prior arrangements should be made with another medical practitioner who has admitting rights and who can take responsibility for ongoing patient care.
In the event of complications requiring hospital admission, the medical practitioner who performed the surgery is responsible for coordinating care until the patient is under the management of the alternative practitioner or hospital.
Collaborative care arrangements with the wider healthcare team, as indicated by a patient’s history and needs, should be considered pre-operatively, organised prior to discharge and made known to the patient.
Further, practitioners must provide written instructions to patients on discharge, such as contact details, details of the surgery performed and anaesthesia used, the usual range of post-surgical symptoms and instructions for medication or unusual paid/symptoms.
The 2016 guidelines only referred to the disclosure of complaints process in the context of obtaining a patient’s informed consent. Within the updated 2023 guidelines, the MBA and AHPRA have gone further to establish an express right for patients to make a complaint where they are dissatisfied with their service.
Now, practitioners must provide information about the range of complaint mechanisms available, such as:
Raising and resolving a complaint directly with the practitioner;
Access the clinic or facility’s complaint process;
Making a complaint to the health complaints entity in the state or territory where the surgery was performed; and
Making a complaint to AHPRA, the Health Care Complains Commission or the Medical Council of NSW.
Further, practitioners must make clear in the terms of any disclosure agreement that the patient, or a person on behalf of a patient, can still make complaints to AHPRA, the Health Care Complains Commission or the Medical Council of NSW.
Training and experience
Procedures should only be provided if the medical practitioner has the appropriate training, expertise, and experience to perform the procedure and deal with all routine aspects of care and any likely complications.
Cosmetic surgery must only be provided by medical practitioners with the appropriate knowledge, training and experience to perform the surgery and deal with all routine aspects of care and any likely complications. (When area of practice endorsement for cosmetic surgery is available) an approved qualification eligible for endorsement for cosmetic surgery is appropriate training. In the interim, the MBA expects that at a minimum, a medical practitioner providing cosmetic surgery will have undertaken appropriate surgical skills training, training in the specific cosmetic surgery being offered, and have completed supervised practice to ensure they are safe to perform the surgery. All medical practitioners must participate regularly in continuing professional development (CPD) that is relevant to their scope of practice. All medical practitioners whose scope of practice includes cosmetic surgery, must undertake CPD that includes activities related to cosmetic surgery, including reviewing their performance and measuring their outcomes.
The new registration standard for endorsement for cosmetic surgery is one of the most disruptive changes ushered in by the new guidelines. Applications for enforcement became available on 1 July 2023, and there are approved qualifications. Practitioners should note that there are currently no approved qualifications as of June 2023.
Qualification and titles
As stated in the 2016 guidelines, practitioners must not make claims about their qualifications, experience or expertise that could mislead patients by implying the practitioner is more skilled or more experienced than is the case.
In addition to this general prohibition, practitioners must now clearly inform their patients of their registration type and must not use a protected title unless they hold the relevant registration type.
The MBA expects that medical practitioners are familiar with relevant legislation, regulations and standards of the jurisdiction in relation to facilities where the procedure will be performed. The MBA expects that medical practitioners are familiar with relevant legislation, regulations and standards of the jurisdiction in relation to facilities where the procedure will be performed
Medical practitioners must know and comply with relevant legislation, regulations and standards of the jurisdiction in which they are practising in relation to facilities, including facility licensing, where the surgery will be performed. All cosmetic surgery must be performed in a facility that is accredited by an Australian Commission on Safety and Quality in Health Care (ACSQHC) approved agency to ACSQHC standards as specified by the MBA. Cosmetic surgery must be performed in a facility that is appropriate for the level of risk involved in the procedure and the risk profile of the patient. Facilities must be appropriately staffed and equipped to manage possible complications and emergencies.
Another relevant change to the guidelines is the requirement that cosmetic surgery be performed in a facility that is accredited by an ACSQHC approved agency, to ACSQHC standards. Practitioners can apply for an existing facility to be accredited or apply to be credentialed at an accredited facility.
Whilst the requirement that facilities should be accredited is effective as of 1 July 2023, there is a provision for medical practitioners to continue to perform cosmetic surgery after 1 July 2023 facilities that are not yet accredited if they can prove:
The facility is registered with an ACSQHC approved accrediting agency; and
They have commenced working towards accreditation and have completed a self-assessment against the NSQHS standards.
Practitioners should note that all facilities in which cosmetic surgery is performed must be fully accredited by 1 July 2024.
The medical practitioner should not provide or offer to provide financial inducements (e.g. a commission) to agents for recruitment of patients.
Medical practitioners should not offer patients additional products or services that could act as an incentive to treatment (e.g. free or discounted flights or accommodation).
The medical practitioner should not offer financing schemes to patients (other than credit card facilities), either directly or through a third party, such as loans or commercial payment plans, as part of the cosmetic medical or surgical services.
Medical practitioners should not offer patients additional products or services that could act as an incentive to treatment (e.g. free or discounted flights or accommodation).
Medical practitioners should ensure that they do not have a financial conflict of interest that may influence the advice that they provide to their patients.
The medical practitioner must not provide or offer to provide financial inducements (such as a commission) to agents for recruitment of patients.
The medical practitioner must not provide or offer to provide free or discounted surgery to prospective patients, including social media influencers or users, for promotion of cosmetic surgery or services.
The medical practitioner must not offer, promote or recommend financing schemes to patients, either directly or through a third party, such as loans or commercial payment plans, as part of the cosmetic surgery. This does not preclude a practitioner from informing patients of accepted payment methods such as credit cards (such as Visa, Mastercard), buy now, pay-later products (such as Afterpay, Openpay, Zip Pay) or from offering the option to pay for cosmetic surgery in instalments in a non-commercial payment arrangement between the medical practitioner and patient. Medical practitioners must not encourage patients to take on debt (for example, personal loans, remortgage) or access superannuation, to access cosmetic surgery.
Medical practitioners must not offer patients additional products or services that could act as an incentive to cosmetic surgery (such as free or discounted flights or accommodation).
Medical practitioners must:
Complying from 1 July 2023
As outlined in both instalments of this series, if you are a medical practitioner performing cosmetic surgery in Australia, is crucial that you understand the new raft of guidelines which commenced on 1 July 2023.
All medical practitioners or business owners should complete a thorough review of all procedures and contracts used within the course of their practice to ensure they remain compliant with the new updates, including (but not limited to):
A GP referral system;
The use of patient assessment using BDD screening tools;
Informed consent requirements;
Limitations on the content of NDAs; and
The accreditation of facilities.
In addition, practitioners will need to keep up to date with the new endorsement registration standard that came into effect from 1 July 2023, as the MBA and AHPRA have signalled that applications will be available later in 2023.
This instalment of Under the Knife has focused solely on guidelines for registered medical practitioners who perform cosmetic surgery. In part 2.2 of this series, the Regulatory and Advertisement Law team at BlackBay Lawyers will delve into the guidelines for performing cosmetic procedures, exploring the differences between the two practices.
If you are concerned about the potential impacts that these new guidelines may have upon your individual practice or business, contact BlackBay Lawyers today to discuss how you can remain compliant and operate confidentiality within the cosmetic surgery industry.