POLICY: Performing Office-based Non-Insured Procedures


PREAMBLE

The College of Physicians and Surgeons of Saskatchewan (CPSS) has the authority to set standards and policies that establish expectations for high quality care for patients regardless of whether the care provided is medically required or purely elective.  In the past number of years, there has been considerable growth in the industries that provide cosmetic/aesthetic care to patients and also procedures aimed at the treatment of pathology that are not considered mainstream or have not traditionally been insured services.  While some of this care is provided in non-hospital treatment facilities (NHTFs) and is therefore governed by Bylaw 26.1, many procedures are performed in non-institutional settings such as physician offices and med-spas (a “clinic” or “clinics”).  When providing these types of care, physicians are expected to comply with policies and procedures that maximize the likelihood of safe and effective patient care. 

This policy is intended to apply to the office-based provision of cosmetic/aesthetic procedures and also non-insured procedures aimed at the treatment of pathology.  Examples of cosmetic/aesthetic procedures may include, but are not limited to:

  1. Application of laser energy and light-based therapies;
  2. Hair transplantation;
  3. Use of neuromodulators (injectable); and
  4. Soft tissue augmentation (injection of dermal fillers).
Examples of non-insured procedures aimed at the treatment of pathology may include, but are not limited to:

  1. Peripheral stem cell injection; and
  2. Platelet rich plasma injection.

For the purpose of this policy, these and any other comparable non-insured procedures are referred to as a “procedure” or “procedures”.

 

Reference to any specific non-insured procedure in this policy does not imply endorsement by the CPSS.  Physicians are cautioned to ensure compliance with the CPSS policy “Complementary and Alternative Therapies.”

POLICY


1. Knowledge, skills and performance

1.1 Physicians are responsible to recognize and work within the limits of their competence, and to refer a patient to another practitioner if they cannot safely meet the patient’s needs.

1.2 Before carrying out a non-insured procedure for the first time, physicians must ensure they have sought and obtained CPSS approval for the appropriate scope of practice in accordance with CPSS policy “Scope of Practice Change”. The current CPSS standards document for Change in Scope of Practice for Medical Aesthetics is attached as Appendix A.

1.3 In addition to obtaining approval for scope of practice, physicians must ensure they can safely perform the procedure, by undergoing training or seeking opportunities for supervised practice.

1.4 Physicians must take part in activities to maintain and develop their competence and performance across the full range of their practice.

1.5 Physicians are expected to practise evidence-based medicine, and to maintain a level of understanding of the available evidence supporting the procedure as it evolves.

 

2. Safety and quality of care

2.1. Physicians must be satisfied that the environment for practice is safe, suitably equipped and staffed and complies with any relevant regulatory requirements, including the CPSS guideline “Infection Prevention and Control Guidelines for Clinical Office Practice”.

2.2. It is each physician’s responsibility to take reasonable steps to ensure that a system is in place for the proper maintenance, cleaning and calibration of equipment used in the medical care they provide.

2.3. Physicians must be open and honest with patients in their care, or those close to them, and disclose if there is an adverse event.  Physicians must be familiar and in compliance with the CPSS policy “Physician Disclosure of Adverse Events and Errors that Occur in the Course of Patient Care”.

2.4. In the event of an adverse event, it is also the responsibility of the physician performing or authorizing the procedure to ensure a care plan is established to mitigate the effects of the adverse event in a satisfactory manner.

 

3. Seeking patients’ consent

3.1. Physicians must be familiar and in compliance with the CPSS policy “Informed Consent and Determining Capacity to Consent”, and the Canadian Medical Protective Association (CMPA) document “Consent: A guide for Canadian physicians” which has been accepted by the CPSS as an authoritative statement of the requirements for informed consent.

3.2. The physician who will be carrying out or supervising the procedure is responsible to discuss it with the patient and seek their consent.  This responsibility must not be delegated or authorized to be performed by another medical practitioner unless the physician is confident the delegatee has the knowledge and experience to provide adequate explanations to the patient.

3.3. The physician must ensure patients have the information they want or need, including access to written information that supports continuity of care and includes relevant information about the medicines or devices used.

3.4. The physician must ensure the patient is provided sufficient time and information to permit them to make an informed decision.

3.5. The physician must consider the patient’s psychological needs and whether referral to another experienced professional colleague is appropriate (i.e. body dysmorphic disorder).

3.6. The physician must take particular care when considering requests for procedures on minors or those with reduced capacity.

 

4. Authorization of non-physician providers

4.1. Physicians most responsible for care must assess the indications and potential contraindications for each patient.  The physician must personally assess each patient undergoing an invasive procedure.  The physician must be available to attend at the same location as the procedure is performed should circumstances arise where they are required to assist non-physician providers or to manage misadventure or complications arising from the procedure.  “Available to attend” in this context means that:

4.1.1. A policy must be in place for emergent complications, including but not limited to anaphylaxis, allergic reaction or acute embolic event, and the authorized non-physician providers present must be appropriately trained to recognize emergent complications;

4.1.2. In the event of an urgent or semi-urgent complication, the physician most responsible for care must be available to attend within a reasonable time consistent with the nature of the complication.

4.2. If the physician most responsible for care is not available to attend as defined, there must be arrangements in place to ensure the availability of an equally competent physician to attend.

4.3. Physicians must ensure that anyone they authorize to participate in the patient’s care has the necessary knowledge, skills, training and experience and is appropriately supervised.

4.4. Physicians must not authorize non-physician providers to perform any procedure unless the physicians are properly qualified to perform the procedure themselves.

4.5. Physicians must not authorize non-physician providers to perform any procedure that is considered the practice of medicine as defined in The Medical Profession Act, 1981 unless delegation is specifically authorized in the regulatory bylaws or the person is a regulated health professional acting within the scope of their profession.

 

5. Obligations of medical director or physician performing, authorizing or supervising a procedure

5.1 If non-insured procedures are performed in a non-hospital treatment facility, the medical director of that facility is subject to the obligations enumerated in Bylaw 26.1.

5.2 If non-insured procedures are performed in a clinic, the physicians performing, authorizing or supervising the procedures are responsible to:

5.2.1. provide adequate and effective direction and supervision of authorized non-physician providers;

5.2.2. ensure that:

5.2.2.1. the procedures employed in the clinic are selected and performed in accordance with current accepted medical practice;

5.2.2.2. a procedures manual for the procedures performed is available and maintained for guidance of the medical staff;

5.2.2.3. the clinic complies with legal and ethical requirements for medical records, including access, confidentiality, retention and storage of medical records;

5.2.2.4. the clinic complies with the bylaws and ethical requirements with respect to the propriety and accuracy of advertising, promotion and other marketing activities for non-insured procedures provided in the clinic;

5.2.2.5. if procedures are performed at the clinic that carry a risk of cardiac arrest or allergic reaction, the physician must ensure the availability of appropriate resuscitation equipment and medications and the presence of staff who are appropriately trained to utilize said equipment and medications.

5.3 With respect to the performance of non-insured procedures, the physicians performing, authorizing or supervising the procedures shall ensure that the clinic does not:

5.3.1. establish criteria for referral of patients to the clinic other than those required by clinical considerations;

5.3.2. contravene the conflict of interest provisions of the College bylaws or guideline;

5.3.3. function to increase its profitability at the expense of sound medical practice;

5.3.4. allow unqualified or inadequately supervised personnel to perform any procedures.

6. Liability coverage

 6.1. Any physician offering non-insured procedures or who is involved in authorizing non-physician providers to provide or assist in the same must ensure that the physician and other non-physician providers have appropriate professional liability protection.

7. Communicating information about services offered

7.1. When advertising office-based non-insured procedures, physicians must follow the applicable provisions in the Bylaws (Part 7) and Code of Ethics.

7.2. Physicians must ensure the information being published is factual and can be checked, and does not exploit patients’ vulnerability or lack of medical knowledge.

7.3. Marketing in this context must be responsible.  It must not minimise or trivialise the risks of procedures, or claim that procedures are risk free.

7.4. If patients will need to have a medical assessment or any additional investigations before a procedure can be performed, this must be made clear in the consent process.

7.5. Physicians must not mislead about the likely results of a procedure.  They must not falsely claim or imply that certain results are guaranteed from a procedure.

 

8. Honesty in financial dealings

8.1. Physicians offering non-insured procedures must be open and honest with their patients about any financial or commercial interests that could be seen to affect the way they prescribe for, advise, treat, refer or commission services for patients.

8.2. Physicians must not allow their financial or commercial interests in a non-insured procedure, or an organization providing non-insured procedures, to affect their recommendations to patients or their adherence to expected good standards of care.

8.3. Physicians must be familiar with and in compliance with the CPSS guideline “Conflict of Interest” as well as Bylaw 9.1.

9. General requirements

9.1. At all times, physicians must maintain full direction and control of their medical practices, including:

9.1.1. the medical care provided to or for a patient; the safety and quality of the premises in which they practise and of the equipment and the supplies used, including proper maintenance, cleaning and calibration of equipment used in the medical care they provide;
9.1.2. the qualification and performance of each staff member supervised by the physician.

 

ACKNOWLEDGEMENTS

 

The information in this document is based upon the following:

UK General Medical Council - Guidance for doctors who offer cosmetic interventions

CPSM - Bylaw 11 Standards of Practice of Medicine