Consultation on the Condition for surgical guides and biomodels on the Prescribed List

Overview

On 13 November 2023, a condition for reimbursement was placed on 37 billing codes for surgical guides and biomodels listed in Part A of Schedule 1 to the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 2) 2023 (the condition).

The condition is as follows:

1. Prescribed List reimbursement is restricted to the use of the device in craniomaxillofacial surgery procedures involving insertion of an implantable medical device, where that implantable device is listed in either sub-category 07.01 - Craniomaxillofacial Reconstruction & Fixation, or 07.02 – Craniomaxillofacial Implants, or 07.04 – Distractor Systems of Schedule 1, or sub-category 07.03 - Dental Implants, but only if the implantable medical device is explicitly identified in the product name or description of the billing code for the surgical guide or biomodel and is used in hospital. Not limiting the above, for a claim for any implantation procedure (defined by the respective MBS items stated in the claim) for a patient, the Prescribed List reimbursement is limited to 3 or less PL benefits for any billing codes for surgical guides or biomodels, or no more than 6 benefits if both surgical guides and biomodels (maximum 3 for each) have been used in an implantation procedure for a patient. This restriction is not impacted by a number of devices implanted during a procedure. The condition is taking effect on 1 February 2024.

Further clarification of the condition was provided via a Frequently Asked Questions document.

At the time of applying this condition, the department committed to monitor the impact of the condition to ensure relevant adjustments could be made where there were unintended consequences.

As part of this commitment, the department is reviewing the operation of part of the condition, and requesting stakeholder views on this.

Background

When groups and subgroups for surgical guides and biomodels were first introduced, the department anticipated that all surgical guides and biomodels would be used for implanting only the implantable devices listed in subcategory 07.02 - Craniomaxillofacial Implants.

However, there has been an increased use of surgical guides and biomodels, including outside the initially intended category. Taking this into account, the former Prostheses List Advisory Committee (PLAC) recommended a post-listing review of surgical guides and biomodels.

The first stage of the post-listing review aimed to determine eligibility of these devices for listing on the PL.

The post-listing review also suggested consideration of:

• Clarifying PL eligibility criteria for listing, and
• Placing limits on the reimbursement of PL benefits, for example by: specifying the MBS categories or devices for which surgical guides and biomodels are eligible for reimbursement
• Limiting the number of surgical guides and biomodels for which a PL benefit is paid per episode of care
• Considering alternative approaches to listing of benefits, such as stratified or tiered approaches.

The condition was inserted followed discussion and advice received from the Medical Device and Human Tissue Advisory Committee (MDHTAC) in September 2023 based on findings of the first stage of the post-listing review.

The condition aims to restrict PL benefit reimbursement to the use of the devices only in the craniomaxillofacial (CMF) and oral surgery (jaw and facial reconstructions), involving provision of an implantable device, and limiting the claims to no more than 3-4 surgical guides or biomodels per procedure.

For any other type of surgical procedures, being non CMF procedures (e.g. orthopaedic), it is proposed that sponsors will be required to apply for listing of the surgical guide and/or biomodel device in that specific category and provide the satisfactory data to demonstrate the device is both essential for implantation of an implantable device and leads to improved clinical outcomes.

Why your views matter

The department is reviewing the operation of the following part of the condition, and invites stakeholders to provide their view on the effect of:

• The requirement that implantable devices listed in ‘sub-category 07.03 - Dental Implants’ be ‘explicitly identified in the product name or description of the billing code for the surgical guide or biomodel’.

In providing your feedback, please note that any amendments to the condition would need to be consistent with the policy outcome of the post-listing review, in particular the findings that:

• surgical guides and biomodels are frequently used in complex craniomaxillofacial surgeries, where they have a range of benefits;
• surgical guides are used in increasing numbers per procedure in less complex surgeries, with surgeons and peak body representatives reporting that they provide minimal clinical benefit in simpler surgeries and questioned if their use was justified, especially in relation to cost.

The department invites written submissions (maximum 5 pages) about the effect of the above by 4:00pm on 25 March 2024.