Surgically implanted prostheses policy

What WorkSafe will pay for

The WorkSafe Agent (the Agent) can pay the reasonable costs of a surgically implanted prosthesis when required as a result of a work-related injury or illness under Victorian workers compensation legislation. WorkSafe adopts the Medicare Benefits Schedule (MBS) items, explanations, definitions, rules and conditions for surgical services provided by medical practitioners.

This policy must be read in conjunction with the following:

Background

Surgically implanted prostheses are provided in a hospital setting. For information regarding private hospital services associated with surgically implanted prostheses, please see the private hospitals policy. For surgically implanted prostheses to manage pain, please also see the implantable pain therapy policy.

WorkSafe refers to the prescribed list of medical devices and human tissue products, published by the Department of Health (DoH), to determine which prostheses are clinically effective and the reasonable cost of these prostheses.

The prescribed list of medical devices and human tissue products has more than 9000 surgically implanted prostheses, including products such as hip and knee replacements, human tissues and other medical devices.

The DoH and an advisory committee of medical practitioners and other health specialists known as the Prostheses List Advisory Committee (PLAC), evaluate prostheses for inclusion on the prescribed list of medical devices and human tissue products by determining which ones are safe and clinically effective.

The evidence shows that the most expensive prostheses are not necessarily the most appropriate ones.

The list comprises no-gap and gap permitted prostheses. For a prosthesis to be included on the prescribed list of medical devices and human tissue products there must be an associated item on the Medicare Benefit Schedule (MBS) that applies to the surgical procedure required to implant that prosthesis.

Definitions

In this policy:

• A surgically implanted prosthesis is an item of equipment or a device that is surgically implanted by a medical practitioner to improve health outcomes for workers. Prostheses include, but are not limited to, screws, plates, nails and human tissue.
• No-gap prostheses are items listed on the prescribed list of medical devices and human tissue products with a single fee and have been assessed as having equivalent clinical effectiveness to gap-permitted prostheses.
• Gap-permitted prostheses have both a minimum and maximum fee listed on the prescribed list of medical devices and human tissue products. Gap-permitted items have no proven improved clinical outcomes in comparison with no-gap prostheses.
• Non-listed prostheses are prostheses that do not appear on the prescribed list of medical devices and human tissue products. These prostheses have either been rejected by the PLAC or have not yet been evaluated for inclusion on the prescribed list of medical devices and human tissue products.

Guidelines

What can the Agent pay for in relation to surgically implanted prostheses?

The Agent can pay for surgically implanted prostheses that are:

• currently included on the prescribed list of medical devices and human tissue products
• required as a result of the work-related injury or illness
• reasonable, necessary and appropriate in the circumstances
• clinically justified, safe and effective
• invoiced in accordance with the prescribed list of medical devices and human tissue products and WorkSafe's guidelines

The Agent will not pay for surgically implanted prostheses which have been the subject of a negative determination by the PLAC. When replacement or modification of a prosthesis is required, and the prosthesis is covered by a supplier/manufacturer warranty, it is the responsibility of the manufacturer to replace or modify the prosthesis or its components.

Who can provide surgically implanted prostheses?

Suitably qualified registered medical practitioners can surgically implant prostheses in a hospital setting.

What information does the Agent require to consider paying for surgically implanted prostheses?

Requests for surgically implanted prostheses will be assessed on an individual basis and will be considered as part of the review process for elective surgery (refer to the elective surgery services policy). Prior written approval from the Agent is required for worker admission to hospital for elective surgery.

The approval of prostheses used within a surgical procedure will be considered as part of the elective surgery review process (see the elective surgery services policy).

The Agent requires specific information when considering paying for surgically implanted prostheses, as follows:

No–gap prostheses

If a medical practitioner is requesting approval for a surgical procedure that will involve the use of a surgically implanted prosthesis, details of the anticipated no-gap prostheses are required.

Gap-permitted prostheses

If a medical practitioner believes that a surgically implanted gap-permitted prosthesis is necessary, the Agent requires the following information in addition to the information required for approval of an elective surgery request:

• clinical justification for the use of a gap-permitted prosthesis instead of a standard no-gap prosthesis
• the prosthesis supply code and description
• the cost of the prosthesis

Non-listed prostheses

The Agent is unable to pay for surgically implanted prostheses which have been the subject of a negative determination by the PLAC.

Requests for surgically implanted prostheses not yet evaluated by the PLAC will only be considered in exceptional circumstances.

If a medical practitioner believes that a non-listed surgically implanted prosthesis (that has not been the subject of a negative determination by the PLAC) is required, the following additional information must be provided for the Agent to consider the request:

• sufficient evidence that the proposed prosthesis will be safe and more effective than a no-gap or gap-permitted prosthesis
• the reasons for proposing a non-listed prosthesis instead of one currently included on the prescribed list of medical devices and human tissue products
• the prosthesis supply code and description
• the cost of the prosthesis

Emergency situations

In emergency situations, no-gap or gap-permitted prostheses may be used at the medical practitioner's discretion.

However, where gap-permitted prostheses are used, clinical justification may be required by the Agent as soon as possible after hospital admission to consider paying for the reasonable costs of the gap item.

When will the Agent respond to a request?

Within 10 working days of receiving the elective surgery request, the Agent will advise whether:

• the request has been approved
• the request has been denied, or
• further information is required to make a decision

Where further information is required, the Agent will advise whether the surgically implanted prosthesis request has been approved or denied within 10 working days of receiving the additional information.

To assist the Agent to make a decision regarding a request for gap-permitted prosthesis, the request may be reviewed by a Medical Advisor. Where indicated, the Medical Advisor may contact the requesting medical practitioner to seek further information and/or discuss the proposed prosthesis prior to making a recommendation to the Agent regarding the request.

The Agent will respond to the request when they have received the Medical Advisor's recommendation.

What are WorkSafe's invoice requirements?

For standard invoice requirements, refer to the Instructions for invoicing WorkSafe guidelines.

In addition to these requirements, please ensure that invoices for surgically implanted prostheses also include all documentation in accordance with the following policies:

Including the following documentation in relation to prostheses:

• prostheses codes - description and cost including whether the item is listed on the prescribed list of medical devices and human tissue products or is a gap-permitted item
• From 1 July 2020 any hospital invoices that include prostheses from the Sub Category: 04.05 - Neurostimulation Therapies for Pain Management of the prescribed list of medical devices and human tissue products, need to include a copy of theatre records and prostheses stickers to support the prostheses invoiced.

What fees are payable for surgically implanted prostheses?

The Agent will pay the listed price for a no-gap prosthesis on the prescribed list of medical devices and human tissue products or the minimum listed price for a gap-permitted prosthesis on the prosthesis list.

The Agent can pay for prostheses surgically implanted by qualified medical practitioners, where the surgery is performed in accordance with the applicable MBS items, explanations, definitions, rules and conditions, unless otherwise specified by the Agent.

In relation to surgically implanted prostheses, what won't the Agent pay for?

The Agent will not pay for:

• treatment or services for a person other than the worker
• surgically implanted prostheses where the associated surgical procedure provided by a medical practitioner has not been approved by the agent
• prostheses required for a condition that existed before the work-related injury or illness or that is not a result of the work-related injury or illness
• surgically implanted prostheses that have been the subject of a negative determination by the PLAC
• prostheses where there is no adequate clinical justification for use
• prostheses where the required documentation has not been provided to the agent
• prostheses where there is no National Health and Medical Research Council level 1 or 2 evidence that the prosthesis is safe and effective
  • refer to the Non-established, New or Emerging Treatments and Services Policy

• prostheses where the cost is included in the hospital bed fee, i.e. for public hospitals
• prostheses handling fees
• modification or replacement of a surgically implanted prostheses that is covered by supplier/manufacturer warranty
• any prosthetic component which is not implanted in the worker (for example, a prosthetic component which is opened but not used, or the components of a external fixator kit that are not used)
• prostheses which are used for sizing purposes and form part of a reusable kit
• treatment or services provided outside the Commonwealth of Australia without prior written approval from the agent
• treatment or services provided by telephone or other non face-to-face mediums that do not align with WorkSafe's telehealth policy
• the cost of telephone calls and telephone consultations between providers and workers, and between other providers, including hospitals