Robyn Smart

Can You Refuse to Serve Someone Who Refuses to be COVID Safe?

Can You Refuse to Serve Someone Who Refuses to be COVID Safe?

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Customers refusing to wear masks while shopping in Victoria, where masks are now mandatory, have attracted a lot of media attention in recent weeks.

Business.gov.au has published a guide to the reasons businesses can refuse to serve customers, including safety, and the relevant aspects of anti-discrimination law. The guide is for all Australian businesses - not just businesses in Victoria.

Robyn SmartCan You Refuse to Serve Someone Who Refuses to be COVID Safe?
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NDIA Releases New AT and Consumables Code Guide

NDIA Releases New AT and Consumables Code Guide

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The revised NDIA Assistive Technology, Home Modifications and Consumables Code Guide is now available.

Please note that there are changes to rentals and ramp codes along with some other amendments.

ATSA recommend taking the time to review the guide, to ensure you are familiar with all the changes.

If you do not use the new codes, this may negatively impact on your NDIA claims.

Learn more about the new codes here.

Robyn SmartNDIA Releases New AT and Consumables Code Guide
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Use of Restraints

Use of Restraints

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An important reminder to members that the NDIS Quality and Safeguards Commission is increasing its’ focus on reportable incidents relating to the use of restraints.

If you are an NDIS provider, you are automatically obligated to report every instance of an unauthorised restrictive practice you have become aware of.

Please refer to the NDIS Commission for more details. It is recommended that before you supply a device that could be considered as a restraint, you should ask to view the “behaviour support plan” for the participant that has been developed by an approved NDIS behaviour support practitioner.

Robyn SmartUse of Restraints
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New Regulation Amendments to Personalised and Custom Medical Devices

New Regulation Amendments to Personalised and Custom Medical Devices

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The Australian Government has made amendments to the regulation of personalised medical devices, including custom-made medical devices and 3D printed devices. This follows the Therapeutic Goods Administration (TGA) consultation processes conducted in 2017 and 2019. Copies of the submissions and a summary of the feedback to the consultations are available on the TGA website.

About the regulatory changes

Minister Hunt has agreed to delay the commencement of the Therapeutic Goods Legislation Amendment (2019 Measure No 1) Regulations 2019, Schedules 1, 2 and 3 that implement changes for a number of devices to be reclassified, modernised, to clarify and improve the way custom made devices and software as a medical device are regulated. This will delay commencement from 25 August 2020 to: 

  • 25 November 2021 for reclassification of certain devices (allowing commencement to be timed for six months after the changed date for implementation of new EU Medical Device Regulations),
  • 25 February 2021 for medical device software, and
  • 25 February 2021 for personalised medical devices (including 3D printed devices). 

Amended regulations

  • Updated definitions for personalised medical devices that allow for the distinction between different design and production methodologies, depending on the level of health professional oversight;
  • Improved TGA oversight of facilities that manufacture personalised medical devices;
  • Introduction of the concept of a Medical Device Production System (MDPS) and a related framework that allows healthcare professionals to produce personalised devices for treating their patients without the need for manufacturing certification;
  • Updates to the Essential Principles to clarify what information must be supplied (to patients) with a personalised medical device; and
  • Updates to the classification rule for medical devices that record diagnostic images to capture a broader range of technologies now being used for this purpose such as 3D-printed models.

An overview of the regulatory changes is also available on TGA website.

You may wish to sign up to TGA Updates in order to be notified of new web content as it becomes available.

More detail about the definitions and transition arrangements

There are now four different definitions; custom-made medical device, patient-matched devices, adaptable medical devices, and medical device production system (MDPS). Each of these categories will have specific requirements under the regulations as outlined below.

1.Custom-made devices

The current exemption for these devices will continue to apply if the new definition of “custom-made” comes into effect. The new requirements for custom-made devices (except where the request for manufacture from a health professional was made prior to this date), includes:

  • annual reporting of custom-made devices;
  • allowing the TGA to inspect production facilities;
  • documentation about the device to be retained for certain periods; and
  • manufacturers to provide information about each custom-made medical device to the intended recipient.

2.Patient-matched devices

Under the new definition, “patient-matched medical devices” (for those custom-made devices that will be patient-matched medical devices under the new definition), a transitional exemption provision will apply. Guidance on this notification procedure will be provided soon.

3.Adaptable medical devices

The regulation of adaptable medical devices will not change.

4.Medical device production system (MDPS)

The MDPS is a new category of medical device which will allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification. MDPS can include devices such as 3D printers, associated software, and resin that is intended by its manufacturer to be used by a dentist to produce dental crowns. In these cases:

  • the MDPS itself will be treated as a medical device;
  • health professionals or persons within a healthcare facility who use the MDPS (e.g., a dentist) will not be classified as a manufacturer under the Therapeutic Goods Act 1989; and
  • sponsors will be able to include MDPS on the Australian Register of Therapeutic Goods (ARTG) after 25 August 2020.  

Compliance with the new regulations

Class I custom-made and patient-matched devices, refer to only therapeutic goods meeting the updated definition of custom-made devices and will continue to remain exempt under the amendments introduced to the Therapeutic Goods (Medical Devices) Regulations 2002. Transitional arrangements have been put in place to ensure that manufacturers and suppliers of what will become ‘patient-matched’ devices can continue to supply these devices while they apply for inclusion in the Australian Register of Therapeutic Goods (ARTG).

Accessing the transitional arrangements will extend the deadline for ARTG-inclusion to 1 November 2024. The TGA are currently finalising guidance around the changes and what manufacturers and suppliers need to do from here. This is will be published soon, if you have any questions on this matter please contact ATSA or the TGA directly.

In the meantime, the Medical device inclusion process section of the Australian Regulatory Guidelines for Medical Devices (ARGMD) is a great source of information and resources relevant to including a Class I device on the ARTG.

Some of these devices will require a conformity assessment depending on the classification that the device falls in. Manufacturers may already have suitable evidence of conformity assessment certification from comparable overseas regulators that will meet regulatory requirements. This includes the EU Medical Device Directive (MDD) or EU MDR conformity assessment certificates.

Amendments to the Essential Principles in the Australian Medical Device Regulations and their implementation are also proposed to be delayed for up to two years after the commencement of European Union Medical Device Regulation changes (i.e. May 2023) and IVD Medical Device Regulations – this is still to be confirmed by the European Parliament, but is likely to be May 2022, so two years after that date.

This would provide time for industry to adjust to the EU regulations and to allow consideration of similar changes in the Australian context and ensure that the transition in Australia is implemented effectively.

Further information about the reforms will continue to be published on the TGA’s website, with the TGA also working closely with stakeholders to identify opportunities for continued consultation on guidance material over the coming months.

Several submissions to the TGA 2019 consultation highlighted the issue of how assistive technology for people with disabilities would be considered under the regulatory changes. The TGA consultation on products used for and by people with disabilities examined possible changes to the excluded goods determination on assistive technologies.  Consultation closed in late October 2019, and submissions have been reviewed. Unfortunately, this work has been impacted by the COVID-19 situation. It is currently with TGA Legal Services and will be circulated to ATSA and other stakeholders for comment prior to submission to the Government for consideration of policy approval.

If you have any questions in relation to the information provided above please contact devicereforms@health.gov.au or David.Sinclair@atsa.org.au

Robyn SmartNew Regulation Amendments to Personalised and Custom Medical Devices
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Where to Find the Latest COVID-19 Information

Where to Find the Latest COVID-19 Information

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ATSA encourages all members to regularly visit the NDIS Commission coronavirus (COVID-19) information page, available here.

This page contains links to updates, training, alerts, and resources for NDIS participants and providers. This information is to inform and support NDIS providers to continue to deliver quality and safe supports and services to NDIS participants.

Robyn SmartWhere to Find the Latest COVID-19 Information
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Proposed Bill to Grant NDIS Commissioner Additional Banning Powers

Proposed Bill to Grant NDIS Commissioner Additional Banning Powers

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The NDIS Amendment (Strengthening Banning Orders) Bill 2020 will soon be introduced to Parliament, with the intention of granting the NDIS Commissioner new powers. If passed, the NDIS Commissioner will have the legislative authority to prevent unsuitable people from working with NDIS participants. The details of the NDIS Amendment (Strengthening Banning Orders) Bill 2020 can be found here.

Key points if Bill is passed:

  • The NDIS Commissioner, who is responsible for regulating NDIS providers and enforcing the NDIS Code of Conduct, will be granted additional banning powers to prevent people who may pose a risk of harm to participants from entering or re-entering the NDIS
  • The NDIS Commissioner will be able to apply banning orders to people even if they are not currently working in the NDIS. This means workers who have left the NDIS, including where they have been fired due to unsuitable behaviour, can be banned from re-entering the field. The amendments also mean the NDIS Commissioner can use information from sources outside the NDIS, such as a person’s conduct in aged care or childcare work, to ban an unsuitable person from entering the NDIS in the first place.

Minister Roberts noted that Banning orders are at the extreme end of the NDIS Commissioner’s regulatory powers and are only used in the most serious of cases. The NDIS Quality and Safeguards Commission makes the details of providers and workers who have been banned publicly available in the NDIS Provider Register. People with disability, their supporters and providers can use the Register to check that the people they are engaging to deliver NDIS services have not had a banning order against them.

Robyn SmartProposed Bill to Grant NDIS Commissioner Additional Banning Powers
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Updated Rules for Imported Disability Vehicles to Comply with Australian Standards

Updated Rules for Imported Disability Vehicles to Comply with Australian Standards

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Imported disability vehicles are now subject to updated rules ensuring that safety considerations are regulated to comply with Australian standards.  Changes have commenced to progressively roll out improvements as part of the new Road Vehicle Standards (RVS) legislation.

ATSA pressed the need for the application of Australian Standards for all imported disability vehicles early in 2018 through several submissions, to the Inquiry into the Road Vehicle Standards Bill 2018 and related bills. The problem was that importers of modified disability vehicles wanted an exemption to “Australian Safety Standards”, yet local vehicle builders/modifiers were required to comply with existing local standards.

ATSA’s main recommendation was:

ATSA does not believe that the intention of the legislation is to trade off safety for profit and recommends that Australian Standards are applied to all imported disability vehicles to ensure only safe product is sold into the Australian market.

After several years of hard work and representation by ATSA, new legislation has now been implemented, requiring all disability vehicles purchased in recent times, and into the future, will need to be compliant with Australian Standards. This is a great win for all who use these vehicles, recognising the need for equality under the law and ensuring that the personal safety of assistive technology users is protected as being as important as all other consumers in the broader community.

Road Vehicles Standards Australia (RVSA) Implementation: Commencement of Testing Facility Approvals provisions commenced on 6 May 2020 that implement these changes.

Details can be found in the Interim arrangements guidance document, relating to specialist and enthusiast vehicles listed page 95, 96, 97, 98, 99.

The Road Vehicle Standards (RVS) legislation is replacing the Motor Vehicle Standards Act 1989 (MVSA) as part of a phased transition over the coming months.

In order to facilitate a smooth transition to the commencement of the first phase of the RVS legislation, the Department of Infrastructure, Transport, Regional Development and Communications (“the department”) conducted a targeted prototype trial in March of the testing facilities module of ROVER (the department’s new IT system that will support applications under the RVS legislation).

Following this successful prototype trial, the Deputy Prime Minister has made the necessary legislative instrument to enable the relevant provisions of the Road Vehicle Standards (RVS) legislation to commence – this instrument is available on the Federal Register of Legislation.

We are therefore pleased to confirm that applications for testing facility approvals under the RVS legislation opened from Wednesday 6 May 2020.

The aim is for a gradual progressive rollout, with further improvements slated for introduction in the coming months. 

It is important to note that, if a test facility has prepared test reports while registered in the department’s Road Vehicle Certification System (RVCS), those reports will  continue to be used to demonstrate compliance with applicable standards provided that the test facility applies for, and is granted, a testing facility approval under the RVS legislation.

Test reports from testing facilities that have been approved under the new RVS legislation will not be required until component type approval applications open in the 3rd quarter of 2020 (anticipated commencement date).

Robyn SmartUpdated Rules for Imported Disability Vehicles to Comply with Australian Standards
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NDIA Releases Status Tracking For Provider Enquiries

NDIA Releases Status Tracking For Provider Enquiries

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The NDIA has released a new feature to the MyPlace provider portal to assist providers in tracking the status of enquiries. The following information has been copied directly from the NDIA notice via the NATA group.

As flagged in the March and April NDIA Provider eNewsletter, the NDIA has improved the payment enquiries process for providers by introducing a ‘Payment Enquiry’ tile in the MyPlace provider portal.

By submitting a payment enquiry through the MyPlace provider portal, registered providers will receive a unique identification number to track the status of the enquiry. They will also be able to view a history of all payment enquiries made through the portal.

These features are not available when lodging payment enquiry emails via the provider.payment@ndis.gov.au inbox.

This new functionality has been implemented as a result of feedback from providers on how to enhance the payment enquiry experience.

Providers can create a payment enquiry through the MyPlace provider portal in three steps:

  • Log into the MyPlace provider portal and click the ‘View Complaints and Enquiries’ tile.
  • Click ‘Add new request’ button.
  • Click ‘Payment enquiry’ button and begin filling in the details of your enquiry.

If you or your members have questions about the use of the ‘Payment Enquiry’ tile, please call the NDIS Contact Centre on 1800 800 110.

Please note, from 29 May 2020 the NDIA will no longer accept payment enquiries to the provider.payment@ndis.gov.au email inbox. We understand this will be a change of process for some providers. 

Robyn SmartNDIA Releases Status Tracking For Provider Enquiries
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Low Cost COVID-19 Assistive Technology Changes

Low Cost COVID-19 Assistive Technology Changes

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The Minister for the National Disability Insurance Scheme (NDIS), the Hon Stuart Robert MP, has announced three changes to help NDIS participants during the COVID-19 pandemic:

  • Increased flexibility for low-cost assistive technology (AT)
  • New support line items for participants living in supported independent living (SIL) arrangements
  • Online access to the NDIS Access Request Form (ARF) and Supporting Evidence Form

Further detail on the low cost AT changes are outlined below:

Increased flexibility for low-cost AT

To ensure continuity in NDIS funded supports and services during the COVID-19 pandemic, the NDIA are temporarily broadening the flexible approach for low cost AT items.

Participants will be able to use their existing NDIS funding to purchase an item if all of the following criteria are met:

  • the AT will maintain existing funded NDIS supports like a program or therapy
  • the provider of supports has confirmed in writing that the device is necessary to continue supports and services while maintaining physical distancing requirements
  • the AT is the lowest specification that will maintain funded supports
  • the participant does not already have the item, another suitable item or access to the item
  • the AT has not been funded by another service system (such as education)
  • the AT or circumstances are not specifically excluded.

How will this work?

The NDIA are recommending participants work with their existing providers to discuss the best way to receive services and supports while maintaining physical distancing – this may include using available technology, developing exercise programs participants can do at home or borrowing equipment and keeping in touch over the phone.

  • Plan-managed or self-managed participants can purchase low cost AT items from any provider.
  • Agency-managed participants can purchase these from any registered NDIS provider. A common approach is for therapy providers to buy the AT item for the participant.

How will this relate to funding?

Not all participants have funding available in core budgets for consumables. There will be a system update 9 May 2020 to increase flexible access in plans.

Participants who only have funding in their capacity building budget will be able to use a special line item to enable use of this new flexible approach (more details on this later in the week).

If a specific item is required to maintain supports, written evidence in the form of a letter/email from the participant’s existing provider will be required to support this purchase.

How will payments be claimed?

Providers, plan managers and self-managing participants need to attach this letter to claim payment. The letter/email should include:

  • the participant’s name and NDIS number;
  • that delivery of current support in the plan has been significantly hindered due to physical distancing restrictions (or other element of COVID-19) and that alternate solutions to maintain delivery/outcome have been considered, but not fully addressed the limitations;
  • how the device is necessary to maintain supports and services while maintaining physical distancing requirements;
  • the specific technologies and associated accessories required, and that these represent the lowest specification capable of delivering the benefit; and
  • that the participant is able to use the device/s to access the support.

Before the participant (or nominee) or provider makes a claim for the selected item, the participant should be sure that:

  • the participant does not already have the item, another suitable item or access to the item, and
  • that a similar or suitable item has not been funded by another service system (such as education), and
  • that the item or circumstances are not specifically excluded under this policy.

When will this take effect?

The arrangement will be in place until September 2020, with a review at the end of June 2020.

To be really clear, this policy does not involve provision of extra NDIS funding into a participant’s plan, but rather flexibility to use existing funding.

Where to find more information

Latest news on NDIA initiatives to support providers and participants during the coronavirus (COVID-19) pandemic can be found on the news and events page of the NDIS website.

More information is also available on the Assistive Technology page of the NDIS website.

Robyn SmartLow Cost COVID-19 Assistive Technology Changes
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New Government Plan to Support People with Disability

New Government Plan to Support People with Disability

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The Australian Government Department of Health has released a new plan that will help support people with disability throughout COVID-19.

The Australian Health Sector Emergency Response Plan for Novel Coronavirus guides the Australian health sector response. This management and operational plan focus on people with disability.

You can download and read the plan here.

The Plan has been developed for people of all ages with disability, their families, carers, support workers and the disability and health care sectors. It will provide high-level guidance on a range of factors that need to be considered in managing and preventing the transmission of COVID-19 for people with disability. The Plan will be informed by a risk-based approach, prioritising individuals whose disability, current health status and setting, places them at significant risk of adverse outcomes related to COVID-19.

The Plan will be a living document and will be reviewed periodically, in line with the Australian Health Sector Emergency Response Plan for Coronavirus. As new evidence and recommendations for how to manage the COVID-19 pandemic emerge, particularly in relation to disability, the Plan will be updated accordingly.

Robyn SmartNew Government Plan to Support People with Disability
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