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Supporting telehealth through regulation: a summary of changes

Melanie Tan and Matthew Goessler

The average reading time for this Alert is eight minutes.

Amongst clinicians, the concept of telehealth is broad and encompasses any transfer of information electronically - synchronously (eg. by video or phone consult), or asynchronously (eg. by email or text message). The RACGP has defined telehealth as ‘a method of delivering healthcare that involves the use of information and communications technology (ICT) to transmit audio, images and/or data between a patient and a healthcare provider.’

When considering relevant regulations or guidelines, it must first be understood what form of ‘telehealth’ they apply to, or whether they apply broadly. For example, under the Medicare Benefits Scheme (MBS), the term ‘telehealth’ refers to video consults only, not consults by phone.

Recent regulatory changes facilitate the use of both video and phone consults (remote consults). Some of these changes are temporary, in response to the pandemic – others are permanent and pre-dated it.

Medicare Benefits Scheme

Before the pandemic set in, there was only limited government funding for telehealth which applied only to specific situations.

One response of the Federal Government to COVID-19 was to expand funding for remote consults. This meant creating temporary MBS item numbers to support remote consults, by way of the Health Insurance (section 3C General Medical Services - COVID-19 Telehealth and Telephone Attendances) Determination 2020 (Health Insurance Determination). The Health Insurance Act 1973 sets out the legislative scheme for Medicare funded services, of which section 3C(1) provides the authority under which the Health Insurance Determination was made.

The Health Insurance Determination commenced on 30 March 2020 and at this stage will be revoked on 30 September 2020 - as will the temporary item numbers. We are yet to know the fate of these item numbers post September. However remote consults can continue unsubsidised, provided informed financial consent is obtained (as non-MBS fees are a private matter between practitioner and patient). Most importantly, consults must always be clinically appropriate and adequate to meet the practitioner’s duty of care and professional standards.

Initially, the temporary item numbers were available only to patients or providers with COVID-19, or who were vulnerable to it. This requirement was lifted on 30 March such that the item numbers allow remote consults in lieu of face to face consults, for management of any condition where it is safe and clinically appropriate to do so (and provided the patient is eligible for Medicare benefits). Particularly pertinent to residential aged care facilities, the patient must be present during the consult, even if assisted by a carer or representative.

As of 20 July 2020, GPs and non-vocationally registered medical practitioners working in general practice, or another practitioner from the same practice, must have had a face to face consult with the patient in the last 12 months to be able to initiate a remote consult. Patients however can self-present, or be referred for a telephone or video consult.

Telephone or video?

While video consults are preferred, the MBS now facilitates telephone consults as well, specified as ‘phone attendances’ – which were not supported pre-pandemic.

The distinction is important as not only do video and phone consults have separate items numbers, but video consults have more stringent requirements in terms of privacy. For ‘telehealth’ (ie. video consults), the practitioner must be satisfied that the software and hardware used to deliver the service meets relevant security and privacy laws. 

Privacy policies should specifically address remote consults, and video consults in particular may require expert input (such as by way of privacy impact assessments). The Department of Health clearly states that phone attendances should be used if there is any uncertainty regarding the security of video platforms – but again, only if appropriate. If a consult can only be safely conducted by visualising a patient and secure video capability is not available, the patient should be seen in person.

Finally, whether a phone or video consult is appropriate should always be considered against the individual patient (that is, rather than applying a ‘blanket’ approach) and practitioners should remain alert to any cues during a remote consult that suggest an in-person consult is necessary. If so, practitioners must consider if this can be billed as a separate consult under the MBS, or whether it is in essence a continuation of the remote consult.

Billing

The temporary item numbers mirror other non-COVID related items, meaning they stand alone and cannot be co-billed with face to face consults. 

There are certain categories of patients whom GPs and non-vocationally registered GPs must bulk bill – ie. Commonwealth Concession Card holders, patients under 16 years of aged, and patients ‘at risk of COVID-19 virus’ (as defined in the Health Insurance Determination). Specialists and allied health services do not need to bulk bill, however must obtain informed financial consent. For the temporary item numbers only, consent from patients to assign their Medicare benefit to a practitioner can be obtained verbally, and documented by the practitioner.

Ultimately, ensure your records of the consult are not only able to justify your management of a patient, but the MBS item number claimed for the consult as well.

Pharmaceutical Benefits Scheme (PBS)

Another component of the government’s response to the pandemic was a temporary change to the PBS to support remote consult arrangements. 

This was implemented by the National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020 (Special Arrangement), which came into effect on 29 April 2020 and will also be repealed on 30 September 2020. Section 100 of the National Health Act 1952 (National Health Act), which sets out the PBS, allows special arrangements for PBS benefits to be more conveniently or efficiently supplied – in this case, in the context of a remote consult.

The Special Arrangement modifies the means by which a PBS benefit can be supplied further to remote consult. A paper prescription must be generated by the prescriber, however the pharmacy or hospital may accept a digital image of it. Prescribers must retain the paper prescription, and pharmacists must retain a copy, for at least 2 years – however other retention periods prescribed by state legislation may apply in addition, such as that in the Health Records Act 2001 (Vic).

Electronic Prescribing

In contradistinction to, and pre-dating the Special Arrangement, electronic prescribing marked a permanent change. Electronic prescriptions, continuing to be rolled out since May, will be an alternative to paper prescriptions - giving patients an option.

Definitions of ‘electronic prescriptions’ and ‘electronic medication charts’, and their requirements, are set out in the National Health (Pharmaceutical Benefits) Regulations 2017 (Regulations), another statutory instrument under the National Health Act.

Further, the National Health (Claims and under co-payment data) Amendment (Electronic Prescriptions) Rules 2019 commenced on 31 October 2019 and amended the National Health (Claims and under co-payment data) Rules 2012 (PB 19 of 2012) to include in the definition of ‘prescription’ , ‘an electronic prescription’. The amendment is significant as it removed the requirement under the PBS for electronic prescriptions to be in printed form. These Rules were also made under the authority of the National Health Act.

Electronic prescriptions are currently only available under the ‘token model’, which consists of a one-time QR code sent to the patient by SMS, email, or via an app. Ultimately the ‘active script list model’ will be available as an additional alternative to obviate the need for individual QR codes per prescription or repeat prescription.

PB19 of 2012 also prescribes the information that must be provided in electronic prescriptions, which have additional requirements to paper prescriptions. Electronic medication charts will have different requirements. Further, under section 10 of the Regulations, a person for whom the electronic prescription is written must consent to it (‘consent’ being within the meaning of subsection 5(1) of the Electronic Transactions Act 1999, such that it can reasonably inferred from the person’s conduct). 

Additional requirements for electronic prescriptions

There are four key instruments applicable to electronic prescriptions. Two of these relate to outpatient prescriptions, and two will relate to electronic medication charts when they become available.

The Form of Electronic Prescription 2019 specifies the information required for electronic prescription and includes metadata. Also, certain information must be available in a human readable format, to include a privacy notice. The Electronic Prescription Technology Requirements 2019 specify system requirements in relation to security, privacy and data storage. 

In addition, the following policies are applicable to electronic prescribing for prescribers and accessible through the Department of Health:

  1. Electronic Prescriptions Security and Access Policy (recognises inherent cyber risks, placing the onus on organisations to manage these risks);
  2. Electronic Prescriptions Privacy Policy (outlines obligations under the Privacy Act 1998).

The Electronic Prescriptions Data Usage Policy is a consumer-directed policy which describes how the information and data contained in electronic prescriptions is collected, used and disclosed. An organisation’s own privacy policy should align with this policy.

Summary

Federal regulatory changes which support remote consults include temporary measures in response to COVID-19, and permanent changes introduced prior to the pandemic. 

There is no doubt that such changes facilitate more efficient and, in the context of a pandemic, safer delivery of healthcare, however they do not justify shortcuts in care. All care, whether provided remotely or otherwise, must be provided in accordance with professional codes of conduct and the common law duty of care. Prior to every consultation, practitioners should consider whether a remote consult is safe, clinically appropriate and reasonable and should continue to review these factors during the consult, as they may evolve. Always remember to think beyond strict clinical needs and consider whether a patient and/or their family would benefit from support that cannot be given over the phone, or even by video. 

How we can help

For further information on telehealth services and the associated legal risk, please contact Melanie Tan or another member of our expert Health Law team. 

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