In this edition: COVID-19 test kits regulated by the Therapeutic Goods Administration, Update to NDIS Price Guide, TGA Infringements for 2019/2020, Improved protection against meningococcal and pneumococcal diseases, VCAT reprimands nurse and Medicare bulk-billing rate remains high.
The latest insights from our Health Law team:
COVID-19 test kits regulated by the Therapeutic Goods Administration
Update to NDIS Price Guide from 1 July
TGA Infringements for 2019/2020
Improved protection against meningococcal and pneumococcal diseases
VCAT reprimands nurse and imposes conditions on registration
Medicare bulk-billing rate remains high at 86.1%
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COVID-19 test kits regulated by the Therapeutic Goods Administration
COVID-19 test kits may be legally supplied in Australia if:
- expedited assessment by the Therapeutic Goods Administration (TGA) approves its inclusion on the Australian Register of Therapeutic Goods (ARTG); or
- the TGA’s emergency exemption for accredited pathology laboratories applies.
This emergency exemption is due to expire on 31 July 2020. A new emergency exemption, the Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2020, will enable the continued use of COVID-19 tests by accredited pathology laboratories for the purpose of donor screening. This is more limited in its application than the current emergency exemption, and will be in effect until 30 June 2021.
The TGA strictly prohibits COVID-19 tests being supplied or advertised to consumers for home use under the Therapeutic Goods (Excluded Purposes) Specification 2010. However, advertisements for COVID-19 test kits may be lawful if directed exclusively to health professionals. Where this is done, there will not be a breach on the prohibition of advertising therapeutic goods to consumers.
Currently, there are 66 COVID-19 test kits included on the ARTG for legal supply in Australia — you can view the full list here.
Update to NDIS Price Guide from 1 July
The National Disability Insurance Agency (NDIA) has published its updated Price Guide for 1 July 2020. This version of the Price Guide removes COVID-19 loading, and introduces a large number of other changes which will have a significant effect on service providers and participants alike.
There have been three main changes to the provision of group supports. Most significantly, this Price Guide update removes ratio-based pricing. This change will be transitioned in over the next twelve months. Other amendments include the new ‘centre capital cost’ line item for supports offered at a service provider’s premises and new guidance for billing non face-to-face supports.
The Price Guide also now includes:
- changes to the price controls for Supported Independent Living;
- new line items for recovery coaches to support participants with psychosocial disabilities;
- amendments to participant transport and provider travel claims;
- programs of supports, to enable service providers to provide term-based supports; and
- amendments to supports that assist participants to seek and maintain employment.
For advice about how this will affect your business, please contact the Russell Kennedy Disability Team.
TGA Infringements for 2019/2020
The TGA has released data on its activities to protect Australian consumers during the 2019/2020 financial year, including relating to the infringement notices issued.
In 2019/2020, the TGA:
- issued 187 infringement notices amounting to almost $1.8 million, including 58 infringements for COVID-19 related matters;
- pursued three civil court actions in relation to advertising under the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code (No 2) 2018; and
- referred five criminal matters to the Commonwealth Department of Public Prosecution.
The TGA’s mandate is to regulate medicines, medical devices and biologicals within the national framework, to ensure their safety, quality, efficacy, timely availability and responsible advertising for the Australian community.
If you would like to read more about the TGA’s enforcement activities, please click here. To learn more about advertising therapeutic goods, please click here.
Improved protection against meningococcal and pneumococcal diseases
On 6 July 2020 the Minister of Health, the Hon. Greg Hunt, announced an amendment to the National Immunisation Program (NIP) effective 1 July 2020 to improve protection for those most at risk against the potentially fatal meningococcal disease. The changes were recommended by the Australian Technical Advisory Group on Immunisation, the Pharmaceutical Benefits Advisory Committee, and other clinical experts.
The changes to the NIP include:
- Meningococcal B vaccine (Bexsero®) being made available for free to Aboriginal and Torres Strait Islander infants under two years, who are almost four times as likely to contract this disease as non-Indigenous children. A catch-up program will be available for Indigenous children aged under two years, until 30 June 2023;
- people aged 70 years and over being eligible for one dose for the pneumococcal vaccine Prevenar 13® to ensure more targeted protection for the elderly;
- Aboriginal and Torres Strait Islander people will be eligible for three pneumococcal vaccines, after they turn 50; and
- more people with medical risk conditions will have access to free pneumococcal, meningococcal ACWY and the Haemophilus Influenzae type b (Hib) vaccines.
Information on the changes for consumers and health professionals is available on the Department of Health website at www.health.gov.au/immunisation.
To view the Minister’s media release, please click here.
VCAT reprimands nurse and imposes conditions on registration
The Victorian Civil and Administrative Tribunal (Tribunal) has reprimanded a nurse and imposed conditions on his registration after finding he engaged in professional misconduct under the Health Practitioner Regulation National Law (Victoria) (National Law).
Mr Christopher Welsh had engaged in a sexually explicit, online conversation with person who had been under his care in the hours leading up to the conversation.
The Tribunal found Mr Welsh had failed to act consistently with his responsibility under the Code of Professional Conduct for Nurses in Australia – August 2008 by failing to maintain professional boundaries between himself and a person under his care.
Despite acknowledging the limited nature of the online conversation, the Tribunal decided Mr Welsh’s conduct substantially fell short of the required standard, given the nature and extent of the power imbalance between Mr Welsh and the person under his care. As such, the Tribunal agreed with the Nursing and Midwifery Board of Australia that Mr Welsh’s conduct amounted to professional misconduct under the National Law.
The Tribunal did not suspend Mr Welsh, after taking into consideration the single instance of professional misconduct, his otherwise professional reputation, and the fact he had become more reserved around patients since the misconduct had occurred. In addition to reprimanding Mr Welsh, the Tribunal imposed education and mentoring as conditions on his registration.
Read the Tribunal’s full decision here.
Medicare bulk-billing rate remains high at 86.1%
The Minister for Health, the Hon. Greg Hunt MP has announced new statistics regarding Medicare bulk billing.
In the past 12 months, as compared with the previous 12 months:
- 86.1% of Australians did not have to pay to visit their GP;
- there was a more than 5.5 million increase in free bulk-billed GP visits; and
- the number of fully subsidised services provided across Medicare rose by 9.6 million, to a total of 343.6 million.
In March 2020, in response to the COVID-19 pandemic, the Australian Government introduced new telehealth items to the Medicare Benefits Schedule. COVID-19 temporary telehealth and telephone items have accounted for:
- in March 2020 alone, 7.5% of GP visits, including 999,470 telephone consultations and 65,996 telehealth consultations; and
- since March 2020, 3.4% of services utilised across Medicare, including 110,060 telehealth consultations and 1,137,873 phone consultations, provided by GPs, specialists and allied health professionals.
To view the Minister’s full release, please click here.
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