This instrument is the Health Insurance (Section 3C General Medical Services – Extracorporeal Photopheresis for Chronic Graft Versus Host Disease) Amendment Determination 2023.

(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	1 July 2023.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under subsection 3C(1) of the Health Insurance Act 1973.

4 Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

Health Insurance (Section 3C General Medical Services – Extracorporeal Photopheresis for Chronic Graft Versus Host Disease) Determination 2022

1 Section 4, Subsection 1

Omit the subsection, substitute:

(1) In this instrument:

Act means the Health Insurance Act 1973.

Pharmaceutical Benefits Scheme means the scheme for the supply of pharmaceutical benefits established under Part VII of the National Health Act 1953.

relevant provisions means all provisions, of the Act and regulations made under the Act, and the National Health Act 1953 and regulations made under the National Health Act 1953, relating to medical services, professional services or items.

relevant service means a health service, as defined in subsection 3C(8) of the Act, that is specified in a Schedule.

Schedule means a Schedule to this instrument.

Note: The following terms are defined in subsection 3(1) of the Act:

 clinically relevant service;

 general medical services table;

 item;

 professional service.

2 Section 7

Omit the section, substitute:

7. Application of treatment cycle and session

(1) For an item in the Schedule, treatment cycle means treatment that is required to deliver extracorporeal photopheresis that:

(a) begins on the day in which the treatment begins; and

(b) ends 12 weeks after the day specified in paragraph (a).

(2) For an item in the Schedule, treatment session means a single extracorporeal photopheresis treatment in a series of sessions that make up a treatment cycle.

3 Schedule (item 13761, column 2)

Omit the cell, substitute:

Extracorporeal photopheresis for the treatment of chronic graft‑versus‑host disease, if:

(a) the person is:

(i) has received allogeneic haematopoietic stem cell transplantation; and

(ii) has been diagnosed with chronic graft versus host disease following the transplantation; and

(iii) steroid treatment is clinically unsuitable as the disease is steroid refractory or the person is steroid‑dependent or steroid‑intolerant; and

(b) the person has not previously received extracorporeal photopheresis treatment; and

(d) the service is provided in combination with the use of methoxsalen that is listed on the Pharmaceutical Benefits Scheme; and

(e) the service is provided by, or on behalf of, a specialist or consultant physician who:

(i) is practising in the speciality of haematology or oncology; and

(ii) has experience with allogeneic bone marrow transplantation.

Applicable once per treatment session

4 Schedule (item 13762, column 2)

Omit the cell, substitute:

Extracorporeal photopheresis for the treatment of chronic graft‑versus‑host disease, if:

(a) the person is:

(i) has received allogeneic haematopoietic stem cell transplantation; and

(ii) has been diagnosed with chronic graft versus host disease following the transplantation; and

(iii) steroid treatment is clinically unsuitable as the disease is steroid refractory or the person is steroid‑dependent or steroid‑intolerant; and

(b) the person has previously received an extracorporeal photopheresis treatment cycle and had a partial or complete response in at least one organ in response to treatment; and

(d) the service is delivered using an integrated, closed extracorporeal photopheresis system; and

(e) the service is provided in combination with the use of methoxsalen that is listed on the Pharmaceutical Benefits Scheme; and

(f) the service is provided by, or on behalf of, a specialist or consultant physician who:

(i) is practising in the speciality of haematology or oncology; and

(ii) has experience with allogeneic bone marrow transplantation.

Applicable once per treatment session