Commonwealth of Australia Bills Commonwealth of Australia Bills[Index] [Search] [Download] [Related Items] [Help]
This is a Bill, not an Act. For current law, see the Acts databases.
2022
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Private Health Insurance Legislation
Amendment (Medical Device and
Human Tissue Product List and Cost
Recovery) Bill 2022
No. , 2022
(Health and Aged Care)
A Bill for an Act to amend the law relating to
private health insurance, and for related purposes
No. , 2022
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
i
Contents
1
Short title ........................................................................................... 1
2
Commencement ................................................................................. 1
3
Schedules ........................................................................................... 2
Schedule 1--Medical devices and human tissue products
3
Part 1--Amendments
3
Private Health Insurance Act 2007
3
Private Health Insurance (Transitional Provisions and Consequential
Amendments) Act 2007
7
Part 2--Application and transitional provisions
9
Schedule 2--Cost recovery
10
Part 1--Amendments
10
Private Health Insurance Act 2007
10
Part 2--Application and transitional provisions
14
No. , 2022
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
1
A Bill for an Act to amend the law relating to
1
private health insurance, and for related purposes
2
The Parliament of Australia enacts:
3
1 Short title
4
This Act is the
Private Health Insurance Legislation Amendment
5
(Medical Device and Human Tissue Product List and Cost
6
Recovery)
Act 2022
.
7
2 Commencement
8
(1) Each provision of this Act specified in column 1 of the table
9
commences, or is taken to have commenced, in accordance with
10
column 2 of the table. Any other statement in column 2 has effect
11
according to its terms.
12
2
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
No. , 2022
1
Commencement information
Column 1
Column 2
Column 3
Provisions
Commencement
Date/Details
1. The whole of
this Act
1 July 2023.
1 July 2023
Note:
This table relates only to the provisions of this Act as originally
2
enacted. It will not be amended to deal with any later amendments of
3
this Act.
4
(2) Any information in column 3 of the table is not part of this Act.
5
Information may be inserted in this column, or information in it
6
may be edited, in any published version of this Act.
7
3 Schedules
8
Legislation that is specified in a Schedule to this Act is amended or
9
repealed as set out in the applicable items in the Schedule
10
concerned, and any other item in a Schedule to this Act has effect
11
according to its terms.
12
Medical devices and human tissue products
Schedule 1
Amendments
Part 1
No. , 2022
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
3
Schedule 1--Medical devices and human
1
tissue products
2
Part 1--Amendments
3
Private Health Insurance Act 2007
4
1 Section 50-5
5
Omit "Private Health Insurance (Prostheses) Rules", substitute "Private
6
Health Insurance (Medical Devices and Human Tissue Products)
7
Rules".
8
2 Subsection 72-1(2) (table item 4
, column headed "There
9
must be a benefit for
... ")
10
Omit "a prosthesis, of a kind listed in the Private Health Insurance
11
(Prostheses) Rules", substitute "a
*
medical device or
*
human tissue
12
product, of a kind listed in the Private Health Insurance (Medical
13
Devices and Human Tissue Products) Rules".
14
3 Subsection 72-1(2) (table item 4, col
umn headed "There
15
must be a benefit for
... ", paragraphs (c) and (d))
16
Omit "prosthesis" (wherever occurring), substitute "medical device or
17
human tissue product".
18
4 Subsection 72-1(2) (table item 4
, column headed "The
19
amount of the benefit must be ... ", paragraph (a))
20
Omit "Private Health Insurance (Prostheses) Rules", substitute "Private
21
Health Insurance (Medical Devices and Human Tissue Products)
22
Rules".
23
5 Subsection 72-1(2) (table item 4
, column headed "The
24
amount of the benefit must be ... ", paragraph (a))
25
Omit "the prosthesis", substitute "the medical device or human tissue
26
product".
27
Schedule 1
Medical devices and human tissue products
Part 1
Amendments
4
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
No. , 2022
6 Subsection 72-1(2) (table item 4
, column headed "The
1
amount of the benefit must be ... ", paragraph (b))
2
Omit "Private Health Insurance (Prostheses) Rules", substitute "Private
3
Health Insurance (Medical Devices and Human Tissue Products)
4
Rules".
5
7 Subsection 72-1(2) (table item 4
, column headed "The
6
amount of the benefit must be ... ", paragraph (b))
7
Omit "the prosthesis", substitute "the medical device or human tissue
8
product".
9
8 Section 72-10 (heading)
10
Omit "
prostheses
", substitute "
medical devices and human tissue
11
products
".
12
9 Subsection 72-10(1)
13
Omit "Private Health Insurance (Prostheses) Rules", substitute "Private
14
Health Insurance (Medical Devices and Human Tissue Products)
15
Rules".
16
10 Subsection 72-10(1)
17
Omit "a kind of prosthesis", substitute "a kind of
*
medical device or
18
*
human tissue product".
19
11 Paragraph 72-10(1)(a)
20
Omit "prosthesis", substitute "medical device or human tissue product".
21
12 Subsection 72-10(2)
22
Omit "Private Health Insurance (Prostheses) Rules list a prosthesis",
23
substitute "Private Health Insurance (Medical Devices and Human
24
Tissue Products) Rules list a
*
medical device or
*
human tissue product".
25
13 Subsection 72-10(5)
26
Omit "Private Health Insurance (Prostheses) Rules", substitute "Private
27
Health Insurance (Medical Devices and Human Tissue Products)
28
Rules".
29
Medical devices and human tissue products
Schedule 1
Amendments
Part 1
No. , 2022
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
5
14 Paragraph 72-10(5)(c)
1
Omit "prosthesis", substitute "
*
medical device or
*
human tissue
2
product".
3
15 Paragraphs 72-10(5)(d) and (e)
4
Omit "prosthesis", substitute "medical device or human tissue product".
5
16 Subsection 72-10(6)
6
Omit "Private Health Insurance (Prostheses) Rules", substitute "Private
7
Health Insurance (Medical Devices and Human Tissue Products)
8
Rules".
9
17 After section 72-10
10
Insert:
11
72-11 Meaning of medical device
12
(1) A
medical device
is:
13
(a) any instrument, apparatus, appliance, software, implant,
14
reagent, material or other article (whether used alone or in
15
combination, and including the software necessary for its
16
proper application) intended, by the person under whose
17
name it is or is to be supplied, to be used for human beings
18
for the purpose of one or more of the following:
19
(i) prevention, monitoring, prediction, prognosis, treatment
20
or alleviation of disease;
21
(ii) monitoring, treatment, alleviation of or compensation
22
for an injury or disability;
23
(iii) investigation, replacement or modification of the
24
anatomy or of a physiological or pathological process or
25
state;
26
(iv) control or support of conception;
27
(v) in vitro examination of a specimen derived from the
28
human body for a specific medical purpose;
29
and that does not achieve its principal intended action in or
30
on the human body by pharmacological, immunological or
31
metabolic means, but that may be assisted in its function by
32
such means; or
33
Schedule 1
Medical devices and human tissue products
Part 1
Amendments
6
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
No. , 2022
(b) any instrument, apparatus, appliance, software, implant,
1
reagent, material or other article specified in the Private
2
Health Insurance (Medical Devices and Human Tissue
3
Products) Rules; or
4
(c) an
*
accessory to an instrument, apparatus, appliance,
5
software, implant, reagent, material or other article covered
6
by paragraph (a) or (b).
7
(2) For the purposes of paragraph (1)(a), the purpose for which an
8
instrument, apparatus, appliance, software, implant, reagent,
9
material or other article (the
main equipment
) is to be used is to be
10
ascertained from the information supplied, by the person under
11
whose name the main equipment is or is to be supplied, on or in
12
any one or more of the following:
13
(a) the labelling on the main equipment;
14
(b) the instructions for using the main equipment;
15
(c) any advertising material relating to the main equipment;
16
(d) any technical documentation describing the mechanism of
17
action of the main equipment.
18
(3) In relation to a
*
medical device covered by paragraph (1)(a) or (b),
19
an
accessory
is
a thing that the manufacturer of the thing
20
specifically intended to be used together with the device to enable
21
or assist the device to be used as the manufacturer of the device
22
intended.
23
72-12 Meaning of human tissue product
24
A
human tissue product
is a thing that:
25
(a) either:
26
(i) comprises, contains or is derived from human cells or
27
human tissues; or
28
(ii) is specified in the Private Health Insurance (Medical
29
Devices and Human Tissue Products) Rules for the
30
purposes of this subparagraph; and
31
(b) is represented in any way to be, or is, whether because of the
32
way in which it is presented or for any other reason, likely to
33
be taken to be:
34
(i) for use in the treatment or prevention of a disease,
35
ailment, defect or injury affecting persons; or
36
Medical devices and human tissue products
Schedule 1
Amendments
Part 1
No. , 2022
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
7
(ii) for use in influencing, inhibiting or modifying a
1
physiological process in persons; or
2
(iii) for use in the replacement or modification of parts of the
3
anatomy in persons; and
4
(c) is not specified in the Private Health Insurance (Medical
5
Devices and Human Tissue Products) Rules as a thing that is
6
not a human tissue product for the purposes of this Act.
7
18 Subsection 333-20(1) (table item 4, column headed
8
"Private Health Insurance Rules")
9
Omit "Private Health Insurance (Prostheses) Rules", substitute "Private
10
Health Insurance (Medical Devices and Human Tissue Products)
11
Rules".
12
19 Clause 1 of Schedule 1
13
Insert:
14
accessory
has the meaning given by subsection 72-11(3).
15
human tissue product
has the meaning given by section 72-12.
16
medical device
has the meaning given by section 72-11.
17
20 Clause 1 of Schedule 1 (paragraph (f) of the definition of
18
private health insurance arrangement)
19
Omit "Private Health Insurance (Prostheses) Rules", substitute "Private
20
Health Insurance (Medical Devices and Human Tissue Products)
21
Rules".
22
Private Health Insurance (Transitional Provisions and
23
Consequential Amendments) Act 2007
24
21 Subsection 12(1)
25
Omit "(1)".
26
22 Subsection 12(1)
27
Omit "Private Health Insurance (Prostheses) Rules", substitute "Private
28
Health Insurance (Medical Devices and Human Tissue Products)
29
Rules".
30
Schedule 1
Medical devices and human tissue products
Part 1
Amendments
8
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
No. , 2022
23 Subsection 12(2)
1
Repeal the subsection.
2
Medical devices and human tissue products
Schedule 1
Application and transitional provisions
Part 2
No. , 2022
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
9
Part 2--Application and transitional provisions
1
24 Applications made before commencement
2
(1)
This item applies in relation to an application made before the
3
commencement of this item under subsection 72-10(2) of the
Private
4
Health Insurance Act 2007
in relation to a kind of prosthesis.
5
(2)
The
Private Health Insurance Act 2007
and any instruments made
6
under that Act have effect, after the commencement of this item, as if
7
the application had been made under subsection 72-10(2) of that Act as
8
amended by Part 1 in relation to a kind of medical device or human
9
tissue product.
10
25 Private health insurance arrangement
11
Paragraph (f) of the definition of
private health insurance arrangement
12
in clause 1 of Schedule 1 to the
Private Health Insurance Act 2007
has
13
effect after the commencement of this item as if a reference to Private
14
Health Insurance (Medical Devices and Human Tissue Products) Rules
15
made for the purposes of item 4 of the table in subsection 72-1(2) of
16
that Act included a reference to Private Health Insurance (Prostheses)
17
Rules made for the purposes of that item before that commencement.
18
Schedule 2
Cost recovery
Part 1
Amendments
10
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
No. , 2022
Schedule 2--Cost recovery
1
Part 1--Amendments
2
Private Health Insurance Act 2007
3
1 Paragraph 72-10(3)(b)
4
Repeal the paragraph, substitute:
5
(b) accompanied by any
*
cost-recovery fee that the applicant is
6
liable to pay at the time the application is made.
7
2 Paragraph 72-10(5)(b)
8
Repeal the paragraph, substitute:
9
(b) the applicant pays to the Commonwealth any
*
cost-recovery
10
fee that the applicant is liable to pay in connection with the
11
initial listing of the kind of
*
medical device or
*
human tissue
12
product to which the application relates;
13
3 At the end of subsection 72-10(5)
14
Add:
15
Note:
Despite this subsection, the Minister may, under section 72-25, refuse
16
to perform a function under this subsection if the applicant fails to pay
17
a cost-recovery fee or medical devices and human tissue products levy
18
that is due and payable.
19
4 Sections 72-15 and 72-20
20
Repeal the sections, substitute:
21
72-15 Fees for certain activities
22
(1) The Private Health Insurance (Medical Devices and Human Tissue
23
Products) Rules may specify fees (
cost-recovery fees
) that may be
24
charged in relation to activities carried out by, or on behalf of, the
25
Commonwealth in connection with the performance of functions,
26
or the exercise of powers, conferred by or under this Act in relation
27
to the list of kinds of
*
medical devices and
*
human tissue products
28
in the Private Health Insurance (Medical Devices and Human
29
Tissue Products) Rules.
30
Cost recovery
Schedule 2
Amendments
Part 1
No. , 2022
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
11
(2) Without limiting subsection (1), the Private Health Insurance
1
(Medical Devices and Human Tissue Products) Rules may do any
2
of the following:
3
(a) specify 2 or more
*
cost-recovery fees for the same matter;
4
(b) specify a method for working out a cost-recovery fee;
5
(c)
specify the circumstances in which a specified cost-recovery
6
fee is payable, including by providing that the fee is payable
7
if the Minister is satisfied of specified matters;
8
(d) specify the circumstances in which a person is exempt from
9
paying a specified cost-recovery fee;
10
(e) specify the circumstances in which the Minister may waive a
11
cost-recovery fee.
12
(3) A
*
cost-recovery fee specified under this section must not be such
13
as to amount to taxation.
14
72-20 Delisting because of unpaid fees or levy
15
(1) The Minister may remove a kind of
*
medical device or
*
human
16
tissue product from the list in the Private Health Insurance
17
(Medical Devices and Human Tissue Products) Rules if:
18
(a) a person is liable to pay a
*
cost-recovery fee in connection
19
with the kind of medical device or human tissue product; and
20
(b) the person fails to pay that fee in accordance with those
21
Rules.
22
Note:
Matters relating to payment of cost-recovery fees, such as the time for
23
payment, may be specified in Private Health Insurance (Medical
24
Devices and Human Tissue Products) Rules (see sections 72-30 and
25
72-45).
26
(2) The Minister may remove a kind of
*
medical device or
*
human
27
tissue product from the list in the Private Health Insurance
28
(Medical Devices and Human Tissue Products) Rules if:
29
(a) a person is liable to pay
*
medical devices and human tissue
30
products levy in respect of the ongoing listing of the kind of
31
medical device or human tissue product; and
32
(b) the person fails to pay the levy in accordance with the Private
33
Health Insurance (Levy Administration) Rules.
34
Schedule 2
Cost recovery
Part 1
Amendments
12
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
No. , 2022
Note:
Matters relating to payment of the levy, such as the time for payment,
1
may be specified in Private Health Insurance (Levy Administration)
2
Rules (see sections 307-1 and 307-30).
3
72-25 Minister may direct that activities not be carried out
4
(1) This section applies if:
5
(a) a person (the
debtor
) is liable to pay a
*
cost-recovery fee or
6
*
medical devices and human tissue products levy; and
7
(b) the fee or levy is due and payable.
8
(2) Despite any other provision of this Act, the Minister may refuse to
9
carry out, or direct a person not to carry out, specified activities or
10
kinds of activities in relation to the debtor under this Division
until
11
the fee or levy has been paid.
12
72-30 When cost-recovery fee must be paid
13
A
*
cost-recovery fee becomes due and payable at the time
14
specified in the Private Health Insurance (Medical Devices and
15
Human Tissue Products) Rules.
16
72-35 Payment of cost-recovery fee
17
A
*
cost-recovery fee must be paid to the Commonwealth.
18
72-40 Recovery of fee
19
A
*
cost-recovery fee that is due and payable:
20
(a) is a debt due to the Commonwealth; and
21
(b) may be recovered as a debt by action in a court of competent
22
jurisdiction by the Commonwealth.
23
72-45 Other matters
24
The Private Health Insurance (Medical Devices and Human Tissue
25
Products) Rules may, in relation to
*
cost-recovery fees, specify, or
26
provide for matters relating to, any or all of the following:
27
(a) the person who is liable to pay;
28
(b) methods for payment;
29
(c) extending the time for payment;
30
Cost recovery
Schedule 2
Amendments
Part 1
No. , 2022
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
13
(d) refunding, in whole or in part, an amount paid;
1
(e) applying overpayments;
2
(f) rules relating to fees to be paid in relation to specified
3
activities.
4
5 After paragraph 304-10(d)
5
Insert:
6
(da) levy imposed under the
Private Health Insurance (Medical
7
Devices and Human Tissue Products Levy) Act 2007
8
(
medical devices and human tissue products levy
);
9
6 At the end of subsection 307-10(1)
10
Add:
11
; (e) a
*
medical devices and human tissue products levy;
12
(f) a late payment penalty in respect of a medical devices and
13
human tissue products levy.
14
7 After paragraph 307-20(1)(b)
15
Insert:
16
or (c)
*
medical devices and human tissue products levy;
17
8 Section 307-30
18
Before "The Private", insert "(1)".
19
9 At the end of section 307-30
20
Add:
21
(2) The Private Health Insurance (Levy Administration) Rules may
22
specify persons who are liable to pay
*
medical devices and human
23
tissue products levy.
24
10 Clause 1 of Schedule 1
25
Insert:
26
cost-recovery fee
has the meaning given by subsection 72-15(1).
27
medical devices and human tissue products levy
is defined in
28
paragraph 304-10(da).
29
Schedule 2
Cost recovery
Part 2
Application and transitional provisions
14
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
No. , 2022
Part 2--Application and transitional provisions
1
11 Definitions
2
In this Part:
3
amended Act
means the
Private Health Insurance Act 2007
as amended
4
by Part 1.
5
commencement time
means the commencement of this Part.
6
initial listing fee
means an initial listing fee mentioned in
7
paragraph 72-10(5)(b) of the
Private Health Insurance Act 2007
as in
8
force immediately before the commencement time.
9
ongoing listing fee
means an ongoing listing fee mentioned in
10
section 72-15 of the
Private Health Insurance Act 2007
as in force
11
immediately before the commencement time.
12
12 Application provision
--cost-recovery fees regarding
13
listing applications
14
Paragraphs 72-10(3)(b) and (5)(b) of the amended Act apply in relation
15
to an application made under subsection 72-10(2) after the
16
commencement time.
17
13 Transitional provisions
--initial listing fees for applications
18
granted before commencement time
19
(1)
This item applies in relation to an application under subsection 72-10(2)
20
of the
Private Health Insurance Act 2007
if:
21
(a) the application is granted before the commencement time;
22
and
23
(b) the kind of prosthesis to which the application relates is not
24
listed in the Private Health Insurance (Prostheses) Rules
25
before the commencement time.
26
(2)
Paragraph 72-10(5)(b) of the amended Act applies in relation to the
27
application as if the reference to cost-recovery fee in that paragraph
28
were a reference to the initial listing fee that the applicant is liable to
29
pay in respect of the application.
30
Cost recovery
Schedule 2
Application and transitional provisions
Part 2
No. , 2022
Private Health Insurance Legislation Amendment (Medical Device and
Human Tissue Product List and Cost Recovery) Bill 2022
15
14 Transitional provisions
--ongoing listing fees imposed
1
before commencement time
2
(1)
This item applies if:
3
(a) immediately before the commencement time, an ongoing
4
listing fee is due and payable in respect of a kind of
5
prosthesis; and
6
(b) after the commencement time, the kind of prosthesis is listed
7
as a kind of medical device or human tissue product in the
8
Private Health Insurance (Medical Devices and Human
9
Tissue Products) Rules.
10
(2)
Subsection 72-20(2) of the amended Act has effect, in relation to that
11
kind of medical device or human tissue product, as if:
12
(a) a reference in that subsection to medical devices and human
13
tissue products levy in respect of the ongoing listing of the
14
kind of medical device or human tissue product included a
15
reference to the ongoing listing fee; and
16
(b) the reference in paragraph (b) of that subsection to the
17
Private Health Insurance (Levy Administration) Rules were,
18
in relation to the ongoing listing fee, a reference to
19
subsection 72-15(2) of the
Private Health Insurance Act
20
2007
as in force immediately before the commencement
21
time.
22
15 Transitional provisions
--power to direct that activities not
23
be carried out
24
Section 72-25 of the amended Act has effect as if:
25
(a) a reference in that section to a cost-recovery fee included a
26
reference to an initial listing fee; and
27
(b) a reference in that section to medical devices and human
28
tissue products levy included a reference to an ongoing
29
listing fee.
30