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HEALTH LEGISLATION AMENDMENT ACT 1986 No. 75 of 1986 - SECT 19
19. (1) After Part II of the Principal Act the following Part is inserted:
"PART IIA-SPECIAL PROVISIONS RELATING TO PATHOLOGY
"Division 1-Preliminary Interpretation
"23DA. (1) In this Part, unless the contrary intention appears-
'officer', in relation to a body corporate, means a director, secretary,
manager or employee of the body corporate;
'relevant offence' means-
(a) a relevant offence within the meaning of Part VB;
(b) an offence against sub-section 23DP (1), (2) or (3); or
(c) an offence against-
(i) section 6, 7 or 7A of the Crimes Act 1914; or
(ii) sub-section 86 (1) of that Act by virtue of paragraph (a) of
that sub-section,
being an offence that relates to an offence against sub-section 23DP (1), (2)
or (3);
'relevant person' means a person-
(a) to whom notice has been given under sub-section 23DL (1) or 23DM (1)
or in relation to whom notice has been given to a Chairperson of a
Medicare Participation Review Committee under sub-section 23DL (4),
23DM (4) or 124D (2);
(b) to whom notice has been given under sub-section 124FA (3) or 124FE
(3);
(c) in relation to whom a Medicare Participation Review Committee has made
a determination under section 124F, 124FB, 124FC or 124FF;
(d) to whom notice has been given under sub-section 95 (1);
(e) in relation to whom a Medical Services Committee of Inquiry has made a
recommendation under section 105;
(f) who has been convicted of a relevant offence; or
(g) who the Minister has reasonable grounds to believe may have committed
a relevant offence.
"(2) A reference in this Part to a conviction of an offence includes a
reference to the making of an order under section 19B of the Crimes Act 1914
in relation to the offence.
"(3) In this Part, 'prescribed person' means a person-
(a) in relation to whom a determination under paragraph 124F (2) (d) or
(e) or sub-paragraph 124FB (1) (e) (iv), (v) or (vi) or 124FC (1) (e)
(iv) or (v) is in force;
(b) who the Minister has reasonable grounds to believe may have committed
a relevant offence, being a relevant offence in relation to which a
determination has not been made under sub-section 124F (2);
(c) who is a convicted practitioner within the meaning of section 19B as
in force before the commencement of Part VB; or
(d) who the Minister has reasonable grounds to believe may have committed
a relevant offence within the meaning of section 19B as in force
before the commencement of Part VB.
"(4) A reference in this Part to disqualification, in relation to a prescribed
person is a reference to-
(a) a determination under paragraph 124F (2) (d) or (e) or sub-paragraph
124FB (1) (e) (iv), (v) or (vi) or 124FC (1) (e) (iv) or (v) in
relation to the person; or
(b) a disqualification of the person within the meaning of section 19B as
in force before the commencement of Part VB. Forms of undertaking
"23DB. (1) The Minister may approve, in writing, forms of undertaking to be
given by persons who wish to become approved pathology practitioners or
approved pathology authorities.
"(2) The Minister may vary, in writing, a form of undertaking approved under
sub-section (1).
"(3) A form of undertaking shall make provision for and in relation to such
matters as the Minister considers appropriate.
"(4) Without limiting the generality of sub-section (3), a form of undertaking
to be given by persons who wish to become approved pathology practitioners may
make provision for-
(a) an undertaking by the person that pathology services in respect of
which medicare benefits may become payable that are rendered on behalf
of the person shall be carried out under the person's personal
supervision;
(b) an undertaking by the person not to render excessive pathology
services; and
(c) an undertaking by the person that pathology services in respect of
which medicare benefits may become payable that are rendered by or on
behalf of the person in an accredited pathology laboratory of which
the person is not the proprietor or a proprietor shall not be rendered
pursuant to agreements or arrangements of a kind specified in the
undertaking.
"(5) Sections 48, 49, 49A and 50 of the Acts Interpretation Act 1901 apply to
approvals under sub-section (1) and variations under sub-section (2) as if in
those provisions references to regulations were references to approvals or
variations, references to a regulation were references to a provision of an
approval or variation and references to repeal were references to revocation.
"(6) Approvals under sub-section (1) and variations under sub-section (2)
shall not be taken to be statutory rules within the meaning of the Statutory
Rules Publication Act 1903, but sub-sections 5 (3) to (3C) (inclusive) of that
Act apply in relation to approvals and variations as they apply to statutory
rules.
"(7) For the purposes of the application of sub-section 5 (3B) of the
Statutory Rules Publication Act 1903 in accordance with sub-section (6) of
this section, the reference in the first-mentioned sub-section to the Minister
of State for Sport, Recreation and Tourism shall be read as a reference to the
Minister administering this Act.
"(8) Section 5 of the Evidence Act 1905 applies to approvals and variations as
that section applies to an order made by the Minister. "Division 2-Approved
pathology practitioners and approved pathology authorities Giving and
acceptance of approved pathology practitioner undertaking
"23DC. (1) Where a person who is a medical practitioner-
(a) signs an undertaking in writing for the purposes of this section, in
accordance with the appropriate approved form; and
(b) gives the undertaking to the Minister together with-
(i) an application for the Minister's acceptance of the
undertaking; and
(ii) a fee of $100 or such higher amount as is prescribed, the
Minister may, subject to sub-sections (3), (4) and (5)-
(c) accept the undertaking on behalf of the Commonwealth and determine the
period (being a period ending not later than 12 months after the day
on which the undertaking comes into force) for which the undertaking
is to have effect; or
(d) refuse to accept the undertaking.
"(2) An application under sub-section (1) shall-
(a) be in writing;
(b) be in accordance with the approved form; and
(c) contain such particulars as are determined by the Minister, in
writing, for the purposes of this sub-section.
"(3) The Minister shall not accept an undertaking given by a person for the
purposes of this section if a determination of the kind referred to in
sub-paragraph 124FB (1) (e) (v) is in force in respect of the person.
"(4) The Minister shall not accept an undertaking given by a person for the
purposes of this section if the Minister is satisfied that-
(a) if the undertaking were accepted, the person who gave the undertaking
would be likely to carry on the whole or a part of the practice or
business of a prescribed person; and
(b) the acceptance of the undertaking would be likely to have the effect
of allowing a person to avoid, in whole or in part, the financial
consequences of the disqualification, or the likely disqualification,
of that prescribed person.
"(5) The Minister shall not accept an undertaking given by a person for the
purposes of this section unless the Minister is satisfied that the person is a
fit and proper person to be an approved pathology practitioner.
"(6) In determining, for the purposes of sub-section (5), whether a person is
a fit and proper person to be an approved pathology practitioner, the Minister
shall have regard to-
(a) the person's formal qualifications and experience;
(b) whether the person is a relevant person;
(c) where a Medicare Participation Review Committee has made a
determination in relation to the person under section 124F, 124FB,
124FC or 124FF-the terms of that determination;
(d) where a Medical Services Committee of Inquiry has made a
recommendation in relation to the person under section 105-the terms
of that recommendation;
(e) in a case where the person conducts, or intends to conduct, a practice
or business of rendering pathology services-
(i) the persons who derive, or can reasonably be expected to
derive, whether directly or indirectly, financial benefit from
the conduct of that practice or business; and
(ii) whether any of those persons is a relevant person;
(f) in a case where the person renders, or intends to render, pathology
services as the employee of another person-whether that other person
is a relevant person;
(g) whether the person is or has been-
(i) associated with a relevant person; or
(ii) in a position to control the operations of a body corporate
that-
(A) is, or has been, an approved pathology authority; and
(B) is a relevant person;
(h) such matters as are prescribed for the purposes of this paragraph; and
(j) such other matters as the Minister considers relevant.
"(7) Where a person gives an undertaking under sub-section (1), the Minister
may, by notice in writing given to the person, require the person to give the
Minister, within such period (being a period ending not earlier than 28 days
after the day on which the notice is given) as is specified in the notice,
such information in relation to the undertaking, or the application that
accompanied the undertaking, as is specified in the notice.
"(8) Without limiting the generality of sub-section (1), where-
(a) the Minister gives a person notice under sub-section (7) in relation
to an undertaking given by the person under sub-section (1); and
(b) the person does not give the Minister the information specified in the
notice before the end of the period specified in the notice, the
Minister may refuse to accept the undertaking.
"(9) Where the Minister accepts or refuses to accept an undertaking given
under sub-section (1), the Minister shall give notice in writing of the
acceptance or refusal to the person who gave the undertaking.
"(10) Where the Minister accepts an undertaking given by a person under
sub-section (1), the notice given to the person under sub-section (9) shall-
(a) specify the period determined by the Minister, pursuant to paragraph
(1) (c), as the period for which the undertaking is to have effect;
and
(b) include a statement to the effect that, subject to the Administrative
Appeals Tribunal Act 1975 , application may be made to the
Administrative Appeals Tribunal for review of the decision of the
Minister determining the period for which the undertaking is to have
effect by or on behalf of a person whose interests are affected by the
decision.
"(11) Where the Minister refuses to accept an undertaking given by a person
under sub-section (1), the notice given to the person under sub-section (9)
shall include-
(a) a statement to the effect that the person may apply to the Minister
under sub-section 23DO (1) for reconsideration of the decision of the
Minister refusing to accept the undertaking; and
(b) a statement to the effect that if a person whose interests are
affected by the decision of the Minister on the reconsideration is
dissatisfied with that decision, that person may, subject to the
Administrative Appeals Tribunal Act 1975 , apply to the
Administrative Appeals Tribunal for review of that decision.
"(12) Sections 48, 49, 49A and 50 of the Acts Interpretation Act 1901 apply to
determinations made under sub-section (2) as if in those provisions references
to regulations were references to determinations, references to a regulation
were references to a provision of a determination and references to repeal
were references to revocation.
"(13) Determinations shall not be taken to be statutory rules within the
meaning of the Statutory Rules Publication Act 1903, but sub-sections 5 (3) to
(3C) (inclusive) of that Act apply in relation to determinations as they apply
to statutory rules.
"(14) For the purposes of the application of sub-section 5 (3B) of the
Statutory Rules Publication Act 1903 in accordance with sub-section (13) of
this section, the reference in the first-mentioned sub-section to the Minister
of State for Sport, Recreation and Tourism shall be read as a reference to the
Minister administering this Act.
"(15) Section 5 of the Evidence Act 1905 applies to determinations as that
section applies to an order made by the Minister.
"(16) Any failure to comply with the requirements of sub-section (10) or (11)
in relation to a decision does not affect the validity of the decision.
"(17) In sub-section (1), 'medical practitioner' includes a person (other than
a medical practitioner) who, immediately before 1 August 1977, was carrying on
the business of rendering pathology services at the request of medical
practitioners, where-
(a) in accordance with an approval granted by the Secretary to the
Department, that person issued to the person who incurred the medical
expenses in respect of a pathology service so rendered (not being the
practitioner who requested the rendering of the service) an account or
receipt of his or her fees in respect of the service; and
(b) medical benefit was paid before that day in respect of the service.
Period of effect of approved pathology practitioner undertaking
"23DD. (1) Where a person gives an undertaking under sub-section 23DC (1) and
the Minister accepts the undertaking, the undertaking-
(a) subject to sub-section (2), comes into force-
(i) on the day on which the undertaking is accepted by the
Minister; or
(ii) on such earlier day (not being a day earlier than the day on
which the undertaking was signed) as is specified by the
Minister in the notice given under sub-section 23DC (9) in
relation to the undertaking; and
(b) subject to sub-section (3), ceases to be in force upon-
(i) the termination of the undertaking under section 23DE;
(ii) the revocation of the Minister's acceptance of the undertaking
in accordance with a determination by a Medicare Participation
Review Committee under section 124FB;
(iii) in a case where the person was a medical practitioner at the
time when the Minister accepted the undertaking-a person's
ceasing to be a medical practitioner; or
(iv) the expiration of the period determined by the Minister,
pursuant to paragraph 23DC (1) (c) or 23DO (2) (b), as the
period for which the undertaking is to have effect,
whichever first occurs.
"(2) Where-
(a) a person gives an undertaking (in this sub-section referred to as the
'second undertaking') under sub-section 23DC (1) and the second
undertaking is accepted by the Minister; and
(b) at the time when the second undertaking is accepted by the Minister,
another undertaking (in this sub-section referred to as the 'first
undertaking') given by the person for the purposes of section 23DC and
accepted by the Minister under that section is in force, the second
undertaking comes into force immediately after the first undertaking
ceases to be in force.
"(3) Where-
(a) a person gives an undertaking (in this sub-section referred to as the
'first undertaking') under sub-section 23DC (1) and the first
undertaking is accepted by the Minister;
(b) while the first undertaking is in force, the person gives another
undertaking (in this sub-section referred to as the 'second
undertaking') under sub-section 23DC (1); and
(c) the period referred to in sub-paragraph (1) (b) (iv) in relation to
the first undertaking expires without the Minister having given the
person notice under sub-section 23DC (9) in relation to the second
undertaking, sub-section (1) applies in relation to the first
undertaking as if the period referred to in sub-paragraph (1) (b) (iv)
were the period commencing on the day on which the first undertaking
comes into force and ending on the day on which the Minister gives
notice to the person under sub-section 23DC (9) in relation to the
second undertaking. Approved pathology practitioner may terminate
undertaking
"23DE. An approved pathology practitioner may, at any time, terminate an
undertaking given by the practitioner for the purposes of section 23DC by
giving, as prescribed, a notice of termination specifying a date of
termination not earlier than 30 days after the day on which the notice is
given. Giving and acceptance of approved pathology authority undertaking
"23DF. (1) Where-
(a) an undertaking for the purposes of this section, in accordance with
the appropriate approved form, is signed by or on behalf of a person
(including a State, the Northern Territory or a public authority); and
(b) the person gives the undertaking to the Minister together with-
(i) an application for the Minister's acceptance of the
undertaking; and
(ii) a fee of $100 or such higher amount as is prescribed, the
Minister may, subject to sub-sections (4), (5) and (6)-
(c) accept the undertaking on behalf of the Commonwealth and determine the
period (being a period ending not later than 12 months after the day
on which the undertaking comes into force) for which the undertaking
is to have effect; or
(d) refuse to accept the undertaking.
"(2) An application under sub-section (1) shall-
(a) be in writing;
(b) be in accordance with the approved form; and
(c) contain such particulars as are determined by the Minister, in
writing, for the purposes of this sub-section.
"(3) Without limiting the generality of sub-section (2), a determination
prescribing the particulars to be contained in an application for the purposes
of that sub-section may, in the case of an application by a body corporate,
prescribe particulars of the directors, shareholders and officers of the body
corporate.
"(4) The Minister shall not accept an undertaking given by a person for the
purposes of this section if a determination by a Medicare Participation Review
Committee of the kind referred to in sub-paragraph 124FC (1) (e) (v) is in
force in respect of the person.
"(5) The Minister shall not accept an undertaking given by a person for the
purposes of this section if the Minister is satisfied that-
(a) if the undertaking were accepted, the person who gave the undertaking
would be likely to carry on the whole or a part of the practice or
business of a prescribed person; and
(b) the acceptance of the undertaking would be likely to have the effect
of allowing a person to avoid, in whole or in part, the financial
consequences of the disqualification, or the likely disqualification,
of that prescribed person.
"(6) The Minister shall not accept an undertaking given by a person for the
purposes of this section unless the Minister is satisfied that the person is a
fit and proper person to be an approved pathology authority.
"(7) In determining, for the purposes of sub-section (6), whether a person is
a fit and proper person to be an approved pathology authority, the Minister
shall have regard to-
(a) whether the person is a relevant person;
(b) where a Medicare Participation Review Committee has made a
determination in relation to the person under section 124F, 124FB,
124FC or 124FF-the terms of that determination;
(c) where a Medical Services Committee of Inquiry has made a
recommendation in relation to the person under section 105-the terms
of that recommendation;
(d) in a case where the person conducts, or intends to conduct, a business
of rendering pathology services-
(i) the persons who derive, or who can reasonably be expected to
derive, whether directly or indirectly, financial benefit from
the conduct of that business; and
(ii) whether any of those persons is a relevant person;
(e) whether the person is or has been-
(i) associated with a relevant person; or
(ii) in a position to control the operations of a body corporate
that-
(A) is, or has been, an approved pathology authority; and
(B) is a relevant person;
(f) in a case where the person is a body corporate-whether any officer of
the body corporate, or any person who is in a position to control the
body corporate, is or has been-
(i) associated with a relevant person; or
(ii) in a position to control the operations of a body corporate
that-
(A) is, or has been, an approved pathology authority; and
(B) is a relevant person;
(g) such matters as are prescribed for the purposes of this paragraph; and
(h) such other matters as the Minister considers relevant.
"(8) Where a person gives an undertaking under sub-section (1), the Minister
may, by notice in writing given to the person, require the person to give the
Minister, within such period (being a period ending not earlier than 28 days
after the day on which the notice is given) as is specified in the notice,
such information in relation to the undertaking, or the application that
accompanied the undertaking, as is specified in the notice.
"(9) Without limiting the generality of sub-section (1), where-
(a) the Minister gives a person notice under sub-section (8) in relation
to an undertaking given by the person under sub-section (1); and
(b) the person does not give the Minister the information specified in the
notice before the end of the period specified in the notice, the
Minister may refuse to accept the undertaking.
"(10) Where the Minister accepts or refuses to accept an undertaking given
under sub-section (1), the Minister shall give notice in writing of the
acceptance or refusal to the person who gave the undertaking.
"(11) Where the Minister accepts an undertaking given by a person under
sub-section (1), the notice given to the person under sub-section (10) shall-
(a) specify the period determined by the Minister, pursuant to paragraph
(1) (c), as the period for which the undertaking is to have effect;
and
(b) include a statement to the effect that, subject to the Administrative
Appeals Tribunal Act 1975 , application may be made to the
Administrative Appeals Tribunal for review of the decision of the
Minister determining the period for which the undertaking is to have
effect by or on behalf of a person whose interests are affected by the
decision.
"(12) Where the Minister refuses to accept an undertaking given by a person
under sub-section (1), the notice given to the person under sub-section (10)
shall include-
(a) a statement to the effect that the person may apply to the Minister
under sub-section 23DO (1) for reconsideration of the decision of the
Minister refusing to accept the undertaking; and
(b) a statement to the effect that if a person whose interests are
affected by the decision of the Minister on the reconsideration is
dissatisfied with that decision, that person may, subject to the
Administrative Appeals Tribunal Act 1975 , apply to the
Administrative Appeals Tribunal for review of that decision.
"(13) Sections 48, 49, 49A and 50 of the Acts Interpretation Act 1901 apply to
determinations made under sub-section (2) as if in those provisions references
to regulations were references to determinations, references to a regulation
were references to a provision of a determination and references to repeal
were references to revocation.
"(14) Determinations shall not be taken to be statutory rules within the
meaning of the Statutory Rules Publication Act 1903, but sub-sections 5 (3) to
(3C) (inclusive) of that Act apply in relation to determinations as they apply
to statutory rules.
"(15) For the purposes of the application of sub-section 5 (3B) of the
Statutory Rules Publication Act 1903 in accordance with sub-section (14) of
this section, the reference in the first-mentioned sub-section to the Minister
of State for Sport, Recreation and Tourism shall be read as a reference to the
Minister administering this Act.
"(16) Section 5 of the Evidence Act 1905 applies to determinations as that
section applies to an order made by the Minister.
"(17) Any failure to comply with the requirements of sub-section (11) or (12)
in relation to a decision does not affect the validity of the decision.
"(18) In this section, 'public authority' means an authority (being a
corporation) established by a law of the Commonwealth, of a State or of an
internal Territory. Period of effect of approved pathology authority
undertaking
"23DG. (1) Where a person gives an undertaking under sub-section 23DF (1) and
the Minister accepts the undertaking, the undertaking-
(a) subject to sub-section (2), comes into force-
(i) on the day on which the undertaking is accepted by the
Minister; or
(ii) on such earlier day (not being a day earlier than the day on
which the undertaking was signed) as is specified by the
Minister in the notice given under sub-section 23DF (10) in
relation to the undertaking; and
(b) subject to sub-section (3), ceases to be in force upon-
(i) the termination of the undertaking by the person under section
23DH;
(ii) the revocation of the Minister's acceptance of the undertaking
in accordance with a determination by a Medicare Participation
Review Committee under section 124FC; or
(iii) the expiration of the period determined by the Minister,
pursuant to paragraph 23DF (1) (c) or 23DO (2) (b), as the
period for which the undertaking is to have effect,
whichever first occurs.
"(2) Where-
(a) a person gives an undertaking (in this sub-section referred to as the
'second undertaking') under sub-section 23DF (1) and the second
undertaking is accepted by the Minister; and
(b) at the time when the second undertaking is accepted by the Minister,
another undertaking (in this sub-section referred to as the 'first
undertaking') given by the person for the purposes of section 23DF and
accepted by the Minister under that section is in force, the second
undertaking comes into force immediately after the first undertaking
ceases to be in force.
"(3) Where-
(a) a person gives an undertaking (in this sub-section referred to as the
'first undertaking') under sub-section 23DF (1) and the first
undertaking is accepted by the Minister;
(b) while the first undertaking is in force, the person gives another
undertaking (in this sub-section referred to as the 'second
undertaking') under sub-section 23DF (1); and
(c) the period referred to in sub-paragraph (1) (b) (iii) in relation to
the first undertaking expires without the Minister having given the
person notice under sub-section 23DF (10) in relation to the second
undertaking, sub-section (1) applies in relation to the first
undertaking as if the period referred to in sub-paragraph (1) (b)
(iii) were the period commencing on the day on which the first
undertaking comes into force and ending on the day on which the
Minister gives notice to the person under sub-section 23DF (10) in
relation to the second undertaking. Approved pathology authority may
terminate undertaking
"23DH. An approved pathology authority may, at any time, terminate an
undertaking given by the authority for the purposes of section 23DF by giving,
as prescribed, a notice of termination specifying a date of termination not
earlier than 30 days after the day on which the notice is given. Repayment of
fee
"23DJ. Where a person gives an undertaking under sub-section 23DC (1) or 23DF
(1) together with a fee and the undertaking is not accepted, the fee shall be
repaid to the person in accordance with the regulations. Request forms and
confirmation forms
"23DK. (1) Where a pathology service has been rendered by or on behalf of an
approved pathology practitioner pursuant to a request made or confirmed in
accordance with section 16A, the approved pathology practitioner shall retain
the written request or the written confirmation of the request for the period
of 18 months commencing on the day on which the service was rendered.
"(2) Where-
(a) a request is made to an approved pathology practitioner (in this
sub-section referred to as the 'relevant pathologist') for a pathology
service or pathology services in relation to a person by the
practitioner who is the treating practitioner in relation to the
person for the purposes of section 16A;
(b) the request is in writing or is confirmed in writing; and
(c) the relevant pathologist makes a request to another approved pathology
practitioner for that service, or for a service included in those
services, in relation to that person, the relevant pathologist shall
retain the written request or the written confirmation of the request
for the period of 18 months commencing on the day on which the request
referred to in paragraph (a) is made.
"(3) An approved pathology practitioner shall, if requested to do so by an
officer of the Commission, produce to the officer, as soon as practicable and
in any case before the end of the day next following the day on which the
request is made by the officer, a written request or a written confirmation of
a kind required to be retained by the approved pathology practitioner under
sub-section (1) or (2).
"(4) An officer may make and retain copies of or take and retain extracts
from, any request or confirmation produced to the officer pursuant to
sub-section (3).
"(5) Where-
(a) a practitioner makes a request for a pathology service to an approved
pathology practitioner;
(b) medicare benefit may become payable in respect of the service; and
(c) the request is made otherwise than in writing, the practitioner shall
confirm the request in writing within the period of 14 days commencing
on the day on which the request is made.
"(6) Where-
(a) an approved pathology practitioner (in this sub-section referred to as
the 'referring pathologist') makes a request for a pathology service
to another approved pathology practitioner;
(b) medicare benefit may become payable in respect of the service; and
(c) the request is made otherwise than in writing, the referring
pathologist shall confirm the request in writing within the period of
14 days commencing on the day on which the request is made.
"(7) For the purposes of this section, where-
(a) a written request or a written confirmation of a request has been
recorded on film or on any other medium approved, in writing, by the
Minister from time to time; or
(b) in accordance with an approval, in writing, of the Minister, a request
or confirmation (other than a written request or a written
confirmation) has been recorded on a tape, disc, film or other medium,
for the purposes of storage and subsequent retrieval when required-
(c) the retention of the record so made shall be deemed to be a retention
of the request or the confirmation, as the case may be; and
(d) the production, or the reproduction, of the record so made shall be
deemed to be a production of the request or the confirmation, as the
case may be.
"(8) Where the Minister gives an approval for the purposes of paragraph (7)
(b), the Minister may set out in the instrument of approval any conditions to
which the approval is subject, and any recording that is not in accordance
with such a condition shall be deemed to be not in accordance with the
approval.
"(9) A reference in this section to a request made or confirmed in accordance
with section 16A includes a reference to a request made or confirmed in
accordance with section 16A of this Act as in force at any time before the
commencement of this section.
"(10) A reference in this section to an approved pathology practitioner
includes a reference to a person who has been an approved pathology
practitioner within the meaning of this Act as in force before the
commencement of this section.
"(11) A reference in this section to a request made to an approved pathology
practitioner includes a reference to a request that is deemed, for the
purposes of section 16A, to have been made to that approved pathology
practitioner. "Division 3-Breaches of undertakings and initiation of excessive
pathology
services Breaches of undertakings by approved pathology practitioners and
approved pathology authorities
"23DL. (1) Where the Minister has reasonable grounds for believing that a
person who is or was an approved pathology practitioner or an approved
pathology authority has breached an undertaking given by the person for the
purposes of section 23DC or 23DF, the Minister shall give notice in writing to
the person setting out particulars of those grounds and inviting the person to
make submissions to the Minister, in accordance with sub-section (2), showing
cause why the Minister should not take further action in relation to the
person under this section.
"(2) A person who is given notice under sub-section (1) may, within the period
of 28 days commencing on the day on which the notice is given, make
submissions to the Minister showing cause why the Minister should not take
further action in relation to the person under this section.
"(3) Where a person makes a submission to the Minister in accordance with
sub-section (2), the Minister shall have regard to that submission in
determining whether to take any further action in relation to the person under
this section.
"(4) Where the Minister gives notice to a person under sub-section (1), the
Minister shall-
(a) if, at the end of the period referred to in sub-section (2), the
person has not made submissions to the Minister in accordance with
that sub-section-give notice in writing to a Chairperson of a Medicare
Participation Review Committee setting out particulars of the grounds
referred to in sub-section (1);
(b) if the person makes submissions to the Minister within the period
referred to in sub-section (2) and the Minister is satisfied that
there has been no breach of the undertaking-determine that no further
action be taken in relation to the person under this section pursuant
to the notice referred to in sub-section (1); or
(c) if the person makes submissions to the Minister within the period
referred to in sub-section (2) and the Minister is satisfied that
there are reasonable grounds (being grounds that were specified in the
notice referred to in sub-section (1)) for believing that there has
been a breach of the undertaking-give notice in writing to a
Chairperson of a Medicare Participation Review Committee setting out
particulars of those grounds.
"(5) Where the Minister makes a decision pursuant to sub-section (4) in
relation to a person, the Minister shall give the person notice in writing of
the decision.
"(6) Where the Minister gives notice pursuant to paragraph (4) (a) or (c) to
the Chairperson of a Medicare Participation Review Committee, the Minister may
determine, in writing, that the undertaking in respect of which the notice is
given be suspended pending the outcome of the proceedings before the
Committee.
"(7) Where the Minister makes a determination under sub-section (6) in
relation to an undertaking, the undertaking ceases to be in force until-
(a) the determination is revoked by the Minister; or
(b) a Medicare Participation Review Committee makes a determination under
section 124FB or 124FC pursuant to the notice referred to in
sub-section (6).
"(8) Where the Minister makes a determination under sub-section (6) in
relation to an undertaking given by a person, the Minister shall give the
person notice in writing of the determination.
"(9) A notice under sub-section (8) shall include a statement to the effect
that, subject to the Administrative Appeals Tribunal Act 1975, application may
be made to the Administrative Appeals Tribunal for review of the decision to
which the notice relates by or on behalf of a person whose interests are
affected by the decision.
"(10) Where the Minister makes a determination under sub-section (6) the
Minister may, if the Minister thinks fit, publish notice of the determination
in the Gazette.
"(11) An action or proceeding, civil or criminal, does not lie against a
person for publishing in good faith a copy of, a fair extract from or a fair
abstract of a publication made in accordance with sub-section (10).
"(12) For the purposes of sub-section (11), a publication shall be deemed to
be made in good faith if the person by whom it is made is not actuated by ill
will to the person affected by the publication or by any other improper
motive. Initiation of excessive pathology services
"23DM. (1) Where the Minister has reasonable grounds for believing that-
(a) a person who is or was a practitioner has initiated excessive
pathology services;
(b) a person has caused or permitted a practitioner employed by the person
to initiate excessive pathology services; or
(c) a person, being an officer of a body corporate, has caused or
permitted a practitioner employed by the body corporate to initiate
excessive pathology services, the Minister shall give notice in
writing to the person setting out particulars of those grounds and
inviting the person to make submissions to the Minister, in accordance
with sub-section (2), showing cause why the Minister should not take
further action in relation to the person under this section.
"(2) A person who is given notice under sub-section (1) may, within a period
of 28 days commencing on the day on which the notice is given, make
submissions to the Minister showing cause why the Minister should not take
further action in relation to the person under this section.
"(3) Where a person makes a submission to the Minister in accordance with
sub-section (2), the Minister shall have regard to that submission in
determining whether to take any further action in relation to the person under
this section.
"(4) Where the Minister gives notice to a person under sub-section (1), the
Minister shall-
(a) if, at the end of the period referred to in sub-section (2), the
person has not made submissions to the Minister pursuant to that
sub-section-give notice in writing to a Chairperson of a Medicare
Participation Review Committee setting out particulars of the grounds
referred to in sub-section (1);
(b) if the person makes submissions to the Minister within the period
referred to in sub-section (2) and the Minister is satisfied that
there are no reasonable grounds for believing that the person has
initiated excessive pathology services, or caused or permitted
excessive pathology services to be initiated as referred to in the
notice under sub-section (1), as the case requires-determine that no
further action be taken in relation to the person under this section
in relation to the notice referred to in sub-section (1); or
(c) if the person makes submissions to the Minister within the period
referred to in sub-section (2) and the Minister is satisfied that
there are reasonable grounds (being grounds that were specified in the
notice referred to in sub-section (1)) for believing that the person
has initiated excessive pathology services, or caused or permitted
excessive pathology services to be initiated as referred to in that
notice, as the case requires-give notice in writing to a Chairperson
of a Medicare Participation Review Committee setting out particulars
of those grounds.
"(5) Where the Minister makes a decision pursuant to sub-section (4) in
relation to a person, the Minister shall give the person notice in writing of
the decision.
"Division 4-Accredited pathology laboratories Accredited pathology
laboratories
"23DN. (1) Where a person-
(a) makes an application, in writing, in accordance with the approved
form, to the Minister for the approval of premises as an accredited
pathology laboratory; and
(b) pays the prescribed fee, the Minister may, in writing, approve the
premises, for the purposes of this Act, as an accredited pathology
laboratory and, where the Minister gives such approval, the Minister
shall specify in the approval-
(c) the kind of pathology services in respect of which the premises are
approved for the purposes of this Act; and
(d) the period (being a period ending not later than 3 years after the day
on which the approval takes effect) for which the approval is to have
effect.
"(2) The Minister may, in writing, determine principles to be applied by the
Minister in the exercise of the Minister's powers under sub-section (1).
"(3) The Minister shall, in exercising the Minister's powers under sub-section
(1) at a particular time, apply the principles determined under sub-section
(2) that are in force at that time.
"(4) An approval under sub-section (1)-
(a) takes effect on the day on which the approval is given or on such
later day as is specified in the approval; and
(b) ceases to have effect upon-
(i) the revocation of the approval; or
(ii) the expiration of the period specified in the approval as the
period for which the approval is to have effect,
whichever first occurs,
"(5) Where the Minister makes a decision under sub-section (1) approving or
refusing to approve premises as an accredited pathology laboratory, the
Minister shall give notice in writing of the decision to the person who
applied for the approval.
"(6) Where the Minister varies or revokes an approval given under sub-section
(1) in relation to premises, the Minister shall give notice in writing of the
variation or revocation to the proprietor of the premises.
"(7) A notice under sub-section (5) or (6) shall include a statement to the
effect that, subject to the Administrative Appeals Tribunal Act 1975,
application may be made to the Administrative Appeals Tribunal for review of
the decision to which the notice relates by or on behalf of a person whose
interests are affected by the decision.
"(8) Where a person gives an application under sub-section (1) together with a
fee and the application is not granted, the fee shall be repaid to the person
in accordance with the regulations.
"(9) Sections 48, 49, 49A and 50 of the Acts Interpretation Act 1901 apply to
determinations made under sub-section (2) as if in those provisions references
to regulations were references to determinations, references to a regulation
were references to a provision of a determination and references to repeal
were references to revocation.
"(10) Determinations shall not be taken to be statutory rules within the
meaning of the Statutory Rules Publication Act 1903, but sub-sections 5 (3) to
(3C) (inclusive) of that Act apply in relation to determinations as they apply
to statutory rules.
"(11) For the purposes of the application of sub-section 5 (3B) of the
Statutory Rules Publication Act 1903 in accordance with sub-section (10) of
this section, the reference in the first-mentioned sub-section to the Minister
of State for Sport, Recreation and Tourism shall be read as a reference to the
Minister administering this Act.
"(12) Section 5 of the Evidence Act 1905 applies to determinations as that
section applies to an order made by the Minister.
"Division 5-Miscellaneous
Review of decisions
"23DO. (1) Where a person gives an undertaking under sub-section 23DC (1) or
23DF (1) and the Minister refuses to accept the undertaking, the person may,
within the period of 28 days commencing on the day on which the person is
given notice, under sub-section 23DC (9) or 23DF (10), as the case requires,
of the Minister's decision, apply to the Minister for reconsideration by the
Minister of the decision.
"(2) Where a person applies to the Minister under sub-section (1) for
reconsideration of a decision by the Minister refusing to accept an
undertaking given by the person, the Minister may-
(a) affirm the decision; or
(b) accept the undertaking on behalf of the Commonwealth and determine the
period (being a period ending not later than 12 months after the day
on which the undertaking comes into force) for which the undertaking
is to have effect.
"(3) Where the Minister makes a decision under sub-section (2) in relation to
an application by a person under sub-section (1), the Minister shall give
notice in writing of the decision to the person who applied for the review.
"(4) A notice under sub-section (3) of a decision by the Minister shall
include a statement to the effect that, subject to the Administrative Appeals
Tribunal Act 1975 , application may be made to the Administrative Appeals
Tribunal for review of the decision by or on behalf of a person whose
interests are affected by the decision.
"(5) Applications may be made to the Administrative Appeals Tribunal for
review of-
(a) a decision by the Minister, under sub-section 23DN (1), approving or
refusing to approve premises as an accredited pathology laboratory for
the purposes of this Act;
(b) a decision by the Minister varying or revoking an approval given under
sub-section 23DN (1);
(c) a decision by the Minister under sub-section (2) of this section;
(d) a decision the Minister, pursuant to paragraph 23DC (1) (c) or
23DF (1) (c), determining the period for which an undertaking is
to have effect; or
(e) a decision by the MInister under sub-section 23DL (6) determining
that an undertaking be suspended.
"(6) In this section, 'decision' has the same meaning as in the
Administrative Appeals Tribunal Act 1975. Offences in relation to request
forms and confirmation forms
"23DP. (1) An approved pathology practitioner who, without reasonable excuse,
contravenes sub-section 23DK (1), (2), (3) or (6) is guilty of an offence
punishable, upon conviction, by a fine not exceeding $1,000.
"(2) A practitioner who, without reasonable excuse, contravenes sub-section
23DK (5) is guilty of an offence punishable, upon conviction, by a fine not
exceeding $1,000.
"(3) An approved pathology practitioner or an approved pathology authority
shall not, without reasonable excuse, provide (whether directly or indirectly)
to a practitioner a pathology request form that is not in accordance with the
approved form.
Penalty: $1,000.
"(4) In this section-
(a) a reference to an approved pathology practitioner includes a reference
to a person who has been an approved pathology practitioner;
(b) a reference to an approved pathology authority includes a reference to
a person who has been an approved pathology authority; and
(c) a reference to a practitioner includes a reference to a person who has
been a practitioner.
"(5) In this section, 'pathology request form' means a document for use by a
practitioner in requesting pathology services.".
(2) A person may give an undertaking for the purposes of section 23DC or 23DF
of the Principal Act as amended by sub-section (1), and the Minister may
accept such an undertaking, as if that sub-section had come into operation on
the day on which this sub-section comes into force but any undertaking so
given and accepted before the day on which sub-section (1) comes into
operation does not come into force until the day on which sub-section (1)
comes into operation.
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