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1998-1999-2000-2001
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
EXPLANATORY
MEMORANDUM
(Circulated
by authority of the Minister for Health and Aged Care,
the Hon. Dr Michael
Wooldridge, MP)
HEALTH LEGISLATION AMENDMENT BILL (No. 3)
2001
The changes made to the Therapeutic Goods Act 1989 will enable the
Mutual Recognition Agreement, entered into between Australia and Singapore, to
be implemented. The amendments will allow the Secretary to accept the
conclusions of Good Manufacturing Practice (“GMP”) inspections and
manufacturing certificates as evidence that the manufacturing processes employed
in Singapore in the manufacture of medicines that are exported to Australia meet
with Australian requirements. The certificates are issued, pursuant to the
Mutual Recognition Agreement, by inspection services designated as such
by the government health regulatory body in Singapore, and approved by the
Secretary in Australia to provide certificates of Good Manufacturing Practices
for medicines imported into Australia. The certificates are taken into account
for the purposes of determining whether medicines imported from Singapore may be
marketed to the general public in Australia.
The amendments also allow
the Secretary to give effect to any other Mutual Recognition Agreements
(“MRAs”) entered into between Australia and other countries that
provide for arrangements similar to those applying under the Singapore MRA.
These other MRAs, features of which may be prescribed in the Regulations, will
enable Australia to accept GMP certificates as evidence that the manufacturing
processes employed in the manufacture of medicines exported from those countries
to Australia meet with Australian requirements.
Other changes effected to
the Therapeutic Goods Act 1989 will enable the Secretary to obtain
information and documents from manufacturers of blood or blood components about
their manufacturing processes and practices. This will enable the Secretary to
monitor the manufacturer’s compliance with new standards for blood, and
new manufacturing standards for the manufacture of blood and blood components.
Such information or documents may be requested by the Secretary, and provided to
the Secretary by manufacturers of blood and blood components without the need
for authorised persons to conduct an audit of the manufacturing premises.
The amendments also clarify when the balance of evaluation fees, payable
for the evaluation of registrable medicines that are, in the main, prescription
medicines, must be paid by applicants seeking to register their medicines in the
Australian Register of Therapeutic Goods. Currently fees are payable when an
evaluation of an application to register a medicine in the Register has been
completed, and a decision of the Secretary to register, or refuse registration,
of a medicine is made and communicated to the applicant. However, following the
completion of an evaluation, the results of which are usually communicated to an
applicant, but before the Secretary notifies the applicant of his/her decision
to register or not register the medicine, an applicant may withdraw its
application. Where this occurs, the Secretary is not able to recover the cost
of the evaluation that has already been completed. The effect of the amendments
is to enable the Secretary to recover the balance of the evaluation fees owing
for the evaluation work completed.
PROFESSIONAL SERVICES REVIEW
The major amendments made by this Schedule amend the provisions of the
Professional Services Review (PSR) Scheme in Part VAA of the Health Insurance
Act 1973 (the Act) to improve the Scheme’s operation.
The
PSR Scheme provides for a system of peer review to determine whether a
practitioner has inappropriately rendered or initiated services which attract a
Medicare benefit, or has inappropriately prescribed under the Pharmaceutical
Benefits Scheme, and to apply sanctions to those found to have practised
inappropriately.
Following a comprehensive review of the PSR Scheme
(Report of the Review Committee of the Professional Services Review Scheme
– March 1999), significant legislative amendments to the provisions
governing the Scheme were made by the Health Insurance Amendment
(Professional Services Review) Act 1999. The proposed amendments made by
this Schedule are machinery in nature and clarify the intention of some of the
earlier proposals and will overcome administrative difficulties experienced with
the effectiveness and operation of the previous changes.
The Bill
clarifies the operation of the Scheme in relation to the following
matters:
• the Director’s investigation of matters referred
by the Health Insurance Commission (the Commission) and a PSR Committee’s
consideration of matters referred by the Director of PSR are not limited by
reasons stated in referrals;
• a practitioner who is to be disqualified
from Medicare, in respect of the rendering of services, for intentionally
refusing or failing to comply with a requirement to produce or give information
during the PSR review process will also be disqualified so that any initiated
service will also not attract a Medicare benefit;
• the instrument
making the adjudicative referral is a separate instrument to other documents
associated with the referral, particularly the report by the Director of PSR to
a Committee which must accompany an adjudicative referral;
• the
removal of existing inconsistencies and the operation of the disqualification
provisions under the PSR Scheme where a person under review does not comply with
a PSR Committee’s request to attend, give evidence and answer questions at
a PSR Committee hearing;
• the provisions of section 105A of the Act,
concerning the power of a PSR Committee to require the production of documents
or the giving of information during the PSR process, apply to matters referred
prior to 1 August 1999 (‘old matters’), the date of commencement of
the relevant provisions of the Health Insurance Amendment (Professional
Services Review) Act 1999.
• the commencement date of 1 August 1999
in relation to other relevant provisions of the Health Insurance Amendment
(Professional Services Review) Act 1999 applies to matters referred prior
to1 August 1999.
The Bill overcomes administrative difficulties in
the following areas:
• specifying the material or information which
may be given by the Director of PSR to the Determining
Authority;
• requiring practitioners disqualified from Medicare under
the PSR Scheme to comply with provisions applicable to practitioners otherwise
disqualified under the Act, particularly to display a notice of disqualification
at their practice location/s;
• replace an optometrist’s right of
appeal of the Minister’s determination to a PSR Tribunal with a right of
appeal to the Administrative Appeals Tribunal;
• technical corrections
of incorrect cross-references, from section 106T to 106TA, in a number of
provisions relating to the PSR Scheme.
NUMBER OF COMMISSIONERS OF HEALTH INSURANCE COMMISSION
The
Bill makes changes to the legislative provisions covering number of
Commissioners of the Health Insurance Commission. Effective in November 2002,
the number of Commissioners will reduce by 2 (rather than by the originally
intended 4). There will then be a Commission comprising the Chairperson, the
Managing Director and 7 additional Commissioners.
This schedule makes some minor technical amendments to subsection 23D(3)
and 23DAA of the Health Insurance Act 1973 which are consequential upon
changes to the administrative law arrangements made by the Administrative
Review Tribunal Act 2001 (the ART Act). Subsection 23D(3) and 23DAA are
inserted by items 4 and 5 of Schedule 2 and provide for merits review by the
Administrative Appeals Tribunal in respect of a decision to refuse to accept an
optometrist undertaking. The ART Act replaces the Administrative Appeals
Tribunal with the Administrative Review Tribunal.
There are two proposed amendments to the National Health Act 1953.
The first of these relates to ‘employee health benefit schemes’.
Since 1 October 1995, employers conducting such schemes have had three
options:
• to register as a health benefits organisation (health
fund) under the Act;
• to terminate the employee health benefits
scheme; or
• to seek a determination from the Minister that their
‘top up’ scheme is not an employee health benefits scheme (and
therefore not health insurance business) under subsection 67(4) of the
Act.
The intention was to ensure that all unregistered health schemes did
not infringe the regulatory requirements applying to registered health funds,
and in particular did not undermine the principle of community
rating.
Many employers who contribute directly towards health expenses
incurred by their employees have sought a determination under subsection 67(4)
of the Act.
However, subsection 67(7) of the Act provides that the
Minister for Health and Aged Care must not make a determination under section
67(4) if the ‘top up’ scheme is the subject of an agreement to which
Part V1B of the Industrial Relations Act 1988 applies. Part V1B applied
to Certified Agreements and Enterprise Agreements.
The proposed amendment
will remove this bar which is a minor anachronism, as these ‘top up’
schemes do not provide any threat to community rating but rather are beneficial
to contributors and to private health insurance generally.
The second
proposed amendment relates to discounts for health fund payments. The
National Health Act 1953 allows funds to offer discounts where a
contributor pays at least six months in advance. There is no policy
justification for not allowing discounts on the quarterly payment of premiums,
as the health insurance industry has confirmed that there are administrative
savings for health funds from such payments.
The amendments to the Therapeutic Goods Act 1989, the National
Health Act 1953 and the PSR Scheme have no significant financial impact.
The financial impact of the amendment relating to number of Commissioners of the
Health Insurance Commission is small (a reduced anticipated saving from November
2002 of about $60,000 per year).
Clause 1: This clause states that the short title of the
legislation is the Health Legislation Amendment Act (No.3)
2001.
Clause 2: sets out the commencement dates for the Bill.
Subclauses (2) and (3) clarify that should the proposed Therapeutic
Goods Amendment (Medical Devices) Act 2001 come into effect either before or
after the commencement of the Health Legislation Amendment Act (No.3)
2001, then relevant definitions for “conformity assessment
certificate” will be either repealed or amended, as the case requires.
Subclause (4) provides that Schedule 4 commences either at the time when
Parts 4 to 10 of the Administrative Review Tribunal Act 2001 (the ART
Act) commence or immediately after the commencement of Schedule 2, whichever
occurs later.
Subclause (5) provides that Schedule 6 may have
retrospective application, commencing immediately after the commencement of item
15 of Schedule 1 to the Health Legislation Amendment (Medical
Practitioners’ Qualifications and Other Measures) Act 2001.
Unless otherwise specified under this clause, the Act commences to
operate on the 28th day after it receives Royal
Assent.
Clause 3: has the effect of stating that, subject to
clause 2, the Act will be amended in the manner specified in each of the
Schedules.
SCHEDULE 1 – THERAPEUTIC
GOODS
Items 1 and 2 repeal the current definitions for
“approved conformity assessment body” and “conformity
assessment body”, as both these definitions have been replaced and
incorporated by new definitions inserted by Items 5 and 6 of
Schedule 1.
Item 3 repeals the definition of “conformity
assessment certificate”.
Item 4 inserts a new definition for
“conformity assessment certificate”, to mean a certificate that is
issued under section 41EE of the Act.
Item 5 inserts a definition
for EC/EFTA attestation of conformity, to refer to attestations of
conformity that are issued by an EC/EFTA conformity assessment body:
- in
accordance with the EC Mutual Recognition Agreement or the EFTA Mutual
Recognition Agreement; and
- where the EC/EFTA conformity assessment body has
been approved, in writing, to be one by the Secretary for the purposes of the
Act.
Item 6 inserts a definition for an EC/EFTA conformity
assessment body. This is a Conformity Assessment Body that has been
designated as such in one of the following Sectoral Annexes to the EC Mutual
Recognition Agreement or the EFTA Mutual Recognition
Agreement:
(a) Sectoral Annex (Medical Devices);
(b) Sectoral Annex
(Medicinal Products GMP Inspection and Batch Certification.
Items 7
and 9 insert definitions for an “international agreement” for
the purposes of the definition of a “non EC/EFTA MRA” in
Item 9. A “non-EC/EFTA MRA” refers to an
international instrument that Australia is bound by, or is a party to, and the
purpose of that instrument is to enable parties bound by that instrument to
recognise attestations of conformity. In addition, the instrument must also be
one that meets any other requirements prescribed in the
Regulations.
Item 8 inserts a definition for “non EC/EFTA
attestation of conformity”. This means, in relation to a particular
non EC/EFTA MRA, an attestation of conformity issued by a Conformity Assessment
Body, after that non EC/EFTA MRA comes into effect, where the Conformity
Assessment Body:
- is designated as such under that non EC/EFTA MRA;
and
- is approved in writing by the Secretary to be a Conformity Assessment
Body for that particular non EC/EFTA MRA.
Item 10 inserts new
section 3B into the Act. New s.3B will enable the Minister to declare, in
writing, that a country specified in the declaration is covered by the
particular MRA, being a non EC/EFTA MRA, identified in the Minister’s
declaration. A declaration made by the Minister under s.3B must be
gazetted.
Items 12, 14 and 16 amend sections 25, 26 and 26A of the
Act. These sections deal with criteria that must be satisfied before different
classes of therapeutic goods may be included in the Australian Register of
Therapeutic Goods (“the Register”). Except in certain circumstances
set out in the Act, unless therapeutic goods have been included in the Register
by their sponsors, they may not be imported, exported, manufactured or supplied
in Australia for use in humans. Section 25 sets out the criterion that
must be satisfied before “registrable therapeutic goods” may be
included in the Register. “Registrable” therapeutic goods refer to
higher risk therapeutic goods, such as prescription medicines or implantable
therapeutic devices, that require a higher level of scrutiny before they may be
included in the Register. Section 26 sets out criteria that must be
satisfied before listable therapeutic devices, or export only therapeutic goods,
including export-only medicines, may be included in the Register.
“Listable” therapeutic goods refer to low risk therapeutic goods,
such as over the counter medicines and most therapeutic devices, that may be
entered into the Register with a level of assessment commensurate with their
status as low risk products. Section 26A sets out the criteria for
including listable medicines in the Register. “Listable medicines”
covered by section 26A are in the main over the counter medicines or
complementary medicines, such as traditional Chinese medicines and herbal
remedies.
One common criterion applying under sections 25, 26 and 26A of
the Act (which specifies how different classes of therapeutic goods may be
included in the Register) relates to whether or not the therapeutic goods that
are the subject of an application under those provisions, and that are
manufactured outside of Australia, meet with acceptable manufacturing standards.
In relation to section 25, where an application is lodged to register a
medicine in the Register and the medicine has been manufactured in a country
covered by a non EC/EFTA MRA, Item 12 inserts a new provision,
subparagraph 25(2)(a)(ia), into s.25 to enable the Secretary to accept
attestations of conformity issued by a Conformity Assessment Body designated as
such under that non EC/EFTA MRA for that country. The Conformity Assessment
body must also have been approved in writing by the Secretary to be a conformity
assessment body for that non EC/EFTA MRA. The attestation of conformity is an
attestation that the medicine which is the subject of a s.25 application under
the Act has been manufactured to an acceptable standard. The attestation can
only be made in relation to that step of manufacture that occurred in the
country covered by the non EC/EFTA MRA. The Secretary is entitled to take into
account the attestation for the purposes of deciding whether the medicine
satisfies the criterion relating to acceptable manufacturing
standards.
Item 14 has the same effect as Item 12. Item 14
inserts a new subparagraph 26(2)(a)(ia) into the Act. Where an application is
lodged to list in the Register listable therapeutic devices, and the devices
have been manufactured in a country that is covered by a non EC/EFTA MRA, new
subparagraph 26(2)(a)(ia) will enable the Secretary to accept attestations of
conformity issued by a Conformity Assessment Body designated as such under that
non EC/EFTA MRA for that country. The Conformity Assessment body must also have
been approved in writing by the Secretary to be a conformity assessment body for
that non EC/EFTA MRA. The attestation of conformity is an attestation that the
therapeutic device which is the subject of a s.26 application under the Act has
been manufactured to an acceptable standard. The attestation can only be made
in relation to that step of manufacture that occurred in the country covered by
the non EC/EFTA MRA. The Secretary is entitled to take into account the
attestation for the purposes of deciding whether the device satisfies the
criterion relating to acceptable manufacturing standards.
Item 16
also has the same effect as Item 12. Item 16 inserts a new paragraph
26A(4)(a)(ia) into the Act. Where an application is lodged to include listable
medicines in the Register under s.26A of the Act, and the medicine is
manufactured in a country that is covered by a non EC/EFTA MRA, new paragraph
26A(4)(a)(ia) will enable the Secretary, in deciding whether to certify that the
manufacturing and quality control procedures used in the manufacture of that
medicine is acceptable, to take into account whether the applicant has provided
a non EC/EFTA MRA attestation of conformity for the step of manufacture
undertaken in the country covered by that non EC/EFTA MRA.
Items 13
and 15 make consequential changes to remove references, in paragraphs
25B(1)(b) and 26AA(1)(b) of the Act, to a “conformity assessment
certificate” and replace these with “an EC/EFTA attestation of
conformity”. These changes reflect the amendments made by Items 3, 4 and
5 of Schedule 1, which repeal the definition for “conformity assessment
certificate” to replace it with “EC/EFTA attestation of
conformity”. The term “conformity assessment certificate”,
which will be a certificate issued under a proposed provision proposed for
insertion in the Act, will only apply in relation to new Chapter 4 of the Act
when this is inserted into the Act.
Item 11 adds a new subsection
24D(6) into the Act, to clarify when the Secretary may recover from an applicant
the balance of evaluation fees that are still outstanding. Currently, an
applicant seeking to include registrable medicines in the Register is only
required to pay ¾ of the evaluation fees before the application is
processed and evaluated. The balance of the evaluation fees payable is due
following the completion of the evaluation within the timeframe prescribed in
the Therapeutic Goods Regulations. Currently, “completion” is taken
to have occurred when an applicant has been notified of the Secretary’s
decision on the application under subsection 25(3) of the Act.
The
evaluation process adopted for the evaluation of registrable medicines involves
the preparation of evaluation reports well before the applicant is notified of a
decision. The contents of these reports, including the recommendations of an
expert committee that advises the Secretary on matters that include applications
to register medicines in the Register, are made known to the applicant. This
process keeps the applicant informed of the progress of its application and
affords an opportunity for the applicant to make any additional submissions.
However, where evaluation reports have been prepared and its contents notified
to the applicant, the applicant could withdraw its application at that point,
before the Secretary makes a decision based on the evaluation reports and the
recommendations of an expert committee. This usually occurs where the reports
themselves, or the recommendations of an expert committee, indicate a possible
unfavourable outcome for the applicant. To enable the Secretary to still
recover the evaluation fees for the evaluation reports prepared in the event the
applicant does withdraw before being notified of the Secretary’s decision
on the application, the amendment effected by Item 11 will enable the Secretary
to recover the balance of any outstanding prescribed evaluation fees owing by
the applicant for its application.
Item 17 inserts a requirement
for an applicant for a manufacturing licence to provide certain information.
Where the applicant proposes to carry out any steps in the manufacture of blood
or blood components and applies for a licence to do so, the application must
contain information relating to any of those steps that may be prescribed in the
regulations
Item 18 inserts a new condition that applies to a
licence issued to a licensee who carries out, or proposes to carry out, any step
of manufacture of blood or blood components, and the regulations prescribe
information that may be required that relates to those steps of manufacture.
Where the Secretary requests the information about the steps of manufacture
prescribed in the regulations, it is a condition of the licence that the
licensee supplies that information to the Secretary.
Item 19
clarifies the application of 3 amendments made by Items 11, 17 and 18. The
amendment made to s.24D will apply to all applications made on or after the
amendment comes into force
The amendment to s.37 of the Act will apply
to all applications for licences made on or after the amendment comes into
force.
The amendment to subsection 40(4) of the Act applies in relation
to a request that is made under paragraph 40(4)(a) after Item 18 commences, and
the request may be made in relation to any licence, including licenses that were
granted before the commencement of Item 18.
Item 20 is a
transitional provision, and has the effect of preserving conformity assessment
bodies that were approved as an “approved conformity assessment
body” before the commencement of the Health Legislation Amendment Act
(No.3) 2001 by deeming those approvals to be approvals for the purposes of
the definition of EC/EFTA attestation of conformity when that definition
comes into force.
Therapeutic Goods Amendment (Medical Devices)
Act 2001
Item 21 purports to amend the proposed
Therapeutic Goods Amendment (Medical Devices) Act 2001 in the event that
Act comes into operation after the Health Legislation Amendment Act (No.3)
2001 commences to operate. If not, this Item will not have any effect.
The item will amend the definition of “conformity assessment
certificate” so that such a certificate is one that is issued under new
section 41EE, inserted into the Act by the Therapeutic Goods Amendment
(Medical Devices) Act 2001 when it comes into operation.
The item amends the definition of “disqualified practitioner’
in subsection 19D(11) to add practitioners who become fully disqualified in
accordance with sections 92 and 105 and paragraph 106U(1)(h) and for the
purposes of section 106ZPM.
The item substitutes new subsections 23D(2) and 23D(3).
New
subsection 23D(2) provides for the Minister’s determination to take effect
28 days after notification of the determination was served on the person. (This
period was that effective under the repealed arrangements).
New
subsection 23D(3) provides that new subsection 23D(2) operates subject to any
order by the Administrative Appeals Tribunal or by a court in relation to an
application for review of a determination by the Minister made under new section
23DAA.
The conduct that may be investigated is that relevant to the definition
of “inappropriate practice” contained in section 82 of the Act.
New subsection 89(3) provides that to avoid doubt the Director may
consider the conduct of a person in deciding whether to set up a committee to
consider whether the person had engaged in inappropriate practice in connection
with rendering or initiating referred services.
New subsection 89(4)
restricts the conduct that may be considered to the extent that it is in
connection with the rendering or initiating of referred services.
New
subsection 89(5) enables the Director to consider the conduct whether or not it
was mentioned in any reasons given by the Health Insurance Commission in the
investigative referral under section 86(4)(b) or during any prior counselling of
the person under review.
New subsection 89(6) specifies those whose
conduct may be investigated for the purposes of new subsection 89(3). The
conduct is that of the person under review, a practitioner employed by the
person under review or a practitioner employed by a body corporate of which the
person under review is an officer.
Inserts new subsection 93(1A) the intention of which is to avoid doubt
that the instrument making the adjudicative referral (in accordance with
subsection 93(1)) need not specify the conduct of the person under review.
Although the Director’s report which, in accordance with existing
subsection 93(6), must be attached to the instrument making the adjudicative
referral must give reasons for that referral, it is not intended that these
reasons in any way limit the conduct which the Committee may consider. (The
amendment made by this Item is related to those contained in Items 9, 12 to 16,
19, 20 and subitem 30(1)).
New section 104 specifies the consequences of a person under review
failing to appear, give evidence or answer questions when required at a
Committee hearing.
New subsection 104(1) provides that new section 104
has effect if the notice of hearing under new subsection 102(4) (Item 17)
requires the person under review to attend and give evidence at a Committee
hearing and the person under review fails to appear or appears at the hearing
but refuses or fails to give evidence or answer questions.
Under new
subsection 104(2) the Committee may notify the Director if a practitioner fails
to attend a hearing or appears but refuses or fails to give evidence or answer
questions. (At present it is mandatory for the Chairperson of a Committee to
notify the Director in these circumstances following which the Director of PSR
must disqualify the person under review). The amendment enables the Committee,
in deciding whether to notify the Director of PSR, to take into account factors
beyond the person under review’s control, for example, a motor accident on
the way to the hearing or the death of a close family member around the time of
the hearing.
New subsection 104(3) provides the Committee with an option
to proceed with the hearing or to propose to hold another hearing in accordance
with section 102.
New subsection 104(4) provides that if the person under
review subsequently appears, gives evidence and answers questions at a Committee
hearing, then the Committee must advise the Director accordingly and the rights
accorded to the person under review by section 103 are reinstated.
New
subsection 104(5) specifies that the Committee may not notify the Director of a
person’s failure to appear or refuse to give evidence or answer questions
at a Committee hearing or may not proceed with the hearing if the person under
review notifies the Committee that he or she has a medical condition and if the
person has complied with any reasonable requirements of the Committee regarding
medical examinations which confirm the medical condition. The circumstances
applying under new subsection 104(5) preclude the application of new subsections
104(2) and (3).
Under new subsection 104(6) the requirements that the
Committee notify the Director of the person’s failure to attend, give
evidence or answer questions at a Committee hearing and the exercise of the
option by the Committee to hold another hearing do not apply if both the person
under review and the Committee believe that answering a question might tend to
be self-incriminating for the person under review.
New section 105
provides for disqualification of a person under review for failing to appear,
give evidence as required or to answer every question when required at a
Committee hearing.
New subsection 105(1) provides that, if upon receipt
of a notice from the Committee under new subsection 104(2) the person under
review (who is a practitioner) has failed to appear, give evidence or has
refused to answer questions at a Committee hearing, then the Director must fully
disqualify the person from Medicare and advise the Commission.
Under new
subsection 105(2) the Director must revoke the disqualification and advise the
Commission of the revocation as soon as practicable after the Director is
informed by the Committee under new paragraph subsection 104(4)(e) that the
person has appeared, given evidence and answered questions.
New
subsection 105(3) provides that a disqualified person may request the Committee,
in writing, to hold another hearing under section 102 and the Committee must
comply with the request as soon as practicable.
Under new subsection
105(4) a request by a disqualified person under new subsection 105(3) to hold
another hearing must be made no later than 21 days after the day on which a copy
of the Committee’s draft report is given to the person under subsection
106KD(3).
New subsection 106H(1A) provides that to avoid doubt the Committee may
consider the conduct of a person in making its findings as to whether the
person had engaged in inappropriate practice in connection with the rendering or
initiating of some or all of the specified services.
New subsection
106H(1B) restricts the conduct which may be considered to the extent that it is
in connection with the rendering or initiating of specified services.
New
subsection 106H(1C) enables the Committee in making its findings to consider the
conduct whether or not it was mentioned in any reasons given by the Health
Insurance Commission in the investigative referral under paragraph 86(4)(b), in
reasons given by the Director of PSR in the report under paragraph 93(6)(a) or
during any prior counselling of the person under review.
New subsection
106H(1D) specifies those whose conduct may be investigated for the purposes of
new subsection 106H(1A). The conduct is that of the person under review, a
practitioner employed by the person under review or a practitioner employed by a
body corporate of which the person under review is an officer.
Item 23 inserts new section 106SA, the purpose of which is to
provide that the Director may give the Determining Authority information.
Examples of information which might be relevant are the nature and circumstances
of any previous conduct of the person that has resulted in a criminal conviction
or disciplinary action (by a registering or licensing body), responses to any
counselling, ratification of a section 92 agreement, a final determination that
has taken effect, and any particular needs of the locality in which the person
under review practices.
New subsection 106SA(1) provides that the
Director may give to the Determining Authority any information the Director
considers relevant to the authority making a draft or final determination in
accordance section 106U.
New subsection 106SA(2) provides that the
information must be given by the Director no later than the day on which the
Committee’s final report is given to the Determining Authority under
subsection 124L(4). The effect of this provision is that the Determining
Authority will consider the information given by the Director at the same time
that it has available the Committee’s final report.
Under new
subsection 106SA(3) the Director must also give to the person under review the
information given to the Determining Authority at the time it is provided to the
Determining Authority.
New subsection 106SA(4) provides that the
Determining Authority must consider the information given by the Director in
making its draft or final determination in accordance with section 106U.
New subsection 106ZPM(2) provides that, where the Director considers that
subsection 106ZPM(1) applies to stop payment of a medicare benefit, the Director
must give such a notice to the person.
New subsection 106ZPM(3) provides
that the Director must give a copy of the notice to the HIC.
Under new
subsection 106ZPM(4) the person is to be taken to be fully disqualified for the
purposes of section 19D if subsection 106ZPM(1) prevents the payment of a
medicare benefit and the Director has given a notice under new subsection
106ZPM(2).
Item 29 - Application
Subitem (1) provides that the
amendment made to subsection 19D(11) by Item 1 applies to a person who becomes
disqualified under the PSR arrangements on or after the commencement of that
Item under section 92, section 105 and paragraph 106U(1)(h) or for the purposes
of section 106ZPM.
Subitem (2) provides that the amendments made by Items
4 and 5 to section 23D and the addition of new section 23DAA apply to
determinations made by the Minister after the commencement of item 63 of
Schedule 1 to the Health Insurance Amendment (Professional Services Review)
Act 1999 at which time the removal of the previous right of appeal to
a PSR Tribunal became effective.
Subitem (3) applies the
provisions of section 23D as amended by Item 4 to determinations made by the
Minister after the commencement of item 63 of the Health Insurance Amendment
(Professional Services Review) Act 1999 and before the commencement of this
subitem.
Subitem (4) provides that the amendments made by Items 17 and 18
to sections 102, 104 and 105 apply in relation to hearings held by Committees
set up after the commencement of those items.
Subitem (5) provides that
the amendment made by Items 24 and 25 to section 106ZPM applies in respect of
notices under subsections 89B(2) and 105A(2) if the notices were given in
relation to an investigative referral made, or a Committee set up, on or after
the commencement of that Item.
Subitem (2) provides that the Director may give information to the
Determining Authority under the amendments made by Item 23 inserting new section
106SA on or after their commencement, in respect of a Committee’s final
report which was prepared before the amendments commence.
HEALTH
INSURANCE AMENDMENT (PROFESSIONAL SERVICES REVIEW) ACT
1999
Items 31, 32 and 33 amend the transitional provisions
contained in Part 2 of Schedule 1 of the Health Insurance Amendment
(Professional Services Review) Act 1999 (the Amendment Act) to clarify the
original intention of those provisions.
The amending Act enhanced the
Committee’s powers in relation to the production of documents in new
section 105A. Although the Amendment Act generally does not apply to matters
referred by the Health Insurance Commission to the Director before its
commencement on 1 August 1999, an exception was made in respect of new section
105A and the related sanctions contained in new sections 106ZPM and 106ZPN. The
Explanatory Memorandum to the Amendment Act indicated that the purpose of the
amendment was to allow a Committee, in considering an ‘old matter’
to have all the powers and sanctions available to it to obtain documents or
information under section 105A. However, item 67(3) of the Amendment Act does
not give effect to this policy intent. These amendments address this technical
defect and ensure the implementation of the original policy intent.
Item
31 amends item 65 of the Amendment Act by inserting a reference to new subitem
67(3A). This is consequential upon the amendment made by item 33.
Item
32 amends subitem 67(3) of the Amendment Act to provide that section 105A, in
force prior to the amendments made by Item 43 of the Amendment Act, ceases to
apply to an ‘old matter’ on or after the commencement of Schedule 2
to the Health Legislation Amendment Act (No. 3) 2001.
Item
33 amends subitem 67 of Schedule 1 of the Amendment Act by inserting new
subsection (3A). Under new paragraphs (3A)(a) and (b) a Committee may exercise
the powers conferred by section 105A concerning the production of documents or
the giving of information in relation to an ‘old matter’.
Item 34 amends Item 68 of the Amendment Act, by inserting a
definition to clarify the commencement of Schedule 1. The definition clarifies
the commencement date for all Items in Schedule 1 (other than Items 8 and 27
relating to medical records) as being 1 August 1999.
SCHEDULE
3 – NUMBER OF COMMISSIONERS OF HEALTH INSURANCE COMMISSION
Item 1 substitutes a reference to “7”
Commissioners under paragraph 10(1)(c) of the Health Insurance Commission Act
1973, for the reference to “5” such Commissioners in Item 81 of
Schedule 1 to the Health Insurance Commission (Reform and Separation of
Functions) Act 1997. Item 81 of the latter Act commences 5 years after
Royal Assent to that Act. When Item 81 commences on 11 November 2002, the Item
1 amendment means that Commission will then comprise the Chairperson, the
Managing Director and 7 paragraph 10(1)(c) Commissioners.
Schedule 4 makes some minor technical amendments to subsection 23D(3) and
section 23DAA of the Health Insurance Act 1973 (inserted by items 4 and 5
of Schedule 2) which are consequential upon changes to the administrative law
arrangements made by the ART Act.
Item 1 repeals subsection 67(7) of the National Health Act
1953. This subsection provides that the Minister for Health and Aged Care
must not make a determination in relation to employee health benefits schemes
where the scheme is the subject of an agreement to which Part V1B of the
Industrial Relations Act 1988 applies. The amendment will have the
effect of removing that anachronism and allowing employers to contribute towards
health expenses of employees subject to such an agreement.
Item 2
will allow health funds to offer discounts where contributors pay three months
or more in advance, rather than the current minimum period of six
months.
Item 1 corrects a reference in the Health Insurance Act
1973.