Commonwealth of Australia Explanatory Memoranda

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PRIVATE HEALTH INSURANCE (NATIONAL JOINT REPLACEMENT REGISTER LEVY) BILL 2009





                                  2008-2009



               THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA




                          HOUSE OF REPRESENTATIVES











  PRIVATE HEALTH INSURANCE (NATIONAL JOINT REPLACEMENT REGISTER LEVY) BILL
                                    2009





                           EXPLANATORY MEMORANDUM














       (Circulated by authority of the Minister for Health and Ageing,
                       the Honourable Nicola Roxon MP)
  PRIVATE HEALTH INSURANCE (NATIONAL JOINT REPLACEMENT REGISTER LEVY) BILL
                                    2009

OUTLINE

This Bill creates a new Act, the Private Health Insurance (National Joint
Replacement Register Levy) Act 2009, for the purpose of establishing the
National Joint Replacement Register Levy, for funding the National Joint
Replacement Registry (NJRR).

The NJRR, which was established by the Australian Orthopaedic Association
in 1998, collects data on the implantation of prosthetic joint replacement
devices and reports revision rates, complications and other outcomes.  The
NJRR also monitors mortality rates.  Its purpose is to define, improve and
maintain the quality of care of patients receiving joint replacement
surgery.  The information collected provides an accurate measure of the
success or otherwise of a procedure.  This information is then used to
inform surgeons, other health care professionals, governments, sponsors of
joint replacement products and patients.

The NJRR provides post-market surveillance of joint replacement prostheses,
and this monitoring of the safety and quality of devices provides
considerable benefit to the industry by improving consumer confidence in
the safety and efficacy of joint replacement devices. Any devices showing
high failure rates can be identified quickly and promptly removed from the
market.

The data produced by the Registry also assists the industry by informing
the development of new prostheses, allowing manufacturers to draw on
reliable performance information for existing products and designs.

The cost recovery arrangements contained in the Bill will ensure continuing
funding for the Registry, while preserving the independence of the
Registry. As levies will be imposed under legislation, and collected by the
Government on behalf of the Registry, there will be no possibility of
funding being withdrawn from the Registry by medical devices sponsors.

Sections 1 and 2 of the Bill will commence on the day on which the Act
receives Royal Assent.  Sections 3 to 9 of the Bill will commence on 1 July
2009 or on the date of Royal Assent, whichever occurs later.

The Bill will enable the costs of operating the NJRR to be recovered by
means of a levy imposed on each joint replacement prostheses sponsor, on
each day specified in the Private Health Insurance (National Joint
Replacement Register Levy) Rules as a national joint replacement register
levy day, and on each day (if any) determined by the Minister for Health
and Ageing, by legislative instrument, as a supplementary national joint
replacement register levy day.  There can be no more than four levy days in
a financial year and the Minister cannot specify more than two
supplementary levy days in a financial year.

A person is a joint replacement prostheses sponsor if a joint replacement
prostheses is currently listed in the Private Health Insurance (Prostheses)
Rules (commonly referred to as the Commonwealth Prostheses List) either as
a result of an application made by the person under subsection 72-10(2) of
the Private Health Insurance Act 2007, or is listed in accordance with
section 12 of the Private Health Insurance (Transitional Provisions and
Consequential Amendments) Act 2007 and the person was the sponsor of that
prosthesis for the purposes of the National Health Act 1953.

Sponsors will be levied according to the number of joint replacement
prostheses they sponsor, and the levies will be used to fund the operating
costs of the Registry.  The Bill provides that there may be different rates
set for different kinds of joint replacement prostheses, that the rate may
be set at zero, and that there will be a maximum rate of $5,000.

There is a wide range of prosthetic devices used in joint replacement
surgery.  These correspond with a great variation in benefits for different
kinds of joint replacement prostheses listed on the Commonwealth Prostheses
List. Benefits for some joint replacement prosthetic devices are set at
less than $50.00, while others receive benefits as high as $67,000 per
product.  The Private Health Insurance (National Joint Replacement Register
Levy) Rules may specify that different kinds of joint replacement
prostheses may have different levies.  Given the variation in benefits for
different kinds of joint replacement prostheses, a maximum rate of levy of
$5,000 for a financial year is considered reasonable.

Financial Impact Statement

The costs of the NJRR have been funded by the Commonwealth since 1998.  The
introduction of cost recovery arrangements will result in estimated budget
savings of $5 million over four years.
  PRIVATE HEALTH INSURANCE (NATIONAL JOINT REPLACEMENT REGISTER LEVY) BILL
                                    2009

NOTES ON CLAUSES

Clause 1 - Short Title
This clause provides that the Bill, once enacted, may be cited as the
Private Health Insurance (National Joint Replacement Register Levy) Act
2009.

Clause 2 - Commencement
This clause provides that Sections 1 and 2 of the Bill will commence on the
day on which the Act receives Royal Assent.  Sections 3 to 9 of the Bill,
once enacted, will commence on 1 July 2009 or on the date of Royal Assent,
whichever occurs first.

Clause 3 - Crown to be bound
This clause provides that the Bill binds the Crown in each of its
capacities. This means that the Crown, including the executive government
of the Commonwealth, States and Territories, is not immune from the
operation of the Bill, once enacted.

Clause 4 - Extension of Act to external Territories
This clause states that the Bill extends in its application to the
Territory of Cocos (Keeling) Islands and to the Territory of Christmas
Island.

Clause 5 - Definitions
This clause defines the terms used in the Bill.  In particular, a person is
a sponsor for joint replacement prostheses if a joint replacement
prosthesis is currently listed in the Private Health Insurance (Prostheses)
Rules (commonly referred to as the Commonwealth Prostheses List) either as
a result of an application made by the person under subsection 72-10(2) of
the Private Health Insurance Act 2007, or is listed in accordance with
section 12 of the Private Health Insurance (Transitional Provisions and
Consequential Amendments) Act 2007 and the person was the sponsor of that
prosthesis for the purposes of the National Health Act 1953.

Subclause (3) provides that the Private Health Insurance (National Joint
Replacement Register Levy) Rules (clause 9 refers) may be used for the
purpose of further defining a joint replacement prosthesis.  This is to
provide flexibility.

Clause 6 - Imposition of national joint replacement register levy
This clause sets out when the national joint replacement register levy is
imposed on each sponsor for joint replacement prostheses.

Subclause (1) provides that the levy is imposed on:
    . each day specified in the Private Health Insurance (National Joint
      Replacement Register Levy) Rules (the Rules) as a national joint
      replacement register levy day for a financial year; and
    . each day (if any) determined by the Minister, by legislative
      instrument, as a supplementary national joint replacement register
      levy day for a financial year.

Subclause (2) provides that the Rules must not specify more than 4 levy
days for a financial year.

Subclause (3) provides that the determination by the Minister must not
specify more than 2 supplementary levy days for a financial year.

Clause 7 - Rate of national joint replacement register levy
This clause sets out how the rate of national joint replacement register
levy is to be determined.

Subclause (1) This clause sets out that the rate of levy imposed on a
national joint replacement register levy day is the rate specified in the
Rules and applies on that day, and that the rate of levy imposed on a
supplementary national joint replacement register levy day is the rate that
is determined by the Minister and applies on that day.

Subclause (2) provides that the rate must be based on the number of joint
replacement prostheses that each sponsor has listed on the Prostheses List
on the national joint replacement register census day or supplementary
national joint replacement register census day. The rate may differ for the
different kinds of joint replacement prostheses sponsored. The rate may be
set at zero for one or more kinds of joint replacement prostheses, and the
maximum rate must not exceed $5,000.00 for a financial year with respect to
any one joint replacement prosthesis sponsored.

Clause 8 - Private Health Insurance (National Joint Replacement Register
Levy) Rules
This clause provides for the Minister to make Private Health Insurance
(National Joint Replacement Register Levy) Rules providing for matters
required or permitted by the Bill to be provided, or necessary or
convenient to be provided in order to carry out or give effect to the Bill.

As described in clause 5, the Rules may provide that one or more kinds of
prostheses are taken, or are taken not, to be joint replacement prostheses
for the purposes of the definition of joint replacement prosthesis.

Clause 9 - Regulations
This clause provides that the Governor-General may make regulations
prescribing matters required or permitted by the Bill to be prescribed, or
necessary or convenient to be prescribed in order to carry out or give
effect to the Bill.




 


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