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Determinations/Health as made
This Determination is to enable the payment of Medicare benefits for the medical procedure to inject poly-L-lactic acid (Sculptra®) for the treatment of severe facial lipoatrophy caused by antiretroviral therapy in HIV positive patients.
Administered by: Health
Registered 06 Jun 2011
Tabling HistoryDate
Tabled HR14-Jun-2011
Tabled Senate15-Jun-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014
Table of contents.

 

 

 

 

Health Insurance (Facial Injections of
Poly-L-lactic acid) Determination 2011

__________________________________________________________________

I, NICOLA ROXON, Minister for Health and Ageing, make this Determination under subsection 3C (1) of the Health Insurance Act 1973.

 

 

Dated   1 June 2011

 

 

 


NICOLA ROXON

MINISTER FOR HEALTH AND AGEING

 

 

 


Contents

 

1.           Name of Determination                                                                           3

2.           Commencement and Cessation                                                               3

3.           Interpretation                                                                                          3

4.           Treatment of a relevant service                                                                3

 

Schedule             Specified Health Service                                                            5

 


1.               Name of Determination

This Determination is the Health Insurance (Facial Injections of
Poly-L-lactic acid) Determination 2011.

2.               Commencement and term

This Determination commences [FI1] on 1 July 2011 and shall remain in force until midnight 31 October 2011.

3.               Interpretation

(1)      In this Determination:

Act means the Health Insurance Act 1973.

accredited injector [FI2] means a medical practitioner with accreditation following completion of injection administration training with Sanofi-Aventis .

Note      Sanofi-Aventis is the responsible person, within the meaning of the National Health Act 1953,  for poly-L-lactic acid branded as Sculptra

relevant provisions means[FI3]  all provisions, relating to professional services or medical services, of:

                        (a) the Act and regulations made under the Act; and

          (b) the National Health Act 1953 and regulations made under that Act

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

Schedule means the Schedule to this Determination.

Note      Unless the contrary intention appears, expressions used in this Determination have the same meanings as in the Act—see section 13 of the Legislative Instruments Act 2003.

(2)      Unless the contrary intention appears, a reference in this Determination to a provision of the Act or the National Health Act 1953 or regulations made under the Act or under the National Health Act 1953 as applied, adopted or incorporated in relation to specifying a matter is a reference to those provisions as in force from time to time and any other reference to provisions of an Act or regulations is a reference to those provisions as in force from time to time.

4.               Treatment of a relevant service

A relevant service provided in accordance with this Determination is to be treated, for the relevant provisions, as if

(a)            it were both a professional service and a medical service[FI4] ; and

(b)            there were an item in the general medical services table that

                                                   i.          related to the service; and

                                                 ii.          specified for the service a fee in relation to each State, being the fee specified in the Schedule in relation to the service.

5.               Application[FI5]  of items 14201 and 14202

Items 14201 and 14202 only apply where the service is rendered by an accredited injector.

6.               Limitations[FI6]  on item 14202

Where the service described in item 14202 has been provided to a patient on 4 occasions – item 14202 only applies to any subsequent services once every 2 years from the date of the last service.

 


Schedule                   Specified Health Service

 

Item

Health Service

Fee for all States

14201

POLY-L-LACTIC ACID, one or more injections of, for the initial session only, for the treatment of severe facial lipoatrophy caused by antiretroviral therapy, when prescribed in accordance with the National Health Act 1953 - once per patient [FI7] 

$227.90

14202

POLY-L-LACTIC ACID, one or more injections of (subsequent sessions), for the continuation of treatment of severe facial lipoatrophy caused by antiretroviral therapy, when prescribed in accordance with the National Health Act 1953

$115.35

Note:   Section 3C(7) of the Act deems an internal territory to form part of the State of New South Wales.

 


 [FI1]This wording is used if the 3C is to operate retrospectively, If the 3C will not operate retrospectively then suggest replacing phrase with ‘…commences’

 [FI2]I note this definition is not used elsewhere to in the 3C, I have suggested a new rule at s 5 which incorporates this definition.

I note that the definition is limited to medical practitioners. I am not sure if other health practitioners can undertake the injection administration training. If they can, this definition will limit it to MPs. I am assuming this is your policy.

 [FI3]Drafting suggestion for clarity and consistency with other 3C determinations.

 [FI4]Not required because of definition of relevant provisions

 [FI5]This section is to make clear that the injecting service can only performed by an accredited injector (as defined).

 [FI6]Your covering email notes that the second item is for up to a maximum of four adjustment treatments, followed by one maintenance injection session every two years.

 

I have suggested this additional section to set out those limitations for item 14202.

 

The PB instrument does not specifically provide for these restrictions, I understand that these restrictions are imposed by the fact that the prescriptions require authorisation from medicare.

 

You will need to check with Medicare that the reckoning of 2 years from the date of the last service is how its systems have been designed.

 [FI7]I have amended to make it clear that it is once per patient, as otherwise it could be taken to mean that a patient could see multiple practitioners, but only once. I note that this might not be practically possible given limitations in the PB instrument.

 

I have also referred to the acid being prescribed under the National Health Act to pick up all instruments under that Act. I have not specifically referred to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 as if that instrument is revoked the item descriptor would technically not work.