National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 2) (No. PB 18 of 2012)

Link to law: https://www.comlaw.gov.au/Details/F2012L00721

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PB 18 of 2012
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 2)
 
National Health Act 1953
___________________________________________________________________________
 
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated                                               27      March 2012
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
___________________________________________________________________
 
 
 
 
 
1              Name of Instrument
 
(1)                This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 2).
 
(2)                This Instrument may also be cited as PB 18 of 2012.
 
2             Commencement
                This Instrument commences on 1 April 2012.
3              Amendments to PB 79 of 2011
                      Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
 
 
Schedule 1                   Amendments
 
[1]    Definitions, after distribution fee         
omit definition of dose and substitute:
 
dose, for a chemotherapy drug, means the quantity of the drug contained in an infusion, including unit of use, such as international units, grams, micrograms, or milligrams.
 
[2]    Definitions, after supplier
insert:
 
under co-payment data means information in relation to the supply under this Special Arrangement of:
(a)    an infusion by an approved pharmacist, approved medical practitioner, approved hospital authority, or HSD hospital authority; or
(b)    a related pharmaceutical benefit by a participating hospital authority;
where a claim is not payable as the dispensed price for the supply under this Special Arrangement does not exceed the amount that the supplier was entitled to charge under subsection 54(2) or 55(2) for supply of an infusion, or under subsection 57(2) for supply of a related pharmaceutical benefit.
Note: The definition of under co-payment data does not apply to a non-approved hospital authority.
 
[3]    After section 35
omit:
 
Part 4                     Claims and payment
 
Division 1             Claims for payment
 
and substitute
 
Part 4                               Claims, payment and provision of under co-payment data
 
Division 1             Claims for payment and provision of under co-payment data
 
 
 
 
 
[4]    After subsection 36(2)
omit section 37 and substitute
 
37                  Modified references for claim and provision of under co-payment data
 
(1)     The rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act apply to a claim or provision of under co-payment data as follows:
(a)         a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority;
(b)        a reference to a number allotted to an approval under regulation 8A of the Regulations includes a reference to a number allotted to an approval under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 for a HSD hospital authority; and
(c)         the definition of under co-payment data in section 4 of this Special Arrangement replaces the definition of under co-payment data appearing in the rules made under subsection 98AC(4) of the Act.
 
[5]    After section 38
omit section 39 and substitute:
 
39              Modified requirements for supply of infusion
 
For a claim or provision of under co-payment data for supply of an infusion, the requirements in the rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act are modified as follows:
(a)    a reference to a pharmaceutical benefit includes a reference to an infusion;
(b)    a reference to an authority prescription in the rules includes a reference to an authority prescription within the meaning given by section 3 of this Special Arrangement;
(c)    the claim or provision of under co-payment data must include:
(i)        a drug code for each chemotherapy drug in the infusion, being the code for the drug published in the Schedule of Pharmaceutical Benefits published by the Department; and
(ii)      the dose of each chemotherapy drug in the infusion; and
(iii)    for a claim submitted on or after 1 April 2012 – the authority prescription number or Streamlined Authority Code in relation to each circumstance, if any, for which authorisation of the prescription or medication chart is required;
(d)    the supplier is not required to include in the claim or provision of under co-payment data:
(i)    the PBS/RPBS Item Code for the supplied pharmaceutical benefit;
(ii)   the brand of the supplied pharmaceutical item;
(iii) whether or not regulation 24 applies; or
(iv)  whether or not immediate supply was necessary.
Note: Section 34 of this Special Arrangement provides that regulation 24, subregulations 25(2) to (4), and subsection 84AAA(1) (early supply) do not apply to the supply of an infusion under this Special Arrangement.
 
[6]    Schedule 1 Part 1, entry for Bleomycin
substitute:
Bleomycin
Powder for injection containing bleomycin sulfate 15,000 I.U.
Injection
Bleo 15K
WQ
MP
C1139 C1198
D

 
 
 
Hospira Pty Limited
HH
MP
C1139 C1198
D

 
[7]    Schedule 1 Part 1, entry for Bortezomib
Insert in the column headed ‘Section 100 only’:
D
 
[8]    Schedule 1 Part 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial with manner of administration Injection/intravesical and brand Adriamycin Solution
substitute:
Doxorubicin
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial
Injection/ intravesical
Accord Doxorubicin
WQ
MP
 
D

 
 
 
Adriamycin Solution
PF
MP
 
D

 
[9]    Schedule 1 Part 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial with manner of administration Injection/intravesical and brand Adriamycin
substitute:
 
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
Injection/ intravesical
Accord Doxorubicin
WQ
MP
 
D

 
 
 
Adriamycin
PF
MP
 
D

 
[10]  Schedule 1 Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL with manner of administration Injection/intravesical and brand Epirubicin Actavis 10
substitute:
Epirubicin
Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL
Injection/ intravesical
Epiccord
WQ
MP
 
D

 
 
 
Epirubicin Actavis 10
TA
MP
 
D

 
 
 
[11]  Schedule 1 Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL with manner of administration Injection/intravesical and brand Epirubicin Actavis 20
substitute:
 
Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL
Injection/ intravesical
Epiccord
WQ
MP
 
D

 
 
 
Epirubicin Actavis 20
TA
MP
 
D

 
[12]  Schedule 1 Part 1, after entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL with manner of administration Injection/intravesical and brand DBL Epirubicin Hydrochloride Injection
insert in the columns in the order indicated:
 
 
 
Epiccord
WQ
MP
 
D
 
[13]  Schedule 1 Part 1, after entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL with manner of administration Injection/intravesical and brand Epirubicin Ebewe
insert in the columns in the order indicated:
 
 
 
Epirubicin Kabi
PK
MP
 
D
 
[14]  Schedule 1 Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL with manner of administration Injection/intravesical and brand Epirubicin Actavis 50
substitute:
 
Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
Injection/ intravesical
Epiccord
WQ
MP
 
D

 
 
 
Epirubicin Actavis 50
TA
MP
 
D

 
[15]  Schedule 1 Part 1, after entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL with manner of administration Injection/intravesical and brand Epirubicin Ebewe
insert in the columns in the order indicated:
 
 
 
Epirubicin Kabi
PK
MP
 
D
 
[16]  Schedule 1 Part 1, after entry for Methotrexate in the form Injection 50 mg in 2 mL vial with manner of administration Injection and brand Hospira Pty Limited
insert in the columns in the order indicated:
 
 
 
Methaccord
WQ
MP
 
 
 
 
[17]  Schedule 1 Part 1, after entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial with manner of administration Injection and brand Hospira Pty Limited
insert in the columns in the order indicated:
 
 
 
Methaccord
WQ
MP
 
PB
 
[18]  Schedule 5, entry for Bleomycin, in the column headed ‘Approved Ex‑manufacturer Price’
omit:
$40.89
substitute:
$34.35
 
[19]  Schedule 5, entry for Bleomycin, in the column headed ‘Claimed Ex‑manufacturer Price’
omit:
$77.67
substitute:
$65.24
 
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 
See http://www.frli.gov.au.