Federal Register of Legislation - Australian Government

Primary content

PB 31 of 2021 Arrangements as made
This instrument provides for the continued operation of the Paraplegic and Quadriplegic Program which assists people with paraplegia and quadriplegia to access bowel management medicines free of charge, and repeals the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (No. PB 118 of 2010).
Administered by: Health and Aged Care
Registered 15 Mar 2021
Tabling HistoryDate
Tabled HR16-Mar-2021
Tabled Senate17-Mar-2021
Table of contents.

Commonwealth Coat of Arms of Australia

 

National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021

I, Elizabeth Flynn, Assistant Secretary, Department of Health, delegate of the Minister for Health and Aged Care, make this Special Arrangement under section 100 of the National Health Act 1953.

Dated   12 March 2021                                   

 

 

Elizabeth Flynn

Assistant Secretary

Office of Health Technology Assessment Policy

Department of Health

 

 

 

 


Contents

Part 1—Preliminary  2

1  Name    2

2  Commencement 2

3  Authority    2

4  Definitions  2

5  Pharmaceutical benefits covered by this Special Arrangement 3

6  Application of Part VII of the Act 3

7  Responsible person  3

8  No prescriber or prescription  4

Part 2—Supply for the paraplegic and quadriplegic program   4

9  Paraplegic and quadriplegic associations  4

10  Eligible persons  5

11  Maximum amount 5

12  Supply    5

13  Co‑payment etc. not to be made  6

14  Payment from Commonwealth  6

15  Charge for delivery  7

16  Claims for payment 7

17  Stock of pharmaceutical benefits etc. 7

18  Internal review of decisions  8

19  Application of this Special Arrangement 8

Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information  9

Schedule 2—Responsible Person Codes  10

Schedule 3—Repeals  11

National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010  11

 

 


 

 

Part 1—Preliminary

Name

(1)  This Special Arrangement is the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021.

          (2)  This Special Arrangement may also be cited as PB 31 of 2021.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after this instrument is registered.

 

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This Special Arrangement is made under section 100 of the National Health Act 1953.

4  Definitions

                   In this Special Arrangement:

ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.

Act means the National Health Act 1953.

authorised association means a paraplegic and quadriplegic association authorised to supply pharmaceutical benefits under this Special Arrangement by section 9.

eligible person means a person that is eligible to receive pharmaceutical benefits under section 10.

Note:          Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislation Act 2003. These terms include:

·                   approved ex‑manufacturer price

·                   brand

·                   claimed price

·                   listed drug

·                   pack quantity

·                   pharmaceutical benefit

·                   pharmaceutical item

·                   proportional ex‑manufacturer price

·                   responsible person.

5  Pharmaceutical benefits covered by this Special Arrangement

(1)  This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.

 (2)  Each pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

Note:          Each listed drug mentioned in Schedule 1 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

6  Application of Part VII of the Act

                (1)  Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.

(2)  A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.

Note:          See subsection 100(3) of the Act.

7  Responsible person

(1)  If a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2)(a) is the responsible person for the brand of the pharmaceutical item.

             (2)  For subsection (1):

 (a)  the person is the person mentioned in Schedule 2 for the code, with the ABN, if any, mentioned in Schedule 2 for the person; and

                     (b)  the pharmaceutical item is the listed drug mentioned in Schedule 1:

                              (i)  in the form mentioned in Schedule 1 for the listed drug; and

(ii)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

Note:          A person identified by a code in the column headed ‘Responsible Person’ in Schedule 1 has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.

8  No prescriber or prescription

             (1)  If a pharmaceutical benefit is supplied in accordance with this Special Arrangement, the following determinations do not apply to the supply:

                     (a)  a determination made under section 88 of the Act about PBS prescribers for the pharmaceutical benefit;

                     (b)  a determination made under paragraph 85(7)(b) of the Act about the circumstances in which a prescription for the pharmaceutical benefit may be written;

                     (c)  a determination made under paragraph 85A(2)(a) of the Act about the maximum quantities or number of units of the pharmaceutical item in the pharmaceutical benefit that may, in 1 prescription, be directed to be supplied on any 1 occasion;

                     (d)  a determination made under paragraph 85A(2)(b) of the Act about the maximum number of occasions on which the pharmaceutical benefit may be directed to be supplied in a prescription.

Part 2—Supply for the paraplegic and quadriplegic program

9  Paraplegic and quadriplegic associations

                    The following paraplegic and quadriplegic associations are authorised to supply pharmaceutical benefits under this Special Arrangement:

                     (a)  The Paraplegic & Quadriplegic Association of NSW (ABN 42 000 355 948); and

                     (b)  Independence Australia Group (ABN 80 973 805 243).

10  Eligible persons

                   A person is eligible to receive a pharmaceutical benefit from an authorised association if the person:

                     (a)  is an eligible person within the meaning of the Health Insurance Act 1973; and

                     (b)  has paraplegia or quadriplegia; and

                     (c)  is a member of the association.

11  Maximum amount

             (1)  The maximum amount of the pharmaceutical item in a pharmaceutical benefit that may, during a month, be supplied by an authorised association to an eligible person is the amount mentioned in the column in Schedule 1 headed ‘Maximum Amount’ for the pharmaceutical benefit.

             (2)  For subsection (1):

                     (a)  the pharmaceutical item is the listed drug mentioned in Schedule 1:

                              (i)  in the form mentioned in Schedule 1 for the listed drug; and

                             (ii)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug; and

                     (b)  the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                              (i)  in the form mentioned in Schedule 1 for the listed drug; and

                             (ii)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

12  Supply

             (1)  An authorised association may supply a pharmaceutical benefit to an eligible person:

                     (a)  on the person’s request; and

                     (b)  despite section 89 of the Act, without a prescription written for the supply to the person.

Note:          Section 89 of the Act provides for pharmaceutical benefits to be supplied only on prescription.

             (2)  The association may supply the pharmaceutical benefit to the person by:

                     (a)  making the pharmaceutical benefit available to be picked up by the person at the association’s premises; or

                     (b)  sending the pharmaceutical benefit to the person.

13  Co‑payment etc. not to be made

                  An authorised association must not demand or receive a payment or other valuable consideration for the supply of a pharmaceutical benefit under this Special Arrangement, other than:

                     (a)  a payment from the Commonwealth under section 14.

                     (b)  a charge mentioned in section 15.

14  Payment from Commonwealth

             (1)  An authorised association that supplies a pack quantity of a pharmaceutical benefit is entitled to be paid by the Commonwealth for the supply the amount worked out under subsection (2).

             (2)  For subsection (1), the amount is:

                     (a)  if there is no claimed price for the pack quantity of the pharmaceutical benefit:

                              (i)  the price to pharmacists for the pack quantity worked out under the determination under paragraph 98B(1)(a) of the Act; and

                             (ii)  a handling fee of 2.75% of that amount; or

                     (b)  if there is a claimed price for the pack quantity of the pharmaceutical benefit:

                              (i)  the claimed price for the pack quantity plus a wholesale mark‑up calculated in accordance with subsection (3); and

                             (ii)  a handling fee of 2.75% of that amount.

             (3)  For paragraph (2)(b), the wholesale mark‑up for the pack quantity of the pharmaceutical benefit is to be worked out using the methodology for calculating the wholesale mark‑up for ready‑prepared pharmaceutical benefits in the determination under paragraph 98B(1)(a) of the Act, subject to the following:

                     (a)  for the purposes of identifying the appropriate wholesale mark‑up formula in Step 2 of the methodology, the ex‑manufacturer price for the relevant quantity is to be worked out proportionately from the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity of the pharmaceutical benefit; and

                     (b)  otherwise, the methodology is to be applied as if the claimed price for the pack quantity of the pharmaceutical benefit were the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity.

15  Charge for delivery

                    If an authorised association supplies a pharmaceutical benefit by sending it to a person the association may charge the person an amount that is equal to the cost of sending the pharmaceutical benefit to the person.

16  Claims for payment

             (1)  An authorised association that wants to receive payment for the supply of a pharmaceutical benefit under this Special Arrangement must make a claim for payment to the Chief Executive Medicare.

             (2)  The Chief Executive Medicare must determine the amount payable for a claim made under this Part and make any payment relating to the claim.

(3) Despite section 99AAA of the Act, the association must submit its claims for the supplies it makes during a month on a form approved in writing by the Chief Executive Medicare for this section.

Note:          Section 99AAA of the Act provides for rules to be made by the Minister about procedures for claims for payment.

17  Stock of pharmaceutical benefits etc.

                   An authorised association may:

                     (a)  order a pharmaceutical benefit from:

                              (i)  the responsible person for the brand of the pharmaceutical item in the pharmaceutical benefit; or

                             (ii)  a wholesaler for the pharmaceutical benefit; and

                     (b)  keep in stock at its premises an adequate supply of pharmaceutical benefits for supply to its members under this Special Arrangement.

 

18  Internal review of decisions

Application for review

             (1)  A person who is affected by a decision of the Chief Executive Medicare under this instrument may apply to the Secretary for review of the decision.

             (2)  An application for review must:

                     (a)  be in writing; and

                     (b)  be made within:

                              (i)  28 days after the day the decision first came to the notice of the applicant; or

                             (ii)  if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.

Review of decision

             (3)  On receiving an application, the Secretary must:

                     (a)  review the decision; and

                     (b)  affirm, vary or set aside the decision; and

                     (c)  if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.

             (4)  The decision (the decision on review) of the Secretary takes effect:

                     (a)  on the day specified in the decision on review; or

                     (b)  if a day is not specified—on the day the decision on review was made.

Notice of decision

             (5)  After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:

                     (a)  the terms of the decision;

                     (b)  the reasons for the decision.

19  Application of this Special Arrangement

                   This Special Arrangement applies to a supply of a pharmaceutical benefit that is made the day after registration.


Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information

(sections 5, 7 and 11)

Listed Drug

Form

Manner of Administration

Brand

Responsible Person

Maximum Amount

Bisacodyl

Tablet, 5mg

oral

Lax‑Tab

AE

400

 

Suppositories 10mg, 10

rectal

Dulcolax

VZ

9

 

 

 

Petrus Bisacodyl Suppositories

PP

9

 

Suppositories 10mg, 12

rectal

Petrus Bisacodyl Suppositories

PP

8

 

Enemas 10mg in 5mL, 25

rectal

Bisalax

AS

2

Macrogol 3350

Sachets containing powder for oral solution 13.125g with electrolytes, 30

oral

APOHEALTH Macrogol with Electrolytes

GX

2

 

 

 

APO-MACROGOL plus ELECTROLYTES

TX

2

 

 

 

Chemists’ Own Macrogol with Electrolytes

RW

2

 

 

 

LaxaCon

EA

2

 

 

 

lax-sachets

AE

2

 

 

 

Macrovic

RF

2

 

 

 

Molaxole

GO

2

 

 

 

Movicol

NE

2

 

Powder for oral solution 510g

oral

OsmoLax

KY

1

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Enemas 3.125g‑450mg‑45mg in 5mL, 12

rectal

Micolette

AE

4

Sterculia with Frangula Bark

Granules 620mg‑80mg, per g, 500g

oral

Normacol Plus

NE

2

 Schedule 2—Responsible Person Codes

(section 7)

Code

Responsible Person

Australian Business Number

AE

AFT Pharmaceuticals (AU) Pty Ltd

29 105 636 413

AS

Aspen Pharmacare Australia Pty Limited

51 096 236 985

EA

Amneal Pharmaceuticals Pty Ltd

11 163 167 851

GO

Mylan Health Pty Ltd

29 601 608 771

GX

Apotex Pty Ltd

52 096 916 148

KY

Key Pharmaceuticals Pty Ltd

21 001 215 130

NE

Norgine Pty Ltd

78 005 022 882

PP

Petrus Pharmaceuticals Pty Ltd

21 108 884 126

RF

Arrow Pharma Pty Ltd

35 605 909 920

RW

Arrow Pharma Pty Ltd

35 605 909 920

TX

Apotex Pty Ltd

52 096 916 148

VZ

Sanofi-aventis Healthcare Pty Ltd

43 076 651 959

 

 

 

 

 

Schedule 3—Repeals

National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010

1  The whole of the instrument

Repeal the instrument