National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (PB 31 of 2015)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015

PB 31 of 2015

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.  

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

Purpose

The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the Act, is to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement).

A number of the amendments made by this instrument are consequential amendments to reflect changes to the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations), as amended by the National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015 on 1 April 2015.

The Regulation amendments provide for a medication chart prescription to be used for hospital patients for prescribing, dispensing, and claiming on the Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS (RPBS).  The Regulation amendments implement the PBS Medication Charts for Public and Private Hospitals measure, announced by the Australian Government as part of the 2014-15 Budget.

Implementation of the measure will reduce the regulatory burden currently placed on PBS prescribers, approved suppliers and nurses in hospitals.  It will remove the need for duplication of PBS/RPBS prescription information, and improve work flows for health professionals, and health outcomes, through a reduction of transcription errors.  The hospital medication chart prescription builds on the existing medication chart prescription for persons at a residential aged care facility which already allows for PBS/RPBS claiming directly from a chart.

The Regulation amendments are aligned with and supported by the Australian Commission on Safety and Quality in Health Care (ACSQHC) PBS Hospital Medication Chart project.  The ACSQHC is developing national standardised medication charts appropriate for use in hospital settings to support PBS/RPBS subsidy directly from a PBS prescriber’s medication chart prescription without the need for separate PBS/RPBS prescriptions.

The amendments in this instrument:

•  align the Special Arrangement to the Regulation amendments allowing use of hospital medication chart prescriptions;
• provide for an ‘infusion medication chart prescription’, which is a medication chart prescription with modifications to reflect infusion-based prescribing under the Special Arrangements;
• retain an old public hospital medication chart method for supply for a transitional period ending on 1 April 2017;
• remove a PBS bulk off-line State or Territory public hospital claiming mechanism for Trastuzumab which is no longer used;
• adds a pharmaceutical benefit ‘Ofatumumab’ and the associated circumstances;
• adds 2 listed brands for the listed drug ‘Docetaxel’ and;
• removes 14 listed brands for the listed drugs ‘‘Docetaxel’, ‘Doxorubicin’,  ‘Epirubicin’, ‘Fluorouracil’, ‘Methotrexate’, ‘Oxaliplatin’, ‘Paclitaxel’ and; ‘Folinic Acid’.

Consultation

Since the announcement of the PBS Medication Charts for Public and Private Hospitals measure in 2014, the Department of Health has undertaken an extensive consultation process involving all key health stakeholders.  These consultations indicate widespread and strong support for the trial of the PBS Hospital Medication Chart and amendments required to the Principal Regulations and associated legislative instruments to support the measure.  Consulted stakeholders include States and Territories, Australian Private Hospital Association, Society of Hospital Pharmacists of Australia, Pharmaceutical Society of Australia, Pharmacy Guild of Australia, Australian Medical Association, Cancer Voices Australia, Consumers Health Forum of Australia, National Prescribing Service, the ACSQHC, and the National E-Health Transition Authority.  

Similarly, the Department of Human Services has received strong support from a range of stakeholders for the implementation of paperless (electronic) claiming of PBS/RPBS medicines.  This includes support for transitional arrangements to ensure stakeholder readiness for the implementation of paperless PBS/RPBS claiming.

Details of the instrument are set out in the Attachment.

This instrument commences on 1 April 2015.

This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

ATTACHMENT

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015

Section 1 Name of Instrument

This section provides that the name of this instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015.  It can also be citied as PB 31 of 2015.

Section 2 Commencement

This section provides that this instrument commences on 1 April 2015.

Section 3 Amendment

This section provides that Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Items 1 to 9 Section 3

Items 1 to 9 amend section 3 of the Special Arrangement, the definitions section, by adding, redefining or deleting definitions for authority prescription, eligible private hospital patient, infusion medication chart prescription, medication chart prescription, non-approved public hospital authority, residential care service, and Streamlined Authority Code.  A note has been deleted (under the definition of under co-payment data), and a further note is relocated to the end of the definitions section. 

A ‘medication chart prescription’ has the meaning given by the Regulations, but it does not include a medication chart prescription for a person receiving treatment in a residential care service.  An ‘infusion medication chart prescription’ means a medication chart prescription directing the supply of an infusion.

Item 10 Subsection 9(2)

Item 10 amends subsection 9(2) to refer to infusion medication chart prescription.

Items 11 and 12 Subsections 10(1) and (2)

Items 11 and 12 relate to section 10 (Maximum quantity- related pharmaceutical benefits).  Subsection 10(1) which related to the repealed section 21 is removed, and reference is made to ‘prescription’, which includes a medication chart prescription.

Item 13 Subsection 11(2)

Item 13 amends section 11 (Maximum number of repeats – chemotherapy drug), by referring to infusion medication chart prescription.

Items 14 and 15 Subsections 12(1) and (2)

Items 14 and 15 relate to section 12 (Maximum number of repeats – related pharmaceutical benefits).  Subsection 12(1) which related to the repealed section 21 is removed, and reference is made to ‘prescription’, which includes a medication chart prescription.

Item 16 Paragraph 14(1)(b)

Item 16 relates to section 14 (Methods of prescribing chemotherapy pharmaceutical benefit).  The amendment provides that an authorised prescriber may prescribe a chemotherapy pharmaceutical benefit under the Special Arrangement by writing an infusion medication chart prescription in accordance with regulation 19AA of the Regulations, as modified by section 16 of the Special Arrangement.

Item 17 Subsections 14(2), (3) and (4)

Item 17 relates to section 14 (Methods of prescribing chemotherapy pharmaceutical benefit).  The amendments:

• provide that an infusion medication chart prescription may be prepared for an ‘eligible public hospital patient’ or an ‘eligible private hospital patient’;
• continue to provide that a chemotherapy pharmaceutical benefit containing the drug bortezomib or trastuzumab may only be prescribed by infusion prescription (the complex authority required means it is impractical to prescribe using an infusion medication chart prescription);
• provide that an infusion prescription or infusion medication chart prescription written in accordance with the Special Arrangement is taken to be a duly written prescription for regulation 19 or 19AA of the Regulations, respectively; and
• continue to provide that paragraph 19(2)(a) of the Regulations (same day prescribing) does not apply to an infusion prescription.  A note to subsection 14(5) reminds the reader that this is already the case for a medication chart prescription (including an infusion medication chart prescription) due to the Regulations.

An ‘eligible public hospital patient’ and an ‘eligible private hospital patient’ are defined in section 3 of the Special Arrangement.  Under the Regulations, a ‘medication chart prescription’ is for a patient receiving treatment in or at a (public or private) hospital.

The definition of ‘eligible public hospital patient’ both limits and extends the patient category otherwise permitted by the Regulations.  The patient must be non-admitted, day-admitted, or on discharge.  However, treatment may be at, or from, the hospital.

The definition of ‘eligible private hospital patient’ extends the patient category otherwise permitted by the Regulations.  The patient must be receiving treatment at, or from, the private hospital.

Under the Regulations, access to medication chart prescriptions is limited to trial hospitals for a period of time, and this limitation continues to apply to infusion medication chart prescriptions supplied under the Special Arrangement.

Item 18 Section 15

Item 18 amends the heading to section 15.

Item 19 Paragraphs 15(2)(c) and (d)

Item 19 relates to section 15 which deals with information to be included in an infusion prescription.  The authority prescription references are removed as they are the same as usual authority required procedures.

Item 20 Section 16

Item 20 relates to section 16 which deals with information to be included in an infusion medication chart prescription, in particular, modification to the usual requirements of regulation 19AA.  The amendments:

• provide that the infusion medication chart prescription must include the name of each chemotherapy drug included in the infusion; and
• for each chemotherapy drug – the dose, frequency of administration and route of administration.

An infusion medication chart prescription does not need to include the form of the chemotherapy drug supplied.

Item 20 also removes from section 16 the information required for the older version of PBS infusion medication chart prescribing for supply by public hospitals.

Item 21 and 22 Paragraphs 17(1)(a) and (b)
Paragraphs 17(3)(a) and (b)

Items 21 and 22 relate to section 17 (Dose and number of repeats greater than maximum).  Section 17 has slightly less words, but continues to provide that regulation 13 authority to increase the maximum quantity and maximum number of repeats is modified to apply to ‘maximum amount’ of the chemotherapy drug, and maximum number of repeats for the chemotherapy drug.

Items 23 and 24 Subsections 18(1) and (3)

Items 23 and 24 relate to section 18 (Direction to vary chemotherapy dose in infusion) by referring to infusion medication chart prescription.

Items 25 and 26 Paragraph 19(1)(b) and subsection 19(2)

Items 25 and 26 relate to section 19 (Methods of prescribing related pharmaceutical benefit) to provide that an authorised prescriber may prescribe a related pharmaceutical benefit under the Special Arrangement by writing a medication chart prescription in accordance with regulation 19AA of the Regulations.  The reference to the older version of PBS public hospital medication chart prescribing for related pharmaceutical benefits for supply by public hospitals, is also removed.

Items 27 and 28 Sections 20 and 21

Items 27 and 28 repeal sections 20 and 21 which related to the older version of PBS medication chart prescribing for related pharmaceutical benefits for supply by public hospitals.

Items 29 to 34  Subsections 22(1), (2), (3), (4), and (5)

Items 29 to 34 relate to section 22 (Authority required procedures to be followed). The amendments insert reference to infusion medication chart prescription, and simplify the drafting by removing reference to authority required procedures which are the same as the usual authority required procedures.  The capacity to provide for ‘Compliance with modified Written Authority required procedures’ in a particular instance remains.

Items 34 to 40  Sections 23 to 29

Items 34 to 40 relate to sections 23 to 29 in Part 2, Division 3 which deals with authority required procedures.  These sections are repealed.  The drafting is simplified by removing reference to authority required procedures which are the same as the usual authority required procedures.  The introduction of medication chart prescriptions in the Regulations allows considerable simplification in drafting – as references to the older version of PBS public hospital medication chart prescribing for infusions and related pharmaceutical benefits are removed.

Items 41 and 42 Paragraph 31(1)(c) and subsection 31(3)

Items 41 and 42 relate to section 31 (Supply of infusion under this Special Arrangement).  The amendments:

• provide that an infusion medication chart prescription can be supplied by an approved pharmacist or an approved hospital supplier (private or public), but not an approved medical practitioner (dispensing doctor).  This is the same as a medication chart prescription under the Regulations;
• continue to provide that unless the infusion contains trastuzumab, a public hospital supplier must be a participating hospital authority.

A ‘participating hospital authority’ is defined in section 3 of the Special Arrangement as an approved hospital authority for a public hospital that is participating in a Pharmaceutical Reform Arrangement within the meaning of the National Health Reform Agreement.  National Health Reform Agreement has the meaning given in the Federal Financial Relations Act 2009.

Items 43 to 48 Subsections 33(1), (2), (3), (6) and (7)
Notes to (6) and (7)

Items 43 to 48 relate to section 33 (Selection of chemotherapy pharmaceutical benefits to make infusion).  The amendments refer to infusion medication chart prescription, and remove a note referring to authority requirements as the situation is the same as the usual authority requirements.

Items 49 to 51  Subsections 34(3) and (5), and after subsection 34(3)

Items 49 to 51 relate to section 34 (Modified application of Act and Regulations).  The amendments remove references to the older version of PBS public hospital medication chart prescribing, and insert reference to infusion medication chart prescription.

Item 52 Section 35

Item 52 repeals section 35 (Medication charts – acknowledging receipt of infusion or related pharmaceutical benefit).  Section 35 referred to the older version of PBS medication chart prescribing for infusions and related pharmaceutical benefits. Patient (or agent) acknowledgement of receipt of pharmaceutical benefit is not required for a medication chart prescription under the Regulations, so is not required for an infusion medication chart prescription under this Special Arrangement.

Item 53 Subsection 36(2)

Item 53 repeals subsection 36(2) which dealt with a PBS bulk off-line State or Territory public hospital claiming mechanism for Trastuzumab which is no longer used.

Item 54 Section 38

Item 54 repeals section 38 which dealt with the older version of PBS public hospital medication chart prescribing.

Items 55 and 56 Paragraph 39(c)(iii) and note to paragraph 39(d)

Items 55 and 56 repeal paragraph 39(c)(iii) which contained a spent transitional provision, and the note to paragraph 39(d).

Items 57 and 58 Sections 44 and 44 

Items 57 and 58 repeal sections 40 and 44 which dealt with a PBS bulk off-line State or Territory public hospital claiming mechanism for Trastuzumab which is no longer used.

Item 59 Subsection 52(1)

Item 59 relates to section 52 (Dispensed price of related pharmaceutical benefit).  A minor technical amendment is made to refer to eligible public hospital patient, to align with drafting in section 32.  The eligibility criteria and dispensing rate are unchanged.

Item 60  Section 56

Item 60 repeals section 56 which dealt with a PBS bulk off-line State or Territory public hospital claiming mechanism for Trastuzumab which is no longer used.

Items 61 to 63  Subsections 57(1), (2) and (3)

Item 61 to 63 relates to section 57 (Supply of pharmaceutical benefit by participating hospital authority).  Minor technical amendments are made to refer to eligible public hospital patient, to align with drafting in section 32.

Item 64 Paragraph 59(c)

Item 64 repeals paragraph 59(c) which relates to repealed section 56 and the bulk off-line claiming mechanism for Trastuzumab which is no longer used.

Item 65 Section 60

Item 65 repeals existing section 60, a spent transitional provision, and inserts a new transitional section 60.

Initially, the new hospital medication chart prescriptions provided for in the Regulations will be available for patients of trial hospitals only.  So, the ability to make use of a public hospital medication chart to prescribe, supply and claim on the PBS under this Special Arrangement is preserved until the transitional or trial period in the Regulations expires immediately before 1 April 2017.  If a public hospital is a hospital medication chart trial hospital under the Regulations and supplying from infusion medication chart prescriptions under this Special Arrangement, then access is available under the Regulations, and therefore also available under this Special Arrangement, and this transitional provision does not apply.

The old public hospital medication chart method under this Special Arrangement involved ‘paperless claiming’, that is, not sending the medication chart or a copy of the medication chart (the prescription) to the Department of Human Services as part of the PBS/RPBS claim.

Amendments to the rules made under subsections 98AC(4) and 99AAA(8) of the Act (the claims rules) on 1 April 2015 mean that paperless claiming will be enabled, and then required, for all PBS/RPBS claims, within timeframes provided for in those rules.  An electronic supply certification will be required under those rules.  Section 60 ensures that before 1 April 2017 the old public hospital medication chart method continues to involve paperless claiming, with the electronic supply certification enabled and then required within the timeframes as indicated in the claims rules.

Item 66 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ by adding the pharmaceutical benefits, which is the listed drug ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 1 mL’ with manner of administration Injection and brand ‘Dotax’.

Item 67 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ by removing the pharmaceutical benefits, which is the listed drug ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 2 mL’ with manner of administration Injection and brand ‘Docetaxel Sandoz’.

Item 68 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ by adding the pharmaceutical benefits, which is the listed drug ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 80 mg in 4 mL’ with manner of administration Injection and brand ‘Dotax’.

Item 69 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Doxorubicin’ by removing the pharmaceutical benefits, which is the listed drug ‘Doxorubicin’ in each of the forms ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial’; ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial’;  and ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial’ with manner of administration Injection/intravesical and brand ‘Doxorubicin Ebewe’.

Item 70 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Epirubicin’ by removing the pharmaceutical benefits, which is the listed drug ‘Epirubicin’ in each of the forms ‘Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL’; ‘Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL’;  ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’; and ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ with manner of administration Injection/intravesical and brand ‘Epirubicin Ebewe’.

Item 71 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Fluorouracil’ by removing the pharmaceutical benefits, which is the listed drug ‘Fluorouracil’ in the form ‘Injection 500 mg in 10 mL’ with manner of administration Injection and brand ‘Fluorouracil Ebewe’.

Item 72 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Methotrexate’ by removing the pharmaceutical benefits, which is the listed drug ‘Methotrexate’ in the form ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’ with manner of administration Injection and brand ‘Methotrexate Ebewe’.

Item 73 inserts a new listed drug ‘Ofatumumab’ into Schedule 1 Part 1 of the Special Arrangement by adding new pharmaceutical benefits, which is the listed drug ‘Ofatumumab’ in the forms ‘Solution concentrate for I.V. 100 mg in 5 mL’ and ‘Solution concentrate for I.V. 1000 mg in 50 mL with the manner of administration ‘Injection’ and brand ‘Arzerra’.

Item 74 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Oxaliplatin’ by removing the pharmaceutical benefits, which is the listed drug ‘Oxaliplatin’ in each of the the forms ‘Powder for I.V. infusion 100 mg’; and ‘Powder for I.V. infusion 50 mg’ with manner of administration Injection and brand ‘Oxaliplatin Ebewe’.

Item 75 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Paclitaxel’ by removing the pharmaceutical benefits, which is the listed drug ‘Paclitaxel’ in the form ‘Solution concentrate for I.V. infusion 100 mg in 16.7 mL vial’ with manner of administration Injection and brand ‘Paclitaxel Ebewe’.

Item 76 amends Schedule 1 Part 2 of the Special Arrangement by adding the maximum amount and number of repeats for the listed drug ‘Ofatumumab’.

Item 77 amends the entry in Schedule 2 of the Special Arrangement for ‘Folinic Acid’ by removing the pharmaceutical benefits, which is the listed drug ‘Folinic Acid’ in the form ‘Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 ml’ with manner of administration Injection and brand ‘Calcium Folinate Ebewe’.

Item 78 amends Schedule 4 of the Special Arrangement by adding circumstance codes, purpose codes and the associated circumstances for pharmaceutical benefits with the listed drug ‘Ofatumumab’.