National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015 (PB 30 of 2015)

EXPLANATORY STATEMENT

National Health Act 1953

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015

PB 30 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).

Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to 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 (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (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 as defined in the Regulations, for non-CAR drugs;
•        retain an old public hospital medication chart method for non-CAR drugs for a transitional period ending on 1 April 2017;
•        remove a bulk off-line claiming mechanism for public hospitals which is no longer used; and
•        provide for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements).

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 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

Details of the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015

Section 1 Name of Instrument
This section provides that the name of this instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015.  It can also be citied as PB 30 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 (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1 Amendments

Items 1 to 5 Section 4

Items 1 to 5 amend section 4 (Definitions) of the Special Arrangement by inserting definitions of medication chart prescription and residential care service.  A medication chart prescription has the meaning given in the Regulations, except it does not include a medication chart prescription for a person receiving treatment in a residential care service, which also has the meaning given in the Regulations.  A number of definitions and a note, which are no longer used in the Special Arrangement, are repealed.

Items 6 and 7 Division 3 – heading and note, and section 10
Items 6 and 7 simplify these headings in the Special Arrangement. 

A medication chart prescription will be available under the Regulations, and this means that authority required procedures for supply under this Special Arrangement are usually the same as the usual authority required procedures for PBS supply, including any adjustments for medication chart prescriptions.  Any particular modifications due to supply under the Special Arrangement continue to be expressly referred to in the Special Arrangement.

Item 8 to 11 Subsection 10(2), sections 11, 12 and 13
Item 8 amends section 10 of the Special Arrangement to provide a cross-reference to the authority required procedures as provided for in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (main listing instrument).  The capacity to provide, if considered appropriate for a particular medicine, for additional authority required procedures in the Schedule to the Special Arrangement remains.

Items 9, 10 and 11 repeal sections 11, 12 and 13 of the Special Arrangement which essentially set out authority required procedures specified in the main listing instrument, or, applied those procedures to the old public hospital medication chart method for supply under this Special Arrangement.

Item 12 Paragraph 18(1)(b)
Item 12 repeals paragraph 18(1)(b) which relates to an old bulk off-line claiming mechanism for public hospitals.  This mechanism is set out in section 28 of the Special Arrangement which is being repealed as it is no longer used.

Item 13 Paragraph 19(b)
Item 13 amends section 19 (Application of regulation 25) of the Special Arrangement to ensure that for a medication chart prescription, regulation 25 of the Regulations applies in the same manner as it does for all medication chart prescriptions.

Item 14 Section 19 - Note
Item 14 repeals the note to section 19.

Item 15 Subsection 21(b)
Item 15 amends section 21 of the Special Arrangement to ensure that medication chart prescriptions prepared in accordance with new regulation 19AA of the Regulations are allowed for non-CAR drugs.

Item 16 Section 22
Item 16 repeals section 22 of the Special Arrangement, which dealt with the old public hospital medication chart method for supply under this Special Arrangement.

Item 17 Section 23
Item 17 amends section 23 of the Special Arrangement to refer to regulation 19 of the Regulations.  

Item 18 Section 26
Item 18 replaces section 26 (Application of regulation 13 in relation to CAR drugs) of the Special Arrangement to simplify its wording while continuing to provide that regulation 13 of the Regulations, which deals with obtaining authority to increase maximum quantity or repeats, does not apply for a CAR drug supplied under this Special Arrangement.

Item 19 Part 3
Item 19 repeals Part 3 of the Special Arrangement, as it only related to an old bulk off-line claiming mechanism for public hospitals in section 28 of the Special Arrangement which is no longer used.

Item 20 Part 4, Division 1
Item 20 repeals Part 4, Division 1 of the Special Arrangement, as it only related to an old bulk off-line claiming mechanism for public hospitals in section 28 of the Special Arrangement which is no longer used. 

Item 21 Section 30
Item 21 repeals a note which refers to ‘on-line claims’.  This note is no longer needed due to the removal of the old CTS non-online claims (diskette) method on 1 April 2015 via amendment to the rules made under subsections 98AC(4) and 99AAA(8) of the Act (claims rules).

Item 22 Part 4, Division 2, subdivision 2
Item 22 repeals Part 4, Division 2, subdivision 2 (Paperless claims for HSD pharmaceutical benefits that have non-CAR drugs).

The option for public hospitals not to send prescriptions for non-CAR drugs to the Australian Government (Department of Human Services) as part of the PBS/RPBS claim is removed.  Due to amendments to the claims rules under the Act on 1 April 2015, this will no longer be an exception, but the usual approach for all suppliers.  Transitional arrangements are provided for in item 32.

This subdivision also provided that the old public hospital medication chart method for supply under this Special Arrangement did not require the medication chart to be sent to the Department of Human Services as part of the PBS/RPBS claim.  This continues to be the case under the new medication chart prescription provided for by the Regulations.  Transitional arrangements are provided for in item 32.

Item 23 Section 45
Item 23 repeals section 45 (Patient contributions if off-line claim is made), as it only related to an old bulk off-line claiming mechanism for public hospitals in section 28 of the Special Arrangement which is no longer used.

Items 24 and 25 Subsections 46(1) and (3)
Items 24 and 25 amend section 46 (Patient contributions in relation to approved hospitals authorities) by removing references related to an old bulk off-line claiming mechanism.

Items 26, 27 and 28     Subsection 47(3), section 48 and subsection 50(1)
Items 26 and 27 amend section 47 (Patient contributions for claims by approved pharmacists) and section 48 (Additional patient contributions) to remove references to section 45, which is repealed by these amendments and related to an old bulk off-line claiming mechanism.  Item 28 repeals subsection 50(1) for the same reason.

Item 29 Paragraphs 51(1)(c), (d) and (e)
Item 29 repeals paragraphs 51(c), (d) and (e) as they are no longer needed.  New paragraph 51(c) ensures a medication chart prescription may be written for eligible patients receiving treatment from a hospital.

Items 30 and 31 Sections 54 and 55
Items 30 and 31 remove transitional provisions no longer in operation. 

Item 32

Item 32 inserts new transitional provisions sections 54 and 55.

Section 54  Transitional arrangements for existing public hospital medication chart prescribing and paperless claiming

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/RPBS 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 prescription trial hospital under the Regulations, then access is available under the Regulations, 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 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 54 ensures that before 1 April 2017 the old public hospital medication chart method continues to involve paperless claiming, with the supply certification enabled and then required within the timeframes as indicated in the claims rules.

Section 55 Transitional arrangements for existing non-medication chart public hospital paperless claiming

A ‘paperless claiming’ option under this Special Arrangement, allowing public hospitals not to send prescriptions for non-CAR drugs to the Department of Human Services as part of the PBS/RPBS claim, is removed by these amendments.  On 1 April 2015 under the claims rules, this will no longer be an exception but the usual approach for all suppliers.

The transitional provision ensures that before 1 April 2017 this ‘paperless claiming’ method under the Special Arrangement remains open, whether or not the public hospital has commenced ‘paperless claiming’ for all of its PBS/RPBS supplies under the claims rules.  The supply certification is also enabled, then required, within the timeframes as indicated in the claims rules.

Items 33 to 50 provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements).

These changes are summarised on the next page.

SUMMARY OF CHANGES

Listed Drugs Added

Alemtuzumab

Apomorphine

Dolutegravir with abacavir

Sucroferric oxyhydroxide

Brands Added

Sildenafil Tablet containing Sildenafil citrate 20mg

Addition of Responsible Person Code

Amneal Pharma Australia Pty Ltd [EA]

Astellas Pharma Australia Pty Ltd [LL]

Fresenius Medical Care Australia Pty Ltd [FN]

Alteration of Responsible Person Code

Alteration of Circumstances