EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 90 of 2010
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR PUBLIC HOSPITALS) SPECIAL ARRANGEMENTS AMENDMENT INSTRUMENT 2010 (No. 3)
Summary
The National Health (Highly specialised drugs program for public hospitals) Special Arrangements Amendment Instrument 2010 (No. 3) (the Instrument) amends the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010) (the Principal Instrument). The amendments provide for the supply of certain highly specialised drugs (known as ‘Complex Authority Required’ or CAR drugs) by an approved pharmacist, for eligible patients receiving treatment at or from a public hospital as a non-admitted patient, day admitted patient or patient on discharge. An approved pharmacist may submit a claim for payment to the Commonwealth for such a supply, at the rate set out in this Instrument.
The amendments are set out in the items of Schedule 1 to the instrument.
Authority
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:
(a) who are living in isolated areas; or
(b) who are receiving medical treatment in such circumstances that pharmaceutical
benefits:
(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
(ii) are inadequate for that medical treatment.
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) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies. Under paragraph 100AA(1)(c) a special pharmaceutical product, for which special arrangements may be made under section 100, includes a drug or medicinal preparation declared under subsection 85(2) of the Act. Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.
The Principal Instrument is an arrangement made under subparagraph 100(1)(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at public hospitals as non-admitted patients, day admitted patients or patients on discharge.
Highly Specialised Drugs (HSDs) are medicines for the treatment of chronic conditions which, because of their clinical use or other special features, are restricted to supply through public and private hospitals having access to appropriate specialist facilities. To prescribe these drugs as pharmaceutical benefit items, medical practitioners are required to be affiliated with these specialist hospital units. Complex Authority Required (CAR) drugs are drugs which require a more complex process of authorisation in order to be validly prescribed. HSDs which are not CAR drugs are known as ‘non-CAR drugs’.
Purpose and operation
This instrument amends the Principal instrument to allow an approved pharmacist to supply CAR drugs to eligible patients receiving treatment at or from a public hospital as a non-admitted patient, day admitted patient or patient on discharge, and to make claims for payment to the Commonwealth for such supplies.
The amendments to the Principal Instrument are taken to have commenced on 1 July 2010.
Further, the Instrument provides that the Special Arrangements – Highly specialised drugs program for public hospitals (PB 125 of 2009) and Special Arrangements – Highly specialised drugs program for public hospitals (PB 61 of 2009) (the old Instruments), which are now repealed, are also taken to have permitted an approved pharmacist to supply CAR drugs, and make claims for payment to the Commonwealth.
Commencement
This Instrument is taken to have commenced on 1 July 2010 and is therefore retrospective in operation. In addition, Part 9 of this instrument ensures that claims by approved pharmacists for CAR drugs under the section 100 special arrangements for highly specialised drugs and public hospitals are permitted back to 1 July 2009 (when a legislative instrument for this section 100 arrangement first commenced).
This Instrument does not retrospectively disadvantage the rights of any person (other than the Commonwealth). Further, no liabilities are imposed on a person (other than the Commonwealth) in respect of anything done before the date of registration.
The amendment confers benefits on approved pharmacists and patients as it ensures that it is clear that an approved pharmacist can submit a claim for CAR drugs in accordance with the relevant section 100 arrangements. This assists patients to have their drugs dispensed in a community setting.
To support the use of an online claiming system in public hospitals, the listing of HSDs in the Schedule of Pharmaceutical Benefits changed on 1 July 2010. Each HSD now has two item codes, one for use when prescribed in a private hospital and one for public hospitals.
The HSD listing changes have highlighted that alternative dispensing arrangements for CAR drugs exist and public hospital prescriptions are, at times, being dispensed, supplied and claimed by approved pharmacists. These amendments ensure that it is clear that, under the section 100 special arrangements for highly specialised drugs and public hospitals, on and from 1 July 2009, approved pharmacists could and can dispense, supply and claim prescriptions for CAR drugs.
Prior to 1 July 2010, Medicare Australia has processed claims from approved pharmacists for CAR drugs at the rate applicable for claims for CAR drugs from approved pharmacists under the section 100 special arrangements for highly specialised drugs and private hospitals. This amendment sets the rate of payment for claims from approved pharmacists for CAR drugs, on and from 1 July 2009, under the section 100 special arrangements for highly specialised drugs and public hospitals, at a rate equivalent to the rate under the section 100 arrangements for highly specialised drugs and private hospitals.
Due to their complex restrictions, all CAR drugs require a medical practitioner to obtain authority approval prior to prescribing by applying in writing to Medicare Australia. Medicare Australia processes the approval and records the applicable item code (public or private) on the prescription which is returned to the doctor or patient. This approval process can take up to ten days.
The supply and claiming for CAR drugs by approved pharmacists is particularly important for patients from rural areas who are treated by specialists in metropolitan areas. Once Medicare Australia has completed the authority approval process and the prescription is available, a patient may have returned to their home in a rural area, where there is only an approved pharmacist in the community available to dispense their medication. It is unreasonable to expect that the patient present at the metropolitan public hospital to have their medication dispensed at each dose. These amendments, by ensuring that an approved pharmacist can claim under the section 100 arrangements, facilitate dispensing in a community setting.
This instrument constitutes a legislative instrument for the purposes of the Legislative Instruments Act 2003.
A provision-by-provision description of the amendment is contained in the Attachment.
This instrument, expressed to commence on 1 July 2010, was made on 18 August 2010.
Consultations
Consultation was undertaken with Medicines Australia and the Pharmacy Guild of Australia. Advice provided by these stakeholders confirmed that these amendments are necessary to enable patients to continue to access their medications in the community.
The amendments also reflect consultation with states and territories through the Highly Specialised Drugs Working Party (HSDWP), regarding dispensing, claiming and payment arrangements. The HSDWP is a non-statutory body established by the Australian Health Ministers Advisory Council. The HSDWP consists of representatives from State and Territory Health Departments and the Australian Private Hospitals Association, and is chaired by a representative of the Commonwealth Department of Health and Ageing.
Medicare Australia was also consulted. Medicare Australia administers the funding of the Highly Specialised Drugs program for public hospitals.
ATTACHMENT
DETAILS OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR PUBLIC HOSPITALS) SPECIAL ARRANGMENTS AMENDMENT INSTRUMENT 2010 (No. 3)
Section 1 – Name of Instrument
Section 1 provides that this instrument is the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Amendment Instrument 2010 (No. 3) and that this instrument may also be cited as PB 90 of 2010.
Section 2 – Commencement
Section 2 provides that this Instrument is taken to have commenced on 1 July 2010.
Section 3
Section 3 provides that Schedule 1 amends the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010) (the Principal Instrument).
Schedule 1 – Amendments
Item 1 – Section 3, definition of CAR drug
This item clarifies that ‘CAR drugs’ are a category of ‘highly specialised drugs’, by inserting the words ‘highly specialised drugs’ into the definition of ‘CAR drug’ in section 3 of the Principal Instrument.
Item 2 – Section 3, definition of dispensed price
Item 2 amends the definition of ‘dispensed price’ in section 3 of the Principal Instrument to insert a reference to the ‘dispensed price’ for the supply by an approved pharmacist of a highly specialised drug that is a CAR drug. The dispensed price in those circumstances has the meaning given by the new section 43A of the Principal Instrument (see Item 12 below).
Item 3 – Subsection 3(2), note
Item 3 inserts a reference to an ‘approved pharmacist’ into the note at the end of section 3 of the Principal Instrument. The note provides that certain terms, including ‘approved pharmacist’, as used in this Instrument and in the Act, the Regulations or a declaration, determination or other instrument made under Part VII of the Act, has the same meaning in this Instrument as it has in the Act, the Regulations, declaration, determination or instrument.
Item 4 – Subsections 5(1) to (3)
Item 4 amends section 5(1) of the Principal Instrument to provide that this Instrument applies to the supply of a highly specialised drug which is a CAR drug by an approved pharmacist, in addition the supply of a HSD by a hospital authority for a public hospital. This item also amends subsection 5(2) of the Principal Instrument to include a reference in that subsection to an approved pharmacist, to provide that an approved pharmacist is not required to supply a highly specialised drug, being a CAR drug, directly to a patient. The item also amends subsection 5(3) of the Principal Instrument to include a reference in that subsection to an approved pharmacist. Subsection 5(3) provides that a CAR drug may be supplied by an approved pharmacist through an agent.
Item 5 – Paragraph 29(c)
Item 5 amends paragraph 29(c) of the Principal Instrument to provide that to be eligible for payment under this Instrument, a highly specialised drug which is a CAR drug supplied by an approved pharmacist must be dispensed by, or under the direct supervision of a pharmacist or medical practitioner.
Items 6 and 7 – Subsection 35(2) and (3)
Items 6 and 7 amend the references to paragraph 99AAA(8)(a) of the Act in subsections 35(2) and (3) of the Principal Instrument to a reference to subsection 99AAA(8).
Subsection 35(2) provides that an approved hospital authority may make a claim for payment in accordance with the rules made by the Minister under subsection 99AAA (8) of the Act (the 99AAA Rules). The 99AAA Rules made by the Minister under paragraph 99AAA (8) of the Act set out the procedures for making a claim for the supply of a pharmaceutical benefit, including the use of PBS on-line claiming systems. Subsection 35(3) clarifies that the 99AAA Rules will apply to a hospital authority that is approved under section 52 of the Principal Instrument, as if it were approved under section 94 of the Act. This subsection also ensures that medication charts prepared in accordance with this Instrument are treated as if they are prescriptions for the purposes of the Rules.
Item 8 – Paragraph 35(3)(c) (second occurring)
Item 8 reletters paragraphs in subsection 35(3) of the Principal Instrument.
Item 9 – Part 4, before Division 3
Item 9 inserts a new Division 2A into the Principal Instrument. Division 2A provides the manner in which a claim for a CAR drug by an approved pharmacist is to be made.
The new section 41A provides that an approved pharmacist that supplies a CAR drug may make a claim for payment in accordance with the rules made by the Minister under subsection 99AAA (8) of the Act. Subsection 41A(2) provides that in the application of those rules to a claim under this section, a reference in the rules to an authority prescription includes a reference to a prescription under this Instrument for a CAR drug.
The new section 41B provides that payments under a claim may be made only for the dispensed price for a CAR drug less any amount of co-payment charged by the approved pharmacist under section 47A. Subsection 41B(2) provides that the dispensed price is to be worked out under section 43A.
Item 10 – Section 42, heading
Item 10amends the heading of section 42 of the Principal Instrument to clarify that that section relates to the dispensed price for a highly specialised drug supplied by a hospital authority for a public hospital.
Item 11 – Section 42
Item 11 amends section 42 of the Principal Instrument to clarify that that section only applies to a hospital authority for a public hospital.
Item 12 – After section 43
Item 12 inserts a new section 43A to the Principal Instrument which sets out the ‘dispensed price’ for the supply of a CAR drug by an approved pharmacist. Subject to section 44 of the Principal Instrument, the ‘dispensed price’ for the supply of a CAR drug by an approved pharmacist is to be worked out in accordance with sections 30 to 35 of the National Health (Highly specialised drugs program for private hospitals) Special Arrangements Instrument 2010:
(a) as if those provisions were referring to the supply of a highly specialised drug that is a CAR drug by an approved pharmacist under this Instrument; and
(b) as if the reference to section 23 in section 35 of that Instrument were a reference to section 11 of this Instrument.
The National Health (Highly specialised drugs program for private hospitals) Special Arrangements Instrument 2010 is a set of arrangements made under subsection 100(1) of the Act for the purpose of ensuring that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at private hospitals as non-admitted patients, day admitted patients or patients on discharge. Sections 30 to 35 of that Instrument set out the manner of working out the dispensed price for highly specialised drugs supplied by approved pharmacists or approved hospital authorities in accordance with that Instrument.
Item 13 – After section 47
Item 13 inserts a new section 47A which refers to the amount that a patient may be charged by an approved pharmacist for the supply of a CAR drug under this Instrument. The approved pharmacist may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient. This is the usual co-payment amount for a supply by an approved pharmacist.
Items 14 and 15 – Subsection 50(1) and (2)
Items 14 and 15 amend section 50 of the Principal Instrument to provide that where an approved pharmacist makes a claim under the instrument, a patient may seek refund from the Commonwealth of all or part of the co-payment, where they were entitled to be charged a lower amount.
Item 16 – After Part 8
Item 16 inserts a new Part 9 into the Principal Instrument, titled ‘Supply by approved pharmacists under old Instruments’.
The new section 55 provides that an approved pharmacist is taken to have been permitted to supply CAR drugs, and make claims for the supply of CAR drugs, under the legislative instruments which preceded the Principal Instrument.
The new subsection 55(1) provides that despite their repeal or revocation, the Instruments mentioned in subsection (2) (the old Instruments) are taken, during the period in which they were in effect, to have permitted an approved pharmacist:
(a) to supply a highly specialised drug that is a CAR drug to an eligible patient under the Instrument; and
(b) to make claims for payment for the supply in accordance with the rules made by the Minister under subsection 99AAA (8) of the Act.
The new subsection 55(2) specifies the ‘old Instruments’ referred to in subsection 55(1), being the Special Arrangements – Highly specialised drugs program for public hospitals (PB 125 of 2009) and Special Arrangements – Highly specialised drugs program for public hospitals (PB 61 of 2009).
Subsection 55(3) provides that subsection 41A (2) of this Instrument – which provides that a reference in the 99AAA Rules to an authority prescription includes a prescription for a CAR drug under the Instrument – is taken to have applied in relation to the rules made by the Minister under subsection 99AAA (8) of the Act.
Subsection 55(4) provides that the old Instruments are taken to have permitted payment for a claim by an approved pharmacist to be made for the dispensed price for a CAR drug less any amount of co-payment permitted to have been charged by the pharmacist under subsection (7).
Subsection 55(5) provides that the dispensed price for the supply of the CAR drug is taken to have been worked out in accordance with sections 22 to 28 of the Special Arrangements — Highly specialised drugs program (PB 54 of 2009):
(a) as if those provisions were referring to the supply of a highly specialised drug that is a CAR drug by an approved pharmacist under the relevant old Instrument; and
(b) as if the reference to paragraph 27 in paragraph 28 of that Instrument were a reference to section 11 of this Instrument.
The Special Arrangements — Highly specialised drugs program (PB 54 of 2009) is the legislative instrument made under subsection 100(1) which provided for the supply of highly specialised drugs by approved private hospital authorities and approved pharmacists to eligible patients receiving treatment at a private hospital. That instrument was in force from 1 July 2009 to
30 June 2010. Sections 22 to 28 of that Instrument set out the manner of working out the dispensed price for the supply of a highly specialised drug by an approved private hospital authority or an approved pharmacist under that Instrument.
Subsection 55(6) provides that if, in an old Instrument, there were 2 or more brands of a CAR drug mentioned in column 4 of the table in Schedule 2 of the Instrument for the drug, the dispensed price is taken to be based on the price ex-manufacturer of the brand that had the lowest dispensed price.
Subsection 55(7) provides that for subsection (4), the approved pharmacist may charge a patient receiving the supply an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.