Commonwealth Numbered Regulations - Explanatory Statements

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NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) AMENDMENT REGULATIONS 2002 (NO. 2) 2002 NO. 344

STATUTORY RULES 2002 No. 344

Issued by the Authority of the Minister for Health and Ageing

National Health Act 1953

National Health (Pharmaceutical Benefits) Amendment Regulations 2002 (No. 2)

Section 140 of the National Health Act 1953 ("the Act") provides that the Governor-General may make Regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.

The purpose of the Regulations is to increase consumer awareness of the amount of Commonwealth subsidy for Pharmaceutical Benefits Scheme (PBS) medicines by requiring the full cost of these medicines to be shown on the label, as well as making a number of minor amendments.

The Regulations would:

•       provide that the full cost of medicines supplied under the PBS be included on the label;

•       update a number of provisions relating to the PBS safety net;

•       enable a doctor's agent to collect and receipt emergency drug (doctor's bag) supplies on the doctor's behalf;

•       remove a requirement pertaining to prescriptions for dangerous drugs, covered by the poisons legislation of the States and Territories;

•       remove the requirement for a tick or cross to be marked on a prescription for a concessional beneficiary or the holder of a concession or entitlement card; and

•       remove the Society of Hospital Pharmacists of Australia as a nominating body for the community pharmacist member of the Pharmaceutical Benefits Advisory Committee.

Paragraph 105(a) of the Act provides that the Regulations may prescribe the terms and conditions subject to which pharmaceutical benefits shall be supplied.

In order to make patients aware of the amount of Commonwealth subsidy, it is that the cost of medicines supplied under the PBS be included on the label, preceded by the words "full cost". The "full cost" is the sum of the Commonwealth dispensed price and any special patient contribution.

There will be no requirement to include the cost on labels in the case of pharmaceutical benefits supplied by approved suppliers exempted from using the Claims Transmission System or by approved hospital authorities, nor will the requirement apply to pharmaceutical benefits obtained as emergency drug (doctor's bag) supplies or to items priced at or below the relevant patient copayment.

Under subsections 84C(6) and (7) of the Act, the safety net record of the supply of a pharmaceutical benefit is required to include certain particulars specified in subsection 84C(7) and particulars prescribed in regulation 9A of the National Health (Pharmaceutical Benefits) Regulations 1960 (the Principal Regulations). One of the prescribed particulars is the maximum value of the pharmaceutical benefit or repatriation pharmaceutical benefit for safety net purposes. It defines the maximum value by removing obsolete provisions and by making it clear that in no case may the amount recorded towards the safety net exceed the amount actually charged to the patient.

Under the Act, a prescription will not be recognised for the purposes of the PBS unless the patient's medicare number is recorded on it. The amending Act inserted a definition of "medicare number" in subsection 84(1) of the Act. It replaces "medicare card number" with "medicare number" for consistency of terminology and to add the medicare number as a requirement in an application for a pharmaceutical benefits entitlement card by a concessional patient who have reached the safety net, consistent with the requirement for an application for a safety net concession card by a general patient.

Subsections 84DA(5) and 84E(5) of the Act require approved suppliers who issue safety net concession cards or pharmaceutical benefits entitlement cards respectively, to lodge certain documents at a prescribed office within one month. It updates the list of prescribed Health Insurance Commission offices.

Section 93 of the Act enables a medical practitioner to obtain certain pharmaceutical benefits for supply direct to patients as an emergency drug (doctor's bag) supply. Medical practitioners obtain these drugs by lodging a signed and dated order form with an approved pharmacist and give a receipt to the approved pharmacist who supplies the drugs. The Principal Regulations do not allow for a doctor's agent to collect the drugs and give a receipt for them. It amends subregulation 16(3) to allow for an agent of the doctor to collect the drugs on the doctor's behalf, but, similar to the agency situation with prescriptions, require the agent to add his or her address.

Paragraph 19(2)(c) of the Principal Regulations provides that a prescription is not duly written if it contains a prescription for a pharmaceutical benefit that is a dangerous drug and also a prescription for another pharmaceutical benefit, if the prescription directs that the supply of one or both of those pharmaceutical benefits is to be repeated. As the requirements for handling prescriptions for dangerous drugs are adequately covered by the poisons legislation of the States and Territories, it removed this provision.

Section 84AA of the Act provides that a prescription shall not be taken to be a prescription for a concessional beneficiary, the dependant of a concessional beneficiary, or the holder of a concession card or an entitlement card, unless the prescription is so marked as prescribed by the Regulations.

Where the approved supplier is lodging electronic claims, the supplier must include the relevant card number in the electronic prescription record and it is not necessary for the number to be marked on the prescription. However, it is still necessary for a tick or cross to be marked in the square provided on a prescription form to indicate that the person is a concessional beneficiary or a dependant of a concessional beneficiary, or the holder of a concession or entitlement card, as the case may be. It removed the requirement for the tick or cross to be marked on the prescription where the approved supplier is lodging claims for payment electronically and provides the card number in the electronic prescription record.

Paragraph 100A(3)(c) of the Act requires that at least one member of the Pharmaceutical Benefits Advisory Committee must be a practising community pharmacist. Paragraph 100B(1A)(c) of the Act provides that the practising community pharmacist is to be appointed from nominations made by associations of professional pharmacist prescribed by the Regulations. It removed the Society of Hospital Pharmacists of Australia as a nominating body, as the members of that society are not normally engaged in community practice.

Details of the Regulations are set out in the Attachment.

Regulations 1 to 3, and Schedule 1, would commence on gazettal. Schedule 2 would commence on 1 August 2003. Schedule 2 relates to the introduction of procedures to show the full cost of PBS medicines on the label. The delay in commencement is intended as the earliest practical date from which all pharmacy dispensing software can reasonably be expected to meet this requirement. The date also coincides with the distribution of quarterly software revisions by software providers.

ATTACHMENT

Regulation 1 of the amending Regulations provides that the name of the amending Regulations is the National Health (Pharmaceutical Benefits) Amendment Regulations 2002 (No. 2).

Regulation 2 of the amending Regulations provides that the amending Regulations will commence on gazettal for Regulations 1 to 3 and Schedule 1, and on 1 August 2003 for Schedule 2.

Regulation 3 of the amending Regulations provides that the National Health (Pharmaceutical Benefits) Regulations 1960 will be amended as set out in Schedule 1 and Schedule 2.

Item 1 of Schedule 1 defines "medicare number" to have the same meaning as in Part VII of the Act, namely:

(a)       in relation to a particular person covered by a medicare card--the particular combination of numbers, or letters and numbers, on the card that is applicable only to that person as a person covered by that card; and

(b)       in relation to a person who the Health Insurance Commission is satisfied is, or is entitled to be treated as, an eligible person within the meaning of the Health Insurance Act 1973 but who is not covered by a medicare card--the particular combination of numbers, or letters and numbers, that would be applicable to that person if that person were covered by a medicare card.

Item 2 of Schedule 1 amends the heading to regulation 9AF to correctly reflect the provision of the Act to which regulation 9AF refers, namely, subsection 84DA(5) of the Act.

Item 3 of Schedule 1 makes a drafting amendment to regulation 9AF to reflect the change of title for the Schedule to the Regulations to "Schedule 1".

Item 4 of Schedule 1 amends subregulation 9A(5):

•       to remove references to particular dates which are no longer required as these were transitional provisions used at the time that pensioners commenced to pay a copayment for pharmaceutical benefits; and

•       to no longer differentiate between pensioners and other concessional beneficiaries, as the patient copayment and safety net provisions applying to them are now the same; and

•       to remove the reference to paragraph 87(2)(d) of the Act, as that paragraph no longer exists; and

•       to make it clear that the amount that can be counted towards the safety net for a prescription in no case can exceed the amount charged for the prescription.

Item 4 of the Schedule also makes a drafting amendment by replacing the term "amount referred to" with the term "price mentioned for the prescription" to ensure closer alignment with the terms used in the Act.

Items 5 and 6 of Schedule 1 amend regulation 9B by inserting new paragraph 9B(1)(f) to provide that an application for a pharmaceutical benefits entitlement card must include the applicant's medicare number.

Item 7 of Schedule 1 makes a drafting amendment to regulation 9BA to reflect the change of title for the Schedule to the Regulations to "Schedule 1".

Item 8 of Schedule 1 inserts new subparagraph 9C(3)(b)(vi) to provide that an application for an additional pharmaceutical benefits entitlement card must include the applicant's medicare number.

Items 9 and 10 of Schedule 1 insert new subparagraph 9D(2)(b)(iv) to provide that an application for a replacement pharmaceutical benefits entitlement card must include the applicant's medicare number.

Items 11 to 13 of Schedule 1 amend subregulation 16(3) to enable an agent of a medical practitioner to collect and give a receipt for pharmaceutical benefits obtained by the medical practitioner as an emergency drug (doctor's bag) supply for the purposes of section 93 of the Act. Paragraph 16(3)(c) in inserted to provide that in such cases the agent must add his or her address to the receipt given on behalf of that medical practitioner.

Items 14 to 16 of Schedule 1 enable the omission of paragraph 19(2)(c) which provides that a prescription is not duly written if it contains a prescription for a pharmaceutical benefit that is a dangerous drug and also a prescription for another pharmaceutical benefit, where the prescription directs that the supply of one or both of those pharmaceutical benefits is to be repeated.

Item 17 of Schedule 1 omits, as a consequence of items 14 to 16, subregulation 19(3), which defines "dangerous drug" for the purpose of regulation 19.

Items 17 and 18 of Schedule 1 amend regulation 19A by omitting subregulation (1A) and inserting subregulation 19A(2A), to provide that, if an approved pharmacist claims payment electronically via the Claims Transmission System for the supply of a pharmaceutical benefit, and the pharmacist provides the card number in the electronic prescription record, there is no requirement for a tick or a cross to be marked on the prescription to indicate that the person is a concessional beneficiary, the holder of a concession card, the holder of an entitlement card or the dependent of a concessional beneficiary, as the case may be.

Items 19 and 20 of Schedule 1 amend regulation 32, as a consequence of item 17, by removing the reference in paragraph 32(1)(b) to the definition of "dangerous drug" in regulation 19 and inserting new subregulation 32(4) to provide a definition of "dangerous drug" for the purposes of regulation 32.

Items 21 and 22 of Schedule 1 provide for the omission of paragraph 38A(3)(c) in order to remove the Society of Hospital Pharmacists from the list of prescribed professional associations which may nominate a pharmacist for membership to the Pharmaceutical Benefits Advisory Committee.

Item 23 of Schedule 1 makes a drafting amendment to change the title for the Schedule to the Regulations to "Schedule 1", and updates the list of prescribed offices for the purposes of Regulations 9AF and 9BA.

Item 24 of Schedule 1 omits the "Medicare card number" from paragraph 9AA(1)(f) and subparagraphs 9AB(3)(b)(vi) and 9AC(2)(b)(iv) and substitutes "medicare number", in order to make the terminology consistent with the Act.

Item 1 of Schedule 2 defines "approved supplier" to have the same meaning as in Part VII of the Act, namely an approved pharmacist, an approved medical practitioner or an approved hospital authority.

Item 2 of Schedule 2 defines "Commonwealth price" to have the same meaning as in Part VII of the Act, namely:

(a)       in relation to a pharmaceutical benefit supplied by an approved pharmacist--the Commonwealth price worked out in accordance with a determination in force under subsection 98B(1); or

(b)       in relation to a pharmaceutical benefit supplied by an approved medical practitioner--the Commonwealth price worked out in accordance with a determination in force under subsection 98C(1); or

(c)       in relation to a pharmaceutical benefit supplied by an approved hospital authority to a patient receiving treatment in or at a hospital in respect of which the authority is approved--the amount of the payment to which the authority is entitled under subsection 99(4) in respect of the supply of the benefit.

Item 3 of Schedule 2 inserts new regulation 36 to provide that the full cost of a pharmaceutical benefit must appear on the label of that pharmaceutical benefit, preceded by the words "full cost", unless:

•       the approved supplier is exempted under section 99AAB of the Act from the requirement to use the Claims Transmission System; or

•       the pharmaceutical benefit is supplied by an approved hospital authority; or

•       the pharmaceutical benefit is obtained by a medical practitioner for the purpose of subsection 93(2) of the Act; or

•       subsections 99(2A), 99(2AB) or 99(2B) of the Act apply to that pharmaceutical benefit.

This item also defines "full cost" to be the sum of the Commonwealth price of that pharmaceutical benefit as defined by Part VII of the Act, plus any special patient contribution charged under 87(2A) of the Act and calculated under subsection 85B(2) of the Act.