National Health Act 1953 - Determinations under sections 85, 85A and 88 - Pharmaceutical benefits (No. PB 68 of 2010)

Determination — Pharmaceutical benefits
(PB 68 of 2010)

as amended

made under sections 85, 85A and 88 of the

National Health Act 1953

This compilation was prepared on 1 November 2010
taking into account amendments up to PB 96 of 2010

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra

Determinations — pharmaceutical benefits (PB 68 of 2010)

Commencement [see Note 1]

1. This instrument commences on 1 August 2010.

Repeal

2. Instrument number PB 15 of 2010 is repealed.

Definitions

3. In this instrument:

“Act” means the National Health Act 1953;

“authorised midwife” has the meaning given by subsection 84(1) of the Act;

“authorised nurse practitioner” has the meaning given by subsection 84(1) of the Act;

“base-priced drug” means —

(a) in relation to ranitidine (tablet, effervescent, 150 mg (as hydrochloride) or syrup 150 mg (as hydrochloride) per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine (tablet 150 mg (as hydrochloride) or tablet 300 mg (as hydrochloride)); or

(b) in relation to lercanidipine or nifedipine (tablet 20 mg (controlled release)): amlodipine, felodipine or nifedipine (tablet 10 mg or tablet 20 mg or tablet 30 mg (controlled release) or tablet 60 mg (controlled release)); or

(c) in relation to eprosartan (tablet 400 mg (as mesylate)): candesartan, eprosartan (tablet 600 mg (as mesylate)), irbesartan, olmesartan, telmisartan or valsartan;

“CFC” means chlorofluorocarbon;

“CFU” means colony forming unit;

“electronic communication” has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;

“g” means gram;

“GP Management Plan” means a comprehensive written plan for the treatment of a patient, prepared by a medical practitioner, that includes a description of the patient's health care needs, management goals, actions to be taken by the patient and  treatment and services the patient is likely to need;

“I.M.” means intramuscular;

“I.U.” means international unit;

“I.V.” means intravenous;

“kg” means kilogram;

“L” means litre;

“m” means metre;

“Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;

“mg” means milligram;

“mL” means millilitre;

“mm” means millimetre;

“mmol” means millimole;

“palliative care patient”, in relation to a purpose specified in Part 2 of Schedule 2, means a patient with an active, progressive, far-advanced disease, and for whom the prognosis is limited and the focus of care is the quality of life;

“participating dental practitioner” has the meaning given by subsection 84(1) of the Act;

“PBS” means Pharmaceutical Benefits Scheme;

“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act;

“Team Care Arrangements” means a document prepared by a medical practitioner, following consultation with collaborating providers, that includes a description of the treatment and service goals for the patient, the treatment and services that all collaborating providers will provide and the actions to be taken by the patient.

Form

4. For the purposes of subsection 85(3) of the Act, where the strength, type of unit, size of unit or other particulars of form are mentioned in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 in relation to a listed drug, these particulars are the form or forms of that listed drug.

4A. For the purposes of subsection 85(3) of the Act, a form mentioned in Schedule 4 is a form of a medicinal preparation composed of one or more drugs or medicinal preparations, including a medicinal preparation containing an additive.

Manner of administration

5. For the purposes of subsection 85(5) of the Act, the manner of administration mentioned under the column headed “Manner of administration” in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 for a form of a listed drug is the manner of administration for that form of the listed drug.

Brand

5A. For the purposes of subsection 85(6) of the Act, a brand mentioned in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 for a listed drug in a pharmaceutical item, in a form and with a manner of administration mentioned for the listed drug, is the brand of that pharmaceutical item.

Participating dental practitioners

5B. For the purposes of subsection 88(1A) of the Act, the pharmaceutical benefits mentioned in Schedule 3 are the pharmaceutical benefits for the supply of which a participating dental practitioner is authorised to write a prescription.

Authorised midwives

5C. For the purposes of subsection 88(1D) of the Act, the pharmaceutical benefits identified in Part 1 of Schedule 1 by “[MW]” in the column headed “Listed Drug”, including where “[NP]” is also mentioned in that column, are the pharmaceutical benefits for the supply of which an authorised midwife is authorised to write a prescription, except where [MW] is also included in the column headed “Form (strength, type, size, etc)”.  Where [MW] is also included in the column headed “Form (strength, type, size, etc)”, the pharmaceutical benefits mentioned for that form or forms of the listed drug, are the pharmaceutical benefits for the supply of which an authorised midwife is authorised to write a prescription.  The [MW] when included in the column headed “Listed Drug” does not constitute part of the name of the listed drug; nor does [MW], when included with the form of a listed drug, constitute part of the form of the pharmaceutical item or pharmaceutical benefit.

Authorised nurse practitioners

5D. For the purposes of subsection 88(1E) of the Act, the pharmaceutical benefits identified in Schedule 1 or Schedule 2 by “NP” in the column headed “Listed Drug”, including where [MW] is also mentioned in that column, are the pharmaceutical benefits for the supply of which an authorised nurse practitioner is authorised to write a prescription, except where [NP] is also included in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats”.  Where [NP] is also included in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats” the pharmaceutical benefits mentioned for that form or forms of the listed drug or for that number of repeats for that form of the listed drug, are the pharmaceutical benefits for the supply of which an authorised nurse practitioner is authorised to write a prescription.  The identifier [NP], when included in the columns headed “Listed Drug”, “Form” or “Maximum number of repeats”, does not form part of the name of the listed drug; form, or number of repeats for the pharmaceutical item or pharmaceutical benefit.

Prescription

6. For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats specified in Part 2 of Schedule 1 or of Schedule 2 for a pharmaceutical item or pharmaceutical benefit are the maximum quantities and number of repeats that a medical practitioner may prescribe or direct on one occasion for the purposes mentioned for the pharmaceutical item or pharmaceutical benefit and no other purposes.

7. For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats specified in Part 2 of Schedule 3 for a pharmaceutical benefit or pharmaceutical item are the maximum quantities and number of repeats that a participating dental practitioner may prescribe or direct on one occasion but only for the purposes mentioned for the pharmaceutical item or pharmaceutical benefit and no other purposes.

7A. For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats in Part 2 of Schedule 1 or of Schedule 2 for a pharmaceutical item or pharmaceutical benefit where [NP] is included in the column headed “Listed Drug”, except where [NP] is also included in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats”, are the maximum quantities and number of repeats that an authorised nurse practitioner may prescribe or direct on one occasion for the purposes mentioned in the pharmaceutical item or pharmaceutical benefit and not for other purposes.  Where [NP] is also included in the column headed “Form (strength, type, size, etc)”, the quantities and numbers of repeats that apply for prescribing by an authorised nurse practitioner are the maximum quantities and number of repeats specified for that form of the listed drug.  Where [NP] is also included in the column headed “Maximum number of repeats” the numbers of repeats that apply for prescribing by an authorised nurse practitioner are the maximum number of repeats specified for the form of the listed drug.

8. For the purposes of subsection 85A(2) of the Act, the manner of administration, if any, mentioned for a pharmaceutical benefit in

(a) Schedule 1 or, if not mentioned in Schedule1, in Schedule 2, is the only manner in which a medical practitioner may, in a prescription, direct the pharmaceutical benefit to be administered; or

(aa) Schedule 1, for a pharmaceutical item or pharmaceutical benefit where [MW] is included in the column headed “Listed Drug”, including where [NP] is also mentioned in that column, or [MW] is also included in the column headed “Form (strength, type, size, etc)”, is the only manner in which an authorised midwife may, in a prescription, direct the pharmaceutical benefit to be administered;

(ab) Schedule 1, or if not mentioned in Schedule 1, in Schedule 2, for a pharmaceutical item or pharmaceutical benefit where [NP] is included in the column headed “Listed Drug”, including where [MW] is also mentioned in that column, or [NP] is also included in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats”, is the only manner in which an authorised nurse practitioner may, in a prescription, direct the pharmaceutical benefit to be administered;

(b) Schedule 3, is the only manner in which a participating dental practitioner may, in a prescription, direct the pharmaceutical benefit to be administered.

9. For the purposes of subsection 85A(2) of the Act, the maximum quantity or number of units of a pharmaceutical item or pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion is:

(a) where a pharmaceutical item or pharmaceutical benefit is mentioned —

(i) in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or

(ii) in Part 2 of Schedule 1 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or

(iii) in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or

(iv) in Part 2 of Schedule 2 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or

(v) in Part 1 of Schedule 3 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or

(vi) in Part 2 Schedule 3 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or

(b) in any other case — the quantity or number, if any, specified in the column headed “Maximum quantity” in Schedule 4 for the form of the pharmaceutical benefit.

10. For the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit may, in one prescription, be directed by a medical practitioner to be repeated is:

(a) where the pharmaceutical benefit is mentioned —

(i) in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(ii) in Part 2 of Schedule 1 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(iii) in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(iv) in Part 2 of Schedule 2 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(b) in any other case — the number, if any, specified in the column headed “Maximum number of repeats” in Schedule 4 for the form of the pharmaceutical benefit.

10A. For the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit mentioned in Part 1 of Schedule 1 where [MW] is included in the column headed “Listed Drug”, including where [NP] is also mentioned in that column, or where [MW] is also in the column headed “Form (strength, type, size, etc)”, may, in one prescription, be directed by an authorised midwife to be repeated is the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit.

10B. For the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit in Schedule 1 or Schedule 2 where [NP] is included in the column headed “Listed Drug”, including where [MW] is mentioned in that column, or where [NP] is also in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats”, may, in one prescription, be directed by an authorised nurse practitioner to be repeated is, where the pharmaceutical benefit is mentioned:

(a) in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(b) in Part 2 of Schedule 1 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(c) in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(d) in Part 2 of Schedule 2 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit.

11. Subject to paragraph 14, the following purposes are specified in relation to each pharmaceutical benefit mentioned in Part 2 of Schedule 1 or 2:

(a) where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;

(b) where a disease or condition is specified in the column headed “Purposes”

(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or

(ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;

(c) where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose;

(d) where it is specified in the column headed “Purposes” that compliance with authority procedures set out in subparagraph 11(d) is required — that a medical practitioner or an authorised nurse practitioner has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit:

(i) by delivering or posting to the Medicare Australia CEO the prescription prepared and signed by the medical practitioner or authorised nurse practitioner:

(A) in a form approved by the Secretary and completed by the medical practitioner or authorised nurse practitioner in ink in his or her own handwriting; or

(B) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubsubparagraph (A); or

(C) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or

(D) by a method approved in writing by the Secretary; or

(ii) by submitting the prescription by giving the Medicare Australia CEO by telephone, details of the prescription which has been prepared and signed by the medical practitioner or authorised nurse practitioner in accordance with subsubparagraph (i); or

(iii) where the medical practitioner or authorised nurse practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (ii) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner or authorised nurse practitioner by the Medicare Australia CEO; or

(iv) by submitting the prescription by giving the Medicare Australia CEO, by means of an electronic communication of a kind approved in writing by the Medicare Australia CEO, details of the prescription which has been prepared and signed by the medical practitioner or authorised nurse practitioner in accordance with subsubparagraph (i).

11A. For the purposes of subparagraph 11(d)(i), a prescription that has been prepared and signed by the medical practitioner or authorised nurse practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees.

12. Subject to paragraph 12B, the authorisation of a prescription submitted under subparagraph 11(d) may be made:

(a) if the prescription was submitted in accordance with subsubparagraph 11(d)(i) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:

(i) if the Medicare Australia CEO requires the medical practitioner or authorised nurse practitioner to alter the prescription — by returning it to the medical practitioner or authorised nurse practitioner for alteration before the medical practitioner or authorised nurse practitioner gives it to the person in respect of whom it was prepared; or

(ii) in any other case:

(A) by returning it to the medical practitioner or authorised nurse practitioner; or

(B) by sending it to the person in respect of whom it was prepared; or

(b) if the prescription was submitted in accordance with subsubparagraph 11(d)(ii) — orally, at the time the Medicare Australia CEO is given details of the prescription; or

(c) if the prescription was submitted in accordance with subsubparagraph 11(d)(iv) — by the Medicare Australia CEO sending his or her authorisation, by electronic communication, to the medical practitioner or authorised nurse practitioner.

12A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 12(b) or (c):

(a) the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, or an authorised nurse practitioner, orally, the number that has been allotted to the authorised prescription; and

(b) the medical practitioner or authorised nurse practitioner must:

(i) mark that number on the prescription; and

(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.

12B. Notwithstanding paragraph 12, if the prescription was submitted in accordance with subsubparagraph 11(d)(iii), authorisation shall be deemed to have been granted upon completion by the medical practitioner or authorised nurse practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner or authorised nurse practitioner by the Medicare Australia CEO.

12BA. If a medical practitioner or an authorised nurse practitioner has written on a prescription, that has been prepared and signed in accordance with subsubparagraph 11(d)(i), the streamlined authority code mentioned in Part 2 of Schedule 1 for a pharmaceutical benefit and purpose:

(a) subparagraph 11(d) is taken to have been complied with; and

(b) the Medicare Australia CEO is taken to have authorised the prescription.

12BB. Paragraph 12BA applies to a prescription only if there is a streamlined authority code for the pharmaceutical benefit and purpose in Part 2 of Schedule 1.

12C. Where a prescription is authorised, or deemed to be authorised, in accordance with paragraph 12, and an authorisation is also granted in accordance with subregulation 13(5) of the Regulations increasing the maximum quantity or number of units of the pharmaceutical benefit that may, in the prescription, be directed to be supplied on any one occasion, or the maximum number of occasions on which the supply of the pharmaceutical benefit may, in the prescription, be directed to be repeated, the authorisation in accordance with paragraph 12 is taken to be for the prescription of the increased quantity, number, or occasions, as the case may be.

13. The following purposes are specified in relation to a pharmaceutical benefit mentioned in Part 2 of Schedule 3:

(a) where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;

(b) where a disease or condition is specified in the column headed “Purposes” —

(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or

(ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;

(c) where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose.

14. Where the purposes “For use in accordance with paragraph 14” are specified in the column headed “Purposes” in Part 2 of Schedule 1, the purposes specified for the purpose of subparagraph 11(c) are:

(a) that the pharmaceutical benefit is to be supplied for the treatment, in conjunction with dietary therapy, of a patient identified as being in one of the following very high risk categories:

(i) coronary heart disease which has become symptomatic;

(ii) cerebrovascular disease which has become symptomatic;

(iii) peripheral vascular disease which has become symptomatic;

(iv) diabetes mellitus with microalbuminuria (defined as urinary albumin excretion rate of greater than 20 micrograms per minute, or urinary albumin to creatinine ratio of greater than 2.5 for males or greater than 3.5 for females);

(v) diabetes mellitus in Aboriginal or Torres Strait Islander patients;

(vi) diabetes mellitus in patients aged 60 years or more;

(vii) family history of coronary heart disease which has become symptomatic before the age of 55 years in two or more first degree relatives;

(viii) family history of coronary heart disease which has become symptomatic before the age of 45 years in one or more first degree relatives; or

(b) if subparagraph 14(a) does not apply — that the pharmaceutical benefit is to be supplied for the treatment, in conjunction with dietary therapy, of a patient who, after at least 6 weeks of dietary therapy, qualifies for the supply of the benefit in accordance with the following table: