1 Name of Instrument
(1) These Rules are the National Health (Claims and under co‑payment data) Rules 2012.
(2) These Rules may also be cited as PB 19 of 2012.
2 Commencement
These Rules commence on 1 April 2012.
3 Revocation
The Rules under subsection 99AAA(8) (PB 49 of 2008) are revoked.
4 Definitions
Note: A number of expressions used in these Rules are defined in the Act, including the following:
(a) Chief Executive Medicare;
(b) Veterans’ Affairs Department;
(c) special patient contribution
(1) In these Rules:
Act means the National Health Act 1953.
actual contribution means the actual amount a patient pays for each prescription, including a special patient contribution.
Note: Does not include any charge for delivery, or for supply of a pharmaceutical benefit outside normal trading hours.
allowable discount has the meaning given by subsection 87(2AAAA) of the Act.
A section means:
(a) in respect of an authority prescription, a repeat authorisation, a deferred supply authorisation, or a prescriber bag supply form—the section of the form upon which the prescription is written that is provided for the purpose of recording the information required in the provision in these Rules in which the expression occurs; and
(b) in respect of a prescription other than a prescription specified in paragraph (a)—the section of the stamp format marked “A” appearing on the prescription.
approved private hospital means a private hospital that has an approved hospital authority.
approved public hospital means a public hospital that has an approved hospital authority.
authority prescription means a prescription that prescribes a pharmaceutical benefit and that has been authorised:
(a) in accordance with subregulation 13(5) of the Regulations; or
(b) in accordance with authority required procedures that:
(i) are part of the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit; or
(ii) are part of the conditions determined by the Minister under subsection 85A(2A) of the Act for the pharmaceutical benefit; or
(iii) are incorporated by reference into the circumstances determined for the pharmaceutical benefit under subsection 85B(4) of the Act.
Note: A Streamlined Authority Code appearing in the prescription may satisfy subparagraph (b)(i), (ii) or (iii) of the definition of authority prescription.
claim means information given, and procedures followed by, an approved supplier to make a claim for payment under section 99AAA of the Act for the supply of a pharmaceutical benefit.
Claims Transmission System has the same meaning as in subsection 99AAA(1) of the Act. It means the procedures defined in rule 6 of these Rules, to be followed by approved suppliers in providing information by electronic means to the Secretary in relation to the supply by them of pharmaceutical benefits.
continued dispensing means a supply of a pharmaceutical benefit by an approved pharmacist in accordance with subsection 89A(1) of the Act and the Regulations.
contribution discount means the amount of the allowable discount for a supply other than an early supply of a specified pharmaceutical benefit.
Note: The contribution discount may be greater than one dollar in the limited cases where subsection 92A(2) of the Act applies to a supply of a pharmaceutical benefit by a friendly society or a friendly society body to an eligible member.
deferred supply authorisation means a deferred supply authorisation prepared under regulation 26A of the Regulations upon which a pharmaceutical benefit has been supplied.
early supply of a specified pharmaceutical benefit has the same meaning as in subsection 84AAA(1) of the Act.
electronic communication has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.
electronic prescription has the same meaning as in the Regulations.
exceptional prescription means a prescription for an extemporaneously‑prepared pharmaceutical benefit that is not a standard formula preparation and for which the price of the ingredients calculated in accordance with sections 19 to 21 of the determination made under paragraph 98B(1)(a) of the Act is not less than twice the amount calculated in accordance with section 30 of that determination, excluding the container price and dispensing fee.
extemporaneously‑prepared pharmaceutical benefit means a pharmaceutical benefit in respect of which there is not in force a determination under subsection 85(6) of the Act.
information technology requirements has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.
manual system has the same meaning as in subsection 99AAA(1) of the Act. It means the procedures defined in rule 8 of these Rules, to be followed by approved suppliers in providing information otherwise than by electronic means to the Secretary in relation to the supply by them of pharmaceutical benefits.
Medicare Australia/DVA copy, for a paper‑based prescription, means the duplicate of the prescription on which appear the words ‘Medicare Australia/DVA copy’.
medication chart prescription has the same meaning as in the Regulations.
paper‑based prescription has the same meaning as it does in the Regulations.
Note: Subregulation 31(4) of the Regulations provides that it is an offence for an approved supplier to make a paperless claim for payment in relation to the supply of a pharmaceutical benefit and not include a completed supply certification form.
PBS prescriber, in relation to a prescription, means the PBS prescriber (within the meaning of Part VII of the Act) who wrote or prepared the prescription.
pharmaceutical benefit has the same meaning as in Part VII of the Act.
prescriber bag supply form means:
(a) an order form for the purpose of regulation 16 of the Regulations; or
(b) a form for the purpose of an approved medical practitioner giving notice of obtaining a pharmaceutical benefit when making a claim using the manual system, as mentioned in subregulation 18A(3) of the Regulations; or
(c) a form for the purpose of an approved medical practitioner creating a written record of obtaining a pharmaceutical benefit if he or she makes a CTS claim in relation to obtaining the benefit, as mentioned in subregulation 18A(5A) of the Regulations.
prescription includes the following:
(a) the Medicare Australia/DVA copy of a paper‑based prescription;
(b) a copy of a medication chart prescription that is not an electronic prescription;
(c) an electronic prescription in printed form;
(d) a repeat authorisation, a deferred supply authorisation, or a prescriber bag supply form, including such an authorisation or form in printed form if it was written or prepared by means of an electronic form.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.
RPBS means the:
(a) Repatriation Pharmaceutical Benefits Scheme, a legislative instrument made under section 91 of the Veterans’ Entitlements Act 1986; or
(b) Repatriation Pharmaceutical Benefits Scheme (Australian Participants in British Nuclear Tests) 2006, a legislative instrument made under section 18 of the Australian Participants in British Nuclear Tests (Treatment) Act 2006; or
(c) MRCA Pharmaceutical Benefits Scheme, a legislative instrument made under paragraph 286(1)(c) of the Military Rehabilitation and Compensation Act 2004.
repeat authorisation means:
(a) a repeat authorisation prepared under regulation 26 of the Regulations using a repeat authorisation form; or
(b) continued dispensing using a repeat authorisation form prepared by an approved pharmacist;
upon which a pharmaceutical benefit has been supplied.
repeat authorisation form has the meaning given in the Regulations.
S section means:
(a) in respect of an authority prescription, a repeat authorisation, a deferred supply authorisation or a prescriber bag supply form, the section of the form upon which the prescription is written that is provided for the purpose of recording the information required in the provision in these Rules in which the expression occurs; and
(b) in respect of a prescription other than a prescription specified in paragraph (a), the section of the stamp format marked “S” appearing on the prescription.
stamp format means the following format, whether made by stamp or otherwise and whether or not the lines are omitted:
standard formula preparation means an extemporaneously‑prepared pharmaceutical benefit that is listed in Schedule 5 to the determination in force under paragraph 98C(1)(b) of the Act.
under co‑payment data means information relating to a supply of a pharmaceutical benefit by:
(a) an approved supplier where subsection 99(2A), 99(2AB) or 99(2B) applies; and
(b) an approved hospital authority where the amount payable by the Commonwealth in accordance with a subsection 99(4) determination is nil due to the dispensed price not exceeding the applicable patient co‑payment, as defined in the subsection 99(4) determination.
Note: When subsection 99(2A), 99(2AB) or 99(2B) of the Act applies, no claim is payable under section 99AAA of the Act.
(2) A reference in these Rules to the supply of a pharmaceutical benefit includes a reference to the obtaining of a pharmaceutical benefit by an approved medical practitioner for the purpose of the supply of the benefit under section 93 of the Act.
5 Procedures
(1) For the purposes of paragraphs 99AAA(8)(a) and 98AC(4)(b) of the Act, an approved supplier, when providing information to the Chief Executive Medicare on behalf of the Secretary, whether making a claim under section 99AAA, or, providing under co‑payment data in accordance with subsection 98AC(1), is to follow these procedures:
(a) the information shall be given in accordance with the relevant form approved by the Chief Executive Medicare (if any); and
(b) except as provided in subparagraph (d), the information shall be given in respect of pharmaceutical benefits supplied during a period not exceeding 35 days; and
(c) except as provided in subparagraph (d), the information shall be furnished to the Chief Executive Medicare not more than 30 days after the last day of the period in respect of which previous information was supplied; and
(d) where the Chief Executive Medicare is satisfied that an approved supplier was unable, through circumstances outside the approved supplier’s control, to comply with paragraphs (b) or (c), the information may be given outside the requirements of those paragraphs; and
(e) except as provided in paragraph (f), the information shall not be furnished to the Chief Executive Medicare during the same calendar month as any previous information relating to supplies of pharmaceutical benefits; and
(f) notwithstanding paragraph (e), the information may be given to the Chief Executive Medicare in the same calendar month as the previous information in accordance with an arrangement between the approved supplier and the Chief Executive Medicare in which the approved supplier has proposed that additional information be accepted in a calendar month and which the Chief Executive Medicare, provided that he or she is satisfied that the arrangement will not impose additional administrative expenses on the Chief Executive Medicare, has accepted.
Certification
(1A) The approved supplier must certify:
(a) that each pharmaceutical benefit to which the information relates was supplied by, or on behalf of, the approved supplier in accordance with the National Health Act 1953 and the instruments made under it, or the RPBS; and
(b) that the information is correct.
Note: Paragraph 6(3)(d) sets out requirements for the Claims Transmission System about warnings and notifications that apply if the certification is not included in a form mentioned in paragraph (1)(a).
(1B) The approved supplier may make the certification in a form mentioned in paragraph (1)(a) or in another manner.
(1C) In certifying for the purposes of paragraph (1A)(a), the approved supplier must:
(a) identify the range of the serial numbers for each payment category referred to in Schedule 1 allotted in respect of the pharmaceutical benefits; and
(b) specify the total number of pharmaceutical benefits for each of those payment categories; and
(c) identify the claim period number, and the claim reference, referred to in Schedule 1 in relation to which the information is given.
Additional procedure if claim made using the manual system
(2) If the approved supplier is making a claim using the manual system, the information must be accompanied by the prescriptions:
(a) upon the presentation of which the pharmaceutical benefits that are the subject of the claim were supplied; and
(b) on each of which that is not an authority prescription, a repeat authorisation, a deferred supply authorisation or a prescriber bag supply form, shall be marked a stamp format in the area on the extreme left of the prescription, horizontally aligned with the pharmaceutical benefit to which it relates in such a way as to avoid obliterating any other information on the prescription; and
(c) on each of which shall be marked in the S section or S sections one or more serial numbers by the approved supplier, allotted in respect of each pharmaceutical benefit as follows:
(i) in respect of general benefit prescriptions—commencing at “1” in each claim and continuing consecutively in respect of that claim; and
(ii) in respect of concessional benefit prescriptions and concession card prescriptions—commencing at “C1” in each claim and continuing consecutively in respect of that claim; and
(iii) in respect of entitlement card prescriptions—commencing at “E1” in each claim and continuing consecutively in respect of that claim; and
(iv) in respect of prescriber bag supply forms—commencing at “1” in each claim and continuing consecutively in respect of that claim; and
Note: The expressions prescription and repeat authorisation have extended meanings under subrule 4(1).
. (d) on each of which that is an authority prescription or a repeat authorisation relating to an authority prescription shall be marked as a prefix to the serial number allocated under paragraph (2)(c) the letter “A”; and
(e) on each of which that is a deferred supply authorisation shall be marked as a prefix to the serial number allocated under paragraph (2)(c) the letter “D”; and
(f) on each of which shall be marked in the A section or A sections:
(i) where the approved supplier has made an election pursuant to subsection 31(1) of the determination made under paragraph 98B(1)(a) of the Act and the prescription is in respect of an extemporaneously‑prepared pharmaceutical benefit that is not a standard formula preparation, the price calculated by the approved supplier in accordance with section 18 of that Determination; or
(ii) where the approved supplier has not made an election pursuant to subsection 31(1) of the determination made under paragraph 98B(1)(a) of the Act and the prescription is an exceptional prescription, the price calculated by the approved supplier in accordance with section 18 of that Determination; or
(iii) where the prescription is in respect of extemporaneously‑prepared ear drops, eye drops or nasal instillations and the supply of the benefit in a glass bottle container is specified by the PBS prescriber or considered necessary by the approved supplier, the words ‘glass bottle’;
except for those prescriptions that were not in the possession of the approved supplier for reasons which are, in the opinion of the Chief Executive Medicare, outside the supplier’s reasonable control.
Note The RPBS provides that a RPBS claim is to be made in accordance with section 99AAA of the Act and these Rules (except where the RPBS otherwise provides). If an RPBS claim is made using the manual system, RPBS prescriptions relating to the claim are given to the Chief Executive Medicare on behalf of the Secretary. The RPBS requires the provision of a serial number that uniquely identifies the RPBS benefit within the category ‘R’, being a serial number marked on the ‘S’ section of the prescription by the approved supplier, commencing at ‘R1’ in each claim and continuing consecutively in respect of that claim made in accordance with rule 5 of these Rules.
(3) The prescriptions mentioned in subrule (2) must be grouped according to whether they are covered by subparagraph (2)(c)(i), (ii), (iii) or (iv), with the prescriptions in each group sorted in accordance with the serial numbers allotted under that subparagraph, starting with the first number allotted.
Note: The RPBS also requires an approved supplier to create a group of RPBS prescriptions sorted in accordance with the “R” serial numbers allotted to the prescriptions, starting with the first number allotted.
Additional procedure if claim made using the Claims Transmission System
(4) If the approved supplier is making a claim using the Claims Transmission System, the approved supplier must comply with the requirements of subrules (2) and (3) in relation to the prescriptions upon the presentation of which the pharmaceutical benefits that are the subject of the claim were supplied, except that those prescriptions need not accompany the information given in accordance with subrule (1).
Exception for medication chart prescriptions
(5) For subrules (2) to (4), a reference to a prescription does not include a reference to a medication chart prescription.
Note: If the information is given using the Claims Transmission System, Schedule 1 has the effect that a serial number is still allotted in relation to the supply of each pharmaceutical benefit on the basis of a medication chart prescription.
6 Claims Transmission System—procedures
(1) For paragraphs 98AC(4)(b) (under co‑payment data) and 99AAA(8)(c) (claims for payment) of the Act, this rule defines the procedures to be followed by an approved supplier in giving information to the Secretary by electronic means.
Note 1: The procedures defined in this rule constitute the Claims Transmission System.
Note 2: The Claims Transmission System may contain modifications due to the effect of special arrangements under section 100 of the Act, or to facilitate the payment of additional fees to approved suppliers that are not paid as a claim under section 99AAA of the Act.
(2) The approved supplier must give the information to the Chief Executive Medicare, on behalf of the Secretary:
(a) in writing; and
(b) by means of an electronic communication; and
(c) in accordance with any other requirements that would need to be met in order for the requirement to give the information in writing to be taken to have been met under the Electronic Transactions Act 1999.
Note: Under that Act, the Chief Executive Medicare may require the information to be given in accordance with particular information technology requirements or by means of a particular kind of electronic communication (or both).
(3) The information must be generated using one or more computer programs that ensure the following:
(a) that the approved supplier is prevented from altering the description in the computer program of the pharmaceutical benefit or its PBS item code under Schedule 1;
(b) that the information in the computer program for each pharmaceutical benefit is:
(i) in accordance with the Act, and instruments made under the Act, as in force at the time the pharmaceutical benefit was supplied; and
(ii) encrypted when it is given to the Chief Executive Medicare;
(c) that the approved supplier is able to take all reasonable precautions to ensure that information relating to the supply of a substance that was not, in the circumstances, a pharmaceutical benefit, or that was a pharmaceutical benefit but was supplied contrary to section 89 of the Act, is not included;
(d) that, if the approved supplier makes the certification required by subrule 5(1A) otherwise than in a form mentioned in paragraph 5(1)(a):
(i) the Chief Executive Medicare is notified of the certification; and
(ii) the approved supplier is warned, before the certification is made, that giving false or misleading information is a serious offence under section 137.1 of the Criminal Code.
7 Information about supplies
For paragraphs 98AC(4)(a) (under co‑payment data) and 99AAA(8)(b) (claims for payment) of the Act, the information that is to be given to the Secretary by an approved supplier in relation to the supply of a pharmaceutical benefit by the approved supplier is as follows:
(a) the approved supplier’s approval number allotted under regulation 8A of the Regulations;
(b) if the approval number is to be given using the manual system and the approved supplier is an approved pharmacist:
(i) the pharmacist’s name; and
(ii) the address of the premises to which the approval number relates;
(c) if the approval number is to be given using the manual system and the approved supplier is an approved medical practitioner:
(i) the medical practitioner’s name; and
(ii) the address to which the medical practitioner wishes correspondence to be directed;
(d) if the approval number is to be given using the manual system and the approved supplier is an approved hospital authority:
(i) the approved hospital authority’s name; and
(ii) the address of the hospital to which the approval number relates;
(e) if the approval number is to be given using the Claims Transmission System—the information required under Schedule 1 to be given in relation to the supply of the pharmaceutical benefit.
Note: Under rule 6, the information is to be given to the Chief Executive Medicare on behalf of the Secretary.
8 Manual System—procedures
For the purpose of paragraph 99AAA(8)(d) of the Act, the procedures to be followed by an approved supplier in providing information otherwise than by electronic means in relation to the supply by the approved supplier of pharmaceutical benefits are to forward a claim to the Chief Executive Medicare on behalf of the Secretary in accordance with rule 5.
Note: Paragraphs 7(a), (b), (c) and (d) of these Rules also apply.
9 Manual System—under co‑payment data
For the purpose of paragraph 98AC(4)(b) of the Act, an approved supplier who is permitted to claim by the manual system in accordance with section 99AAB of the Act is not required to provide under co‑payment data when claiming by the manual system.
Note Subsections 99AAA(4) and (5) and section 99AAB of the Act provide that an approved supplier must use the Claims Transmission System, unless permitted to use the manual system under section 99AAB of the Act.
10 Claim processing procedures
For the purpose of subparagraph 99AAA(8)(e)(i) of the Act, the procedures to be followed by the Chief Executive Medicare, on behalf of the Secretary, in processing and determining claims by an approved supplier for payment relating to the supply of pharmaceutical benefits, are to institute reasonable checks to satisfy him or herself that:
(a) the information provided by the approved supplier in respect of a claim made using the manual system accurately reflects the information recorded on the prescriptions submitted in support of the claim; and
(b) the approved supplier is entitled to be paid in accordance with the Act and instruments under the Act an amount in respect of the claim.
Note: Advance payments are permitted in accordance with subsection 99AB(1) of the Act. Advance payments are associated with claims made using the Claims Transmission System.
11 Claim payment procedures
For the purpose of subparagraph 99AAA(8)(e)(ii) of the Act, the procedures to be followed by the Chief Executive Medicare, on behalf of the Secretary, in making payments in respect of claims by an approved supplier in relation to the supply of pharmaceutical benefits, are that:
(a) payment shall be made by an electronic funds transfer from the Commonwealth to the account at a financial institution nominated in writing by the approved supplier; and
(b) a statement of account shall be forwarded to the approved supplier in respect of each claim for payment.
12 Application and transitional provisions for the National Health (Claims and under co‑payment data) Amendment (Medication Chart Prescriptions) Rule 2015
Removal of requirement to send prescriptions and introduction of electronic certification
(1) If:
(a) an approved supplier gives information for the purposes of subsection 98AC(1) or section 99AAA of the Act on or after 1 April 2015 in relation to the supply of a pharmaceutical benefit; and
(b) at least one of the supplies to which the information relates was made before that date;
the approved supplier must give the information in accordance with the old Claims Rules (subject to subrule (4)), except to the extent to which the information relates to a medication chart prescription of a kind mentioned in subrule (5).
(2) If:
(a) an approved supplier gives information for the purposes of subsection 98AC(1) or section 99AAA of the Act in relation to the supply of a pharmaceutical benefit; and
(b) none of the supplies to which the information relates was made before 1 April 2015; and
(c) at least one of the supplies to which the information relates was made before 1 July 2015 or a later date determined for the approved supplier under subrule (3);
then, except to the extent to which the information relates to a medication chart prescription of a kind mentioned in subrule (5), the approved supplier may give the information:
(d) in accordance with the old Claims Rules (subject to subrule (4)); or
(e) in accordance with the new Claims Rules.
(3) For paragraph (2)(c), the Chief Executive Medicare may, by writing, determine a later date for an approved supplier if the Chief Executive Medicare is satisfied that exceptional circumstances exist in relation to the approved supplier. The date must be before 1 April 2017.
Removal of CTS non‑online claiming
(4) The old Claims Rules continue to apply for the purposes of subrule (1) and paragraph (2)(d) in relation to information given in relation to a pharmaceutical benefit that is supplied on or after 1 April 2015 as if paragraphs 6(3)(b) and (4)(b), subparagraph 7(1)(d)(ii), and paragraph 7(2)(b), were omitted.
Note: This means that information relating to a pharmaceutical benefit supplied on or after 1 April 2015 that is given to the Chief Executive Medicare using the Claims Transmission System must be given using a computer system and cannot be given by forwarding a diskette.
Medication chart prescriptions—approved hospitals
(5) Information that relates to a medication chart prescription written for a person who is receiving treatment in or at an approved hospital must be given in accordance with the new Claims Rules.
Definitions
(6) In this rule:
new Claims Rules means these Rules as in force on 1 April 2015.
old Claims Rules means these Rules as in force immediately before 1 April 2015.
13 Application and transitional provisions for the National Health (Claims and under co‑payment data) Amendment (Discount co-payment and patient charges data) Rule 2015
(1) If:
(a) an approved supplier gives information for the purposes of subsection 98AC(1) or section 99AAA of the Act in relation to the supply of a pharmaceutical benefit; and
(b) at least one of the supplies to which the information relates was made on or after 1 January 2016, but before 1 March 2016, by an approved pharmacist or approved medical practitioner, or before 1 July 2016 by an approved hospital authority, or a later date determined for the approved supplier under subrule (2);
then, the approved supplier may give the information:
(c) in accordance with the old Claims Rules; or
(d) in accordance with the new Claims Rules.
(2) For paragraph (1)(b), the Chief Executive Medicare may, by writing, determine a later date for an approved supplier if the Chief Executive Medicare is satisfied that exceptional circumstances exist in relation to the approved supplier. The date must be before 1 April 2017.
Definitions
(3) In this rule:
new Claims Rules means these Rules as in force on 1 January 2016.
old Claims Rules means these Rules as in force immediately before 1 January 2016.
