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NATIONAL HEALTH AMENDMENT (IMPROVED MONITORING OF ENTITLEMENTS TO PHARMACEUTICAL BENEFITS) BILL 2000

1998-1999-2000



THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA



HOUSE OF REPRESENTATIVES








NATIONAL HEALTH AMENDMENT (IMPROVED MONITORING OF ENTITLEMENTS TO PHARMACEUTICAL BENEFITS) BILL 2000







EXPLANATORY MEMORANDUM








(Circulated by the authority of the Minister for Health and Aged Care,
the Hon Dr Wooldridge MP)






ISBN: 0642 450927

NATIONAL HEALTH AMENDMENT (IMPROVED MONITORING OF ENTITLEMENTS TO PHARMACEUTICAL BENEFITS) BILL 2000


OUTLINE


The purpose of this Bill is to amend the National Health Act 1953 (‘the Act’) in order to build on the current objective of Part VII in that Act, namely, to assist patients to receive high quality care through quality use of medicines, to subsidise the costs of prescribed pharmaceuticals and to provide appropriate accountability for expenditure of public funds. In broad terms, the Bill will require the inclusion of medicare numbers on prescriptions for pharmaceutical benefits. This will help to ensure that only those persons entitled to pharmaceutical benefits under Part VII of the Act will receive them. The Bill provides for medicare numbers to remain private and confidential and not to be used for purposes other than ensuring entitlement to pharmaceutical benefits.

There will be three stages to the implementation of the final arrangements provided for in the Bill. Stage 1 establishes the privacy regime and explicitly allows medicare numbers to be collected, placed on prescriptions and stored by prescribers and suppliers. This stage applies from the date of Royal Assent. Stage 2 requires medicare numbers to be collected and placed on prescriptions by pharmacists (or other suppliers) for the purpose of identifying entitlement to pharmaceutical benefits. This stage applies from 1 January 2001. Stage 3 prevents payments to pharmacists (or other suppliers) in relation to the dispensing of prescriptions for pharmaceutical benefits where there has been a failure to comply with the requirements of stage 2 above or where the number endorsed on a prescription does not match the number held by the Health Insurance Commission. This stage applies from 1 July 2001.

The main amendments to the Act are as follows:

Stage 1

(a) it is made clearer that a person must be an ‘eligible person’ in order to receive pharmaceutical benefits;
(b) it is made clearer that a person must be in Australia at the time of supply in order to receive pharmaceutical benefits;
(c) prescribers and pharmacists will be authorised, with the consent of the person (or other authorising party), to collect from the person (or other authorising party) the person’s medicare number, to hold the number for future reference, and to include the number in prescriptions for pharmaceutical benefits. The collection of the person’s medicare number will not then be necessary for future prescriptions to be dispensed by a pharmacist holding the number, provided the person’s medicare number remains current;
(d) if the prescriber has included the person’s medicare number on the prescription, the pharmacist (or other dispenser) will be authorised to check it and alter it if he or she concludes the number on the prescription is erroneous;
(e) there is a general prohibition on prescribers and pharmacists disclosing or using the medicare numbers obtained for the purpose of prescribing or dispensing pharmaceutical benefits under Part VII of the Act except for the purposes of that Act or regulations under that Act in relation to the Pharmaceutical Benefits Scheme, or for purposes under the Health Insurance Commission Act 1973 in relation to that Scheme;
(f) the above prohibition on disclosure or use of the medicare numbers extends to persons acting for or on behalf of prescribers and pharmacists, such as employees and contractors;
(g) contravention of the prohibition will be an offence;

Stage 2

(h) pharmacists are required to ask the customer for the person’s medicare number, if it is not already included on the person’s prescription or available to the pharmacist from his or her own records, and to endorse that number on the prescription;
(i) if the prescriber has included the person’s medicare number on the prescription, the pharmacist will be authorised to check it and amend it if he or she concludes that the number on the prescription is erroneous;
(j) if the person is an eligible person but is unable to provide a medicare number, the pharmacist is required to follow the alternative arrangements for such persons as determined by the Minister;

Stage 3

(k) failure to comply with the requirements described in paragraphs (h) and (j) in stage 2 above or a mismatch with the medicare number held by the Health Insurance Commission will result in the pharmacist not receiving any payment from the Commonwealth. However, the pharmacist will be entitled to a payment where the sole reason for a mismatch between the medicare number appearing on the prescription and that held in the records of the Health Insurance Commission is because the number on the prescription had expired within 60 days (or such period as the Minister may determine) preceding the date of supply.

FINANCIAL IMPACT STATEMENT


Due to the improved Pharmaceutical Benefits Scheme entitlement monitoring, it is anticipated that savings will occur of $5.7m in 2000-2001, $18m in 2001-2002, $20.7m in 2002-2003 and $22.2m in 2003-2004, as announced in the 2000-2001 Budget papers.

REGULATION IMPACT STATEMENT


INTRODUCTION

The Pharmaceutical Benefits Scheme (PBS) provides timely, reliable and affordable access by the Australian community to necessary and cost-effective prescription medicines.

Most medicines available on prescription are subsidised under the Scheme. The maximum cost to general patients for each item supplied under the PBS is generally $20.30. For concessional beneficiaries such as pensioners and health care card holders the maximum is $3.30 per item. Around 80 per cent of prescriptions are for patients in the concessional category.

When the aggregate patient copayments in a calendar year for an individual or family exceeds a threshold ($631.20 for general patients, $171.60 for concessional beneficiaries), the PBS safety net further reduces the cost to the patient for the remainder of the calendar year (to $3.30 per item for general beneficiaries, nil for concessional beneficiaries).

When a dispenser has supplied a pharmaceutical benefit in accordance with the relevant legislation (mainly part VII of the National Health Act 1953 and National Health Regulations), the dispenser becomes entitled to a payment from the Commonwealth equal to the difference between the Commonwealth Price and the patient contribution (for items for which the Commonwealth price is greater than the copayment). The payment is claimed by means of a paper form accompanied, in all but a very small proportion of cases, by an electronic record of each prescription and supply on a diskette or e-mailed as an encrypted file. A proportion of claims are rejected because they do not comply with statutory requirements

When the Scheme began in 1953, the only eligibility requirement for consumers was that he or she be under treatment by a medical or dental practitioner. In 1996 the definitions of "general patient" and "concessional beneficiary" in the National Health Act 1953 were amended to require that these beneficiaries be eligible persons as defined in the Health Insurance Act 1973, that is eligible for Medicare.

The main categories of people eligible for Medicare are persons residing in Australia who are Australian or New Zealand citizens, holders of permanent visas, or holders of temporary visas who have applied for permanent visas and meet certain requirements. Bilateral reciprocal health care agreements between Australia and eight other countries provide for visitors from those countries to be entitled to pharmaceutical benefits. There are increasing numbers of temporary residents who are not eligible for Medicare and are not covered by reciprocal health care agreements, for example employees recruited from the USA and Asia who have not applied for permanent visas.

Determining whether a particular individual is eligible for Medicare can be a complex process, beyond what a pharmacist or a pharmacist's assistant could be expected to carry out. For example, few non-specialists would be able to say whether a citizen of the Cook Islands married to a New Zealand citizen visiting Australia is eligible for Medicare.

The PBS operates only within Australia.

The Repatriation Pharmaceutical Benefits Scheme (RPBS) provides benefits to veterans whose eligibility is evidenced by gold or white Veterans’ cards (covering all health conditions, and service-related conditions respectively) issued by the Department of Veterans Affairs. The range of medicines covered and the level of subsidy differ from the PBS. All RPBS prescriptions and claims for payment must include the veteran’s card number.

Claims and payments for both the PBS and RPBS are administered by the Health Insurance Commission which also administers claims and payments of Medicare benefits.

PBS claims data held by the Commonwealth is protected by stringent secrecy provisions in the National Health Act 1953, binding guidelines issued by the Privacy Commissioner under section 135AA of that Act, and the Privacy Act 1986.

In 1998-1999 the PBS dealt with nearly 129 million prescriptions at a cost to government of $2.8 billion. In the year to 30 June 2000 annual expenditure on the PBS grew by 14 per cent.


PROBLEMS

The major problems being addressed are problems of accountability in demonstrating that pharmaceutical benefits are obtained only by persons entitled to them. The proposed legislation also goes some way to address problems in maintaining records for consumers for safety net purposes and for consumers' own use.

The high price of some medicines creates an incentive for consumers to seek subsidies even when they are not entitled to them.

At present, the legislation provides that dispensers may not supply a pharmaceutical benefit (that is, they may not supply the medication at the subsidised price) unless they are satisfied that the patient is entitled to a pharmaceutical benefit (subsection 87(3A) of the National Health Act 1953), but they are not required to take any specific action to check Medicare eligibility. General patients (or their agents) verify that pharmaceutical benefits have been supplied by signing prescriptions, but are not required to provide any proof of identity.

Prescriptions show the names and addresses of patients, which is often not exactly the same name and/or address as recorded by the Health Insurance Commission in its Medicare enrolment file. The name and address details included in the prescription are not sufficient to enable eligibility for Medicare to be determined reliably by reference to the Medicare enrolment file.

Concessional beneficiaries are required to produce cards issued by Centrelink or the Department of Veterans’ Affairs and the number of the card is transcribed onto the prescription and is included in the dispenser's claim for payment. Concessional beneficiaries (or their agents) also sign the prescription to confirm supply of the benefit.

Since in the case of a general patient the dispenser is not required to undertake any specific action to ensure that consumer is eligible for Medicare, there is a risk that benefits will be supplied to persons who are not eligible for Medicare, for example tourists from other countries not covered by reciprocal health care agreements, and that the Commonwealth will make payments to dispensers in respect of such supplies of benefits.

In cases where a dispenser considers it would be appropriate to check the eligibility of a consumer, he or she may face difficulties, for example because the consumer is unwilling to produce a Medicare card or the law relating to the case in question is complex, or because the consumer may feel that he or she is being targeted because of cultural or language differences. The lack of legislative backing for specific mechanisms of checking eligibility makes this role difficult for dispensers.

Since non-concessional PBS prescriptions generally do not carry any identifying number for the patient, there is a lack of an appropriate audit trail to demonstrate that the benefit has been supplied, and payment made to the dispenser, in accordance with the eligibility requirements of the legislation.

The lack of identification of general patients also carries the risk that persons eligible for Medicare will receive benefits, and the Commonwealth will pay dispensers, when the legislation does not provide for those benefits. For example, there are statutory limits on how often a person may receive a benefit for the same item - there is a minimum interval of four days, and often 20 days between prescriptions. If a patient presents successive prescriptions for the same item to different pharmacists, this rule cannot be monitored. This weakness facilitates abuse of the scheme by persons obtaining excessive numbers of prescriptions for recreational drug use or commercial export (known colloquially as "doctor shoppers").

When concessional beneficiaries obtain a concessional benefit the number of the relevant card (pensioner concession card, health care card, or Commonwealth Seniors Health Card) is recorded and included in the dispenser's claim for payment. Centrelink provides copies of its card number files to the Health Insurance Commission, which attempts to match the cardholder's name and address details on the Centrelink file to the name and address details on its own enrolment file in order to identify the person. In a significant proportion of cases these details cannot be matched. While the holder of a properly issued card is certain to be eligible for Medicare, the lack of reliable matching to HIC enrolment records means that the benefit histories for individual concessional beneficiaries cannot be reliably assembled and compliance with the rules about the frequency of supply of items cannot be reliably monitored.

Given the size and rate of growth of total PBS expenditure there is a strong public interest in ensuring accountability for the expenditure.

The Health Insurance Commission is not currently able to provide consumers with fully reliable benefit histories to enable them to document their entitlement to the PBS safety net. Consumers are increasingly requesting such histories for safety net and other purposes and are surprised when they find that such histories are unavailable or incomplete.

A final issue of concern is privacy. Some medical practitioners and dispensers may currently collect and retain Medicare numbers in their computer systems, for example when the prescription is of a kind which must be authorised by the Health Insurance Commission at the time of prescribing, in which case the Medicare number is often written on the prescription as part of the authorisation process, or when a medical practitioner has obtained the number in order to "bulk-bill". At present such collection and storage is not subject to any Commonwealth statutory regulation. Some State and Territory legislation may apply to personal health information and professional codes of medical and dental practitioners and pharmacists would generally require protection of patient confidentiality. However, consumers have no clearly defined assurance that their expectations that Medicare numbers provided solely for PBS purposes are not being used or disclosed for other purposes.


OBJECTIVES

The broad aims of Part VII of the National Health Act 1953 are to assist patients to receive high quality health care through quality use of medicines, to subsidise the costs of prescribed pharmaceuticals and to provide appropriate accountability for expenditure of public funds.

The major specific objective of the proposal is to remedy the deficiency, identified above, in accountability for the PBS in demonstrating that benefits have been supplied only to persons who are entitled to them, without impeding legitimate access, while protecting the privacy of the Medicare number when used for this purpose.

A lesser objective is to assist consumers in obtaining safety net entitlements and to obtain information about their PBS prescription history.

The Government announced the Improved Entitlement Monitoring for the PBS initiative in the Budget for 2000-2001.

OPTIONS

Option 1- the Status Quo


The existing arrangements leave it open to prescribers and dispensers to check eligibility by seeking consumers' Medicare card numbers and to include them in prescriptions and claims for payment in respect of supply of pharmaceutical benefits.

Option 2 - Specific entitlement monitoring requirements


This option would involve:
Specifying Medicare numbers as evidence of Medicare eligibility;
Allowing prescribers to ask for Medicare numbers, endorse them on prescriptions, and, with the consumer's consent, store them for use in writing future prescriptions;
Requiring dispensers to ask for Medicare number when a consumer requests supply of an pharmaceutical benefit for which an amount will be payable by the Commonwealth to the dispenser (while providing alternative arrangements for cases where the person is eligible but unable to provide a Medicare number, for example in emergency situations or where the person is a homeless youth and has no documentation);
Requiring pharmacists to include the Medicare numbers on prescriptions and in claims for payment, and making payment conditional on fulfilling this requirement;
Enabling dispensers, with the consumer's consent, to store the number for use in supplying future pharmaceutical benefits; and
Providing privacy protection for this use of Medicare numbers, including prohibition of use or disclosure of Medicare numbers acquired for PBS purposes for other uses.

These arrangements would be introduced in a phased manner in order to give consumers and practitioners time to adapt.


IMPACTS

Impact Group Identification


The groups affected by each of these options can be described as follows:

• the Commonwealth Government and its agencies - the Health Insurance Commission and the Department of Health and Aged Care.

• Businesses such as pharmacies and private hospitals which supply pharmaceutical benefits, medical practitioners and dentists who prescribe PBS medicines.

• Consumers for whom medicines are prescribed - including those not eligible for Medicare and those who are eligible for Medicare but who will generally not be able to provide a Medicare number, such as such as some homeless people and some indigenous people.


Impacts of option 1 - Status Quo

Government


Cost

Under the status quo, costs to the Commonwealth from payments for supply of pharmaceutical benefits to people not entitled would continue. There is potential for increases in these costs in line with increasing numbers of temporary residents in Australia who are not eligible for Medicare.

Benefit


No benefits flow to the Commonwealth Government from maintaining the status quo.

Business

Cost


Maintaining the status quo would have little or no cost impact on business.

Prescribers and dispensers have no incentive to spend extra time and effort in ascertaining Medicare eligibility, and dispensers face a disincentive in lost sales if they refuse to supply benefits to persons as a result of discovering that they are ineligible. Without specific legislative backing, dispensers also face disincentives in accusations of discrimination if they checked Medicare eligibility selectively, or if checking were done non-selectively, indignation from consumers who considered their eligibility self-evident.

Benefit


Maintaining the status quo would have no additional beneficial impact on business unless there were an increase in payments presented for persons not entitled to subsidies in line with increasing numbers of temporary residents in Australia who are not eligible for Medicare.

Consumers


Cost

If the status quo were maintained there would be no cost impact on consumers.


Benefit

Some consumers would continue to receive some PBS subsidies to which they are not entitled.

Impacts - Option 2- Specific entitlement monitoring requirements.

Government


Cost

The costs to the Commonwealth of this option would comprise mainly:

• the cost of a communication and education strategy for consumers, prescribers and dispensers; and
• development of Health Insurance Commission systems.

The total costs would be of the order of $0.25m - $0.75m

Benefit


Indicative cost savings in the health portfolio from reduced outlays on pharmaceutical benefits for people not entitled (ineligible people and eligible people accessing benefits when not entitled) are estimated at $5.7 million in 2000-2001 and $18.4 million in 2001-2002. A total saving in the health portfolio of $66.6 million, and in the Veterans’ Affairs portfolio of $1.7 million is anticipated over four years.

This option would create significant gains in accountability.

Business

Cost


Prescribers might face additional time costs in obtaining Medicare numbers and consent to store numbers, and in including numbers in prescriptions. However, since medical practitioners must obtain Medicare numbers (or have their staff do so on their behalf) in order to bulk bill medical services, this impact should be minimal.

Dispensers would face additional time costs in obtaining Medicare numbers and consent to store numbers (or have their staff do so on their behalf), and in including numbers in prescriptions. Since dispensing and claiming of payment are handled by pharmacy software, there should be little or no impact on time costs in these areas. Dispensers might face reduced turnover arising from fewer supplies of pharmaceutical benefits to people who are not entitled. Dispensers would be encouraged to assist consumers who need to enrol in Medicare or take other administrative action in order to access pharmaceutical benefits: this would generate additional time costs.

There may be costs to prescribers and dispensers in purchasing software updated to take account of the new requirements.

Benefit


Prescribers and dispensers who wished to limit provision of pharmaceutical benefits to people who were entitled would have explicit legislative backing and would have clear procedures to follow for eligible members of vulnerable groups who would have difficulty in producing a Medicare number.

Consumers

Cost


Eligible consumers enrolled in Medicare will face slight time costs in providing Medicare numbers and consent for prescribers and pharmacists to store those numbers. Eligible persons not enrolled in Medicare may face an initial time cost and inconvenience in arranging enrolment and possibly obtaining refunds from the Health Insurance Commission of costs of prescription medicines bought initially on a private basis. Since there will be arrangements in place to enable eligible people who cannot provide a Medicare number to access benefits, there will be no adverse health impact for these consumers.

Ineligible persons will no longer receive subsidised pharmaceutical benefits and will therefore have to pay the full cost or insure themselves.

Benefit


Consumers will be able to access better help from the HIC in obtaining PBS prescription histories in order to assist them to develop the necessary documentation for accessing the PBS safety net.



CONSULTATION

Consultation has been undertaken with representatives of consumers, pharmacy and medical practitioner groups, and the office of the Commonwealth Privacy Commissioner

Broad consumer groups being consulted are the Consumers' Health Forum, the Australian Consumers Association, and the Council on the Ageing.

Groups representing eligible consumers who may have difficulty in providing Medicare numbers are being consulted about special arrangements to enable those people to continue to access Medicare benefits. These include the National Aboriginal Community Controlled Health Organisation (NACCHO) and the Council to the Homeless.

Business / professional groups being consulted include the Pharmacy Guild of Australia, the Australian Medical Association, the Royal Australasian College of Physicians, the Pharmaceutical Society of Australia, the General Practice Partnership Advisory Council, the National Prescribing Service and the General Practice Computing Group

Pharmacy representatives are concerned that the administrative costs should be minimised by streamlining the procedures, especially procedures for entitled persons who cannot provide a Medicare number and procedures for checking that Medicare numbers given are valid.

The AMA has indicated that it is concerned that Medicare numbers may be used as patient identifiers for other functions.

This proposal has also received in principle support from the office of the Commonwealth Privacy Commissioner.

CONCLUSION

As indicated in the issues section above, the status quo has not been successful in ensuring an adequate level of accountability.

The option embodied by the proposed legislation would be significantly effective in addressing the problems with accountability and would go some way to addressing the problems with information for consumers about their PBS histories. It is therefore the preferred option.

IMPLEMENTATION AND REVIEW

As indicated above, the Government announced the Improved Entitlement Monitoring for the PBS initiative in the Budget for 2000-2001.

The initiative will be implemented by:

passage of amendments to the National Health Act 1953 in the current sittings of Parliament, with associated amendments to regulations under that Act and making of instruments, providing for a phased approach as follows:
− Privacy provisions to take effect immediately;
− Prescribers and dispensers allowed immediately to ask for Medicare numbers for future use, and, with consumer consent, to retain those numbers;
− From 1 January 2001, dispensers required to ask for Medicare numbers, with alternative arrangements in place for vulnerable groups, and include the numbers in prescriptions and claims for payment; and
− From 1 July 2001, payment of pharmacists to be conditional on inclusion of Medicare numbers in prescriptions and claims for payment;

Education and information campaigns directed to consumers, prescribers and dispensers will be undertaken from the date of commencement of the legislation:
− The main focus of these campaigns would be to establish the production of a Medicare card as a normal part of having a prescription dispensed;
− This will include information and assistance on options for eligible persons who need to enrol in Medicare, apply for refunds, or seek the voluntary assistance of the dispenser in supplying a medicine in anticipation of the consumer providing the Medicare number later etc;
and
Working with software suppliers to enable them to make the necessary developments in their products

As indicated above, the new arrangements will involve some additional time and effort costs for dispensers, these being concentrated in the first 9 to 12 months of operation.

The effectiveness of the initiative will be assessed mainly by ongoing analysis of PBS claims and expenditure data to evaluate the percentage of claims which lack valid Medicare numbers matching the name on the prescription, changes in expenditure etc. There will also be ongoing monitoring of, and response to, reports from representatives of groups of people who may have difficulty in providing Medicare cards.

As the initiative would be an integral part of an ongoing major program, a sunset provision would be inappropriate.

NATIONAL HEALTH AMENDMENT (IMPROVED MONITORING OF ENTITLEMENTS TO PHARMACEUTICAL BENEFITS) BILL 2000


Notes on Clauses

Clause 1: Short title


This section cites the short title of the proposed legislation as the National Health Amendment (Improved Monitoring of Entitlement to Pharmaceutical Benefits) Act 2000.

Clause 2: Commencement


The section provides that the Act commences on the day on which the legislation receives Royal Assent. Note that some provisions only apply after specified dates (for example, subsection 99(7) applies from 1 July 2001).

Clause 3: Schedules


This section notes that each Act that is specified in the Schedule is to be amended or repealed as set out in the applicable items in the Schedule.

Schedule 1: Amendment of the National Health Act 1953


Item 1

This item amends subsection 84(1) to add a definition of communicated prescription to mean a prescription that is communicated to an approved pharmacist in circumstances set out in regulation 22 of the National Health (Pharmaceutical Benefits) Regulations. Regulation 22 deals with the supply of pharmaceutical benefits before the surrender of written prescriptions. For example, a presciber may ring a pharmacist for an emergency supply of a medicinal preparation to a person, with the prescription paperwork to follow later.

Item 2


This item amends subsection 84(1) to add a definition of expiry date in relation to a medicare number for the purposes of Part VII of the Act. Where the card does not specify a particular expiry date or specify a month at the end of which the card expires, the Minister can specify a date on which it expires.

Item 3

This item amends subsection 84(1) to add a definition of medicare card for the purposes of Part VII of the Act. This is defined as a card issued by the Health Insurance Commission and commonly known as a medicare card. This card evidences a person’s status as an eligible person within the meaning of the Health Insurance Act 1973 (‘Health Insurance Act’), and also evidences a person’s eligibility for pharmaceutical benefits under the Act. Medicare card is also defined to mean a card or written authorisation provided to a person which evidences a person’s eligibility for pharmaceutical benefits under the Repatriation Pharmaceutical Benefits Scheme established under the Veterans’ Entitlements Act 1986, or any other card that may be prescribed in regulations under the Act.

Item 4

This item amends subsection 84(1) to add a definition of medicare number for the purposes of Part VII of the Act. This is defined to mean, in relation to a person covered by a medicare card, the particular combination of numbers, or letters and numbers, on the card applicable to the person covered by that card. It includes the sub-numerate next to a person’s name on the card. This definition also covers the combination of numbers, or letters and numbers, that are applicable to a person as if that person was covered by a medicare card. Persons who are, or who are entitled to be treated as, eligible persons under the Health Insurance Act but do not have a medicare card would include, for example, foreign persons covered by reciprocal health care agreements which entitle those persons to hold a medicare card (such as English citizens) but whom may be travelling and will not stay in one place long enough to obtain a medicare card.

Item 5

This item amends subsection 84(1) to add a definition of special number. This is defined as being the particular combination of numbers, or letters and numbers, allocated in accordance with a procedure determined by the Minister under new subsection 86E(4) of the Act, that is unique to that person as a person included in a class of persons identified by the Minister in a determination under new subsection 86E(1).

This provision is intended to cover those persons who are entitled to pharmaceutical benefits but who, for various reasons, do not have a medicare card or whose medicare number will not be known or available at the time of supply of pharmaceutical benefits. In relation to some groups, a special number may be allocated to the group as a whole, rather than a particular number being allocated to each member of the group. Classes that may be the subject of a determination under subsection 86E(1) include persons who are not legally competent, persons requiring drugs or medicinal preparations in an emergency, persons in respect of whom a prescription is communicated by a practitioner to an approved supplier, and foreign persons covered by reciprocal health care agreements under section 7 of the Health Insurance Act which do not entitle those persons to hold a medicare card (for example, Irish and New Zealand citizens).

Item 6

This item inserts new subsections (8), (9) and (10) after subsection 84(7) of the Act.

Subsection 84(8) provides that the provision to a person or body of a medicare number as a number applicable to a particular individual can be satisfied by either:
• the production to that person or body of a medicare card having on it the medicare number applicable to the particular individual; or
• the provision of any other information, whether in documentary form or provided orally, that indicates the medicare number applicable to the particular individual.

Subsection 84(9) similarly applies in respect of the provision to a person or body of the expiry date in relation to a medicare number provided as a number applicable to a particular individual.

In this way, prescribers and suppliers are not limited to collecting the medicare number, or medicare number and expiry date, only by production of the medicare card.

Subsection 84(10) makes clear that a reference to a medicare number or special number that ultimately appears on a prescription means a number as it appears on the prescription at the time it is sent to the Health Insurance Commission with a claim for payment by an approved supplier.

Item 7

This item repeals the existing section 86 and inserts new sections 86 to 86E.

New section 86 deals with entitlement to receive pharmaceutical benefits. This section makes clear that a person has to be an ‘eligible person’ within the meaning of the Health Insurance Act and be receiving medical treatment by a medical practitioner or dental treatment by a participating dental practitioner in order to be entitled to receive pharmaceutical benefits under the Act.

Section 86A requires that a person must be in Australia at the time of supply in order to receive pharmaceutical benefits under Part VII of the Act

Subsection 86B(1) sets out the grounds on which an approved supplier, such as a pharmacist, may request a person presenting a prescription to provide their medicare number (or the number applicable to the person to whom the prescription relates), and the expiry date in relation to that number.

Subsection 86B(2) makes clear that an approved supplier may request provision of the medicare number, or medicare number and expiry date in relation to that number, even if:
• the prescription already contains a medicare number as a number applicable to the person to whom the prescription relates; or
• the approved supplier already has the medicare number, or number and expiry date, in his or her records.

The checking and endorsement powers of an approved supplier in respect of a prescription (except for a prescription communicated by a practitioner – see subsection 86B(5)) where a medicare number is provided to the approved supplier are set out in subsection 86B(3). These powers enable a supplier to endorse a prescription with a medicare number if the prescription has not already been so endorsed, or confirm, alter or disregard the number where the prescription has already been endorsed and the supplier has better information. Where an expiry date in relation to a medicare number is provided or is contained in the approved supplier’s records, the approved supplier may confirm that the supply of a pharmaceutical benefit authorised by the prescription is not being sought after the expiry date.

This subsection also takes account of the fact that a medicare number (with or without an expiry date in relation to that number) may be provided to the supplier by means other than its inclusion on a prescription. A medicare number may, for example, be provided to the supplier for his or her records on a receipt or piece of paper or orally.

Subsection 86B(4) sets out the endorsement powers of an approved supplier in respect of a prescription (other than a communicated prescription as defined in item 1 above) covering those classes of persons who do not have a medicare number but who have been given a special number by Ministerial determination under subsection 86E(1).

Subsection 86B(5) sets out an approved supplier’s endorsement power in relation to a written version of a communicated prescription (as defined at item 1 above) which does not contain a medicare number as a number applicable to the person to whom the prescription relates. Under subsection 86B(5) the prescription (once the written version is received) may be endorsed by the approved supplier with:
• the medicare number as a number applicable to the person to whom the prescription relates and which is already retained in the approved supplier’s records in accordance with section 86D; or
• the special number applicable to the person under subsection 86E(1) as a person in respect of whom a prescription has been so communicated if the medicare number is not retained in the approved supplier’s records.

From the date of Royal Assent up until 1 January 2001 it is discretionary whether or not an approved supplier requests the provision of a person’s medicare number, or medicare number and expiry date, or endorses the prescription with that number, number and expiry date or special number, or confirms, alters or disregards the number where the prescription is already so endorsed.

Section 86C applies from 1 January 2001. From this date, the approved supplier must request the provision of a medicare number and expiry date where it is not endorsed on a prescription. Where that medicare number is provided to the approved supplier and a benefit is payable under the Pharmaceutical Benefits Scheme, the approved supplier must endorse that medicare number on the prescription. Failure to provide a medicare number when presenting a prescription for the supply of a pharmaceutical benefit (or satisfy the special number requirements) does not preclude a person from paying full price for a drug or medicinal preparation and then seeking the appropriate refund from their local Medicare office or writing to the Health Insurance Commission seeking the refund. This claiming process operates under existing legislation and does not need to be modified.

Under subsection 86C(1), an approved supplier is required to request provision of the medicare number and expiry date in relation to that number if presented with a prescription for the supply of a pharmaceutical benefit to a person where:
• the prescription does not contain a medicare number as a number applicable to the person to whom the prescription relates; and
• the approved supplier’s records do not already contain such a number.
Paragraph 86C(1)(b) ensures that this provision only applies in respect of pharmaceutical items where the Commonwealth is to pay a benefit under the Pharmaceutical Benefit Scheme; that is, where the price exceeds the copayment.

Subsection 86C(2) provides that an approved supplier may request provision of the medicare number and expiry date in relation to that number even if:
• the prescription already contains a medicare number as a number applicable to the person to whom the prescription relates; or
• the approved supplier already has the medicare number and/or expiry date recorded and retained in his or her records in accordance with section 86D.

Subsection 86C(3) provides that an approved supplier must endorse a prescription for the supply of pharmaceutical benefits if a medicare number is provided under subsection 86C(1) or is already included in his or her records in accordance with section 86D, and the prescription has not already been so endorsed.

Subsection 86C(4) provides that where:
• a medicare number is provided under subsection 86C(2) or is included in an approved supplier’s records in accordance with section 86D; and
• the prescription has already been endorsed with a medicare number as a number applicable to the person to whom the prescription relates
the approved supplier may confirm or alter the endorsed number, or may disregard the number provided or included in his or her records in preference for the endorsed number.

Subsection 86C(5) provides that an approved supplier may check to ensure that the supply of a pharmaceutical benefit authorised by the prescription is not being sought after the expiry date of the relevant medicare number.

Subsection 86C(6) sets out the endorsement requirements for an approved supplier in respect of a prescription (other than a communicated prescription as defined in item 1 above) covering those classes of persons who do not have a medicare number but who have been given a special number by Ministerial determination under subsection 86E(1).

Subsection 86C(7) sets out an approved supplier’s endorsement powers in respect of a written version of a communicated prescription not containing a medicare number. Under subsection 86C(7) the prescription (once the written version is received) must be endorsed by the approved supplier with the medicare number as a number applicable to the person to whom the prescription relates if this number is already retained in the approved supplier’s records, or endorsed with the special number applicable to the person under subsection 86E(1) as a person in respect of whom a prescription has been so communicated. Paragraph 86C(7)(b) ensures that this requirement is in respect of a prescription for pharmaceutical items where the Commonwealth is to pay a benefit under the Pharmaceutical Benefit Scheme; that is, where the price exceeds the copayment.

Section 86D sets out the power of approved suppliers to record and retain medicare numbers and expiry dates where that has been authorised by the person providing the medicare number, or medicare number and expiry date. This section enables a medicare number (with or without the expiry date in relation to that number) to be provided to an approved supplier without it already being endorsed on a prescription. For example, it is open to a person to provide their medicare number by showing an approved supplier their medicare card, or by showing a receipt which has the medicare number recorded on it, or by orally advising the approved supplier of the number. The approved supplier must be satisfied that the person providing the number, or number and expiry date, is the person in respect of whom the number was provided, or the person’s legal guardian, or another person capable of giving an authorisation under subsection 86D(1).

Subsection 86D(1) provides that where a medicare number is provided to an approved supplier as the result of a request under section 86B or 86C, or it is provided with a view to facilitating the supply of pharmaceutical benefits in the future, the approved supplier may, with the authorisation of the person providing the number, or number and expiry date:
• record and retain the medicare number, or number and expiry date, in his or her records; or
• if he or she already has those particulars recorded and retained, check the accuracy and completeness of those recorded particulars and modify them if necessary.
These are the permitted storage and retention activities as defined in subsection 86D(6).

Subsection 86D(2) enables an approved supplier to record and retain medicare numbers and expiry dates supplied to him or her by a practitioner in respect of communicated prescriptions (as defined in item 1 above). An approved supplier can only be informed of a medicare number (with or without an expiry date in relation to that number) with the authority of the person whose number it is, or of another person on that person’s behalf, as required under subsection 88(3B) (see item 8 below).

Subsection 86D(3) clarifies that there is no obligation on a person to authorise an approved supplier to record and retain (in an approved supplier’s records) a person’s medicare number, or the expiry date in relation to such a number.

Subsection 86D(4) provides that an approved supplier is responsible for storage and security of those medicare numbers, or numbers and expiry dates in relation to those numbers, retained in his or her records.

Subsection 86D(5) provides that determinations under subsection 86D(1) are disallowable instruments.

Section 86E sets out the powers of the Minister to define classes of persons for whom special numbers are available. The determinations (which must be in writing) under this section are intended to cover persons who are entitled to pharmaceutical benefits but who, for various reasons, do not have a medicare card or whose medicare number will not be known or available at the time of supply of pharmaceutical benefits.

Subsection 86E(1) gives the Minister the power to determine that certain classes of persons be classes in respect of whom an entitlement to pharmaceutical benefits can be evidenced otherwise than by production of a medicare number.

Subsection 86E(2) provides that classes that may be so determined include persons who are not legally competent, persons requiring drugs or medicinal preparations in an emergency, persons in respect of whom a prescription is communicated by a practitioner to an approved supplier, and foreign persons who are covered by reciprocal health care agreements under section 7 of the Health Insurance Act. Persons in the latter class may be required to produce their passport or proof of permanent residency in order to prove their entitlement to pharmaceutical benefits. The Minister may also determine classes of persons not included in the specified examples.

Subsection 86E(3) provides that a determination under subsection 86E(1) may set out the things an approved supplier must be satisfied of before being satisfied that a person falls within a particular class, and the procedure to be followed in establishing such matters.

Subsection 86E(4) requires the Minister to include in each determination under subsection 86E(1) the procedure for allocating a special number applicable to particular classes of persons.

Subsection 86E(5) provides that determinations made under subsection 86E(1) are disallowable instruments.

Item 8


Subsection 88(3A) provides that a medical practitioner or participating dental practitioner may request the provision of a medicare number applicable to a person and the expiry date in relation to that number and, if that number is provided or if it is already retained in the practitioner’s records, endorse that medicare number on a prescription written for that person. This provision also applies to a subsequent written version of a communicated prescription.

Subsection 88(3B) applies in relation to communicated prescriptions. It provides that a medical practitioner or participating dental practitioner must not inform an approved supplier of a person’s medicare number, or medicare number and expiry date in relation to that number, for the purpose of that supplier recording and retaining that number or number and date, unless the person whose number it is or another person authorised on that person’s behalf authorises the practitioner to do so. This subsection is not intended to prevent the subsequent inclusion of a medicare number in the written version of a communicated prescription under subsection 88(3A).

This provision does not place any requirement on medical practitioners or participating dental practitioners to obtain the medicare number from a person or to endorse a prescription with that number. Nor is there any obligation on a person to provide a medicare number to a practitioner or authorise a practitioner to inform an approved supplier of such a number for the purpose of recording and retaining it in the supplier’s records (see subsection 88(3C)).

Item 9


Section 88AA sets out the power of medical practitioners and participating dental practitioners to record and retain medicare numbers and expiry dates.

A person could provide their medicare number to the practitioner by producing their medicare card, or by showing a receipt which has the medicare number recorded on it, or by orally advising the practitioner of the number. The practitioner must be satisfied that the person providing the number, or number and expiry date, is the person whose number it is, or the person’s legal guardian, or a person capable of giving an authorisation under this section. There is provision for the making of determinations by the Minister to specify other persons capable of giving authorisation for the purposes of this section.

Subsection 88AA(1) provides that where a medicare number (whether with or without the expiry date in relation to that number) is provided to a practitioner as the result of a request under subsection 88(3A), or is provided with a view to facilitating the writing of a prescription for the supply of pharmaceutical benefits in the future, the practitioner may, with the authorisation of the person providing the medicare number, or medicare number and expiry date:
• record and retain the medicare number, or medicare number and expiry date, in his or her records; or
• if he or she already has those particulars recorded, check the accuracy and completeness of the record and modify the record if necessary.

Subsection 88AA(2) makes clear that there is no obligation on a person to authorise a practitioner to record and retain (in a practitioner’s records) a person’s medicare number, or the expiry date in relation to such a number, provided as a result of a request under subsection 88(3A).

Subsection 88AA(3) provides that a practitioner is responsible for storage and security of those medicare numbers, or numbers and expiry dates in relation to those numbers, retained in his or her records. The practitioner is also obliged to do everything reasonably within his or her power to prevent unauthorised use or disclosure of the information contained in the record where others have access to that record in connection with the provision of services to the practitioner. The latter may include, for example, persons employed by the practitioner or independent contractors.

Item 10


This item adds subsections 99(7), (8) and (9), which will apply from 1 July 2001.

Section 99 deals with payment for the supply of a pharmaceutical benefit. Subsection 99(7) provides that an approved supplier is not entitled to be paid by the Commonwealth for the supply of pharmaceutical benefits to a person on a prescription presented to the approved supplier from 1 July 2001 unless:
• the prescription ultimately contains a medicare number, or special number, as a number applicable to the person to whom the prescription relates; and
• if the number so appearing is a medicare number, that medicare number corresponds with a medicare number held in the records of the Health Insurance Commission as a number applicable to that person.

This subsection stops payment of benefits to an approved supplier if a valid medicare number or special number is not included on the prescription when the claim is made to the Health Insurance Commission. The reference to the ‘ultimate’ medicare number or special number is intended to cover situations where, for example, a person has forgotten his or her medicare card or a person’s agent is unaware of the person’s medicare number, but the approved supplier is confident that the person is an eligible person. In such situations, it is open to the approved supplier to supply all or part of the pharmaceutical item on condition that the patient later inform the supplier of the patient’s medicare number for endorsement on the prescription.

As stated in item 7 above, failure to provide a medicare number or satisfy the special number requirements when presenting a prescription for the supply of a pharmaceutical benefit does not preclude a person from paying full price for a drug or medicinal preparation and then seeking the appropriate refund from their local Medicare office or writing to the Health Insurance Commission seeking the refund. This claiming process operates under existing legislation and does not need to be modified.

Subsection 99(8) deals with the situation where the medicare number ultimately appearing on the prescription does not correspond with the medicare number applicable to that person which is held in the records of the Health Insurance Commission. Where the sole reason for the non-correspondence of number and name is that the medicare number on the prescription expired within 60 days preceding the date of supply, then the approved supplier is entitled to payment in respect of the supply as if that medicare number had not expired and had continued to correspond with the number and name of the person held in the records of the Health Insurance Commission. The reason payment to an approved supplier is allowed in this situation is that, in most cases, a person in this group will in fact be an eligible person within the meaning of the Health Insurance Act at the time of supply, but their card has expired and a new card has not yet been obtained.

The period of 60 days specified in paragraph 99(8)(e) may be varied by Ministerial determination.

Subsection 99(9) provides that determinations for the purposes of subsection 99(8) are disallowable instruments.

Item 11


This item inserts section 135AAA after existing section 135A concerning privacy of medicare numbers. The language used in new section 135AAA is consistent with that used in existing provisions such as section 135A.

New section 135AAA sets out the privacy requirements for prescribers and approved suppliers in relation to medicare numbers and expiry dates provided for the purposes of the Pharmaceutical Benefit Scheme. Section 135AAA extends the provisions that already apply to persons performing duties under the Act (such as Health Insurance Commission staff) to other persons who will have access to medicare numbers.

Subsection 135AAA is consistent with the Privacy Act in that a medicare number, or medicare number and expiry date, provided to a practitioner or approved supplier can only be used for those purposes for which it was provided. In respect of a medicare number (or medicare number and expiry date) provided to a practitioner, the specified purpose or purposes are:
• to enable a practitioner to write or communicate a prescription for the supply of a pharmaceutical benefit; or
• to enable the medicare number or medicare number and date to be recorded and retained by a practitioner to facilitate the writing of those prescriptions in the future; or
• both of the above purposes (see subsection 135AAA(1)).

In respect of a medicare number (or medicare number and expiry date) provided to an approved supplier, the specified purpose or purposes are:
• to enable an approved supplier to supply a pharmaceutical benefit; or
• to enable the medicare number, or medicare number and date, to be recorded and retained by an approved supplier in his or her records to facilitate the supply of pharmaceutical benefits in the future; or
• to enable an approved supplier to record and retain that medicare number, or medicare number and date, in order to complete the written version of a communicated prescription; or
• all or several of the above purposes (see subsection 135AAA(3)).

It is an offence for a practitioner (subsection 135AA(1)) or an approved supplier (subsection 135AAA(3)) to directly or indirectly make an unauthorised disclosure or unauthorised use of a medicare number or expiry date in relation to that number where that number and date have been provided for one or several of the above purposes. Under subsections 135AAA(2) and (4) an unauthorised disclosure or unauthorised use occurs where such disclosure or use is not made or undertaken:
• in the performance of the duties, or in the exercise of the powers or functions, of that person as a practitioner or approved supplier under the Act in relation to the Pharmaceutical Benefits Scheme; or
• for the purpose of enabling a person to perform functions under the Health Insurance Act in relation to the Pharmaceutical Benefits Scheme.

The penalty for a breach of subsection 135AAA(1) or (3) is 50 penalty units ($5000) or imprisonment for 2 years, or both.

Subsection 135AAA(5) extends the prohibitions in subsections 135AAA(1) and (3) to persons employed or engaged by a practitioner or an approved supplier, or a company that provides services in support of a practitioner or approved supplier.

The prohibition on disclosure continues to apply even after a person ceases to be a practitioner, approved supplier, or employed or engaged by a practitioner or approved supplier, and is subject to the same obligations and liabilities as specified above.

Subsection 135AAA(6) provides that a person to whom a medicare number, or medicare number and expiry date in relation to that number, is disclosed in contravention of subsection 135AAA(1), (3) or (5) is guilty of an offence if:
• the person knows or ought reasonably to know that the disclosure of the medicare number, or medicare number and expiry date, was in contravention of that subsection; and
• the person directly or indirectly discloses that medicare number or that expiry date to any person, or otherwise makes use of that number or that date.
The penalty for this offence is also 50 penalty units ($5000) or imprisonment for 2 years, or both.

Under subsection 135AAA(7), a person or body to whom a medicare number, or medicare number and expiry date in relation to that number, are provided for a purpose referred to in subsection 135AAA(1), (3) or (5) (see above), may disclose that number or expiry date to another person for another specified purpose with the express authority of the person in respect of whom that number was provided, or the person’s legal guardian, or another person capable of giving an authorisation (as determined by the Minister under section 86D or 88AA).

A person to whom the medicare number, or medicare number and expiry date, is disclosed in accordance with an express authority under subsection 135AAA(7), is guilty of an offence under subsection 135AAA(8) if the person:
• directly or indirectly discloses that number or that date to another person; or
• makes use of that number or that date;
other than for the purpose specified by the person giving the authority under subsection 135AAA(7).

Subsection 135AAA(9) provides that a medicare number or expiry date in relation to such a number can still be communicated to a court for the purpose of proceedings under section 135AAA.

Subsection 135AAA(10) defines approved supplier, expiry date, medicare number and participating dental practitioner to have the same meaning within section 135AAA as in Part VII of the Act dealing with pharmaceutical benefits.

Item 12


This item inserts new subsection 135AA(5A) after existing subsection 135AA(5). The amendment is of a consequential nature to allow the Health Insurance Commission to continue to store pharmaceutical benefits information. It does not disturb the effect of the current guidelines for storing information developed by the Privacy Commissioner and issued under section 135AA.

Subsection 135AA(5A) allows a pharmaceutical entitlements number (defined in item 14 below) applicable to a person to whom a claim for benefits under the Pharmaceutical Benefits Program relates, to be included in a database held by the Health Insurance Commission. This subsection will include persons covered by a benefit entitlement card as defined in item 13 below, and persons included within a class determined by the Minister under subsection 86E(1).

Item 13


This item inserts a new definition into subsection 135AA(11). The term benefit entitlement card is defined to mean a medicare card as defined in item 3 above, and a card which provides evidence of a person’s status as a concessional beneficiary within the meaning of subsection 84(1). This amendment ensures that the terms used in the Act and in the guidelines issued by the Privacy Commissioner under section 135AA are consistent.

Item 14


This item amends subsection 135AA(11) to add a definition of pharmaceutical entitlements number. This term has been added to ensure consistency with the guidelines issued by the Privacy Commissioner under section 135AA. Pharmaceutical benefits number is defined to have the same meaning as that for the term medicare number (defined in item 4 above), but also includes the number on a card issued by the Commonwealth to a concessional beneficiary (see subsection 84(1) of the Act).

 


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