Program Information

Program Objectives

• To provide funding arrangements to meet the cost of drugs with a high unit cost that have a significant role in maintaining patients in a community setting.
• To clearly define the funding responsibilities of the Commonwealth and the States/Territories for these drugs.

Background

Establishment

The Commonwealth/State Highly Specialised Drug Program was established through an initiative of the Australian Health Ministers' Advisory Council (AHMAC) in 1991.
The agreement between the Commonwealth and the States/Territories was signed in September 1991 for the funding of Cyclosporin and Erythropoietin, and the Commonwealth reimbursed its share of the expenditure from 1 January 1991. This agreement is revised on an ongoing basis, with the addition and deletion of drugs as determined by the Pharmaceutical Benefits Advisory Committee.

Policy & Program Development

AHMAC's Highly Specialised Drugs Working Party

Overview

The Highly Specialised Drugs Working Party (HSDWP) was established in 1991 to provide advice to health Ministers and the Pharmaceutical Benefits Advisory Committee (PBAC). The HSDWP has representation from the health departments of each State and Territory, the Commonwealth and the Australian Hospitals Association.
The HSDWP is not a technical committee but considers the funding and administrative aspects of the supply of certain specialised drugs through the hospital system.
Role of the Highly Specialised Drugs Working Party
The role of AHMAC's Highly Specialised Drugs Working Party is to:

• Identify drugs which might be suitable for funding under the Highly Specialised Drugs arrangements and provide advice to the PBAC;
• Provide advice on applications made directly to the PBAC for supply as pharmaceutical benefits under the special supply arrangements under section 100 of the National Health Act, where the PBAC has recommended supply under these arrangements;
• Monitor new drugs which potentially might come under the funding arrangements;
• Monitor the quality of drugs supplied under these arrangements; and
• Investigate and make recommendations on procedures to monitor drugs supplied by hospitals, under the highly specialised drugs arrangements, to patients in community settings.

Appendix 1 contains the terms of reference, the membership of the Committee, and the selection criteria for identifying drugs to be included in the Program. Submissions by hospitals to the Department should follow the format suggested in Appendix 1.

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Pharmaceutical Benefits Advisory Committee

Overview
The Pharmaceutical Benefits Advisory Committee is established under the National Health Act 1953 to make recommendations to the Federal Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits, and to advise the Minister about any other matters relating to the Pharmaceutical Benefits Scheme. The Committee is also required by the Act to consider the effectiveness and cost of a proposed benefit relative to other therapies.

Role of the Pharmaceutical Benefits Advisory Committee

The Committee considers the effectiveness, cost effectiveness and clinical place of a product relative to other products already listed in the Pharmaceutical Benefits Scheme (PBS) for the same or similar indications. Where there is no listed alternative, the Committee considers the benefits that the new product will provide for patients compared with the cost of achieving those benefits.

The PBAC considers submissions from interested parties, such as the Highly Specialised Drugs Working Party or the drug's manufacturer, for inclusion of a pharmaceutical under the special funding arrangements under section 100 of the National Health Act. When PBAC recommends a drug for inclusion in the Highly Specialised Drugs Program it also defines the clinical indications which the Commonwealth will subsidise. The PBAC is obliged to make recommendations about a product consistent with the uses of the drug that have been approved for marketing by the Therapeutic Goods Administration.
In recommending listings, the PBAC also advises the Pharmaceutical Benefits Pricing Authority about the cost effectiveness of new products in relation to those products already listed.

Process for Incorporating New Drugs in the Program

The process of incorporating new drugs in the highly specialised drugs arrangements parallels the process for general benefits listings, with two exceptions:

• drugs need to be assessed to ensure they conform to the criteria for eligibility as Highly Specialised Drugs. This may occur where the drugs are identified by the HSDWP or the drugs are referred to the HSDWP by the Pharmaceutical Benefits Advisory Committee; and
• Commonwealth subsidy of the drug cannot commence until States and Territories have agreed to the administrative arrangements for each drug. 

Principles

Patient Eligibility

• The patient must be entitled to hold a Medicare Card in accordance with the National Health Insurance Act 1953 or be an eligible overseas representative. Appendix 4 provides the extract on patient eligibility as set out in the Commonwealth/State Administrative Arrangements.
• Prescribing of the drug must be in accordance with the criteria recommended by the Pharmaceutical Benefits Advisory Committee which are set out in Appendix 2.

Prescriber Eligibility Guidelines

A person eligible to prescribe HSDs can be a staff hospital specialist, a visiting or consulting hospital specialist, or a hospital doctor or general practitioner who has gained accreditation through a recognised State program.
Hospital based doctors and general practitioners may prescribe HSDs in the following situations:

• Where they are accredited prescribers of HIV/AIDS and/or Hepatitis C medication;
• To provide maintenance therapy in situations where it is impractical to obtain a prescription from the treating specialist and with their agreement; or
• Where the State/Territory and Commonwealth agree on a specific arrangement.

A general practitioner or non-specialist hospital doctor can be accredited to prescribe HIV/AIDS and/or Hepatitis C medication following State or Territory approval.

Funding

• The Commonwealth is responsible for meeting the cost of drugs approved for the Highly Specialised Drugs Program in accordance with the PBAC criteria for patients in a community setting.
• Patients must be charged a co-payment in accordance with their status under the Commonwealth/State Joint Pharmaceutical Safety Net Scheme. A co-payment is charged per medication per one month supply, regardless of the number of strengths required to make up that supply.
• Hospitals fund the use of drugs in accordance with the PBAC criteria for overnight stay or inpatients.
• Hospitals fund the use of drugs which do not meet the PBAC criteria.
• For the purposes of this Program the costs borne by the Commonwealth for 'community patients' have been defined in the following terms.

"The Commonwealth Government meets the agreed price, above the patient standard contribution, for each issue of specified, highly specialised drugs provided through hospital pharmacies associated with the Highly Specialised Drugs Program for patients in the community when the drugs are provided in accordance with restrictions identified under section 100 of the National Health Act. The Commonwealth Government covers the cost of these medicines for patients in the community or attending day services, ie. non inpatients."

• An amount representing the estimated average co-payment collected, is deducted from the Commonwealth payments to States. The co-payment is determined by a formula applied by the Commonwealth based on the number of patients, by drug, as reported by the State and represents the proportion of general, concessional and fully safety net patients extrapolated from Pharmaceutical Benefits Scheme information. This formula also assumes patients receive a monthly supply of the drug. Further details of co-payment deductions are provided in Appendix 8. This amount is currently calculated at 0.8% of the gross expenditure.

Agreed Price Lists

The Pharmaceutical Benefits Pricing Authority is responsible for negotiating a national price list with the drug's supplier. The Commonwealth Department of Health and Ageing provides information on agreed price based on the Pharmaceutical Benefits Pricing Authority's negotiated position. This price list, referred to as the agreed price, is used as the basis for reimbursement and is set out at Appendix 3. This Appendix will be updated as required by hospital circular which will be dated with effective dates. Hospitals should not purchase the drugs at a higher price, however, if a higher price is paid, reimbursement will only be at the agreed price.

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PRIVATE HOSPITALS

As of 1 November 2000, the Commonwealth, via Medicare Australia, will administer Highly Specialised Drugs (HSDs) supplied through private hospitals.

Prescribers in private hospitals will need to obtain prior authority approval from Medicare Australia on PBS/RPBS prescription pads before these drugs can be dispensed. When telephoning for approval specify it is an HSD authority immediately. Not more than 2 months supply (one for Clozapine) and 5 repeats will be authorised.

Authority approval:

PBS - FREE CALL 1800 888 333
RPBS - FREE CALL 1800 552 580

Prescriptions for Highly Specialised Drugs originating from a private hospital can be dispensed by a community pharmacy. Private hospitals submit their claims for Highly Specialised Drugs directly to Medicare Australia, as with other PBS/RPBS scripts. All private hospitals currently dispensing HSDs are automatically approved. Private hospitals seeking approval to participate in the HSD Program after 1 November 2000 should contact the Commonwealth Government Adviser on 02-6289 7238.
Further information is available from the Medicare Australia on 132 290 or in the Schedule of Pharmaceutical Benefits.

Funding and Reporting Arrangements

Hospital Obligations
To receive funding under the Highly Specialised Drugs Program the hospital must abide by the following conditions otherwise payments may be suspended until all criteria are met.

• Clinical Eligibility

Claim for only eligible patients who meet the PBAC clinical indications and the restrictions as set out in Appendix 2 .
Note: Eligibility for Commonwealth funding is patient based. A hospital referring a patient to another hospital should provide a certified statement that the person meets the Pharmaceutical Benefits Advisory Committee's clinical criteria. Likewise, hospitals dispensing drugs prescribed by general practitioners authorised to treat people with HIV/AIDs and/or Hepatitis C (as listed in Appendix 6) or that have an arrangement with another public hospital (such as a rural hospital providing drugs to patients treated by metropolitan teaching hospitals) must receive a certified statement that this person meets the PBAC clinical criteria from the prescribing doctor before the drug is dispensed.

• Patient Certification

Prescribing doctors must certify that the patient meets the Pharmaceutical Benefits Advisory Committee criteria using a form(s) similar to that in Appendix 5. The Pharmaceutical Benefits Advisory Committee's clinical criteria must be stated on the certification form for each drug. It is recommended that this form is printed on coloured paper, and is provided to the pharmacist. The forms are to be held by the hospital for audit, and under no circumstances should they be provided to the Department as this would breach patient confidentiality requirements.
If treatment ceases, the certification form should be placed on the patient's medical record or kept in pharmacy for at least 3 years. Any break in continous treatment requires re-certification.

• Co-payment

Where applicable, charge patients the appropriate fee according to their status under the Joint Commonwealth/State Pharmaceutical Safety Net Scheme; either general patient rate or concessional rate.
A patient is required to pay a contribution for each supply of a highly specialised drug.

• Payment

Public hospitals must claim on a monthly basis for the quantity of the drugs dispensed in accordance with the Health Service Agreement and using the online claim accessed through Appendix 8. Most public hospitals are paid on a fortnightly basis in advance, based on estimates provided to the Department by each hospital. The payment for Highly Specialised Drugs is contained within the fortnightly Specified Grants payment, with the breakdown being found in the cash flow statements provided to each public hospital's finance department. Small Rural Health Services will be paid by reimbursement following processing of their claim.
Claiming can be done monthly through the online claiming portal. The claiming portal will be open for one week at the start of each month, the responsibility for making a claim rests with the hospital.

• Information Management

Maintain an information system to enable auditing of claims on a patient basis. However, it is not necessary that all the information is held in one location/database. Appendix 7 contains a list of the information to be held.
Hospitals are reminded that nominated Hepatitis C centres must, as a condition of funding, comply with all requirements of the National Hepatitis C Database.Details for the Project/Data Manager for the Hepatitis C Database are as follows:
Project/Data Manager
Hepatitis C National Database
Locked Bag 1
Hunter Regional Mail Centre
NEWCASTLE NSW 2310
Tel: (049) 217 431

• Audit certification

At the end of each financial year, (ie 30 June) undertake an audit of at least 3%of all patients on the Program at the hospital during that financial year and provide a certified statement to the Department, from the Director of Medical Services, the Chairperson of the Pharmacy Advisory Committee or other person nominated to undertake the audit, by 30 September. (ie: no later than 3 months after the end of the relevant financial year.) It is important to complete the audit and submit the certification document by the due date to ensure our records are current. Failure to do so may result in claim reimbursements being withheld until the audit and certification procedures are completed.
The original of the certification document must be sent to:

The Program Manager
Highly Specialised Drugs Program
Metropolitan Health and Aged Care Services
Department of Human Services
19/50 Lonsdale Street
MELBOURNE VIC 3000

A copy of the original certification should be sent to the relevant Department of Human Services Regional Office.

Suggested wording for the audit certification statement is set out below.

"On the basis of an audit of the records of hospital's name in full, I certify that during the financial year 200X/200X, all community patients who received drugs funded under the Highly Specialised Drug Program met all the requirements of the Program, including compliance with the Pharmaceutical Benefits Advisory Committee's clinical indications and Medicare eligibility as set out in the Commonwealth/State Highly Specialised Drugs Program Guidelines amended at (indicate date of most recent amendment including updates via hospital circular)"

The certification statement must clearly indicate the signature, name and position of the person undertaking and certifying the audit. The audit must be undertaken by the person nominated to do so on behalf of the hospital.

Note: Appendix 7 contains the minimum audit requirements.

Financial Reporting Requirements

Monthly Claiming

The process for claiming is set out in Appendix 8.

Public Hospitals shall submit a certified claim form for reimbursement to the department within 30 days after the end of each month. In all cases claims should specify the following:

• Number of eligible patients by type of drug
• Number of items dispensed by dosage
• Total expenditure by dosage
  

It should be noted that the Commonwealth has advised that any outstanding retrospective claims made by hospitals for a previous financial year will not be met. All claims must be sent to the Department of Human Services within 1 month of the end of the financial year.

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