Highly Specialised Drugs (HSDs) program
Background
Highly Specialised Drugs (HSDs) are medicines for the treatment of chronic conditions which, because of their clinical use or other special features, are restricted to supply through public or private hospitals having access to appropriate specialist facilities. To prescribe these drugs as pharmaceutical benefit items, medical practitioners must be affiliated with these specialist public hospital units. A general practitioner (GP) or non-specialist hospital doctor, who is not affiliated with the public hospital, may only prescribe HSDs to provide maintenance therapy under the guidance of the treating specialist affiliated with the public hospital. The HSD program is a joint initiative of the Australian Government and the states and territories.
In 2008, Council of Australian Governments (COAG), in conjunction with the Department of Health and Ageing (DoHA), agreed to cease funding public patient access to HSDs through Special Purpose Payments (SPPs) to states and territories, and fund these payments through an alternative Commonwealth Own Purpose Expenditure (COPE) mechanism.
As part of this change, Medicare Australia will administer the HSD program and Pharmaceutical Benefits Scheme (PBS) trastuzumab from 1 July 2009, with payments initially being made through an offline solution, to states and territory health departments (or equivalent).
The legislative basis of this program is a special arrangement made under section 100 of the National Health Act 1953.
From late 2009, Medicare Australia will provide a full online paperless eClaiming and payment process for all approved public hospitals supplying HSDs. Hospitals which want to claim HSDs under these arrangements will need a section 94 approval which will allow them to claim HSDs through Online Claiming for PBS. In the interim period, while approved public hospitals transition to the online process, an offline solution will be available.
Offline solution (Phase 1)
In the interim period (2009 – 2012), while approved HSD public hospitals transition to the eClaiming (online) solution for HSD payments to the states and territories, Medicare Australia will implement an offline solution to process these payments. This offline solution will commence from 1 July 2009 and will cease on 30 June 2012 when all approved HSD public hospitals who want to claim HSDs and PBS trastuzumab will need to be approved under S94 and must have implemented the full online eClaiming solution through Online Claiming for PBS (Phase 2).
State and territory health departments will receive, by email from Medicare Australia, an updated claim form (Excel spreadsheet) each month to claim eligible HSDs that have been dispensed through approved HSD public hospitals.
View a flow diagram of the offline solution - HSDs in public hospitals overview flowchart [PDF, 29Kb]
.
Online solution (Phase 2)
Phase 2 involves the development and implementation of a full eClaiming solution through Online Claiming for PBS and is planned to be rolled out gradually and implemented over a three (3) year period from 2009.
Medicare Australia plans to start Phase 2 roll out in late 2009. More information on how this will affect you will soon be available for public hospitals that are ready to move from Phase 1 to Phase 2.
Patient eligibility
A patient must attend a HSD approved public hospital and be (for both the offline and online solution):
- a day admitted patient
- a non-admitted patient
- a patient on discharge.
The patient must be under appropriate specialist medical care. They must also be an eligible person under the Health Insurance Act 1973 (the Act, as amended from time to time). If the criteria under the Act should change, then the eligible person requirements will adjust accordingly. An eligible person means being:
- an Australian resident
- a person covered by a Reciprocal Health Care Agreement
- an eligible overseas representative.
An Australian resident is a person who resides permanently in Australia and is:
- an Australian citizen
- a person who holds a permanent visa
- a New Zealand citizen
- an applicant for a permanent residence in certain circumstances (see INTERIM CARD below).
An eligible person is entitled to have one of the following Medicare cards:
- Medicare card (green) issued to Australian permanent residents
- Medicare card (blue) stamped INTERIM CARD, issued in certain circumstances to persons who have applied for permanent resident status. These cards have an expiry date beyond which eligibility is invalid for PBS subsidy (including HSDs)
- Medicare card (green) stamped RECIPROCAL HEALTH CARE, issued to visitors from the UK, Malta, Italy, Sweden, Finland, Norway and the Netherlands.
- Visitors from New Zealand and the Republic of Ireland are not issued with cards, their eligibility for the PBS is on presentation of their passports.
- Visitors from Belgium will be eligible for reciprocal health care, on presentation of their passports or a Medicare card (green) stamped RECIPROCAL HEALTH CARE, from 1 September 2009.
- Supply of drugs to eligible persons from the above countries is limited to the original prescription only. Repeat prescriptions for these patients are not permitted.
An eligible person who has enrolled in Medicare, but is waiting for, and has not yet received their card, may utilise their Medicare card receipt (with their Medicare number printed on it) as evidence of eligibility.
An eligible overseas representative is:
- the head of a diplomatic mission or consular post, established in Australia comprised of those countries with which Australia has a Reciprocal Health Care Agreement, except for New Zealand and Norway
- staff of those diplomatic missions or consular posts
- family members of heads or staff of those diplomatic missions or consular posts.
Eligible overseas persons will have a Medicare card (green).
Prescriber eligibility
A person eligible to prescribe HSDs will be:
- a staff hospital specialist
- a visiting or consulting hospital specialist
- an accredited prescriber of HIV/AIDS medication
- an accredited prescriber of Hepatitis C maintenance medication
- a hospital doctor or GP.
Hospital based doctors and GP may prescribe HIV/AIDS HSDs where they are accredited prescribers of HIV/AIDS medication.
GPs and community based non-specialist doctors may prescribe hepatitis C HSDs for maintenance where they are accredited prescribers of hepatitis C medication
A GP or non-specialist hospital doctor can be accredited to prescribe HIV/AIDS medication following relevant state or territory approval
A GP or community based non specialist doctor can be accredited to prescribe hepatitis C maintenance medication following relevant state or territory approval
Hospital based doctors and community based non-specialist doctors may prescribe HSDs to provide maintenance therapy:
- in situations where it is impractical to obtain a prescription from the treating specialist and with that specialist’s agreement
- where the state/territory and Commonwealth agree on a specific arrangement.
Dispensing requirements
HSDs and PBS trastuzumab must be dispensed by pharmacists in HSD approved public hospitals to be eligible for payment under this program.
Where a HSD public hospital utilises an outreach service to prison or similar, or a community pharmacy supplies HSDs as an agent of the hospital, the claim must be lodged by the HSD public hospital overseeing the dispensing.
Applicable medicines
Only those drugs determined to be HSDs, and trastuzumab (Herceptin®) funded through the PBS for early stage breast cancer are included in these arrangements. Trastuzumab (Herceptin®) for late stage breast cancer is funded outside the PBS and is not included in these arrangements.
For further information visit the PBS
website.
Complex Authority Required Highly Specialised Drugs (CAR HSDs) and PBS trastuzumab
Complex Authority Required (CAR) drugs and PBS trastuzumab are HSDs that have additional requirements, including the need for approval from Medicare Australia prior to dispensing. As of 1 July 2009, the CAR HSDs include:
- Abatacept
- Bosentan
- Epoprostenol
- Etanercept
- Iloprost
- Infliximab
- Rituxumab
- Sildenafil Citrate
- Sitaxentan
Complex Authority Required Highly Specialised Drugs (CAR HSDs)
Patient co-payments
All eligible patients will incur a co-payment fee in respect of each supply of medication so as to complement charges levied on medications received through the PBS or the Repatriation Pharmaceutical Benefits Scheme (RPBS).
HSD approved public hospitals will be required to establish all patient eligibility for concessional benefits.
Medicare Australia will deduct co-payments from claims. Currently, the agreed deduction will be 0.8 per cent of the item price.
PBS Safety Net
All items dispensed under this initiative will be eligible to accrue to an eligible person’s PBS Safety Net threshold.
Under the PBS Safety Net, patients whose annual out-of-pocket costs for prescription medicines exceed a specified threshold receive additional PBS benefits. The PBS Safety Net threshold may be reached using prescriptions filled at both community pharmacies and out-patient pharmacies at public hospitals.
Medicare Australia can only pay refunds for PBS items supplied through approved pharmacies. Refunds for hospital supplied items should be referred to the relevant state/territory hospital or health department
More information on the PBS Safety Net.
Contacts
The following information is for the use of state and territory Health departments only.
Medicare Australia will only liaise with state and territory health departments. Individual HSD public hospitals will need to liaise through their respective health department.
Phone: 1800 700 270** (option 5)
Email: public.hospital.HSD@medicareaustralia.gov.au
Fax:1300 093 177*
Mail:
HSD in Public Hospitals Program
GPO Box 9822
Hobart Tasmania 7001
* Call charges apply.
** Call charges apply from mobile and pay phones only.
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Last updated: 13 January, 2010