Highly Specialised Drugs (HSD) program

Background

Highly Specialised Drugs (HSD) are subsidised through the PBS. These medicines are for the treatment of chronic conditions that, because of their clinical use or other special features, are restricted to supply through public and private hospitals that have appropriate specialist facilities. To prescribe these medicines under the Pharmaceutical Benefits Scheme (PBS), medical practitioners must be affiliated with these specialist public or private hospital units. A medical practitioner or non-specialist hospital medical practitioner, who is not affiliated with the public or private hospital, may only prescribe HSD to provide maintenance therapy under the guidance of the treating specialist affiliated with the public or private hospital.

The HSD program is a joint initiative of the Australian Government and the states and territory governments.

In 2008, the Council of Australian Governments (COAG) agreed to stop funding public patient access to HSD through Special Purpose Payments (SPP) to states and territories, and fund these payments through a new Commonwealth Own Purpose Expenditure (COPE) mechanism.

As part of this change, Medicare Australia started administering the HSD program and PBS trastuzumab early stage (Herceptin®) program with payments being initially made to state and territory health departments through an offline claiming solution.

The legislative basis of this program is an arrangement made under section 100 (s100) of the National Health Act 1953 (NH Act).

From 1 July 2010, Medicare Australia began providing an electronic paperless online claiming and payment process for all public hospitals supplying HSD. Electronic claiming and payment is via Medicare Australia’s existing Online Claiming for PBS claiming channel.

Public hospitals that want to claim HSD under this initiative will need a section 94 (s94) approval (or section 100 in the case of non-dispensing public hospitals) under the NH Act which will allow them to supply PBS medicine.

Special arrangements are in place under s100 of the NH Act to allow HSD to be claimed by non-dispensing public hospitals. Non-dispensing public hospitals will need a s100 approval under the NH Act which will allow them to claim HSD.

A non-dispensing public hospital is allowed to use an agent for the supply of HSD provided the non-dispensing public hospital has obtained s100 approval. Non-dispensing public hospitals will be treated as if they were approved under s94, for the purposes of claiming under this program.

HSD are listed under section 100 of the Schedule of Pharmaceutical Benefits (the Schedule) and are listed as Authority required (STREAMLINED), with the exception of Complex Authority Required (CAR) medicines which will remain as Authority required. The medical practitioner does not need prior approval from Medicare Australia when prescribing Authority required (STREAMLINED) HSD for public hospital HSD clinic patients. In order to supply the medicine as a PBS benefit, the public hospital pharmacist should make sure the medical practitioner has included the four digit streamlined authority code on the prescription.

To gain access to a government funded medicine under this program, a patient must attend a participating hospital and be a:

• day admitted patient
• non-admitted patient or
• patient on discharge.

A Government subsidy is not available for hospital in-patients. Patients must also be under appropriate specialist medical care, meet the specific medical criteria and be an Australian resident in Australia (or other eligible person).

Phase 1—offline solution

Medicare Australia currently makes payment to state and territory health departments for HSD dispensed by approved public hospitals using the offline solution or when claiming CAR HSD through the Claims Transmission System (CTS). The offline solution and CTS will remain in place until 31 December 2012. This is to allow time for HSD public hospitals wanting to claim HSD and PBS trastuzumab to be approved under s94 (or s100 for non-dispensing public hospitals) and implement electronic claiming through Online Claiming for PBS (Phase 2).

View a flow diagram of the offline solution - HSD in public hospitals overview flowchart [PDF, 49Kb].

• Claiming Procedures
• Payments
• Audits

 More information on payment and reconciliation can be found in the HSD in public hospitals – Offline Solution Guide [PDF, 635Kb].

Phase 2—online solution

From 1 July 2010, Medicare Australia began providing an electronic paperless online claiming and payment process for all public hospitals supplying HSD. This online solution provides a simple, secure, electronic claiming option for public hospitals when claiming for PBS HSD. Public hospitals wanting to claim HSD under this program will require a s94 approval (or s100 approval for non-dispensing public hospitals), which will allow them to supply and/or claim HSD.

The electronic claiming system will be integrated into the existing Online Claiming for PBS system. Public hospitals not currently using Online Claiming for PBS will need to apply to Medicare Australia to use Online Claiming for PBS.

Public hospitals participating in the Pharmaceutical Reform Arrangements (participating public hospitals) already using Online Claiming for PBS can claim HSD through their existing online claiming system. 

Participating public hospitals not currently using Online Claiming for PBS and public hospitals not participating in the Pharmaceutical Reform Arrangements (non participating public hospitals) will need to either change or upgrade their software to allow them to claim HSD through Online Claiming for PBS or continue to claim using the offline solution (or through CTS for CAR HSD) until they make the changes to their dispensing software.

Online Claiming for PBS for public hospitals

Become an approved supplier/Hospital authority

PBS for prescribers

PBS for pharmacists

More information on payment and reconciliation can be found in the Online Information Guide [PDF, 1.4Mb].

Information for hospitals and pharmacies

Prescriber eligibility

A person eligible to prescribe HSD will need to be:

• a registered staff hospital specialist
• a visiting or consulting hospital specialist
• an accredited medical practitioner of HIV/AIDS medicine
• an accredited medical practitioner of Hepatitis C maintenance medicine
• a hospital medical practitioner or general practitioner (GP) to provide maintenance therapy.

Prescribers must have a prescriber number to prescribe HSD. The prescriber number must be recorded on all public hospital prescriptions for HSD.

Hospital based medical practitioners and GPs may prescribe HIV/AIDS HSD where they are accredited prescribers of HIV/AIDS medicines.

GPs and community based non-specialist medical practitioners may prescribe hepatitis C HSD for maintenance where they are accredited prescribers of Hepatitis C medicine.

A GP or non-specialist hospital medical practitioner can be accredited to prescribe HIV/AIDS medicines following relevant state or territory approval.

A GP or community based non-specialist medical practitioner can be accredited to prescribe Hepatitis C maintenance medicine following relevant state or territory approval.

Public or private hospital based specialist medical practitioners may prescribe HSD for initiation therapy. Community based non-specialist medical practitioners may only prescribe HSD to provide maintenance therapy:

• in situations where it is impractical to get a prescription from the treating specialist and with that specialist's agreement; and
• where the state or territory and Commonwealth agree on a specific arrangement.

A person eligible to prescribe trastuzumab funded through the PBS for early stage breast cancer (PBS trastuzumab) must be a medical practitioner.

Dispensing requirements

Public hospital non-CAR HSD can only be dispensed and claimed by public hospital pharmacies, or by a community pharmacy or friendly society who acts as an agent for the public hospital.

If a community pharmacy or friendly society acts as an agent for the public hospital, the claim for the HSD must be lodged by the public hospital overseeing the dispensing.

Public hospital CAR HSD may be dispensed and claimed by either the public hospital pharmacy or a community pharmacy.

Private hospital HSD (CAR and non-CAR) can be dispensed and claimed by a private hospital pharmacy or by a community pharmacy.

Community pharmacies cannot claim public hospital non-CAR HSD.

Pharmacists are authorised to supply pharmaceutical benefits only after they receive:

• a valid Repatriation Pharmaceutical Benefits Scheme (RPBS) prescription which is no more than 12 months old from the date of prescribing by the medical practitioner
• an approved authority PBS/RPBS prescription or an authority to prescribe which is no more than 12 months old from the date of prescribing by the medical practitioner
• a repeat authorisation attached to a PBS/RPBS prescription no more than 12 months after the date of the original PBS/RPBS prescription.

Note: a public hospital pharmacist must not supply an Authority required (STREAMLINED) medicine unless the medical practitioner has written the four digit streamlined authority code on the PBS/RPBS prescription. Streamlined codes are not for private hospital HSD patients and cannot be dispensed in community pharmacies.

Patient eligibility

A patient must attend a public or private hospital and be a:

• day admitted patient
• non-admitted patient
• 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 HI Act). An eligible person must be:

• an Australian resident
• a person covered by a Reciprocal Health Care Agreement
• an eligible overseas representative.

If the criteria under the HI Act should change, then the eligibility requirements will adjust accordingly.

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 (not a parent application) who has a valid visa with permission to work or has a parent spouse or child who is an Australian citizen or holds permanent resident status   (holds an interim card - see INTERIM CARD below).

Interim Card

Important: Repeat prescriptions for interim cardholders are not permitted.

An eligible person is entitled to have:

• a Medicare card (green) which is issued to Australian permanent residents and Australian citizens.
• a Medicare card (blue) stamped INTERIM CARD, which is issued in certain circumstances to persons who have applied for permanent resident status. These cards may have an expiry date later than the eligibility date both for Medicare and for PBS subsidy (including HSD). Confirmation may have been received from the Department of Immigration and Citizenship advising that the applicant's application has been withdrawn or refused.
• a Medicare card (yellow) stamped RECIPROCAL HEALTH CARE, which is issued to visitors from Finland, Italy, Malta, the Netherlands, Norway, Sweden, Belgium and the United Kingdom.
  • 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.

Supply of medicines to eligible persons from the above countries is limited to the original prescription only.

An eligible person who has enrolled in Medicare, but has not yet received their card, may use their Medicare card receipt (with their Medicare number printed on it) as evidence of eligibility. Medicare card receipts are issued at Medicare offices.

An eligible overseas representative includes:

•  the head of a diplomatic mission or consular post, established in Australia, 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 need to present a Medicare card (green) before the medical practitioner prescribes HSD. Where a Medicare card (green) is not available, a Medicare special number can be used in these instances.

Community pharmacy and friendly society information

The introduction of this initiative brings about some changes for community pharmacy and friendly society. These changes include:

Public hospital HSD, CAR HSD and PBS trastuzumab have been allocated new item codes. Community pharmacy and friendly society will not have access to the new public hospital HSD (non-CAR) item codes and will not be able to claim for these medicines. However, they will be able to dispense and claim public hospital CAR HSD and PBS trastuzumab prescriptions.

Public hospital non-CAR HSD prescriptions can only be dispensed in a public hospital, unless the public hospital has made arrangements with the community pharmacy or friendly society to act as an agent, for example, if the public hospital does not have a dispensary. Where a community pharmacy or a friendly society acts as an agent for a non-dispensing public hospital, the claim for the HSD must be lodged by the public hospital. The community pharmacy or friendly society will have a private arrangement with the hospital in respect of how the prescription paperwork is returned to the public hospital in order for the hospital to process the claim, and in respect of remuneration.

If a community pharmacy or friendly society attempts to claim public hospital HSD through Online Claiming for PBS, the claim will be rejected by Medicare Australia. Community pharmacy and friendly societies are only able to dispense and claim public hospital CAR HSD and PBS trastuzumab prescriptions.

There has been a change to the way HSD are listed in the PBS Schedule for both public and private hospitals. HSD are now listed with maximum quantities and maximum repeats, instead of pack sizes. As a result of this listing by maximum quantities there is a change in reimbursement.

Under this initiative, CAR HSD and PBS trastuzumab dispensed by a public hospital, or by a community pharmacy or friendly society acting as an agent for the public hospital, will not have mark-ups applied. Standard community mark-ups apply to CAR HSD and PBS trastuzumab dispensed by community pharmacy and friendly society.

Applicable medicines

Only medicines determined to be HSD (including Complex Authority Required medicines) and PBS trastuzumab funded through the PBS for early stage breast cancer are included in this initiative.

Trastuzumab for late stage breast cancer is funded outside the PBS and is not included in this initiative, and therefore should not be claimed via Online Claiming for PBS or through the HSD offline solution.

For more information on the Schedule of Pharmaceutical Benefits go to the PBS website.

Complex Authority Required Highly Specialised Drugs (CAR HSD) and PBS trastuzumab

Complex Authority Required (CAR) medicines and PBS trastuzumab are HSD that have additional requirements, including the need for approval from Medicare Australia before dispensing.

Complex Authority Required Highly Specialised Drugs (CAR HSD)

Consumer information

HSD prescribed in public hospitals will be supplied to the patient by the public hospital pharmacy. Where the public hospital does not have a pharmacy or dispensary on site, the hospital may have an arrangement with a community pharmacy, friendly society or agent for the supply of the medicine to the patient.

Note:CAR HSD and PBS trastuzumab may be supplied by a community pharmacy or friendly society.

The introduction of maximum quantities and repeats aligns the HSD program with the remainder of the PBS. The introduction of maximum quantities and repeats should not affect patients as patients will continue to be prescribed clinically appropriate quantities.

Receipting of HSD prescriptions

The patient, or an agent of the patient, must sign and date the HSD prescription after it has been supplied to certify receipt of the medicine. Agents acting on behalf of the patient must sign, date and write their own address on the receipt. Where it is impractical to get a receipt, acknowledgement from the patient or their agent, then the approved pharmacist must certify the benefit was supplied.

A certification requires the following details:

• the reason why a receipt could not be received from the patient/agent; and
• the date of supply.

Pharmacy staff must not act as an agent or certify supply in the ordinary course of pharmacy business.

Patient contribution

All eligible patients will incur a contribution fee (general/concessional) for each supply of medicine to complement charges levied on medicines received through the PBS or the RPBS.

Patient contributions will be the same as for the general PBS and have the same charges (for example, concessional, eligibilities and Safety Net provisions).

Public hospitals supplying HSD are required to establish all patient eligibility for concessional benefits.

PBS Safety Net

All PBS HSD dispensed under this initiative will be eligible to accrue to an eligible person’s PBS Safety Net threshold. HSD approved hospitals must be registered as Safety Net hospitals. This includes non participating public hospitals supplying HSD.

Under the PBS Safety Net, patients receive additional PBS benefits when their annual out-of-pocket costs for prescription medicines exceeds a specified threshold. The PBS Safety Net threshold may be reached using prescriptions filled at both community pharmacies/friendly societies and out-patient pharmacies at public hospitals.

For more information go to the PBS Safety Net.

Public hospital education material

Note: To view the speaker notes for these presentations, click the small box in the top left corner of each slide. 

If you would like to receive these presentations in a powerpoint format please email your request to medicare.education@medicareaustralia.gov.au or pbs.education@medicareaustralia.gov.au

• A powerpoint presentation covering requirements for claiming Highly Specialised Drugs in public hospitals 
• A powerpoint presentation on requirements for dispensing Highly Specialised Drugs in public hospitals
• A powerpoint presentation on writing prescriptions for Highly Specialised Drugs in public hospitals NOT participating in pharmaceutical reforms
• A powerpoint presentation on writing prescriptions for Highly Specialised Drugs in public hospitals participating in the pharmaceutical reforms

Further information on the PBS is available on the Department of Health and Ageing website.

Contacts

Online solution contacts

Call 132 290* (option 2)

Offline solution contacts

Medicare Australia will only contact state and territory health departments regarding claims and payments made under the offline solution.

Individual HSD public hospitals will need to contact their state and territory health department with any enquiries.

Email: public.hospital.HSD@medicareaustralia.gov.au

Write: 
HSD in Public Hospitals program
GPO Box 9822
Hobart Tasmania 7001

Call: 1800 700 270**(option 5)

Fax: 1300 093 177*

*Call charges apply.

**Call charges apply from mobile and pay phones only.

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Last updated: 31 October, 2011

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