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, Department of Human Services (Human Services) 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, Human Services began providing an electronic paperless online claiming and payment process for all public hospitals supplying HSD. Electronic claiming and payment is via Human Services 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)for public hospitals, with the exception of Complex Authority Required (CAR) medicines and trastuzumab which will remain as Authority required. An authority approval is required for HSD increased quantities and HSD increased repeats. The medical practitioner does not need prior approval from Human Services 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. Streamlined codes are not for HSD patients in private hospitals and cannot be dispensed in community pharmacies.

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

Human Services 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 for all drugs under the HSD Program will remain in place until 30 June 2013. 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).

From 1 July 2013 to 31 December 2013, public hospitals can continue to claim clozapine only via the offline claiming channel. 

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, Human Services 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 Human Services 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

An affiliated specialist medical practitioner means a medical practitioner who:

(a) is affiliated with the hospital at or from which the patient is receiving treatment; and

(b) is either:

  (i)a staff hospital specialist; or

  (ii)a visiting or consulting specialist of the hospital.

An accredited prescriber of medication for the treatment of Hepatitis C means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of Hepatitis C for this Special Arrangement.

An accredited prescriber of medication for the treatment of HIV or AIDS means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of HIV or AIDS for this Special Arrangement.

A person eligible to prescribe HSD, HSD CAR and PBS trastuzumab (Herceptin®) will be a person who is:

  (a) an affiliated specialist medical practitioner; or

  (b) for the prescription of medication for the treatment of HIV or AIDS — an accredited prescriber of medication for the treatment of HIV or AIDS; or

  (c) for the prescription of medication for the treatment of Hepatitis C — an accredited prescriber of medication for the treatment of Hepatitis C (maintenance therapy only); or

  (d) for the prescription of medication for maintenance therapy if it is impractical to obtain a prescription from the treating affiliated specialist medical practitioner and the treating staff hospital specialist has agreed to the prescription — a medical practitioner; or

  (e) for the prescription of medication for maintenance therapy — a medical practitioner whom the Commonwealth and the State or Territory Government has agreed may give such a prescription.

Dispensing requirements

Non-CAR HSD prescribed in public hospitals 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.

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

HSD (CAR and non-CAR) prescribed in private hospitals 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

An eligible patient is a person who:

• is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
• is receiving medical treatment by a medical practitioner at, or from, a hospital as:
  • a non-admitted patient; or
  • a day admitted patient; or
  • 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 HI Act). An eligible person must be:

• an Australian resident
• a person covered by a Reciprocal Health Care Agreement, or
• 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, or
• 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

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.

Eligible overseas representative means:

• 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, or
• family members of heads or staff of those diplomatic missions or consular posts.

Eligible overseas persons will have a Medicare card (green).

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 Human Services. 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 Human Services 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.

Contacts

Online solution contacts

Call 132 290* (option 2)

Offline solution contacts

Human Services 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: 7 February, 2013

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