Education guide - Prescribing, dispensing and claiming HSD

Highly Specialised Drugs (HSDs) are subsidised through the Pharmaceutical Benefit Scheme (PBS) and are administered under Section 100 of the National Health Act 1953.

HSDs are for the treatment of complex medical conditions that require ongoing specialised medical supervision.

These drugs are listed in the Schedule of Pharmaceutical Benefits (the Schedule) under the following programs:

  • Highly Specialised Drugs Program (Public Hospital) - identified in the Schedule as S100 HSD Public
  • Highly Specialised Drugs Program (Private Hospital) - identified in the Schedule as S100 HSD Private, and
  • Highly Specialised Drugs Program (Community Access) – identified in the Schedule as S100 HSD Community Access

Public hospital HSD, private hospital HSD and community access HSD are listed in the Schedule with separate item codes. Items are also listed in the Schedule as either:

  • Authority required, or
  • Authority required (STREAMLINED)

Some items are dual listed under the HSD program and in the general Schedule, but may be listed with a different restriction criteria. Refer to the Schedule on the PBS website for more information.

Regulation 24 arrangements apply where appropriate.

Patient eligibility

Patients must meet all of the requirements in the following table.

A patient requiring HSD public, HSD private and HSD Complex Authority Required (CAR) items must: A patient requiring HSD community access (CA) arrangement items must:
  • attend or have attended an approved HSD hospital as a day admitted patient, non-admitted patient or a patient on discharge. Hospital in‑patients are not eligible for HSD.
  • be under appropriate specialist care of the approved hospital’s HSD unit
  • meet the criteria for the item as listed in the Schedule
  • be an Australian resident or other eligible person who holds a valid Medicare card, or a person from a country with a Reciprocal Health Care Agreement (RHCA) with Australia. If a patient is eligible to be treated under the RHCA, the supply is limited to the original prescription only.
  • be under appropriate medical care from an eligible medical practitioner
  • meet the criteria for the item as listed in the Schedule
  • be an Australian resident or other eligible person who holds a valid Medicare card, or a person from a country with a RHCA with Australia. If a patient is eligible to be treated under the RHCA, the supply is limited to the original prescription only.

When you prescribe public hospital HSD items, you acknowledge the patient’s eligibility by endorsing the streamlined authority code on the prescription. The exceptions are:

Prescribers must apply for an authority approval to prescribe these items and give the Department of Human Services (the department) the provider number of the approved public hospital where the patient is being treated.

When you prescribe private hospital HSD items, you confirm patient eligibility when you give the department the provider number of the approved private hospital where the patient is being treated.

When prescribing HSD items, you acknowledge the patient’s eligibility by giving the streamlined authority code on the prescription. The exceptions are increased quantities and repeats for HSD Authority required (STREAMLINED) items, and any items listed as requiring a specific authority type (ie telephone or written). You must apply for an authority approval from the department to prescribe these items.

Patients are entitled to the quantity and repeats listed in the Schedule for any HSD, except for clozapine, of which you can prescribe 1 month’s supply and up to 5 repeats. Prescribers may apply for an authority approval to prescribe increased quantities and or repeats, if the listed quantity and repeats provide less than 12 month’s supply for Authority required (STREAMLINED) items.

Prescriber eligibility

To write HSD prescriptions, a prescriber must be a medical practitioner issued with a PBS prescriber number and meet at least 1 of the requirements in the following table:

A medical practitioner prescribing HSD public, HSD private and HSD CAR items must be: A medical practitioner prescribing HSD community access arrangement items must be:
  • a staff hospital specialist, or a visiting or consulting hospital specialist affiliated with the public or private hospital unit
  • an accredited prescriber of HIV/AIDS medicine
  • a general practitioner or non-specialist hospital doctor who provides maintenance therapy under the guidance of a treating specialist
  • an accredited prescriber of HIV antiretroviral therapy, clozapine maintenance therapy or chronic hepatitis B therapy – community or hospital-based

HSD CAR items may also have additional prescriber requirements. Refer to the item’s restriction criteria in the Schedule on the PBS website for more information.

Supplier eligibility and restrictions

Certain pharmacies can dispense and claim HSDs. The following table lists eligibility criteria and restrictions:

HSD Item Dispense from a
s. 94 public hospital
Dispense from a
s. 94 private hospital
Dispense from a
s. 90 community pharmacy
Dispense from a
s. 92 dispensing doctor
HSD public - non‑CAR item yes no no no
HSD public - CAR item yes no yes no
HSD private - non‑CAR item no yes yes no
HSD Private - CAR item no yes yes no
HSD - community access arrangement item yes yes yes yes

Hospitals not approved under section 94 can apply for approval to prescribe and supply HSDs under the National Health (Highly specialised drugs program for hospitals) Special Arrangements Instrument 2010.

Pharmacies must only dispense and claim HSDs appropriate for their pharmacy type. The patient's eligibility determines the item code approved and the type of pharmacy that can dispense and claim the prescription. Pharmacies are not eligible for payment if the prescription is dispensed by the incorrect type of pharmacy.

Requirements for HSD public items - excludes HSD CAR items

Listing in the Schedule Authority required (STREAMLINED)
Prescribing

Prescribe using either:

  • a PBS public hospital prescription
  • a PBS authority prescription, or
  • an approved hospital medication chart if supplied within a public hospital

A PBS authority or public hospital prescription must be used when you either:

  • prescribe HSD CAR items, or
  • prescribe a quantity or number of repeats greater than the maximum listed in the Schedule

You are not required to contact the department if the prescription is for the listed quantity and repeats. However, you must write the 4-digit streamlined authority code on the prescription.

Authority approval is required from the department if the prescription is for an increased quantity or repeats or both.

You can also seek authority approval to prescribe an increased quantity and/or repeats for an Authority required (STREAMLINED) item online via the Health Professional Online Services (HPOS). 

To seek authority approval to prescribe an increased quantity or repeats for an Authority required (STREAMLINED) item, call the Authority Approval Telephone Line on 1800 700 270.

  • Write the authority approval number on the prescription using the format PUB Z XXXXAA.
Supplying You may dispense from a public hospital pharmacy only.

Requirements for HSD private items - excludes HSD CAR items

Listing in the Schedule Authority required
Prescribing Prescribe using:
  • a PBS authority prescription

Authority approval is required from the department.

You can also seek authority approval to prescribe online via the Health Professional Online Services (HPOS).

For approval to prescribe Authority required (telephone) items, call the Authority Approval Telephone Line on 1800 700 270.

  • Write the authority approval number on the prescription using the format PTE Z XXXXAA
Supplying You may dispense from:
  • a private hospital pharmacy, or
  • a community pharmacy

Requirements for HSD community access arrangement items

Listing in the Schedule – authority required (STREAMLINED)

Listing in the Schedule Authority required (STREAMLINED)
Prescribing Prescribe using either:
  • a PBS public hospital prescription
  • a PBS authority prescription, or
  • an approved hospital medication chart if supply will occur within the public hospital

A PBS authority or public hospital prescription must be used when the quantity or number of repeats is greater than the maximum listed in the Schedule.

You are not required to contact the department if the prescription is for the listed quantity and repeats. However, you must write the 4-digit authority code on the prescription.
Authority approval is required from the department if the prescription is for an increased quantity or repeats.

You can also seek authority approval to prescribe an increased quantity and/or repeats for an Authority required (STREAMLINED) item online via the Health Professional Online Services (HPOS). 

To seek authority approval to prescribe an increased quantity or repeats for an Authority required (STREAMLINED) item, call the Authority Approval Telephone Line on 1800 700 270.

  • Write the authority approval number on the prescription using the format PUB Z XXXXAA.
Supplying Dispense from:
  • a public hospital pharmacy
  • a private hospital pharmacy
  • a community pharmacy
  • a dispensing doctor

Requirements for HSD Complex Authority Required (CAR) items

Listing in the Schedule Authority required
Prescribing For public hospital HSD CAR items you can prescribe using:
  • a PBS authority prescription, or
  • a PBS public hospital prescription
For private hospital HSD CAR items you can prescribe using:
  • a PBS authority prescription
Authority approval is required from the department to prescribe HSD CAR items.
  • For approval to prescribe Authority required (phone) items, call the Authority Approval Telephone Line on 1800 700 270 (Note: there are limited circumstances where a phone approval may be granted. More information on item details are available on the PBS website), or
  • For approval to prescribe Authority required (written) items, submit a written application and prescription to
Department of Human Services
Complex Drugs Programs
Reply Paid 9826
Hobart TAS 7001

The completed prescription and supporting documentation, including patient clinical details, must be submitted with the application.

Requirements for applications are outlined in the Schedule.

For phone approval:

  • write the authority approval number on the prescription using the format CAR ZXXXXAA
  • write the approved item code on the prescription, as provided by our delegate

For a written application prescriptions, the department will endorse:

  • by stamping it ‘Approved by PBS-DHS’, marking the quantity and number of repeats authorised, and placing initials in the space marked ‘delegate’
  • by stamping it ‘Public hospital PBS item code’ or ‘private hospital PBS item code’
  • by stamping it ‘Section 100 CAR approved’, and
  • by including the appropriate approved item code from the Schedule written in the ‘delegate approval’ section of the prescription
Supplying For public hospital HSD CAR items you can dispense from:
  • a community pharmacy
  • a public hospital pharmacy
For private hospital HSD CAR items you can dispense from:
  • a community pharmacy
  • a private hospital pharmacy

Prescription requirements

The following information must be completed on all HSD private prescriptions:

  1. Prescriber's name, practice address and prescriber number
  2. Authority prescription number – the department requires this number to grant an authority approval. It is also used by the pharmacy as a reference when dispensing. The authority prescription number is generated by the prescribing software for computer generated prescriptions.
    Note: The exact location of this number on the prescription may vary.
  3. Patient’s name, address and card details
  4. Authority required item name, form and strength
  5. Dose or instructions for use
  6. Quantity and number of repeats
  7. Signature of the prescriber and the date the prescription was written
  8. Authority approval number
  9. An indication whether the prescription is to be supplied under the PBS or RPBS (Repatriation Pharmaceutical Benefits Scheme)

Prescribers will be required to quote the hospital provider number when applying for an authority approval online or over the phone. The hospital provider number must be written on the prescription for written applications. The hospital provider number is not required for HSD CA items.

HSD Private prescription

An example HSD PTE prescription with the doctor, patient, and perscription filled in

The following information must be completed on all HSD public prescriptions:

  1. Hospital name, address, phone number, prescriber number and provider number
  2. Authority prescription number
  3. Patient’s name and address
  4. Authority required item name, form and strength
  5. Dose or instruction for use
  6. Quantity and number of repeats
  7. Prescriber’s name and signature, and the date the prescription was written
  8. Authority approval number
  9. An indication whether the prescription is to be supplied under the PBS or RPBS

HSD Public Prescription

Hospital prescriptions must include the hospital name and hospital provider number. Medication charts used in public hospitals must meet the same requirements as a hospital prescription.

The hospital name, address, phone number and provider number will be printed on every prescription on the top left corner or is generated by the prescribing software for computer generated prescriptions. Hospital prescriptions may vary depending on the state or territory government.

Additional information for pharmacists

You should determine if the HSD prescription can be dispensed by your type of pharmacy. The authority approval on the prescription will help you to identify which pharmacy type can dispense the prescription. For example:

  • Regulation 25, where immediate supply is necessary, only applies to HSD private and HSD CAR items, and
  • pharmacists can defer the supply of HSD items on public hospital prescriptions only

Authority approval cannot be obtained retrospectively.

After you complete the required information in the pharmacy dispensing software (PDS), you will need to act on any warning or rejection messages. A warning or rejection message will be displayed if the prescription cannot be supplied by your pharmacy type. You can contact us if you need clarification.

If a PBS/RPBS authority prescription is presented to your pharmacy without appearing to be approved, contact the prescriber to confirm the prescription’s approval status.

Claiming requirements

Public hospital pharmacies

Prescriptions must be filed in the corresponding claim for:

  • Authority required (STREAMLINED) items
  • Authority required items, including increased quantities and or repeats of Authority required (STREAMLINED) items
  • HSD CAR items

If the supply has been dispensed using an approved medication chart, pharmacists must certify supply of all paperless claims for the claim period completing the ‘Close a Claim’ transaction through PBS Online claiming.

Public hospital pharmacies who make a claim for HSDs must keep paperwork for a minimum of 2 years from the date of dispensing.

Private hospital pharmacies

Prescriptions must be filed in the corresponding claim for:

  • HSD CA Authority required (STREAMLINED) items
  • Authority required items, including increased quantities and or repeats of HSD CA Authority required (STREAMLINED) items
  • HSD CAR items

Private hospital pharmacies who make a claim for HSDs must keep paperwork for a minimum of 2 years from the date of dispensing.

Community pharmacies

Prescriptions must be filed in the corresponding claim for:

  • HSD CA Authority required (STREAMLINED) items
  • Authority required items, including increased quantities and or repeats of HSD CA Authority required (STREAMLINED) items
  • HSD CAR items

Community pharmacies who make a claim for HSDs must keep paperwork for a minimum of 2 years from the date of dispensing.

Pricing

HSDs are subject to different mark-ups compared to other PBS items.

Payment to approved suppliers is based on the ex-manufacturer price, and does not allow for a wholesale mark-up.

The Department of Health recommends that approved suppliers order HSDs directly from manufacturers.

Example 1
A public hospital eligible patient for HSD prescriptions sees the nephrologist in the outpatient clinic who correctly writes a prescription for darbepoetin alfa as a HSD public, Authority required (STREAMLINED) item on a public hospital prescription. The patient presents the prescription to the local community pharmacy to be dispensed.

In this example:
  • the patient can only have this prescription dispensed from an approved public hospital
  • a community pharmacy cannot dispense a public HSD prescription
  • if the community pharmacy tries to dispense the prescription, an online claiming for PBS warning message will be displayed and they will not receive payment from the department if they supply the item
Example 2
A private hospital eligible patient for HSD prescriptions sees the nephrologist in the outpatient clinic who correctly writes and gets approval for a prescription. It is for sevelamer as a HSD private, Authority required item on an authority prescription. The patient presents the prescription to the local community pharmacy to be dispensed.

In this example:
  • a community pharmacy can dispense as a HSD private prescription
  • the patient can choose to have this prescription dispensed from an approved private hospital or community pharmacy
  • care needs to be taken when dispensing. Sevelamer has multiple listings in the Schedule including:
    • HSD private Authority required - to be dispensed in private hospital and community pharmacies only
    • HSD public Authority required (STREAMLINED) - to be dispensed in a public hospital pharmacy only, and
    • section 85 general Schedule Authority required (STREAMLINED) with different criteria - to be dispensed at a community pharmacy, public hospital pharmacy or a private hospital pharmacy
    • it is important to choose the correct HSD private listing in the PDS when dispensing sevelamer to ensure correct payment

More information

Online:

You can contact the department for:

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Page last updated: 14 October 2016

This information was printed Thursday 8 December 2016 from humanservices.gov.au/health-professionals/enablers/education-guide-information-about-prescribing-dispensing-and-claiming-hsd It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.