Maintain PBS approval + claim accurately for PBS-listed medicines
Pharmacy approval-to-supply under s 90 National Health Act; PBS claiming subject to compliance review.
Who must comply
Pharmacists approved under s 90 of the National Health Act 1953 (approved pharmacists), for each set of approved premises. Other approved suppliers, such as approved hospital authorities and friendly society pharmacies, are also issued approval numbers.
What triggers it
Supplying PBS (or RPBS) medicines and claiming reimbursement from the Commonwealth for that supply.
When due
Approval must be held before any PBS supply. Unless other arrangements are made with Services Australia, each claim covers one month's supply and is sent within 30 days of supply; claims for supplies more than 18 months old may not be accepted for processing. Prescription copies retained for at least two years.
Evidence required
Section 90 approval and PBS Pharmacy Approval Number for each premises; dispensing records showing supply at the approved premises; Claim for Payment Forms and claim period records; Services Australia/DVA copies of PBS prescriptions and authority approvals; copies of all PBS prescriptions kept for at least two years; stock records Services Australia may request.
Max penalty
A breach of a condition of approval can lead to reprimand, suspension or revocation of PBS approval after referral to the Pharmaceutical Services Federal Committee of Inquiry, and prosecution for a criminal offence under the National Health Act 1953 or the Criminal Code; claims for supply in breach of a condition cannot be paid
Who must comply with this? The applicability test by industry, business structure and size.
Summary
Pharmaceutical benefits are mainly supplied by pharmacists approved under section 90 of the National Health Act 1953 to dispense from particular approved premises. Each approval carries a unique PBS Pharmacy Approval Number for those premises, and an approved pharmacist may supply pharmaceutical benefits only at or from premises for which they are approved. Unapproved pharmacists cannot be involved in PBS supply, because payment cannot be made for supply in breach of a condition of approval. Approved pharmacists are bound by conditions of approval, including the National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination, whose current conditions took effect on 1 June 2023. Claiming for PBS medicines not supplied at the approved premises, sharing an approval number with another pharmacist, or arrangements that facilitate supply to patients presenting at another pharmacy are breaches of those conditions. Claims for payment are made to Services Australia, which prices each PBS prescription; pharmacists must keep copies of all paper and electronic PBS prescriptions for at least two years from the date of supply.
Enforced by
Source legislation
Topics
Related
- CWLTHMaintain controlled drugs register (Schedule 8 / 9)Pharmacies + medical practices must keep contemporaneous register of S8/S9 medicines.
- CWLTHIn-vitro diagnostic medical device classification + ARTGIVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
- CWLTHConduct post-market surveillance of therapeutic goodsARTG-included goods must be monitored post-market for safety + performance.
Reading
Frequently asked questions
- Who must comply with PBS approval + claim accurately for PBS-listed medicines?
- Pharmacists approved under s 90 of the National Health Act 1953 (approved pharmacists), for each set of approved premises. Other approved suppliers, such as approved hospital authorities and friendly society pharmacies, are also issued approval numbers.
- What triggers PBS approval + claim accurately for PBS-listed medicines?
- Supplying PBS (or RPBS) medicines and claiming reimbursement from the Commonwealth for that supply.
- When is PBS approval + claim accurately for PBS-listed medicines due?
- Approval must be held before any PBS supply. Unless other arrangements are made with Services Australia, each claim covers one month's supply and is sent within 30 days of supply; claims for supplies more than 18 months old may not be accepted for processing. Prescription copies retained for at least two years.
- What is the maximum penalty for PBS approval + claim accurately for PBS-listed medicines?
- A breach of a condition of approval can lead to reprimand, suspension or revocation of PBS approval after referral to the Pharmaceutical Services Federal Committee of Inquiry, and prosecution for a criminal offence under the National Health Act 1953 or the Criminal Code; claims for supply in breach of a condition cannot be paid
- What evidence is required for PBS approval + claim accurately for PBS-listed medicines?
- Section 90 approval and PBS Pharmacy Approval Number for each premises; dispensing records showing supply at the approved premises; Claim for Payment Forms and claim period records; Services Australia/DVA copies of PBS prescriptions and authority approvals; copies of all PBS prescriptions kept for at least two years; stock records Services Australia may request.
Source: https://www.pbs.gov.au/healthpro/explanatory-notes/section1/Section-1-3-Explanatory-Notes. Rules Mate is not a law firm. Always verify against the live regulator source before acting.