As pharmacists should know the Federal Minister for Health ("the Minister") can refer matters involving PBS issues to the Federal Committee of Inquiry ("the Committee").
This is a long process that can ultimately result in a pharmacy losing its PBS approval completely.
A recent trend we have seen for pharmacies approved under the PBS is the increasing number of referrals being sent by the Minister to the Committee.
We have been dealing with these inquiries for a number of years regarding approved pharmacies around the country. From the recent referrals there are several changes we have observed as follows:
- more referrals are being made to the Committee and the Committee is seeking to hold more hearings;
- the focus of the Committee is changing as most of the new referrals are looking at issues of overclaiming for repeats that should not have been provided or saying the PBS item was not provided at all;
- high-cost PBS medicines that require an approval to dispense are a major focus;
substantial electronic audits have usually been carried out into the approved pharmacy and conclusions reached in reports that go to the Committee without the pharmacists being consulted until after the audit is done;
- the referrals are getting broader and asserting a right to enquire into any approved pharmacies that involve an individual pharmacist;
- the Committee is keen to organise inquiries into multiple approved pharmacists at once; and
- the approved pharmacist is being told of a proposed hearing date which is often only a few months away in the same letter that they first find out about the referral to the Committee.
These inquiries are factually and legally complex and there is no independent judge hearing these matters. Legal advice and representation are essential during the inquiry process to get advice on:
- whether the referral can be challenged in the Federal Court;
- how to make sure any information provided to the Committee can't be used to take other proceedings or other prejudicial steps against you;
- preparing for and appearing at any inquiry hearing;
- responding to any report provided to the Minister by the Committee; and
- appealing any decision made by the Minister if necessary.
If you have received notice of a referral, please contact Andrew Lambros of our office urgently.
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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.