This is an HTML version of an attachment to the Freedom of Information request 'PHI Circulars - Compliance and GUI'.




FOI 5328 - Document 1
General use items 
Pre-consultation paper – 27 June 2024 
workshop with private health insurance 
stakeholders
Under 
Health And Aged Care
Information Act 1982 
This Document Has Been Released 
Freedom Of 
TheBy The Department Of 
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FOI 5328 - Document 1
Overview 
On 1 May 2024, the Minister of Health and Aged Care announced that general use items (GUI) 
would be retained in Part D of the Prescribed List (PL). This decision follows continuous feedback 
from multiple stakeholders that removing the GUIs from the PL would have negative clinical 
implications and potential adverse outcomes for patients. 
The announcement comes two years after the initial planned removal of the GUIs from the PL, 
and a year after insurers and hospitals were requested to negotiate alternative funding 
arrangements. 
We acknowledge the concerns of private health insurers that the announcement about retaining 
GUI on the PL represent. The department is undertaking further consultation and engagement to 
identify ways in which these concerns might be addressed – both regulatory and non-regulatory. 
What we invite you to do 
We ask that you provide us with practical suggestions about ways to increase the integrity of the 
settings of the PL as well as mechanisms to reduce increased growth in usage of GUIs per 
episode of care and the resulting increased growth in expenditure (i.e. without any clinical need). 
Under 
In considering your input to this matter we ask that you provide as much detail and eviden
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ce as 
possible. Please ensure your suggestions remain in the context of the Prescribed List and are 
reasonable, pragmatic and within the authority of the department. 
1982 Aged 
Questions 
Released 
Act And 
At the workshop, we would like to discuss your answers to the following questions. 
Been 
Integrity 
Has 
Health 
Information 
Of 
1.
What do you see are the key areas of concern for the integrity of the PL settings in the
context of the GUIs?
Of 
2.
If you were to consider prioritisation of these, what would that look like?
3.
What are the potential system bas
Document  ed-actions (i.e. not fixing of individual errors) that could
be taken, by who and when?Department 
This  Freedom 
4.
How would you suggest the success of these actions are measured?
The  The 
5.
What are the likely consequences – positive/negative and who would they effect?
By 
Utilisation and growth in expenditure 
6. What sub-categories of GUIs on the PL represent the key areas of growth in utilisation per
episode of care and therefore increase in benefit expenditure?
7. Are there specific procedures that represent higher growth in utilisation?
8. If there are concerns that the growth in use is not related to clinical need, how is this
determined/measured? Who can validate this?
9. What system-based mechanisms are either in place or need to be put in place to address
this problem?
a. Would these mechanisms be different if there was a demonstrated clinical need?
10. How would you suggest the success of these actions are measured?
11. What are the likely consequences – positive/negative and who would they effect?
General use items - Pre-consultation paper 

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FOI 5328 - Document 1
 
Other matters 
12. Are there other areas of concern with the retention of GUIs on the PL that need to be 
considered? 
 
 
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FOI 5328 - Document 4
General Use items controls and tweaks to the list 
DRAFT AS AT NOON THU 2 MAY 2024 
PHA’s major concern is volume and cost being added with no demonstrable clinical 
benefits. For example, there was a 12.9% volume growth in GUI in 2017/18 on flat 
surgery volumes. 
Recommended overall rules 
• Price/volume agreements
o If the total use of items under each subcategory increases by more than
10% in any year (adjusted for any increases in surgical volume), the price
of al  items under that code should be reduced by 10% (rounded up to the
nearest dollar).
• Ensure no out of pocket costs for consumers as a conditio
Under  n of listi
Careng. This is
likely to require the price to hospitals not to exceed the PL price.
1982 
• Any price increases (i.e. through amendment applications) to
Aged   demonstrate a
public interest case, including the clinical and eco
Released 
Act  nomic benefits. These public
And 
interest cases should be published by the Minister each PL cycle.
• Hospitals provide feedback on the costs
Been   of medical devices and standard usage
patterns to their medical staff (as previously offer
Health ed by hospital groups).
Has 
• Where hospitals use general use items at a
Of   si
Information gnificantly higher rate than their
peer group (for example, over 20
Of % to 50% higher than the average depending on
distribution), payment wil  be provided in ful  only where the treating doctors
certify that the unusual use 
Document is reasonable and necessary, otherwise a 120% to
150% expenditure cap wil  apply.
Freedom 
Department 
• Remove suffices
This   which do not impact on the patient outcome. These would
The 
include price reduc
The  tions where there is no consumer benefit from device
By 
characteristics (we have a list to consider, see below)
Fix mistakes on the list 
• Address error in pricing and al  adhesion barriers with the same ARTG back to
public price (reduce spend by $1.018m)
• Use the Surgiflo price 6ml for Floseal, Purastat 5mls as there’s no difference in
price at the higher volume between Floseal and Surgiflo (reducing spend by
$0.620m)
• Hemoblast VB002 reduced to same price as Floseal, Surgiflo (reducing spend by
$0.225m)
• Applicators (03.05.05.05 - Accessory Extender) removed, as they should be
incorporated into the device as per public prices (reducing spend by $0.022m)
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FOI 5328 - Document 4
• Move ET082 PureRegen Gel Sinus from adhesion barriers to nasal code (no price
impact)
• Remove internal adhesive applicators (03.08.02.04 - Adhesive Accessory) as
they should be included in device cost as per public prices (reduce spend by
$1.792m)
• Add conditions of use for Tisseal etc to vascular and dura consistent with IFU
• Remove Evicel as it is a listed medicine, not a device (not eligible)
• Remove ET065 as it is a suture and not eligible
• Remove ET066 as not eligible (reduce spend by $1.081m)
• Tristapler MI287 and GIA stapler AS209 repriced to the sum of the component
parts (reduce spend by $2.004m)
• Remove CoreKnot, these are surgical instruments (DE606, DE609)
• Remove anomaly where larger sponges receive much higher remuneration,
change to per cm for al  sizes (reduce spend by $0.083m)
• Reprice all liquid repair sealants to the highest volume price, rather than paying
Under 
more for the smal er sizes.
Care
• Place condition on use for al  liquid repair sealants to dura, as per IFUs
1982 Aged 
• ER279 OverStitchTM Endoscopic Suturing System repriced to comparator FQ002
Released 
Act 
Recommended price reviews 
And 
Been 
• Remove premium for powered stapler as no HTA assessment was undertaken
Health 
(reduce spend by $1.129m)
Has Information 
Of 
• Remove premium for endoscopic suffice for staplers as no clear difference in
Of 
performance in most instances (reduce spend by $12.759m).
• Reprice KI010 to $90 as it is readily available at that price (here)
• Reduce price for 03.08.04.
Document  04 - Staplers, Non-bone with Disposable Applier to
the same as 03.08.04.02 – 
Freedom  Staplers
Department . There is no justification for the premium.
This 
Suggested changes t
The o impr
The  ove integrity 
By 
• Remove capital items for infusion pumps and increase cassette cost to
compensate (no net financial impact).
o Remove 03.02.03 - Infusion Pumps, Battery Powered
o The price of the 03.02.05.02 - Administration Cassettes would need to
increase from $26 to $51 to compensate for these items coming off
• Use a single price for pliable patches to remove incentives for larger sizes (no net
financial impact)
• Use a per gram price for haemostatic power to remove incentives for larger sizes
(no net financial impact)
• Use a single price for absorbable sponges to remove incentives for larger sizes
(no net financial impact)
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FOI 5328 - Document 5
Subject: RE: Meeting/workshop request on general use items [SEC=OFFICIAL]
Thanks Andrew

Ben Harris
DIRECTOR OF POLICY AND RESEARCH
M: s47F
 | E: s47F
@pha.org.au
‌w‌w‌w‌.‌privatehealthcareaustralia‌.‌org‌.‌au‌
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Follow us on
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From: RINTOUL, Andrew <s22
@health.gov.au> 
Sent: Thursday, May 9, 2024 4:35 PM
To: Ben Harris <s47F
@pha.org.au>
Cc: s22
health.gov.au>; s22
@Health.gov.au>; s22
@health.gov.au>; s47F
 s47F
; Rachel David <s47F
@pha.org.au>;
s22
@Health.gov.au>
Subject: RE: Meeting/workshop request on general use items [SEC=OFFICIAL]
Under  Care
Hi Ben,
I’ll ask s22
 to coordinate internally and come back to you with a range of
1982 Aged 
times to hold the meeting.
Kind regards
Released 
Act And 
Andrew
Andrew Rintoul
Been 
Assistant Secretary
Health 
<image003.png>
Has Information 
Of 
Protheses List Reform Taskforce | Technology Assessment and Access Division
Of 
Australian Government Department of Health and Aged Care
T: +61 2 6289 s22  | M: s22
 E: s22
@health.gov.au
Location: Sirius 9.N.101
Document 
PO Box 9848, Canberra ACT 2601, Australia
The Department of Health acknowledges the traditional owners of country throughout Australia, and
Freedom 
Department 
their continuing connection to land, sea and community. We pay our respects to them and their cultures,
This 
and to elders both past and present.
The  The 
From: Ben Harris <s47F
By 
@pha.org.au> 
Sent: Wednesday, May 8, 2024 5:12 PM
To: RINTOUL, Andrew <s22
@health.gov.au>
Cc: s22
@health.gov.au>;s22
@Health.gov.au>; s22
@health.gov.au>; s47F
 s47F
; Rachel David <s47F
@pha.org.au>
Subject: Meeting/workshop request on general use items
REMINDER: Think before you click! This email originated from outside our organisation. Only
click links or open attachments if you recognise the sender and know the content is safe.
Andrew,
Rachel and I met with s47F
 and s47F
 on Friday on general use items
on the PL. They have encouraged us to engage with you on our list of errors,
integrity issues and consumer protection measures sent last week.
I ask for an extended meeting/workshop with you and your staff on the 40 issues
Page 4 of 5

FOI 5328 - Document 5
we have raised with general use items. I recognise that other than s22  many of
your staff have not been around long enough to have had exposure to the general
use item history – in particular, the EY report and the department’s report on
general use items. We have the advantage of the history and the data from funds
to add to the repository of knowledge the department has collected over the years,
plus the expertise of former device company staff who will be able to help the
department come to decisions on how to proceed with protecting consumers’
interests.
We propose going through the technical suggestions, where they have come from
(eg the EY report), and why we are recommending what we are recommending (eg
using the Hereco framework for regrouping). Our line-by-line examination of the
general use category as part of the investment we have made while looking for a
solution to general use items should be of value to the taskforce.
I think we could get it done in three hours, with me, s47F and s47Fgoing through
the list of recommendations to inform your decisions going forward.
Let me know when would suit you and your team,
Thanks
Ben

Ben Harris
Under  Care
DIRECTOR OF POLICY AND RESEARCH
M: s47F
 | E: s47F
@pha.org.au
‌w‌w‌w‌.‌privatehealthcareaustralia‌.‌org‌.‌au‌
1982 Aged 
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Of 
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FOI 5328 - Document 6
s22
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FOI 5328 - Document 6
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FOI 5328 - Document 6
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Document Outline