okay I think we'll commence
0:06
I'm speaking to you today from the traditional lands of the nunawa people here in the act and I'd like to pay my
0:13
respects to the traditional I've been recorded across Australia where we are all meeting today and extend that
0:20
respect to any First Nations people who are joining us on this webinar
0:26
I'm Elizabeth Flynn I'm the lead for the prosthesis list reform task force and
0:32
today's webinar is going to be about changes to the prosthesis list time frames for this year and next mainly
0:39
this year and I have with me here Jeff Storer from projects assured and
0:44
together we're going to walk you through what what we have planned for the year to come
0:50
so just some housekeeping we're using slido to do the question and answer session you can open slido on the right
0:57
hand side of your screen by clicking on the link in the chat or using the QR code that you see on the right of your
1:04
screen we'll remind you again later in the seminar but if you want to set up slow
1:09
down slido now you can please use the thumbs up button to vote for those questions you would like
1:15
answered first or type your own question questions can be posted at any time
1:22
during the webinar but they'll be answered after our presentation so out of scope questions questions that aren't
1:29
related to the topics that we're discussing today will not be addressed at this webinar but we'll give you some
1:35
contact email addresses at the end where you can send those questions if they're burning for you
1:41
and you can access closed captions they're located at the bottom left of the screen and you click on the symbol
1:48
the CC symbol you can turn them on or off okay what to expect from this webinar
1:54
today uh we're giving you an overview of the timing and impact of bypassing the
1:59
March 2024 update then we'll walk through information on the prosthesis list reforms and
2:05
consultations planned for 2023 and the main part of the webinar is an
2:10
opportunity for stakeholders to ask questions or raise concerns about the proposed changes now we started
2:17
communicating about these changes before Christmas when we send an email to all of the sponsors and we also sent out a
2:24
message in a Phi bulletin but we're following up in this webinar because we really want to reach as many people as
2:31
possible who might be planning to put in an application for a listing in this in
2:36
this year so just a bit of a description of um uh
2:42
how the prosthesis list reforms uh are working together and interacting with
2:48
the move to the Health Products portal on the left hand side of the screen you'll see there's a number of
2:54
um elements so the prosthesis list reform that will progress this year the first one is the new application
3:00
Pathways that we consulted on last year there are three new Pathways
3:05
and we're defining those Pathways for items that are eligible for inclusion on
3:12
the prosthesis list and removing ineligible items those pathways are finalized in November 2022 and we're
3:19
moving into implementation this year the new grouping structure for the prosthesis list you will know that we've
3:26
been doing a lot of Consulting on a new grouping structure which we hope is uh has a clinical logic in it and it's more
3:33
simple simple for all of us to navigate and we will be finalizing net grouping
3:39
structure by March 2023 we're just commencing some consultations on what
3:45
the structure looks like in February there are benefit reductions occurring
3:51
this year both in March and July the ones in March are for the general use items and the ones in July are the
3:58
annual reductions that we're doing it's a second year of reductions of a planned
4:03
three-year Reduction Program and then we're updating cost recovery
4:09
fees so the updated cost recovery Arrangements will take effect from the 1st of July and of course there'll be
4:15
consultation consultation on that before it is finalized so there's a lot of work in
4:21
the reform space and it will interact with the Health Products portal and I'll just hand over to Jeff Storer now who'll
4:28
talk more specifically about what's being planned for the Health Products bottle thanks Jeff thanks Elizabeth and
4:34
most of you or many of you will have heard from Masters part of the development of the Health Products portal we've written out to all members
4:41
who have items listed on the prosthesis list inviting them to participate in the process and many of you haven't
4:46
participated in that process and we thank you for that contribution an overview the HPP is really a larger
4:52
technological transformation and business transformation across the Department of Health across Hall regulated and subsidized items but
4:59
specifically in the in the devices space we're looking to simplify the process of
5:05
applying tracking and paying and managing all regulated and reimbursed Health products and services and
5:10
specifically devices we have been working with the industry around the three application Pathways
5:19
and many of you have participated in the beta exercise and we have decided as part of the
5:24
prosthesis reformers as we bring new legislation into place instead of
5:30
building it into the old capability we'll be putting that into the new technology many of Industry have
5:36
provided advice back to the department about some of the limitations of our existing technology so we're starting to
5:42
update that technology platform and business processes in line with the prosthesis reform changes we will be in
5:49
contact with industry specifically around the next phases of the development of the health product portal again through the similar channels but
5:56
Elizabeth and I thought it's a good opportunity to make sure that people understand that there is a significant intersect between these two things and
6:03
one of the primary drivers around bypassing one of the application Cycles is to ensure that we have a stable
6:08
environment to implement both the new reforms part of the program and the technology part of the program
6:16
so this is the visual describing the activities uh over the next essentially
6:22
the next year and most of you will have seen this in one of the updates and also
6:28
in recent correspondence from the department and what we're showing is the overlap between the Cycles So currently
6:34
the applications uh in January 2023 for the July cycle will be unchanged the
6:42
following cycle which Begins for the publishing cycle in November this year
6:48
again will be largely unchanged but it's the one that we refer to as the March publishing cycle where applications are
6:56
usually commenced around May is the one that we will be removing which means
7:02
that they will have an impact on people's ability to make new applications or managing existing applications and that will be some of
7:08
the questions that we will address today and you can see on the left down the bottom it's so that the reforms that are
7:15
proposed so the new application Pathways finalize the new grouping structure of finalized and the new cost recovery
7:21
arrangements are fine lines so that we can put that capability into the new system and have applications in
7:28
the HPP commencing for the July 24 publishing cycle around September this
7:36
year but I'm sure there'll be some questions in more detail when we get to questions and answers at the end of the webinar
7:45
so what this means um for July November supported by plms using existing PL policy so largely
7:52
nothing will change March 2024 cycle so the publishing cycle will be bypassed and then in July 24
7:59
cycle the full cycle will be supported by the new functionality and the new policy as part of the pl reforms package
8:14
okay so now we're moving on to some information about the prosthesis list reforms and some of the consultations
8:20
that we're planning this year
8:28
so first off for listing Pathways I think most of you would know that we've designed three new Pathways tier one
8:35
tier 2 tier three the tier one pathway is completely in-house and it's for
8:41
medium or lower risk devices the tier 2 pathway is one that requires external
8:48
clinical advice and in some cases Health economics advice and it will go to the
8:54
advisory committee which at the moment is plaque but plaque is getting a bit of
9:00
a makeover as well and then the tier three pathway is the one we uh the
9:05
applicant will go directly to msac for novel technology
9:10
devices where there are no comparators or there's no relevant MBS item
9:16
so all of that will be embedded in the new HPP in the grouping structure as you
9:21
know the prosthesis comprises of at the moment uh four parts Part A is the
9:28
largest part and that's where the medical devices reside Part B is for
9:33
human tissue products part C is for exceptional circumstances and we created
9:39
a Part D last year for the general use items which will be removed from the 1st of July that part G is just for ease of
9:47
identification really now part A has been the subject of the regrouping that
9:54
herrico's been working on um we will also look to do regrouping for Part B but that will come at a later
10:00
date so uh we'll just park that for the moment while we've engaged PWC to do
10:06
some consultations on that area of the prosthesis list Parts C is relatively
10:11
small um the exceptional circumstances that hasn't been the structure there hasn't
10:17
changed and as I mentioned Part D those items will be removed
10:23
so most of the work is happening in part A and then cost recovery uh we are
10:28
moving to a new cost recovery regime that is compliant with the Australian government charging framework
10:34
[Music] um it's interesting to note that cost recovery hasn't changed really for the
10:39
prosthesis list since it was introduced in 2007 and if you compare that for
10:44
those of you who interact with TGA you get new fees and charges and a
10:50
consultation on that every year so there's quite a striking difference between uh prosthesis list and and TGA
10:58
and we just want to modernize I guess the cost recovery arrangements and there'll be further consultation on that
11:03
in the first part of this year the new cost recovery arrangements are scheduled to commence from the 1st of July and
11:10
they will be embedded I guess in the HPP
11:16
foreign so we've also we're also introducing
11:22
quite a raft of legislative changes tranche one has been introduced into
11:27
Parliament and it will be debated in the first half of this year we anticipate
11:33
um that one was for the name change uh we call it we're renaming the prosthesis
11:38
list the prescribed list of medical devices and human tissue products so you can still shorten it to PL if you want
11:45
to we're introducing new definite definitions for medical devices and
11:51
human tissue products and also the cost recovery Provisions so they've all they're all available and and have been
11:58
seen by stakeholders in the first part of this year we'll be working on tranche
12:03
2 which is bundling arrangements for General use items on the pl which will be taken out of the prosthesis list but
12:11
will still be mandated in a different area of the Private health insurance act and we'll be Consulting on that shortly
12:19
um I hack for just an ad for them I hackapa is running an information webinar tomorrow
12:26
um about the consultation on Arrangements scheduled for the first quarter of 2023.
12:31
and then listening criteria for part A and part C uh we're modernizing those as
12:37
well and we'll be doing consultation on them scheduled for the first quarter of 2023 and as I mentioned cost recovery
12:43
fees will be done in parallel with that uh We've also introduced a more
12:48
programmatic style of post listing reviews and we've kicked off the first four of those post listening reviews
12:55
they are looking into surgical guides and buyer models spinal cord stimulators
13:01
metal back patella and neurogynecological mesh devices we've done targeted consultation with the
13:08
sponsors of these device types and we will continue to do that targeted consultation through the first half of
13:14
2023 and then when we identify further reviews we'll let everybody know about
13:21
that we're just working on a program that makes sense and then
13:26
um with these four first reviews uh we're learning as we go about what works
13:32
and what doesn't and we'll feed those lessons into the post listing review framework which is available on our
13:38
website at the moment and then compliance so we've consulted
13:45
on a compliance strategy uh and that has that closed that consultation happened in October last year we've looked at the
13:52
feedback uh before finalizing the strategy and we'll put a response paper up on the website shortly and you'll
13:59
hear about that through a Phi Bulletin and then the compliance strategy and response paper will be published as I
14:07
said in the first quarter of 2023.
14:13
so the prosthesis guide as we change the listing pathways
14:18
um and the grouping structure we have to um update the guide as well so we're in
14:24
the process of developing that to assist applicants for the new application processes uh the guide and the new
14:30
listing criteria the guide will be a reference point on how to collect and compile clinical evidence to meet
14:36
government requirements we'll be Consulting on the guide in the first quarter of 2023 and we'd like to hold
14:43
some workshops on developing successful applications so that people can
14:49
understand what level of evidence is is required for each of those tier one tier
14:54
two tier 3 Pathways so we'll do our best to help people to develop really
15:00
successful applications
15:07
so here's a bit of a summary of the consultation schedule for 2023
15:12
um the next thing you'll hear about is the ihakapa webinar webinar tomorrow on modeling arrangements for the general
15:19
use items uh then we'll do a webinar the
15:25
department will do a webinar to provide an overview of the regrouping approach to part A and part C including
15:30
methodology to address some mixed benefit groups um and then we'll do consultation on the
15:37
mixed benefit groups following that webinar so we really want to set the scene uh with the webinar and then we'll
15:42
come out and consult with sponsors on uh what the next benefits groups might mean
15:47
for their products um then we'll do targeted consultation
15:53
on regrouping for Part B as I said that's part of the work with commission PWC to do the part B work is moving more
16:01
slowly I would say than part A and part C and it probably won't be concluded until
16:07
uh late this year or next year we'll also do targeted consultation on
16:13
the pilot post listening reviews that will be with the impacted sponsors
16:19
I will do consultation on the prosthesis list guide that will kick off in this first quarter
16:28
um we'll also be doing consultation on the charge 2 of legislative changes specifically the listing criteria and
16:35
the bundling arrangements as well as cost recovery and then
16:41
um this is this is highlighted specifically because it's beta testing for PL apply and Jeff will talk about
16:48
this more I think or do you want to talk about it yeah no thanks Elizabeth again many of you have participated in the T1
16:55
application beta process um we are going out for what we call public beta for the tier one tier 2 and
17:04
tier three public beta testing where basically we enable industry to use the
17:09
system in a lower environment in anger and then provide us with some feedback so you'll hear you'll get some detailed
17:16
correspondence from the program team around how to participate in this um and yeah and we look forward to your
17:23
continued supporting them thanks Jeff and then finally in this first quarter
17:29
consultation on the bonding Arrangements again led by our hackbar so there's the
17:34
webinar tomorrow but I have to do to finalize those bundles in March so
17:40
um it's sort of bookended I guess by the webinar tomorrow and then finalizing it in March
17:46
and then the next quarter starts with targeted consultation on
17:51
pilot post listing reviews again
17:56
and the consultation on the prosthesis list guide and various workshops uh consultation on
18:05
trans2 legislative changes again
18:10
and sponsor participation in beta testing for PL apply again is that right
18:17
yeah um and then consultation on funding
18:23
arrangements for generally asylums via our hackback will actually be finalized by then so everyone will know the result
18:29
in that second quarter in the third quarter
18:35
again consultation on post System review framework that will be to Circle back and see what we've learned from the
18:41
initial reviews that we've been doing um and then over to Jeff for the pl
18:46
apply user onboarding yeah and as I described earlier we will be starting to use the new capability uh in September
18:53
and so we will be running an activity where we'll be onboarding all users so setting up user accounts and making sure
19:00
that people have a good understanding through uh user guides Etc on how to use the new application process
19:07
and then following on to that we'll be running onboarding and training activities so webinar series around uh
19:14
where we actually run through each of the functionality and provide kind of Hands-On support for people
19:20
and then moving into you working with the hospitals insurers to participate in the published process private beta so
19:28
that we make sure that the information from those that use information is available in the format in in which they
19:34
use it thanks Jeff so that's the plan for this
19:40
year as you can see there's a lot of consultation which is interrelated but we're trying to
19:46
um I guess bundle it into bite-sized pieces for you through the year
19:52
so I think we might move on to the uh to the question and answer session now um
19:57
we did invite you to send your questions through prior to the webinar so we've picked out some of these to
20:04
um kick off the discussion while people might be typing in their their questions in the system so these are some
20:12
questions that we received prior to the webinar first one is why does a PDL update need to be bypassed so um I might
20:20
kick off with that one um obviously um where we've got a number of Reform
20:26
elements uh that are due to um occur during the year we can't embed those
20:32
reform elements in the existing online system plms um a lot of you will know if you use
20:38
plms it's quite unstable and it's just holding together at the moment but it
20:43
just won't tolerate all of the changes that are coming due to the reforms so we need to plan to move to the HPP uh to
20:51
make those reforms part of the new system Jeff if you've got anything any other comment you'd like to make yeah
20:57
I'm Elizabeth that the alignment between finalizing the reforms in a timely way
21:02
so that we can build that capability in a new system to support it I think is the key reason so it's the intersect
21:08
between changes in legislation and changes in capability to support that legislation
21:14
right thank you so the next question we had was what alternatives are available to submit an application during the
21:20
bypass period uh the short answer is there will be no alternative mechanism for submitting an application during
21:27
this time we don't run a paper-based system really it's all done through plms at the moment so our choices are plms
21:34
and then HPP when we move over to it so we're talking about a period of uh it's
21:41
probably between May and September this year when we won't be able to accept new applications
21:52
so the next question if the if the department will continue to have access to plms can sponsors email the
21:58
department to finalize their documents to an application on their behalf related questions are what options are
22:04
available to finalize applications that have already been recommended but are pending their artg or MBS number
22:11
and I will transfer response to Applications be available they're all related because I guess the the
22:17
fundamental question there is you know I'm almost through the system I've got a small change that I want to make what
22:22
can we do about that during that period from May to September so we're working
22:27
through these questions and we'll provide answers in the coming months uh
22:32
it really depends on uh whether we can make those adjustments in plms or not
22:38
and there has to be I guess I'm calling on Jeff now but there has to be a sort of a cut off period when we've got all
22:46
of the data in plms and it's not going to change anymore and then that transfers over to HPP so that's what
22:52
we're trying to juggle in yeah it's a really important point Elizabeth is maintaining data Integrity through
22:57
transition is fundamental success for all of us so making sure that we have a stable current state so that we can
23:04
transfer the data new capability and people can seamlessly manage their items and also make application against them
23:11
new application structure in the new grouping structure I guess I would also want to say that if
23:18
you've got you know obviously if you're waiting on an artg number or an MBS number that's out of your hands I
23:23
understand that but if you've got small changes or transfer a sponsor or that kind of thing to do please do it now
23:30
please get it done before May if you can that would be our message
23:36
and Elizabeth I just add that as we work through trying to answer some of these
23:41
questions it is almost a case-by-case consideration because they are all unique in their own kind of limitations
23:48
so that's why we're kind of saying the answer is no but if there are some
23:53
things that we can get done in the short term then that will certainly help everybody out yes we'll do our best to accommodate you
24:01
okay um so here's another set oh
24:07
do we do all those okay um another set of three that are quite
24:14
similar or the answer is quite similar if the department will continue to access plms can sponsors email the
24:20
department no we've done those ones haven't we yeah sorry yeah
24:25
all right so I think we're handing over now to Jane who's going to run us through uh the questions that we've
24:32
received so this is your opportunity to type it out
24:37
um and just a reminder that you can access slido through the QR code on your
24:42
screen and I'll hand over to Jane now thank you
24:48
thank you Elizabeth um thank you for reminding um attendees that questions can only be
24:53
asked to slider and they will be moderated there are a few ways to access so I know firstly by opening the app on
25:00
the right hand side of the screen or by using the QR code and password on this slide
25:06
um on the right hand side of the screen you will see the slider bar which will show the questions as they are approved
25:12
and we encourage you to use the thumbs up button to indicate the most popular questions to be addressed first in the
25:18
interest of timing and scope the panel only new addressing questions related to changes to the plus thesis list time
25:25
frames foreign
25:35
in a second
25:40
well we'll have Jeff storera and Wendell Curry from the Health Products portal team and we'll have Elizabeth Flynn
25:47
training parish and an arena sudanova from the prosthesis list
25:58
foreign first question is will there be a
26:05
definition for high-risk products are we talking about classifications per TGA risk class
26:12
I as a general yes I think we are lining up with the risk classifications
26:18
um for is it on yeah uh yes we will try and align where possible with TGA
26:26
thanks Elizabeth all right the next question is what will be the difference between a clinical
26:32
report submitted to TGA and one required by tag
26:37
foreign so I mean it's the same as
26:42
um occurs at the moment um I I guess the main difference between what we do to consider listing on the pl
26:48
compared to TGA is that we're looking for clinical comparators um because uh we want to know that the
26:56
the device that you want listed is at least as effective as the group it's going into
27:02
so that's a different kind of assessment than the one that TGA does
27:09
thank you next question is will the workshops
27:15
mentioned on developing successful applications be relevant to Part B or
27:20
only part a given the expected pace of Part B consultations
27:25
I think in the first instance there'll only be relevant to part A and if we identify a need to run workshops
27:33
specifically for Part B we'll do that later thank you
27:39
all right so what happens if legislation is delayed what flexibility does the
27:44
system have
27:50
um I don't anticipate the legislation is going to be delayed uh but most of what
27:56
we're embedding into the HPP because these this seminar is about you know what to expect in terms of your online
28:03
applications this year what we're embedding into the HPP isn't really dependent on the legislation
28:10
not um significantly no
28:17
well PL items re-classified as general use items the automatically transfer to the
28:24
rearrangement or responses need to reapply Jane can you just um read that again
28:31
we'll automatically be transferred to what to the new arrangements or what
28:36
sponsors need to reapply so um the general designers in part D
28:42
will will be removed from the prosthesis list as of first of July
28:47
so they won't be in the new system on the prosthesis list um they will be listed in a separate
28:55
area of the Private health insurance act but they won't be on the pl anymore
29:04
my next question is ask the March 2024 cycle has been bypassed is it possible
29:11
to have a May 2024 cycle in the room
29:18
I guess um what we think we need to do is
29:24
um make an assessment about that a bit closer to the time
29:30
um I I don't know the capacity of you know participants here today to get an
29:36
application into an earlier cycle or you know like we don't know what the need will be
29:42
um come you know March next year but we'll make an assessment of that as we
29:47
move through the year I think thank you all right so will the criteria for
29:55
moving an application from T1 to ten two or two three be clearly laid out for the
30:02
new PL guidelines yes
30:11
um so this is a clarification question um someone is asking if they can confirm when we say device are we referring to
30:18
both medical devices and human tissue products
30:23
so at the moment um everything we're talking about is medical devices uh there is a
30:30
consultation that is just about to kick off around Part B the human tissue products so um I think where we can
30:38
align the two parts of the pl we will but I'm not going to draw any
30:43
conclusions about that until the consultation um has has happened so for the moment
30:49
um the applications we're talking about are part A applications um and so we're Focus the first Focus
30:55
the initial focus is on uh part a
31:01
we're just looking do you expect that results of the part B
31:07
consultation will be fed into my second update or consultation on the listing
31:12
guide at a date related and current report [Music]
31:17
yes
31:23
um I think yes the results of the part B consultation are where they where they
31:29
are signaling a need to update the guide we will do a second update of the guide
31:38
um what platform will Communications and or requests for information from your department to sponsors them sponsor
31:45
responses be sent from May 23 submissions
31:51
backward movements for May 23 since
31:56
it'll miss you plms will still be functioning
32:08
right can you confirm the main 2023 submission cycle that mine is the 14th
32:14
of May with the plms open to submit
32:21
age yes
32:27
so um I want to be clear you have to get it in before the 14th of
32:33
May that's when after the 14th of May it's period when we won't be accepting applications anymore the 14th of May
32:40
deadline is for the November 2023 publication cycle
32:46
does that make sense yeah
32:52
so if you don't get your application in before the 14th of May you will then have to wait until September
33:02
put some all right so the next question is what documentation requirements oh
33:08
sorry what are the documentation requirements for established and to not
33:14
establish Technologies are we talking about peer review Publications
33:19
I think that question a bit out of scope for this for this webinar
33:25
um it's probably you need to wait for our consultation on the PO guide
33:32
excellent um just a quick one on getting a lot of requests to make the slides available
33:38
since we could just confirm that uh we'll be releasing the slides uh to
33:44
the um participants today but also there's a recording that will be
33:49
published for those that have been unable to um participate today so we'll be
33:56
publishing the recording thank you
34:02
all right so what are the top level changes or differences to HPV in
34:08
comparison to plms is that one Jim
34:15
um so I guess the the main changes between the biggest changes between PLS and HPP are that we have the new pathway
34:21
applications in the HPP uh but there are other changes in the HTTP to address current pain points with plms to address
34:30
the user experience and to make that better for all of the users of plms but the best way to see I'm going to have a
34:37
plug here the best way to see the changes between plns and the HPP is to participate in the upcoming public beta
34:44
you'll be able to jump into the HPP experience it for yourself and provide us with some feedback but I think you'll
34:50
find that the HPP will be certainly what it would definitely be more stable than plms and and much easier to use as well
34:58
but please come and check it out for yourself thankful though
35:05
all right so in regards to the March 24 PL are there any benefit adjustments
35:12
which will be delayed or skipped so there won't be a March 24 update so
35:19
therefore there won't be any reductions that we will anchor to that one
35:24
[Music] uh the initial beta testing was only for
35:31
T1 will there be exposure to tier two and three bio to public figure testing
35:40
uh no so you'll get to see the tier 2 and tier 3 applications in the public
35:47
beta testing and that will kick off with an introductory webinar that you'll be invited to attend so we'll do a demo of
35:54
that tier two and three and then you'll be able to jump in and use the user system in public beta
36:01
I think that also answers the next question which will start when we join the beta testing of the http
36:09
yes I will be sending out an email to invite you to participate and that will
36:14
have the links to the the webinars so you'll be able to come along to those
36:22
um and will all billing code history and previous applications from the plms being transfer to that HPP
36:30
uh that is a very good question uh we are working through that uh but it is
36:37
our understanding so all of all historical information is required by the department in order to make assessments so that will be available to
36:44
the department but we're working through how we can make that available to sponsors to meet their requirements to
36:50
view historical information as well but obviously we've got a lot of things to consider given we're moving from one
36:57
grouping structure to another from one to other model to another so we're we're still working through that at the moment
37:07
um all right so will there be changes in the timelines for small changes such as updating arcg only
37:17
okay so I think this uh relates to a question we answered earlier which is if
37:24
you've just got a small something or other can we help you out with that during this period when we're not accepting applications
37:32
um we're exploring what what plms might be able to accommodate there but I can't
37:38
give any guarantees at this time um so again I would just encourage people if you have small changes or
37:45
changes or sponsors or something like that please get it in before May because the risk is that you might have to wait
37:52
until September if you don't get it in by May Now understand when you're waiting for an artg number it's out of
37:57
your control uh you you it's just when you get it from TGA but we can't cannot
38:03
guarantee in that period that we can update those small changes
38:12
all right the next question seeking parification the plms does remain open
38:18
to submit applications by the deadline 10th of September therefore these applications are assessed for July 2024
38:26
PL ANS
38:34
no uh so the deadline is on the 11th of September
38:39
for the July 2024 publication but that will be in the HPP plms will no longer
38:45
be available uh as of the 11th of September so you'll need to Lodge your
38:50
applications for July 2024 in the HPP
38:56
statements all right um so what are the details of post listing reviews is this similar to
39:03
TGA post Market of arrangements so um I just drawing attention to the
39:09
fact that the post listing review framework is available on our website um and it's really not you know we're
39:17
talking about the HPP and um the bypass of the cycle in this webinar but I would
39:22
direct you to our website and search for the process listing review framework
39:30
foreign
39:42
good question uh I think with the time frames um the consultation on the PO guide will
39:48
probably be happening in parallel to our public beta testing what we have in the Health Products portal is a suite of
39:56
knowledge-based Articles and we have some draft content in there for you to have a look at so you'll be able to
40:01
understand how the knowledge base articles will work and then some of that guide content once the consultation has
40:08
completed can be put into those knowledge base articles so the HPT has in-context help and some of the guide
40:15
content will be either replicated in the HPP or just put in the HTTP instead of
40:20
in the guide so really good question we'd love for it to be there in public better so you can test both at the same
40:26
time but the timing probably won't line up before public beta
40:34
um will updates for General news either is one route or contact bundling be made
40:39
by a HTC all items falling under these categories be automatically updated as
40:45
to UI so there won't be any updating of gym reviews items
40:52
um once they're taken off of the prosthesis list um the the group that we have at the
40:58
moment is the group um I think you know what we're intending is that when we implement this new
41:05
bunding Arrangement it's separate to because by Stacy's list we'll do a review of how it's working after about
41:12
two years and we'll see where that tastes but there won't be any um routine updating of the bundles
41:25
so what date is the HPB expected to be available for September deadline
41:31
so I think I might have confused everybody a little bit here in previous answer so there's not a September
41:38
deadline so the September deadline would have been for the March cycle which
41:43
we're bypassing so the HTTP will be available on the 11th of September for
41:50
the January deadline for the July publication cycle so apologies if I'm
41:56
confused people and I think Paul's question is similar um in vain the next question so yes the HTTP will be
42:02
available on the 11th of September for the deadline in January and we'll make
42:09
sure that you're all onboarded and you have heaps of support Up Until That September 11 date where you'll be able
42:15
to start jumping in and drafting your applications and lodging them through the HPP
42:22
that's great thank you for firefighting and from Barclays by story it's confusing all these dates get a bit
42:28
confusing um so the next one is will the same billing phones and all data be
42:34
transferred to their Google system uh yes
42:41
um but of course the data so we'll be getting the data out of plms will then be transforming that data into the new
42:47
grouping structure and then putting that new grouping structure into the HPP
42:53
foreign just a few questions left um HTTP current uses what other
43:00
requirements for the pl to be enabled at a user level
43:05
right so um thanks for this question Stephanie so Stephanie's already a user of the HPP uh
43:12
so you won't have to do anything you'll just log on to the HTTP as you usually do on the 11th of September and you'll
43:19
just see that the applications for prosthesis list will have appeared in the HPP so for existing HPP users you
43:27
won't have to do anything your experience will be the same you'll just start to be able to apply to the
43:32
prosthesis list through the HPP on the 11th of September
43:40
um I'm not sure about just a lot of answers the next one which is Glory Be will we have an opportunity
43:45
to test for functionality at HPV including access to historical data prior to removal appearance
43:54
um it sounds like that's quite an important uh point so we will take that question away and have a think about
44:00
that and we certainly can provide another round of testing so we'll have a
44:05
consideration of that and work out when we might be able to fit that in to the plan so yeah really good question thank
44:12
yous like Michelle Costa's got the same yeah um so our final question which we have
44:17
foreign
44:34
ones [Music]
44:45
no thanks Jane it looks like we've come to the end of the questions uh we're doing a repeat of this webinar
44:51
next week if you've sat in on this one you don't need to come to the the one next week because we'll be doing it all
44:57
over again um there's suddenly two more questions so James excellent thank you everybody
45:03
so which cycle well then you would expect to look here
45:10
July the first one out of the HPP which is July 24th
45:17
and do users need to rewrap the stuff for each treatment
45:24
so if you're an existing HPP user you won't need to re-register but in order
45:29
to start using the Hep you will need to register using your ligov ID so we're
45:35
not we can't automatically transfer your plms registration over so we'll help to
45:40
take you through the process of registering in the HPP and linking your mygov ID to your HPP profile so all that
45:48
will be will take you through all of that in the onboarding activities later this year okay looks like we've come to a pause
45:56
again thank you very much Jane for helping us out there and thank you to all the participants
46:02
that's been really helpful to us to identify your key concerns and things that we need to take away and have a bit
46:08
more of a think about we'll continue to um compound information about this
46:16
um My Hope Is that you we get the feedback that you've heard it all before because we really want to make sure that
46:21
we reach everybody who might be planning to put an application in of any sort this year because they need to know
46:28
about uh these changes that we've had to put in place uh for the big move
46:34
so um final slide here is about getting in touch with us we do have quite a
46:40
number of email addresses depending on what your question is I think the most important one
46:46
um out of this webinar is the Health Products portal one so the people who want to know how to register for the
46:53
public beta and that kind of thing that the communications coming out but you've got an email address there in the middle
46:59
uh for those of you who are asking questions about the general use items and the bundling Arrangements there's an
47:07
email there from ihackpa and they are delivering a webinar tomorrow as well
47:12
which you should know about and then for the prosthesis reforms if you have a
47:18
question about applications just be Au style questions about applications
47:23
there's an email address there if you have a general question about the reforms we have an email address
47:29
uh if you specifically want to know more about post listing reviews there's an email address or if you specifically
47:36
want to know about compliance there's a separate email address there so I hope that will help you navigate navigate
47:42
your way to get the information that you need as I said we'll be repeating this webinar next week but it is a repeat so
47:50
you don't have to sit in on both and we'll continue to provide information to you uh frequently as we
47:58
move through this year so thank you all for your attendance bye
Presenters
- Elizabeth Flynn – Assistant Secretary, Prostheses List Reform Taskforce
- Penny Parrish – Director, Prostheses List Reform Taskforce
- Jeff Storer – Program Director, Regulation & Reimbursement Transformation Program
- Lyndal Parry – Delegate Product Owner, Regulation & Reimbursement Transformation Program