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mister chairman ladies and gentlemen thank you first to be able
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today to have this talk at this very interesting congress
00:00:10
about regular mentoring aspects ruling the reimbursement of africa
00:00:14
analyses in the context of compulsory health insurance
00:00:21
during my talk i will give you some general information about
00:00:24
coverage of medical care by the compulsory health insurance
00:00:28
i was after after that talk about the least of analyses i will give you
00:00:33
some information about the laboratories um of which should be analysis will be reimbursed
00:00:39
i will give you some indication as well on the uh the refinements to add a new analyses on
00:00:45
the list of basic healthcare lab analysis and the last i will give you some information about
00:00:52
in which situation is actually one of the analysis covered remembers
00:00:57
and indeed but ill patients and then from last considerations and the summary i
00:01:05
first what does the law say that about the law says that the compulsory
00:01:10
health insurance happens the costs of medical k. needed to buy it no
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or to treat diseases and consequences but also
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this is very important sorry uh_huh mm
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that the medical care provider mostly need to scare to the name of the tree it's
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yeah the coverage of um of the analysis by the uh
00:01:39
compulsory health insurance now's also expand to some preventive measures
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but the legislature has posted in a very rest to keep wording
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and it has to be in the aim of cost saving
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so there is a limited coverage and it's set in the
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lot and the two certain sorry akin to a man
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that it's here it is you need to you need to to certain tests and to detect diseases in time
00:02:08
and to put some preventive measures for particularly threatened insured people
00:02:14
i'm these preventive measures have to be leased it positively in the article twelve d.
00:02:20
and twelve e. of the overdone also sleepless that's shorter less holes this one
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now the coverage of uh the compulsory health insurance
00:02:31
he's that one of all the health technologies that
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are based on the principle of unique lists
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they're ah i'm not that are in the are compulsory health insurance
00:02:45
our dynamic and flexible and you have closed least that mean exhaustive list and you have openly
00:02:51
the close lists for example are the least analyses oh buddies that
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means that and and devices which is also important today
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and leave leave it can be implemented and the value at the brink principle
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how does this go um in the uh and if i miss someone wants to have an analysis covered by
00:03:12
the compulsory health insurance he has to submit to the
00:03:15
federal office of public health or request for coverage
00:03:19
these requests for coverage will then be studied by the
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federal advisory commissions and these commissions will indeed
00:03:27
a recommendation to the federal department of house affairs who've been
00:03:31
in the and take that they should decision coverage window
00:03:37
now what are the yeah and the criteria that are important to decide if
00:03:43
uh have technology should be covered or not buy this c. huge time
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we caught the eye we call that the legal e. i.
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e. criteria the first heating for effectiveness and efficacy
00:03:56
the second the a a being for appropriateness and and that that we understand suitability
00:04:02
quality insurance missions and also appropriateness of use and also
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consistency with political and socio social and ethical aspects
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and last but not least the last he's for economic efficiency in which we have at least
00:04:19
the price level the cost impact phonetic okay and the cost effectiveness
00:04:24
all these criteria are important not only to that that we had to help
00:04:29
technology and their regulations but also to define indications and quantitative limits
00:04:35
as well as to divide the quality insurance specifications
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now i told you already about the bring in principle what passed this mean it means that
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any medical care provider or i. v. d. manufacturer
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we'll have to submit a request to the federal office of
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public health for it for his analysis to be covered
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and it can come from different instance these mainly scientific
00:05:04
societies over medical care provider like an apple
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tree for example for the medical for the elaborate to analyses or an identity manufacturer et cetera
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no just a few words about the terry if you have to go and look at
00:05:20
the car if he's there also defined by law and different things are important here
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first the kerry if has to be determined respecting the economy call
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principles and it has to be structured in an appropriate manner
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it has to cover up the most that transparently proven cost of an efficient health technology
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it can be said either by agreement for example the time it or
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by the competent authority for example within the least of analyses that
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the tirade once that has to be applied by all the medical providers
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and charging higher targets is not allowed except for the list of items
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and which is called the least of medical of mean sorry and devices
00:06:06
no no these were they generally informations about i'm a coverage by the compulsory
00:06:11
health insurance i will now go to the least of analysis itself
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as you probably know the federal department of housing face it takes a list of analysis with terry
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what does this mean it means that only the analysis contained in this list
00:06:29
will be covered by this th alright that means also
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that current analogy invoicing is is not a lot
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the car you which is in this um at least he's a maximal identity terry if that means that higher
00:06:44
and higher cherries and not allowed to be charged but
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of course rubber targets are allowed to be charged
00:06:51
the list of analysis is applicable for ambulatory care for hospital in here page for
00:06:57
hospital inpatient here the analyses are of course included in the d. r. g.
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hell is i'm not the least of analysis and they it's made of five chapters
00:07:11
of which the importance ones are one two three which contain the actual analysis lease
00:07:17
and chapter five where you have some specific restricted list for specialities
00:07:22
and there for example the chapter five line is quite important sorry i will have to do this all the time
00:07:28
and in chapter five one you have the least analysis for basic health care and the least
00:07:34
of analysis the medical specialities you will get something for more information about this later on
00:07:40
now when you want to put a new analysis on this list it will
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have just follow the same procedure that i have told you about before
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but for chapter five for example the requests i'm uh to add a new
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analyses should comment from a nationally active
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scientific society and for preventive analyses
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you need to put two as to make a signal pain is
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replaced with the federal commissions for general services and principles
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because one of these analyses also have to figure in article twelve of the corpus
00:08:18
now when when you submit the request for coverage
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you are probably familiar with and the things that blue where you have
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all the slides that is phases of the buyer marker development
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and i can tell you their request comes here that means after all the development
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why because during the procedure analyses and to see if these analyses
00:08:43
cover and cut and ease fulfils the criteria of right e.
00:08:48
we will need all the information that had been collected here we need analytical validity
00:08:54
we need clinical validity we need clinical useless use usefulness we need effectiveness
00:09:00
and of course ideally we also need cost effectiveness analysis
00:09:08
now if you want to submit and a request to um no add
00:09:12
a new analyses admit to the federal office of public health
00:09:16
and this is all the documents that you have to um submit under this and or to t. v. and get
00:09:23
an idea about the work that you have to do it it's about like writing an article for medical journal
00:09:31
so what do you need you need the regular meant to read documentation
00:09:34
of the i. d. v. device um see marking et cetera
00:09:38
then we need the indications for the test this well this is the epidemiology of the disease
00:09:44
then we need the diagnostic and therapeutic algorithm prior to the
00:09:49
new analyses and with the new analysis to see
00:09:51
if there is a change and you know the procedure
00:09:55
then we need the technical documentation of the test
00:10:00
we also need all the climate quality insurance documentation
00:10:04
including and internal and external quality control
00:10:08
we need to know if they um that the uh a device is off the rice on the on the mat and swiss market
00:10:15
and then we need all the scientific any evidence as i've told you before
00:10:19
i met on analytical and clinical performance clinical utility and effectiveness
00:10:26
and you will have to do to give us information about the impact on the medical
00:10:30
case before and after the test and there has to be also risk analyses
00:10:35
last but not least we also need all the documentation about the finances and in the economy
00:10:41
and there will have to give us information about the investments in
00:10:46
material automates and the start to justify the to read
00:10:49
and then we will need cost effectiveness and cost the fish shows efficiency analyses
00:10:55
and of course we need the budget impact on the suisse medical pupils
00:11:00
once we have all these documentation to the particular office of public health
00:11:06
will evaluate the at the request on completeness and by yes
00:11:10
and if necessary get more information and um with the external sources of information
00:11:16
or with expert opinion then the federal commissions for analyses means and devices
00:11:22
will deliver a recommendation in the intention of the federal department of house affairs
00:11:28
should these test be reimbursed yes no and
00:11:32
if yes with constraints on the constraints
00:11:37
the decision is then taken by the federal department of house affairs
00:11:41
and and the modifications of the list of the analysis that published regularly in the federal system the collection
00:11:47
what you have to know is there is no to really cool way to change to change these modifications that
00:11:54
at any time it is possible to submit to submit new replies
00:11:58
for changing on an existing analyses or if for
00:12:02
example the analysis has been rejected first
00:12:05
and as soon as there is new evidence and that that um the full feel
00:12:10
that the u. a. e. criteria you can again and submit new requests
00:12:17
now i want to give you some information about collaborative because this is also important not
00:12:22
any laboratory and we'll have clear analysis covered by the c. h. ah a.
00:12:28
and there you have the legal uh criteria and at the equality requirements
00:12:35
the legal specifications for the medical laboratories figure in the low
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got fifty three and fifty four of the other than of the last year false analogy
00:12:44
and there is also a detailed description in the truth that the function model but rather
00:12:48
than it is a medical which are actually and this was good laboratory car directed
00:12:54
and we'll go through and a piece a little bit and
00:12:57
later and uh in a few details you more details
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there is also and um specifications legal specifications
00:13:08
for genetic analyses in the other than also like values genetically men as well as in
00:13:13
the other than oscillate apple ipod in computers you uh might for biological analyses
00:13:20
now in switzerland we can faith that the world at the laboratory is roughly separated into types
00:13:27
the basic healthcare laboratories and the external order laboratories
00:13:35
and there are quite a few basic health scalable trees
00:13:38
and we'll go through them um now quite quickly
00:13:42
um first you have collaborative medical practitioners and what is important here is
00:13:48
this laboratory you can only do analysis for the needs of the medical doctor
00:13:52
and he can and the the coverage analyses
00:13:56
figure in these three lists of analyses
00:13:59
the rapid analyses the complimentary ones as well as the analysis for home visit
00:14:04
for nine other medical specialities these lines have only to have and all of them looked
00:14:10
at least the analysis that they also can do in their medical packed it's
00:14:17
another level tree of basic health care use the hospital that
00:14:21
type a. b. c. the hospital out for small hospital
00:14:25
and these um that latitude you also can only do analysis for the only
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and i'm not the least of analysis they can do that harvard privacy
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hates by will be in this list of full hospital dance
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then you have the pharmacy map the slab is having that directed by a
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pharmacist with the federal diploma and here are the analysis that are covered
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have to be on medical prescription and only to the patient that is at the time in the pharmacy
00:14:56
so that means that they can't do analyses on external older what are you
00:15:00
there and they also have the reading list of analysis in chapter five
00:15:06
now can have this new entity and i think that's one of the points of the discussion today as well
00:15:12
um that you have this entity which is called the centralise diagnostic at the patient's bed in hospital
00:15:18
ah in other words p. o. c. t. although this is not
00:15:21
so clever to call these uh these um laboratory like these
00:15:26
and here this lab is one that has to be located in
00:15:30
the hospital units but outside the lab of the hospital parts
00:15:36
the analysis which i'd and there are done and that there's responsibility of the head of the hospital
00:15:42
lab type b. or c. will see this after who has two parents all the
00:15:47
quality insurance measures and as well as that this that is properly trained
00:15:53
if i'm of these and the laboratory here is in the hospital
00:15:57
where you don't have a laboratory type b. or c.
00:16:00
then it is considered as a hospital lab type a and it it
00:16:04
has to fulfil the truth there yeah that we've seen before
00:16:09
the list of covered analyses your is also restricted it's only for the own needs of the hospital you need
00:16:16
and and it is limited to to the analysis of figuring
00:16:20
in the least for hospital out of chapter five
00:16:25
now we come to hospital i'm allowed type b. beef is
00:16:29
a bit of a hybrid hospital hospital lot because and
00:16:35
if for the analyses of the own needs of the hospital it it
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can do any analyses in the range of chapter one two three
00:16:43
as long as it's in the range of the title of the head of that or of the supervisor
00:16:49
but on external request i'm you can only only the
00:16:53
analysis of basic health care will be covered
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finally we come to one of the um the external audit elaborate trees
00:17:03
and there you have the elaborate to the hospital appetite see as well as the private property
00:17:09
and these laboratories can do all the analysis at the least of analysis as long
00:17:15
as if it's in covered by the title of the specialist elaborate too many scene
00:17:20
the hospital labs can do these analyses but that their own needs as well as an external requests
00:17:26
and obviously the external request ever trees could only
00:17:30
duties analyst these analyses on external replaced
00:17:36
well now we've gone through various legal specifications of the latter cheese
00:17:41
and we'll we'll we'll um i will give you some information about the quality requirements so this laboratories
00:17:51
and as you probably below no big quality requirements are requested by now
00:17:56
in the last as particular weren't t. of the health technology and
00:18:01
has to be i'm not done and here are the
00:18:04
federal council he's an actor that means you can take measures
00:18:08
all he can barely cake images in controlled in
00:18:14
what about the quality documents that are necessary wonderful at medical laboratories for
00:18:19
their analysis to be covered by the c. h. ah a.
00:18:22
first of all of course you have the gnome the ice on them then you
00:18:26
have an information in the consequence that's that's service quality don't label hypothetical
00:18:32
then you have the see the c. fans all the good laboratory praxis and then you also have quality space
00:18:40
the other than almost a line at least in eighty two million for genetic analyses
00:18:43
or in the overdose usually double that latin club eulogy for microbiology colour analyse
00:18:49
and then for some analyses you even have some quality
00:18:52
specification is inside to the least of analyses
00:18:56
for example accreditation is compulsory for high throughput sings
00:18:59
sequencing and the full constitutional genetic analyses
00:19:06
the slide is quite important because you will understand that
00:19:10
there is no it's not only the difference between right in it then maybe collaborators in switzerland
00:19:15
and a link to the analysis that that are reimbursed but also the quality level
00:19:22
on the side you have the basic healthcare naps and for the slats under the quality level is
00:19:28
the minimum one and for these labs you have an extensive quality and quality insurance system
00:19:35
here for example for these labs and that the um the f. f.
00:19:39
i. m. h. title of the appalachian magazine is not required
00:19:43
and then run that's no special specific and apply for cases for the personally who does the analyses
00:19:50
i it's analytical symbols analytical systems have to be simple
00:19:55
and the quality insurance system is minimal and these labs i'm not appreciated
00:20:01
the i. c. q. is not and is also not very and very strict
00:20:06
and it has to be done minimum once for two weeks all according to the manufacturer and actually in
00:20:12
specific cases situations it has to be done more often
00:20:16
for example if they're technical problems et cetera
00:20:20
i thought the latter cheese and that that can do the external water
00:20:24
here the habit laboratory was that the visor has to be
00:20:28
a specialist in every two minutes in the performance of the analysis has to be done
00:20:33
by at least applications the analytical systems your have to be simple or complex
00:20:40
by these that have to show that they have a quality insurance system according to the
00:20:45
u. i. so long um the fifteen one eight nine of two thousand and twelve
00:20:50
and there is an increased tendency although it's not compulsively
00:20:54
in switzerland yeah it i make two accreditation
00:20:58
finally the uh externally by internal quality controls are pretty straight
00:21:03
and they they they have to be done nine minimum once they he or one spurt or series
00:21:09
and it's valid twelve uh twelve hours of fifteen tests
00:21:13
and each module of the analysis of the
00:21:15
analytical system has to be controlled by an i. c. q. if if the complex analytical system
00:21:23
now i'm doing this i think is pretty important for you
00:21:27
and it's when what other pretty requirements to add an analysis on belief
00:21:32
of basic else care that i mean for example appears to test
00:21:40
first of all these analyses has to figure in chapter one three one two
00:21:45
three then it passed on the on the shell a problem benefit
00:21:49
and that that this analysis in this setting and and that i
00:21:53
should be done rather than in an external would turn that
00:21:57
then it has to answer frequently asked question in the cactus in general admission
00:22:03
and the result has to be available during the consultation that means i'm not that but i
00:22:08
cannot have don't diagnose it has to be done in the presence of the patient
00:22:13
then and this is very important and it also has already been
00:22:17
i'm not a change to this morning by professor sent it has to be of high diagnostics if a significant
00:22:24
that means that the early diagnosis and therapy should be able to avoid complications and walking injury
00:22:31
due to the delay of outsourcing the test when external order request laboratory
00:22:37
and also if the result is normal it should be able
00:22:40
to avoid new consultation within a short period of time
00:22:45
then you need a few more thing this past has to be performed by itself
00:22:50
that means that the diagnostic procedure should not be increased or
00:22:54
not more expensive as the existing diagnostic procedure now
00:22:58
it has to be easy handling that that means it has to be on
00:23:02
if possible and now native simple with little volume and no preparation
00:23:07
and the analytic system has to be a simple one
00:23:11
then there is also some performance and quality specification
00:23:15
these two have to be at least equivalent to the same analysis provided by enlisting request now
00:23:21
and finally the price has to be cheaper or at the same
00:23:25
price then the analyses provided in the external repressed up
00:23:30
these are all that we carry out that have to be fulfilled for an
00:23:33
analysis to be and implemented in these restrictive lists for basic health care
00:23:42
now i'm in a i'm a just a few information and also got to understand
00:23:47
and when actually an analysis is hampered by the c. h. i. e. in the individual case
00:23:54
the presence of the house technology on the positive least doesn't mean yes that it will be covered
00:24:00
and it in your patient for example what has to be um the uh what are the requirements for it
00:24:07
well me and the criteria that i will give you now will be checked by the
00:24:11
insurer in each individual case to decide whether or not these analyses will be covered
00:24:18
obviously the analysis has oops sorry again has to be in the least of analyses and
00:24:24
on the specific least if it's done in a lab with the rest activities
00:24:27
it has to be ordered by a medical doctor or a chiropractor it has
00:24:32
to be done in the medical out according to the no well and
00:24:37
he has to fulfil the e. criteria in the individual case and i come back to this
00:24:42
article of the law which says the medical care provider must leave it is clear to the aim of the treatment
00:24:49
and actually the quality of the analysis has to be warranted and last for diagnostic
00:24:56
tests you will have also to show the proof of medical therapeutic consequences
00:25:02
and if you're i quote and that the preamble of the list of analyses
00:25:07
where it is said that i'd diagnostic test has to allow within acceptable probably t.
00:25:12
either to decide to the treatment is necessary or to what i'm not
00:25:16
real rain tate the treatment that has been done until now
00:25:19
all to redefine the new needed tests of the results of the yeah analyses
00:25:24
ought to be able to keep up some some future tests
00:25:28
because the diagnosis has been done with these analyses
00:25:32
and it's clear that analyses which at the time of the water in
00:25:36
and where it's also already to your back you will feel a men
00:25:40
not at least one of these criteria will not be covered
00:25:45
now i come almost to the end of my tall and i come to the last considerations and the summary
00:25:53
um what i have to tell you is that in the opinion of the federal office of topic of
00:25:59
the word p. o. c. t. is not very accurately used for us
00:26:04
because and i see what you have seen today and you will probably seen in
00:26:09
in the evening again and it has been appointed wide range range of techniques
00:26:14
from simple and cheap techniques like natural fro
00:26:17
analyses quite complex than it expected expensive
00:26:22
and it has like a nut for example the multiplex piece here
00:26:26
is you are even if they are cacti easy to use
00:26:30
so for us easy to use doesn't mean it is a simple
00:26:34
analytical system that can be used for basic okay yeah that
00:26:39
and now actually an easy to use test still has to be
00:26:42
done with respect of all federal laws and ordinances as well
00:26:46
as according to the norms for medical laboratories and an easy
00:26:50
to use test doesn't mean yes get this this case
00:26:54
can be done in your c. setting or should be done in a
00:26:57
p. o. c. setting or even should be covered enough cutesy thirteen
00:27:03
now i come to the summary the coverage of the healthy collared technology including laboratory finally
00:27:11
sees through the c. h. i. is limited to cast that have three been proven
00:27:17
to be effective appropriate and economically efficient and this is in
00:27:21
general as well as in the in the grouping
00:27:24
and for the time reef it has to be calculated on transparency probing efficient efficient costs
00:27:32
thank you for your attention i'm have now finished and some questions how
00:27:44
or you're right
00:27:48
oh
00:27:52
if
00:27:57
wow that's for sure you're rich so there's this sort
00:28:06
your page it's sure it's
00:28:13
has some kind of show of trim know what that you
00:28:18
mean if it's covered in the european country will
00:28:21
it be um that will be a bit will they be in the business for switzerland no no
00:28:26
yeah the systems are quite different the reimbursements assistance i fight difference
00:28:31
and i'm not uh it is not possible to um the two would just overtake the uh
00:28:37
uh the information say oh it's i've covered in france so it's covered covered in switzerland
00:28:42
but we also have to say that that for some um the tests we are even had the ever even have one cat
00:28:48
probably know that the and then non invasive for natal test is already
00:28:52
covered in switzerland but not yet in other countries in europe
00:28:57
which for a few

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Conference program

Welcome Note
Gaëtan Cherix, Director - School of Engineering
26 Oct. 2017 · 10:08 a.m.
Welcome Note
Marc E. Pfeifer, Symposium Chair
26 Oct. 2017 · 10:15 a.m.
349 views
Point-of-care Diagnostics: what are the real needs of general practioners?
Nicolas Senn, PMU, UNIL
26 Oct. 2017 · 10:19 a.m.
Recent developments in microtechnologies for point-of-care testing
Philippe Renaud, EPFL
26 Oct. 2017 · 10:47 a.m.
GenePOC, a breakthrough solution in molecular point-of-care testing
Patrice Allibert, GenePOC
26 Oct. 2017 · 11:19 a.m.
Reglementary aspects ruling the reimbursement of laboratory analyses in the context of the compulsory health insurance
Michèle A. Fleury-Siegenthaler, Federal Office of Public Health
26 Oct. 2017 · 2:12 p.m.
114 views
Recent advances in non-invasive diagnostics
Samantha Paoletti, CSEM
26 Oct. 2017 · 3:53 p.m.
How nanofluidics bring diagnostics closer to the patient
Fabien Rebeaud, Abionic
26 Oct. 2017 · 4:17 p.m.
Keynote Session introduction
Marc E. Pfeifer, Symposium Chair
26 Oct. 2017 · 5:07 p.m.
Keynote session: Accessible Bioanalysis for the Developing World and the Point of Care
George M. Whitesides, Harvard University, Cambridge - USA
26 Oct. 2017 · 5:09 p.m.
126 views
Conclusions
Marc E. Pfeifer, Symposium Chair
26 Oct. 2017 · 6:25 p.m.

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Bandverletzungen am Daumen: Sattelgelenk
T. Ly, Aarau
17 May 2018 · 4:26 p.m.
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