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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
Thursday, Oct. 26, 2017 · 2:12 p.m. · 29m 04s
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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
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about regular mentoring aspects ruling the reimbursement of africa
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analyses in the context of compulsory health insurance
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during my talk i will give you some general information about
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coverage of medical care by the compulsory health insurance
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i was after after that talk about the least of analyses i will give you
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some information about the laboratories um of which should be analysis will be reimbursed
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i will give you some indication as well on the uh the refinements to add a new analyses on
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the list of basic healthcare lab analysis and the last i will give you some information about
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in which situation is actually one of the analysis covered remembers
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and indeed but ill patients and then from last considerations and the summary i
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first what does the law say that about the law says that the compulsory
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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
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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
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and to put some preventive measures for particularly threatened insured people
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i'm these preventive measures have to be leased it positively in the article twelve d.
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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
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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
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our dynamic and flexible and you have closed least that mean exhaustive list and you have openly
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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
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the compulsory health insurance he has to submit to the
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federal office of public health or request for coverage
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these requests for coverage will then be studied by the
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federal advisory commissions and these commissions will indeed
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a recommendation to the federal department of house affairs who've been
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in the and take that they should decision coverage window
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now what are the yeah and the criteria that are important to decide if
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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
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the second the a a being for appropriateness and and that that we understand suitability
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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
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the price level the cost impact phonetic okay and the cost effectiveness
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all these criteria are important not only to that that we had to help
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technology and their regulations but also to define indications and quantitative limits
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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
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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
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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
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no no these were they generally informations about i'm a coverage by the compulsory
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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
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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
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and higher cherries and not allowed to be charged but
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of course rubber targets are allowed to be charged
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the list of analysis is applicable for ambulatory care for hospital in here page for
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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
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of which the importance ones are one two three which contain the actual analysis lease
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and chapter five where you have some specific restricted list for specialities
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and there for example the chapter five line is quite important sorry i will have to do this all the time
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and in chapter five one you have the least analysis for basic health care and the least
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of analysis the medical specialities you will get something for more information about this later on
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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
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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
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cover and cut and ease fulfils the criteria of right e.
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we will need all the information that had been collected here we need analytical validity
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we need clinical validity we need clinical useless use usefulness we need effectiveness
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and of course ideally we also need cost effectiveness analysis
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now if you want to submit and a request to um no add
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a new analyses admit to the federal office of public health
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and this is all the documents that you have to um submit under this and or to t. v. and get
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an idea about the work that you have to do it it's about like writing an article for medical journal
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so what do you need you need the regular meant to read documentation
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of the i. d. v. device um see marking et cetera
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then we need the indications for the test this well this is the epidemiology of the disease
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then we need the diagnostic and therapeutic algorithm prior to the
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new analyses and with the new analysis to see
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if there is a change and you know the procedure
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then we need the technical documentation of the test
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we also need all the climate quality insurance documentation
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including and internal and external quality control
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we need to know if they um that the uh a device is off the rice on the on the mat and swiss market
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and then we need all the scientific any evidence as i've told you before
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i met on analytical and clinical performance clinical utility and effectiveness
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and you will have to do to give us information about the impact on the medical
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case before and after the test and there has to be also risk analyses
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last but not least we also need all the documentation about the finances and in the economy
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and there will have to give us information about the investments in
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material automates and the start to justify the to read
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and then we will need cost effectiveness and cost the fish shows efficiency analyses
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and of course we need the budget impact on the suisse medical pupils
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once we have all these documentation to the particular office of public health
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will evaluate the at the request on completeness and by yes
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and if necessary get more information and um with the external sources of information
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or with expert opinion then the federal commissions for analyses means and devices
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will deliver a recommendation in the intention of the federal department of house affairs
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should these test be reimbursed yes no and
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if yes with constraints on the constraints
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the decision is then taken by the federal department of house affairs
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and and the modifications of the list of the analysis that published regularly in the federal system the collection
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what you have to know is there is no to really cool way to change to change these modifications that
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at any time it is possible to submit to submit new replies
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for changing on an existing analyses or if for
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example the analysis has been rejected first
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and as soon as there is new evidence and that that um the full feel
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that the u. a. e. criteria you can again and submit new requests
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now i want to give you some information about collaborative because this is also important not
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any laboratory and we'll have clear analysis covered by the c. h. ah a.
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and there you have the legal uh criteria and at the equality requirements
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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
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and there is also a detailed description in the truth that the function model but rather
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than it is a medical which are actually and this was good laboratory car directed
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and we'll go through and a piece a little bit and
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later and uh in a few details you more details
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there is also and um specifications legal specifications
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for genetic analyses in the other than also like values genetically men as well as in
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the other than oscillate apple ipod in computers you uh might for biological analyses
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now in switzerland we can faith that the world at the laboratory is roughly separated into types
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the basic healthcare laboratories and the external order laboratories
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and there are quite a few basic health scalable trees
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and we'll go through them um now quite quickly
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um first you have collaborative medical practitioners and what is important here is
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this laboratory you can only do analysis for the needs of the medical doctor
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and he can and the the coverage analyses
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figure in these three lists of analyses
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the rapid analyses the complimentary ones as well as the analysis for home visit
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for nine other medical specialities these lines have only to have and all of them looked
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at least the analysis that they also can do in their medical packed it's
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another level tree of basic health care use the hospital that
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type a. b. c. the hospital out for small hospital
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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
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so that means that they can't do analyses on external older what are you
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there and they also have the reading list of analysis in chapter five
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now can have this new entity and i think that's one of the points of the discussion today as well
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um that you have this entity which is called the centralise diagnostic at the patient's bed in hospital
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ah in other words p. o. c. t. although this is not
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so clever to call these uh these um laboratory like these
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and here this lab is one that has to be located in
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the hospital units but outside the lab of the hospital parts
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the analysis which i'd and there are done and that there's responsibility of the head of the hospital
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lab type b. or c. will see this after who has two parents all the
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quality insurance measures and as well as that this that is properly trained
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if i'm of these and the laboratory here is in the hospital
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where you don't have a laboratory type b. or c.
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then it is considered as a hospital lab type a and it it
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has to fulfil the truth there yeah that we've seen before
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the list of covered analyses your is also restricted it's only for the own needs of the hospital you need
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and and it is limited to to the analysis of figuring
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in the least for hospital out of chapter five
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now we come to hospital i'm allowed type b. beef is
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a bit of a hybrid hospital hospital lot because and
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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
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as long as it's in the range of the title of the head of that or of the supervisor
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but on external request i'm you can only only the
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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
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and there you have the elaborate to the hospital appetite see as well as the private property
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and these laboratories can do all the analysis at the least of analysis as long
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as if it's in covered by the title of the specialist elaborate too many scene
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the hospital labs can do these analyses but that their own needs as well as an external requests
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and obviously the external request ever trees could only
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duties analyst these analyses on external replaced
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well now we've gone through various legal specifications of the latter cheese
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and we'll we'll we'll um i will give you some information about the quality requirements so this laboratories
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and as you probably below no big quality requirements are requested by now
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in the last as particular weren't t. of the health technology and
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has to be i'm not done and here are the
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federal council he's an actor that means you can take measures
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all he can barely cake images in controlled in
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what about the quality documents that are necessary wonderful at medical laboratories for
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their analysis to be covered by the c. h. ah a.
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first of all of course you have the gnome the ice on them then you
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have an information in the consequence that's that's service quality don't label hypothetical
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then you have the see the c. fans all the good laboratory praxis and then you also have quality space
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the other than almost a line at least in eighty two million for genetic analyses
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or in the overdose usually double that latin club eulogy for microbiology colour analyse
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and then for some analyses you even have some quality
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specification is inside to the least of analyses
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for example accreditation is compulsory for high throughput sings
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sequencing and the full constitutional genetic analyses
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the slide is quite important because you will understand that
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there is no it's not only the difference between right in it then maybe collaborators in switzerland
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and a link to the analysis that that are reimbursed but also the quality level
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on the side you have the basic healthcare naps and for the slats under the quality level is
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the minimum one and for these labs you have an extensive quality and quality insurance system
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here for example for these labs and that the um the f. f.
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i. m. h. title of the appalachian magazine is not required
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and then run that's no special specific and apply for cases for the personally who does the analyses
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i it's analytical symbols analytical systems have to be simple
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and the quality insurance system is minimal and these labs i'm not appreciated
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the i. c. q. is not and is also not very and very strict
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and it has to be done minimum once for two weeks all according to the manufacturer and actually in
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specific cases situations it has to be done more often
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for example if they're technical problems et cetera
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i thought the latter cheese and that that can do the external water
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here the habit laboratory was that the visor has to be
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a specialist in every two minutes in the performance of the analysis has to be done
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by at least applications the analytical systems your have to be simple or complex
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by these that have to show that they have a quality insurance system according to the
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u. i. so long um the fifteen one eight nine of two thousand and twelve
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and there is an increased tendency although it's not compulsively
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in switzerland yeah it i make two accreditation
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finally the uh externally by internal quality controls are pretty straight
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and they they they have to be done nine minimum once they he or one spurt or series
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and it's valid twelve uh twelve hours of fifteen tests
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and each module of the analysis of the
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analytical system has to be controlled by an i. c. q. if if the complex analytical system
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now i'm doing this i think is pretty important for you
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and it's when what other pretty requirements to add an analysis on belief
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of basic else care that i mean for example appears to test
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first of all these analyses has to figure in chapter one three one two
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three then it passed on the on the shell a problem benefit
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and that that this analysis in this setting and and that i
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should be done rather than in an external would turn that
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then it has to answer frequently asked question in the cactus in general admission
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and the result has to be available during the consultation that means i'm not that but i
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cannot have don't diagnose it has to be done in the presence of the patient
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then and this is very important and it also has already been
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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
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due to the delay of outsourcing the test when external order request laboratory
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and also if the result is normal it should be able
00:22:40
to avoid new consultation within a short period of time
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then you need a few more thing this past has to be performed by itself
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that means that the diagnostic procedure should not be increased or
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not more expensive as the existing diagnostic procedure now
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it has to be easy handling that that means it has to be on
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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
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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
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price then the analyses provided in the external repressed up
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these are all that we carry out that have to be fulfilled for an
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analysis to be and implemented in these restrictive lists for basic health care
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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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Jean-Charles Sanchez, CMU, UNIGE
Oct. 26, 2017 · 3:25 p.m.
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Recent advances in non-invasive diagnostics
Samantha Paoletti, CSEM
Oct. 26, 2017 · 3:53 p.m.
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Fabien Rebeaud, Abionic
Oct. 26, 2017 · 4:17 p.m.
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Keynote Session introduction
Marc E. Pfeifer, Symposium Chair
Oct. 26, 2017 · 5:07 p.m.
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Oct. 26, 2017 · 5:09 p.m.
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Conclusions
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Oct. 26, 2017 · 6:25 p.m.
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