<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">N.M. Vandevelde</style></author><author><style face="normal" font="default" size="100%">Pieter Vermeersch</style></author><author><style face="normal" font="default" size="100%">Katrien M J Devreese</style></author><author><style face="normal" font="default" size="100%">Vincent, Marie-Françoise</style></author><author><style face="normal" font="default" size="100%">Béatrice Gulbis</style></author><author><style face="normal" font="default" size="100%">Eyskens, François</style></author><author><style face="normal" font="default" size="100%">Boemer, François</style></author><author><style face="normal" font="default" size="100%">André Gothot</style></author><author><style face="normal" font="default" size="100%">Viviane O Van Hoof</style></author><author><style face="normal" font="default" size="100%">Carolien Bonroy</style></author><author><style face="normal" font="default" size="100%">Hedwig Stepman</style></author><author><style face="normal" font="default" size="100%">Geert A Martens</style></author><author><style face="normal" font="default" size="100%">Bossuyt, Xavier</style></author><author><style face="normal" font="default" size="100%">Laurence Roosens</style></author><author><style face="normal" font="default" size="100%">Julie Smet</style></author><author><style face="normal" font="default" size="100%">Hilde Laeremans</style></author><author><style face="normal" font="default" size="100%">Weets, Ilse</style></author><author><style face="normal" font="default" size="100%">Jean-Marc Minon</style></author><author><style face="normal" font="default" size="100%">Kris Vernelen</style></author><author><style face="normal" font="default" size="100%">Wim Coucke</style></author></authors><translated-authors><author><style face="normal" font="default" size="100%">Advisory Board of the Action 1 of the Belgian National Plan for Rare Diseases</style></author></translated-authors></contributors><titles><title><style face="normal" font="default" size="100%">Belgian rare diseases plan in clinical pathology: identification of key biochemical diagnostic tests and establishment of reference laboratories and financing conditions.</style></title><secondary-title><style face="normal" font="default" size="100%">Orphanet J Rare Dis</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Belgium</style></keyword><keyword><style  face="normal" font="default" size="100%">budgets</style></keyword><keyword><style  face="normal" font="default" size="100%">Diagnostic Tests, Routine</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Laboratories</style></keyword><keyword><style  face="normal" font="default" size="100%">Rare diseases</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2021</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2021 Feb 17</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">16</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;&lt;b&gt;BACKGROUND: &lt;/b&gt;One objective of the Belgian Rare Diseases plan is to improve patients' management using phenotypic tests and, more specifically, the access to those tests by identifying the biochemical analyses used for rare diseases, developing new financing conditions and establishing reference laboratories.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;METHODS: &lt;/b&gt;A feasibility study was performed from May 2015 until August 2016 in order to select the financeable biochemical analyses, and, among them, those that should be performed by reference laboratories. This selection was based on an inventory of analyses used for rare diseases and a survey addressed to the Belgian laboratories of clinical pathology (investigating the annual analytical costs, volumes, turnaround times and the tests unavailable in Belgium and outsourced abroad). A proposal of financeable analyses, financing modalities, reference laboratories' scope and budget estimation was developed and submitted to the Belgian healthcare authorities. After its approval in December 2016, the implementation phase took place from January 2017 until December 2019.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;RESULTS: &lt;/b&gt;In 2019, new reimbursement conditions have been published for 46 analyses and eighteen reference laboratories have been recognized. Collaborations have also been developed with 5 foreign laboratories in order to organize the outsourcing and financing of 9 analyses unavailable in Belgium.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;CONCLUSIONS: &lt;/b&gt;In the context of clinical pathology and rare diseases, this initiative enabled to identify unreimbursed analyses and to meet the most crucial financial needs. It also contributed to improve patients' management by establishing Belgian reference laboratories and foreign referral laboratories for highly-specific analyses and a permanent surveillance, quality and financing framework for those tests.&lt;/p&gt;
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