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Les organismes d'assurance maladie, ainsi que les mutuelles, les institutions de prévoyance et les sociétés d'assurance, peuvent conclure des accords, à l'échelon local ou national, avec les distributeurs de dispositifs médicaux à usage individuel, notamment en ce qui concerne la qualité, les prix maximum pratiqués et les modalités de dispense d'avance de frais.
\n
Ces accords doivent comporter des dispositions adaptées à la situation des bénéficiaires du droit à la protection complémentaire en matière de santé. A ce titre, pour les dispositifs médicaux à usage individuel figurant sur la liste mentionnée au cinquième alinéa de l'article L. 861-3, ces accords prévoient soit l'obligation pour les distributeurs de proposer un dispositif à un prix n'excédant pas le montant des frais pris en charge défini par l'arrêté mentionné à l'article L. 861-3, soit le montant maximal pouvant être facturé aux bénéficiaires du droit à la protection complémentaire en matière de santé.
\n
En l'absence d'accord ou lorsque les dispositions de l'accord ne répondent pas aux conditions définies à l'alinéa précédent, un arrêté fixe les obligations mentionnées à l'alinéa précédent s'imposant aux distributeurs.
\n
Les dispositions du titre VI de l'ordonnance n° 86-1243 du 1er décembre 1986 relative à la liberté des prix et de la concurrence sont applicables aux infractions prévues par cet arrêté.
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Les organismes d'assurance maladie, ainsi que les mutuelles, les institutions de prévoyance et les sociétés d'assurance, peuvent conclure des accords, à l'échelon local ou national, avec les distributeurs de dispositifs médicaux à usage individuel, notamment en ce qui concerne la qualité, les prix maximum pratiqués, sous réserve que ces produits ou prestations ne fassent pas l'objet d'un arrêté pris en application de l'article L. 165-3, et les modalités de dispense d'avance de frais.
\n
Ces accords doivent comporter des dispositions adaptées à la situation des bénéficiaires du droit à la protection complémentaire en matière de santé. A ce titre, pour les produits ou prestations de santé mentionnés à l'article L. 165-1 figurant sur la liste mentionnée au cinquième alinéa de l'article L. 861-3, ces accords prévoient soit l'obligation pour les distributeurs de proposer un produit ou prestation à un prix n'excédant pas le montant des frais pris en charge défini par l'arrêté mentionné à l'article L. 861-3, soit le montant maximal pouvant être facturé aux bénéficiaires du droit à la protection complémentaire en matière de santé.
\n
En l'absence d'accord ou lorsque les dispositions de l'accord ne répondent pas aux conditions définies à l'alinéa précédent, un arrêté fixe, après avis du comité économique des produits de santé, les obligations mentionnées à l'alinéa précédent s'imposant aux distributeurs.
\n
Les dispositions du titre VI de l'ordonnance n° 86-1243 du 1er décembre 1986 relative à la liberté des prix et de la concurrence sont applicables aux infractions à cet arrêté.
\n
Les accords nationaux signés par les organismes nationaux d'assurance maladie et une ou plusieurs organisations nationales syndicales des distributeurs de produits ou prestations mentionnés à l'article L. 165-1 peuvent être rendus applicables à l'ensemble des distributeurs par arrêté interministériel, pris après avis du comité économique des produits de santé. Les ministres peuvent, lorsque l'accord ou un avenant comporte une ou des dispositions non conformes aux lois et règlements en vigueur ou lorsqu'une ou des dispositions relatives aux prix proposés ne sont pas compatibles avec les critères de l'article L. 162-38, disjoindre ces dispositions dans l'arrêté.
" } }, "LEGIARTI000006740903": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L165-6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2005-12-20", "DATE_DEBUT": "2004-08-17" } }, "META_COMMUN": { "ID": "LEGIARTI000006740903", "URL": "article/LEGI/ARTI/00/00/06/74/09/LEGIARTI000006740903.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SSAXXXXXXXX1X165L06AXXAC" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000866621", "#text": "Décret 85-1353 1985-12-17", "@sens": "source", "@cidtexte": "JORFTEXT000000866621", "@numtexte": "85-1353", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1985-12-17" }, { "@id": "JORFTEXT000000333548", "#text": "Ordonnance 86-1243 1986-12-01", "@sens": "source", "@cidtexte": "JORFTEXT000000333548", "@numtexte": "86-1243", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1986-12-01" }, { "@id": "LEGIARTI000006214348", "@num": "2", "#text": "Arrêté du 14 août 2002 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000598578", "@nortexte": "SANS0222216A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2002-08-14" }, { "@id": "LEGIARTI000006223419", "@num": "2", "#text": "Arrêté du 26 juin 2003 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000241815", "@nortexte": "SANS0322312A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2003-06-26" }, { "@id": "LEGIARTI000006758972", "@num": "43", "#text": "Loi n°2004-810 du 13 août 2004 - art. 43 () JORF 17 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000625158", "@nortexte": "SANX0400122L", "@numtexte": "2004-810", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-13" }, { "@id": "LEGIARTI000029222479", "@num": "5", "#text": "ARRÊTÉ du 4 juillet 2014 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029218161", "@nortexte": "ERNC1327912A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-04" }, { "@id": "LEGIARTI000041925517", "@num": "1", "#text": "Ordonnance n°2020-505 du 2 mai 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041842221", "@nortexte": "SSAX2010307R", "@numtexte": "2020-505", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-05-02" }, { "@id": "LEGITEXT000045162844", "#text": "Décret n°2022-169 du 11 février 2022 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045160998", "@nortexte": "SSAS2137123D", "@numtexte": "2022-169", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-02-11" }, { "@id": "LEGIARTI000045292668", "@num": "L162-1-14-1", "#text": "Code de la sécurité sociale. - art. 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L165-1 (MMN)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740893", "@num": "L165-1", "#text": "Code de la sécurité sociale. - art. L165-1 (MMN)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741433", "@num": "L165-3", "#text": "Code de la sécurité sociale. - art. L165-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741443", "@num": "L165-5-1", "#text": "Code de la sécurité sociale. - art. L165-5-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033694635", "@num": "L165-5-2", "#text": "Code de la sécurité sociale. - art. L165-5-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740970", "@num": "L182-2", "#text": "Code de la sécurité sociale. - art. L182-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006745383", "@num": "L861-3", "#text": "Code de la sécurité sociale. - art. L861-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050942587", "@num": "R147-3", "#text": "Code de la sécurité sociale. - art. R147-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020062784", "@num": "R147-4", "#text": "Code de la sécurité sociale. - art. R147-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024350018", "@num": "R182-3", "#text": "Code de la sécurité sociale. - art. R182-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024350026", "@num": "R182-3-2", "#text": "Code de la sécurité sociale. - art. R182-3-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006185864", "@fin": "2999-01-01", "#text": "Sous-section 1 : Conditions de prise en charge", "@debut": "1999-12-30" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006172525", "@fin": "2999-01-01", "#text": "Section 1 : Dispositions générales relatives aux fournitures et appareils pris en charge au titre des prestations sanitaires", "@debut": "1999-12-30" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006156030", "@fin": "2999-01-01", "#text": "Chapitre 5 : Dispositifs médicaux à usage individuel", "@debut": "1999-12-30" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141605", "@fin": "2999-01-01", "#text": "Titre VI : Dispositions relatives aux prestations et aux soins - Contrôle médical - Tutelle aux prestations sociales", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126885", "@fin": "2999-01-01", "#text": "Livre I : Généralités - Dispositions communes à tout ou partie des régimes de base", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006106050", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "1985-12-21" } ] }, "@cid": "LEGITEXT000006073189", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la sécurité sociale", "@debut": "1958-10-16", "@id_txt": "LEGITEXT000006073189", "@c_titre_court": "Code de la sécurité sociale." } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006740901", "@fin": "2000-12-24", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "1999-12-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006740902", "@fin": "2004-08-17", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2000-12-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006740903", "@fin": "2005-12-20", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2004-08-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006740904", "@fin": "2014-03-19", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2005-12-20", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028749127", "@fin": "2016-01-28", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2014-03-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031928887", "@fin": "2019-11-01", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037950343", "@fin": "2020-12-16", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2019-11-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042686075", "@fin": "2022-12-25", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2020-12-16", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000046811471", "@fin": "2023-12-28", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2022-12-25", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048697490", "@fin": "2999-01-01", "@num": "L165-6", "@etat": "VIGUEUR", "@debut": "2023-12-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les organismes d'assurance maladie, ainsi que les mutuelles, les institutions de prévoyance et les sociétés d'assurance, peuvent conclure des accords, à l'échelon local ou national, avec les distributeurs de dispositifs médicaux à usage individuel, notamment en ce qui concerne la qualité, les prix maximum pratiqués, sous réserve que ces produits ou prestations ne fassent pas l'objet d'une décision prise en application de l'article L. 165-3, et les modalités de dispense d'avance de frais.
\n
Ces accords doivent comporter des dispositions adaptées à la situation des bénéficiaires du droit à la protection complémentaire en matière de santé. A ce titre, pour les produits ou prestations de santé mentionnés à l'article L. 165-1 figurant sur la liste mentionnée au cinquième alinéa de l'article L. 861-3, ces accords prévoient soit l'obligation pour les distributeurs de proposer un produit ou prestation à un prix n'excédant pas le montant des frais pris en charge défini par l'arrêté mentionné à l'article L. 861-3, soit le montant maximal pouvant être facturé aux bénéficiaires du droit à la protection complémentaire en matière de santé.
\n
En l'absence d'accord ou lorsque les dispositions de l'accord ne répondent pas aux conditions définies à l'alinéa précédent, un arrêté fixe, après avis du comité économique des produits de santé, les obligations mentionnées à l'alinéa précédent s'imposant aux distributeurs.
\n
Les dispositions du titre VI de l'ordonnance n° 86-1243 du 1er décembre 1986 relative à la liberté des prix et de la concurrence sont applicables aux infractions à cet arrêté.
\n
Les accords nationaux signés par les organismes nationaux d'assurance maladie et une ou plusieurs organisations nationales syndicales des distributeurs de produits ou prestations mentionnés à l'article L. 165-1 peuvent être rendus applicables à l'ensemble des distributeurs par arrêté interministériel, pris après avis du comité économique des produits de santé. Les ministres peuvent, lorsque l'accord ou un avenant comporte une ou des dispositions non conformes aux lois et règlements en vigueur ou lorsqu'une ou des dispositions relatives aux prix proposés ne sont pas compatibles avec les critères de l'article L. 162-38, disjoindre ces dispositions dans l'arrêté.
" } }, "LEGIARTI000006740904": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L165-6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2014-03-19", "DATE_DEBUT": "2005-12-20" } }, "META_COMMUN": { "ID": "LEGIARTI000006740904", "URL": "article/LEGI/ARTI/00/00/06/74/09/LEGIARTI000006740904.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SSAXXXXXXXX1X165L06AXXAD" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000866621", "#text": "Décret 85-1353 1985-12-17", "@sens": "source", "@cidtexte": "JORFTEXT000000866621", "@numtexte": "85-1353", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1985-12-17" }, { "@id": "JORFTEXT000000333548", "#text": "Ordonnance 86-1243 1986-12-01", "@sens": "source", "@cidtexte": "JORFTEXT000000333548", "@numtexte": "86-1243", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1986-12-01" }, { "@id": "LEGIARTI000006214348", "@num": "2", "#text": "Arrêté du 14 août 2002 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000598578", "@nortexte": "SANS0222216A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2002-08-14" }, { "@id": "LEGIARTI000006223419", "@num": "2", "#text": "Arrêté du 26 juin 2003 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000241815", "@nortexte": "SANS0322312A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2003-06-26" }, { "@id": "LEGIARTI000006759201", "@num": "54", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 54 (V) JORF 20 décembre 2005", "@sens": "source", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000029222479", "@num": "5", "#text": "ARRÊTÉ du 4 juillet 2014 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029218161", "@nortexte": "ERNC1327912A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-04" }, { "@id": "LEGIARTI000041925517", "@num": "1", "#text": "Ordonnance n°2020-505 du 2 mai 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041842221", "@nortexte": "SSAX2010307R", "@numtexte": "2020-505", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-05-02" }, { "@id": "LEGITEXT000045162844", "#text": "Décret n°2022-169 du 11 février 2022 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045160998", "@nortexte": "SSAS2137123D", "@numtexte": "2022-169", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-02-11" }, { "@id": "LEGIARTI000045292668", "@num": "L162-1-14-1", "#text": "Code de la sécurité sociale. - art. L162-1-14-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046812229", "@num": "L162-14-3", "#text": "Code de la sécurité sociale. - art. L162-14-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741415", "@num": "L162-38", "#text": "Code de la sécurité sociale. - art. L162-38 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740893", "@num": "L165-1", "#text": "Code de la sécurité sociale. - art. L165-1 (MMN)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740893", "@num": "L165-1", "#text": "Code de la sécurité sociale. - art. L165-1 (MMN)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741433", "@num": "L165-3", "#text": "Code de la sécurité sociale. - art. L165-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741443", "@num": "L165-5-1", "#text": "Code de la sécurité sociale. - art. L165-5-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033694635", "@num": "L165-5-2", "#text": "Code de la sécurité sociale. - art. L165-5-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740970", "@num": "L182-2", "#text": "Code de la sécurité sociale. - art. L182-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006745383", "@num": "L861-3", "#text": "Code de la sécurité sociale. - art. L861-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050942587", "@num": "R147-3", "#text": "Code de la sécurité sociale. - art. R147-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020062784", "@num": "R147-4", "#text": "Code de la sécurité sociale. - art. R147-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024350018", "@num": "R182-3", "#text": "Code de la sécurité sociale. - art. R182-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024350026", "@num": "R182-3-2", "#text": "Code de la sécurité sociale. - art. R182-3-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006185864", "@fin": "2999-01-01", "#text": "Sous-section 1 : Conditions de prise en charge", "@debut": "1999-12-30" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006172525", "@fin": "2999-01-01", "#text": "Section 1 : Dispositions générales relatives aux fournitures et appareils pris en charge au titre des prestations sanitaires", "@debut": "1999-12-30" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006156030", "@fin": "2999-01-01", "#text": "Chapitre 5 : Dispositifs médicaux à usage individuel", "@debut": "1999-12-30" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141605", "@fin": "2999-01-01", "#text": "Titre VI : Dispositions relatives aux prestations et aux soins - Contrôle médical - Tutelle aux prestations sociales", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126885", "@fin": "2999-01-01", "#text": "Livre I : Généralités - Dispositions communes à tout ou partie des régimes de base", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006106050", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "1985-12-21" } ] }, "@cid": "LEGITEXT000006073189", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la sécurité sociale", "@debut": "1958-10-16", "@id_txt": "LEGITEXT000006073189", "@c_titre_court": "Code de la sécurité sociale." } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006740901", "@fin": "2000-12-24", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "1999-12-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006740902", "@fin": "2004-08-17", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2000-12-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006740903", "@fin": "2005-12-20", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2004-08-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006740904", "@fin": "2014-03-19", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2005-12-20", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028749127", "@fin": "2016-01-28", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2014-03-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031928887", "@fin": "2019-11-01", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037950343", "@fin": "2020-12-16", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2019-11-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042686075", "@fin": "2022-12-25", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2020-12-16", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000046811471", "@fin": "2023-12-28", "@num": "L165-6", "@etat": "MODIFIE", "@debut": "2022-12-25", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048697490", "@fin": "2999-01-01", "@num": "L165-6", "@etat": "VIGUEUR", "@debut": "2023-12-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les organismes d'assurance maladie, ainsi que les mutuelles, les institutions de prévoyance et les sociétés d'assurance, peuvent conclure des accords, à l'échelon local ou national, avec les distributeurs de dispositifs médicaux à usage individuel, notamment en ce qui concerne la qualité, les prix maximum pratiqués, sous réserve que ces produits ou prestations ne fassent pas l'objet d'une décision prise en application de l'article L. 165-3, et les modalités de dispense d'avance de frais.
\n
Ces accords doivent comporter des dispositions adaptées à la situation des bénéficiaires du droit à la protection complémentaire en matière de santé. A ce titre, pour les produits ou prestations de santé mentionnés à l'article L. 165-1 figurant sur la liste mentionnée au sixième alinéa de l'article L. 861-3, ces accords prévoient soit l'obligation pour les distributeurs de proposer un produit ou une prestation à un prix n'excédant pas le montant des frais pris en charge défini par l'arrêté mentionné à l'article L. 861-3, soit le montant maximal pouvant être facturé aux bénéficiaires du droit à la protection complémentaire en matière de santé.
\n
En l'absence d'accord ou lorsque les dispositions de l'accord ne répondent pas aux conditions définies à l'alinéa précédent, un arrêté fixe, après avis du comité économique des produits de santé, les obligations mentionnées à l'alinéa précédent s'imposant aux distributeurs.
\n
Les dispositions du titre VI de l'ordonnance n° 86-1243 du 1er décembre 1986 relative à la liberté des prix et de la concurrence sont applicables aux infractions à cet arrêté.
\n
Les accords nationaux signés par les organismes nationaux d'assurance maladie et une ou plusieurs organisations nationales syndicales des distributeurs de produits ou prestations mentionnés à l'article L. 165-1 peuvent être rendus applicables à l'ensemble des distributeurs par arrêté interministériel, pris après avis du comité économique des produits de santé. Les ministres peuvent, lorsque l'accord ou un avenant comporte une ou des dispositions non conformes aux lois et règlements en vigueur ou lorsqu'une ou des dispositions relatives aux prix proposés ne sont pas compatibles avec les critères de l'article L. 162-38, disjoindre ces dispositions dans l'arrêté.
" } }, "LEGIARTI000006741287": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L161-37", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2006-12-22", "DATE_DEBUT": "2004-08-17" } }, "META_COMMUN": { "ID": "LEGIARTI000006741287", "URL": "article/LEGI/ARTI/00/00/06/74/12/LEGIARTI000006741287.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SSAXXXXXXXX1X161L37AXXAA" } }, "NOTA": { "CONTENU": "
Nota : Loi 2004-810 2004-08-13 art. 35 II : lors de la 1ère constitution de la Haute Autorité de santé, sont désignés par tirage au sort, à l'exception du président, 4 membres dont les mandats prennent fin à l'issue d'un délai de 3 ans.
\n
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000031217592", "@num": "21", "#text": "Loi n° 78-753 du 17 juillet 1978 - art. 21 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000339241", "@numtexte": "78-753", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-07-17" }, { "@id": "JORFTEXT000000866621", "#text": "Décret 85-1353 1985-12-17", "@sens": "source", "@cidtexte": "JORFTEXT000000866621", "@numtexte": "85-1353", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1985-12-17" }, { "@id": "LEGIARTI000006758963", "@num": "35", "#text": "Loi n°2004-810 du 13 août 2004 - art. 35 (V) JORF 17 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000625158", "@nortexte": "SANX0400122L", "@numtexte": "2004-810", "@typelien": "CREATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-13" }, { "@id": "LEGIARTI000033158385", "@num": "1", "#text": "Arrêté du 31 décembre 2009 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021683534", "@nortexte": "SASH0931982A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-12-31" }, { "@id": "LEGIARTI000042012478", "@num": "7", "#text": "Ordonnance n° 2010-49 du 13 janvier 2010 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021683301", "@nortexte": "SASX0927179R", "@numtexte": "2010-49", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGIARTI000021684172", "@num": "1", "#text": "Ordonnance n°2010-49\n du 13 janvier 2010 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000021683301", "@nortexte": "SASX0927179R", "@numtexte": "2010-49", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGIARTI000022657890", "@num": "3", "#text": "Arrêté du 21 juillet 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022630498", "@nortexte": "SASH1019846A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-07-21" }, { "@id": "LEGIARTI000030094090", "@num": "1", "#text": "ARRÊTÉ du 29 décembre 2014 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030005444", "@nortexte": "AFSS1431280A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-12-29" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916230", "@num": "179", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 179", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031935878", "@num": "1", "#text": "Décret n°2016-46 du 26 janvier 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000031922237", "@nortexte": "AFSP1526854D", "@numtexte": "2016-46", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000032896250", "@num": "5", "#text": "Ordonnance n°2016-967 du 15 juillet 2016 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000032894095", "@nortexte": "AFSP1614796R", "@numtexte": "2016-967", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2016-07-15" }, { "@id": "LEGIARTI000034618363", "@num": "1", "#text": "Décret n°2017-815 du 5 mai 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034602650", "@nortexte": "AFSA1710836D", "@numtexte": "2017-815", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-05-05" }, { "@id": "LEGIARTI000037047883", "@num": "1", "#text": "Décret n°2018-465 du 11 juin 2018 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000037047116", "@nortexte": "SSAA1805331D", "@numtexte": "2018-465", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2018-06-11" }, { "@id": "LEGITEXT000045162844", "#text": "Décret n°2022-169 du 11 février 2022 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045160998", "@nortexte": "SSAS2137123D", "@numtexte": "2022-169", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-02-11" }, { "@id": "LEGITEXT000050737119", "#text": "Décret n°2024-1138 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731558", "@nortexte": "SAEA2429058D", "@numtexte": "2024-1138", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000051059776", "@num": "unique", "#text": "LOI n°2025-74 du 29 janvier 2025 - 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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :
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1° Procéder à l'évaluation périodique du service attendu des produits, actes ou prestations de santé et du service qu'ils rendent, et contribuer par ses avis à l'élaboration des décisions relatives à l'inscription, au remboursement et à la prise en charge par l'assurance maladie des produits, actes ou prestations de santé ainsi qu'aux conditions particulières de prise en charge des soins dispensés aux personnes atteintes d'affections de longue durée. A cet effet, elle émet également un avis sur les conditions de prescription, de réalisation ou d'emploi des actes, produits ou prestations de santé et réalise ou valide des études d'évaluation des technologies de santé ;
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2° Elaborer les guides de bon usage des soins ou les recommandations de bonne pratique, procéder à leur diffusion et contribuer à l'information des professionnels de santé et du public dans ces domaines, sans préjudice des mesures prises par l'Agence française de sécurité sanitaire des produits de santé dans le cadre de ses missions de sécurité sanitaire ;
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3° Etablir et mettre en oeuvre des procédures d'évaluation des pratiques professionnelles et d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;
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4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;
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5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé.
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Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence française de sécurité sanitaire des produits de santé, l'Institut national de veille sanitaire et l'Agence française de sécurité sanitaire des aliments. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.
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Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.
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La Haute Autorité de santé établit un rapport annuel d'activité adressé au Parlement et au Gouvernement avant le 1er juillet, qui porte notamment sur les travaux des commissions mentionnées à l'article L. 161-41 du présent code ainsi que sur les actions d'information mises en oeuvre en application du 2° du présent article.
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Les décisions et communications prises en vertu des 1° et 2° du présent article sont transmises sans délai à la Conférence nationale de santé prévue à l'article L. 1411-3 du code de la santé publique.
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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :
\n
1° Procéder à l'évaluation périodique du service attendu des produits, actes ou prestations de santé et du service qu'ils rendent, et contribuer par ses avis à l'élaboration des décisions relatives à l'inscription, au remboursement et à la prise en charge par l'assurance maladie des produits, actes ou prestations de santé ainsi qu'aux conditions particulières de prise en charge des soins dispensés aux personnes atteintes d'affections de longue durée. A cet effet, elle émet également un avis sur les conditions de prescription, de réalisation ou d'emploi des actes, produits ou prestations de santé et réalise ou valide des études d'évaluation des technologies de santé ;
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2° Elaborer les guides de bon usage des soins ou les recommandations de bonne pratique, procéder à leur diffusion et contribuer à l'information des professionnels de santé et du public dans ces domaines, sans préjudice des mesures prises par l'Agence française de sécurité sanitaire des produits de santé dans le cadre de ses missions de sécurité sanitaire ;
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3° Etablir et mettre en oeuvre des procédures d'évaluation des pratiques professionnelles et d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;
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4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;
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5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;
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6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs.
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Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence française de sécurité sanitaire des produits de santé, l'Institut national de veille sanitaire et l'Agence française de sécurité sanitaire des aliments. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.
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Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.
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La Haute Autorité de santé établit un rapport annuel d'activité adressé au Parlement et au Gouvernement avant le 1er juillet, qui porte notamment sur les travaux des commissions mentionnées à l'article L. 161-41 du présent code ainsi que sur les actions d'information mises en oeuvre en application du 2° du présent article.
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Les décisions et communications prises en vertu des 1° et 2° du présent article sont transmises sans délai à la Conférence nationale de santé prévue à l'article L. 1411-3 du code de la santé publique.
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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :
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1° Procéder à l'évaluation périodique du service attendu des produits, actes ou prestations de santé et du service qu'ils rendent, et contribuer par ses avis à l'élaboration des décisions relatives à l'inscription, au remboursement et à la prise en charge par l'assurance maladie des produits, actes ou prestations de santé ainsi qu'aux conditions particulières de prise en charge des soins dispensés aux personnes atteintes d'affections de longue durée. A cet effet, elle émet également un avis sur les conditions de prescription, de réalisation ou d'emploi des actes, produits ou prestations de santé et réalise ou valide des études d'évaluation des technologies de santé ;
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2° Elaborer les guides de bon usage des soins ou les recommandations de bonne pratique, procéder à leur diffusion et contribuer à l'information des professionnels de santé et du public dans ces domaines, sans préjudice des mesures prises par l'Agence française de sécurité sanitaire des produits de santé dans le cadre de ses missions de sécurité sanitaire ;
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3° Etablir et mettre en oeuvre des procédures d'évaluation des pratiques professionnelles et d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;
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4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;
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5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;
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6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs.
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Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence française de sécurité sanitaire des produits de santé, l'Institut national de veille sanitaire et l'Agence française de sécurité sanitaire des aliments. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.
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La Haute Autorité de santé rend publics l'ordre du jour et les comptes rendus assortis des détails et explications des votes, y compris les opinions minoritaires, à l'exclusion des informations relatives au secret des stratégies commerciales, des réunions de la commission prévue à l'article L. 5123-3 du code de la santé publique siégeant auprès d'elle et consultée sur l'inscription des médicaments inscrits sur les listes prévues à l'article L. 162-17 du présent code et à l'article L. 5126-4 du code de la santé publique, ainsi que son règlement intérieur.
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Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.
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La Haute Autorité de santé établit un rapport annuel d'activité adressé au Parlement et au Gouvernement avant le 1er juillet, qui porte notamment sur les travaux des commissions mentionnées à l'article L. 161-41 du présent code ainsi que sur les actions d'information mises en oeuvre en application du 2° du présent article.
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Les décisions et communications prises en vertu des 1° et 2° du présent article sont transmises sans délai à la Conférence nationale de santé prévue à l'article L. 1411-3 du code de la santé publique.
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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

3° Etablir et mettre en oeuvre des procédures d'évaluation des pratiques professionnelles et d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;

6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs.

Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence française de sécurité sanitaire des produits de santé, l'Institut national de veille sanitaire et l'Agence française de sécurité sanitaire des aliments. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.

La Haute Autorité de santé rend publics l'ordre du jour et les comptes rendus assortis des détails et explications des votes, y compris les opinions minoritaires, à l'exclusion des informations relatives au secret des stratégies commerciales, des réunions de la commission prévue à l'article L. 5123-3 du code de la santé publique siégeant auprès d'elle et consultée sur l'inscription des médicaments inscrits sur les listes prévues à l'article L. 162-17 du présent code et à l'article L. 5126-4 du code de la santé publique, ainsi que son règlement intérieur.

Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

Dans le cadre de ses missions, la Haute Autorité de santé émet des recommandations et avis médico-économiques sur les stratégies de soins, de prescription ou de prise en charge les plus efficientes.

Les décisions et communications prises en vertu des 1° et 2° du présent article sont transmises sans délai à la Conférence nationale de santé prévue à l'article L. 1411-3 du code de la santé publique.

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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

3° Etablir et mettre en oeuvre des procédures d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;

6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale.

Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence française de sécurité sanitaire des produits de santé, l'Institut national de veille sanitaire et l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.

Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;

6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale.

Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

3° Etablir et mettre en oeuvre des procédures d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;

6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale.

Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

1° Procéder à l'évaluation périodique du service attendu des produits, actes ou prestations de santé et du service qu'ils rendent, et contribuer par ses avis à l'élaboration des décisions relatives à l'inscription, au remboursement et à la prise en charge par l'assurance maladie des produits, actes ou prestations de santé ainsi qu'aux conditions particulières de prise en charge des soins dispensés aux personnes atteintes d'affections de longue durée. A cet effet, elle émet également un avis sur les conditions de prescription, de réalisation ou d'emploi des actes, produits ou prestations de santé ainsi que sur leur efficience. Elle réalise ou valide notamment les études médico-économiques nécessaires à l'évaluation des produits et technologies de santé. Un décret en Conseil d'Etat précise les cas dans lesquels cette évaluation médico-économique est requise, en raison notamment de l'amélioration du service médical rendu par le produit ou la technologie et des coûts prévisibles de son utilisation ou prescription, et les conditions dans lesquelles elle est réalisée, notamment les critères d'appréciation et les délais applicables ;

3° Etablir et mettre en oeuvre des procédures d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;

6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale ;

8° Coordonner l'élaboration et assurer la diffusion d'une information adaptée sur la qualité des prises en charge dans les établissements de santé à destination des usagers et de leurs représentants.

Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence française de sécurité sanitaire des produits de santé, l'Institut national de veille sanitaire et l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.

Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

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Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur mentionnée au premier alinéa du présent III, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

\n
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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

3° Etablir et mettre en oeuvre des procédures d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;

6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale ;

Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence nationale de sécurité du médicament et des produits de santé , l'Institut national de veille sanitaire et l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.

Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

La Haute Autorité de santé établit un rapport annuel d'activité adressé au Parlement et au Gouvernement avant le 1er juillet, qui porte notamment sur les travaux des commissions mentionnées à l'article L. 161-41 du présent code ainsi que sur les actions d'information mises en oeuvre en application du 2° du présent article. Les commissions spécialisées mentionnées au même article L. 161-41 autres que celles créées par la Haute Autorité de santé remettent chaque année au Parlement un rapport d'activité mentionnant notamment les modalités et principes selon lesquels elles mettent en œuvre les critères d'évaluation des produits de santé en vue de leur prise en charge par l'assurance maladie.

" } }, "LEGIARTI000028393826": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L161-37", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2014-12-25", "DATE_DEBUT": "2013-12-25" } }, "META_COMMUN": { "ID": "LEGIARTI000028393826", "URL": "article/LEGI/ARTI/00/00/28/39/38/LEGIARTI000028393826.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

\n
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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

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3° Etablir et mettre en oeuvre des procédures d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

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4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

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5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;

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6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

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7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale ;

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9° Rendre les avis mentionnés, respectivement, au dernier alinéa de l'article L. 4011-2 du code de la santé publique et au second alinéa du I de l'article L. 4011-2-3 du même code.

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Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

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Les organismes d'assurance maladie, ainsi que les mutuelles, les institutions de prévoyance et les sociétés d'assurance, peuvent conclure des accords, à l'échelon local ou national, avec les distributeurs de dispositifs médicaux à usage individuel, notamment en ce qui concerne la qualité, les prix maximum pratiqués, sous réserve que ces produits ou prestations ne fassent pas l'objet d'une décision prise en application de l'article L. 165-3, et les modalités de dispense d'avance de frais.

Ces accords doivent comporter des dispositions adaptées à la situation des bénéficiaires du droit à la protection complémentaire en matière de santé. A ce titre, pour les produits ou prestations de santé mentionnés à l'article L. 165-1 figurant sur la liste mentionnée au sixième alinéa de l'article L. 861-3, ces accords prévoient soit l'obligation pour les distributeurs de proposer un produit ou une prestation à un prix n'excédant pas le montant des frais pris en charge défini par l'arrêté mentionné à l'article L. 861-3, soit le montant maximal pouvant être facturé aux bénéficiaires du droit à la protection complémentaire en matière de santé.

En l'absence d'accord ou lorsque les dispositions de l'accord ne répondent pas aux conditions définies à l'alinéa précédent, un arrêté fixe, après avis du comité économique des produits de santé, les obligations mentionnées à l'alinéa précédent s'imposant aux distributeurs.

Les infractions à l'arrêté mentionné au troisième alinéa sont constatées et poursuivies dans les conditions prévues au titre V du livre IV du code de commerce.

Les accords nationaux signés par les organismes nationaux d'assurance maladie et une ou plusieurs organisations nationales syndicales des distributeurs de produits ou prestations mentionnés à l'article L. 165-1 peuvent être rendus applicables à l'ensemble des distributeurs par arrêté interministériel, pris après avis du comité économique des produits de santé. Les ministres peuvent, lorsque l'accord ou un avenant comporte une ou des dispositions non conformes aux lois et règlements en vigueur ou lorsqu'une ou des dispositions relatives aux prix proposés ne sont pas compatibles avec les critères de l'article L. 162-38, disjoindre ces dispositions dans l'arrêté.

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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

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1° Procéder à l'évaluation périodique du service attendu des produits, actes ou prestations de santé et du service qu'ils rendent, et contribuer par ses avis à l'élaboration des décisions relatives à l'inscription, au remboursement et à la prise en charge par l'assurance maladie des produits, actes ou prestations de santé ainsi qu'aux conditions particulières de prise en charge des soins dispensés aux personnes atteintes d'affections de longue durée. A cet effet, elle émet également un avis sur les conditions de prescription, de réalisation ou d'emploi des actes, produits ou prestations de santé ainsi que sur leur efficience. Elle réalise ou valide notamment les études médico-économiques nécessaires à l'évaluation des actes mentionnés aux articles L. 162-1-7-1 et L. 162-1-8 et des produits et technologies de santé. Un décret en Conseil d'Etat précise les cas dans lesquels cette évaluation médico-économique est requise, en raison notamment de l'amélioration du service attendu de l'acte, de l'amélioration du service médical rendu par le produit ou la technologie et des coûts prévisibles de son utilisation ou prescription, et les conditions dans lesquelles elle est réalisée, notamment les critères d'appréciation et les délais applicables ;

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3° Etablir et mettre en oeuvre des procédures d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

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4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

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5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;

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6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

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7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale ;

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9° Rendre les avis mentionnés, respectivement, au dernier alinéa de l'article L. 4011-2 du code de la santé publique et au second alinéa du I de l'article L. 4011-2-3 du même code.

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Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence nationale de sécurité du médicament et des produits de santé, l'Institut national de veille sanitaire et l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.

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Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

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1° Procéder à l'évaluation périodique du service attendu des produits, actes ou prestations de santé et du service qu'ils rendent, et contribuer par ses avis à l'élaboration des décisions relatives à l'inscription, au remboursement et à la prise en charge par l'assurance maladie des produits, actes ou prestations de santé ainsi qu'aux conditions particulières de prise en charge des soins dispensés aux personnes atteintes d'affections de longue durée. A cet effet, elle émet également un avis sur les conditions de prescription, de réalisation ou d'emploi des actes, produits ou prestations de santé ainsi que sur leur efficience. Elle réalise ou valide notamment les études médico-économiques nécessaires à l'évaluation des actes mentionnés aux articles L. 162-1-7-1 et L. 162-1-8 et des produits et technologies de santé. Un décret en Conseil d'Etat précise les cas dans lesquels cette évaluation médico-économique est requise, en raison notamment de l'amélioration du service attendu de l'acte, de l'amélioration du service médical rendu par le produit ou la technologie et des coûts prévisibles de son utilisation ou prescription, et les conditions dans lesquelles elle est réalisée, notamment les critères d'appréciation et les délais applicables ;

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3° Etablir et mettre en oeuvre des procédures d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

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4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

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5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé ;

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6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

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7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale ;

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9° Rendre l'avis mentionné au dernier alinéa de l'article L. 4011-2 du code de la santé publique ;

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10° Rendre l'avis mentionné au second alinéa du I de l'article L. 4011-2-3 du code de la santé publique, ainsi qu'un avis portant évaluation de chacun des actes prévus par les protocoles de coopération conformément au 1° du présent article.

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Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence nationale de sécurité du médicament et des produits de santé, l'Institut national de veille sanitaire et l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.

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Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

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1° Procéder à l'évaluation périodique du service attendu des produits, actes ou prestations de santé et du service qu'ils rendent, et contribuer par ses avis à l'élaboration des décisions relatives à l'inscription, au remboursement et à la prise en charge par l'assurance maladie des produits, actes ou prestations de santé ainsi qu'aux conditions particulières de prise en charge des soins dispensés aux personnes atteintes d'affections de longue durée. A cet effet, elle émet également un avis sur les conditions de prescription, de réalisation ou d'emploi des actes, produits ou prestations de santé ainsi que sur leur efficience. Elle réalise ou valide notamment les études médico-économiques nécessaires à l'évaluation des actes mentionnés aux articles L. 162-1-7-1 et L. 162-1-8 et des produits et technologies de santé. Un décret en Conseil d'Etat précise les cas dans lesquels cette évaluation médico-économique est requise, en raison notamment de l'amélioration du service attendu de l'acte, de l'amélioration du service médical rendu par le produit ou la technologie et des coûts prévisibles de son utilisation ou prescription, et les conditions dans lesquelles elle est réalisée, notamment les critères d'appréciation et les délais applicables ;

1° bis Elaborer ou mettre à jour des fiches sur le bon usage de certains médicaments permettant notamment de définir leur place dans la stratégie thérapeutique, à l'exclusion des médicaments anticancéreux pour lesquels l'Institut national du cancer élabore ou met à jour les fiches de bon usage ;

2° Elaborer les guides de bon usage des soins ou les recommandations de bonne pratique, procéder à leur diffusion et contribuer à l'information des professionnels de santé et du public dans ces domaines, sans préjudice des mesures prises par l'Agence nationale de sécurité du médicament et des produits de santé dans le cadre de ses missions de sécurité sanitaire. Elle élabore ou valide également, à destination des professionnels de santé, dans des conditions définies par décret, un guide des stratégies diagnostiques et thérapeutiques les plus efficientes ainsi que des listes de médicaments à utiliser préférentiellement, après avis de l'Institut national du cancer s'agissant des médicaments anticancéreux ;

3° Etablir et mettre en oeuvre des procédures d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

5° Participer au développement de l'évaluation de la qualité de la prise en charge sanitaire de la population par le système de santé et élaborer des référentiels de compétences, de formation et de bonnes pratiques dans le domaine de la médiation sanitaire et de l'interprétariat linguistique ;

6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale ;

9° Rendre l'avis mentionné au dernier alinéa de l'article L. 4011-2 du code de la santé publique ;

10° Organiser des consultations précoces avec ses services à la demande des entreprises développant des spécialités pharmaceutiques, des produits ou prestations innovants du fait de leur nouveau mécanisme d'action et d'un besoin médical insuffisamment couvert, avant la mise en œuvre des essais cliniques nécessaires à l'évaluation mentionnée au 1° du présent article.

Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence nationale de sécurité du médicament et des produits de santé, l'Institut national de veille sanitaire et l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.

Sans préjudice de l'application de la loi n° 2013-316 du 16 avril 2013 relative à l'indépendance de l'expertise en matière de santé et d'environnement et à la protection des lanceurs d'alerte, les associations agréées au titre de l'article L. 1114-1 du code de la santé publique disposent également d'un droit d'alerte auprès de la Haute Autorité de santé. A ce titre, elles peuvent la saisir de tout fait ayant des incidences importantes sur la santé, nécessitant que la Haute Autorité fasse usage de ses compétences définies au présent chapitre.

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La Haute Autorité de santé rend publiques les suites qu'elle apporte aux saisines des associations ainsi que les modalités selon lesquelles elle les a instruites. Elle peut entendre publiquement l'association auteur de la saisine ainsi que toute personne intéressée.

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La Haute Autorité de santé rend publics l'ordre du jour et les comptes rendus assortis des domaines d'action prioritaires et des objectifs de la stratégie nationale de santé mentionnée à l'article L. 1411-1-1 du code de la santé publique.

Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

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L'Union nationale des caisses d'assurance maladie, les organismes d'assurance maladie, ainsi que les mutuelles, les institutions de prévoyance et les sociétés d'assurance, peuvent conclure des accords, à l'échelon local ou national, avec les distributeurs de produits et prestations de santé mentionnés à l'article L. 165-1, notamment en ce qui concerne la qualité, les prix maximaux pratiqués, sous réserve que ces produits ou prestations ne fassent pas l'objet d'une décision prise en application du I de l'article L. 165-3, et les modalités du mécanisme de tiers payant.

Des accords peuvent également être conclus au niveau national pour prévoir des dispositions adaptées à la situation des bénéficiaires du droit à la protection complémentaire en matière de santé et des bénéficiaires de l'aide au paiement d'une assurance complémentaire de santé mentionnés aux articles L. 861-3 et L. 863-2. A ce titre, pour les produits ou prestations de santé mentionnés à l'article L. 165-1 figurant sur la liste mentionnée au sixième alinéa de l'article L. 861-3, ces accords prévoient soit l'obligation pour les distributeurs de proposer un produit ou une prestation à un prix n'excédant pas le montant des frais pris en charge défini par l'arrêté mentionné à l'article L. 861-3, soit le montant maximal pouvant être facturé aux bénéficiaires du droit à la protection complémentaire en matière de santé et aux bénéficiaires de l'aide au paiement d'une assurance complémentaire de santé.

Les infractions à l'arrêté mentionné au troisième alinéa sont constatées et poursuivies dans les conditions prévues au titre V du livre IV du code de commerce.

Les accords nationaux signés par l'Union nationale des caisses d'assurance maladie et une ou plusieurs organisations nationales syndicales des distributeurs de produits ou prestations mentionnés à l'article L. 165-1 peuvent être rendus applicables à l'ensemble des distributeurs par arrêté interministériel, pris après avis du comité économique des produits de santé. Les ministres peuvent, lorsque l'accord ou un avenant comporte une ou des dispositions non conformes aux lois et règlements en vigueur ou lorsqu'une ou des dispositions relatives aux prix proposés ne sont pas compatibles avec les critères de l'article L. 162-38, disjoindre ces dispositions dans l'arrêté.

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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique dotée de la personnalité morale, est chargée de :

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1° Procéder à l'évaluation périodique du service attendu des produits, actes ou prestations de santé et du service qu'ils rendent, et contribuer par ses avis à l'élaboration des décisions relatives à l'inscription, au remboursement et à la prise en charge par l'assurance maladie des produits, actes ou prestations de santé ainsi qu'aux conditions particulières de prise en charge des soins dispensés aux personnes atteintes d'affections de longue durée. A cet effet, elle émet également un avis sur les conditions de prescription, de réalisation ou d'emploi des actes, produits ou prestations de santé ainsi que sur leur efficience. Elle réalise ou valide notamment les études médico-économiques nécessaires à l'évaluation des actes mentionnés aux articles L. 162-1-7-1 et L. 162-1-8 et des produits et technologies de santé. Un décret en Conseil d'Etat précise les cas dans lesquels cette évaluation médico-économique est requise, en raison notamment de l'amélioration du service attendu de l'acte, de l'amélioration du service médical rendu par le produit ou la technologie et des coûts prévisibles de son utilisation ou prescription, et les conditions dans lesquelles elle est réalisée, notamment les critères d'appréciation et les délais applicables ;

3° Etablir et mettre en oeuvre des procédures d'accréditation des professionnels et des équipes médicales mentionnées à l'article L. 1414-3-3 du code de la santé publique ;

4° Etablir et mettre en oeuvre les procédures de certification des établissements de santé prévues aux articles L. 6113-3 et L. 6113-4 du code de la santé publique ;

6° Rendre un avis sur tout projet de loi ou de décret instituant des modes particuliers de soins préventifs ou curatifs ;

7° Rendre l'avis mentionné à l'article L. 1414-5 du code de la santé publique sur les références aux normes harmonisées prévues pour l'accréditation des laboratoires de biologie médicale ;

9° Rendre l'avis mentionné au dernier alinéa de l'article L. 4011-2 du code de la santé publique ;

Pour l'accomplissement de ses missions, la Haute Autorité de santé travaille en liaison notamment avec l'Agence nationale de sécurité du médicament et des produits de santé, l'Agence nationale de santé publique et l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Elle peut mener toute action commune avec les organismes ayant compétence en matière de recherche dans le domaine de la santé.

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Dans l'exercice de ses missions, la Haute Autorité tient compte des objectifs pluriannuels de la politique de santé publique mentionnés à l'article L. 1411-2 du code de la santé publique.

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La Haute Autorité de santé, autorité publique indépendante à caractère scientifique, est chargée de :

Décret n° 2022-169 du 11 février 2022 relatif à la certification des prestataires de service et distributeurs de matériels