Key Benefits:
Publics concerned: health professionals, health industries, learned societies, national professional councils, High Health Authority, health institutions, clinical and medico-economic research actors, National Agency for the Safety of Medicines and Health Products, Technical Agency for Hospital Information, health insurance funds.
Subject: modalities for the application of the accelerated registration procedure to the nomenclature of innovative acts necessary for the care of health insurance.
Entry into force: the text comes into force on the day after publication.
Notice: in order to allow for the rapid registration (180 days) of the innovative acts necessary for the use or care by the health insurance of one of the health products defined in the articles L. 5211-1 or L. 5221-1 the Public Health Code, a derogatory procedure has been established. This decree sets out the modalities for the application of the derogatory procedure for prioritization of the innovative act. In this capacity, he specifies the criteria of the innovative act, based in particular on the improvement of the expected service of the act.
References: this decree is taken for the application of the articles L. 162-1-7-1 and L. 162-1-8 the Social Security Code, in their writing from theArticle 52 of Act No. 2013-1203 of 23 December 2013 Social Security Funding for 2014.
The provisions of Social Security Code Amended by this decree may be consulted, in their writing resulting from this amendment, on the website Légifrance (http://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Social Affairs, Health and the Rights of Women and the Minister of Finance and Public Accounts,
Vu le Social Security Codeincluding articles L. 162-1-7-1 and L. 162-1-8;
Having regard to the advice of the Board of the National Health Insurance Fund for Employees dated 26 June 2014;
Having regard to the advice of the National Health Insurance Union Board of 3 July 2014;
Considering the opinion of the Central Board of Directors of the Agricultural Social Mutuality of July 3, 2014;
The State Council (Social Section) heard,
Decrete:
Article R. 162-52 of the Social Security Code is amended as follows:
« 1° After the fourth paragraph of I, an Ibi is inserted as follows:
"Art. 1 bis. - The registration and pricing procedures provided for in sections L. 162-1-7-1 and L. 162-1-8 apply to the innovative acts necessary for the use or care by the health insurance of a medical device for which the High Health Authority has issued pursuant to paragraph 2 of section R. 162-52-1 an improvement in the expected major, important or moderate service. » ;
2° In the third paragraph of paragraph II, after the words: "health insurance funds", the following sentence is added:
"This period also applies where the act is necessary for the use or care by the health insurance of a medical device and the procedures set out in the second paragraph of section L. 162-1-7-1 and section L. 162-1-8 are applicable. »
At the c of 2° of the I of Article R. 162-52-1 of the same code, the word "population ; is replaced by the provisions as follows: "population. This assessment leads to the consideration of the improvement of service expected as major, important, moderate, minor or to the absence of service; "
In section 8 of chapter II of title VI of book I of the same code, after article D. 162-28, it is added an article D. 162-29 as follows:
"Art. D. 162-29.-The deadline for the second paragraph of Article L. 162-1-7-1 is six months.
"The time limit set out in the first paragraph of Article L. 162-1-8 is five months.
"The time limit set out in the second paragraph of Article L. 162-1-8 is 30 days. »
Section 1 of chapter I of Book II title II (Part Three: Orders) of the same code is repealed.
The Minister of Finance and Public Accounts, the Minister of Social Affairs, Health and Women's Rights and the Secretary of State responsible for the budget are responsible, each with regard to him, for the execution of this decree, which will be published in the Official Journal of the French Republic.
Done on February 18, 2015.
Manuel Valls
By the Prime Minister:
Minister of Social Affairs, Health and Women ' s Rights,
Marisol Touraine
Minister of Finance and Public Accounts,
Michel Sapin
The Secretary of State in charge of the budget,
Christian Eckert
