The ordinances of 12 May 2021: Closer, simpler, safer?
Certification of local hospitals / Restructuring of the territorial health professional communities (CPTS) / Relaxation of the status of multi-professional health centres / Restructuring of authorisation law / Development of secure digital health services
In view of the ageing population, the need to treat chronic diseases and the demographic disparities in medical care, the current health system needs to adapt.
Recent reforms aim to bring health care closer to users and to simplify the organisation of the health care system to improve the quality of care.
In this sense, Law No. 2019-774 of 24 July 2019 on the organisation and transformation of the healthcare system (OTSS) undertook this transformation and empowered the Government to legislate by ordinance.
Four orders were published on 12 May 2021.
- The certification of local hospitals
On the remains of the former rural and local hospitals, the Social Security Financing Law for 2015 had enshrined local hospitals in the law.
Characterised by a limited volume of activities in medicine, this status was intended to benefit from a derogatory mode of financing, combining activity-based pricing (T2A) and a fixed allowance.
Since 2016, 240 establishments have been listed as local hospitals and benefit from this funding model.
The Ma Santé 2022 plan has proposed the strengthening and development of local hospitals and has set the objective of certifying 500 to 600 local hospitals by 2022, i.e. more than double their current number.
Thus, the OTSS law redefined the missions of local hospitals and the Government published Order No. 2021-582 of 12 May 2021 on the certification, governance and operation of local hospitals and Decree No. 2021-586 of 12 May 2021 on the certification of local hospitals, which specify this new procedure.
A voluntary and regional certification.
Under the previous regime, inclusion in the list of local hospitals was initiated by the ARS and was national.
Indeed, the regional health agencies ARS proposed to establishments that met the eligibility conditions to be included on the list of local hospitals. The latter had a period of one month to refuse and the list was drawn up by the ministers responsible for health and social security.
From now on, the certification procedure instituted by the order is guided by two principles.
On the one hand, it is regional: it is up to the Director General of the ARS to draw up a list of establishments certified as local hospitals for each region.
On the other hand, it is voluntary: it is up to the applicant establishment to make a prior request to be included on the list.
It submits an application to the ARS, which has six months to notify its decision. If the application is rejected, the establishment or facility may not reapply for a period of one year.
More eligibility criteria.
Until now, an establishment was eligible for inclusion on the list of local hospitals if it held a medical licence, excluding surgery or obstetrics, and did not exceed a ceiling of 5,500 stays.
The decree sets out four eligibility conditions listed in Article R. 6111-24 of the Public Health Code.
To qualify for the certification, the applicant establishment or facility must, in addition to practising medicine without surgery or obstetrics, have or provide access to technical imaging and medical biology platforms and telehealth equipment.
It must offer, in addition to the services available in the region, a range of care and consultations in several specialities carried out by private doctors, employees or public officials within the centre or in partner health establishments.
This offer should not be limited to the care of a particular disease or population group.
Lastly, it must cooperate with the health actors in its territory who provide primary care, in the form of self-employed professionals or those employed by the local hospital who monitor patients and coordinate health care pathways.
These conditions must be met by the applicant health care establishment or by the facility if the health care establishment to which it belongs does not meet them.
The order also specifies that unincorporated facilities meeting these criteria can become local hospitals.
Delisting possible at any time.
Before the reform, the list of local hospitals drawn up by the Minister was valid for at least two years.
An establishment could not therefore be delisted, at its own request or at the request of the ARS, during this period, except in the event of a change in its authorisations for health care activities (loss of authorisation for medical activities or acquisition of a new authorisation for surgery or obstetrics, for example).
Neither the OTSS law, nor the order, nor the decree set a period of validity for the certification.
The hospital may be delisted at its own request, or at the request of the ARS if it no longer meets the conditions or is no longer able to ensure the continuity of patient care.
It will be up to the Director General of the ARS to set the de-listing date within a period not exceeding 12 months.
Redesigned operation and of governance.
Local hospitals are required to conclude an agreement with the health, social and medico-social players in the area.
The latter has two purposes:
Firstly, it determines the scope of cooperation: access to care, permanence of care, organisation of health care pathways, methods of sharing information between the parties and organisation of this cooperation.
Secondly, it defines the body responsible for monitoring and evaluating the implementation of cooperation. It may be the medical board (CME) or the medical conference of the local hospital, the governance body of one of the CPTSs party to the agreement, a governance body of a local health contract of the territory or a specific governance body created by the agreement.
The governance arrangements are therefore quite flexible and will allow actors to adapt their bodies to their territorial situation.
In addition, local hospitals with public status are required to conclude a second agreement with the support establishment of the regional hospital groups (GHT) to which they are party.
Its aim will be to organise its relations with the GHT in the exercise of its local missions (reciprocal obligations, support to GHT members for the local hospital’s missions; methods of participation by the local hospital in the implementation of the GHT’s shared medical project).
To further facilitate cooperation, these operating and governance conditions can be adapted.
On the one hand, a local hospital with public status that has been awarded a certification may ask the ARS, after receiving a favourable opinion from the bodies concerned, to allow external persons, in particular representatives of the CPTS, to be included as members with voting rights at meetings of their CME and their management board.
On the other hand, the establishment to which a local hospital without legal personality or under joint management belongs must adapt the operation and organisation of the local hospital to the conduct of the cooperation established.
In order to fulfil this obligation, a sub-committee of the CME or a medical/healthcare committee can be set up to deal with these local missions.
- Reform of the status of the CPTS
The Ma santé 2022 plan and the Ségur de la santé had highlighted the need to improve access to unscheduled care and the organisation of local care, in order to address the difficulties of medical demography.
The government’s ambition was strong: by 2022, local care should be organised throughout the country within coordinated practice structures such as the territorial professional health community (CPTS), making isolated practice an exception.
Order No. 2021-584 of 12 May 2021 on territorial professional health communities and health centres removes the difficulties raised during the consultations in order to promote their development.
Form of association imposed.
Created by the law on the modernisation of the health system of 26 January 2016, CPTS had a poorly defined framework. The Government had highlighted the legal difficulties in deploying CPTSs.
Indeed, no status was imposed to implement a CPTS. The aim was to give territorial actors greater flexibility and freedom to choose the legal structure according to the missions they wished to entrust to it and their organisation.
However, it turned out that none of the existing structures was sufficiently satisfactory for health professionals. The management of an inter-professional ambulatory care company (SISA) was complex, the groupings unsuitable and the associative status, due to its non-profit nature, posed financing and remuneration problems.
From now on, the new article L. 1434-12-1 of the health code requires CPTSs to be set up as associations. CPTSs established under a separate legal form prior to this order will have a period of one year to be established in this form.
The exercise of public service missions.
The missions of the CPTS were not specific enough. Indeed, Article L. 1431-12 of the Public Health Code referred to two articles of the same code relating to primary and secondary care and specified that the CPTSs were intended to ensure better coordination and structuring of care pathways.
The order redefines the missions of the CPTS. It gives them the option to carry out public service missions listed in Article L. 1434-12-2 of the Public Health Code.
These include improving access to care, organising care pathways involving several health professionals, developing territorial prevention actions, developing the quality and relevance of care, supporting health professionals in their territory and participating in the response to health crises.
In order to carry out these missions, CPTSs must conclude an agreement with the ARS and the Caisse primaire d’assurance maladie (primary health insurance fund), the content and duration of which, as well as the methods of compensation for public service missions, will be determined by decree.
Appropriate tax and financing rules
By imposing the associative form, it was necessary to adapt their tax regime. Indeed, this legal structure does not allow remuneration of the members or redistribution of financing between the members of the CPTS.
However, CPTS must be able to remunerate its members or compensate for their loss of resources due to their participation in this cooperation.
The order therefore adapts the economic regime of the CPTS. It allows them to make payments of allowances or remuneration to its members.
Furthermore, the order emphasises that CPTSs that carry out public service missions by agreement benefit, on the one hand, from specific aid from the State or the national health insurance fund and, on the other hand, from exemptions from corporation tax and business property tax.
In order to benefit from these tax exemptions, the CPTS health project must have been approved by the director general of the ARS.
- Relaxation of the status of multi-professional health centres
The characteristic of the nursing homes lies in the status of the professionals: they work on a private basis. This is what distinguishes them from health centres where the professionals are salaried. Most nursing homes are therefore structured as inter-professional ambulatory care companies (SISA).
However, the medical demography can make difficult the implementation of their missions given the medical deserts in certain territories. This difficulty is exacerbated by the fact that it is impossible for an SISA to employ professionals other than medical auxiliaries.
Consequently, Order No. 2021-584 of 12 May 2021 on territorial professional health communities and nursing homes allows for resorting to salaried employment while remaining a private practice.
The acceptance of paid workforce
Multi-professional health centres set up in the form of SISAs now have the possibility of employing professionals themselves. As such, they may receive lump-sum remuneration and redistribute it to their members.
This option of salaried employment has two objectives :
On the one hand, to respond, through the recruitment of health professionals, to the needs of territories experiencing difficulties in medical demography. Young practitioners and retired persons wishing to continue their practice are increasingly seeking this type of practice, which is considered less complex and avoids isolation.
The order also provides that salaried doctors may be chosen as treating doctors. In this case, the tariffs applicable to the acts of salaried health professionals are the conventional tariffs applied to liberal professionals.
On the other hand, by recruiting all professionals contributing to the implementation of the health project, to promote comprehensive care, particularly adapted to populations in precarious situations.
In order to maintain private practice while accepting salaried workers, SISAs must, in order to employ professionals, include in their articles of association the practice of primary or secondary care as well as any other activity contributing to the implementation of the health project of the nursing homes through its employees.
It should be noted, however, that the number of salaried health professionals carrying out care activities must always be lower than the number of associated liberal professionals.
Lastly, the period for the judge to order the dissolution of the SISA in the event of failure to comply with the number of partners has been extended: the six-month period may be extended to eighteen months if the company employs a number of doctors at least equal to the number of required partner doctors, or if it employs a medical auxiliary when there is a lack of such professional among the partners.
The opening of ad hoc interventions
For greater flexibility and in order to promote the multi-professional nature of the nursing homes, the order opens up the possibility of having recourse to ad hoc interventions.
In this manner, nursing homes will be able to offer care without resorting to salaried employment and without involving the professional concerned.
Nursing homes will receive lump-sum subsidies for interventions, which they will redistribute to the parties involved.
The opening of the employer group
The order also amends Article L. 1253-3 of the French Labour Code and allows SISAs to develop employer group activities for the benefit of all or some of their members.
SISAs will be able to place medical assistants at the service of GPs, who will define their missions alone, without this representing a burden or responsibility for the other partners.
The aim of this option is to free up medical time. The Ségur de la santé and the Ma santé 2022 plan had stressed the need to give more time to doctors, to relieve them from certain tasks such as receiving patients, checking vaccination status or updating patient records, so that they could concentrate on care and coordinating care.
- Advance reform of the authorisation of health care activities
Authorisations allow the State to control the activities undertaken by health care facilities and to ensure the quality of care and equal access to care throughout the country.
However, changes over time in the texts relating to activities subject to authorisation have led to the application of disparate regimes depending on the activity concerned.
In order to bring everything up to date, the Government intended to reform the regime of activity authorisations, resulting in a first order in 2018 simplifying the regime of health authorisations.
In this same perspective, Order 2021-583 of 12 March 2021 modifying the system of authorisations for care activities and major medical equipment extends the scope of activities subject to authorisation while streamlining the procedure for renewing authorisations and removing the link between multi-annual agreements in respect of objectives and means (CPOM) and authorisation.
An extension of the scope of permitted activities.
Two activities are concerned: psychiatric hospitalisation without consent and hospitalisation at home.
Until now, the ARS designated, after consultation with the representative of the State in the department concerned, the establishments authorised in psychiatry responsible for providing psychiatric care without consent. It was therefore a designation scheme.
However, the Government has considered it necessary to improve the quality and safety of psychiatric care and the supervision of inpatient care without consent.
This is why the order modifies the authorisation regime for psychiatric activities: establishments admitting patients without consent are now subject to an authorisation regime.
Thus, as of 1 June 2023, the establishments concerned will have to apply for an authorisation. In the meantime, the designations made are valid until an authorisation decision is taken by the ARS.
For its part, home medical care has until now been subject to an ad hoc regime that does not correspond to either a care activity or an alternative to hospitalisation. Home medical care was attached to an existing care activity but had its own operation.
In order to unify the applicable regimes, home medical care will be subject to authorisation as of 1 June 2023. It therefore becomes a care activity in its own right.
Thus, in application of the new Article L. 6125-2 of the Public Health Code, the use of the name “home care facility” will be reserved for holders of a healthcare activity authorisation whose purpose is to provide hospital-at-home services.
However, it will be necessary to wait for the adoption of a decree that will create and regulate this new activity.
A streamlined renewal of authorisation.
The renewal of a licence was as complex as the initial application.
It was up to the holder to submit a file to the ARS, identical to that of a first application since the same conditions as for its granting had to be complied with, completed with an evaluation file, fourteen months before the expiry of the authorisation.
The procedure was therefore cumbersome, time-consuming and irrelevant.
However, in 2018 the government had already undertaken to make the authorisation regime more flexible (removal of the systematic nature of compliance visits, extension of the period of validity from five to seven years).
The Ségur de la santé, in measure no. 20, therefore requested a relaxation of the regime for the renewal of authorisations, or even tacit renewal without an application file for certain activities.
Taking note, the order abolishes the systematic assessment file and the authorisation will no longer automatically set quantitative and qualitative objectives for activities. From 1 January 2022, renewal will be made by simple request of the establishment.
However, in order to maintain a certain of quality and safety control, several safeguards are introduced, allowing for a continuous evaluation of the establishment’s activity.
On the one hand, vigilance indicators in terms of quality and safety of care are put in place. The latter, defined by order of the Minister of Health, will aim to show an alert level to be analysed.
In this case, authorisation holders will be required to launch a consultation with the ARS in order to consider possible corrective measures. If this consultation is refused, the authorisation may be suspended or withdrawn.
On the other hand, the report attached to this order recalls that there are several channels of information for the ARS on current authorisations, such as the certification reports of the French High Authority of Health, and a minimal collection of information will be kept that will be targeted on the human resources deployed in support of the authorisation.
The independence of the CPOM and the authorisation for care activities.
Order 2020-1407 of 18 November 2020 on the missions of regional health agencies had already carried out a major revision of the CPOM.
Deemed bulky, inflexible and increasingly less strategic due to successive legislative and regulatory changes, it had reduced the scope of the contract and the workload of the agencies, refocusing it on strategy.
The conclusion of a CPOM was therefore no longer necessary for holders of a care authorisation but only for health care establishments.
Noting these changes, this order removes the obligation for CPOM to hold authorisations for care activities and thus removes any reference to CPOMs in the chapter on authorisations.
- The development of secure digital health services
The Ma Santé 2022 plan estimated that digital health, which offers the prospect of real progress, is thriving.
As France lags behind other countries in this area, the OTSS law was intended to bring about a genuine digital shift in the transformation of the healthcare system, which is seen as a major challenge for the quality and efficiency of our healthcare system.
The Ségur de la santé had then insisted on the importance of the massive development of digital health in the transformation of the health system.
In furtherance of the reforms introduced by the OTSS law, Order 2021-581 of 12 May 2021 on the electronic identification of users of digital health services and health insurance beneficiaries makes electronic identification a key element in the development of digital health.
The report attached to the Order states that these provisions are intended to address three issues relating to electronic identification.
On the one hand, many users and professionals cannot access digital health services.
On the other hand, the level of security with regard to electronic identification is unsatisfactory for many digital health services.
Lastly, issuing and maintaining electronic means of identification is time-consuming for digital health service providers, preventing them from improving their service.
In response to these difficulties, the order inserts a section in the public health code, entitled “digital health service”, consisting of six articles, L. 1470-1 to L. 1470-6, organised into two chapters.
It defines digital health services as “information systems or digital services or tools implemented by natural or legal persons under public or private law, including health insurance organisations, offered by electronic means, which contribute to preventive, diagnostic, care or medical or medico-social monitoring activities, or to interventions necessary for the coordination of several of these activities”.
Their users are health, social and medico-social professionals and establishments as well as users of the health system.
It then provides a legal basis for the professional directories of reference.
Simplify the electronic identification of digital health services.
The order provides a legal basis to the sectoral directories of professional identity, in particular the RPPS and FINESS, with the aim of ensuring their extension.
Indeed, the aim of this consecration is to allow all professionals and establishments in the health, social or medico-social sector to be able to register in these directories.
It is also expected that the provision of electronic means of identification, necessary to use digital health services, is conditional on registration in these sectoral reference directories.
Securing electronic identification of digital health services.
Lastly, it should be noted that the order repeals two articles that were introduced by the OTSS law and were scheduled to come into force in 2023.
These two articles L. 1110-4-1 and L.1110-4-2 of the Public Health Code governed the use of interoperability and security reference systems to guarantee the exchange, sharing, security and confidentiality of personal health data. This reference system was to be developed by the public interest grouping responsible for the development of shared health information systems.
The order introduces Article L. 1470-2 of the Public Health Code, which secures the electronic identification of these services: it guarantees an appropriate level of security and protection of personal data processed by the service.
In this respect, it provides for the publication of a reference system which will specify, on the one hand, the minimum level of guarantee required for electronic identification and, on the other hand, the means of electronic identification required by the services for professionals.
This reference system should be based on European regulations.
These four orders thus complete the major transformation brought about by the OTSS law following the Ma santé 2022 plan and give concrete expression to some of the long-awaited measures of the Ségur de la Santé.
Although they still require the application of decrees or orders for further clarification, they nevertheless confirm the Government’s determination to rethink the organisation of health care, to adapt the supply of health care to the needs of the territories, with a desire to coordinate all the actors in the health, social and medico-social sectors, with the aim of improving the health care system.
 Law no. 2014-1554 of 22 December 2014 – article 52. These provisions were supplemented by Decree No. 2016-658 of 20 May 2016 on local hospitals and their financing Order of 23 June 2016 establishing the list of local hospitals mentioned in article R. 6111-25 of the public health code; Order of 27 May 2019 establishing the list of local hospitals mentioned in article R. 6111-25 of the Public Health Code  Article L. 1434-12-1 of the Public Health Code Article 207, 17°, of the General Tax Code Article 1461 A of the General Tax Code  Article L. 4041-2 of the Public Health Code  Article L. 162-5-3 of the Social Security Code  Article L. 162-14-1 of the Social Security Code  Article L. 4041-2 of the Public Health Code  Article L. 4041-4 II of the Public Health Code  Order No. 2018-4 of 3 January 2018 on the simplification and modernisation of authorisation schemes for healthcare activities and major medical equipment Article L. 6122-10 of the Public Health Code  Article L. 6122-8 of the Public Health Code  Article L. 6122-5 of the Public Health Code