The patient reimbursement: who is in charge and how does it work?
During your career, you may deal with patient reimbursement:
- Either as a project manager: you will have to foresee in your budget, right from the beginning of the study, patient reimbursement costs by choosing a provider; either as CRA promoter: with your project manager, you must not forget this aspect in the study implementation;
- Either as Site Study Coordinator, especially if you interact with patients in a clinical trial.
But the patient reimbursement, how does t work? Who is in charge?
In this article, let us clarify you about it.
1. What is the difference between “reimbursement” and “compensation”?
Reimbursement and compensation are two separated terms. We talk about “Compensation” when the promoter pays healthy volunteers or patients whose disease is not related to the research.
The compensation is the same for all participants of a study. It is neither a salary nor a fee and compensates the constraints experienced by the volunteer participants. For example, a hospitalization or unpleasant or painful procedures performing.
The amount and terms of compensation must be included in the protocol, the consent and the patient information note. They are reported to Ethics Committee for approval. It is forbidden for vulnerable people (minors, persons under guardianship, prisoners …)
Meanwhile, the “reimbursement”, involves patients participating in an interventional clinical trial protocol. By agreeing to participate, the patient will have additional tests defined by the Protocol, requiring travel on site, and therefore additional costs in relation to “classic” monitoring. These expenses relate to transportation (taxi, VSL, personal vehicle, etc.), but can also take into account the accommodation and catering. The reimbursement types expenses and their limits are defined by the promoter, and submitted to the company providing the patient services reimbursement with which he contracted.
2. What does French laws texts say?
“No compensation can be allocated to one that lends himself to experimentation, to body parts taking, or product collection of his person” Article 16-6 of the Civil Code.
“The biomedical research does not lead to any direct or indirect financial compensation for consenting persons, except the reimbursement of expenses, if need be, to payment by way of compensation for the suffered constraints (…)” Article L1121 -11 of the Code of Public Health
Currently, the regulations address the issue of compensation. As said earlier, compensation is paid by the promoter and is limited to € 4,500 for 12 consecutive months (amount defined by the Ministerial Order of April 25th 2006), to avoid any excess “with regard to the fundamental principle of the body non-commercialization and to avoid a possible concentration of risk.” Moreover, these persons are recorded by the investigator in the National Patient File, established by Huriet-Sérusclat Act. This file ensures the participants safety as it ensures respect for the exclusion period (that is to say his non-participation in another biomedical research) but also the compensation limit. This file is only accessible by the investigators.
Regarding reimbursement, there is no regulatory text on it for the moment.
3. How does this really happen in France?
Under the Act of 6 August 2004, the promoter should have no access to the patient’s personal data. This is why patients are identified by a number since the consent signature. To ensure their security and the confidentiality of their data, promoters must then go through a service company, which shall have the only right to access the patient’s confidential data (names, address, registered on the application reimbursement forms and on all attached supporting documentation such as bills, or on the RIB or vehicle registrations for example, provided by the hospital). The project manager or the CRA promoter of the study will, of course, accept the visits, but the service provider makes repayments.
4. Would it be easier to set a flat rate for patients in the same study?
To facilitate the study project manager budget management, one might wonder if a package containing all the expenses related to the protocol for the patient could be expected.
Flat rate can be applied for compensation, but not for repayments. Patients from all parts of France, and the centers are mostly located in large cities; this idea seems difficult to realize. Indeed, the travel costs are highly variable from one patient to another. They may be from a few tens of euros to a thousand euros for a single journey. So there is a huge variability within the same group of patients for a given study, and this could be an obstacle for a patient to participate.
Moreover, it would go against the law. For example, a fee of € 50 per patient. If the actual cost of the journey for the patient exceeds this amount, the patient must cover the costs himself. However, the Code of Public Health states that the patient is reimbursed for all expenses. It is therefore preferable to carry out on case-by-case basis in the patient’s interest, but also to prevent possible abuse.
The patient reimbursement is a subject that you do not necessarily think when you are a project manager, CRA or CET. It is important to think about it from the beginning of the study, so that you do not to exceed your budget, but also that you could make the reimbursement as soon as possible.
To date, the legal texts evoke the patient compensation. However, it would be interesting to develop the legal texts concerning the repayment to better fit them for biomedical research carried out in France, but also in other countries of the European Union.
Update 06 July 2020: “The new text of the MR-001, updated on 3 May 2018, has introduced provisions for reimbursement of patient costs.
On the one hand, reimbursement of research-related expenses incurred by the person concerned has been included in the list of categories of personal data relating to persons suitable for research that can be processed.
On the other hand, the text stipulates that subcontractors, acting on behalf of the processor and not having the quality of a research location, may be receiving administrative data identifying persons who are suitable for research (name, first name, postal contact information, electronic and telephone contact information, telephone details) if the treatment is, in particular, for the purpose of reimbursement of the costs of transporting persons and/or the payment of allowances.
In other words, the treatment by subcontractors, of which Pharmaspecific is a part, of identifying data of persons willing to research as part of the patient reimbursement is now in accordance with the MR-001. »
Also visit the website of Pharmaspecific, http://www.pharmaspecific.fr and discover our activities. We perform patients reimbursement of expenses.
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Brochure “Clinical studies in 20 questions” of Leem
Texts (available on the website of Legifrance):
- Article 16-6 of the Civil Code
- Article L1121-11 of the Code of Public Health, and his decree of 25 April 2006
- Article R1121-3 CSP
- Article L1123-7 CSP
CNIL Act of 6 August 2004 on the protection of individuals with regard to the processing of personal data.Recherches utilisés pour trouver cet article :le blog de la recherche clinique remboursement patient,remboursement patient recherche clinique CPP,avance de frais par les patients dans un essai clinique,évaluer les frais de transport des participants à un essai clinique,indemnisation participation recherche clinique hospitalisation,indemnité patients recherche clinique,loi francaise remboursement frais déplacement patient recherche clinique