Accelerating Access to Innovative Digital Medical Devices through Anticipated Reimbursement
The innovation cycle for digital medical devices (DMD) is short and new technologies can quickly emerge, bringing added value to patients and healthcare organizations. In line with the “Digital Health” acceleration strategy, which aims to make France a leader in digital health, the French government has introduced the Digital Anticipated Coverage (PECAN) through the Social Security Financing Act 2022. With a budget of €718 million, this strategy is consistent with the various government programs in digital health, including the ministerial roadmap for digital health.
PECAN, which is provided for by Article 58 of the Social Security Financing Act for 2022, allows patients to quickly benefit from innovative digital medical advances. The March 31, 2023 decree outlines the application process and allows manufacturers to submit their applications to the ministries responsible for health and social security.
A One-Year Springboard for Access to Reimbursement by Health Insurance
This derogatory process allows patients to receive early coverage from health insurance for a presumed innovative digital medical device for medical monitoring or therapeutic purposes, provided it is prescribed by a physician. This allows for quick access to innovation, with the requirement that companies provide the necessary data for the evaluation of the medical device and that it already complies with safety requirements.
This one-year derogatory period gives manufacturers the opportunity to begin operational deployment while finalizing their request for regular coverage. This request must be submitted before the end of the derogatory period to secure the reimbursement of the digital medical device.
Accelerated Evaluation for Obtaining Derogatory Funding
Who is eligible?
PECAN is available to digital medical devices presumed to be innovative:
- For therapeutic purposes, which are intended to be included in the list of reimbursable products and services (LPPR);
- or for medical monitoring activities and which are intended to be included in the new list of medical monitoring activities (LATM).
What are the prerequisites for applying?
Candidate devices must demonstrate a certain level of maturity:
- They must have a valid CE medical mark for the indication concerned, regardless of the risk class of the medical device;
- They must be presumed innovative, particularly in terms of clinical benefit or progress in healthcare organization, based on the available data and relevant comparators;
- They must be able to provide evidence of the benefit of their solution within the prescribed timeframe so that the French National Authority for Health (HAS) can assess the usefulness of the solution before the end of the derogatory period;
- They must comply with the interoperability and security framework for DMDs established by the National Agency for Digital Health to ensure the exchange, sharing, security, and confidentiality of patient health data.
What is the evaluation process?
To reduce delays, the competent agencies carry out a parallel 60-day evaluation:
- The National Agency for Digital Health (ANS) verifies the compliance of the solution based on the interoperability and security framework for DMDs, approved by the February 22, 2023, decree. Applications must be submitted on the Convergence platform.
- The French National Authority for Health (HAS) assesses the presumption of innovation of the digital solution in order to improve patient care through health insurance. Applications must be submitted on the EVATECH platform to be evaluated by the National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS).
Based on these evaluations, the decision to provide digital anticipated coverage is made within 30 days by the ministers…