Article 36 of the Social Security Financing Act for 2022 (LFSS 2022) provides for the entry into common law of the coverage of remote monitoring by the health insurance (to find out the terms of coverage, see our article of November 12, 2021 – in french). A decree will specify the date of entry into force of this new system, which is set for July 1, 2022 at the latest.
As a reminder, the reimbursement of remote monitoring activities will be subject to their registration on a “remote monitoring” list. This registration will be carried out by a ministerial order, following the opinion of the CNEDiMTS. The opinion of the CNEDiMTS will take the form of a reference framework.
Without waiting for article 36 of the LFSS 2022 to come into force, the CNEDiMTS has just published four guidelines relating to (i) diabetes, (ii) chronic respiratory failure, (iii) chronic renal failure and (iv) chronic heart failure.
These guidelines define the minimum requirements applicable to the remote monitoring operator and the technical requirements for the digital device and the necessary collection accessories.
What functions must MD have to be eligible for this coverage?
The table below summarizes the functions that digital MD must have in order to be eligible for specific coverage of remote monitoring activities.
| DIABETES | RESPIRATORY INSUFFICIENCY | RENAL INSUFFICIENCY | CARDIAC INSUFFICIENCY | |
|---|---|---|---|---|
| Data to be collect |
Mandatory and recommended data listed here +Patient Quality of Life Questionnaire |
Mandatory and recommended data listed here +Patient Quality of Life Questionnaire |
Mandatory and recommended data listed here +Patient Quality of Life Questionnaire +Access to data from medical laboratories via reference services (DMP, MSSanté, etc.) |
Mandatory and recommended data listed here +Patient Quality of Life Questionnaire +Access to data from medical laboratories via reference services (DMP, MSSanté, etc.) |
| Data transmission | To the remote monitoring operator and the patient +Possibility for the operator to transmit to the medical control services the data necessary to monitor the effective use of the MD and the results of use in real life |
To the remote monitoring operator and the patient +Possibility for the operator to transmit to the medical control services the data necessary to monitor the effective use of the D and the results of use in real life |
To the remote monitoring operator and the patient +Possibility for the operator to transmit to the medical control services the data necessary to monitor the effective use of the MD and the results of use in real life |
To the remote monitoring operator and the patient +Possibility for the operator to transmit to the medical control services the data necessary to monitor the effective use of the MD and the results of use in real life |
| Purpose of the alerts | Reporting capillary glucose or interstitial glucose measurements outside the target range Reporting of severe hypoglycemia with the possibility of customizing both the frequency and the threshold of hypoglycemia Non-transmission of data necessary for the operation of alerts |
Safety related to the operation of ventilation MD on consecutive days Trend with measurement history Non-transmission of data necessary for the operation of alerts +Oxygen saturation alert for patients on oxygen therapy |
Reporting of measured data outside the target area Non-transmission of data necessary for the operation of alerts |
Reporting of suspected incipient cardiac decompensation that may require treatment adjustment Non-transmission of data necessary for the operation of alerts |
It should be noted that in addition to these requirements, the guidelines published by the CNEDiMTS make reimbursement subject to conditions of prescription, distribution and use.
The HAS has announced that a fifth reference document will be published at the beginning of March 2022 for implantable defibrillators and pacemakers.
In addition, the HAS is currently working on the definition of indicators that would allow the evaluation of the achievement of results in real life use.
