The two French “anti-kickback” Ministerial Orders published
On 14 August 2020, the two ministerial orders completing the new French “anti-kickback” regulation were published.
On 14 August 2020, the two ministerial orders completing the new French "anti-kickback" regulation were published, defining :
the amounts from which an agreement is subject to an authorisation (1.); and
the amounts below which benefits in kind or in cash are considered to be of negligible value (2.).
1. Regarding the Ministerial Order of 7 August 2020, defining the amounts from which an agreement provided within Article L. 1453-8 of the French Public Health Code and providing the grant of benefits, is subject to an authorisation
The thresholds are identical to those provided within the latest version of the draft Ministerial Order. However, the Ministerial Order:
is completed to mention the thresholds applicable to compensation of services rendered by associations of HCPs and/or medical students - they are identical to those applicable to HCPs; and
deletes, for medical students, the threshold applicable to the funding of professional training.
As a reminder,
either the amount of the benefits granted within an agreement is below to these thresholds, the signed agreement should be notified; or
the amount of these benefits exceeds these thresholds, the draft agreement should be subject to a prior authorisation.
The applicable thresholds depend on the status of the beneficiary and the type of benefit (see chart here).
2. Regarding the Ministerial Order of 7 August 2020, defining the amounts below which benefits in kind or in cash are considered to be of negligible value according to Article L. 1453-6, 4° of the French Public Health Code
This Ministerial Order is identical to the latest version of the draft Ministerial Order.
Consequently, benefits, in kind or in cash are considered to be of negligible value if their market value, including all taxes, is less than or equal to, per beneficiary, the following amounts and within the limit of the frequencies defined (see chart here)
Both Ministerial Orders come into force on 1 October 2020, which is date for the entry into force of the Decree of 15 June 2020.
