Transitional (pre-LPPR) coverage for the Insides System for chyme reinfusion in France

On June 11, 2023, the Ministry of Health and Prevention published an Order in the Official Journal of the French Republic on the transitional coverage for the Insides System from Insides Company for the treatment of intestinal failure associated with temporary double enterostomy or enterocutaneous fistula by actively reinfusing chyme into the distal intestine.

Transitional coverage of certain products and services (prise en charge (PEC) transitoire), according to article L165-1-5 of the Social Security, is a pathway to obtain temporary reimbursement for CE-marked, presumably innovative medical devices intended for the treatment of rare or serious diseases (or compensation for a disability), which are falling with the scope of the List of Reimbursable Products and Services (LPPR). This mechanism allows reimbursement of medical devices for one year (with a possibility of renewal), with the goal of establishing additional evidence, before submitting an application for regular reimbursement via the LPPR list.

The following new codes for the transitional coverage of the device are registered in the LPPR:

• 5231371 “Chyme reinfusion system, THE INSIDES SYSTEM, initiation kit” with a reimbursement tariff of €2,230;
• 5242392 “Chyme reinfusion system, THE INSIDES SYSTEM REFILL, renewal kit” with a reimbursement tariff of €1,859.

See the details in French here.

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