Reinforced coverage and "zero out-of-pocket expenses

As part of the policy aimed at eliminating the remaining out-of-pocket expenses in the fields of dentistry, optics and audiology, Law No. 2018-1203 of December 22, 2018 on the financing of social security ("LFSS") for 2019 provided that registration on the list of reimbursable products and services ("LPPR") provided for in Article L. 165-1 of the Social Security Code ("CSS") may distinguish, within the same category of products and services, several classes, defined, on the one hand, according to the primary nature of the service rendered and, on the other hand, according to the relationship between this service and the tariff or price envisaged.

At least one of these classes is likely to be the subject of increased coverage, through the application of appropriate responsibility rates, or even sales limit prices.

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The different reimbursement schemes for optical equipment

In terms of optics, the introduction of the "100% health" offer byArticle 51 of the LFSS for 2019 has resulted in the creation of 2 categories of coverage for lenses and optical equipment within the LPPR.

• Class A, which concerns lenses and optical equipment with no out-of-pocket expenses for the patient and is part of the 100% health care program. Products in this class are fully reimbursed by health insurance and complementary social protection schemes and their prices are capped.
• Class B, which includes equipment other than 100% health, for which the price is free. A remaining charge for patients is therefore likely to exist for this class of product.

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Registration of optical equipment in the LPPR

To be reimbursed, optical equipment must be listed on the LPPR. There are two ways for this equipment to be registered: registration under a generic line (generic description) or registration under a brand name.

In the first case, it is important to attach the product to the corresponding generic line, i.e., to a homogeneous category of medical devices subject to minimum technical specifications, as well as, if applicable, to indications and conditions of prescription and delivery specified on the LPPR. In this context, it is necessary to obtain an individual identification number for the product in the LPPR in order to obtain its attachment to an identified generic line.

In the second case, when the product does not correspond to any generic description, it can be registered under a brand name. In this case, a complete file must be submitted to the CNEDiMTS (the National Commission for the Evaluation of Medical Devices and Health Technologies), which will evaluate the clinical benefit of the DM product, as well as its place in the therapeutic strategy.

Class A and Class B - In Practice

If both classes are registered in the LPPR, the referencing or registration of lenses or optical equipment in either of these classes, on a generic line, is subject to specific registration procedures, via the website démarches-simplifiées.fr.

Some special features to know:‍

• ‍ Class A lenses must be "referenced"

Theorder of December 3, 2018, modifying the terms and conditions for the reimbursement of DM and associated services for the reimbursement of medical optics in Chapter II of the LPPR provides for a specific referencing procedure for class A lenses via the submission of a technical file subject to a specific format.

• ‍Themarketing of class B lenses is conditional on the listing of at least one class A lens of identical correction

A manufacturer wishing to market class B lenses must list at least one class A lens with identical correction. It should be noted that a manufacturer must be able to quickly provide distributors with all the lenses it has listed.

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The consequences of the registration of optical lenses and equipment in the LPPR

Sales Reporting Requirements:

Class A or B manufacturers are concerned by the obligation to declare sales set forth in Article L. 5121-18 of the French Public Health Code ("CSP"). This declaration concerns manufacturers subject to VAT who make their first invoicing of DM defined in article L. 5211-1 of the CSP in France, namely lenses and optical equipment.

Also since 2021, a declaration of sales prices (net of discounts or taxes) must be made by operators or suppliers of retail distributors of products and services registered on the LPPR to the CEPS. For more information: New reporting obligation for companies marketing at least one health product registered on the LPPR.

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Towards a framework for sales prices?

The LFSS for 2023 has been adopted and, contrary to all expectations, the optical sector has not been spared from the regulation of the margins of healthcare professionals dispensing DM within the framework of the LPPR. The consequence of 14° of article 58 of the LFSS is therefore the creation of a new article L. 165-3-4 of the CSS giving the ministers responsible for the economy, health and social security the power to set the distribution margins for products registered on the LPPR. Another consequence of this article is the introduction of a control measure for discounts granted by suppliers, which " may not exceed, per calendar year and per product line, for each retail distributor, a percentage of the operating price excluding tax of these products ".

The amendment introduced by the Senate to exclude optical and hearing products from the scope of application of this article was not retained. The Constitutional Council was asked to rule on the constitutionality of this article and issued a decision on December 20, 2022 declaring the article to be in conformity with the Constitution.  

As the LFSS for 2023 currently stands, optics are therefore affected by this new framework. No decree or order has yet been published to provide further details.

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