Competition law: what are the changes for private and public healthcare?

On 27 August 2022, the ‘Annual Market and Competition Law 2021’ (published in the Italian Official Gazette No. 188 of 12 August 2022) came into force. It aims to promote the development of competition and to remove regulatory obstacles to open markets, including in healthcare.

But what were the innovations introduced in healthcare?

In an attempt to make the healthcare system more transparent and competitive, significant changes were made to Legislative Decree No. 502/1992 on the reorganisation of the healthcare sector. The Competition Law has made significant adjustments in the area of healthcare accreditation and contractual agreements between accredited entities and health authorities.

More precisely:

On health accreditation (Article 8-quater, Leg. Decree No 502/1992)

In the case of applications for accreditation by new facilities or for the initiation of new activities in pre-existing facilities, a ‘provisional' accreditation is no longer to be granted subject to positive verification of the volume of activity carried out and the quality of its results.

The current wording of Art. 8-quater, para. 7 of Leg. Decree No. 502/1992 focuses on the possibility for new providers to obtain (definitive) accreditation on the basis of the quality and volume of services to be provided. The activities already performed and the results previously obtained are to be only ‘potentially’ indicated, taking into account the objectives and results of the control and supervisory activities in terms of quality, safety and appropriateness of healthcare services on the part of the Administration.

This amendment has the merit of opening up the scope of healthcare provision on behalf of the SSN (Italian National Health Service):

• to those subjects which, although they have not been in the healthcare market for years, can still meet the legal requirements for the issue of the licence as well as the demands of the Public Administration;
• to potential providers of home care, which, due to the 'public' nature of the activity provided, find themselves having to apply for health authorisation (a prerequisite for initiating practice) and accreditation at the same time or within a short period of time, as they are unable to demonstrate the results of previous healthcare activity.

On contractual agreements (Article 8-quinquies, Leg. Decree No 502/1992)

The real legislative breakthrough certainly relates to the introduction of a selective procedure for the purpose of entering into contracts with the health authority.

In fact, before the recent legislative intervention, the accredited party could access the relevant contract for the provision of health services borne by the SSN without having to participate in a tender procedure.

Now, instead, with the introduction of para. 1-bis, art. 8-quinquies, Leg. Decree no. 502/1992, the private entities accredited to stipulate the contract must be identified 'through transparent, fair and non-discriminatory procedures’, following the publication by the Regions of a notice containing objective selection criteria, which give priority to the quality of the specific healthcare services to be provided. The selection of these entities must be carried out periodically, taking into account the regional healthcare planning and on the basis of checks on any rationalisation needs of the network under agreement and, for entities already holding contractual agreements, on the activity performed).

It goes without saying that the provision of a selective procedure is expected to guarantee an increasingly competitive public-private healthcare system and, at the same time, foster the good performance of the Public Administration with regard to the criteria for selecting contractors and the timeframes (which to date have often been uncertain) for entering into contractual agreements.

On the other hand, it is equally true that requiring a provider who has already obtained accreditation to also successfully compete in a selective procedure after ascertaining the possession of a series of specific requirements in addition to those related to the authorisation, and the subsequent positive outcome of the assessments by the Public Administration, could further complicate access to the health services borne by the SSN.

In this sense, it will be up to the Regions to make the most of the introduction of this tender system governed by Art. 8-quinquies, Leg. Decree No. 502/1992, enhancing the objective of implementing increasingly high-quality and accessible healthcare for users.

Lastly, although the most significant interventions were in the area of accreditation and contractual agreements, it is worth mentioning a further amendment to Leg. Decree No 502/1992 introduced by the Competition Law.

In an attempt to promote supplementary healthcare (the so-called 'conventions'), the scope of supplementary SSN funds has been extended to include new types of services, in addition to those that are already provided for. These are:

• primary and secondary prevention and long-term care (LTC) services that were not already borne by the National Health Service;
• social services aimed at meeting the needs of chronic patients that are not covered by the National Health Service, without prejudice to the application of the provisions of Article 26 of Law No 328 of 8 November 2000 (‘Framework law for the implementation of the integrated system of interventions and social services’).

In conclusion, it seems that the recent regulatory intervention may be able to make competition in healthcare (concretely) applicable, an objective that the Italian lawmaker had set itself since 1999 with the so-called 'Bindi Reform' (Leg. Decree No. 229/1999).