A distanza di quasi 7 anni dall’entrata in vigore della L. 24/2017 e pur con un (poco giustificabile) ritardo sulla “tabella di marcia” originariamente prevista entro 90 giorni dall’aprile 2017, il regolamento attuativo sotteso all’art. 10 della norma è giunto alla sua versione definitiva e tradotto in un decreto già firmato dai ministeri competenti e finalmente pubblicato il 01.03.2024 in Gazzetta Ufficiale.
Given the time elapsed, it should be added that “finally” we are able to consider the long process for the issuing of this decree to be concluded. This decree is tasked with determining both the minimum requirements for insurance policies for public and private healthcare facilities and for healthcare professionals, as well as, contemporaneously, the so-called other analogous measures, concerning the hypothesis that the entity chooses to assume the risk itself.
While it is open to improvement, this decree has at least the merit of establishing certain firm points regarding a matter – medical liability insurance – which urgently needed more precise regulation.
Consider the recurring dilemma of “who must insure what,” or the regulation of the operational methods that entities without “coverage” (whether due to total self-insurance or because they have policies with very high SIRs) would now be required to comply with, or again, the issue of the so-called direct claim against the insurer, which will finally no longer be left to the assessment of the lower courts, which have too often, in this regard, proved inconsistent.
Without claiming to be exhaustive and wishing to avoid going into legal technicalities which would require many more lines than are available here, the aim of this first preliminary comment is to offer a concise critical analysis of the text published yesterday.
One of the themes certainly most complex to clarify concerned the understanding of who, specifically, should have assured and for what (and/or in whose interest).
Pursuant to Article 10, first paragraph of Law 24/2017, it has always been accepted that public and private healthcare facilities are required to ensure their civil liability towards third parties arising from the conduct of anyone working within them, regardless of their capacity, and likewise, to provide insurance cover for the personal liability of employed and affiliated healthcare professionals.
The final paragraph of this clause – which unequivocally establishes the obligation for the facility to insure its employed (or contracted) doctor – states that the content of that provision does not apply “...in relation to healthcare professionals referred to in paragraph 2”.
This arrangement, the latter being, after reading paragraph II of the same article, allowed for interpretative doubts that were not easily resolvable regarding the position of the freelance professional who had not entered into a contractual obligation with the patient.
Pursuant to the aforementioned paragraph II, the healthcare professional who “carries out their activity outside one of the facilities referred to in paragraph 1 of this article, or who provides their services within the same on a freelance basis, or who avails themselves of the same in fulfilling their contractual obligation assumed with the patient...” is required to ensure their professional liability.
As the expression “...or that” inserted between the indication of the healthcare professional operating within the facility under a freelance contract and that of the healthcare professional who has instead assumed a contractual obligation with the patient is not easily interpretable, three hypotheses of doctors required to insure themselves seemed to arise:
i) the healthcare professional operating outside of a facility,
ii) the healthcare professional working in a facility under a freelance contract,
iii) the healthcare professional operating within a facility in fulfillment of a direct contractual obligation to the patient.
Therefore, the question “who should be insured and for what” was not easy to answer unequivocally when posed by a private entity operating with many healthcare professionals engaged on a freelance basis but who did not enter into contractual obligations with patients (“should we insure them too?”) or, conversely, the latter (“should I insure my personal professional liability?”).
This interpretative issue appears to be resolved by the decree which states, in essence, that the only scenario in which there is an obligation to insure one's professional civil liability concerns doctors who enter into a contractual obligation with the patient. Conversely, it is the organisation that must insure the personal civil liability of healthcare professionals who, despite operating under a freelance contract, have no contractual ties with third parties.
In this sense, Article 3(II) of the decree provides.
And yet, if this is the will of the legislator, they perhaps ought to have paid closer attention when defining, in Article 1(g) of the decree, what is to be understood by “person engaged in freelance professional activity,” where the interpretative doubts concerning the second paragraph of Article 10 of the Law (and the three possible hypotheses) seem, in truth, to return with greater force.
It is not clear why the person operating the freelance professional activity has been defined as someone who works “...even under agreement with the National Health Service, outside the facility or within the same facility or which they use in fulfilment of their contractual obligation with the patient, regardless of the type of relationship with the facility or the role held”.
If, in Article 10 of the Law, the expression “or” could have created the aforementioned interpretive confusion, with this definition and with the use of the letter “or” (“or within the same or which they make use of in fulfilment of their own obligation contractually undertaken with the patient”) that previous doubt seems to be dispelled (and therefore, pursuant to the second paragraph of Article 10 of the rule, the freelancer who has not assumed direct contractual obligations must also be assured), however, this is then excluded in the subsequent Article 3, paragraph II of the decree in question.
All in all, it could have been done better.
Remaining on the definitions provided for in Article 1 of the decree, the impact of the definition of “claim” provided for in letter “o” is not irrelevant.
Without wishing to go into the merits of the long specification offered by the article, one wonders how the communication that the structures notify to healthcare professionals pursuant to art. 13 of the Gelli Law should be interpreted.
This communication is not specifically contemplated within the definition of a claim, with the consequence that, upon its receipt, the doctor would find themselves, on the one hand, unable to report the “damage” to their insurer and activate the policy, and on the other, obliged to disclose it upon renewal or the taking out of new cover, with the concrete risk of not finding cover for any claim that might subsequently arise from that very communication.
It would have been appropriate to include such communication in the definition of a claim, or alternatively, to impose the so-called deeming clause as a minimum requirement, capable of bringing the future claim under the policy in effect at the time of receipt (and precautionary notification) of that very communication.
Continuing with the analysis of the text, a further doubt arises from reading Article 3 “Subject of insurance cover”.
It is not understandable why the insurer's obligation regarding the guarantee provided in favour of the structure should be limited solely to the hypothesis of its contractual liability.
If it is true that, pursuant to Article 7 of the Gelli Law, the structure is always liable under Articles 1218 of the Italian Civil Code and 1228 of the Italian Civil Code, it is equally true that not only is the injured patient given the option to act both contractually and, cumulatively, also under Article 2043 of the Italian Civil Code, but that the claim for damages sought *iure proprio* by the patient's next of kin, according to almost unanimous case law, is actually exclusively regulated within the scope of tortious liability.
With the consequence that, in this latter scenario, the structure would effectively be without insurance cover.
Similarly, the last paragraph of the first subsection of Article 3 of the decree is not clear, where it specifies that the coverages subscribed to by the facilities are considered to extend also to the non-contractual liability of doctors “...even if chosen by the patient and even if they are not employees of the facility, whose work the facility avails itself of for the fulfilment of its own obligation to the patient”.
Well, regardless of the difficulty in understanding the distinction between a doctor “chosen by the patient” and a doctor who assumes a contractual obligation with them (presumably billing...?), wasn't it more appropriate to state, much more directly, that the coverage of the facilities is understood to extend also “to all healthcare professionals whom the facility engages in fulfilment of its obligation to the patient, with the exception of healthcare professionals who, in execution of a contractual obligation assumed by them with the patient, have operated within the facility”?
Article 3 of the decree merits one final consideration: paragraph 6 introduces the obligation for the insurer to cover the liability (of the facility or the healthcare professional) in full, even in cases of joint and several liability. This provision has (or will have) a direct impact on the insurance policies currently on the market which, without distinction, exclude coverage for amounts the insured person is jointly and severally liable for to a third party due to the act of a co-debtor.
It is also true that, with such a provision, the legislator has done nothing more than align itself with the orientation expressed on the matter by case law (of legitimacy and merit).
Continuing with the examination of the decree and taking note of the minimum caps set by Article 4, the provision established in Article 5 deserves observation, as it definitively sanctions the effectiveness and validity of claims-made cover: the insurance must apply to claims first received during the term of the policy, with an extension for retroactive events to the preceding 10 years and, in the event of the insured ceasing business, for a further 10 years of tail cover.
This forecast lacks a position on the extent of the cap for claims in so-called retroactivity for which, instead, insurers often consider a so-called “aggregate” cap, meaning a single one for all claims relating to events prior to the policy's start date, but with the first claim made during the policy's term. In the absence of a specific provision in this regard, it is highly probable that companies will adopt, even for new coverages, the system of maximum “aggregate” exposure.
In the second paragraph of Article 5(I), it is established that “In the event of renewal, the insurance guarantee applies from the start date of the first policy”.
As clear as it is, in the opinion of the writer, this forecast leaves some doubts regarding the calculation of the “retroactivity” period, as it is not specified whether or not the one regulated in the first policy should be taken as a reference (as it would seem).
It is also true that the statute of limitations for the claimant's action (10 years for contractual claims and 5 years for tort claims) leads one to consider the question superfluous, given that it is unlikely – because the claim for damages would be time-barred – that an insured party who has renewed the policy, hypothetically for 5 years, could seek indemnity for a claim made during the term of the last renewal but for an event that occurred 15 years earlier (i.e., within the 10 years of retroactivity provided for in the original insurance contract).
Article 6 – which governs the insurer's right to terminate – has the merit of preventing companies from terminating the contract mid-term, providing for the sole, unrealistic hypothesis of early termination in the case of multiple convictions for grossly negligent conduct by the insured, established by final court rulings.
However, the Legislator's excessive zeal, which evidently aims to protect the insured, seems not to fully achieve the hoped-for outcome: the absence of an obligation for the insurer to renew the policy upon its expiry will likely lead to a market with annual contracts. As a consequence, a doctor who has received a communication pursuant to Art. 13 of Law Gelli while the policy is in force would find themselves in difficulty in finding valid insurance cover for that event, should the subsequent claim arrive after the expiry of the policy which the insurer would, however, have no obligation to renew.
It is certainly of interest what has been established in Article 8, where the exceptions that the insurer may raise against the injured party who has brought a direct action against the insurer are specified. These can be summarised as follows:
- Harmful consequences arising from carrying out activities outside of cover
- events occurring and claims made outside the periods of cover
- deductible and SIR
- Non-payment of premium
Regardless of the absence, among such exceptions, of the policy limit, which is however contemplated by the Civil Code as a delimitation of risk, any legal professional cannot fail to foresee how such provisions will generate an intricate evolution of litigation, characterised by a series of reciprocal cross-claims (by the insurer against the insured) or by the initiation of separate proceedings to recover amounts paid to a third party by the company, even in the absence of insurance cover.
Title III of the decree is dedicated to the regulation of the minimum guarantee requirements and operating conditions for so-called "analogous measures" in the event that the structure chooses not to insure itself and to assume and manage the risk in-house.
The forecasts contained herein would merit a separate comment and more in-depth discussion.
It is simply highlighted how, to date, very few structures are capable of guaranteeing autonomous and effective management and governance of insurance risk.
However, it is difficult to understand how it is possible to comply with the provisions of such a title ’at zero cost“: beyond the setting up of the risk fund (Art. 10) and the reserve fund (Art. 11), their certification by an auditor and the continuous assessment required of the CVS and Risk Management, one must wonder how the presence – contemplated by the decree also as ”external“ to the company – of loss adjusters, legal counsel and (optionally) an actuary, can be maintained ”without new or increased burdens on public finances“ (Art. 16) and in compliance with the provisions of Art. 19 on financial neutrality.
Furthermore, the absolute difference in compliance that Ivass law and regulations impose on insurance companies, compared to what appears to be set for facilities in the decree, seems unfair – and certainly disadvantageous for the injured party. The latter might be pushed for economic reasons (premium savings) not to insure, trusting they can manage the risk themselves without, however, having “the capacity” for it and without having to comply with the external requirements and controls that are instead envisaged for insurers.
The greatest risk is that it could encourage the (uncontrolled) use of similar measures by companies which, when put to the test, might prove unable to sustain the financial outlays for claims that, by their nature, are long-term and require constant assessment, even if only for annual provisions.
All to the detriment of an injured patient who would not find redress for the harm suffered.
Any entity that opts for self-insurance without the mandated controls for insurance companies (even simply on the assessment of reserves) would expose itself to the risk of uncontrolled management, leading to an – inevitable – future financial collapse, ultimately to the detriment of the community.
If the Legislator's objective was to foster competition in the health insurance market and the signing of a greater number of policies, perhaps something “went wrong”.
The hypothesis of lowering the tax rates currently applied to insurance premiums, which are so high that they themselves act as a disincentive to insurance coverage, has not even been considered, in favour of an “analogous measure” that would instead allow the organisation to save those costs.
