Policy responses for Italy - HSRM


Policy responses for Italy

3.3 Maintaining essential services

Outpatient services
After the Ministry of Health suspended such activities on 29th February 2020, in Phase 2 regions have started individually defining guidelines to restart outpatient and elective surgical activity. This has been the case in most Southern regions (Puglia, Campania, Calabria, Sicily), whereas in the North only Emilia Romagna and Veneto have resumed the aforementioned services by 8th May. By May 26th, practices, recommendations and instructions to reactivate outpatient and elective surgeries were defined at a regional level in 85% of Regions and by June 9th, the percentage rose to 90%.

On 1st June 2020, the Ministry of Health issued "Guidelines for the reorganization of deferrable elective activity during the  COVID-19 emergency", aimed at gradually reactivating all essential levels of assistance guaranteeing safety in social or health services that had been reduced or suspended.

If required, regions are allowed to progressively reactivate specialized outpatient activities, with particular attention to all activities related to oncologic screening, according to the priority class given to such services defined in the National Plan for the Management of Waiting Lists Government (PNGLA) for the period 2019-2021. Such plan categorizes all outpatient services into 4 categories: U (Urgent) to be performed within 72 hours; B (Brief) to be performed within 10 days; D (Deferrable), to be performed within 30 days in case of visits or 60 days for check-ups and diagnostics; P (Programmed) to be performed within 120 days. Thus, for categories D, P and all outpatient activities possibly deferred due to the emergency from COVID-19, it is required that all general prevention measures are guaranteed, with specific attention towards:

• Preferring virtual management of booking and payments, including access to waiting rooms;
• Preferring virtual service delivery systems (telemedicine, video call, video conference) when possible
• Reorganizing logistics and organizational flows to avoid overcrowding within facilities and to guarantee social distancing, for example by setting up dedicated routes, extending opening hours.
• Detecting body temperature and respiratory symptoms for all those entering the facilities;
• Maintaining hand hygiene (providing gel dispensers instructions for correct hand washing) and monitoring of the correct use of compulsory PPE;
• Activating protection measures for staff and for the most vulnerable patients, for example creating separate paths for cancer, transplant, immunosuppressed, paediatric and geriatric patients;
• Providing effective protocols for the sanitation of rooms, with particular attention to the frequent and adequate ventilation of rooms;
• Conducting surveillance and on-site visits to make sure that safety conditions are being maintained, on behalf of Infection Control Committees or Risk Management Units.
• Training staff adequately and promoting informative systems for users.

The Ministry of Health and Regions have agreed to scale-up GPs and paediatricians’ diagnostic possibilities, following the 2020 Budget Law that allocated EUR 235 million for this purpose. With the needs of non-Covid-19 patients (especially chronic patients and cancer patients) in mind, the Head of the Department of Civil Protection has been requested to purchase additional medical devices for primary care, including telecare, tele-health services, telemonitoring and tele-dermatology devices that will be distributed by Regions through specific agreements, to prepare for future containment measures. Consequently, doctors will have to be specially trained for their usage and will receive a ‘certification’ for acquired skills.  Management costs will be borne by physicians themselves who are not allowed to use the technology for freelance activity.

Inpatient care
During Phase 1, most regions defined their own plan for the re-organization of hospital care. In fact, in almost all Italian regions ICU bed capacity was increased by over 50%, exceeding the amount suggested by the Ministry of Health.

During the first week of Phase 2, however, it was shown that as of 8th May 2020, only two regions out of 20 (Tuscany and Emilia Romagna) started planning and remodelling the hospital network for the new phase. In this period, with the combination of an overall increase in number of beds and a reduction of patients requiring IC, indicators measuring bed capacity saturation showed that the situation is currently sustainable, with a national average of 11.79%.

By 26th May 2020, the organization of hospital care was showing a very heterogeneous behaviour among Italy’s regions, however none of them had issued specific resolutions or acts relating to the reorganization of hospital care for phase 2. Only 9 regions defined Covid-19 hospital networks, albeit with different levels of detail and, by 11th June 2020, the number rose to 10 out of 20.

By July 8th 2020, 13 regions had reorganized their hospital network. Throughout the country, the management of inpatient stay for Covid-19 was mainly organized by setting-up Covid-19 hospitals, as shown in Marche, Umbria, Abruzzo, Sicily, Basilicata and Sardinia; Lombardy, Liguria, Veneto and Tuscany have preferred a network model, whereas Lazio, Emilia-Romagna (only for IC), Puglia and Calabria are oriented towards a Hub and Spoke system.

Regarding delivered services, Phase 1 was characterized by the high volume of hospitalizations for Covid-19 and the saturation of ICUs, as well as by a decrease in the number of hospitalizations for non-Covid causes. Comparing volumes of interventions in 2019 and in 2020, significant reductions of procedures with greater impact on intensive care have emerged. For example, since the end of February, the number of hospitalizations for acute coronary syndrome diminished, with repercussions on the number of percutaneous transluminal coronary angioplasties (PTCAs) performed. At a national level it appears that there have been impacts on timeliness and accessibility to hospitalization even for acute events like Acute Myocardial Infarction with repercussions in terms of mortality and time-to-care. Furthermore, it was also shown that cardiologic Hub&Spoke models have allowed to contain the impact of Covid-19 on clinical outcomes with a crucial role played by the re-definition of patient pathways.

As for gastroenterology divisions, an ALTEMS report shows that, at a national level, only 2.5% did not vary their activity volume during the emergency. Centers carrying out endoscopic practices suspended services in 3.8% of cases, while 66.7% recorded a 60% decrease in volumes. The variation, however, was lower for emergency procedures.

The "Guidelines for the reorganization of deferrable elective activity during the COVID-19 emergency” suggest the same progressive approach as for outpatient services (see paragraph above) for elective hospitalizations belonging to classes B, C and D. For such services, however, the Ministry of Health advises to base the reprogramming also on risk-benefit evaluations in relation to the clinical status of individual patients.

Alongside elective procedures, specific safety measures must be guaranteed:

• Prior to their hospitalization, patients must be systematically screened (i.e. SARS-CoV2 virus swab, X-ray or chest ultrasounds, chest CTs). In case of suspected or confirmed positivity, patients will undergo a re-evaluation of eligibility to hospitalization/surgery. Should such service be postponed, all risk-containing preventive measures are to be activated. Patients treated in a different region from their residency should, in fact, carry out the pre-hospitalization screening in their region of provenance.
• Prior to hospital admission, body temperature must be taken and respiratory symptoms checked. Patients with a temperature above 37.5 ° C or with respiratory symptoms will undergo a re-evaluation of eligibility to hospitalization/surgery.

Furthermore, patients are recommended to minimize all social interactions or even isolate at home in the two weeks prior to hospitalization.

Special Units for Continuity of Care
By June 9th, special units for continuity of care (USCAs), which provide care for patients who do not need hospitalization, reached coverage of 47% of the population, with an increase mainly due to the progressive activation of more USCAs Marche, Sicily, Liguria, Sardinia Campania and Puglia. The highest coverage rates belong to Valle d’Aosta and Emilia Romagna while in Campania (South), Lombardy and Lazio continue to experience the lowest coverage rates in the country.

Intermediate care
Intermediate care responds to the health needs of patients who require nursing assistance and monitoring with low amount of medical attention. In response to this, regions have been adopting several approaches. Almost all regions (85%) have made available some of their existing nursing homes, health and social care facilities exclusively to Covid-19 patients. During the months of the epidemic, though, more and more regions followed the Northern example and converted hotels or community hospitals to deliver intermediate intensity care. At 8th May, these facilities are found in Lombardy, Veneto, Trentino-Alto-Adige, Liguria, Piedmont, Emilia Romagna, Tuscany, Marche, Umbria, Lazio, Abruzzo, and Molise.  
Overall, each region has chosen their own ratio to balance intermediate care services and home care, however Tuscany, Veneto, Lazio, Emilia Romagna Marche and Lombardy seem to be the most dedicated to managing their services at a territorial level, whereas Calabria, Sicily and Friuli Venezia Giulia are at the opposite end.

Digital solutions
From 1st March to 8th of May 2020, Italy witnessed the launch of a total of 108 initiatives to enhance the delivery of services through digital technology, rising to 149 by May 26th and to 174 by June 11th. Of these, 50 are Covid-specific, whereas the others are dedicated to diabetology, cardiology, general medicine, oncology, neurology and psychology and the latest aim to respond to health needs that are not Covid-19 related. At 11th June 2020, such services resort to phone calls (20%) or video calls (29%), with the possibility of exchanging documents by e-mail or through instant messaging platforms. Some of these are Apps that have been specifically designed for teleconsultations and monitoring (13%) and some web platforms allow access collaboration between multiple operators (38%). The services mostly provided by using digital solutions are medical examinations (47%) and monitoring of some vital parameters (33%), followed by counselling (8%). Also included are assistance to nursing homes, and contacts with family members. The aforementioned web platforms are mostly used for Covid-19 and cardiology patients. Diabetic patients, on the other hand, are usually assisted through telephone contact and web video-calls. Telephone contacts are frequently used by GPs while oncologic doctors and dermatologists have reported to resort to web platforms.

In June 2020, the Ministry provided the “Guidelines for the progressive reactivation of elective activities considered deferrable during the COVID-19 emergency” in which it recommends the switch to remote assistance methods (teleconsultations, telemedicine) whenever possible, precisely referring to check-ups and updates of treatment plans). It also advises to favour remote methods for booking and payments such as phone calls or online transactions. 

By 26th May 2020, four Italian regions (out of 20) - Emilia Romagna, Lombardy, Tuscany and Veneto – plus the Autonomous Province of Trento had already formally enabled provision of health services through telemedicine by issuing regional resolutions. Initiatives to formalise the delivery of services via telemedicine within the National Health Service are, in fact, a competence of regions as defined by the National Guidelines defined by the Ministry of Health in 2014.

A report by ALTEMS shows that, by 3rd September, the number of regions that released resolutions to define the implementation of telemedicine within their health systems rose to 10 plus two autonomous provinces. Whereas some have defined general organizational plans, others have defined instructions for specific health problems such as diabetes or autism in Abruzzo (April); targeted specific categories of the population, such as Lazio with paediatric patients (June/July). Lombardy (May/August) and Piedmont (July) have established which precise services are deliverable at a distance. Seven have defined specific tariffs (Tuscany and the Province of Trento in April; Veneto in May; Lazio and the Province of Bolzan in June and Sardinia in August).

Governmental guidelines  and support regarding the use of Telemedicine

On 14th April, the ISS released a set of guidelines in the report “Temporary indications for telemedicine assistance during the COVID-19 health emergency” valid at national level.
Since the beginning of the emergency, the National Center for Telemedicine and New Assistive Technologies of the National Health Institute, has been collaborating with local bodies around Italy to support the realization of practical solutions for home assistance via telemedicine, that are rapidly applicable for those in isolation in order to proactively monitor their health conditions, in relation both to the prevention and treatment of COVID-19 and grant the continuity of care that may be necessary to accompany also other health issues.

The ISS’s recommendations point out that, as at the time being there is little experience in the field, it is not advisable to resort to telemedicine services with:

● Unknown patients who manifest altered state of consciousness, dyspnea at rest and low values of systolic pressure;
● Patients with acute pathologies or exacerbations of chronic pathologies, even if in isolation;
● Frail or chronic patients for whom home stay would not constitute a safe choice in the presence of COVID-19 symptoms.

However, the final evaluation of suitability for each patient is still up to the attending physician. Additionally, in a parliamentary hearing of 10th June 2020, the Minister of Health stressed the need to invest in AI, digitization also to connect research institutions and territorial healthcare facilities to other centers located in other parts of the country and the world.

It was also mentioned that a study carried out by the Digital Innovation Observatory in Health showed that most citizens use at least one online service and high approval and adherence of citizens to the digitalized medical prescription that was introduced during the Covid emergency.

The March call for proposals on behalf of the Ministry for Technological Innovation and Digitization:
On March 31st 2020, the Ministry for Technological Innovation and Digitization set up a Working Group divided into the following subgroups:

1. General coordination of activities;
2. Infrastructure and data collection;
3. Economic impact;
4. Web data and socio-economic impact;
5. Medical tele-assistance
6. Technologies for emergency management;
7. Big data & AI for policies;
8. Legal profiles of data management related to the emergency.

In particular, Subgroups 5 and 6 dealt with evaluating the proposals and technological solutions presented to the "Fast Call for technologies to combat the spread of Covid-19" launched from 24th to 26th March and promoted together with the Ministry of Economic Development, the Ministry of University and Research and the Ministry of Health. The aim was to identify the best apps and technical remote assistance solutions for patients at home, both for diseases related to COVID-19, and for others, including chronic ones. The proposals had to be available already usable and available on the market.  The selection gave priority to solutions focused on active surveillance of patients in home isolation for Covid-19, to aid the delivery of home assistance services.

The call for proposals led to a total of 504 technological solutions from which five were extracted and selected for their technical characteristics, methodology of identification and authentication of patients and citizens and for the time necessary for their implementation. The 5 solutions found, detailed in the section “How are digital tools being used for isolation and quarantine?” are: LazioDrCovid, Co4Covid-19, Smart Axistance Covid-19 Control, Ticuro Reply and eLifeCare Covid-19.

Mental Health
The Italian Society of Psychiatry has estimated that an extra 300,000 patients are suffering from post-traumatic stress linked to losing their beloved ones, financial damage and uncertainty about the future. Thus, as these individuals are likely to develop psychological issues, they will need access to mental health services. A study conducted by the Universitat Oberta de Catalunya confirmed the relevance of such concern as 42% of Italians are at risk of developing mental health issues because of the pandemic. Up to 59% of the population has experienced feelings of stress, anxiety or depression during the lockdown.

Pediatric Patients
The Pediatric Units of Fondazione Policlinico Universitario A. Gemelli – IRCCS, a tertiary care centre in Rome, has designed a remote assistance program dedicated to families who have children with complex pathologies and disabilities who have not been able to access health services and have been kept at a distance from healthcare facilities during the emergency. The project is developed on several levels of care and is called "Contactless: no place is far". Assistance will be provided with intervention methods such as structured video conferences, training of caregivers through special tutorials and psychological support for both children and their families.

Vaccination Services
Public health measures that have required people to stay at home, except for reasons of health, work or urgent needs, have led some people to decide to postpone scheduled vaccinations for themselves or their children. In addition, the need to reorganize health services to increase the availability of dedicated personnel to deal with the emergency had an impact on the regular performance of vaccination activities.

The Ministry Of Health published the results of a survey the showed that almost all of the Local Health Authorities (94/97 = 96.9%) had a decrease in vaccinations during the COVID-19 emergency, compared to the corresponding period of the previous year. Furthermore, at national level more than 33% of the health personnel (doctors, nurses, health assistants, administrative staff), have been reallocated to COVID19 related activities (especially contact tracing). About 5.5% of the staff working in the vaccination centres contracted the SARS-CoV-2 infection.

Different organizational methods have been adopted for maintain vaccinations during the COVID-19 emergency, consisting, more frequently, in carrying out vaccination by reservation only, assigning priority to some vaccines / subjects (primary cycles (<1 year) and vaccinations of pregnant women, people at risk, and vaccinations in case of emergencies, such as trauma, bites, etc.) and extending the vaccination time to avoid overcrowding. Concerning age groups, the most affected by the reduction in vaccinations were children aged over 1 year, adolescents and adults; HPV, Herpes Zoster, DTPa and Meningococcal B, IPV and MPR are the most affected vaccinations.

Following this analysis, the Ministry Of Health provided a series of general recommendations to restore services, strengthen communication, recover the immune gaps and expand routine vaccination services to reach the unvaccinated. The Ministry encourages the activation of a local task force led by the department of prevention aimed to cooperate with all the figures that could help to fill the gap, in particular General Practitioners and Paediatricians, Occupational Physicians and schools and to identify all possible solutions to expand vaccination services and supply. 
In this context, most of the Local Health Authorities s have organized (or are going to organize) mass vaccination campaigns using large buildings (such as sports halls) or innovative ways, such as Drive-Through Vaccination Clinics.

- Law Decree 19th May 2020, n. 34  - Urgent measures in the field of health, support for work and the economy, as well as social policies connected to the epidemiological emergency caused by COVID-19. [Available at https://www.gazzettaufficiale.it/eli/id/2020/05/19/20G00052/sg]
- Amendments to Law Decree 19th May 2020, n. 34 of 28th June – [Available at http://www.quotidianosanita.it/allegati/allegato8651425.pdf]
- https://www.adnkronos.com/fatti/cronaca/2020/09/09/vaccino-astrazeneca-sospende-test-reazione-anomala_p6S4kDrmy7iFwCdUpSAx2J.html
- https://www.adnkronos.com/fatti/esteri/2020/09/12/vaccino-covid-riparte-test-astrazeneca-oxford_98kvqRSD85ND1kXPfMDzXK.html 
- https://www.google.it/amp/www.strettoweb.com/2020/11/vaccino-coronavirus-astrazeneca-marzo-2021-costo-dosi-dettagli/1082835/amp/
- http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=89880
- Ministry of Health. (2020). Covid-19, approvate dal Parlamento le linee guida del piano strategico sui vaccini anti-Covid. [Avalialble at: shorturl.at/cPW26]
- https://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=91256
- http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=92606
- https://www.sanita24.ilsole24ore.com/art/europa-e-mondo/2021-02-15/giornata-contro-cancro-infantile-primo-report-impatto-pandemia-102217.php?uuid=ADs0y3JB
- http://www.salute.gov.it/portale/nuovocoronavirus/dettaglioContenutiNuovoCoronavirus.jsp?lingua=italiano&id=5452&area=nuovoCoronavirus&menu=vuoto
- https://www.corriere.it/cronache/21_febbraio_17/coronavirus-piano-draghi-vaccini-produzione-anche-italia-protezione-civile-3c2b859a-7138-11eb-b26f-1b97a5632ac6.shtml
- https://www.difesa.it/Primo_Piano/Pagine/Il-Ministro-Guerini-al-Presidio-vaccinale-anticovid-alla-Cecchignola-Roma.aspx
- https://www.government.nl/latest/news/2020/06/03/france-germany-italy-and-the-netherlands-working-together-to-find-a-vaccine-for-countries-in-europe-and-beyond
- http://www.salute.gov.it/portale/ministro/p4_5_2_4_2.jsp?lingua=italiano&menu=uffCentrali&label=uffCentrali&id=1360
- https://lab24.ilsole24ore.com/numeri-vaccini-italia-mondo/

Rather than specifying which services must be maintained during the outbreak, national and regional policies identify those activities that can be suspended or simply transferred to other entities or organizational units. National policy eased requirements for pharmaceutical prescriptions so that it is not required to physically hand in prescriptions to receive medical therapies (see also Section 1.3).

Decisions about the re-organization of services are taken at regional and local level. In some hospitals, especially in the areas with the highest number of cases, beds have been re-purposed in order to increase the capacity of units dealing with COVID-19. This included the closure of some wards and the suspension of non-urgent elective cases. For example, the regional policy of Piedmont requires the suspension of all surgical activities except for urgent cases, for life-threatening conditions or for oncological diseases.

Civil protection personnel, municipality employees and volunteers, and a number of NGOs work to support vulnerable people at home and in long-term care facilities. Despite major efforts, however, fatality rates for the most vulnerable segments of society appear particularly high.
We are not aware of any explicit national policy to expand access to mental health services as a result of the outbreak. However, it is reported that mental care services are under increased pressure to manage the worsening conditions of some patients and to take care of new cases probably attributable to the outbreak. These services are also requested to support health professionals who are under increasing psychological stress.

Protecting pregnant women, newborns and the elderly:

On 31st March, the Ministry of Health released recommendations regarding childbirth, women in labour and new mothers. Childbirth clinical pathways are to remain in function, with the obligation to adopt all safety measures, however all check-ups that are deferable must be postponed. All women showing symptoms, or likeliness, of acute respiratory syndrome or infection, must be tested for Covid-19 and, while awaiting for the result, must stay in dedicated pre-triage rooms within the Obstetric Emergency Room, for precautionary isolation. Those who then result positive must be transferred to specific hubs, known as “Birth Points” of the Maternal and Neonatal Network identified by each region. Transport will be responsibility of the sender.

Particular attention is given to nursing homes for the elderly in which mortality rates have reached 9.7% nationwide, with significant variations across regions (from 5% in Emilia Romagna to 19.2% in Lombardy, for example). Compared to other countries, Italian nursing homes are in fact more similar to long term care facilities with demanding healthcare needs as they are limited to the frailest: 75% of residents over 80 and mostly severely functionally impaired.
On 14th April, the ISS released a survey conducted in State-owned elderly homes managed by regional authorities. In Italy there are more than 4,500 elderly homes, mostly located in the northern regions of which 1,083 - with about 80,000 residents - participated to this survey. The report highlighted that in such centres, since February 2020 a total of 6,773 residents have died and 40.2% were either Covid-19 positive patients or presented flu-like symptoms compatible with Covid-19, but were never tested. In some regions, such as Lombardy and Emilia Romagna, the percentage of deceased patients (Covid-19 positive or with compatible symptoms) reached respectively 53.4% and 57.7% of the total.
In light of this, on 18th April, the ISS released a guide for the prevention and control of Covid-19 infection within nursing homes, specifying organizational and structural requirements aimed at avoiding catching the virus, managing positive cases and guaranteeing an effective flow of information with Local Health Units and families. Among these, for example, family members and people with symptoms are not allowed to visit for the entire duration of the emergency; new residents can be authorized to move in after being tested for Covid-19 and must be placed in a dedicated area, isolated from other residents. Furthermore, nursing homes are recommended to avoid sending their residents to hospitals for diagnostic tests and medical visits. Group activities and the use of shared spaces are to be suspended; all staff, suppliers and maintenance workers must be properly equipped with PPE. As soon as a resident shows signs of a likely infection s/he must be isolated and tested immediately. If positive, they must be kept in isolation when structurally possible and, otherwise, transferred to an appropriately equipped facility. Special Units for Continuity of Care (for further information please see paragraph 3.2) are responsible for guaranteeing continuous communication with infectious disease specialists and protocols to be followed will be those emitted by the Directorates of each facility. Nursing homes with suspected or ascertained Covid-19 cases (even those awaiting transfer), must provide medical and nursing support 24 hours per day.
- Sources: Ministry of Health, 31st March 2020. Circular N° 0011257 http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=73787&parte=1%20&serie=null
- Arlotti M, Ranci C. Un’emergenza nell’emergenza. Cosa è accaduto alle case di riposo del nostro paese?. Covid-19 Review n° 29 – 13th March 2020, Banchieri, Vannucci
- ISS, Indicazioni ad interim per la prevenzione e il controllo dell’infezione da SARS-COV-2
- in strutture residenziali sociosanitarie, Rapporto ISS COVID-19  n. 4/2020 Rev, 17th April 2020 [available at http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=73875&parte=1%20&serie=null]
- https://www.epicentro.iss.it/coronavirus/pdf/sars-cov-2-survey-rsa-rapporto-3.pdf