Establishing Ortho and Cardiology Ambulatory Surgical Centres in Europe

Expected Impact:

The action under this topic is expected to achieve the following impacts:

1. Contribute to IHI JU SRIA objectives, driving cross-sectoral health innovation for a competitive European health industry;
2. Infrastructure funding initiatives establishing ASCs in orthopaedics and cardiology;
3. New long term healthcare strategy, planning and funding in HCP recruitment and training as well as digital solutions and medical technology for efficient ASC services;
4. Implementing new payment systems (coding and reimbursement) allowing for patient referral to ASC based on medical and clinical decisions and provider capacity, rather than on payment system;
5. Establishment of a sustainable network of ASCs followed by the creation of national and regional ASCs associations;
6. Regulation and accreditation of ASC facilities;
7. Comprehensive and interoperable digital solutions supporting people-centred care, disclosing entire patient treatment pathways and experiences including points of access for patients;
8. Treatment database/registry as a source of evidence enabling research, decision making, further development and improvement of ASCs.

The action will also support the EU political priority to boost European competitiveness and contribute to a number of European policies/initiatives, which include the European Commission’s European Health Data Space Regulation (EHDS)¹ and the EU Artificial Intelligence Act².

¹ _{https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500327}

²_{https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689}

Expected Outcome:

With advances in clinical and surgical techniques, medical technology, pain management as well as pre- and post-surgical care, more procedures that have been traditionally performed in hospital settings can now be performed in facilities outside hospitals with no overnight stays required, easing the demand on overstretched hospitals and reducing hospital acquired infections. These facilities are referred to as ambulatory surgical centres (ASCs).

The actions under this topic contribute to all the following outcomes:

1. consensus-based understanding on the hurdles, needs and requirements to establish ASCs within a European healthcare setting with a regional/national expert committee driving the community involved and acting as reference opinion leaders;
2. comprehensive framework and ‘know how’ for establishing ASC facilities with details on infrastructure, medical technology, protocols and healthcare resources required for establishing new facilities;
3. training schemes and programmes including care pathways and enhanced recovery protocols for all health care providers (HCPs) involved in ASCs in orthopaedics and cardiology, operating safe scalable models that achieve high quality results;
4. creation of a clinical database and generation of economical evidence forming a basis towards European acceptance, standardisation and funding allowing establishment of ASC services as an integrated part of healthcare services provided;
5. the availability of an interoperable IT technology solution required to integrate clinical data from multiple stages of the patient journey and the related digital health solutions for patient preparation, post-discharge management and home monitoring.

Target group for the outcomes are:

• hospital managers, healthcare system providers, medical technologies and digital companies seeking solutions in European, national and regional healthcare services, to address capacity and efficiency hurdles in hospitals in the fields of orthopaedics and cardiology;
• HCPs establishing ASCs in orthopaedics and cardiology to further provide and advance healthcare services and efficiency;
• patient groups and carer associations working towards patient access to more convenient locations, shorter waiting times and easier scheduling (relative to hospital inpatient and outpatient procedures). This will improve patient experience, satisfaction and outcomes from pre-procedure to recovery at home;
• HCPs and researchers working on incorporating advanced medical technology in and out of hospital settings for improved patient outcomes and healthcare efficiency;
• reimbursement bodies as well as HTA bodies providing guidelines and innovative payment schemes.

Scope:

The EU’s ageing population and a rising burden of diseases and disorders, in particular noncommunicable diseases (such as cardiometabolic diseases, cancers, neurodegenerative or musculoskeletal disorders), have resulted in increasing health care costs and limited procedural capacity in operating rooms and cath labs (catheterisation laboratory). Lack of specialists is also an issue. This delays patient access to health care and increases the need for alternative and more cost-effective forms of care [5]. The shift of inpatient surgeries and treatments to ambulatory surgical centres (ASCs) could potentially provide a solution to the hospital capacity problem as well as reducing hospital acquired complications and providing improved access to healthcare services for patients in rural areas. ASCs are healthcare facilities focused on providing same-day surgical care, including diagnostic and preventative procedures for patients who do not require overnight stays. It is believed that ASCs can transform the outpatient experience for patients by providing them with a more convenient alternative to hospital-based outpatient procedures. ASCs can be operated by private or public healthcare services.

Numerous factors influence whether surgical procedures can be carried out within ambulatory surgical centres. The key drivers are changes and further development in clinical practice and medical technology. The action funded under this topic will be focused on ASCs specialised in orthopaedics for knee and hip joint replacement surgery as well as ASCs specialised in cardiology for cardiac ablation procedures and elective rhythmology. All of these procedures are elective and will increase in the next years due to the ageing population, improved diagnostics and extension of medical guidelines. Based on patient selection, these procedures have been proven suitable for ambulatory settings. This is reinforced by the downward trend in length of stay in hospitals for these procedures in recent years. This also reflects developments in medical technology in these procedures over the last years, that have led to more precise, faster, easier, gentler and more patient-specific interventions. Shifting those procedures from hospitals into ASCs can help to relieve inpatient capacities, enabling faster patient access to those surgeries and in the end reducing overall health care costs. It is important to stress that treatment in ASCs requires good patient selection prior to the surgery based on medical classifications – like the American Society of Anaesthesiologists’ risk classification for estimating the perioperative risk – and social factors, such as the individual domestic situation of the patient, to make the intervention in ASC successful. Severe and complicated cases will still have to be treated in hospitals.

ASCs offer a lot of benefits to the health care system and can address some problems associated with inpatient treatments in hospitals. Studies show that outpatient procedures are safe and can achieve similar or superior functional outcomes compared to inpatient procedures and, for example, the early mobilisation facilitated by outpatient pathway in hip and knee replacement surgeries contributes to faster recovery timelines [1] [2].

Due to the fact that the costly infrastructure of the hospital is not needed, and patients go home the same day after an outpatient procedure, the shift of procedures into the outpatient setting results in significant cost savings (an outpatient total shoulder arthroplasty (TSA) results in a 40% decrease in charges [3] and unicompartmental knee replacement (UKR) saving up to roughly EUR 18 000 [USD 20 500] per patient [4]). Enhanced healthcare resource utilisation and reduced patient waiting times are additional benefits. Additionally, there are also some patient-related benefits of outpatient procedures. It is proven that patients benefit from recovering in familiar home setting, with various technologies to help monitor their recovery and provide them with access to HCPs. This reduces anxiety [1] and leads to earlier mobility, thus a faster recovery time and a quicker return to daily activities. Overall, this enhances patient satisfaction [1] [2]. On top of that, ASCs decrease the risk of nosocomial infections with the reduced exposure to hospitals environment.

Effective implementation of ASCs faces multiple hurdles including:

1. reimbursement models: lack of reimbursement and funding procedures, limiting financial incentives to move procedures from in-hospital to ASCs;
2. stakeholder acceptance: non-clinical decision-makers are not fully comfortable with ASC as a part of the solution to the capacity and demand problem;
3. evidence: lack/limitation of safety and quality data measuring performance and outcomes;
4. human resource readiness: HCPs are not trained to perform in ASCs and run them efficiently;
5. digital infrastructure: data privacy hurdles, interoperability, digital exclusions;
6. protocols: lack of standardised care models across different therapies. Limited implementation of patient-centred evidence-based approaches for quicker and improved recoveries – enhanced recovery programmes;
7. patient readiness: patient expectations and previous experiences making them unwilling to accept procedures in ASCs;
8. home recovery and care system: lack of integration of ASCs with the broader healthcare systems.

Applicants should envisage the following activities as part of the action funded under this topic:

• Establish a multistakeholder advisory board leading and advocating for change in national and regional healthcare services. The advisory board will quantify the requirements for establishing ASCs in orthopaedics and cardiology including different financial and resource models, training modules, reimbursement pathways, digital health solutions for patient preparation and post-discharge management, registry databases as well as clinical and economical end points required for studies and reimbursement pathways;
• Demonstrate the safety of targeted procedures for patients performed in ASC facilities through the conduct of two medical cohort studies: one in orthopaedic joint replacement and another in cardiology cardiac ablation. These studies will assess the risks, patient medical eligibility complications, and patient outcomes of ASCs in comparison to hospital-based procedures;
• Generate and share protocols and best practices across multiple centres in same country and beyond borders, including a strategy for contextual adaptation for ASC scalability across Europe;
• Create a network of selected ASCs, with successful ASCs leading in sharing best practice, protocols, trainings, and efficiency models;
• Collect real world evidence (RWE) to demonstrate and model the cost-effectiveness of ASCs vs hospital-based procedures. The study should be multicentre and will establish a registry database answering proposed research questions;
• Develop a shared framework for clinical data interoperability, and combine an interoperable IT technology solution to integrate clinical data collected at multiple stages of the patient journey with the related digital health solutions that are used for patient preparation, post-discharge management and home monitoring. Adequate consideration should be given to relevant ethical and privacy aspects.
• Provide a sustainability strategy for the maintenance, update, and validation of the project’s results beyond the project duration.

Applicants should consider learnings and synergies with relevant initiatives at national and European level to maximise the potential impact of the future project.