Cost coverage for robot-assisted therapy in outpatient treatment in Germany

Claudia Müller-Eising and Alisa Berger address the problem of the costs for treatment with gait robots in outpatient facilities not being covered by statutory health insurance providers with reference to the Federal Joint Committee (G-BA). This contrasts with the desire to offer patients early, effective and high-frequency treatment. Possible solutions are presented.

Robotic systems have become indispensable in modern neurorehabilitation [14]. In particular, they enable severely affected patients to receive early, intensive motor training, which is not possible with conventional therapy methods [13]. According to Mehrholz et al., one in eight walking impairments after a stroke could be averted by robot-assisted gait therapy [7]. In contrast to inpatient care, therapies with robotic systems in the outpatient setting are not reimbursed by statutory health insurance providers. The reason usually given is that treatment with robotic systems is a new treatment method that has not yet been recognised by the Federal Joint Committee (G-BA), which is why the costs are not covered for legal reasons. The professional associations, liability insurers and private health insurance companies behave differently. Their insured persons receive treatment in outpatient facilities that work with modern robotic systems. To date, the statutory health insurance providers have not addressed the issue of robotics in neurorehabilitation.

This means that people with statutory health insurance are denied access to outpatient care with robotic systems. This article discusses the issue of whether on the basis of the current legal situation the G-BA is responsible for the use of robotic systems and whether a positive assessment is required as justification to compel the health insurance providers to cover the costs. At present, this issue is only relevant for the care of statutorily insured persons within the framework of the provision of therapeutic products, not within the framework of outpatient neurological rehabilitation. To date, this has only been envisaged for patients who have “independence in the area of self-care and active locomotion (in the general Barthel Index ≥ 80), a consistent ability and willingness to co-operate, the ability to act and learn, and sufficient orientation” (BAR framework recommendations, item 2.7 [1]). Moderately and severely affected patients (Barthel Index < 80), for whom treatment with robotic systems is of much greater relevance than for mildly affected patients, are excluded from services for outpatient neurological rehabilitation (BAR framework recommendations, item 5 [1]).

Robotic systems in neurorehabilitation

Damage to the brain or spinal cord is often accompanied by persistent motor impairment [15]. Gait and balance disorders as well as impaired arm and hand coordination are common symptoms of the damage [5, 6]. If left untreated, they prevent a self-determined life, occupational activity or social participation, and are often the cause of a long-term care dependency [4, 11, 16]. In neurorehabilitation, the relearning of lost motor functions is therefore of particular importance. While it was assumed until the middle of the last century that the central nervous system of an adult is not changeable in its functions and structures, it is now undisputed and proven by numerous findings on neuroplasticity that it can regenerate and restructure itself even in old age [8]. The degree of functional regeneration depends on the frequency and intensity of the use of neuronal resources [3].

Robotic systems are increasingly being used in neurorehabilitation to provide intensive and highly repetitive training for motor impairments. They enable early, intensive, variable, task-specific and multisensory training, which is essential for motor recovery and neuroplastic changes [3, 15].

This applies to inpatient, but particularly to outpatient neurorehabilitation, in order to prevent pathological patterns and chronification of the damage patterns. Although recent clinical studies have shown that functions can improve even after several years, there is a critical window of about six months after brain or spinal cord damage in which regeneration and reorganisation can optimally take place due to higher neuroplastic processes [9, 10]. Early and highly repetitive treatment using modern robotic systems is key for the outcomes of neurological patients.

While robotic systems in inpatient facilities are covered by statutory health insurance providers within the framework of the flat rate per case, they are regularly rejected in outpatient rehabilitation settings on the grounds that they are a new treatment method that the Federal Joint Committee (G-BA) has not yet recognised or for which it has not yet issued a positive assessment. Therefore, the costs are not covered by the collective body of the insured.

The G-BA is mandated and authorised to issue guidelines that specify the statutory criteria for the use and provision of healthcare services (Section 92 of Volume V of the German Social Security Code (SGB V)). Section 92(1) sentence 2, no. 5 of SGB V includes, in particular, guidelines for the introduction of new examination and treatment methods. What constitutes a new examination and treatment method has been defined by the highest court of the Federal Social Court (Bundessozialgericht (BSG)). According to established case law, a new method is “a medical procedure [...] if it is based on its own theoretical-scientific concept which distinguishes it from other procedures and which is intended to justify its systematic application in the treatment of certain diseases” (BSG, judgement of 23/07/1998, reference: B 1 KR 19/96 R).

These may only be provided in an outpatient neurorehabilitation setting under Section 135(1) of the SGB V at the expense of the statutory health insurance providers if the G-BA has issued a corresponding recommendation. In the case of outpatient rehabilitation, prohibition with reservation of permission applies; in the case of inpatient rehabilitation, permission with reservation of prohibition applies. With regard to treatments with robotic systems in an outpatient neurorehabilitation setting, it is therefore crucial to determine whether robot-assisted therapy is a new treatment method.

Robot-assisted therapy – a new treatment method?

In accordance with the case law of the Federal Social Court and in the opinion of the G-BA (https://www.g-ba.de/themen/methodenbewertung/, last accessed on 11 January 2023), a new method is a procedure for the examination or treatment of specific diseases or injuries that follows its own theoretical-scientific concept and differs from other methods. Robot-assisted therapy is not based on a separate theoretical-scientific treatment concept. Robotic systems support patients and therapists by providing the patient with a stable, physiologically correct movement sequence over a long period of time [12]. Beyond that, there is no clear demarcation from other methods. Instead, robotic systems are integrated into conventional treatment methods. Robot-assisted gait therapy uses the gait training treatment method, which has been recognised in science and as a billable service for years [2]. Therefore, robotic systems can only be as good as the therapeutic treatment concept on which they are based. It is not the robotic system but the therapeutic treatment concept that determines how a robotic system is used and which treatment goal is pursued. Their mode of action depends on the damage pattern, the symptoms and the dosage of the robot-assisted therapy (e.g. duration, intensity, frequency). Consequently, robot-assisted therapy is by definition not a new method. Instead, robotic systems are therapy systems if they are used to restore a function in rehabilitation or aids if they are used to compensate for functional deficits in everyday life without therapeutic intervention.

Therefore, robot-assisted therapy can be permissibly provided as a service within the framework of the provision of therapeutic products at the expense of the statutory health insurance providers. However, in practice, there is no market for this, as the reimbursement rates within the framework of prescriptions for therapeutic products for the use of robotic systems are not sufficient. In contrast to materials used in conventional therapy (e.g. treadmill, therapy couch, etc.), they are very cost-intensive to purchase and cannot be refinanced through the reimbursement rate.

What are the potential solutions?

The treatment of neurological patients is complex. In order to achieve the goals of rehabilitation – to avert, eliminate, alleviate, compensate for or prevent the worsening of disabilities or the need for long-term care, or to mitigate their consequences (Section 11(2) of SGB V) – it is essential to rethink neurorehabilitation formats in the healthcare system in order to be able to provide patients with damage to the brain or spinal cord with suitable therapies at an early stage and in a sustainable manner [16]. Access to appropriate treatments with modern robotic systems is undoubtedly a part of this.

On the one hand, prescriptions for therapeutic products could be extended by a reimbursement figure for treatment with robotic systems. Without question, different devices must be given due consideration. On the other hand, the legislator could extend the cases of private co-payments in the SGB V. To date, prescription co-payments have only been permitted in the cases expressly mentioned by law. Private co-payments for the use of therapy equipment are not included. This also applies to creative models, such as prescription billing for the therapeutic service and a private rental payment for use of the device. The co-payment system is not alien to SGB V. Private co-payments for special treatments have existed for a long time in dentistry, and it is also worth remembering the self-funding IGeL services (individual healthcare services). This solution is simple from a legislative perspective and can be implemented quickly. It is cost-neutral for health insurance providers and would give many patients access to up-to-date and high-quality treatment in an outpatient setting. It would also provide robust data in terms of patient care needs and outcomes, which are essential for appropriate care management.