The end of assumption of approval! - Federal Social Court of Germany backpedals at patients’ expense
The right of patients

Part of the legislator’s intention behind the Patient Rights Act at the beginning of 2013 was the noble objective of compelling statutory health insurance providers to make decisions more quickly. Since then, they must take decisions on applications within 3 weeks or 5 weeks (after obtaining an expert report). If this deadline is missed, the so-called “assumption of approval” comes into effect. The service is then deemed to have been approved as applied for.

A comparable arrangement was adopted for all rehabilitation insurers in the Federal Participation Act (BTHG) as well as in volume nine of the German Social Security Code (SGB IX), the law on rehabilitation and participation of people with disabilities.

prompt care of children

Particularly where children and adolescents are involved, the time that elapses between application for a technical aid and its delivery is extremely important. Children and adolescents are still growing, continuing their development, and therefore require prompt provision for each one’s specific needs appropriate for their age.

What has happened now?

For years, the Federal Social Court of Germany (BSG) has acknowledged this to the benefit of the patient, regardless of whether or not patients have procured the service applied for, e.g. the required technical aid, themselves or the statutory health insurance providers had to be obligated to provide the benefit in kind.

Unnecessarily, and at the expense of patients, the BSG abandoned this positive jurisdiction in its rulings on 26.05.2020 (B 1 KR 9/18 R) and 18.06.2020 (B3 KR 13/19 R). The assumption of approval now only creates a provisional legal position. In simplified terms, this means the patients’ option of procuring the required aid themselves ends as soon as the statutory health insurance provider makes a decision, even if the deadline has passed.

Rapid independent procurement at own expense impossible for families

Jörg Hackstein, chairman of rehaKIND
Jörg Hackstein, chairman of rehaKIND

Based on the example of the provision of technical aids, lawyer Jörg Hackstein, chairman of rehaKIND, explains: “In order to use the assumption of approval, patients must now obtain a technical aid quickly at their own expense in the period between the expiry of the deadline and the belated decision of the statutory health insurance company, in other words, at their own risk and with up-front financing. The entitlement to benefits in kind, i.e. procurement by the patient and the insurance company must pay afterwards, no longer applies. In some cases, it takes a lengthy opposition and appeal procedure to establish whether the purchase was justified.

It can be assumed that only a few families will be willing and financially able to take on this financial risk. The BSG has thus significantly undermined patients’ rights. If the legislator continues to have an interest in strengthening patients' rights and in particular in quick decisions by the statutory health insurance providers, it must effectively sanction the funding agencies' non-adherence to decision deadlines to the benefit of patients and assure this above all for claims for benefits in kind. Very few patients can afford to obtain services themselves at their own risk.”

Jörg Hackstein, lawyer and specialist solicitor for procurement law

Here you can inform yourself about the marketplace Child and Youth Rehabilitation at REHAB:

Child and Youth Rehabilitation

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Inclusive education between light and shadow – the latest Bertelsmann study takes stock after ten years of inclusion

The implementation was discussed both euphorically and critically in public. Time to take stock and venture an outlook:

The Bertelsmann study published in June 2020 provides no evidence to back up claims that society perceives inclusion as failed. It is true, however, that the growth of inclusion is only making sluggish headway.

Special schools remain: the number of pupils taught in schools for children with learning difficulties is constant nationwide but varies from one German state to another. The number of inclusive pupils is rising as more special educational needs are being identified. High-performing children tend to receive inclusive schooling, which depends on the need for support.

Assessments depend on personal experience

Inclusive lessons at general education schools

The majority of the population is in favour of inclusion, seeing it as promoting greater tolerance, greater social cohesion, and improved coexistence.

The opinion of parents is also good overall. Parents with experience of inclusion give a more positive assessment than those with no specific experience of it. The generally positive perception, however, depends on the nature of the special needs. Parents with experience of inclusion attest to a greater readiness for cooperation amongst teaching staff, better collaboration between parents and teachers, and a more positive relationship between teachers and pupils.

There are proven learning successes in inclusive lessons: more pupils pass the “Hauptschulabschluss” (basic secondary school qualification in Germany) in mainstream schools than those in special schools do. The alignment that inclusive pupils with special needs seek when learning amongst their peers with normal abilities has the effect of enhancing their performance. The motivation of some pupils with special needs, however, declines when faced with the performance of their classmates with unimpaired abilities.

Teaching staff are considerably more critical: all teachers want an additional colleague in inclusive lessons and the majority of them complain about inadequate know-how and missing equipment in schools. Teachers supervising inclusive classes are significantly more positive in their judgment than those without experience are.

According to the study, inclusion cannot be regarded as a failure – the general public and teachers have a mostly negative impression whereas the majority of parents and pupils with experience of inclusion are positive to very positive in their feedback.

Joint painting between inclusion students and normally enabled classmates

Germany is still a long way from reaching its objective: the existing shortage of qualified staff, particularly qualified special-needs teachers, psychologists, and teachers in all areas outside Germany’s upper secondary-school (“Gymnasium”) system, will continue to escalate. Some federal states are making progress with inclusion whereas others are choosing to backpedal. The latest forecasts for the individual German states therefore give grounds to expect stagnation in the implementation of collective learning until 2030.

Information about inclusive sports complex at REHAB can be found:

Inclusive sports complex

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Artificial intelligence in healthcare: Karlsruhe’s IT competence ensures safe applications
Artificial intelligence

AI-based assistance systems help early identification of illnesses, enable rapid analysis of large volumes of image and laboratory data, and offer the opportunity for individualised therapies.

Prof. Jörn Müller-Quade
Prof. Jörn Müller-Quade

Prof. Jörn Müller-Quade of the KIT Karlsruhe Institute of Technology addresses the issue of better healthcare with the aid of AI and the ensuing challenges for IT security: “Health records are a huge treasure trove that must be learned from ... this is important, particularly in these time of a global pandemic, in order to recognise patterns and develop strategies. The bigger the volumes of data are, the greater are the insights gained from them. The challenge is to use the confidential, personal data and at the same time evaluate it without infringing privacy.”

Due to interprofessional collaboration in medicine, therapy, and care along with the involvement of other players in the healthcare sector, many people require potential access to patients’ records. “This makes it difficult to protect sensitive heath data from unauthorised access”, says the Karlsruhe cryptographer. “Information technology is a facilitator, but only with a very strict rulebook and multiple levels of security for safe data transmission and access control.” The Federal Ministry of Health is currently preparing the foundations for the electronic prescription and electronic patient file (ePA), “but if the terminal devices, i.e. the PCs of chemists, health insurance companies, and medical professionals, are not secure, we will be faced with problems that could lead to data scandals”, says Müller-Quade, who heads the cryptography and security research group at the KIT and is the initiator of the KASTEL centre of competence for IT security.

Learning systems must be monitored by people

Sensitive Data

In addition to manufacturers’ liability, he also considers certification of AI systems and databases in medicine as well as the electronic patient file to be an essential requirement. “Health records must not be permitted to be used to the detriment of patients, for example where someone could be refused employment due to the disclosure of pre-existing medical conditions.”

The planned introduction of the ePA will give patients full control over their health records, which are then stored on their own PC as well. This makes it all the more important to adhere to the basic principles of IT security – to always use the latest operating system and secure passwords –, otherwise the PC can become an open gateway for intruders and reveal a patient’s medical history.

The computer scientist sees the use of constantly-learning AI systems whose software changes when operating without human surveillance as “a mixed blessing. The decisions taken by an AI system of this kind must always be checked for plausibility by the people performing the treatment. “Doctors must not apply the suggested result without reflection.”

Further information on AI in medicine can also be found in the following whitepaper with a cancer patient as an example:


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One year until REHAB - 21st European trade fair for rehabilitation, therapy, care and inclusion
REHAB 2019 Hall 1

One year before REHAB 2021 opens its gates, the effects of the COVID 19 pandemic affect the health and medical technology industry. In order to enable all market participants, exhibitors and visitors to be safe at REHAB 2021, concepts for the adequate implementation of safety measures and hygiene regulations are being providently prepared.

Approximately half of the available exhibition area has already been booked. Months in advance of the upcoming fair, numerous well-known manufacturers, dealers and service providers from Germany and other European countries have reserved their stands in Karlsruhe and thus in Baden-Württemberg, which is Germany’s leading state for medical technology. Returning exhibitors include industry giants such as Otto Bock HealthCare Deutschland GmbH, Paravan GmbH and the Danish company Alu Rehab ApS. Manufacturers of children’s wheelchairs such as Rehatec Dieter Frank GmbH, SORG Rollstuhltechnik GmbH + Co KG and Berollka-aktiv Rollstuhltechnik GmbH have likewise confirmed their intention to participate in REHAB, which is held every two years and is the most important platform for high-quality mobility aids and children’s aids from Germany and other European countries. “The high quality of this trade fair and its visitors convince manufacturers and retailers alike. In 2019, REHAB had approximately 18,500 visitors and 468 exhibitors on 40,000 square meters. We continue to place great importance on optimal distribution of exhibitors in the halls and on the fair’s unique atmosphere”, explains REHAB’s Project Manager Annika Gehrmeyer.

The proven concept of theme-oriented marketplaces such as “Mobility & Daily Living Aids”, “Child & Youth Rehabilitation” and “Cars & Traffic” will continue to structure the comprehensive range of products and services presented at the important trade fair and promote interdisciplinary sharing among experts from the care-giving sector, the health industry, people with disabilities and their carers. In addition to innovations in the assistive aids industry, REHAB provides information about new therapeutic options and offers a diverse supporting program with opportunities for further training, lectures and live demonstrations. A special area on the subject of ambient assisted living (AAL) presents technologies and digital assistance systems for independent living and living in the home and care environment. Interested companies can still book stand space at the early-bird rate until 30 June 2020. The Future Pavilion offers opportunities for start-ups and academic institutions to present their innovations, above all in the areas of digitization and robotics.

AAL, telemonitoring and digital consultation hours – how digitalisation is gathering pace in the industry
Instruction via video chat

Prohibited contact, infection risks, and inadequate protective equipment are a major obstacle to attending to patients’ needs in the current COVID-19 pandemic. Both the legislator and the professional associations are temporarily relaxing the conditions for digital consultation hours and care administered by service providers for the duration of the bans on contact.

What are the options?

The use of technical AAL (ambient assisted living) systems in the home environment and in care offers considerable potential for relieving some of the load on care staff and relatives and enabling those in need of assistance to retain as much independence as possible. The “Pflege-Cockpit” (“Care-Cockpit”) app of the Thomashilfen company, for example, provides the means for calling up information about bedridden patients. A decubitus guide-app for caregiving relatives can help with bedsore prevention whereas a patient’s own medication can be checked and controlled with the help of the PApp of RWTH Aachen.

Clinics, SPCs (sociopaediatric centres) and other medical facilities are currently upgrading their operations: general consultation, anamnesis, weekly progress meetings and interdisciplinary consultation hours are possible via telephone or video conference. Mobile monitoring devices and the digital patient file ensure the exchange of treatment documents, prescriptions, X-ray images and the like.

App-based exercise programmes with professional guidance make continuous training possible in the fields of ergotherapy, speech therapy, and rehab-sport: Thieme Tele Care, for example, offers sensor and app-controlled back-strengthening exercises for people with back problems. The Bauerfeind company uses a therapy app for customised exercises with the use of knee bandages. Many other apps in the health and therapy sector can also be found in the Rehadat database. Telephone contact with patients provides further support for therapy already underway.

Medical supply stores use digital platforms for documenting healthcare processes (e.g. BEB or ICF-CY Web app). Subsequent supply runs for consuming specific aids are currently possible without a signature after prescription by telephone as well. Telephone contact to customers or video conferences help to check supplies or to enable instructions to be given online. Apps also offer guidance and information on how to use various aids: they help diabetics, for example, to manage the data of their blood glucose meter or – like Ottobock’s Cockpit app – enable independent prosthetics adjustment. YouTube videos and livechats on how to use daily-living aids such as those by the company Saljol are also useful digital helpers.

Digital technologies are optimising the work processes in crafting too. In the form of 3D printing, digitalisation has arrived in assistive-device fabrication. Digital micromotion studies and scans serve as a basis for treatment.

The problems with data protection and the means for invoicing digitally rendered services have not been satisfactorily clarified yet.

Many service providers are walking the path nonetheless and are investing in the future. User-friendly communication systems, secure means of transmitting patient data, and reliable interfaces between the people involved are necessary parameters for acceptance and successful implementation.

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 Arrival of a new tool – the digital workshop for orthotics and prosthetics
Presentation of the digital workflows for Orthetik of the company Mecuris
Presentation of the digital workflows for Orthetik of the company Mecuris

Orthopaedic technicians are often inventors who want to be part of the development process and give the highest possible degree of personal attention to the customer’s needs: growing competition coupled with rising pressure from costs and constraints on time frequently make it difficult to assure this measure of individuality. At the same time, knowledgeable users insist on tailored solutions to suit their own tastes, no longer willing to hide his/her prosthesis from view, for example, and set on fostering a more self-confident relationship with their particular aid.

The fast-paced development in industrial 3D printing and digitalisation now offer new solutions that enable every orthopaedic technician to perform customised and yet digital fabrication. The Munich-based medical engineering company Mecuris, for example, presented a form of “digital workbench”, which meaningfully enhances the work of a technician. The intuitive design enables this digital tool to be used with no previous experience of 3D technology. To achieve this, Mecuris, as a service provider, translates the traditional orthopaedic craft into digital workflows and patient-specific products that can be manufactured using industrial 3D printing.

On its online platform, the company puts these workflows at the disposal of the technician so that he/she can configure customised orthotics and prosthetics. In doing so, the individual steps are kept as straightforward as possible and are partly automated in some areas. This platform is organised into two production units or workshops, one for orthotics and one for prosthetics.

In the orthotics workshop – new since April 2020 – a technician can use the digital procedures and tools according to his/her requirements either in partial steps or as a complete process. The latter ends with the production of a customised 3D-printed orthosis.

In the prosthetics workshop, on the other hand, workshops are available for creating patient-specific prosthetic feet and made-to-measure prosthetics covers.

The individual modules of the digital services – the software solutions, the printing operation, and the certified final products – are constantly being refined as well as adjusted to suit the changing market circumstances, such as the EU Medical Device Regulation.

Are you interested in the topic of orthopaedic aids? Then take a look at our topic area for this:

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EU postpones Medical Device Regulation (MDR)
European map with medical equipment

In April, the European Commission decided to postpone the entry into force of the Medical Device Regulation (MDR) by a year – initially until 26 May 2021. This decision serves the fight against the COVID-19 pandemic and is aimed at improving the availability of essential medical products in the EU.

The MDR’s goal is to assure the protection of consumers and patients. The regulation applies for all economic players and healthcare facilities throughout Europe and contains numerous obligations for all players manufacturing medical products, modifying them, making them available on the market, or using them in their business. In this way, many regulations already in existence are being further tightened or fine-tuned.

All requirements relating to the supply of aids in focus

This concerns not only manufacturers but also service providers such as medical supply stores. A present, it is still unclear whether or not transitional periods relating to the existing certification of products will be extended.

The so-called “designated bodies” are the mainstay of the new rigorous tests – only this select few are still permitted to perform certification in “on-site audits”: in view of the current safety measures and the applicable travel restrictions, it is not yet clear if and to what extent the designated bodies can issue the required certificates on time. In order to maintain the supply of medical products in Europe, professional and industry associations are therefore calling for the deferral of the transition periods and an extension of the periods for liquidation of current stocks.

Documentation, hygiene, results monitoring: strict requirements for all

The industry must continue to make preparations nonetheless: specialist retailers/medical product suppliers must fulfil comprehensive traceability and control obligations and cooperate more closely with manufacturers and preliminary suppliers. They must ensure, more than ever, that the manufacturers’ prescribed product-specific storage and transport conditions are adhered to.

The requirements for controls and storage have far-reaching effects on product management because, as is becoming clear during the COVID-19 pandemic, every supplier must always have an accurate overview of existing goods and their condition.

This creates the obligation to provide comprehensive documentation: detailed provisions on hygiene and preparation of the aids must be observed. Dealers, too, must gather, document, evaluate, and relay complaints from users and patients.

The German society for interprofessional aid supplies (DGIHV – Deutsche Gesellschaft für Interprofessionelle Hilfsmittelversorgung e.V.) has reworked all of the key rights and obligations arising for manufacturers and service providers from the EU-MDR into clearly-structured guidelines: www.dgihv.org/mdr/

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