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Pathways for digital solutions to enter the statutory (regulated) healthcare market

The statutory health insurance system, with more than 150 independent health insurers, is based upon the solidarity of the insured community. Each insured person pays a defined percentage (currently 15%) of their income for healthcare coverage. Beyond providing the foundation for the revenue side of health insurance financing, federal regulations also define the reimbursement of healthcare services for statutorily insured individuals. On one hand, these regulations are designed to ensure the quality of care. On the other hand, the regulations aim for efficiency and focusing on proven benefits in the interest of the community of insured individuals. Prior to being included in the remuneration scheme of the statutory health insurance system, medical services, devices, and other products are required to meet a number of requirements. First and foremost, safety must be assured. These safety aspects are predominantly covered in pharmaceutical law, medical device law, or in healthcare professional training law. In some cases, however, German social law imposes additional requirements.

Personal diagnostic or therapeutic services, are provided by healthcare professionals. These are natural persons with the appropriate training and skills, who have agreed to provide medical services under the regulatory and remuneration regime defined by the statutory health insurance system. In addition, there are medically prescribed or authorised services that cover therapies provided by nurses or therapists (e.g., physiotherapy, speech therapy, etc). Similarly, there are clear rules for the prescription of medication or medical support devices.

Prior to the passage of the 2019 Digital Healthcare Act (DVG), comprehensive coverage of digital products was virtually impossible. Only § 137f of the German Code of Social Law (SGB V), amended in May 2019, provided for digital applications as part of disease management programmes, but there was virtually no market access for digital solutions as therapeutic methods or medical aids. By virtue of selective contracts between individual statutory health insurers and providers of digital solutions, a very limited number of digital products, mainly focussing on prevention, were successful in entering the healthcare system.

While regulations on clinical trials, video consultations, and the electronic health card/telematics infrastructure also relate to eHealth, they do not cover remuneration of prescribed digital applications (see fig. 2).

Diagnostic and therapeutic services

Medical diagnostic and therapeutic services may only be provided by a person qualified to practise medicine in accordance with the generally recognised state of medical knowledge. They must, however, take medical progress into account (§ 2, Paragraph 1, Sentence 3 German Code of Social Law [SGB V]). Prior to reimbursement of new diagnostic or therapeutic method by statutory health insurers in the outpatient setting, the law requires the Federal Joint Committee to recommend the method’s use via its guidelines. This assessment must be based on a thorough evaluation procedure (§ 135 German Code of Social Law [SGB V]).

Fig. 2 Despite a multitude of potential pathways to market access, none proved viable for digital applications prior to passage of the Digital Healthcare Act (DVG)

According to decisions of the Federal Social Court, the use of new medical devices in the context of medical treatment may also constitute a new method if the treatment is essentially based on the use of the medical device and if new risks may arise for the patient (see Federal Social Court Judgment of 08.07.2015—B 3 KR 6/14 R, Federal Social Court 2015a and Federal Social Court Judgment of 08.07.2015—B 3 KR 5/14 R). This rationale could in theory be applied by the Federal Joint Committee to assess DiGA. However, the financial hurdles and time requirements associated with a full-blown methodological assessment proved practically prohibitive for innovative digital products. Hence, to-date the Federal Joint Committee has not approved any digital tools.

Federal lawmakers have therefore decided to take a different approach for low-risk digital medical devices: within the framework of the accelerated Fast-Track testing procedure at the Federal Institute for Drugs and Medical Devices (BfArM), such medical devices can become eligible for reimbursement within the statutory insurance system without completing a full-blown methodological assessment by the Federal Joint Committee.

Based on this approach, reimbursement is now possible in a digital product’s trial phase, allowing the manufacturer to generate evidence while being reimbursed. The trial phase is intended to last one year, however it can, under certain circumstances, be prolonged by an additional 12 months. Final inclusion in a list of reimbursed DiGA by the BfArM is possible only if sufficient evidence is available to demonstrate positive care effects, as required by manufacturers for approval by the BfArM (DiGA-Regulation). The Federal Joint Committee has virtually no say in this matter. It is instead left with the rather theoretical possibility to exclude an individual DiGA based on negative results from a methodological assessment procedure (§ 33a para. 4, German Code of Social Law [SGB V]).

If the use of a method is not excluded, the question remains: under what conditions would a prescription be possible and how might manufacturer reimbursement be realised?

Medical aids, therapeutic methods provided by non-physicianss (e.g., physiotherapy, speech therapy), medicinal products, and DiGA—What is what?

Before DiGA found their way into the German Code of Social Law (SGB V), the following categories existed for prescription in the outpatient sector: medical aids, therapeutic methods provided by non-physicians (e.g., physiotherapy, speech therapy), bandaging materials, and drugs.

Drugs, with their pharmacological, immunological, or metabolic effect(s), intended to cure, alleviate, or prevent disease or pathological conditions are easy to distinguish from bandaging materials. The latter are designed to cover and heal parts of the body which have been injured.

The distinction between therapeutic methods provided by non-physicians (e.g. physiotherapy, speech therapy) and medical aids is a bit more complex. Legal process has clarified that therapeutic methods provided by non-physicians (e.g., physiotherapy, speech therapy) are non-physician services, while medical aids are physical objects (e.g., walking aids, insoles, wheelchairs, etc.).

It remained unclear, however, into which category software products would fall. Software-based medical products are not physical objects. At the same time, they interact with an insured person in a manner similar to therapists. Software was not specifically considered at the time of the legislation but also was not explicitly excluded. Because of the personal provision of services, which is the defining characteristic of therapeutic methods provided by non-physicians, classification as a medical aid appeared most suitable. § 33 of the German Code of Social Law (SGB V), characterizes medical aids as follows:

“which are necessary in individual cases to ensure the success of the treatment of the sick, to prevent an impending disability, or to compensate for a disability, insofar as the aids are not to be regarded as general objects of daily use or are excluded under section 34(4)”.

DiGA appear to fulfil these requirements. They are not objects of daily use, as they are specifically designed to meet the needs of sick or disabled people (Lungstras 2020).¹Moreover, DiGA are also not excluded under Section 34(4) of the German Code of Social Law (SGB V). Furthermore, legal process had also already shown that software can fall under the definition of a medical aid (cf. LSG Bayern judgment of 4.9.2008—L 4 KR 15/07, LSG Berlin-Brandenburg judgment of 13.4.2011—L 9 KR 182/09).

In reality, however, DiGA have not really made it into standard care, let alone the medical aid directory of the National Association of Statutory Health Insurance Funds. The practical hurdles faced by specific digital health tools in applying for inclusion in the medical aid directory were the reason for the establishment of the Fast-Track. If the National Association of Statutory Health Insurance Funds had created transparent rules for the inclusion of digital tools in the directory, The DiGA Fast-Track would not have been necessary.²

As part of the Fast-Track, federal regulators have implemented a separate category for DiGA in § 33a of the German Code of Social Law (SGB V). This is intended to supplement the list of known prescribable benefits. The law does not limit digital applications to this novel pathway. Rather, it introduces a new specific pathway. Thus, the already-existing (if infrequently used) options for entering the German statutory healthcare market via the medical aids directory, selective contracts, model projects, or disease management programmes remain available. Furthermore, the German Patient Data Protection Act also explicitly maintains the option that DiGA can be offered as a statutory benefit by health insurers.

DiGA constitute a new benefit category of prescribable services for standard care within the German statutory health insurance system. They are considered health treatments under § 33a of the German Code of Social Law (SGB V). Other pathways to reimbursement remain available, so potentially feasible pathways should be closely compared. Required effort, costs, duration, and scope can differ considerably. Theoretically, the manufacturer of a DiGA can pursue several pathways in parallel.