12 September 2022
The legislator continues to pursue its efforts to make health care future-oriented through digitalization and innovative care structures.
At the end of 2019, the German legislator included in the reimbursement catalog of the statutory health insurance also digital health applications ("DiGA") via amendments to the Social Security Code Book 5 – SGB V through the DVG ("Digital Health Care Act").
In 2021, digital nursing applications ("Digitale Pflegeanwendungen – DiPa") have now also found their way into the benefits catalogue of the long-term care insurance funds. For this purpose, the DVMPG ("Digital Supply and Care Modernisation Act") introduced in the Social Security Code Book 11 – SGB XI an entitlement to reimbursement of the costs of DiPAs as well as to supplementary care and support for care recipients in home care.
The subject of this entitlement to benefits are digital nursing applications that meet the requirements according to § 78a paragraph 4 SGB XI for functional suitability, security, quality, data protection and data security and can prove a nursing benefit.
This article provides an overview of the new DiPA regulations and how they interact.
A legal definition of DiPA can be found in § 40a I SGB XI. According to this, DiPA are essentially based on digital technologies and are used by the person in need of care themselves, or the relatives caring for them, other voluntary carers or authorised outpatient care facilities, in order to reduce impairments to the independence or abilities of the person in need of care or to counteract a worsening of the need for care, insofar as the application is not to be provided by the health insurance or other responsible service providers due to illness or disability.
§ 40a I a SGB XI expands this definition to include such applications that support the caregiver in the areas mentioned in § 14 II SGB XI or in household management and stabilize the home care situation of the person in need of care.
For those in need of care, the entitlement to care arises from § 40a SGB XI.
In terms of content, this entitlement is limited to such DiPAs that are included by the BfArM in a directory of digital nursing applications ("DiPA directory") to be established in accordance with § 78 para. 3 SGB XI. In addition, the long-term care insurance fund must determine the necessity of the care in the specific individual case at the request of the person in need of care in accordance with § 40 Para. 2 SGB XI.
Ultimately, the group of persons eligible for a reimbursement is limited to those insured persons in need of care who are in home care. The care level assigned to the insured person is irrelevant.
Furthermore, in May 2022, a time limit of a maximum of six months was added to the initial approval. During this period, the purpose and achievement of the use of the DiPA are to be reviewed.
Furthermore, those entitled under § 40a SGB XI are also entitled to supplementary support services under § 39a SGB XI. The reimbursement of supplementary support covers support services provided by approved outpatient care facilities that are necessary in the use of the respective DiPA.
The claim for reimbursement of costs for a DiPA and supplementary support services of the person in need of care is limited to a total of € 50 per month according to § 40b SGB XI.
§ 78a SGB XI defines the legal basis for the inclusion of a DiPA in the DiPA register maintained by the BfArM (German Federal Institute for Drugs and Medical Devices). A DiPA can be included in the DiPA register upon application by the manufacturer. This application must be accompanied by evidence that the requirements for safety, functional capability, quality, nursing benefit as well as data protection and data security are fulfilled by the respective DiPA.
Those requirements as stipulated by § 78a IV 3 SGB XI in interaction with a legal ordinance still to be issued on the basis of § 78 VI SGB XI shall built a uniform requirement profile for all DiPAs.
In addition to the legal requirements of the SGB XI and the related legal ordinance; the framework for DiPAs will also be determined by various agreements between the involved parties.
The legal basis for the remuneration amount and its provision is found in § 78a para. 1 sentences 1 and 2 SGB XI. Within three months of inclusion of a DiPA in the DiPA register, the manufacturer and the National Association of Long-Term Care Insurance Funds (“Spitzenverband Bund der Pflegekassen”) shall negotiate and agree on both the remuneration amount and the technical and contractual framework conditions for the provision of the DiPA. This agreement will apply retroactively from the time of inclusion of the DiPA in the DiPA register.
According to § 78a II SGB XI, standards for these agreements on remuneration amounts as well as for principles regarding the framework conditions for the provision of a DiPA are to be agreed in a framework agreement. This framework agreement is to be concluded between the National Association of Long-Term Care Insurance Funds (“Spitzenverband Bund der Pflegekassen”) and the umbrella organisations of the DiPA manufacturers, at the federal level within three months after the entry into force of the legal ordinance to be issued on the basis of § 78 VI SGB XI.
The remuneration for the complementary support services is determined by agreement between the providers of the care service and the service providers according to § 89 SGB XI.
The main difference between DiGAs and DiPAs, already recognisable by their names, is their purpose. DiGAs serve medical purposes such as the treatment or alleviation of illnesses. DiPAs aim to strengthen the abilities of the person in need of care, to reduce impairments and to prevent an increasing need for care.
To implement these purposes, a DiPA does not necessarily have to be used by the care recipient himself/herself. Caregivers or nursing homes can also be considered as users of a DiPA.
Only medical devices as defined in Art. 2 No. 1 of the Medical Devices Regulation 2017/745/EU can be included in the DiGA directory. On the other hand, DiPAs can be a medical device, but other digital applications are also eligible. Consequently, there is no prescription requirement for a DiPA.
One difference will be that for DiGAs, the insured patient beneficiary can use the DiGA free of charge via an activation code and billing will be done directly in the relationship between the DiGA manufacturer and the statutory health insurance fund. For DiPAs, on the other hand, the person in need of care only receives a cost reimbursement claim against his or her long-term care insurance fund.
It remains to be seen how the "Ordinance on the Eligibility for Reimbursement of Digital Nursing Applications - VDiPA", which is still to be issued on the basis of § 78a para. 6 SGB XI, will concretize the procedure and requirements. The Federal Ministry of Health presented a draft ordinance in July 2022. According to the draft ordinance, the contents and requirements transferable from the Digital Health Applications Ordinance (DiGAV) are to be considered in order to ensure a comparable level of requirements for digital health applications and digital nursing applications.
Further benchmarks for the remuneration amounts as well as principles of the technical and contractual framework conditions for the provision of the digital nursing applications will be determined by a framework agreement at federal level, which shall be reached between the umbrella organization of the long-term care insurance funds in agreement with the federal association of the supra-local providers of social assistance and integration assistance with the relevant umbrella organizations of the manufacturers of digital nursing applications formed to represent the economic interests (see § 78a para. 2 SGB XI).
Authors: Dr. Andrea Sautter, Farina Simon