Draft for “Law for better care through digitization and innovation” approved in Germany

The draft for a "Digital Supply Law," approved by the Cabinet on July 10, 2019, promotes digitization in the health sector. Among other things, the law should help to integrate digital applications more quickly into the standard care, to further develop and promote the use of the electronic patient record (ePA), to strengthen telemedicine and to connect more actors to the telematics infrastructure.

Main aspects of the “Digital Supply Act” concern:

• Digital applications
  • In the future, physicians will be able to prescribe health apps (including software and other medical devices based on digital technologies with health-related purpose, e.g., “health apps”) at the expense of the statutory health insurance
  • For an accelerated approval process and rapid admission to standard care, the Federal Institute for Drugs and Medical Devices (BfArM) is entrusted with the task of maintaining an official list of reimbursable digital health applications and deciding on the inclusion at the request of the manufacturers. In addition to fulfilling the requirements for safety, functionality, quality, data protection, and data security, the prerequisite for admission is proof of positive effects for health care, provided by the manufacturer
  • If proof of positive health care benefits is not yet available, digital health care applications can be initially scheduled for a limited period of twelve months, and the health insurances should reimburse the price set by the manufacturer. During this time, the proof of the positive supply effect must be provided
  • If proof is provided during this period, the reimbursement amount shall be negotiated between the GKV Spitzenverband and the manufacturer
• Administrative processes digitization. Electronic patient record (ePA)
  • Voluntary accession to a statutory health insurance fund can in the future also be performed through an electronic declaration. Insured persons can be informed electronically about innovative care offers by the health insurance funds
  • The GKV-Spitzenverband has to report to the Federal Ministry of Health and the supervisory authorities regularly on the progress of digitization of the administrative services of health and long-term care funds and the connection of their own administrative portals to joint portal networks for digital administration services
  • Doctors have to prove to their competent fund associations by June 30, 2021, that they have the necessary components to access the ePA. Otherwise, the fees will be reduced by 1%
• Telematics infrastructure (TI)
  • The 1% fees reduction will be increased to 2.5% for medical practices that have not joined TI by March 2020
  • Pharmacies have to join TI by March 31, 2020
  • Hospitals have to join the TI by March 1, 2021
  • As a further step, care institutions, midwives or maternity nurses, as well as physiotherapists, can initially voluntarily join the TI. If these service providers voluntarily join the TI, they will receive reimbursement of equipment and operating costs
  • In perspective, the connection to the TI should become mandatory
• Telemedicine
  • If video consultation hours are offered, physicians will be allowed to inform on their website about the offer
  • In addition, the previous education by the doctor and the consent of the patient, which previously had to be performed in person or in writing, should be possible during the video consultation
  • The use of teleconsulting should be expanded and reimbursed extrabudgetary. For this purpose, the amended evaluation committee has to decide on corresponding regulations within nine months
• Promotion of digital innovations by health insurances
  • In order to improve the quality and cost-effectiveness of care, health insurance companies become the opportunity to promote the development of digital innovations (digital medical devices, artificial intelligence, telemedical or IT-based procedures)
  • Funding may be provided through the acquisition of units of investment funds, which may include up to 2% of their financial reserves if combined with substantive cooperation between the health insurance fund and the investment management company. It also makes it easier to sign contracts for a special supply of digital care services providers
• Innovation Fund
  • The financing of the Innovation Fund will continue in the period from 2020 to 2024, amounting to €200 million (of which €100 million will be financed by the health insurance funds and €100 million by the liquidity reserve of the health fund)
  • The promotion of new forms of care will be carried out in a two-stage process, preceded by a consultation process involving external expertise, and more responsibility for the innovation committee's professional and flexible management of funded projects
  • Newly introduced is the funding option for the development of guidelines for which there is a particular need in health care. Scientific and practical expertise will be integrated into the funding process via a broad pool of experts
  • In order to swiftly transfer successfully tested care approaches into regular care, it is stipulated that the Innovation Committee must deal with the evaluation or result reports of the completed projects
  • For projects on new forms of care, the Innovation Committee must decide within three months on whether the new forms of care (possibly partially) should be transferred to standard care. For health service research projects, the Innovation Committee may decide on a recommendation. The decisions must contain a concrete proposal describing how the transfer to regular care should be performed. If the Federal Joint Committee (G-BA) is responsible for the admission to health care, it must decide within twelve months.

The Federal Council does not have to approve the law. It is scheduled to enter into force in January 2020.

The full details in German can be found here.

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