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Germany healthcare news | 2023 | Bundestag reforms | Digital Health | iPharmaCenter

September 29, 2023

The German government commission urges stable financing for child and adolescent medicine, pediatric outpatient clinics, and more flexible mental health treatment.

The government commission tasked with modernizing and improving hospital care has proposed reform proposals for pediatric medicine and treating mental illnesses. These proposals aim to ensure stable funding for child and adolescent therapy, introduce outpatient clinics within pediatric institutes, and make mental health treatment in hospitals more flexible.

Pediatric Medicine:

  • The commission suggests the development of binding quality standards for surgical and conservative pediatric and adolescent medicine.

  • The commission recommends a permanent increase in the future reserve budget to secure the financial stability of pediatric and pediatric surgery services. This increase would involve a surcharge of up to 20% of the previous aDRG revenue volumes for specialist departments in surgical and conservative pediatric and adolescent medicine. The creation of a special fund is advised for this purpose.

  • Following the successful model in child psychiatric care, the commission proposes the establishment of institute outpatient clinics for somatic child and adolescent medicine. These clinics would participate in outpatient statutory health care. Children who require hospital treatment due to the nature, severity, rarity, or duration of their illness or their geographical distance from suitable specialists for children and adolescents should have access to outpatient treatment after being referred by a contracted doctor.

  • In the short term, the commission recommends streamlining occupancy checks for day-clinic treatments when exceeding the upper limit of length of stay and suspending exposure time when exceeding the lower limit dwell time. This would help alleviate the burden on clinics and departments of pediatric and adolescent medicine.

Mental Health Treatment:

  • The commission emphasizes the availability of psychiatric, psychosomatic, and child and adolescent psychiatric care in all level I to III (U) hospitals.

  • Level II hospitals are encouraged to collaborate with relevant clinics or departments, especially in geronto-psychiatric care.

  • To address regional disparities, child and adolescent psychiatry expansion should primarily focus on underserved regions. Outpatient care should also be ensured if local practising doctors cannot bridge the gap.

  • Close cooperation between both disciplines is essential to ensure a seamless transition for adolescents from child and adolescent to adult psychiatric care. Integrated somatic and psychiatric care offerings are also required in child and adolescent medicine.

  • The commission recommends aligning staffing levels for treating mental illnesses with those required for somatic medicine, reducing documentation requirements, and easing sanctions.

  • Flexibility in the setting of hospital treatment for mental illness is advocated. This means that psychiatric beds should be utilized in day clinics, and separate billing channels should be eliminated.

  • The commission introduces the concept of a quarterly flat rate model project (§ 64b SGB V) for psychiatric care. Under certain circumstances, all health insurance companies must enter contracts (compulsory contracting). A nationwide framework concept for budget determination and financing would replace individual regional negotiations. The contractual partner landscape would also include the KV side in the future.

  • The commission suggests maintaining the remuneration system for psychiatric and psychosomatic services introduced in 2018 based on daily remuneration rates (PEPP). This system encompasses holding costs and should continue to be monitored for its effects.

The Cabinet has given the green light to two key laws: the "Digital Act" (Digital-Gesetz - DigiG) and the "Health Data Utilization Act" (GDNG), both designed to foster digital solutions for improved patient care and research opportunities.

Under the Digital Act, a significant component is the introduction of the electronic patient record (ePA) for all statutory health insurance holders who do not opt-out. Starting in 2025, the ePA will facilitate the exchange and utilization of health data and initially focus on digital medication management. Additionally, the e-prescription will be standardized for medication supply.

The GDNG establishes the foundation for better access to health data to position Germany as a global leader in health, research, and business. A decentralized health data infrastructure, including a central access point, will be established to facilitate the use of health data for public welfare purposes. The law also aims to bolster the development of a globally competitive health data infrastructure.

Key highlights of the digital healthcare legislation include:

  • Electronic Patient Record (ePA): The ePA will be available to all statutory health insurance holders from early 2025, with the option to opt out. Privately insured individuals may also have access to an ePA with opt-out capabilities provided by private insurance companies. The ePA will offer a comprehensive digital medication overview, aiding in preventing drug interactions and supporting healthcare providers in treatment.

  • e-Prescription: The e-prescription will be further developed and standardized for medication supply starting January 1, 2024.

  • Digital Health Applications (DiGA): Integration of DiGAs into healthcare processes will be enhanced, including digital medical devices of risk class IIb, enabling their use in more complex treatment processes, such as telemonitoring.

  • Telemedicine: To promote telemedicine as a fundamental part of healthcare, quantity limits will be lifted, and assisted telemedicine will provide easy access to care.

Under the Health Data Utilization Act (GDNG), provisions include:

  • Central Data Access and Coordination Point: A centralized point will be established for accessing and coordinating health data, reducing bureaucratic hurdles and enabling data linkage from different sources.

  • Data Protection Supervision for Research: Extended data protection supervision for transnational research projects encompassing all health data coordinated by a state data protection officer.

  • Health Research Data Center (FDZ): The FDZ at the BfArM will be enhanced, and eligibility for access will be based on the common good's purposes rather than the applicant's.

  • Opt-Out Procedure: An opt-out procedure will be introduced to facilitate the release of data from the ePA for research or other authorized purposes at the FDZ, with a simplified administration for patient objections.

  • Data Processing by Insurance Companies: Health and long-term care insurance companies will be allowed to process data when it can be demonstrated that such processing protects the individual health of the insured

The German Bundestag has passed the "Act to Combat Supply Bottlenecks for Off-patent Drugs and to Improve the Supply of Pediatric Drugs" (ALBVVG) in response to the ongoing supply bottlenecks. The new legislation includes measures to ease price regulations for children's medicines and ensure the availability of discounted drugs in the future.

Under the new law, pharmacies will have greater flexibility in providing alternative medicines when there is a shortage. Additionally, sick leave by telephone, which proved successful during the pandemic, will be implemented indefinitely. The legislation also grants federal states the authority to introduce drug-checking initiatives.

Key provisions of the Supply Bottleneck Combating Act include the relaxation of price regulations for children's medicines. For children's treatments, fixed prices and discount agreements will be abolished, allowing pharmaceutical companies to increase their prices by up to 50 per cent of the last applicable fixed price or the price moratorium. Fixed price groups for pediatric medicines will no longer be permitted.

The Act also addresses the price pressure resulting from co-payment exemption rules. The co-payment exemption limit will be reduced from the current 30 per cent to 20 per cent, enabling the National Association of Statutory Health Insurance Funds to exempt pharmaceuticals from co-payment if the price is at least 20 per cent below the fixed amount. This adjustment aims to alleviate price pressure on fixed amounts.

To simplify medication exchange procedures, pharmacists can dispense drugs with the same active ingredient when the prescribed medication is unavailable. Pharmacies and wholesalers will receive a surcharge for such exchanges. Additionally, if medications can only be dispensed in small packs or a partial quantity is required, the insured person's co-payment will be limited to the amount dispensed.

The legislation also provides flexibility in pricing instruments for critically needed medicines during market shortages. If there is a shortage of essential medications due to insufficient suppliers, the fixed price or price moratorium can be increased by 50 per cent once.

To address the issue of delivery bottlenecks, pharmaceutical companies will be required to store discounted medicines for a minimum of six months. This measure aims to prevent short-term supply disruptions, accommodate increased acute demands, and ensure a reliable supply. Hospital pharmacies and pharmacies supplying hospitals must also increase their stocks of parenteral drugs and antibiotics for intensive care. When shortages of cancer drugs are anticipated, pharmacies producing ready-to-use preparations from these drugs will also be subject to increased stockpiling requirements. Wholesalers must increase their stockpiles of children's medicines for four weeks.

The Act also strengthens existing structures for managing delivery bottlenecks. The Federal Institute for Drugs and Medical Devices (BfArM) will receive enhanced information rights from manufacturers and hospital pharmacies. An early warning system will also be established to identify potential delivery bottlenecks in advance.

Other provisions of the law include adjusting pricing rules to provide financial incentives for pharmaceutical companies to research and develop new reserve antibiotics and authorizing emergency paramedics to administer narcotics based on standardized medical guidelines in emergencies where a doctor is not immediately available.

Furthermore, the law allows for sick leave by telephone, instructing the Federal Joint Committee to permit this method when the doctor is familiar with the insured person and the symptoms are not considered "severe."

Lastly, the legislation creates legal provisions for drug-checking model projects to be carried out in the federal states. The objective is to enhance education and advice for drug users, minimize harm, and better understand the situation at the local level. The implementation of these projects will be the responsibility of the respective federal states.


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