Germany is currently undergoing substantial legislative changes in the healthcare sector. While the current Government had announced these reforms already in its coalition agreement 2013, it is only now beginning to act on them. Although not part of an overall masterplan, the various elements aim towards building a more compliant, digitalized and patient-focused German healthcare system.

By way of background to the German healthcare sector: Statutory healthcare providers – as public bodies – provide health insurance for about 80 per cent of German citizens. They are co-financed in equal parts by payments of the employers and employees, and governed by multiple rules and regulations (e.g. the German Social Code). Reform of the regulatory environment is an ever-ongoing project for every German government. This government is no exception to this rule.

There are currently three major reforms under discussion, which target the following main areas:

  • healthcare compliance (new section 299a German Criminal Code);
  • digital networking of patient data (new German E-Health Act); and
  • hospital patient discharge management (revised section 39 German Social Code V).

The wide ranging scope of these reforms is expected to have a material impact not only on doctors, but also on other stakeholders and industry players including national and international pharmaceutical and medical device companies as well as hospitals / hospital operators.

The reforms are expected to be enacted still in 2015, or early 2016 at the latest.

Germany: New healthcare reforms 2015

  1. Criminal Anticorruption Law
  • Earlier this year, the German Ministry of Justice and Consumer Protection (BMJV) introduced its far-reaching draft of a new specific criminal offence regarding active and passive corruption of a wide range of healthcare professionals in the healthcare sector (Section 299a German Criminal Code). The draft bill foresees a penalty of up to three years imprisonment.
  • The main objective of the law is to increase compliance and fight corruption in the healthcare sector. The introduction of a new criminal offence has become necessary since the German Federal Supreme Court (BGH) ruled in 2012 that doctors licensed by the statutory healthcare providers (Vertragsärzte) do not fall under the existing criminal anticorruption laws, thereby leaving a “gap” in the compliance landscape. In the Supreme Court’s case, sales representatives of a pharmaceutical company paid doctors to incentivize the prescription of the company’s pharmaceuticals. But they could not be convicted because the Supreme Court ruled that doctors do not qualify as suitable addressees of bribes under the existing criminal anticorruption laws.
  • The new anticorruption law was initially “only” envisaged to close such gap. The currently discussed draft, however, clearly goes beyond such objective and could become an example of how “hard cases make bad law”:
    • First, it has a far wider ranging personal scope: It not only covers doctors, and other academic healthcare professionals for whom professional associations exist (e.g. dentists, veterinarians, psychotherapists, pharmacists, etc.), but also paramedical healthcare professionals / medical assistant professions which require a state-regulated education (e.g. all types of nurses, occupational therapists, masseurs, etc.).
    • Second, and more important, it has a far-reaching material scope, almost like a “catch-all” rule: It criminalizes the improper influencing of a healthcare professional’s decision-making regarding the use or prescription of pharmaceuticals, therapeutic remedies / aids, and medical devices as well as unduly influencing referrals of patients and channeling of sample materials. In addition, violations of professional duties by healthcare professionals – if induced by advantages/benefits granted from a third party – are sanctioned. As a result, a breach of any professional code of conduct is “upgraded” to a potential criminal offence. For example, the professional codes for doctors prohibit particular forms of cooperation so as to safeguard the doctor’s independence / independent decision-making . In particular, doctors are not permitted to accept payments or other advantages for the prescription of pharmaceuticals, therapeutic remedies / aids and medical devices; likewise they are barred from accepting excessive benefits under any type of co-operation agreement with healthcare companies (Sections 31 – 33 Model Professional Code for Physicians (MBO-Ärzte).
  • In conclusion, the currently envisaged new Section 299a German Criminal Code would significantly sharpen the German healthcare anticorruption rules as far as the interaction between healthcare companies with doctors and other healthcare professionals is concerned. It bears the risk of legal uncertainty, in particular when criminalizing the violation of the often unspecific professional rules. And even more important: Many legitimate and beneficial types of collaboration run the risk of being criminalized. As an undesired and undesirable consequence, healthcare professionals could become “over-sensitive” and reluctant to continue, or engage into, co-operations and other contractual arrangements currently well within market practice. The new law will particularly create challenges for pharmaceutical and medical devices companies; the exact legislative scope, first practical experiences and best practices / guidelines therefore need to be monitored closely.
  • The – in any event – stricter criminal anticorruption law will most-likely be enacted still in 2015.
  1. E-Health Act
  • This month the German Bundestag conducted its first reading on the highly anticipated bill on the so-called “E-Health Act” (Statute for Secure Digital Communication and Applications in the Health Sector).
  • The main objective of the law will be to create the technical prerequisites within the next three years so that medical data can be transmitted electronically in the future. By the end of 2016, the Berlin Gesellschaft für Telematik (gematik), a company founded in 2005 by the leading healthcare associations in Germany, shall define “secure methods for transmitting medical documents “, as it says in the law. It is the gematik’s objective to build a private data network that can securely transmit patient data.
  • At the same time, the law is aimed at doctors, hospitals and health insurance companies. It comprises incentives and threatened sanctions to use electronic offerings quickly. Not only does the draft enact defined timelines and incentives for networking and electronic applications, but also sanctions if time frames are not met. Until June 30, 2016, the telematics infrastructure for clinics, hospitals, and statutory health insurance funds must be available. It is expected that it will take an additional two years to furnish the whole health care system with the respective applications.
  • With the E-Health Act, Germany opens up the telematics infrastructure for other electronic applications of healthcare and healthcare research – next to the electronic health card (elektronische Gesundheitskarte) that was introduced a few years ago. As a consequence, the E-Health Act will approach a much broader spectrum of applications and services and will attract a lot more industry players than the electronic health card alone. In order to alleviate or even avoid dependencies, all such applications and services must meet certain criteria for functionality, interoperability and security. With a certification procedure, gematik shall ensure that those criteria are indeed met.
  • It is anticipated that the e-health law will come into force beginning of 2016.
  1. Hospital patient discharge management
  • The German parliament has just recently passed revised rules governing patient discharge management for patients leaving the hospital (revised section 39 German Social Code V).
  • The main objective of the revised law is to strengthen the hospitals’ key responsibility for the patient discharge management, and to ensure a seamless care for leaving patients. As part of the reform, hospitals now have the possibility to issue prescriptions for medication covering the immediate time after hospitalization. Similarly, they can now issue prescriptions for homecare services for up to seven days after the patient leaves the hospital.
  • Under the new rules, hospitals can (fully) outsource patient discharge management to doctors, but not e.g. to homecare providers or medical aid suppliers. This restriction was one of the main points of criticism during the legislative process. Because in practice, it is often the homecare providers which are closest to the patient, and organizing comprehensive care for patients is an essential part of their work. The fact that they are barred from organizing patient discharge management may constitute one of the major flaws of an otherwise well-meant aspect of this part of the German healthcare reform.
  • Many details of the new rules regarding patient discharge management will be addressed in a yet to be concluded framework agreement between the representative bodies of the statutory healthcare providers, hospitals and doctors. To secure the best possible outcome for patients, it should be ensured that homecare providers and similar market players are included in the process of patient discharge management as far as the revised section 39 German Social Code V allows. One way of doing so could be by specifically allowing them to participate in the process as service provider / sub-contractor of the hospital with the hospital remaining in charge of patient discharge management in general.
  • The revised rules have already been adopted by parliament already, and will enter into force soon in 2015.