TSVG law adopted by Bundestag

The Bundestag (German Federal Parliament) has passed the Terminservice und Versorgungsgesetz (TSVG) law regarding tendering for certain medical devices, the inclusion of new medical devices in the in-patient setting and the inclusion of medical apps into the reimbursement setting through disease management programmes. The law will come into force in May 2019, and is not subject to any further approval by the Bundesrat (Federal Council).

Jens Spahn, the Federal Health Minister, said:

“Our healthcare needs an update. Patients should receive medical appointments faster. They are also entitled to good medical care in rural areas. And they rightly demand that we make everyday life easier with digital solutions. In a vital area like health care, the state has to work. Getting better is the goal of our law.”

Translated by Google Translate

Primary aims of the law are to improve patients’ access to doctors, allowing them to get appointments faster and increasing the minimum hours of work for doctors. MAP’s partner in Germany, Dr Alex Natz (LL. M.) notes other implications of the new law:

“The law includes the following measures with relevance for the pharmaceutical, MedTech and biotech industry:

  • Tenders for medical devices (such as walking aids) will be abolished. This ensures that there are no compromises in the quality of the supply of the devices. Certain transposition periods are foreseen for tenders conducted already during which the SHI has to terminate the contract. Hence, market access for medical devices will largely rely on contracting with SHIs also in the future but not by exclusive contracts but rather by so-called ‘open-house’ contracts where all bidders willing to accept the terms & conditions of the SHI will be part of the SHI coverage
  • Pharmaceuticals intended to prevent infection with the HIV virus (“pre-exposure prophylaxis, PrEP”) are covered by SHI for people with an increased risk of infection
  • The supply of vaccines is improved. The possibility of exclusive contracts with individual manufacturers for seasonal influenza vaccines is eliminated and the pharmacy remuneration for these vaccines is newly regulated
  • Simplified procedures will be introduced at the Federal Joint Committee (GBA) for testing new examination and treatment methods: Manufacturers of medical devices are given the opportunity to commission the scientific monitoring and evaluation of a trial themselves. If you decide against this or if you allow the deadline set by the G-BA to expire, the G-BA will continue to award the contract following a tendering procedure

The TSVG legislation also includes some measure to make better use of digitalisation tools in the provision of care such as apps:

  • Patients want easy, secure and fast access to their treatment data. Hence, an electronic patient file should become part of everyday life. It aims at improving medical care
  • Apps can above all help chronically ill patients to organise their everyday life. For this reason, health insurance companies should be allowed to use digital applications in structured treatment programs for the chronically ill (known as DMPs or disease management programmes)”

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Published on 14. March 2019 in News, News Germany