Despite strong opposition and critique raised by almost all stakeholders, the draft law on the financial stabilization of statutory health insurance (GKV-FinStG), which was revealed on 4 July 2022, has been agreed upon by the Federal Cabinet on 27 July 2022.
The agreed version of the new law includes all previously presented plans and cost containment measures, even those that raised the strongest criticisms.
Lauterbach emphasised again that “it was the most important that there were no service cuts to patients”. However, clinician associations repeatedly said that the exact opposite will be achieved.
Removal of “new patient regulation”
The agreed law to stabilise the SHI finances will remove the “new patient regulation” that was introduced with the TSVG in May 2019. This regulation rewards clinicians with €10 for every new patient on top of their regular budget.
Lauterbach claimed that the introduction of the “new patient regulation” was not successful and that there were no data to show that even one additional patient was treated as a result of it.
The removal of the regulation was “especially important” to him since the TSVG will become more important in the future, as the service points introduced with the TSVG will be integrated with the planned health kiosks.
Data from Central Institute for Health Insurance Physicians (Zi)
This contradicts the data published on the same day by the Central Institute for Health Insurance Physicians (Zi). The data showed that more than 25% of SH-insured patients benefitted from the regulation, especially children, adolescents and people of working age.
The number of new patients increased by 12% in Q4 21 compared with Q4 2019, despite the overall clinical treatment capacities decreasing in these two years.
Reactions from clinician associations
The removal of this regulation was strongly criticised by clinician associations, as the incentive is a critical part of the honoraria. They underline that despite the claim of no service cuts to patients, this removal will have a big impact on patients. With reduced honoraria, clinicians will have to cut back on their service offerings. This will results in fewer appointments and longer wait times, thereby directly impacting patients.
The KBV flagged again that the removal of the “new patient regulation” contradicts the agreed coalition contract, which stated to strengthen the ambulatory sector. Instead, many clinicians would now be forced to reduce the number of appointments. The new act was “a hit in the face of patients”.
The KBV board will now consult and coordinate with the KVs and the professional associations on how to proceed.
Health kiosks
Last May, Lauterbach said that plans for the development of health kiosks will be delivered this year. These health kiosks should be placed in underserved areas and focal points and become part of standard care. Most of this is already well prepared, and he will probably present his plans for a nationwide introduction shortly.
Hospital sector
Lauterbach claimed there would be no cost cuts in the hospital sector, and that he only wants to clean up some identified double payments.
This focuses on reducing the number of nursing staff in hospitals that are considered in the care /nursing budget. From 2024, costs of qualified nursing staff can be taken into account in the budget only if the staff is used in direct patient care on wards with beds.
The hospital commission is already working on concrete proposals for structural reforms. They will be discussed for the first time on 28 July 2022 in a federal-state meeting. However, the difficult economic situation must also be taken into account, as many hospitals will have to cope with enormous gas bills in the next weeks.
Lauterbach ensures that he is fully aware of the situation in hospitals.
Reaction from the DKG
The DKG can’t understand why Lauterbach explicitly mentions the critical hospital situation, while at the same time cutting €375 mn from their budget.
The change in the nursing staff funding means that hospitals will have to remove staff from the nursing/care sector. In the worst case, this was estimated to result in 20,000 job losses. “This is crazy, given the current staff shortages”. Instead, political measures for staff recruitment and relief would be needed.
Pharmaceutical industry
Lauterbach sees no economic problem for the pharmaceutical industry. He didn’t accept the concerns that his proposed cost measures would risk manufacturers moving away from Germany. Instead, he referred to the sales of last year, which increased by 13%, without vaccines and COVID-19 medications. For this year, an increase of 8% was expected. He doesn’t see any emigration or insolvency and only sees higher profits.
Lauterbach sees no signs that the pharmaceutical industry could not compensate for his request for higher contributions.
The updated agreed new law is not publicly available yet. However, it appears that Lauterbach’s previous request for “solidary contributions” of €1 bn in 2023 and 2024 has been removed.
Instead, it includes two key measures:
- the mandatory manufacturer discount will be increased for one year from 7% to 12%.
- the price cap for products outside of reference price groups (German: “Preismoratorium”) will be extended for another 4 years.
Reactions from the pharmaceutical industry
The vfa continues to criticise the plans. “The pharmaceutical innovation and investments in Germany will be put at risk.”
Pharmacies
Lauterbach thanked the pharmacies, as they are having an increasingly important role in the medical care of patients. This includes vaccinations being carried out by pharmacists and the newly planned services that can be delivered and are reimbursed for pharmacies (pDL).
Nonetheless, the agreed new law includes that the mandatory discount given by pharmacies (German: “Apothekenabschlag”) will be increased from €1.77 to €2.00 for two years.
SHI funds
According to the new law, SHI funds need to reduce their financial reserves to the legal minimum, which results in a reduction of €4 bn.
Reactions by SHI funds
The AOK feels that the law does not include any measures for the short- or long-term stabilisation of the SHI finances. Instead, the insurance premiums are increased, the financial reserves are removed and more debt will be incurred.
Minimal changes were made to the draft law in response to the concerns raised, but these “cosmetical fixes” further show that the law is not aimed at a sustainable financing solution but was “just a short-lived one-year law”.
Further reading related to HTA in Germany
- Which endpoints are important to the G-BA and IQWiG?
- How does the G-BA pick the appropriate comparator?
- When can an off-label drug be the appropriate comparator therapy?
- Regular and abbreviated early benefit assessments – Is this the end of orphan drug privileges?
- HTA guide
- EUnetHTA21 starts preparation for joint HTA from 2024
- G-BA assessment of orphan drug gene therapies, Zolgensma and Libmeldy
- Why did the G-BA assess Trimbow now?
- IQWiG methods version 6.0, English
- The biggest SHI fund, the AOK, proposes an end to free pricing in Germany
- New government coalition plans AMNOG, pricing and other reforms
- Prof. Dr. Karl Lauterbach is the new German health minister
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In the Pharmaceutical industry section, you mention that the agreed new law is not publicly available yet. Do you know when it will be available, so we can see all its provisions?
The final version of the new law can now be found here: https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/Gesetze_und_Verordnungen/GuV/G/GKV-Finanzstabilisierungsgesetz_Kabinettvorlage.pdf