Healthcare and Life Sciences
Second COVID-19 Population Protection Act adopted
On 14 May 2020 the Federal Parliament adopted the “Second Act on the protection of the population in the event of an epidemic situation of national importance” (Zweites Gesetz zum Schutz der Bevölkerung bei einer epidemischen Lage von nationaler Tragweite). The Federal Council declared its approval on 15 May 2020. The purpose of the Act is to further develop and supplement the regulations and measures already taken in order to mitigate the financial consequences for health care caused by the SARS-CoV-2 virus and to further contain its spread. One particular focus of the Act is to expand the digital infrastructure in the health care system and to strengthen nursing care provision. Here is a summary of the most important provisions:
I. Preventative testing to be financed through the statutory health insurance scheme
Via an addition to section 20i German Social Security Code, Book V, the statutory health insurance funds can in future be obliged by statutory order of the Federal Ministry of Health to finance both coronavirus and coronavirus antibody tests also for asymptomatic patients, i.e. for patients for whom, according to the general provisions of section 27 German Social Security Code, Book V, there is no entitlement to medical treatment. The provision aims to increase the number of tests carried out, particularly in nursing and old people's homes.
There was rightly some prior criticism of this provision on the basis that the extension to testing goes beyond the protection traditionally offered by statutory health insurance. Inasmuch, the collective bodies of insured that pay into the statutory health insurance scheme have costs imposed on them that generally form part of the health care or preventive infection control that is to be financed by the state through taxes. This applies all the more to the provision in section 20i(3), no. 2 German Social Code, Book V, inserted by the Health Affairs Committee, according to which persons not in the statutory health insurance scheme can also obtain a right to appropriate testing by statutory order.
Compensation in the form of an increased state subsidy to the statutory health insurance scheme and its level are to be determined in the second half of 2020.
II. Increases in influenza vaccine reserves
The insertion of section 106b(1a), sentence 1 German Social Security Code, Book V, enables doctors to order an additional reserve of 30% of the influenza vaccine, based on the number of influenza vaccinations retrospectively established as having been carried out, for their practice requirements in the 2020/2021 influenza season, without having to fear additional charges from the statutory health insurance funds. The additional vaccine reserve is intended as a preventive measure to safeguard the health care system against further strain from an influenza wave as well.
III. Corona bonus in recognition and appreciation of the work done by nursing staff
In new section 150a German Social Security Code, Book X, the Act provides for an individual tax- and social security-free, non-attachable bonus payment (so-named “Corona bonus”) of up to EUR 1,000 for personnel who work in a care facility or in the area of care and support or in other areas for at least three months during the period from 1 March to 31 October 2020. This is in recognition of the especial physical and psychological strain on staff during the corona pandemic and the increased risk of contracting COVID-19 themselves:
- The bonuses are graduated according to the extent of direct contact with persons in need of nursing care. Those who work primarily in direct care and support on a full-time basis are to receive EUR 1,000, those “engaged in” a care facility, e.g. in the kitchen or in providing security services, are to receive EUR 667, trainees in nursing professions are to receive EUR 600, and all other employees EUR 334. The federal states and the care facilities themselves are free to increase the corona bonuses up to a maximum of EUR 1,500. The bonuses are to be paid out in the period from 15 July to 15 December 2020.
- The bonuses are to be reimbursed in advance through the public nursing insurance scheme or, in the outpatient sector, pro rata through the statutory health insurance scheme. The Federal Ministry of Health and the Federal Ministry of Finance will determine in the second half of the year whether and to what extent the Federal Government will refinance the payment of the one-off bonus. The additional expenditure for payment of the bonuses is estimated for the public nursing insurance scheme at approximately EUR 870 million and, for the statutory health insurance scheme, at approximately EUR 130 million.
IV. Digitalisation of local health offices
To expedite the technical modernisation and digitisation of local health offices and to enable them to connect to the electronic registration and information system, new section 5(2), no. 9 Infection Protection Act enables the Federal Government to provide the federal states, local authorities and associations of local authorities with grants totalling EUR 50 million. Each of the 375 local health offices therefore has a financing share of EUR 100,000 to EUR 150,000 at its disposal for this purpose. The details will be set out in administrative agreements.
V. Digital prescription of digital health applications in pilot projects
Digital health applications, i.e. in particular medical device apps that measure or monitor body conditions and make therapy recommendations, have been included in the scope of services of the statutory health insurance scheme since 1 January 2020 and can be prescribed by SHI-accredited physicians provided that the relevant application has been listed by the Federal Institute for Drugs and Medical Devices in accordance with section 139e German Social Security Code, Book V.
- To avoid the expense of a paper-based procedure and the risk of infection when visiting a physician, new section 67(3) German Social Security Code, Book V now enables digital health applications to be prescribed electronically, supplied by the manufacturer and also billed to the statutory health insurance scheme within the scope of temporary pilot projects between statutory health insurance funds, manufacturers and physicians.
- So long as the telematics infrastructure procedures remain unavailable, there is considerable freedom of design when implementing pilot projects, which are limited to a maximum period of two years, in this context.
VI. Changes due to the postponement of the Medical Device Regulation
Owing to the temporary postponement of the start of validity of Regulation (EU) 2017/745 due to the COVID-19 pandemic, the entry into force of the Medical Devices EU Adaptation Act and the simultaneous expiry of the Medical Devices Act has been adapted to the deferred start of validity of the Medical Device Regulation and postponed until 26 May 2021.
However, Article 59 Medical Device Regulation, which governs the procedure for special approval of medical devices without a conformity assessment procedure, is to enter into force early. To enable the Federal Institute for Drugs and Medical Devices to grant special approvals for urgently needed medical devices on the basis of Article 59 Medical Device Regulation, section 7 Medical Device Law Implementation Act will take retroactive effect to 24 April 2020. Section 7 Medical Device Law Implementation Act specifies the procedure to be followed for the granting of special approvals, the details of which must be determined by the Federal Ministry of Health by statutory order.
VII. New provisions in hospital law
The Act sets out diverse new provisions in hospital law:
- Establishment of EUR 185 as the minimum nursing fee for the period 1 April to 31 December 2020, including for hospitals with a particularised nursing fee that has already been agreed, with simultaneous waiver of compensation payments for the year 2020
- Introduction of a new additional fee to finance the costs of testing in-patients for a SARS-CoV-2 infection (section 26 Hospital Fees Act)
- Postponement of the audit-rate system until 2021/2022
- Temporary audit exemptions for the hospital treatment of patients infected with SARS-CoV-2 with respect to minimum procedure classification (OPS) requirements
- Additional penalty-backed data transfer obligations on hospitals for the purpose of assessing the effects of the COVID-19 Hospital Relief Act
1. Extension of the increase in the provisional nursing fee until the end of 2020
In the COVID-19 Hospital Relief Act to strengthen the liquidity of hospitals, the legislator increased the provisional nursing fee from EUR 146.55 to EUR 185 for the period from 1 April 2020 to 31 December 2020. However, this provision only pertains to hospitals for which the hospital-specific nursing fee cannot yet be calculated because the nursing budget for 2020 has not been agreed. To prevent discrimination against hospitals that have already agreed their nursing budget and have a lower hospital-specific nursing fee, a nursing fee of EUR 185 now applies throughout. There is no obligation to repay excess funds received in 2020 as a result of excess cover. As such, the legislator has established a minimum nursing fee for 2020 for all hospitals that is independent of actual nursing staff costs.
2. New additional fee to finance testing costs
In order to finance the costs to hospitals of testing fully or partially hospitalised patients for infection with the SARS-CoV-2 virus, an additional charge is to be introduced that can be invoiced in future for newly admitted patients. The level of the additional charge is to be determined by the contracting parties at federal level within one week of the promulgation of the Act. If no agreement is reached, this task is to be taken over by the Federal Arbitration Board, which has one additional week for this purpose.
3. Postponement of the introduction of the audit-rate system
A further support measure for hospitals is the postponement of the introduction of a quarterly audit rate of 12.5% maximum. This is postponed until 2021. The variable, hospital-specific audit rate will apply from 2022 onwards. This provision supplements the 2020 quarterly audit-rate limit introduced by the COVID-19 Hospital Relief Act of up to 5% of final invoices.
4. Temporary audit exemptions for the hospital treatment of patients infected with SARS-CoV-2 with respect to minimum procedure classification (OPS) requirements
For the second quarter of 2020 the Act includes an exemption for the treatment of (suspected) COVID-19 cases from Medical Service audits re compliance with the minimum requirements of certain procedure classifications. The reason for this is that the intensive care units of the hospitals are being expanded and, during the pandemic, personnel who do not otherwise work in this area are being deployed there. The legislator considers that, as a result, in particular the minimum requirements of the complex intensive care medicine classifications may not be fulfilled in every case, but that this should not cause the repayment of payments to hospitals. The German Institute of Medical Documentation and Information (DMDI) is to compile a list of those minimum requirements of procedure classifications that are exempted from audit. The exemption provision can be extended by the Federal Ministry of Health for a total of up to six months with the approval of the Federal Council.
5. Additional data transfer obligations on hospitals for the purpose of assessing the effects of the COVID-19 Hospital Relief Act
In order to be able to check the effects of the measures under the COVID-19 Hospital Relief Act on the economic situation of the hospitals on a valid data basis, hospitals are required to submit part of the data that is in any case to be supplied to the Institute for the Hospital Remuneration System (InEK) an additional two times a year. This is first and foremost for the purpose of examining whether and to what extent there are backlog effects from postponed operations and how high the proportion of dialysis is for corona patients receiving intensive care.
Failure to comply with the obligation to provide data during the year is penalised by a reduction of EUR 10 per case, but at least EUR 20,000 per hospital location. This does not apply in the event that it would cause the hospital undue hardship. The Institute for the Hospital Remuneration System has the task of determining the details of this hardship provision.