Implications for testing of the Second COVID-19 Population Protection Act
On May 14, the federal parliament passed the ‘Second Act for protecting the Population in the Event of an Epidemic Situation of National Importance’ including a bundle of laws which concern testing, reporting obligation of test results, health and long-term care professionals and financing. The law is meant to expand the provisions of the first pandemic law passed at the end of March.
The amount of testing being carried out will be widely expanded, especially in care homes or hospitals to stop the chain of infection before it spreads further. The Ministry of Health can compel SHI funds to cover the cost of the COVID-19 tests and antibody tests for recovered patients. As a result, more tests will be possible also for asymptomatic individuals who suspect they have the virus or have come into contact with an infected person. Public health offices will be able to invoice costs for COVID-19 tests with the SHI funds. 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. To cover costs for COVID-19 tests of patients treated in hospitals, an additional charge will be introduced that can be invoiced in future for newly admitted patients (see also Section 4.2).
Ordinance on the entitlement for testing: the new testing strategy
On June 9, the federal Ministry of Health passed a new ordinance which extends COVID-19 testing. The new regulation allows to test asymptomatic persons that had contact with a sick person for at least 15 minutes or live in the same household. Laboratory costs incurred for testing asymptomatic persons ordered by the public health service (ÖGD) (EUR 50,50 per test) will be financed by the SHI funds for all person irrespective of their health insurance states. This also applies retrospectively to tests of asymptomatic persons already performed since May 14. Eligible for COVID-19 tests are also nurses, hospital staff, school and child care staff, users of the planned voluntary Corona Warning app that received a warning, as well as people who are or have been in a high risk areas (with more than 50 cases per 100,000 inhabitants cumulatively in the past seven days). With this, series tests and precautionary tests can be carried out in day-care centres, schools or nursing homes in the case of corona cases. The public health service will be able to mandate test series in schools, childcare facilities, rehabilitation facilities, dialysis centers, asylum seekers' homes and prisons. These test series will be conducted if there is a confirmed case in these facilities and will be funded by the SHI funds. Testing in nursing homes and in ambulatory long-term care services can be conducted without a confirmed case. In addition, all patients admitted to hospitals will be tested as part of their pre-inpatient treatment, irrespective of their insurance status. This also applies to patients that receive day surgeries and in other outpatient surgery facilities.
Subsequent agreements for the financing of test were reached in mid-June in the Extended Valuation Committee between the Federal Association of Sickness Funds and the Federal Association of SHI Physicians. Reimbursement of testing depends on the service provider. Testing in ambulatory setting by SHI physicians is reimbursed with EUR 39,40 per test until March 31, 2021 by the SHI funds. Tests of people that are privately insured are remunerated according to the catalogue of tariffs for physicians (GOÄ) at EUR 120. Prior negotiated reimbursement rate between hospitals and SHI funds is EUR 52,50 per test (EUR 63 until June 15, 2020) until at least August 1, 2020. The expanded test strategy will be financed from the liquidity reserve of the Central Reallocation Pool (Gesundheitsfonds; literally, “Health Fund”) which contains SHI contributions but also federal tax money.
The new national testing strategy is depicted in this table: https://www.rki.de/SharedDocs/Bilder/InfAZ/neuartiges_Coronavirus/Teststrategie.png?__blob=poster&v=3
Test center at Frankfurt Airport
On June 29, the Frankfurt Airport began operating its COVID-19 test center in an effort to better screen private and business travelers entering Germany. This is the first to be opened at an airport in the country, and officials commented that the current testing capacity is around 300 tests per hour, with plans to later expand. Test results will be made available privately and securely to passengers on a platform that links to their plane ticket, the cost is EUR 59 and the results would be available five to six hours after the test. A fast-track option, where the result is available between two and three hours later, will cost EUR 139 and can be helpful to passengers who have been in a third country that may normally require isolation for 14 days after entering Germany.
Different testing strategies in federal states
Due to the relaxed social distancing measures, the state of Thuringia announced plans to significantly expand the laboratory tests on May 5. Precautionary tests for nursing home, outpatient care and hospital staff should also be introduced. Staff treating COVID-19 patients, as well as personnel working in ICU, geriatrics and/or cancer departments could be tested two to three times per week. In addition, tests could be performed in institutions within regions with high prevalence. Furthermore, all incoming patients to healthcare facilities should be screened.
Testing should be stepped up to protect the most vulnerable as normal society creaks back to life, with plans to screen hospital and nursing staff who even show no or few symptoms, with up to two tests per week. In addition, there would be staff in particularly vulnerable areas such as ICU, geriatric departments and cancer wards of hospitals, as well as staff in clinics and nursing homes in regions with a particularly high infection rate. People should also be tested if they are newly admitted to nursing homes or return to them after hospital stays, and testing people with existing respiratory symptoms should be expanded.
Laboratory capacities for the expansion of testing will rise from the currently processed 11,000 per week to 30,000 per week through the use of new technology and the integration of laboratories of the State Office for Consumer Protection. The state initially intends to cover the costs which is estimated at EUR 25 million.
Beginning on July 1, the Bavarian State Government will make free testing available for the entire population. Daily testing capacity will be increased from 20,000 to 30,000 per day and the state will cover all costs in cases where health insurance companies are not already obliged to pay, and approximately EUR 200 million is being made available by the state government to cover the new strategy.
On July 28 the state of Mecklenburg-Western Pomerania decided that travelers returning from high-risk areas will only be able to come out of quarantine after a second negative test result. Upon returning to the state, a first test should be taken right away and then a second test after 5 to 7 days according to an agreement by the state’s cabinet. The state will pay in advance for the cost of the tests.
In the state of North Rhine-Westphalia, everyone working in public and private schools as well childcare facilities will be able to be tested for COVID-19 for free and voluntarily starting on August 3, 2020. NRW’s Ministry of Health announced the plan in cooperation with the Associations of Statutory Health Insurance Physicians and includes non-educational staff as well.
Testing of returning travelers
On July 24, state governments decided to expand testing options for travelers from high-risk areas. Testing at e.g. the airport will be offered free of charge on a voluntary basis. This also applies for persons entering the country from non-risk-areas, even though testing will not be provided directly upon entry for those persons.
Furthermore, travelers from high-risk areas will be asked to fill out passenger locator forms when entering the country by ship, bus and train. In addition, the health ministers agreed that random checks will be carried out at road entry points near the border.
Persons entering the country from high-risk areas are still obliged to self-quarantine for 14 days upon entry. Only persons with negative test result are exempt from that rule.
On July 27 the Federal Minister of Health announced that testing of persons entering the country from high-risk areas will be mandatory upon entry starting in the first week of August 2020. Citing the Protection against Infection Act as legal basis, mandatory testing will be offered free of charge for travelers. Minister Spahn’s stated goal is to detect cases entering the country and to prevent potential transmission chains as there are currently 140 countries are classified. The central assessment criterion is whether states or regions showed more than 50 new cases per 100,000 inhabitants cumulatively in the past seven days. In the same draft of the new regulation the Health Ministry also announced that testing would also be free to patients entering rehabilitation facilities.
On August 1, the Federal Ministry of Health issued an amendment to the statutory ordinance for testing for SARS-CoV-2. According to the amendment, all returnees from abroad can be tested at the health office, at test stations at airports and train stations or in a doctor's office within 72 hours upon entry, beginning on August 1. In addition, testing is expanded to other vulnerable groups, e.g. rehabilitation facilities.
Based on the ordinance, the reimbursement rate for testing is EUR 15. Statutory health insurance (GKV) bears the cost of the tests. The ministry expects additional costs of EUR 50.5 million per million tests through laboratory services and EUR 15 million through the flat-rate remuneration.
On August 8, the Federal Ministry of Health issued an ordinance for mandatory testing on SARS-CoV-2 for returnees from high-risk areas. According to the ordinance, there will be two options for returnees from high-risk areas in the future: either they can be tested in the holiday country in the 48 hours before departure (in which case testing needs to be paid out-of-pocket), or returnees can be tested for free up to three days after returning to Germany. Mandatory testing does not apply after transit through a high-risk area without a stay. Testing will be possible for example, at airports, train stations and other travel hubs, in health authorities’ offices or medical practices. Information on test sites can be obtained by calling the medical service telephone number 116 117. Returnees who do not comply with the test requirement face fines of up to EUR 25,000.
In addition, travelers only need to stay in quarantine at home until the test result is available. According to the Federal Ministry of Health, this usually takes 24 to 48 hours.
This measure will be financed from the liquidity reserve of the Central Reallocation Pool, which is to receive higher federal subsidies for this.
At several points of entry (airports, train stations, motorway service stations), SARS-CoV-2 test centres have been established. Until August 19, at the airports, out of 43,810 persons tested, 478 had a positive result (1.09%); at the motorway stations, out of 32,011 persons tested, 709 had a positive result (2.21%); at the two train stations, out of 3,571 persons tested, 49 had a positive result (1.37%). Overall, a large percentage of new COVID-19 cases reported in July and August 2020 are being identified among travellers entering Germany, especially among younger age groups.
On August 27, the Federal Chancellor and the heads of the 16 states agreed among others that the free testing that has been available for travelers returning to Germany from abroad will be made available to only those coming back from designated risk areas starting on September 16. The new strategy also envisages to only test those people for whom there is a specific reason, for instance, if they are displaying symptoms or are particularly at risk due to their job. As of October 1, there will be a mandatory quarantine for travelers returning from risk areas. They can end their obligatory quarantine at the earliest with a negative COVID-19 test starting on the fifth day after returning. Any violations of the initial quarantine will be subject to fine. Furthermore, the federal and state governments want to ensure that no compensation for loss of income will be paid to people who have to quarantine if they willingly chose to travel to a risk area which was already designated as such before their departure.
Strained testing capacities in summer
According to a press release of the Association of Accredited Medical Laboratories in Germany (ALM e.V.) on August 11, the current utilisation of laboratories increased in recent weeks to around 67% with regional differences. This partly reflects expansion of testing to e.g. returning travelers. The ALM estimates that the additional test requirement for travel returnees could be around 250,000 tests per week.
According to RKI there was a backlog of 17,142 tests to be processed for the week of August 10-16. 41 laboratories notified as having delivery problems for reagents. Testing numbers have steadily risen, first from around 360,000 weekly at the end of April to 578,000 to weekly at the end of July, and now up to 875,000 weekly by the middle of August. The limited shelf lives of reagents and the dependence on delivery chains and some individual manufacturers can hinder the testing capacities in one of the 250 labs registered by RKI.
Travelers returning to Germany have been straining the testing capacities of laboratories in Germany. While the national average reported on August 26 stated that facilities were working at 85% capacity, some labs reported peak workloads of over 100%, according to the Accredited Laboratories in Medicine (ALM) In the week of August 17-23 alone the number of COVID-19 tests processed in 153 laboratories was 889,815, which marked a 17% increase (the positive rate of the tests remained almost the same at 0.9%). The backlog of PCR tests exceeded 25,000 on August 17, whereas the backlog was at around 13,000 the week before. The chairman of the ALM said that the testing capacity goal should be for facilities to remain between 65 and 80% utilization. The maximum test capacity available at short notice is 1,064,000.
Strained testing capacities in autumn and winter
German labs processed 1,017,728 PCR tests in the second week of September, which was another record number as the nationwide utilization rate of labs sits at nearly 90 percent. Returning to schools and the associated increase of testing teachers and students is a major factor in this rise, and the backlog of tests grew 9% (32,400 tests) between the first and second weeks of September.
By the end of October, German testing labs were at 89% capacity utilization and some federal states were already exceeding their capacity to process COVID-19 tests feasibly. More than 1.2 million tests were carried out in the previous week (the 43rd calendar week of 2020) in 162 total labs nationwide, which was a 12% rise over the previous week. The positivity of the tests also rose, from 3.7% in week 42 to 5.7% in week 43.
New test strategy in place since mid-October 2020
The National Testing Strategy was updated on the basis of an ordinance on testing for SARS-CoV-2 which will enter into force on 15 October 2020. The overall objective of the National Testing Strategy remains the care for symptomatic COVID-19 cases, the protection of vulnerable groups and the prevention of the spread of the coronavirus SARS-CoV-2. The update includes the targeted use of antigen testing especially medical facilities such ashospitals and nursing homes and the extension of testing to more population groups. A infographic on the new test strategy can be found here: https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/C/Coronavirus/Nationale_Teststrategie_Grafik_131020.pdf
People with respiratory infection (cough, runny nose, sore throat) can ask to be tested for COVID-19 if the following conditions apply: 1) if they have had contact with a laboratory-confirmed COVID-19 patient during the last two weeks; 2) if there is a pre-existing condition or the respiratory infection gets worse (develop high fever, cough etc.); 3) if there is contact with individuals who are considered vulnerable during work or voluntary work (e.g. in hospitals or elderly care). Prior to test results, these persons should self-isolate (stay at home, avoid contacts with distance less than 2-meter, respect hand hygiene and use a mask during contact to others (if available).
Criteria for possible cases requiring testing has changed throughout the course of the pandemic. Initially people who returned from a high-risk area were also tested to identify possible cases. On March 25, the stay in a high-risk area was taken from the list of criteria for testing.
Persons who have had personal contact with someone confirmed as carrying SARS-CoV-2 should immediately, and irrespective of symptoms, contact their competent health office, get in touch with the doctor or call the 116117 non-emergency medical on-call service (directing patients to medical assistance when the need is urgent but not life-threatening) – and stay at home. In general, hospitals and family physicians decide who will be tested. They base their decision on the recommendations of the RKI. Also, public health offices provide information on COVID-19 testing and provide appointments.
The RKI launched a nationwide laboratory survey to determine the number of laboratory tests being performed for COVID-19 in Germany. This survey is supplemented by three further data collections from the Network for Respiratory Diseases (RespVir, RKI), the national network for the surveillance of antibiotic resistance in Germany (ARS, RKI) and the Association of Accredited Medical Laboratories in Germany (ALM e.V.). From the response of 174 laboratories, a total of at least 483 295 samples were tested up to and including week 12/2020, most in calendar week 11 (127 457 samples) and week 12 (348 619 samples). According to the Professional Association of German Laboratory Doctors 40 000 tests are currently performed per day in Germany with increasing tendency.
After the first COVID-19 PCR test was developed by the German Center for Infection Research (DZIF) at Charité Berlin, German scientists are currently preparing to carry out a test in April to find out who has already developed antibodies to fight off the COVID-19.
According to the RKI situation report of April 8, a total of 1,317 887 tests have been performed in Germany up to calendar week 14 of which 100,901 (7.7%) have been tested positive on COVID-19. There are currently 143 testing laboratories, of which 132 reported a cumulative testing capacity of 116,665 per day according to the RKI (calendar week 14). However, 30 laboratories stated a backlog of 7,185 samples to be analyzed and 59 laboratories reported difficulties in the supply of reagents.
On April 8, the Charité, Germany's largest university hospital based in Berlin, announced to start stepwise large-scale COVID-19 testing and a voluntary antibody testing for employed medical personal to better assess infection rates among medical personal.
On April 9, the Robert-Koch-Institute announced the launch of a large-scale COVID-19 antibody study to better assess infection rates and monitor the spread of the virus more effectively. The study entails three serological tests: (1) as of early April samples of about 5,000 blood donors will be examined every 14 days, (2) as of mid-April antibody tests will be conducted in a representative sample of 2,000 people in each of four areas that had seen large outbreaks of the virus, and (3) a representative study of the broader population (15,000 people) will be carried out in 150 study locations across Germany as of mid-May (with first results expected in June).
Until April 21, a total of 2,072,669 tests were performed in Germany. The number of weekly performed tests recently declined to 323,449 (calendar week 16) even though the number of laboratories increased to 161. In calendar week 16, 21,538 (6,7%) of these tests were positive. Test capacity however was further increased to 136,064 tests per day or 818,426 per week according to the RKI.
Until April 26, 2,427,493 tests were performed in Germany. Test capacity was further increased to 141,815 tests per day or 860,494 tests per week. In total 29 laboratories reported a backlog of a total of 2,393 samples to be processed and 45 laboratories mentioned delivery problems for reagents, mainly extraction kits and swabs.
On May 4, the Federal Minister of Health reached an agreement with the Swiss pharmaceutical company Roche for the delivery of three million corona antibody tests. The first tests should be delivered to health facilities in Germany in May, and further five million tests will be delivered in the following months.
Until May 3, in total 2,755,770 tests were performed in Germany of which 186,331 were positive. Test capacity was further increased to 153,698 tests per day or 964,962 tests per week. The number of antibody tests also increased over the last weeks. In calendar week 19, in total 61,299 antibody tests were performed in Germany, twice the number of tests performed three weeks earlier.
Until May 13, 3,147,771 tests were performed in Germany of which 197,101 were positive. Test capacity was further increased to 157,150 tests per day or 1,038,223 PCR-tests per week, performed by 134 laboratories. 29 laboratories reported a backlog of a total of 3,224 samples to be processed. 45 laboratories mentioned delivery problems for reagents, mainly extraction kits and swabs.
Until June 28, 5,873,563 laboratory tests were performed in Germany of which 229,240 have been tested positive for SARS-CoV-2. To assess the test numbers, data from university hospitals, research institutions as well as clinical and outpatient laboratories throughout Germany are merged weekly at the RKI. These are transmitted via an internet-based RKI test laboratory survey, via the network for respiratory viruses (RespVir), via the laboratory-based SARS-CoV-2 Surveillance established at the RKI (an extension of the Antibiotic Resistance Surveillance (ARS)) and via the enquiry of a professional association of laboratory medicine.