Coronavirus Surveillance Ordinance – Federal Republic of Germany 2021

Ordinance on the Molecular Genetic Surveillance of the Coronavirus SARS-CoV-2 (Coronavirus Surveillance Ordinance – CorSurV)

Federal Republic of Germany


Issue date: 01/18/2021

full quote:

“Coronavirus Surveillance Ordinance of January 18, 2021 (BAnz AT January 19, 2021 V2), which has been amended by Article 3 of the Ordinance of November 12, 2021 (BAnz AT November 12, 2021 V1)”


Input formula

§ 1 Obligation to transmit data
§ 2 Reimbursement
§ 3 Procedure for payment from the federal budget
§ 4 Transparency
§ 5 Evaluation
§ 6 Coming into effect, expiration

Law

Input formula 

On the basis of Section 13 paragraph 4 sentences 2 and 3 of the Infection Protection Act of July 20, 2000 (BGBl. I p. 1045), paragraph 4 sentence 2 of which was last amended by Article 1 number 10 letter b of the law of November 18, 2020 (BGBl. I p. 2397) and whose paragraph 4 sentence 3 was inserted by Article 1 number 10 letter b double letter aa of the law of May 19, 2020 (Federal Law Gazette I p. 1018), the Federal Ministry of Health orders:

§ 1  Obligation to transmit data

(1) Laboratories and the facilities mentioned in Section 23 (3) sentence 1 of the Infection Protection Act that examine test material and isolates of pathogens in relation to the SARS-CoV-2 coronavirus and carry out full genome sequencing of the SARS-CoV-2 coronavirus in the Federal Republic of Germany (investigative bodies) are obliged to provide assembled full genome sequences of isolates of the coronavirus SARS-CoV-2 for each individual case of full genome sequencing in a form defined by the Robert Koch Institute for the purpose of monitoring the spread of the coronavirus SARS-CoV-2 (coronavirus surveillance) in pseudonymised form to the Robert Koch Institute. If available at the examination centers, the following information must also be transmitted:

1. information about the sender,

2. date of sampling,

3. type of sample,

4. used sequencing technology,

5. Information on the existence of an epidemiological reason for whole genome sequencing published by the Robert Koch Institute at http://www.rki.de/corsurv.

Research centers must be qualified to carry out full genome sequencing, including bioinformatic evaluation; they must be under the supervision of a specialist doctor or be part of a university or non-university research facility or have close legal and organizational ties with such a facility. Reporting obligations according to Section 7 paragraph 1 sentence 1 number 44a of the Infection Protection Act, in particular the obligation to report the allocation features for further examinations and including the sequencing-related pseudonym according to Section 9 paragraph 2 sentence 1 number 3 of the Infection Protection Act remain unaffected. The obligation according to sentence 1 does not apply to full genome sequencing that was carried out for test purposes within the framework of quality controls, performance tests or interlaboratory comparisons.

(2) The electronic reporting and information system pursuant to Section 14 of the Infection Protection Act is to be used for data transmission pursuant to paragraph 1. The Robert Koch Institute determines the technical transmission standards and the procedure for pseudonymization.

(3) The information pursuant to subsection 1 sentences 1 and 2 shall be transmitted within 10 days after proof of nucleic acid amplification has taken place or after the sample pursuant to Section 2 subsection 2 sentence 1 has been submitted.

§ 2  Reimbursement

(1) The testing centers are entitled to remuneration for the transmission of information pursuant to Section 1 (1) sentences 1 and 2. The remuneration amounts to EUR 220 for each transmission of information on a whole genome sequencing that has been carried out. If the whole genome sequencing is already being paid for from other sources, the compensation amounts to 20 euros, in deviation from sentence 2. With regard to the samples that were examined by the respective examination center itself as part of the diagnostics using nucleic acid amplification technology in relation to the coronavirus SARS-CoV-2, the claim under sentence 1 applies at most to up to 5 percent of the samples that were examined by the examination center have tested positive in the past calendar week. If the number of new infections with the coronavirus SARS-CoV-2 in the Federal Republic of Germany did not exceed 70,000 in the calendar week before the diagnostics were carried out, the entitlement according to sentence 1, in deviation from sentence 4, exists for a maximum of up to 10 percent of the samples, who have been tested positively by the testing center in the past calendar week. In the context of outbreak investigations carried out or supported by state health authorities or the Robert Koch Institute, the entitlement also exceeds the number of transmissions specified in sentences 4 and 5. Sentence 6 also applies to full genome sequencing that is initiated by health authorities for an epidemiologically relevant reason in accordance with the recommendations of the Robert Koch Institute published at http://www.rki.de/corsurv.

(2) Facilities according to Section 23 (3) sentence 1 of the Infection Protection Act and laboratories that examine test material and isolates of pathogens relating to the coronavirus SARS-CoV-2 as part of diagnostics using nucleic acid amplification technology, but do not have the technical requirements or sufficient capacities themselves have full genome sequencing (senders) can send up to 5 percent of the samples they tested positive for the SARS-CoV-2 coronavirus to investigation centers for full genome sequencing each week; Paragraph 1 sentences 5 and 6 apply accordingly. In the case of a shipment in accordance with sentence 1, the sender is entitled to reimbursement of shipping costs in the amount of 20 euros for each sample sent. The sender must obtain the approval of the testing center before sending the sample.

(3) The examination centers and the sender settle the remuneration and the shipping costs according to paragraphs 1 and 2 with the Association of Statutory Health Insurance Physicians in whose district the examination center or the sender has his or her seat. The information to be transmitted to the Association of Statutory Health Insurance Physicians must not relate to the person concerned, whose test material has been subjected to laboratory diagnostics.

(4) The examination centers and the senders are obliged to document the information specified by the National Association of Statutory Health Insurance Physicians in accordance with paragraph 5 in the accounting documents in relation to the process of data transmission or the submission of samples and monthly at the latest by the end of the third month following the accounting period electronically to the Association of Statutory Health Insurance Physicians responsible under paragraph 3. The information to be transmitted must not relate to the persons whose test material has been subjected to laboratory diagnostics.

(5) The National Association of Statutory Health Insurance Physicians, in consultation with the relevant associations of doctors and institutions that provide laboratory diagnostics services, will determine the details by February 5, 2021 at the latest: 1. the information to be transmitted by the examination centers and the senders for the settlement of the remuneration and the shipping costs and for the purposes of § 4 to the associations of statutory health insurance physicians and the documentation required to prove the correct settlement, 2. the form of accounting documents, 3. the fulfillment of the obligations of the investigating bodies and senders, 4. the fulfillment of the obligations of the Association of Statutory Health Insurance Physicians.

(6) The Associations of Statutory Health Insurance Physicians receive an administrative cost reimbursement of 0.7 percent of the respective total amount of the statements for the effort involved in settling the remuneration of the examination centers and the shipping costs of the senders in accordance with paragraphs 1 and 2 of this ordinance. For examination centers and senders who are not members of an Association of Statutory Health Insurance Physicians and have not yet billed them for services, the Association of Statutory Health Insurance Physicians will receive a reimbursement of administrative costs of 3.5 percent of the total amount of the bills.

§ 3  Procedure for payment from the federal budget

(1) Every Association of Statutory Health Insurance Physicians transmits the following information to the Federal Office for Social Security and the respective supreme state health authority on a monthly basis: 1. the respective amount of the statement resulting from § 2 paragraph 3, 2. the amount of the administrative costs according to § 2 paragraph 6.

Factual or arithmetic errors in the information transmitted in accordance with sentence 1 must be corrected by the respective Association of Statutory Health Insurance Physicians in the next transmission. The Federal Social Security Office pays the amounts transmitted in accordance with sentences 1 and 2 from the federal budget to the respective Association of Statutory Health Insurance Physicians.

(2) The Federal Social Security Office determines the details of the transmission procedure pursuant to subsection 1 sentences 1 and 2 and the procedure for payments from the federal budget pursuant to subsection 1 sentence 3.

(3) The Associations of Statutory Health Insurance Physicians are obliged to store or retain the information they have provided in accordance with Paragraph 1 Clause 1 and 2 and the information provided to them in accordance with Section 2 Paragraph 3 until December 31, 2024.

(4) The Federal Office for Social Security shall send the Federal Ministry of Health a list of the amounts paid to the Associations of Statutory Health Insurance Physicians immediately after making the payments pursuant to Paragraph 1 Clause 3.

§ 4  Transparency

The Associations of Statutory Health Insurance Physicians must send the Federal Ministry of Health the following information every month via the National Association of Statutory Health Insurance Physicians: 1. the number of cases in which investigative bodies and senders have charged them for remuneration or shipping costs, 2. the amount of administrative costs according to § 2 paragraph 6 and 3. the number of cases in which investigation bodies and senders have charged them a fee or shipping costs and in which the transmission of information pursuant to Section 1 paragraph 1 sentences 1 and 2 refers to outbreak investigations carried out or supported by state health authorities or the Robert Koch Institute within the meaning of § 2 paragraph 1 sentence 6 or event-related full genome sequencing by health authorities within the meaning of § 2 paragraph 1 sentence 7.

§ 5  Evaluation

This ordinance is continuously evaluated on the basis of current epidemiological findings.

§ 6  Coming into effect, expiration

This regulation comes into effect on January 19, 2021 and expires on September 30, 2022. A data transmission according to § 1 paragraph 1 to the Robert Koch Institute is permitted for the last time on June 30,


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