Laboratory reform counteracts the WHO hepatitis C elimination strategy in Germany

Kramer et al., 2019 (akzeptiert zur Publikation im Journal of Viral Hepatitis)

Jan Kramer1,2, Ingmar Wolffram3, Uli Früh4, Olaf Bätz2, Thomas Berg5, Johannes Wiegand5
1) Accredited Laboratories in Medicine (ALM) e.V., Invalidenstraße 113, 10115 Berlin; 2) LADR Laboratory Group Dr. Kramer & Colleagues, Lauenburger Str. 67, 21502 Geesthacht; 3) Querweg 47, 33098 Paderborn; 4) WCG Consulting, Obere Wässere 1, 72764 Reutlingen; 5) Klinik für Gastroenterologie, Universität Leipzig, 04103 Leipzig

Address of correspondence:
Prof. Dr. Johannes Wiegand
Universität Leipzig, Klinik für Gastroenterologie
Liebigstr. 20
04103 Leipzig
Tel.: +49-341-9712330
Fax: +49-3419712339

After the invention of direct antiviral agents (DAA) to treat chronic hepatitis C infection the World Health Organization has announced an initiative to eliminate the infection until the year 2030 (1). This initiative has been adapted to Europe and Germany by the HCV Elimination Manifesto and the national “BIS 2030 Strategie” of the German Government (2, 3). To eliminate HCV infection, two major principles must be fulfilled:

(i) adequate early laboratory testing to detect so far undiagnosed infections and

(ii) adequate treatment with direct antiviral agents (4).

The latter is already possible in Germany, because the German health care system allowed reimbursement of all different DAA regimens after marketing authorization without major restrictions which induced a dramatic decline of patients listed for liver transplantation due to HCV induced cirrhosis (5) and has shifted the spectrum of HCV infected patients to early disease stages with absent or minimal fibrosis (6).

However, adequate screening and detection of so far undiagnosed infections still need improvement. Early detection strategies in the primary care setting, which is the most important entry level to the health care system in Germany, have recently been evaluated and rely on the testing of anti-HCV in serum as screening parameter for risk patients and patients with elevated aminotransferases (7). In the past, anti-HCV testing was extra-budgetary reimbursed by statuary health care insurances and not taken into account when the laboratory budget of each outpatient physician was estimated. This policy has changed since 1st April 2018: Here, a nationwide laboratory reform initiated by the Association of Statutory Health Insurance Physicians(“Kassenärztliche Bundesvereinigung (KBV)”) was established which should reduce the demands of blood samples and because of that the laboratory costs of patients insured in the statuary health care insurances.

The reform determines lower and high laboratory costs per lab-order for each medical group (e. g. for primary care physicians, internal medicine doctors, gynecologists, etc.) in the outpatient field. These values are specified by the KBV and they are fixed for a longer time. If an individual outpatient physician has laboratory costs below the lower value of his peer-group (i. e. a primary care physician in the group of primary care physicians), a gratuity will be paid 100 %. If an individual outpatient physician has laboratory costs over the high value of his peer-group, a gratuity will not be paid (0 %).If the lab costs are between the lower and high value, the gratification is paid pro rata.

Thus, it is attractive to order a priori as few laboratory tests as possible in order to be below the mean laboratory costs of the peer group at the end of the reference period. In addition to this policy, the reimbursement strategy of the anti-HCV test was changed: Now, anti-HCV in serum (code: EBM 32618) is not an extra budgetary test any more, but is included in the laboratory budget and is therefore relevant for the budget calculation. In contrast to anti-HCV, the status of HBsAg as screening parameter for chronic hepatitis B infection has not been changed, and HBsAg is still extra-budgetary (code: EBM 32781). We therefore analyzed the impact of the laboratory reform on the order of anti-HCV tests in large laboratory institutes.

“ALM  e.V.” is the professional association of Accredited Laboratories in Medicine in Germany ( and includes > 200 medical laboratories. We analyzed the number of anti-HCV tests (code: EBM 32618) in 510.656 anonymized patient data sets of the quarters I/2018 (the quarter before the initiation of the laboratory reform), and II and III/2018 (the first two quarters after the initiation of the laboratory reform), in comparison to the number of anti-HCV tests in the quarters I–III of the year 2017. Due to the number of participating laboratories and the number of analyzed patient data sets the results are considered to be representative for Germany.

The number of anti-HCV tests ordered by physicians of the outpatient setting declined by 9.4 % in quarters I–III 2018 in comparison to the same time period of the year 2017 (figure 1). The number of tests declined already in quarter I/2018, because announcements on potential economical disadvantages were released prior to the start of the laboratory reform. The number of ordered HBsAg tests has declined by 7.4 % in the same observation period, indicating that the reduced anti-HCV laboratory orders are not parameter-specific, but most likely a surrogate of the intention of the laboratory reform to generally lower the demands of blood samples and laboratory costs.

Thus, the laboratory reform impairs successful hepatitis screening strategies and might also affect the regulatory reporting of HCV infections to the National Institute of Infectious Diseases (Robert Koch Institut). The German Society of Gastroenterology (DGVS) has addressed this issue to the Association of Statutory Health Insurance Physicians and demands that at least the anti-HCV test is excluded again from the laboratory reform and re-classified as an extra-budgetary screening parameter. If the current policy is not changed, the laboratory reform directly counteracts the WHO hepatitis C elimination strategy in Germany.

Relative number of anti-HCV (EBM code 32618) and HBsAg (EBM code 32781) laboratory requisitions in comparison to the quarter of the preceding year

Figure 1: Relative number of anti-HCV (EBM code 32618) and HBsAg (EBM code 32781) laboratory requisitions in comparison to the quarter of the preceding year



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