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Laboratory reform counteracts the WHO hepatitis C elimination strategy in Germany
Jan Kramer1,2, Ingmar Wolffram3, Uli Früh4
1Accredited Laboratories in Medicine (ALM) e.V., Berlin, Germany.
Insights
A German laboratory reform led to a 9.4% decrease in hepatitis C virus (HCV) screening tests, hindering the WHO
Area of Science:
- Hepatology
- Public Health Policy
- Healthcare Economics
Background:
- The World Health Organization (WHO) aims to eliminate chronic hepatitis C by 2030.
- Adequate screening is crucial for detecting undiagnosed hepatitis C virus (HCV) infections.
- Anti-HCV antibody testing is a primary screening method.
Purpose of the Study:
- To analyze the impact of a German nationwide laboratory reform on the ordering of anti-HCV tests.
- To assess how changes in reimbursement policies affect viral hepatitis screening.
- To evaluate the reform's alignment with the WHO's hepatitis C elimination goals.
Main Methods:
- Retrospective analysis of 510,656 anonymized patient datasets.
- Comparison of anti-HCV test orders before and after the laboratory reform.
- Inclusion of data from January-September 2017 and January-September 2018.
Main Results:
- A 9.4% decline in anti-HCV tests was observed in the post-reform period (Q1-Q3 2018 vs. Q1-Q3 2017).
- A 7.4% decline in HBsAg tests suggests a general reduction in laboratory orders, not specific to HCV.
- The reform's cost-reduction objective appears to be lowering screening test demands.
Conclusions:
- The German laboratory reform has inadvertently reduced essential hepatitis C screening.
- Political decisions in healthcare significantly influence public health initiatives like viral hepatitis elimination.
- Current policies may counteract the WHO's hepatitis C elimination strategy in Germany if unchanged.
Abstract:
The World Health Organization and the German government have announced an initiative to eliminate chronic hepatitis C until the year 2030. To reach this goal, one important step is adequate screening and detection of so far undiagnosed infections. The most common initial test is anti-HCV. This parameter was extra-budgetary reimbursed by statuary healthcare insurances in the past. However, this policy has changed after a nationwide laboratory reform which should reduce the laboratory costs of patients insured in the statuary healthcare insurances. We therefore analysed the impact of the laboratory reform on the order of anti-HCV tests in 510 656 anonymized patient data sets before and after the initiation of the reform. The number of anti-HCV tests declined by 9.4% in quarters I-III 2018 in comparison with the same time period of the year 2017. The number of HBsAg tests declined by 7.4%, 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 scenario is an important example, how political decisions of the medical self-government influence the screening setting for viral hepatitis: if the current policy is not changed, the laboratory reform directly counteracts the WHO hepatitis C elimination strategy in Germany.
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