The field of advanced molecular diagnostics, including next-generation sequencing (NGS), has had a complicated history in Germany. When we performed research on this field late last year, stakeholders painted a relatively bleak picture of the country’s market access landscape for such testing. This stemmed in large part from a decision by the Evaluation Committee (Bewertungsausschuss; BewA) – the entity tasked with managing the ambulatory sector’s Uniform Value Scale (Einheitlicher Bewertungsmaßstab; EBM) – to stop reimbursing various such tests from October 2013. The decision followed a cost study of genetic medical services, which led the Committee to conclude that then current rates of reimbursement were creating a positive contribution margin for laboratories, who had over time achieved cost efficiencies.

The EBM never included a dedicated code for NGS tests. Instead, until October 2013, laboratories were able to use code 11322, which broadly covered sequencing-based tests designed to screen for genomic mutations. However, this stopped being possible from October 2013, with code 11322 reserved exclusively for Sanger-sequencing based tests. In addition, the Committee confirmed that codes 11320 and 11321, covering probe hybridization and the Polymerase Chain Reaction (PCR), respectively, could no longer be used for microarray testing. As a result of the changes brought about by the Evaluation Committee, high-throughput testing only become reimbursable through the public sector when used as part of a step-wise diagnostics strategy in a number of defined indications such as cystic fibrosis and hereditary breast and ovarian cancer, where such testing would be used to confirm Sanger sequencing. All three codes -11320, 11321 and 11322 – also had their reimbursement rate ceilings decreased by 30%.

This reality forced some laboratories to revert to older technologies relying on single-gene tests, prompting outrage from stakeholder groups such as the Germany Society of Human Genetics and the Association of German Human Geneticists, who went on to lobby for change. As part of its 2013 decision, the BewA also announced the intent to task a working group with a broader overhaul of genetic testing items on the EBM, to be completed by 1 July 2014.

A generally positive overhaul

Although the deadline for this overhaul was subsequently postponed a number of times, in March 2016 the Committee introduced major changes to Chapter 11 of the EBM, that portion concerned with human genetics. From 1 July 2016, NGS is now reimbursable, both in diagnosis of hereditary diseases and for analysis of tumor genetics. A key change is that individual entries in the EBM are henceforth methodology agnostic: they are defined with reference to the underlying genetic mutations, rather than in terms of specific testing technologies. Another boon is that, until June 2020, tumor genetic testing and companion diagnostic testing in general will be reimbursed via a separate budget, so that increased utilization does not compromise their point value in the EBM.

Because the EBM historically lacked a degree of granularity enabling identification of specific molecular tests, this created sufficient ambiguity for the insurance sector to challenge the billing of some testing. Laboratories historically had to rely on piecing together a long list of codes from the EBM in order to fully capture the discrete stages associated with testing, identical to the so-called “code stacking” phenomenon in the US. The move toward a test-agnostic framework will hopefully help to address this issue.

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Some remaining discontent

Current discontent surrounding the new changes focuses on some of the fine print: going forward, prior authorization will be required for reimbursement of tests of more than 20 kilobases of DNA when analyzing tumor genetics, and of more than 20 kilobases when diagnosing hereditary diseases. What is more, there are specific exclusions on certain forms of testing, including those based on circulating cell-free DNA and pharmacogenomics (i.e. tests which examine how genetic variants may impact drug response).

The DNA length restrictions will force labs to be creative, who may choose to run tests on larger panels but limit analysis to the relevant number of kilobases – with subsequent prior authorization or patient out-of-pocket payments potentially necessary if the first test is inconclusive. Notably, the German Federal Ministry of Health has objected to the prior authorization requirement, prompting the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) to file suit.

An improving, if imperfect, access landscape

The changes ushered in by the BewA represent a positive course correction for the molecular diagnostic field in Germany. The kilobase restrictions notwithstanding, the new framework puts the country’s market access landscape for advanced molecular diagnostics on par with other likely “early adopter” countries. In the US, for instance, there is a great deal of uncertainty surrounding the clinical utility of the more advanced forms of testing, meaning that where they have chosen to cover panel tests, payers have often restricted usage to narrow population groups.

In this broader sense, access to molecular diagnostic testing remains frustrated, with reimbursement frameworks needing to catch up to the science, or the science needing to achieve additional breakthroughs which make it more conducive to how healthcare systems work.

But for the German doctor in our research who opined that “As an innovative country, [Germany is] a developing country in terms of molecular testing,” the latest changes should go some way in restoring faith.