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Practice Sues German Reimbursement Administrator Over Unpaid Sanger Dx Tests Coupled With Free NGS

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NEW YORK (GenomeWeb) – Reimbursement for next generation sequencing-based hereditary disease testing by Germany's statutory health insurance system remains in limbo after a committee twice postponed an update of the existing reimbursement catalog, citing the complexity of recent technological advances in the field.

A number of German laboratories have continued to offer NGS-based testing to patients, and some have billed insurance for initial diagnostic Sanger sequencing tests, which are reimbursable under the current rules, while offering NGS panels free of charge. But at least one lab has run afoul of its regional public health insurance reimbursement administrator for doing so. 

Praxis für Humangenetik Tübingen, a medical genetics practice closely aligned with molecular diagnostics firm CeGaT, is now suing its regional administrator, Kassenärztliche Vereinigung Baden-Württemberg (KVBW), which has refused to pay for more than 1,000 Sanger-based diagnostic tests that were followed by free NGS panels.

While labs offering NGS-based panel or exome testing for diagnosing rare genetic diseases maintain that their tests have a higher diagnostic rate than Sanger-based approaches, and save money in the long run by avoiding further testing and unwarranted therapies, payors and other stakeholders in Germany have balked at the ballooning costs of NGS-based tests, expenses they say need to be cut elsewhere in the system.

NGS-based molecular genetic disease testing is currently not reimbursable under Germany's statutory health insurance system, though individual sickness funds (Krankenkassen) have paid for it on a case-by-case basis.  

Two years ago, the Evaluation Committee (Bewertungsausschuss), which maintains a catalog of codes for reimbursable medical services called Unified Evaluation Standard (EBM), decided that as of October 2013, labs could only bill for Sanger sequencing-based but not NGS-based genetic tests for the detection of disease-relevant mutations.

Up until then, the code, No. 11322, which is part of the human genetics chapter of the EBM, did not prescribe Sanger sequencing, so a number of labs billed for NGS-based tests under the code.

Following the change, some genetic testing labs, including CeGaT, kept performing diagnostic NGS panels but only billed insurance for Sanger sequencing to fill underrepresented regions in the panel. According to Dirk Biskup, co-founder and co-CEO of CeGaT, KVBW was initially willing to reimburse for this but stopped doing so in early 2014, arguing that only stepwise diagnostics that start with Sanger sequencing are reimbursable under the new rules.

CeGaT went on to perform such stepwise diagnostics, but in cases where test results were negative, offered patients and their doctors NGS panels free of charge. Praxis für Humangenetik Tübingen, which is headed by Saskia Biskup, CeGaT's other founder and CEO, and is closely aligned with the company, only filed reimbursement claims for Sanger testing.

KVBW has been denying payments for these tests for more than a year. After filing several objections, the practice sued the authority earlier this year in the social law court Stuttgart. According to Dirk Biskup, no court date has been set yet.    

CeGaT says the practice is entitled to reimbursement for Sanger sequencing tests that were ordered by a doctor, even if it later offered NGS panels free of charge.

"We were ordered to do Sanger sequencing, and we want to get paid for Sanger sequencing," Biskup said. "We only filed claims for Sanger sequencing, never anything else. We never used the 11322 code for NGS."

CeGaT maintains that NGS panels are in the best interest of patients, and it will continue to provide panel testing in cases where Sanger testing provides no answer. "From a medical point of view, we are absolutely convinced that NGS is the right way," Biskup said. "The doctors who send us samples want a diagnosis for their patients to treat them as well as possible."

One solution to keep total costs for human genetics services in check, Biskup said, would be to prohibit Sanger sequencing for certain heterogeneous diseases that can be caused by dozens of genes, such as epilepsy or neuromuscular diseases, and instead reimburse a fixed amount for NGS panels covering these disorders. "You would save money [overall], because if you have a fixed fee per patient, you would save a lot of money on Sanger sequencing," he said.

To offset losses by many human geneticists who currently rely on Sanger sequencing for much of their income, he said, insurance could raise reimbursement for genetic counseling services these doctors provide, which are currently reimbursed at low rates. 

A spokesperson for KVBW declined to comment for this article, but in a newsletter for doctors and medical personnel published in July, the organization explained its position to some extent.

Claims it received for human genetics services increased from €5 million in the third quarter of 2009 to just under €15 million in the third quarter of 2013, mostly from molecular genetic tests, KVBW said, draining resources from other medical areas.

Molecular diagnostic tests should thus only be ordered if the chances of detecting the disease cause and starting differential therapy based on the results are high, according to the newsletter.

In particular, panel diagnostics without prior stepwise diagnostics is prohibited, KVBW said, and if such parallel testing is primarily intended by the ordering doctor, "it cannot be legitimized by changing the order, after consulting with the laboratory, to stepwise diagnostics and offering additional panel diagnostics free of charge or at inadequately low costs."    

While Praxis für Humangenetik Tübingen's legal dispute with KVBW is ongoing, the company and several other German laboratories, including Centogene in Rostock and the Center for Human Genetics and Laboratory Diagnostics (MVZ) in Martinsried, continue to provide NGS-based diagnostic hereditary disease testing, and some have turned increasingly to international markets and patients covered by private health insurance.

In the meantime, the Evaluation Committee is dragging its feet on updating the reimbursement catalog. Following its decision to exclude NGS and other high-throughput technologies two years ago, the committee said it established a working group to overhaul human genetics services covered under the EBM to adjust them "to the state of the art of science and technology" by July 1, 2014. Industry observers widely expected that this would lead to the inclusion of NGS.

However, the committee postponed the deadline twice, first to April 1, 2015, and again this spring, to March 31, 2016. In a note accompanying the latest delay, the committee said deliberations to adjust human genetics services to the state of the art of science and technology "requires more time because of their complexity."

As of October 1, the committee also further decreased reimbursement levels for molecular genetic tests in order to finance newly established reimbursement for human genetics counseling and interpretation services.

 

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