Bad Heart Devices: good deals for clinics?

With probably thousands of patients, a cardiac device had to be replaced due to injury. The manufacturer claimed to provide a free replacement. But many clinics let the devices pay.

By Oda Lambrecht, Christian Baars, NDR

When Klaus Schmidt from Münster received the message that he was perhaps carrying a defective heart apparatus, this was a shock. Two years ago, in October 2016, the US manufacturer St. Jude warned that the batteries of the devices could unload unexpectedly.

Klaus Schmidt was scared because he was relying on his special pacemaker. It is an implanted defibrillator, a kind of mini shock device. When his heart races, the device sends a powerful push to normalize the heartbeat. If the battery runs out of sight, the unit could not react in case of emergency. After the warning of the product, his doctors decided to replace the device. Klaus Schmidt had to be operated on again.

AOK-Federal Association: clinics enrich

After research by NDR, WDR and the "Süddeutsche Zeitung" clinics were able to pay for equivalent replacement devices from health insurance companies, even if they were provided free of charge by the manufacturer. The federal badociation of AOK accuses hospitals of unjustifiably enriching it. However, how many patients have had such an exchange is not clear. The AOK badumes that, out of more than ten thousand patients in Germany, the devices used have been changed due to the battery problem. We do not know how many really exist. The manufacturer did not respond on request.

Here's how billing presents itself, says Jürgen Malzahn, of AOK, who said that these foreign exchange transactions in the coffers on a fixed amount would be charged – on the lump sum. In this amount, for example, 11,000 euros, then the total operating costs are included, ie the personnel costs, but also the cost of the replacement device for an amount of approximately 7,000 euros.

Hospitals charge for free replacement devices

In this way, clinics get money from crates that they have never spent before. So you make an extra profit. The Federal Association of AOK believes that this is not justified and requires the deduction of equipment costs from the lump sum in case of serial damage.

In the only case of defective defibrillators, Malzahn estimates the damage done to the AOK to several tens of millions of euros. But this is not an isolated case, says Malzahn. There are several serial anomalies per year for different medical devices such as hip prostheses or bad implants. AOK suspects that clinics are also installing here.

The hospital society supports the AOK

The Association of German Hospitals, which groups together the higher and national badociations of hospital operators, shares the opinion of the AOK that this cost advantage is not attributed to clinics. Upon request, she announced that hospitals should inform the funds of these cases and reduce billing based on equipment costs.

However, a number of clinics do not see it that way. The federal badociation of AOK is trying for two years to collect money again. This seems like a tedious undertaking. Jürgen Malzahn says that most clinics would not even inform health insurance companies, so they do not even know if and where replacement devices would be used after a series of injuries.

Medical lawyer: non transparent billing system

The forensic physician Andreas Spickhoff of the Ludwig-Maximilians University of Munich also considers the billing system as non-transparent in many ways. Clinics are in fact obliged to inform health insurance companies if they exchange defective devices. If clinics did not report such cases, it would be "perfectly illegal", according to Spickhoff.

Jürgen Malzahn, of AOK, criticizes the fact that there is no appropriate sanctions. If the clinics did not fulfill their reporting obligations, it would have had no consequence so far. He therefore asks for the introduction of a fine.

First refund

In practice, the AOK reads information about public safety or, as in the case of battery problems, safety information provided by the manufacturer, explains Malzahn. In this case, the clinics would be contacted. Many have reacted only under pressure from law firms, for example. After all, after two years, about half of the hospitals have reimbursed the cost of AOK replacement heart defibrillators.

One of the first was the Klinikum Oldenburg. He shared on request of NDR, WDR and "SZ" with, it was important for him to repay the money, so that the insured community is not harmed. There was "no involuntary enrichment" wanted.

Some clinics persistently refuse

Apparently, other clinics are still negotiating with the AOK, some refuse to provide information to NDR, WDR and "SZ", however, persistent. The reporters asked for some of these houses as an example. Concrete questions about alternative defibrillator billing were answered either not at all, or simply with a general statement.

The basic argument: the actual processing costs are not important for a flat rate settlement. If the devices are defective and need to be replaced, the cash registers may be able to reimburse the full replacement cost of the manufacturer. But the problem for insurance companies: they usually do not know when and where an exchange is made because of a series of damage.

Clinic and manufacturers benefit

In this respect, clinics and device manufacturers have benefited from the current practice, says Andreas Spickhoff. The producer has given free replacement devices to the clinics, hoping that they "perform the replacement surgery silently" and give full account of it, says the lawyer. The manufacturer then has lower costs than he's wholly responsible and the clinics would have a bigger profit.

Spickhoff therefore speaks of a "tangled system" and sees the required policy. In his opinion, they must change the laws so that free replacement devices can not be billed at the end of the checkout.

Gesundheitsministierum does not see the need to act

However, the Federal Ministry of Health seems to consider that clinic actions are legal. In response to a request for NDR, WDR and "SZ" informed the ministry that the "average cost" would be paid. In that regard, it was irrelevant, in the case of invoicing, to determine whether those costs "also occur in each particular case". This means that, from the ministry's point of view, clinics continue to be allowed to charge for the complete replacement of equipment, even if it was provided to them free of charge.

The magazine ARD Panorama reports on this topic – today at 21:45.