With the new regulatory requirements, the complexity for medical technology companies increases: After the publication of the Medical Device Regulation (MDR), which will come into force on May 26, 2020, additional requirements have been imposed by German legislation (Medical Device Adaptation Act (MPAnpG-EU) and Medical Device Implementation Act ( MDG) presented.
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The Patients' Perspective
Sabina and Jan Casagrandes say they've had really good care from the German health system. And they've used it a lot.
Sabina is American, Jan is German. They live in a fourth-floor walkup with their two little girls in Cologne, an ancient city on the Rhine in western Germany.
"I've probably been very expensive for the health insurance system here," Sabina says. "When I was 33 years old, I had a giant lump on my neck all of a sudden, where your thyroid is. And it was a big tumor."
It took two operations to remove her cancer. Luckily it was curable with surgery and radiation. Sabina says she had the best care she could imagine.
"Then I came home to my little daughter, who I couldn't really lift up because of my neck having been cut open," Sabina says. "So I asked my doctor, 'What can I do?' And she said, 'Well, your health insurance will pay for someone to come help you in the house.'"
Sabina's health insurer paid a friend to shop, cook and even help care for the baby until Sabina was back on her feet. That's not unusual in Germany. In fact, under the country's system for long-term care, family members can choose to be paid for taking care of a frail elder at home if they want to avoid nursing home care.
Coverage For All
The health care system that took such good care of Sabina is not funded by government taxes. But it is compulsory. All German workers pay about 8 percent of their gross income to a nonprofit insurance company called a sickness fund. Their employers pay about the same amount. Workers can choose among 240 sickness funds.
Basing premiums on a percentage-of-salary means that the less people make, the less they have to pay. The more money they make, the more they pay. This principle is at the heart of the system. Germans call it "solidarity." The idea is that everybody's in it together, and nobody should be without health insurance.
"If I don't make a lot of money, I don't have to pay a lot of money for health insurance," Sabina says. "But I have the same access to health care that someone who makes more money has."
But she acknowledges that nearly 8 percent of her salary is a sizable bite.
"Yes, it's expensive. You know, it's a big chunk of your monthly income," Sabina says. "But considering what you can get for it, it's worth it."
Actually, it's about the same proportion of income that American workers pay, on average, if they get their health insurance through their job. The big difference is that U.S. employers pay far more, on average, than German employers do — 18 percent of each employee's gross income versus around 8 percent in Germany.
More Added Benefits In Germany
Moreover, German health insurance has more generous benefits than U.S. policies cover. There are never any deductibles, for instance, before coverage kicks in. And all Germans get the same coverage.
For instance, the Casagrandes' insurance covers an expensive medicine Jan needs for a chronic intestinal problem. He says if they moved to America, they might not be able to buy insurance at all because of their pre-existing conditions — a nonproblem in Germany.
"He says for himself — or for us — the health care system in the United States is the major reason why we have never moved there, and never will move there. Because both of us have chronic illnesses that have to have a lot of medical attention, and we would go broke," Sabina says, translating for Jan.
Jan adds something else. "It's also the No. 1 reason in the United States that people personally go bankrupt," Sabina translates, "which would never happen here ... never!"
Coverage For The Family
On the other side of Germany, in Berlin, we meet another couple who know both the American and German health systems.
Nicole and Chris Ertl own Tip Toe Shoes, a children's shoe shop in a well-off area of the German capital. The Ertls sell high-quality European shoes — tiny Italian sandals, French and Danish boots and clogs in wonderful colors.
Chris is from San Diego, Nicole is German. She also works part time as a physician therapist and gets her health care through her job like the great majority of Germans. Like the Casagrandes, she's happy with her coverage.
"It's a good deal!" she says. "It's really good because it's a package."
It's a package many Americans might envy. Nicole pays a premium of $270 a month for insurance that covers her children, too. Nicole pays a single $15 copayment once every three months to see her primary-care doctor — and another $15 a quarter to see each specialist, as often as she wants. She pays no copayments for her children's care ---and her insurance even covers her daughter's orthodontia bill.
"They always have good care," Nicole says, "because for kids, everything is free. The drugs, it's always free" until they turn 18.
Different Rules For The Self-Employed
But even though her insurance covers the kids, it doesn't cover her husband. Because Chris Ertl is self-employed, he has to buy insurance on his own, from a for-profit insurance company.
About one in 10 Germans buy this so-called "private" coverage. It's not just for people who are self-employed. Civil servants and anyone who makes more than $72,000 a year can opt out of the main system. It's a kind of safety valve for people who want more and can pay for it.
But most people don't opt out. Chris says that's because there's a fundamental difference in the way Germans view health care and the government's role — which, in Germany, means refereeing the system and making sure it's fair and affordable.
"The general opinion in Germany is always that the government will do it for us, everything will be OK," Chris says. "In the States, I think you grow up knowing that no one's going to help you do anything. If you want health care, go get it."
It's important to remember that the German government doesn't provide health care or finance it directly. It does regulate insurance companies closely — the nonprofits in the main system and the for-profits where Chris gets his coverage. So Chris' insurer can't raise his rates if he gets sick or jack up his premiums too much as he gets older. The government also requires insurers to keep costs down so things don't get too expensive.
"Where am I better off medically?" Chris says. "I would probably say Germany."
In some ways, Chis Ertl's coverage is better than his wife's. He gets his choice of top doctors — the chief of medicine, if he wants. If he goes into the hospital, he gets a private room. When he goes to the doctor, he gets a free cup of coffee and goes to the head of the line. All this embarrasses him — and annoys Nicole.
"When he goes to the doctor, he has a lot more service," she complains.
Germans really hate any hint of unfairness in health care. The fundamental idea is that everybody must be covered and, preferably, everybody should get equal treatment. So the fact that 10 percent or so can buy some perks is an irritant — something Germans complain about but manage to put up with.
But it's unthinkable that 48 million people wouldn't have health insurance at all — the situation in America. As an American, Chris thinks that's shameful. "It's terrible," he says. "It's unbelievable. It shouldn't happen."
Germans, he says, would never tolerate that. And their system has been working pretty well for 125 years.
