Who determines the medical standard?

The gap between what is medically feasible and what can be financed in practice

Berlin (pag) – The medical standard is important for the individual treatment of the patient, but also for good and fair care. The problem: Physicians determine it differently than economists or possibly ethicists. It is particularly tricky for physicians when the requirements of liability and social law collide. A conference in Berlin shows that the exchange between the disciplines is overdue, but also very laborious.


Who determines the medical standard?


Prof. Christiane Woopen and Prof. Christiane Woopen have dealt with the different interpretations of the medical standard. Christiane Woopen and Prof. Christian Katzenmeier-led expert group deals. The group presents its work at a conference in Berlin.

No patent solution has been found, Katzenmeier dampens expectations. It is important to raise awareness of the problem. The jurist's words are correspondingly forceful in his lecture – which makes it all the more regrettable that hardly any political representatives are present at the event, which focuses in particular on the divergences between social and liability law. This is not an academic problem, because the tensions between due diligence and economic considerations are pressuring physicians and having a detrimental effect on patient care, according to the tenor of the event.

The gap between "promise and fulfillment"

Katzenmeier states that liability law is oriented toward what is medically feasible and thus tends to demand optimal treatment. On the other hand, according to social security law, benefits may only be provided if they are necessary and economical. He formulates the explosive question: "If the financing of the medical standard by health insurance companies is no longer secured, the legal system may oblige the physician to take measures that he may not be able to liquidate?"

With the currently full health insurance funds, such cases are rarely brought before the courts, but that will change in the future, the legal scholar predicts. In view of rising costs, limited financial resources and medical progress, he sees a gap in the health care system between what is theoretically feasible in medicine and what can be financed in practice – "a gap between promise and fulfillment". In the future, physicians will have to consider not only the benefit for the individual patient, but also the effects on society as a whole, when determining indications.

Prioritization instead of hidden rationing

Katzenmeier considers rationing unavoidable. However, the doctor on site, who decides whether to heal or save a specific human life, is morally overburdened by the withholding of effective medical services. The place of decision is the health policy discourse. Instead of the currently practiced covert rationing, the expert advocates a prioritizing procedure. This could bring more transparency, rationality, accountability and acceptance to patient care.

It is striking that the biggest battles at the conference are not fought between ethicists and economists or doctors and lawyers, but within the legal science guild. The ideas of the social law expert Prof. Katzenmeier are particularly far-reaching. Thorsten Kingreen, University of Regensburg, and the legal advisor to the Federal Joint Committee (G-BA), Dr. Dominik Rothers, apart.

Constitutionally tricky

According to Kingreen, the discrepancy between social-law and liability-law standards can lead to a constitutional dilemma. "It is constitutionally tricky if a doctor were to be held liable for treatment that he was obliged to provide under liability law according to the standards of the guidelines, but which he would not be allowed to provide at all under health insurance law due to a lack of cost-effectiveness." He cautions against minimizing this discrepancy by imposing educational obligations on physicians, because that would push the tension into the doctor-patient relationship. The idea of making the standard under health insurance law the yardstick for liability law is also problematic in Kingreen's view – because of the disputed democratic legitimacy of the G-BA. The committee's legal counsel, on the other hand, believes a problematic divergence between social and liability standards is contrived. The discrepancy does not cause problems because both draw from the same source, evidence-based medicine.

Language problems and implicit economic influences

In the discussion, Prof. Ina Kopp, guideline expert of the Association of Medical Scientific Societies, a language problem that makes communication between the disciplines difficult: In medicine – for example, in guideline work – there is never any talk of standards, "we always talk about quality.". There is "a delta" between what is assessed as a benefit in terms of quality in medicine and what the G-BA can cast into guidelines for feasibility reasons alone.


Who determines the medical standard?


Implicit economic influences are another issue. For the health economist Prof. Jurgen Wasem, lack of health economic evaluations in the measurement of the standard is one of the reasons that the G-BA runs the risk of implicit economic considerations in benefit assessment. "Only he hides that in an appropriate design of the benefit assessment." Wasem urges better transparency about costs, "otherwise we are lying in our pockets as a society".

Vera von Pentz, judge at the Federal Court of Justice and deputy chairwoman of the VI. Civil senate, warns against an economic infiltration of the liability-legal care requirements. "In our Senate, we have the impression that the standard is being creepingly lowered."This is what happens when a medical expert considers a service to be no longer necessary because it is not eligible for reimbursement under the statutory health insurance system and is therefore practiced less and less frequently. If he does not disclose this in the expert opinion, the judges would have no chance to recognize that the standard of care relevant under liability law was influenced by the lower standard under social law. A convergence of standards is taking place – without anyone, except the expert, making a decision.

"It's not good," says Vera von Pentz.


Who determines the medical standard?


The physician: "The patient cannot be standardized"
Prof. Hans-Detlev Saeger, former director of the Clinic for Visceral, Thoracic and Vascular Surgery at Dresden University Hospital
"The standard needs constants – but which ones??", asks Saeger. He mentions, among other things, the keywords evidence-based medicine, guidelines, quality assurance, value-based medicine, but also the cost-effectiveness requirement. Personalized medicine does not make it easier to determine a standard. The doctor stresses that waiting – "and not hammering in the knee replacement right away" – or even skipping therapy can also be standard in certain situations. Basically: "The patient cannot be standardized."


Who determines the medical standard?


The medical reviewer: operating on the learning curve
Prof. Hans-Friedrich Kienzle, Chief Physician of the Surgical Clinic Cologne-Holweide i.R.
From the medical expert's point of view, it is a matter of determining the standard for the specific individual case. "In the appraisal, standards are tested, not developed," he says. The specialist standard, guideline and guidelines and documentation play a role in the test. "A huge problem" is posed by a standard in development, says Kienzle – for example, when new surgical methods are used, but they are not yet in widespread use. In such cases, education plays a particularly important role. Closely related to this is the problem of the learning curve. The expert's rhetorical question: "Who wants to be operated on the learning curve??"


Who determines the medical standard?


The social judge: "The individual case can be lost from view"
Dr. Anne Barbara Lungstras, Judge at the Social Court of Berlin
The standard usually becomes relevant in social courts when it is a question of which new therapies may be provided at the expense of the SHI system. Using the example of the head orthosis, the judge depicts the conflict between what the doctor advises and what the health insurance company pays for. The quality imperative and the cost-effectiveness imperative formed the pillars of standard setting in Social Code V. The standard is not determined on a case-by-case basis by the individual physician, but rather by a preliminary decision. "The idea can get out of sight," admits the judge. Exceptions – "Santa Claus", rarity and system failure cases – served as "cushioning". According to Lungstras, quantity-limiting measures have nothing to do with the standard provision in SGB V; they do not restrict the SHI benefits catalog in any way.


Who determines the medical standard?


The liability judge: a physician's corridor of action
Wolfgang Frahm, presiding judge at the Schleswig Higher Regional Court
Frahm cites the following criteria for determining the standard: Diligence of the physician, concrete treatment situation, individual needs of the patient, the point in time (ex ante), professional knowledge and experience as well as the limitation to the relevant field of expertise. The judge emphasizes that the doctor is allowed to move within a corridor – from the gold standard to treatment that is still adequate. In court, experts play an important role; it is important for them to have equal expertise, outstanding expertise, objectivity and impartiality. The Federal Court of Justice grants legal norm quality to G-BA guidelines, says Frahm. "What it says is the minimum standard – also for privately insured patients."


Who determines the medical standard?


The ethicist: Treatment alliance between doctor and patient
Prof. Christiane Woopen, ceres University of Cologne
Woopen considers patient welfare to be of central importance. The German Ethics Council has defined three elements for this: care that enables self-determination, good quality of treatment, and equity of access and distribution. Physician and patient form a "treatment alliance" on the basis of which. The ethicist would like to see this fact taken into account as early as the research stage, for example in the definition of outcome parameters. Benefit assessments, guidelines and co., The fact that the medical standard is developed on the basis of this alliance still falls short in this respect, she criticizes. "For ethics, patient preferences are from the outset a genuine component of what should be included in a medical standard."It is essential to inform patients about possible treatment alternatives.


Who determines the medical standard?


The economist: The illusion of not rationing
Prof. Jurgen Wasem, University of Duisburg-Essen
According to pure health economics, the decision on whether new services should be reimbursed by the SHI system would have to be based on a comparison of society's willingness to pay for innovations and their cost-benefit ratio. The usual outcome measure for this is QALYs. With their determination social conception of justice could be considered by weights. In this country, however, there are no threshold values for society's willingness to pay. Wasem appeals: "We need results of economic evaluation as an information basis for a qualitative social decision-making process."It is regrettable that in fact no reasonable health economic evaluation is made in the measurement of the standard. "This gives the illusion that we don't ration and make everything."

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