[Medical Methods: What Makes them Medically Necessary? Part II: Further Criteria, Overuse, Moving Thresholds, and...

Area of Science:

• Health Services Research
• Medical Ethics
• Social Medicine

Background:

• The concept of "medical necessity" (MedN) lacks precise definition, impacting healthcare regulation.
• Part I established efficacy, net benefit, and evidence as obligatory MedN criteria.
• This study, Part II, proposes and evaluates additional criteria for a more robust MedN framework.

Purpose of the Study:

• To concretise the concept of medical necessity (MedN) for healthcare regulation.
• To suggest and discuss further criteria beyond obligatory ones for defining MedN.
• To support Germany's statutory health insurance system with a refined MedN concept.

Main Methods:

• Critically assessed additional MedN criteria including effectiveness, routine care acceptance, beneficiaries, theoretical basis, cost, and availability of alternatives.
• Examined patient-related factors: self-responsibility, cooperation, and preferences.
• Considered potential for mis- and overuse, such as "indication creep" and "disease mongering".

Main Results:

• Additional criteria (effectiveness, acceptance, cost, patient factors) do not solely establish or exclude MedN.
• If obligatory criteria (efficacy, benefit, evidence) are not met, further criteria cannot reverse the rejection of MedN.
• Methods meeting obligatory criteria are not inherently "more or less necessary" based on these additional factors.

Conclusions:

• While advocating for a binary MedN concept, not all medically necessary methods possess equal clinical relevance.
• Further criteria help contextualize MedN but do not alter its binary determination.
• Prioritization techniques can assess differences in relevance within the established range of MedN.