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Defining 'medical necessity' in an age of personalised medicine: A view from Canada
Timothy Caulfield1, Amy Zarzeczny
1Health Law Institute, University of Alberta, Edmonton, Alberta, Canada.
Insights
Defining medical necessity in Canadian healthcare is complex, especially with personalized medicine. Physicians face challenges in defining genetically-informed medical necessity, potentially impacting cost savings.
Area of Science:
- Health Policy
- Genetics
- Healthcare Systems
Background:
- Medical necessity is crucial for healthcare funding decisions in Canada.
- Defining and implementing medical necessity presents significant challenges.
- Personalized medicine introduces new complexities to healthcare policy.
Purpose of the Study:
- To explore the challenges of defining medical necessity in the context of personalized medicine.
- To analyze the implications of genetically-informed medical necessity for healthcare policy and physician obligations.
Main Methods:
- Conceptual analysis of medical necessity in Canadian healthcare.
- Examination of the impact of personalized medicine on healthcare policy.
- Discussion of physician's legal and ethical roles in defining medical necessity.
Main Results:
- Medical necessity remains difficult to define and operationalize.
- Personalized medicine is expected to exacerbate these definitional challenges.
- Physicians will play a key role in defining genetically-informed medical necessity.
Conclusions:
- The integration of personalized medicine complicates the established concept of medical necessity.
- Physicians' obligations may limit the anticipated cost-saving benefits of personalized medicine.
- Clearer policy frameworks are needed to address genetically-informed medical necessity.
Abstract:
The concept of medical necessity plays a central role in many healthcare systems, including Canada's, by helping determine which healthcare services will receive funding. Despite its significance in health policy frameworks, medical necessity has proven to be notoriously difficult to define and operationalise. A shift toward a more personalised and genetically-informed approach to the provision of healthcare seems likely to heighten associated policy challenges. One of the stated goals of personalised medicine is to save healthcare systems money by facilitating the use of less and more effective treatments. However, any cost saving potential may ultimately be thwarted by physicians' legal and ethical obligations, given that physicians will inevitably be required to implement and define the bounds of genetically-informed medical necessity for their patients.
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