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- Arizona Pathologists, CAP Secures Amendment in Genetic Testing Legislation
The Arizona Society and Pathologists (ASP) and the CAP successfully amended state legislation to protect Arizona pathologists’ scope of practice who conduct genetic testing. The amendment included in the state house bill proposes to regulate non-medical testing with no impact on medical genetic testing, which would cause legal confusion and increase reporting burdens for Arizona pathologists. The amendment will protect pathologists from great legal confusion and regulatory burdens in Arizona.
In a letter to Arizona state house leadership, ASP President Richard Eisen, MD, FCAP, reiterated how “the bill intends to regulate non-medical testing, such as genetic tests offered from private companies (like 23andme Inc.) and not to impact medical genetic testing which is now the standard of care for diagnosing and evaluating appropriate cancer therapies and other complex diseases.” The ASP and the CAP secured an amendment to the bill clarifying that genetic testing will be the exclusive property of the person testing and only when it is “not the subject to the federal health insurance portability and accountability act of 1996.”
Direct to consumer tests fall outside the scope of HIPAA and the regulation of medical information outside of the traditional health care context. Both the CAP and the ASP were concerned about bill’s intent and impact on medical genetic testing when physicians, clinical laboratories, and other entities retain and rely on genetic testing specimens and its clinical information to help patients.