Insurance Denials of Care Amount to Unlicensed Medical Practice.

DISCLOSURES: No funding supported the writing of this article. The author has nothing to disclose.

Diagnostic test allergens used for in vivo diagnosis of allergic diseases are at risk: a European Perspective.

In the European Union (EU), allergens used for diagnostic tests (TAs) are defined as medicinal products and have to be registered by national authorities. The current situation is not homogeneous. Existing authorizations need to be kept in the market in some EU states, while others need complete new authorizations requiring clinical trials, quality assurance methods, stability studies, and periodic safety update reports. Allergen manufacturers argue that offering a comprehensive panel of TAs may be economically disastrous. Expenses for initiation and maintenance of TA authorizations far exceed their related revenues and manufacturers may be forced to significantly limit their allergen portfolios. The availability of a wide range of high-quality TAs is very important for in vivo diagnoses of IgE-mediated allergies. Increased regulatory demands induce costs that need to be covered by public health organizations or reimbursed by health insurance companies.

Payers and the assessment of clinical utility for companion diagnostics.

The decision makers who approve or deny payment for health-care services review many new technologies. Reimbursement for companion diagnostics for expensive drugs ("personalized medicine") is already under close policy scrutiny, in line with long-standing concerns about overuse of diagnostic tests. Evaluation of diagnostic tests adds some complexities to the payer's comparative-effectiveness evaluation for drugs alone. Currently, decision-making frameworks suitable for companion diagnostics are being developed for practical application by payer policy makers.

The clinical utility of precision medicine: properly assessing the value of emerging diagnostic tests.

Assessments of the clinical utility of biomarkers and genomic tests often ignore individual utility and fail to account for downstream changes to the care delivery model. Tests that identify outliers are often undervalued in favor of those that help direct treatment for the "average" patient. By reducing uncertainty, these tests also enable lower-cost providers and even patients to assume increased responsibility for care in more convenient and affordable settings.