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The MAC will consider PGx testing reasonable and necessary after a physician has narrowed a patient's treatment options to specific medications.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
Under the LCD, pharmacogenomic tests are covered when medications are being considered for use that are known to have a clinically actionable gene-drug interaction.
Hygea's software platform will help physicians order and manage genetic tests, such as Admera Health's PGxOne Plus pharmacogenomic test.
The available data suggests PGx may be useful in managing medications for COVID-19 patients and in helping people struggling with the mental health impact of the pandemic.
The Helsinki-based firm is making its panel available for free to people who already have been genotyped by consumer genomics services or biobanks.
Regulators told the lab industry that they can continue to offer PGx lab tests without FDA approval if they make evidence-based claims.
The agency compiled the evolving list by drawing on information from drug labeling and the published literature and is asking stakeholders to provide feedback.
The companies will join their respective technologies to provide pharmacogenomic information for patients undergoing genetic testing.
Consumers have filed complaints about the San Diego-based firm's questionable business practices and lack of response in the last year.