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AMA adopts new strategy for genetic tests, therapeutics

AMA recently voted to advance the development of a comprehensive strategy that allows more consistent coverage of genomic and genetic tests and precision medicine, a move intended to enhance patient access to useful new genetic tests and therapeutics that have clinical impact.

“Precision medicine tests, technologies and therapeutics are increasingly being adopted into clinical practice as evidence of their effectiveness grows,” AMA Board Member William E. Kobler, MD, said in a press release. “However, many patients do not have access to precision medicine because most public and private health insurers do not offer coverage for genetic or genomic services unless certain clinical criteria and evidentiary standards are met. As a result, access to this next generation of clinical testing services is often limited.”

AMA said there is a lack of a consensus among private and public payers regarding the evidence requirements for genomic and genetic tests and services, as well as the void of transparency and standardization across payer coverage determination processes.

Specifics of the new policy include:

• describing the evidence under consideration and processes to update the evidence;
• allowing chances for comment, review, and “meaningful” reconsiderations;
• advancing transparency and clarity;
• assimilating value assessments that consider the value of genomic and genetic tests and therapeutics to society as a whole, families and patients, including the impact on quality of life and survival; and
• involving multidisciplinary stakeholders, including genomic and genetic medicine experts and relevant national medical specialty groups.

According to the release, newer tests are quickly becoming available on an ongoing basis, but the clinical utility of many new genetic tests and therapeutics cannot feasibly be shown using traditional approaches, prompting the new policy.

Disclosure: Healio Family Medicine was unable to determine Kobler’s relevant financial disclosures prior to publication.