More transparency needed on precision medicine coverage

Andis Robeznieks , Senior News Writer

A new policy adopted at the 2017 AMA Interim Meeting seeks to facilitate consistent coverage of genetic medicine and more transparency in how coverage is being determined.

The new policy calls for more transparency and clarity in the processes that determine coverage and payment. It notes the unique challenges of developing evidence under traditional methods such as randomized controlled trials and calls on payers to work with test developers, clinical experts and relevant national medical specialty societies to establish thresholds for acceptable evidence for coverage.

“Precision medicine tests, technologies and therapeutics are increasingly being adopted into clinical practice as evidence of their effectiveness grows,” said AMA Board Member William E. Kobler, MD. “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.”

In determining coverage in this area, the new policy says, public and private payers also should:

  • Describe the evidence being considered and methods for updating the evidence.
  • Provide opportunities for comment and review as well as meaningful reconsiderations.
  • Incorporate value assessments that consider the value of genetic/genomic tests and therapeutics to patients, families and society as a whole, including the impact on quality of life and survival.

The policy stems from a joint report of the AMA Council on Medical Service and the AMA Council on Science and Public Health. The councils initiated the report to provide physicians an overview of coverage and payment for genetic/genomic precision medicine, describe AMA policy and activity on this issue and make policy recommendations.

The delegates also adopted policy encouraging national specialty societies to develop clinical practice guidelines for incorporating genetic and genomic medicine approaches into practice and continued support for research demonstrating the validity, meaningfulness and value of precision medicine.

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Existing AMA policy acknowledges the increasingly important role of genomic-based precision medicine  applications. It also calls for the development of educational resources and tools to assist in the implementation of genomic-based medicine, and supports appropriate use of genetic testing, pre- and post-test counseling and the development of best-practice standards for such counseling.

The timeliness of the report was considered significant because of the passage of the 21st Century Cures Act and continued funding of the National Institutes of Health’s All of Us Research Program and the National Cancer Institute’s Cancer Moonshot. The report also mentions the speed and volume of advances in precision medicine, its complex and costly implementation, and the rapid generation of evidence supporting its use.

The report highlights the AMA’s general concerns about prior authorization and other utilization-management programs. The AMA worked with several state and national medical societies and patient organizations to develop 21 reform principles for these programs and more than 100 stakeholder organizations have signed on in support.

“Several large private insurers have established national prior-authorization programs for genetic/genomic testing and will deny payment for services that have not been properly authorized or, in some cases, ordered by a geneticist or genetic counselor or carried out by insurer-approved laboratories,” the report states.

Delegates agreed with the report’s recommendation to reaffirm AMA policy that utilization-management programs should permit variation to account for patient differences and allow physicians to appeal decisions.

The report highlights how considerable variability exists among private and public payers regarding the evidence they require before providing coverage of genetic tests and services. It notes that evaluation criteria generally include traditional measures such as analytical validity, clinical validity and “clinical utility,” but added that clinical utility “is a highly subjective term that does not have a universally accepted definition.”

“The councils are concerned by the lack of transparency and standardization across payer coverage determination processes, which may hinder access to valid and meaningful tests and therapeutics as well as future innovations,” the report states.

Read more news coverage of the 2017 AMA Interim Meeting.