AMA and ACMG question insurance prior authorization policies

The insurance industry's spotty and inconsistent coverage of genomic tests has prompted a call from the American Medical Association (AMA) to adopt more transparent coverage and payment policies. The policy brief was announced in late 2017 at the group's interim annual meeting and included several dozen professional groups as cosigners, including ACMG. The Prior Authorization and Utilization Management Reform Principles seeks to move payers toward establishing thresholds for acceptable evidence that would guarantee 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, in a statement. “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.”

The new policy says public and private payers should:

  • Promote transparency and clarity

  • Involve multidisciplinary stakeholders, including genetic/genomic medicine experts and relevant national medical specialty societies

  • 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

As part of the adopted policy, the AMA is encouraging professional societies to develop clinical practice guidelines for incorporating genomics in routine medical practice and to advocate for research designed to demonstrate the validity and value of precision medicine. —Karyn Hede, News Editor

British project to sequence 100,000 genomes lagging behind schedule

The ambitious 100,000 Genomes Project, launched in 2012 by the British government, is way behind its self-imposed deadlines, and its future is in question. The large national sequencing project was intended to focus on cancer and rare diseases. In late 2017, Liberal Democrat health spokesperson Norman Lamb addressed the British House of Commons Science and Technology Select Committee and acknowledged that the rate of progress has slowed. He noted that just over 36,000 genomes had been sequenced and that the group will miss its 2018 deadline, The Pharmaceutical Journal reported in December 2017. The group may take until July 2020 for its target to be reached. A National Health Service (NHS) spokesperson reportedly stated that it will stop providing samples to the project by September 2018 or earlier. Instead, an NHS genomic medicines service will be launched that will include a new testing system to help determine which genomic tests are appropriate in individual cases. Evidence from the new service will be gathered and reviewed periodically to ensure that the most up-to-date tests are offered. In addition, a new data warehouse will link, with patient consent, genomic test results to a research database. —Karyn Hede, News Editor