A New Regulatory Threat to Cancer Patients

The federal government is threatening to limit treatment options for doctors fighting cancer. A regulatory decision due Wednesday from the Centers for Medicare and Medicaid Services could undermine the care delivered to the more than 1.6 million Americans who are diagnosed with cancer each year.

At issue is whether reimbursements will be available to most physicians, hospitals and patients for a diagnostic technology known as next-generation sequencing. A cornerstone of the emerging field of precision medicine, NGS tests analyze molecular changes that occur in cancerous tumors and show up in biopsies.

To fight tumors, DNA-sequencing-based tests can determine how genes and mutations differ from one patient to the next. NGS tests enable oncologists to prescribe and administer customized, highly targeted drug therapies. The technology limits patients’ exposure to unnecessary toxic drugs and helps doctors make vital treatment decisions. Hundreds of thousands of cancer patients have already received NGS testing.

The proposed new CMS policy would abruptly change the way NGS testing is regulated and administered. It would drastically limit insurance coverage by requiring that tests be approved by the Food and Drug Administration. Current NGS tests are conducted at accredited clinical laboratories and premier academic medical centers under strict regulation. They are as accurate and reliable as FDA-approved testing. There is no evidence that restricting reimbursement to FDA-approved tests would improve care.

Read more of this The Wall Street Journal op-ed by Olivier Elemento by clicking here.

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