Related Coverage of Lab Developed Tests
At first glance, it’s hard to imagine anything as obscure as a policy by a private contracting firm that runs the Medicare program in the Carolinas, Virginia and West Virginia.
But look closer: a “local coverage determination” by Palmetto GBA addresses an urgent, vexing problem of precision oncology: how advanced molecular testing can be used to determine treatment options for individual patients and what insurers will be willing to pay for.
The coverage determination, titled “Comprehensive Genomic Profiling for Non-Small Cell Lung Cancer” popped up on a government website well after close of business Jan. 22. There was no press release; no rollout whatsoever.
How is this for a plan:
Replace the U.S. system for validation and payment for cancer genomic tests with something that actually makes sense.
Dane Dickson, a doctor in Idaho, who until recently had the distinction of being the only oncologist working under the roof of Centers for Medicare and Medicaid Services, would like to do just that—and some important players in cancer research are betting on his success.
Dane Dickson would like to change the U.S. system for validation and coverage of molecular tests, thereby opening the road to development of complex tests and comprehensive genomic assays.
It’s possible that molecular testing is doing a lot of good, pinpointing cancer therapies that are most likely (or least likely) to work.
It’s also possible that Medicare is paying for molecular tests that are marketed aggressively despite being based on flimsy evidence.
The latter picture is painted in a suit filed by two former employees of Caris Life Sciences Inc., a company that markets the “Caris Molecular Intelligence” test, a panel of assays previously called “Target Now.”
Tumor profiling information Caris Life Sciences provides in its reports isn’t backed by sufficient evidence to justify some clinical decisions, said Daniel Hayes, a breast cancer expert at the University of Michigan.
Hayes, the university’s Stuart B. Padnos Professor of Breast Cancer Research and a member of a recent Institute of Medicine committee that issued a report on omics, was clicking through the Caris website as he spoke with Paul Goldberg, editor and publisher of The Cancer Letter.
FDA announced two plans to resolve a cluster of impediments to personalized cancer care:
• At the same time, the agency will begin phasing in oversight of the essentially unregulated terrain of laboratory-developed tests.
The American Association for Cancer Research urged FDA to regulate high-risk laboratory-developed tests, a category of assays that has escaped scrutiny because of loopholes in the regulatory process.
Normally, FDA requires that diagnostic tests developed by manufacturers adhere to three measures: analytic validity, clinical validity, and clinical utility. However, laboratories can get around this requirement by using laboratory-developed tests, or LDTs.
FDA published two draft guidance documents Oct. 3 for regulatory oversight, notification and medical device reporting for laboratory developed tests.
LDTs are a category of assays that has escaped scrutiny because of loopholes in the regulatory process—laboratories can get around FDA measures of analytic validity, clinical validity and clinical utility using LDTs.