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CMS Starts to Cover Broad Cancer DNA Tests, Boosting Foundation, Thermo

(Xconomy Boston) Mar 19, 2018 - The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations.

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Winston Wong, PharmD (Posted: April 05, 2018)

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From a payer perspective, the CMS approval for coverage means that reimbursement for medicare and medicaid plans are mandated. This does not mean that coverage for the commercial population is mandated. Coverage for commercial members will be based upon the clinical utility study results. If the tests are specific to a drug, and will predict if a drug will be effective or not, then commercial business will follow suit. This is because the clinical utility of the test is sound. Anything beyond this will be suspect, and will undergo much scrutiny. There still need to be clinical justification for coverage. As I have noted in the past, FDA approved indication based upon genomic profiling results will prove to be a challenge for payers, and so far, that has held true.

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