December 11, 2019
After years of resistance, CMS is now prepared to pay for germline (inherited) next-generation sequencing (NGS) testing of Medicare early-stage cancer patients under certain conditions. Here’s a look at the new national coverage determination (NCD) that the agency proposed on October 29, 2019.
The CMS About-Face
We’ve now come full circle. At the start of 2019, CMS issued an NCD instructing Medicare Administrative Contractors (MACs) to apply coverage limitations on use of NGS test panels to detect somatic mutations of advanced cancer patients to germline testing of early-stage cancer patients. The new and unexpected coverage cutback provoked an outcry among testing labs and cancer patient advocates. (For more on the coverage controversy, see NIR June 17, 2019.)
In the proposed NCD, CMS acknowledges that “the evidence for cancers of the breast and ovary suggests that the use of NGS can identify germline mutations which can lead to better stratification of patients in the physician management of inherited cancers of the breast and ovary.” Accordingly, CMS says Medicare will cover germline NGS testing of cancer patients to assess their inherited risk for such cancers
The 4 Required Coverage Conditions
The NCD also lists conditions regarding:
1. Who Can Order Tests
First, the tests must be ordered by the treating physician for purposes of managing the patient’s treatment. This is standard stuff.
2. Which Patients Can Have the Tests
Tests are covered only if the patient:
3. Which Tests Can Be Provided
Ordered NGS tests must be cleared or approved by the FDA and the patient must be tested for an indication for which the test has been cleared or approved.
4. Who Can Perform the Tests
Tests must be performed by a CLIA-certified lab and the test results must be furnished to the patient’s doctor and indicate treatment options based on the genetic test results.
More Coverage to Come?
The NCD also gives Medicare Administrative Contractors (MACs) the authority to adopt local coverage determinations for NGS germline tests for cancers other than ovarian or breast cancer subject to the same above criteria. Exception: The ordered test would not have to be approved or cleared by the FDA.
Takeaway
The NCD is just a proposal. After getting public comments, CMS is scheduled to finalize the policy on January 27, 2020.
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This article originally appeared in G2 Intelligence, National Intelligence Report, December 2019
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