Medicare Reimbursement: CMS Eases Coverage Restrictions on NGS Testing of Early-Stage Cancer Patients

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 Oct. 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 National Intelligence Report (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:

• Has breast or ovarian cancer;
• Has clinical indications for germline testing;
• Has risk factors for germline breast or ovarian cancer; and
• Hasn’t previously been tested using NGS.

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) to adopt local coverage determinations for NGS germline tests for other cancers in patients with ovarian and 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 Jan. 27, 2020.