Genetic Testing: New Medicare Early NGS Cancer Test Coverage Policy Is Less than Meets the Eye

For Myriad Genetics, Foundation Medicine and other manufacturers of next-generation sequencing (NGS)-based test panels for early-stage cancer risk assessment, the recent announcement of CMS’ decision to provide limited Medicare coverage for germline breast and ovarian cancer looks like positive news. But while a lot better than the previous version, the proposed National Coverage Determination (NCD) is much less than even the half a loaf it looks like.

The NGS Testing Controversy

While the benefits of using NGS testing of BRCA1/2 genes to direct treatment of poly ADP ribose polymerase (PARP) inhibitors in advanced breast and ovarian cancer patients is well documented, the clinical utility of germline testing of early-stage patients for purposes of determining the need for preventive screening and surgical interventions is less certain. With that in mind, CMS tried to pump the brakes by instructing Medicare Administrative Contractors (MACs) not to pay for such early-stage testing.

The New Coverage Proposal

But if the agency’s idea was to fly under the radar, it didn’t work. After a public outcry from industry and providers, CMS issued a new coverage proposal acknowledging the benefits and agreeing to pay for the testing. At first glance, the new proposal is a major reversal on germline NGS cancer testing coverage. In fact, it’s anything but.

Problem 1: Just Ovarian & Breast Cancer

The first problem is that the proposal covers testing only for breast and ovarian cancer. Evidence supporting the use of germline NGS testing for pancreatic cancer, mesothelioma, astrocytoma and other inherited cancers is still limited, CMS claims. The silver lining: The agency acknowledges that the evidence of effectiveness of testing for other cancers “is rapidly developing” and gives the MACs discretion to make local coverage determinations on testing for cancers other than ovarian and breast as new evidence arises.

Problem 2: Coverage Conditions Are Too Strict

Medicare will only pay for NGS germline testing of early-stage cancer testing if five strict conditions are met:

1. The tests must be FDA-approved or -cleared and ordered for an approved or cleared indication.

2. The tests must be ordered by a treating physician.

3. The patient for whom the tests are ordered must have:

• Ovarian or breast cancer;
• Clinical indications for germline (inherited) testing;
• Risk factors for germline (inherited) breast or ovarian cancer; and
• Not been previously tested using NGS.

4. The ordered NGS test must generate results provided to the treating physician for management of the patient using a report template to specify treatment options.

5. The test must be performed by a CLIA-certified lab.

While the coverage criteria may look reasonable, there’s not a single germline NGS test currently on the market that can meet them, advises reimbursement expert Bruce Quinn:

• Myriad Genetics’ BRACAnalysis CDx is FDA-approved but isn’t an NGS test;
• Myriad’s NGS test myChoice CDx is FDA-approved for analyzing BRCA1/2 genes but is a somatic rather than a germline test;
• The Myriad MyRisk NGS panel is a germline test but hasn’t been FDA-approved; and
• Foundation Medicine’s FoundationOne CDx and FoundationFocus BRCA test are NGS and FDA-approved, but aren’t germline tests.

Another problem pointed out by Quinn is the restriction that patients not have any prior NGS testing which excludes patients from getting germline testing after having previously received somatic NGS testing.

Takeaway:  Whether deliberate or not, CMS’ proposed new coverage policy continues to bar Medicare reimbursement for NGS germline cancer testing, even with regard to the applications it purports to cover.