Genetic Testing: Proposed New Medicare Coverage Rules for NGS Germline Testing of Early-Stage Cancer Patients

Medicare coverage of germline next-generation sequencing (NGS) panels for early-stage cancer patient has been a topic of controversy of late. The problem began when the Centers for Medicare and Medicaid Services (CMS) instructed its Medicare Administrative Contractors (MACs) to impose new coverage restrictions on early-stage cancer testing. But after a public outcry, the agency seems to have backed off. Or has it? The NGS Tests at Issue NGS technology enables laboratory testers to read the order of nucleotide molecules on DNA and more effectively provides detailed information on multiple types of genetic alternations simultaneously. The NGS oncology panel tests also facilitate personalization of treatment by giving patients and providers a more comprehensive genetic profile of cancer and information relevant to potential cancer treatments. The NGS testing at issue is germline NGS testing of BRCA1/2 genes. Such testing can be used to direct treatment of poly ADP ribose polymerase (PARP) inhibitors in advanced breast and ovarian cancer patients; but it can also be used at early stages to assess patients for their inherited risks for these and other cancers. Early-stage NGS germline testing results generate risk information that can be determining a patient’s need for preventive screening and surgical interventions. The Testing Controversy However, the clinical benefits of early-stage NGS germline testing are less well documented than late-stage testing. Accordingly, CMS attempted to pump the brakes by issuing a National Coverage Determination (NCD) on late-stage testing that suggested early-stage testing should be restricted. Shortly thereafter, CMS instructed MACs to align their NGS testing policies in accordance with the new NCD. Earlier this year, one of the biggest MACs, Palmetto GBA, revised its Local Coverage Determination (LCD) for BRCA1 and BRCA2 genetic testing to restrict coverage for NGS panels when performed for individuals with early-stage disease to the detection of somatic mutations driving the cancer and bearing on personalization of treatment. Germline testing was left on the cutting room floor. Genetic testing laboratories, providers and patient groups raised vocal objections to the new policy for harming early-stage cancer patients by depriving them of badly needed treatment options. CMS read the message loud and clear. And on Oct. 29, it issued a new coverage proposal to address the concerns. The New Coverage Proposal CMS has backed down and is now proposing to cover germline NGS testing for early-stage breast and ovarian cancer patients under certain conditions. “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,” the agency acknowledges while also noting that knowledge of germline mutations associated with increased inherited risk of breast and ovarian cancer can help tailor treatments for Medicare beneficiaries. The 5 Coverage Conditions While providing for coverage of NGS germline testing of early-stage cancer patients, the CMS proposal also would impose strict limitations. There are five coverage conditions:

1. The tests must be FDA-approved or -cleared.

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:

• Have U.S. Food and Drug Administration (FDA) approval or clearance;
• Be for an FDA-approved or -cleared indication; and
• 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 laboratory.

The proposal would also give MACs authority to make LCDs providing local coverage for physician-ordered NGS tests performed in a CLIA-certified laboratory that are not FDA-approved, including for patients with breast or ovarian cancer who also have risk factors indicating a need for testing for inherited cancers other than breast or ovarian cancer, provided that such patients have not previously received an NGS test. What’s Next? CMS is slated to finalize the proposed national coverage determination on Jan. 27, 2020. Takeaway: The Coverage Policy Is Half a Loaf, At Best  Although it is certainly an improvement, the new CMS coverage proposal does not go as far as genetic testing laboratories and other stakeholders would have liked.  First and foremost, the proposal is limited to testing for breast and ovarian cancer. According to the agency, there is limited evidence supporting the use of germline NGS testing for pancreatic cancer, mesothelioma, astrocytoma and other inherited cancers. “We believe that, for other cancers, the evidence is rapidly developing,” CMS notes. “We are therefore maintaining the Medicare Administrative Contractors' discretion to make coverage decisions on diagnostic uses of NGS testing for patients with inherited cancers based on new evidence that may arise.”  Even for breast and ovarian cancer, finding a covered test will be tricky. According to reimbursement expert Bruce Quinn, no germline NGS test currently on the market meets all the national coverage criteria:  Myriad Genetics’ BRACAnalysis CDx is FDA-approved but not an NGS test;

• While FDA-approved, Myriad’s NGS test myChoice CDx for analyzing BRCA1/2 genes is a somatic rather than germline test;
• The Myriad MyRisk NGS panel is a germline test but has not been FDA-approved; and
• Foundation Medicine’s FoundationOne CDx and FoundationFocus BRCA test are NGS and FDA-approved, but are not 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.