CMS Proposes New National Coverage Policy for NGS Germline Testing

NEW YORK – The Centers for Medicare & Medicaid Services, after listening to stakeholders' concerns, has proposed a new national coverage policy for germline next-generation sequencing panels for cancer patients, removing previously suggested restrictions around testing early-stage patients. 

The government payor now proposes to cover US Food and Drug Administration-approved or -cleared germline NGS testing for breast and ovarian cancer patients who have risk factors that suggest they should receive testing to assess their inherited risk for these cancers. Patients cannot have previously had NGS testing, doctors must order testing, and the lab must perform testing in a CLIA-certified lab. 

Additionally, in order to garner Medicare coverage under the new national policy proposal, the test must be FDA approved or cleared; the patient must be tested for one of the FDA-approved or -cleared indications on the NGS test; and the test results must be furnished to the patient's doctor and indicate treatment options associated with the genetic test results. 

Under this proposal, CMS would allow its Medicare Administrative Contractors to determine local coverage for physician-ordered NGS tests that are performed in a CLIA-certified lab but aren't FDA approved. In order to receive local coverage, patients must have a cancer diagnosis but not breast or ovarian cancer, and have risk factors indicating the need for inherited cancer risk testing, and not have previously received an NGS test. 

"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," CMS said in the proposed policy, adding that knowledge of germline mutations associated with increased inherited risk of breast and ovarian cancer can help tailor treatments for Medicare beneficiaries. 

However, CMS has also determined 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," the agency wrote. "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."

Stakeholders have 30 days to comment on the present proposal. CMS is slated to finalize the national coverage determination on Jan. 27, 2020.

The present proposal came about after a widespread outcry against CMS' instruction to MACs about coverage of germline NGS testing. At the start of the year, Medicare contractor Palmetto GBA raised concerns among genetic testing labs and cancer patient advocates when it revised a local coverage determination for BRCA1 and BRCA2 genetic testing to restrict coverage for NGS panels when performed in individuals with early-stage disease. 

Palmetto's revision came at the behest of CMS, which had directed MACs to align the terms of their genetic testing LCDs with an NCD it issued a year ago for next-generation sequencing for advanced cancer patients. However, based on the language of that NCD, most stakeholders thought the policy was restricted to NGS panels used to detect somatic mutations driving patients' cancer and to personalize treatment.

Germline NGS testing of BRCA1/2 genes can be used to direct treatment of PARP inhibitors in advanced breast and ovarian cancer patients, and such testing is used much more widely to assess patients for their inherited risks for these and other cancers. This risk information can be important for preventative screening and surgical interventions, and restricting coverage to late-stage disease would hinder access for early-stage patients when this information may be most useful. 

After labs, patient advocacy organizations, and professional societies all told CMS its proposed policy would be harmful to patients, CMS decided to reopen the NCD. The government payor heard from numerous stakeholders during the comment period about the flaws in its policy. The latest proposal is CMS' attempt to address stakeholders' concerns and doesn't include any coverage restrictions on patients' stage of cancer. 

However, stakeholders may still find the new proposal falls short of covering medically necessary germline NGS testing for patients. For example, as reimbursement expert Bruce Quinn pointed out in his blog, the restriction that patients not have any prior NGS testing doesn't account for situations where patients may be getting germline testing after having previously gotten somatic NGS testing.

Lastly, Quinn pointed out that there is currently no germline NGS test that meets all the national coverage criteria. Myriad Genetics' BRACAnalysis CDx does have FDA approval but isn't NGS, and the company recently received FDA approval for its NGS myChoice CDx which gauges BRCA1/2 genes but is a somatic test. Myriad's MyRisk NGS panel, meanwhile, does germline testing, but isn't FDA approved. Foundation Medicine's FoundationOne CDx and FoundationFocus BRCA test are NGS and FDA approved, but also not germline. 

In a note to investors, Cowen analyst Eric Assaraf wrote that CMS' policy as proposed may not negatively impact Myriad, because it has a BRCA test for breast and ovarian cancer risk that utilizes Sanger sequencing and therefore wouldn't fall under the NGS-specific coverage policy. 

However, the proposed determination will likely impact providers of NGS hereditary cancer tests, Assaraf predicted. Medicare reimbursement accounts for 23 percent of Invitae's test sales and up to 12 percent of its volume, for example. He noted that Invitae could benefit from the fact that CMS no longer restricts germline NGS testing by cancer stage and that its tests can continue to be paid by MACs outside of breast and ovarian cancer. 

However, Invitae also doesn't have an FDA-approved or -cleared NGS hereditary breast and ovarian cancer risk test, which could be a potential downside. "The company has been meeting with the FDA for over a year on securing FDA clearance for its test, which we believe could indicate that clearance may be awarded in the near term," Assaraf wrote. "Additionally, we believe the inconsistency between hereditary breast/ovarian and other cancer types will ultimately be resolved with the finalized document, especially given the current dependency of clinicians on non-FDA cleared/approved tests in this high-volume application which has demonstrated clinical utility."