Medicare will pay for certain genetic tests for people with inherited ovarian and breast cancer while allowing Medicare administrative contractors (MACs) flexibility to decide whether to cover these tests for other uses.

The Centers for Medicare & Medicaid Services (CMS) on Monday released an update of its payment rules for diagnostic tests using next-generation sequencing (NGS).

It was just in 2018 that Medicare issued its first national coverage policy for this kind of testing, opting to cover NGS for recurrent, relapsed, refractory, metastatic, or advanced cancers (stage III or IV). But the giant federal health program has faced calls to revise its coverage of NGS, even as researchers continue to try to prove strong clinical benefits for this testing.

"The evidence for ovarian and breast cancer suggests that using NGS to identify germline mutations can lead to better stratification of patients in the physician management of inherited cancers of the breast and ovary," CMS staff wrote in the decision memo.

The American Society of Breast Surgeons recommends that all patients with breast cancer be offered universal genetic testing. However, the question of whether all breast cancer patients should be tested with multigene panels remains controversial, as reported previously by Medscape Medical News, with critics arguing that "more genes create more problems." A pertinent issue, until now, has been the question of who should pay for this testing.

That issue has now been resolved, at least for Medicare patients.

As part of this mandated coverage, Medicare will require use of NGS tests that have been approved by the US Food and Drug Administration (FDA). In these cases, results must be provided to physicians for management of the patient using a report template to specify treatment options, CMS said.

Medicare covers about 60 million Americans who are aged 65 years or older or who have disabilities. Its policies can influence those of other insurers, even beyond its role as the largest single purchaser of healthcare in the United States. Many groups and individuals asked CMS during its reconsideration of the NGS payment policy to mandate national coverage of other cancers. For now, the agency has rebuffed those requests while allowing MACs discretion in setting payment policies for NGS tests.

"At this time, there is insufficient evidence of clinical utility for other cancer types including male breast cancer, colorectal, lung, pancreatic and prostate cancer," CMS staff wrote in the memo while stressing that "evidence in this field is rapidly developing."

In the memo, CMS officials said the agency's intent is "to expand coverage" of NGS.

With this aim, CMS made several revisions to its draft coverage decision.

These included clarifying language to emphasize MACs' ability to consider coverage "for any cancer diagnosis including tests that are not FDA approved or cleared for breast and ovarian cancer provided all the criteria is met."

The memo also spelled out that MACs have discretion even for uses outside the scope of the national coverage decision.

The contractors have discretion to determine coverage of diagnostic laboratory tests using NGS "for any non-cancer (eg, infectious disease and heart disease)," CMS staff wrote.

CMS also said it changed its stance about cases of repeated NGS testing for patients.

"In response to public comments and to support further innovation and patient access, we have clarified our decision to include coverage for appropriate repeat NGS testing for germline (inherited) cancer and somatic cancers when criteria are met," CMS said.

However, agency staff noted limitations with the current body of evidence about use of NGS testing. These include a lack of meta-analyses and randomized controlled trials that specifically addressed NGS testing. The available studies "varied in quality for a number of reasons," including small samples of patients, agency staff wrote.

"Of all of the different types of cancers associated with germline mutations, only studies of breast and ovarian cancer had high quality evidence, and were able to demonstrate clinical utility through the use of NGS," CMS staff said.

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Medicare to Cover Gene Tests in Inherited Breast, Ovarian Cancer - Medscape

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