CMS said it is expanding coverage of next generation sequencing (NGS) for use as a diagnostic for patients with germline breast and ovarian cancer, paving the way for Medicare beneficiaries to receive more personalized medicine. However, an advocate said the wording of CMS' decision could actually limit testing access for some women with breast or ovarian cancer.
This story has been updated.
CMS Monday announced that it is expanding coverage of next generation sequencing (NGS) for use as a diagnostic for patients with germline breast and ovarian cancer, paving the way for Medicare beneficiaries to receive more personalized medicine. In addition, CMS also gave Medicare contractors more leeway to use NGS for other cancers as well.
The national coverage decision (NCD) applies to FDA-approved or cleared laboratory diagnostic tests. However, an official with a leading advocacy organization for increasing access to testing said the NCD is not the positive step forward portrayed in the CMS announcement.
Lisa Schlager, vice president of community affairs and public policy at FORCE, said the precise wording of the NCD requires that germline NGS be “FDA approved,” and at this point, no such testing exists. Thus, she said, the policy as written would actually limit access to germline NGS for women with breast and ovarian cancer.
Schlager contacted The American Journal of Managed Care® to explain that FORCE and other groups pointed out this issue to CMS, but the wording remained unchanged. Now, the matter may have to be addressed by Congress, she said.
In a statement, CMS noted Medicare first began covering laboratory diagnostic tests using NGS in March 2018 for patients with advanced cancer that met specific criteria.
With Monday’s decision, CMS has determined that NGS is reasonable and necessary when performed in a clinical laboratory improvement amendments (CLIA)-certified laboratory, when ordered by a treating physician when the patient has ovarian or breast cancer, and as a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer.
In addition, the patient must have a risk factor for germline (inherited) breast or ovarian cancer and must not been previously tested with the same germline test using NGS for the same germline genetic content.
All of the conditions must be met, CMS said.
Besides being FDA approved, the diagnostic laboratory test using NGS must provide results to the treating physician for management of the patient using a report template to specify treatment options.
The question of FDA's role in approving diagnostic tests has been ongoing for more than 5 years. As the of testing in precision medicine increased, questions arose about the varying quality of tests, as well as clinical utility of tests--meaning, how much does a test direct the course of care. Payers want to see if tests do more than offer additional information; they want to know if they help doctors make healthcare decisions or potentially save healthcare dollars by showing that some treatments won't work, thus saving unnecessary spending and instead using optimized therapies.
Given the speed at which the field is moving, CMS said it is also giving regional Medicare administrative contractors (MACs) discretion over whether to cover certain other indications. MACs may determine NGS coverage, in line with the first set of conditions, when the patients has:
CMS also said it is clarifying the existing policy related to diagnostic tests for somatic (acquired) cancer.
“We recognize that cancer patients shoulder a heavy burden, so we’re leaving no stone unturned in supporting women’s health and getting all patients the care they need. NGS testing provides clinically valuable information to guide patients and physicians in developing a personalized treatment plan,” said CMS Administrator Seema Verma.
The first FDA-approved test, FoundationOne CDx, was approved in December 2017.