NGS Based Cancer Tests Covered By Medicare
Will part of Trump’s lasting legacy be full scale introduction of NGS coverage under Medicare? Maybe, if we see more news like this.
Late last week, the Centers for Medicare & Medicaid Services (CMS) in the USA, announced cover for Next Generation Sequencing (NGS) based tests to determine best treatment for patients with advanced cancer. They are treating NGS as a companion diagnostic that can help better identify the appropriate FDA approved treatment option. In instances where an ideal treatment cannot be identified, it is hoped that NGS can also help determine a patient’s candidacy for appropriate clinical trials.
“We want cancer patients to have enhanced access and expanded coverage when it comes to innovative diagnostics that can help them in new and better ways,” said Seema Verma, CMS Administrator. “That is why we are establishing clear pathways to coverage, while at the same time supporting laboratories that currently furnish tests to the people we serve.”
In addition to covering the FDA-approved F1CDx™, CMS is covering FDA-approved or cleared companion in vitro diagnostics when the test has an FDA-approved or cleared indication for use in that patient’s cancer and results are provided to the treating physician for management of the patient using a report template to specify treatment options.
“These tests can help doctors consult with patients about more targeted care or enrolment in a clinical trial,” said Kate Goodrich, M.D., CMS chief medical officer and director of the Center for Clinical Standards and Quality (CCSQ). “The expanded coverage in this final NCD now includes additional tests for relapsed, refractory, and earlier stage III cancers to aid in the treatment of these cancer patients.”
The statement goes on to outline the nature of the coverage for future tests that meet with FDA approval or clearance. It ends by encouraging laboratories to continue to produce data, and publish results to increase evidence of clinical utility and develop new technologies within the healthcare system.