Targeted therapies have made tremendous progress in oncology, with some products essentially rendering some cancers chronic conditions. According to the National Cancer Institute, the FDA has approved hundreds of targeted therapies across 30 types of cancers. Genomic testing can help determine whether a patient is a candidate for a particular therapy, and CVS Health has launched a program focused on boosting patient access to this.
In 2018, CMS finalized a national coverage determination (NCD) for diagnostic laboratory tests that use next-generation sequencing (NGS) for patients with advanced cancer in order to gain a comprehensive genomic profile (RSP 4/18, p. 12). The NCD said that CMS will cover NGS in vitro diagnostic (IVD) tests for Medicare beneficiaries with advanced cancer who have not been tested with the same NGS technology. It also said CMS will cover FDA-approved or cleared companion IVDs “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.”