WASHINGTON, D.C. – Recent proposals from the Centers for Medicare & Medicaid Services (CMS) would have widespread, detrimental consequences on cancer care for millions of Medicare beneficiaries, specifically for patients with a genetic predisposition for breast and ovarian cancer. In new comments submitted to the agency, the American Clinical Laboratory Association (ACLA) called on CMS to remove barriers to coverage of germline tests using NGS technology – now the standard of care for cancer patients – and to ensure those with early-stage cancers can access the tests that will directly benefit their health.
Earlier this year, ACLA and more than 60 other leading health care organizations called on CMS to reverse initial guidance that would have imposed significant restrictions on NGS-based testing. In response, CMS has opened a reconsideration of the NCD and opened a comment period on a proposed decision memo requesting additional stakeholder feedback on how best to address a number of Medicare policy provisions moving forward.
“Restricting access to vital, ground-breaking clinical testing for cancer care will undermine the tremendous progress that we have made to improve the health and lives of millions of Americans,” Julie Khani, ACLA President, said. “It’s imperative CMS ensures that providers, seniors and their families have the clinical tools, including NGS-based testing, that are necessary to intervene early and prevent the progression of cancer in the future.”
As part of its formal response to the proposed decision memo, ACLA reiterated its support for national Medicare coverage of germline tests using NGS technology. Key highlights from the letter are included below:
CMS is expected to finalize the national coverage determination by the end of January 2020.
To read the ACLA’s full comments, click here.