WASHINGTON, D.C.— In response to the Centers for Medicare and Medicaid Services’ (CMS) Final Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R), ACLA President Julie Khani released the following statement:
“We applaud CMS for making important changes to protect Medicare beneficiary access to NGS-based testing for any germline cancer, including breast and ovarian cancer, regardless of stage. Beneficiaries with early-stage cancers deserve access to the medically necessary hereditary testing they need for their health, and CMS’s final coverage decision will help ensure providers have the clinical tools available to intervene early and prevent the progression of cancer for the seniors in their care.
While the final decision includes many meaningful improvements in access for beneficiaries, ACLA was disappointed in the Agency’s decision to limit national coverage to tests that have been FDA-cleared or -approved. However, we are pleased that the Agency has expanded Medicare Administrative Contractor (MAC) discretion to cover germline cancer tests using NGS technology for any cancer diagnosis when certain criteria are met. This flexibility acknowledges the complexity of our rapidly evolving scientific landscape and supports patient access to the vital, groundbreaking diagnostic tools available today as well as future discoveries on the horizon.
ACLA will continue to review the final decision and discuss further implications with our members and peers. We are fully committed to expanding access to accurate and innovative tests for Medicare beneficiaries and look forward to working closely with MACs and CMS to advance this shared goal.”
Last year, ACLA joined 60 leading health care organizations to highlight key challenges facing access to NGS-based testing and to call on CMS to reverse initial guidance that would have placed significant restrictions on NGS-based testing.
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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.