The AAMC Jan. 17 submitted comments to the Centers for Medicare and Medicaid Services (CMS) on the Proposed National Coverage Decision (NCD) entitled “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.” The comment period ended Jan. 17 after CMS extended it from its original end-date of Dec. 29. In a Dec. 14 letter, the AAMC called on CMS to extend the deadline in order to provide stakeholders with additional time to develop thoughtful comments.
CMS has proposed to cover NGS as a diagnostic laboratory test only when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, ordered by a treating physician, and when the test has been approved or cleared by the Food and Drug Administration (FDA). The AAMC argues that requiring FDA approval as a condition of coverage for diagnostic tests created using NGS could impede innovation, increase the use of older or outdated technology, result in Medicare beneficiaries receiving lower quality diagnostic testing, and drive institutions to seek approval from the FDA for diagnostic tests, although no such approval is now required. Ultimately, the AAMC asks CMS to delay issuing a final national coverage decision.
In its comments, the AAMC also discussed how the Proposed NCD could impact the regulation of laboratory-developed tests (LDT). Specifically, LDTs are not currently regulated by the FDA, although there is an ongoing debate about the regulation of LDTs and what role CMS has or should have through CLIA. By requiring FDA approval, the Proposed NCD raises questions about when and through what mechanism such approval should be considered and granted.
The laboratory community has expressed frustration with the Proposed NCD, claiming that requiring FDA approval would have a chilling effect on the development of new laboratory tests, which could derail innovations in personalized medicine. The American Clinical Laboratory Association (ACLA), for example, stated, “Restricting conditions of coverage for other tests using NGS technology would have a chilling effect on the development of cutting-edge tests using NGS technology, and would deny Medicare beneficiaries access to innovative, medically necessary testing.”