This spring, despite widespread industry opposition, the U.S. Food and Drug Administration granted itself oversight of laboratory-developed diagnostic tests. Now, industry groups say they're facing a costly and convoluted agency approval process — one they hope they can dismantle based on the Supreme Court's recent decision to overturn Chevron deference. While the FDA is taking a larger role in safety enforcement of laboratory-developed tests, CMS will still oversee the coding, coverage and reimbursement processes for Medicare, which have always been complex, according to Matthew Wetzel, Life Sciences Regulatory & Compliance partner at Goodwin. Regardless of how things play out, LDTs are developing rapidly. Wetzel said this will require the agencies to stay on top of things and ensure coverage. "It would be important for CMS to keep up with that pace and ensure rapid coverage and sufficient reimbursement levels, and not to let approved technology linger without good insurance coverage," Wetzel said. For more on the FDA rule with Chevron Reversal, read the article on Law360.