CMS announced a new drug payment model called the GENErating cost Reductions for U.S. Medicaid (GENEROUS) Model that the agency plans to pilot next year.
By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...
