In Depth Analysis

On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as intended for clinical use and are designed, manufactured and used within a single clinical laboratory that meets certain regulatory requirements. The final rule amends FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FDCA), including when the manufacturer of the IVD is a laboratory. Along with this amendment, FDA finalized its policy to phase out, over the course of four years, its general enforcement discretion approach for many LDTs. The agency also issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.

On April 22, 2024, the Centers for Medicare & Medicaid Services (CMS) published the Medicaid and Children’s Health Insurance Program Managed Care Access, Finance, and Quality final rule. CMS finalized several substantial updates to the Managed Care Rule with implications for state directed payments (SDPs), payment transparency, medical loss ratios (MLRs), wait time standards and in lieu of services (ILOS). Read on for key takeaways and our full analysis of the final rule.

On April 22, 2024 the Centers for Medicare & Medicaid Services (CMS) published the Medicaid Program; Ensuring Access to Medicaid Services final rule. The rule has a particular focus on home- and community-based services (HCBS), including direct care worker compensation requirements, HCBS waitlists, grievance process development, critical incident reporting definitions and HCBS quality reporting. The final rule also seeks to increase transparency in payment rates.

On April 10, 2024, the Centers for Medicare & Medicaid Services (CMS) posted the Hospital Inpatient Prospective Payment System (IPPS) proposed update for fiscal year (FY) 2025, along with proposed policy and regulation changes. The proposed rule would update Medicare payment policies and quality reporting programs relevant for inpatient hospital services, and build on key agency priorities, including advancing health equity and improving the safety and quality of care.

Our new, interactive dashboard shows the actual costs to hospitals for providing care to Medicare fee-for-service inpatients based on data published by the Centers for Medicare & Medicaid Services (CMS) as part of its rulemaking cycle.

This +Insight explores how Medicare fee-for-service (FFS) site-of-service patterns vary across states and metropolitan statistical areas.

This article explores the Congressional Review Act (CRA) and how it might impact the current administration’s regulatory agenda.