Regulatory NewsBREAK: CMS Issues Final Notice on Transitional Coverage for Emerging Technologies
On Aug. 12, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a Final Notice on Transitional Coverage for Emerging Technologies (Final Notice). This notice describes how CMS will use the national coverage determination (NCD) and Coverage with Evidence Development (CED) processes to provide transitional coverage for emerging technologies (TCET), for certain Breakthrough Devices that are Food and Drug Administration (FDA) market authorized. Access the Regulatory NewsBREAK to learn more.
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On May 22, 2025, the President’s Make America Healthy Again Commission published the MAHA report. The report raises concerns about the chronic childhood disease, processed food, environmental chemicals, lack of physical activity, mental health, and overmedicalization of American children.
On May 12, 2025, President Trump signed an Executive Order (EO) requiring agencies to take steps to encourage manufacturers to provide most-favored-nation pricing for prescription drugs.
On April 16, 2025, the Centers for Medicare and Medicaid Services (CMS) issued guidance on CY 2026 Part D Formulary Submissions (Guidance). The Guidance includes important dates related to CY 2026 formulary submissions.
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