Centers for Medicare & Medicaid Services

Rule Changes

Issuing proposed procedural notice; TCET pathway paused for new candidates

For nearly a decade, medical device makers have faced the same bottleneck: the FDA clears a breakthrough device, and then Medicare spends another year or more deciding whether to pay for it. On April 23, 2026, the two agencies jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway — it cuts that timeline to as little as two months. They simultaneously paused the existing Transitional Coverage for Emerging Technologies (TCET) program for new applicants, consolidating all breakthrough-device coverage work under RAPID.

Updated May 31

Rule Changes

Source of baseline spending projections and historical data

For decades, American health care spending grew faster than the economy. Government actuaries projected in 2010 that it would hit 21.2 percent of GDP by 2024 (about $6.3 trillion), but actual spending came in at 18%, roughly $977 billion less.

Updated May 31

New Capabilities

Determining reimbursement rates for blood tests

For decades, diagnosing Alzheimer's meant either a $5,000 brain scan with radiation exposure or a painful spinal tap. In October 2025, the FDA cleared Roche's blood test for use in primary care—a simple blood draw that rules out Alzheimer's 97.9% of the time. It's the second blood test approved in five months, transforming a diagnosis that once required specialists and imaging centers into something your family doctor can order.

Updated May 19

Rule Changes

Administering BALANCE model to expand GLP-1 access

Medicare has been banned from covering weight loss drugs since 2003. CMS launched BALANCE in December 2025, a voluntary model offering $50-per-month Ozempic and Wegovy access for 10% of Medicare enrollees starting July 2026.

Updated May 16

Rule Changes

Linked to a new CBD access pilot described alongside the executive order

Trump's executive order instructing DOJ to fast-track marijuana's move to Schedule III immediately triggered a familiar split. Public health and industry groups cheered the potential research and tax impacts, while House Republicans organized opposition, urging Trump to keep marijuana in Schedule I.

Updated May 15