Newsletters
Clinical Laboratory Algorithmic Tests – New Proposed Reimbursement Framework
August 2026
Companies developing clinical laboratory algorithmic tests may want to evaluate if their tests could be affected by the Centers for Medicare and Medicaid Services (CMS) proposal to reclassify the payment methods for algorithmic analyses.
Software as a Medical Service – Proposed Reimbursement Framework
July 2026
Companies developing AI-enabled clinical data-analysis products may want to evaluate if their services could be affected by the Centers for Medicare and Medicaid Services (CMS) proposal to establish a new Medicare payment category, Software as a Medical Service.
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) Announce a new Medicare Coverage Pathway
May 2026
For companies who develop class III devices and certain class II devices and believe national Medicare coverage is an important US commercialization milestone, this new national Medicare coverage pathway is important. The new pathway is called Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway.
U.S. Healthcare Spending Reached $5.3 trillion in 2024
January 2026
Based on the recent Center for Medicare and Medicaid Services (CMS) publication, U.S. healthcare spending reached $5.3 trillion in 2024, a 7.2% increase from $4.9 trillion spent in 2023.
Physician Fee Schedule finalized: Used by Most U.S Health Insurance Payers
November 2025
The Centers for Medicare & Medicaid Services (CMS) released the final 2026 Physician Fee Schedule effective January 1, 2026. It is important to understand that the Medicare Physician Fee Schedule is not exclusive to Medicare. The fee schedule is also used by the U.S commercial health insurance payers to inform or determine the reimbursement amounts paid to physicians in their health plans.
New Medicare Physician Payment Model and its Impact on Medicare Reimbursement
September 2025
The CMS Innovation Center proposed a new alternative payment model, the Ambulatory Specialty Model for implementation starting January 2027. Physician participation in the Model is required. If you work with physicians, understanding who and how physician reimbursement will be impacted by the Model would be useful to know.
New TEAM mandatory Bundled Payment Program
May 2025
We believe Medicare’s TEAM Quality Payment Program (effective January 2026) may provide an opportunity to monetize your medical device, digital health technology, or diagnostic test in the absence of fee-for-service reimbursement.
Medicare/Medicaid Want to Improve Maternal Health Care Outcomes
February 2025
Using the context of maternal health care this newsletter demonstrates the legal and broad scope of Medicare’s and Medicaid’s authority outside of their reimbursement mandate. Medicare and Medicaid are the two largest health plans in the US.