CMS & CMMI Updates

Key Actions:

1. Local Coverage Determinations (LCD) Updates: CMS has released two LCDs relevant for stakeholders:

- L38065: Covers Plasma-Based Genomic Profiling in Solid Tumors and is scheduled for implementation on 2026-04-06. This determination emphasizes the necessity for clear evidence of clinical utility to support reimbursement for this type of genomic testing. Full details can be found here.

- L37011: Concerns the ProMark® Risk Score and was also issued on 2026-03-14, indicating it’s part of a broader effort to incorporate advanced risk assessment tools in patient eligibility and treatment planning. Additional information can be accessed here.

2. Medicare Drug Price Negotiation: CMS confirmed manufacturer participation in the third cycle of Medicare drug price negotiations as of 2026-03-13. This ongoing initiative signifies CMS's intent to negotiate drug prices directly with manufacturers, potentially impacting pricing strategies for plan sponsors and patients. More details are available here.

3. Transmittals and Operational Guidance:

- R13686CP: Releases the April 2026 update for the Hospital Outpatient Prospective Payment System (OPPS); implementation is set for 2026-04-06. This will affect hospital billing practices, particularly for outpatient services. Details can be accessed here.

- Additional transmittals (e.g., R13674OTN, R13676COM) were issued addressing Provider Education for the Review Choice Demonstration and the SSI/Medicare Beneficiary Data effective from 2026-04-13.

Implications for VBC Stakeholders:

The recent actions signal an evolving emphasis on evidence-based decision-making and the importance of risk assessment tools, making it essential for ACOs, MA plans, and health systems to align with these standards. The introduction of LCDs and risk scores can necessitate adjustments in documentation practices and care strategies to ensure compliance and optimize reimbursement. Specifically, stakeholders dealing with the newly defined genomic profiling and risk scores will need to enhance their clinical protocols.

As CMS continues to implement drug price negotiations, stakeholders will need to assess their pricing models for pharmaceuticals to address potential impacts on margins.

What to Watch:

In the upcoming 30-60 days, stakeholders should monitor the effective dates of the new LCDs and associated policy changes. Additionally, pay attention to feedback from the third cycle of Medicare drug price negotiations as it may set precedents for future negotiations. Key implementation dates of the recent transmittals must be tracked to ensure readiness and compliance with updated operational guidelines, notably those regarding the OPPS update on April 6, 2026.