CMS Sets New Medicare 2026 Rates Across Five Innovation Categories

What the New Medicare 2026 Rates Mean for Access and Adoption

The U.S. Centers for Medicare & Medicaid Services (CMS) has delivered a rare cluster of reimbursement decisions that collectively mark one of the most significant access-defining weeks of 2025. Spanning neuromodulation, molecular diagnostics, AI imaging, autoimmune disease therapy, and oncology support care, the rulings create new payment pathways that will reshape 2026 utilization across hospitals, imaging centers, ambulatory surgery centers, and physician offices.

What You Need To Know

CMS issued five major reimbursement decisions impacting neuromodulation, RA neuroimmune therapy, MRD assays, AI cardiac diagnostics and oncology support care.
LivaNova, Personalis, SetPoint, Caristo and Paxman each received new or finalized payment pathways effective late 2025 or January 2026.
Decisions include New Technology APC assignments, TPT status, OPPS/PFS pricing, and new CPT code reimbursement structures.
The rulings materially influence hospital economics, physician adoption, and long-term patient access across multiple high-need therapeutic areas.

LivaNova: VNS Therapy Receives a Major Outpatient Payment Upgrade

CMS assigned LivaNova’s VNS Therapy for drug-resistant epilepsy to New Technology APC 1580 for new patient implants while elevating end-of-service procedures to Level 5 APCs. Beginning January 1, 2026, Medicare outpatient payments rise approximately 48% for new implants and 47% for battery-replacement procedures, according to the company’s announcement .

For years, reimbursement shortfalls have been a critical bottleneck to VNS adoption, particularly among Medicare patients whose cases often carry higher care complexity. With the new payment levels, hospital economics shift meaningfully and LivaNova argues this removes a structural barrier that slowed procedure penetration. The upgrade comes as real-world data continues to validate VNS outcomes, including seizure reductions of 80–95% across seizure subtypes in the CORE-VNS study.

For a therapy marketed to an underserved population with limited surgical alternatives, CMS’ action may be one of the most economically transformational moves the epilepsy field has seen in years.

Personalis: MRD Surveillance Test Secures New Pricing Under CMS Molecular Diagnostics

Personalis received a revised Medicare rate for its NeXT Personal MRD assays used in post-treatment surveillance of stage II–III breast cancer. Effective December 1, 2025, the NeXT Personal Dx Breast MRD test will be reimbursed at $4,266, while the single-plasma MRD test is priced at $1,164, according to the company’s SEC filing .

Coverage applies once per cancer diagnosis for the MRD recurrence-monitoring test and for up to six years post-treatment for the single-plasma test. The rate aligns the assay with other premium MRD technologies, signaling CMS’ recognition of highly sensitive liquid-biopsy platforms in long-term surveillance strategies.

For oncology clinics that have struggled to fund routine MRD monitoring for Medicare beneficiaries, the new price point offers a clearer reimbursement path and may bolster physician willingness to integrate ultra-sensitive molecular assays into post-treatment workflows.

SetPoint Medical: Breakthrough Neuroimmune Modulation Device Wins TPT Status

SetPoint Medical announced that CMS has granted Transitional Pass-Through (TPT) payment status for its FDA-approved neuroimmune modulation device for rheumatoid arthritis. The new HCPCS device category, C1607, enables incremental payment for outpatient and ASC procedures for up to three years starting January 1, 2026 .

As the first non-pharmacologic RA therapy cleared under FDA’s Breakthrough Devices Program, SetPoint’s system offers an implant-based alternative for patients who fail biologics or targeted DMARDs. The TPT decision signals CMS’ intent to support emerging device-driven immunomodulation strategies, particularly those backed by large cost-offset potential from reduced drug use.

For hospitals, the ruling removes near-term economic uncertainty that often slows adoption following innovative device approvals.

Caristo Diagnostics: AI Coronary Plaque Analysis Secures Full OPPS + PFS Payment Pathway

Caristo’s CaRi-Plaque AI analysis received a $950.50 OPPS rate for hospital outpatient billing, complementing the 2026 Physician Fee Schedule (PFS) payment of over $1,000 tied to new Category I CPT code 75577 .

Together, the dual-setting coverage finalizes nationwide Medicare payment for AI plaque characterization on coronary CT angiography. Hospitals, imaging centers, and physician offices now have a unified path to bill for CaRi-Plaque starting January 1, 2026.

CMS continues to accelerate reimbursement for AI diagnostic tools, and CaRi-Plaque’s placement underscores growing federal confidence in algorithmic imaging augmentation, particularly for high-burden diseases like coronary artery disease.

Paxman: Mechanical Scalp Cooling Receives Final 2026 Rates, Though Without Increases

CMS finalized 2026 payment rates for three newly created CPT codes (97007, 97008, 97009) covering mechanical scalp-cooling procedures. OPPS assigns an APC 1517 rate of $1,516 for the initial fitting and education visit, while the Medicare Physician Fee Schedule lists $1,883.43 per patient per treatment cycle for the same code. Additional per-treatment payments include $55.80 for pre-cooling and $32.31 per 30-minute post-infusion cooling unit, according to Paxman’s release .

Despite broad provider advocacy for higher rates, CMS finalized the payment amounts without modification. Paxman noted disappointment but emphasized continued work with providers to ensure viable economics for scalp-cooling programs aiming to minimize chemotherapy-induced alopecia.