On April 15, 2025, CMS released the final Part C/Part D rule for 2026, with the total length cut in half from draft to final (many topics dropped - here). That rule was a "Biden" proposal and a "Trump" final.
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On April 11, 2025, CMS released the inpatient proposed rule for CY2026. Find the CMS fact sheet here. Find the inspection copy here, and look for the typeset Fed Reg copy on April 30.
It's Still Long - Equity for Measures Dropped
It's still long under the new adminstration; the inspection copy (typescript) runs 1361pp. The term "equity" appears about 60 times, but often in context of proposed dropping of hospital quality measures containing the term "equity." I had no matches on the term "artificial intelligence." (There is one on "Machine learning," in an NTAP discussion).
There is a discussion of developing national cost to charge ratios (inspection, 217ff).
The SEP-1 sepsis measure has been somewhat controversial but remains in the 2026-27-28 measures.
New Tech Applications
Add on new tech payments (NTAP) beging at E, page 221 (inspection) and run to page 485. Sunsetting and continuing NTAP are at page 243 (inspection), table II.E-01.A and .B. There were 19 new applications under the normal pathway (page 247, inspection). 14 are carried forward into the current discussion (starting (a) AUCATZYL, page 249 inspection).
There's at least one diagnostic test, TRIVERITY (sepsis), page 473ff (inspection). Alternate pathway NTAPs begin at page 481 (inspection).
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AI CORNER
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For a CMS policy audience, here's a structured summary of the FY 2026 New Technology Add-On Payment (NTAP) applications and policy context under the Inpatient Prospective Payment System (IPPS), as outlined in the FY2026 Proposed Rule (CMS-1833-P):
1. NTAP Program Purpose and Criteria
CMS offers NTAPs under 42 CFR 412.87 to provide temporary additional payments for eligible new medical services and technologies that:
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Are new (not substantially similar to existing technologies)
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Are costly, such that the MS-DRG payment is inadequate
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Offer substantial clinical improvement over existing treatments
Alternate pathways are available for:
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FDA-designated Breakthrough Devices
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Qualified Infectious Disease Products (QIDPs)
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Limited Population Antibacterial Drug (LPAD) pathway products
Add-on payments are not budget neutral and are typically up to 65% or 75% of the cost above the standard MS-DRG payment, depending on technology type.
2. New Application Volume and Process
For FY2026, CMS received:
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19 traditional pathway applications
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14 applications are reviewed in the proposed rule
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2 were ineligible (no FDA marketing authorization by May 1, 2025)
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3 were withdrawn
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CMS has also detailed the process improvements, including:
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Earlier FDA authorization deadline: now May 1 (previously July 1)
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Greater transparency: public posting of NTAP applications and methodology at https://mearis.cms.gov/public/publications/ntap
3. Summary of Continuing, New, and Discontinued NTAP Technologies
A. Continuing NTAPs in FY2026 (selected technologies)
(See Tables II.E-01.A and II.E-01.B)
Examples include:
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CASGEVY™ and LYFGENIA™: gene therapies for sickle cell disease, with NTAP amounts up to $2.3 million
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TriClip™ G4 (mitral valve repair): $26,000
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EPKINLY™ and COLUMVI™ (B-cell lymphomas): $6,504
B. Discontinued NTAPs
(Table II.E-02)
Technologies are discontinued if the 3-year anniversary of market entry occurs before April 1, 2026. Discontinued examples include:
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CYTALUX® (ovarian indication)
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GORE® TAG® Thoracic Branch Endoprosthesis
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iFuse Bedrock Granite
Note: CERAMENT® G was approved for one indication in a prior year but now has a new FY2026 application for a different clinical use.
4. Highlights from FY2026 Traditional Pathway Applications
Detailed summaries are included for each technology in the Proposed Rule and MEARIS. Example:
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AUCATZYL® (obecabtagene autoleucel): A CAR-T cell therapy for relapsed/refractory B-ALL. FDA approved November 2024. Uses new ICD-10-PCS codes XW0338A and XW0438A.
Other applicants include novel biologics, implantable devices, and diagnostics, each evaluated against the newness, cost, and clinical improvement criteria.
5. Strategic Implications for Stakeholders
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Hospitals should ensure they code eligible discharges properly to capture NTAP.
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Manufacturers must align FDA timelines with CMS deadlines (May 1), submit cost modeling data, and clearly differentiate their technology.
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Policy teams should monitor MEARIS for transparency in applications and rulemaking trends, particularly for high-cost therapies (e.g., gene therapy NTAPs exceeding $1M).
Highlight a few examples from the NTAP applications.
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In the FY2026 CMS IPPS proposed rule, several of the 14 reviewed NTAP applications stand out for their clinical novelty, technological sophistication, or potential policy significance. Among the most striking is CASGEVY™ (exagamglogene autotemcel), a gene therapy approved for sickle cell disease (SCD), which carries a proposed NTAP of $1.65 million. CASGEVY™ uses CRISPR-based gene editing to reprogram the patient’s own stem cells—a dramatic shift from conventional transfusion-based SCD management.
Closely related is LYFGENIA™ (lovotibeglogene autotemcel), another cell-based gene therapy for SCD, with an even higher proposed NTAP of $2.325 million, underscoring the emergence of ultra-high-cost genetic interventions and CMS’s evolving role in bridging access through temporary add-on payments.
Equally innovative is the HEPZATO™ KIT, which combines melphalan chemotherapy with a hepatic delivery system that isolates liver circulation during infusion, enabling high-dose chemotherapy targeted to liver tumors. The proposed NTAP of $118,625 reflects both the technical complexity and the potential to extend life in metastatic disease settings with few alternatives.
Another standout is the EVOQUE™ Tricuspid Valve Replacement System, one of the first devices to target tricuspid valve regurgitation—a historically undertreated condition. With a proposed NTAP of $31,850, EVOQUE™ signals CMS’s growing recognition of structural heart innovations beyond the aortic and mitral domains.
Finally, the Paradise™ Ultrasound Renal Denervation System represents a novel application of ultrasound to modulate sympathetic nerves in the renal artery, offering an interventional therapy for patients with resistant hypertension. The device is seeking a $14,950 NTAP, and its inclusion highlights CMS’s increasing engagement with neuromodulatory devices that cross disciplinary boundaries between cardiology and nephrology. Together, these several applications reflect the growing diversity and sophistication of NTAP submissions, and the policy challenge of integrating frontier therapies into a prospective payment model.
