Ambulatory Surgery Center Expansion 2026: CMS OPPS/ASC Final Rule, 573 New Procedures, and Medical Device Commercialization Strategy

What This Article Covers

On November 21, 2025, CMS published the Calendar Year 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule. It is the most consequential outpatient site-of-service regulation in over a decade. The rule adds 573 surgical procedures to the ASC Covered Procedures List (CPL), begins phasing out the Medicare Inpatient-Only (IPO) list, and expands device pass-through payment categories. Cardiac ablation — one of the fastest-growing electrophysiology procedures — is now reimbursable in an ASC for the first time.

For medical device manufacturers, this is not a reimbursement abstract. It is a market access event that changes where devices are used, who decides to use them, how they are purchased, and what price the market will bear. This article covers the specific regulatory changes, the procedures now eligible for the ASC setting, the device payment implications, and what manufacturers should do in response.

What This Article Does NOT Cover

This article focuses on the commercialization implications of the 2026 ASC expansion for medical device manufacturers. It does not cover general ASC operations, hospital outpatient payment methodology, or physician practice management. For Medicare coverage determination fundamentals, see the Medicare NCD vs LCD Guide. For reimbursement coding strategy, see the CPT/HCPCS/ICD Coding Guide. For the NTAP new technology payment pathway, see the NTAP Guide.

The 2026 OPPS/ASC Final Rule: Key Changes

Payment Rate Update

CMS finalized a 2.6% update to both OPPS and ASC payment rates for CY 2026, based on a hospital market basket increase of 3.3% reduced by a 0.7 percentage point productivity adjustment. CMS estimates total OPPS payments of approximately $101.0 billion and total ASC payments of approximately $9.2 billion in CY 2026 — an increase of roughly $8.0 billion and $450 million respectively from CY 2025.

ASCs that fail to meet Ambulatory Surgical Center Quality Reporting (ASCQR) program requirements face a 2.0 percentage point reduction in payments.

Expansion of the ASC Covered Procedures List

The most impactful change is the expansion of the ASC CPL. CMS revised the regulatory criteria under 42 CFR §416.166 by eliminating five of the general exclusion criteria and moving them into a new section as nonbinding physician safety considerations. Under the revised criteria, CMS added:

Per the Ambulatory Surgery Center Association (ASCA), which compiled the count from the final rule tables.

The five eliminated exclusion criteria previously barred procedures that: (1) typically required an overnight stay, (2) posed more than minimal safety risk, (3) required active medical monitoring past midnight, (4) involved significant blood loss, or (5) required specialized postoperative care. CMS determined these criteria are no longer necessary given the capabilities of modern ASCs, shifting the clinical judgment to the treating physician.

Three general exclusion criteria are retained: procedures that must be performed in a sterile operating room, procedures requiring more than 24-hour recovery, and procedures that cannot be safely performed in an ASC under any circumstances.

Phase-Out of the Inpatient-Only List

CMS began phasing out the Medicare IPO list over three years, starting with the removal of 285 mostly musculoskeletal services for CY 2026. The IPO list still consists of more than 1,400 Healthcare Common Procedure Coding System (HCPCS) codes as of 2026, but the trajectory is clear: CMS intends to eliminate it entirely, giving physicians and hospitals full discretion over site of service.

Device Pass-Through Payments

For CY 2026, CMS estimates pass-through spending for drugs, biologicals, and devices at $307 million, representing 0.30% of OPPS spending. Two new device categories received pass-through status effective January 1, 2026:

• C1607: New device pass-through category
• C1608: New device pass-through category

CMS also updated payment indicators and long descriptors for existing device categories including C1741 (anchor/screw for sacroiliac and pelvis fusion), C1604, and C1740. Renal denervation catheter device offset amounts (C1735, C1736) were updated to $0, meaning full pass-through payment is now available.

The Cardiovascular Frontier: Cardiac Ablation in the ASC

Why Cardiac Ablation Matters

The addition of cardiac catheter ablation procedures to the ASC CPL is the single most commercially significant change for medical device manufacturers in 2026. The American College of Cardiology and the Heart Rhythm Society advocated for this change for years, citing accumulating safety data and advances in electrophysiology technology.

Specific CPT codes added include:

At least 26 cardiology-focused ASCs opened or were announced in 2024, and industry analysis estimates that nearly a third of cardiac procedures could eventually occur in ASCs. Pulse field ablation (PFA) — a non-thermal ablation technology that has seen rapid adoption since FDA clearance — is particularly well-suited to the outpatient setting due to shorter procedure times and reduced complication risk.

Implications for Device Manufacturers

Cardiac ablation in the ASC creates specific commercial dynamics:

1. Different buyer. ASCs are typically physician-owned joint ventures or health system subsidiaries with different capital budgets, purchasing processes, and decision-making speed compared to hospital catheterization labs.

2. Price sensitivity. ASCs receive a fixed ASC payment rate per procedure — there is no separate device reimbursement outside of pass-through categories. The device cost must fit within the procedural bundle.

3. Volume concentration. Electrophysiology procedures are capital-intensive, requiring mapping systems, recording equipment, and specialized staffing. ASCs performing cardiac ablation will be high-volume centers.

4. Technology fit. Devices that simplify the procedure, reduce fluoroscopy time, shorten procedure duration, or enable same-day discharge will have a competitive advantage in the ASC setting.

Spine and Orthopedic Expansion

Lumbar Fusion and Spine Codes

CMS added posterior lumbar interbody fusion (CPT 22630) and combined posterior/interbody fusion (CPT 22633) to the ASC CPL. These are among the most common spine surgery procedures and represent a significant expansion of spine surgery into the outpatient setting.

Sacral and pelvic fusion devices (HCPCS C1737) received updated coding that allows pairing with additional CPT codes, expanding the range of procedures in which these devices can be used in ASCs.

Orthopedic Volume Drivers

The phase-out of the IPO list began with 285 musculoskeletal services, reflecting years of data showing that many orthopedic procedures — including total joint arthroplasty in selected patients — can be safely performed in an outpatient setting. While total joints are not yet ASC-eligible for CY 2026, the trajectory suggests continued expansion.

For manufacturers of orthopedic implants, instruments, and robotics, the ASC channel requires:

• Instruments and trays optimized for ASC turnover and storage constraints
• Implant systems that simplify surgical technique
• Economic models that align device cost with ASC procedural margins
• Evidence supporting same-day discharge protocols

Market Size and Growth Trajectory

Current ASC Market

The U.S. ambulatory surgery center market was valued at approximately $88.66 billion in 2025 and is projected to reach $93.25 billion in 2026 (5.2% CAGR), growing to $113.36 billion by 2030 at a 5.0% CAGR, according to Research and Markets.

CMS projects approximately $9.2 billion in total ASC payments for CY 2026, up $450 million from CY 2025. The MedPAC March 2026 report notes that approximately 3,700 procedures are now on the ASC CPL, but actual ASC service volume remains concentrated in a relatively small number of high-frequency procedures. It is not yet clear how quickly the addition of 573 procedures will translate into volume growth.

M&A and Consolidation

The ASC market is consolidating rapidly. Ascension announced a $3.9 billion deal to acquire AmSurg. HCA Healthcare is divesting hospital assets in favor of outpatient growth. Tenet Healthcare continues expanding through its USPI ambulatory platform. Independent and smaller ASCs face financial pressure from rising labor and supply costs combined with reimbursement rates that are not keeping pace, creating acquisition targets.

For device manufacturers, consolidation means fewer but larger buying organizations, with increasing leverage over pricing and contract terms.

Device Commercialization Strategy for the ASC Channel

1. Reassess Your Site-of-Service Mix

Map your current procedure volumes by site of service — hospital outpatient department (HOPD) vs. ASC vs. physician office. The addition of 573 procedures to the ASC CPL means procedures that were exclusively hospital-based may now migrate. Manufacturers who understand this migration first can reposition their sales force, adjust pricing, and build ASC-specific value propositions before competitors.

2. Develop ASC-Specific Economic Models

ASC reimbursement is fundamentally different from HOPD reimbursement. In an ASC, the facility receives a single bundled payment per procedure. The device cost must be absorbed within that payment. Manufacturers need to build economic models that demonstrate:

• Device cost as a percentage of ASC procedural payment
• Potential for improved throughput (more cases per day) with the device
• Reduction in procedure-related complications that could extend recovery
• Total cost-of-care advantage vs. competing devices

3. Pursue Device Pass-Through Status

Device pass-through payments provide additional reimbursement above the standard ASC bundled payment for qualifying new devices. CMS approves new pass-through categories quarterly. The application process requires demonstrating that the device represents a substantial clinical improvement and that the cost is not otherwise covered by existing payment categories.

With two new device pass-through categories approved for CY 2026 and renal denervation catheter offset amounts reduced to $0, there is active regulatory appetite for innovative device payment pathways.

4. Build ASC-Specific Sales and Distribution

ASCs make purchasing decisions differently from hospitals. The decision-making unit is smaller, the sales cycle is shorter, and the relationship is often directly with the physician-owner. Device companies need:

• Dedicated ASC sales specialists who understand ambulatory economics
• Consignment and inventory management solutions appropriate for smaller facilities
• Training and credentialing programs adapted for ASC staff
• Service and support models that account for the fact that ASCs have limited biomedical engineering resources

5. Generate Outcomes Evidence for the ASC Setting

CMS explicitly moved the five exclusion criteria into "nonbinding physician safety considerations," but safety evidence remains critical for physician adoption and payer coverage. Manufacturers should invest in:

• Prospective registries tracking outcomes for procedures performed in ASCs
• Health economics data comparing ASC vs. HOPD outcomes and costs
• Real-world evidence supporting same-day discharge criteria
• Patient-reported outcome measures specific to the ambulatory setting

The American College of Cardiology has already launched a first-of-its-kind registry to track cardiac procedures in ASCs — manufacturers who participate early will generate the evidence that shapes future coverage decisions.

Commercial Payer Dynamics

CMS policy is only part of the picture. Commercial payers are pushing site-of-service optimization more aggressively than Medicare. Self-insured employers, facing unsustainable annual cost increases exceeding 10%, are pursuing direct contracting with ASCs for common procedures like joint replacements, colonoscopies, and orthopedic repairs.

For device manufacturers, this means:

• Commercial payer coverage for ASC procedures may expand faster than Medicare
• Payer-driven site-of-service mandates may accelerate the migration of procedures from HOPD to ASC
• Device price transparency requirements may intensify as payers scrutinize the cost components of ASC bundles
• Prior authorization requirements may differ by site of service

What to Watch in 2027

The CY 2027 OPPS/ASC proposed rule, expected in summer 2026, will determine the next phase of IPO list phase-out and potential further ASC CPL expansion. Key areas to monitor:

• Additional IPO list removals: CMS is expected to continue removing services from the IPO list, potentially expanding into higher-acuity procedures
• Cardiac ablation volume data: Early data on cardiac ablation volumes in ASCs will inform future coverage and payment policy
• Pass-through device applications: Quarterly review cycles offer ongoing opportunities for new device categories
• State regulatory barriers: Some states impose certificate-of-need requirements or other restrictions on ASC development that may limit expansion
• Workforce constraints: The availability of surgeons, anesthesiologists, and specialized nursing staff will determine how quickly ASCs can absorb new procedure categories

Key Takeaways

1. The CY 2026 OPPS/ASC Final Rule adds 573 procedures to the ASC Covered Procedures List and begins phasing out the Inpatient-Only list — the most significant outpatient site-of-service expansion in over a decade.

2. Cardiac ablation, posterior lumbar fusion, and vascular procedures are now ASC-eligible, creating new commercial channels for device manufacturers in cardiovascular, spine, and vascular specialties.

3. ASC reimbursement is bundled — the device cost must fit within the procedural payment. Manufacturers must build ASC-specific economic models and consider pursuing device pass-through status.

4. The ASC market is projected to reach $93.25 billion in 2026, with rapid consolidation creating larger but fewer buying organizations with increasing pricing leverage.

5. Manufacturers who invest early in ASC-specific sales capabilities, outcomes evidence, and economic value propositions will be positioned to capture share as procedures migrate from hospitals to ambulatory settings.