Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots

For CY 2025, the scalp cooling service is described by temporary CPT codes 0662T and 0663T. CPT code 0662T (Scalp cooling, mechanical; initial measurement and calibration of cap) became effective on July 1, 2021, to describe initial measurement and calibration of a scalp cooling device for use during chemotherapy administration to prevent hair loss. According to Medicare's National Coverage Determination (NCD) policy, specifically, NCD 110.6 (Scalp Hypothermia During Chemotherapy to Prevent Hair Loss), the scalp cooling cap itself is classified as an incident to supply to a physician service, and would not be paid under the OPPS; however, interested parties have indicated that there are substantial resource costs of around $1,900 to $2,400 associated with calibrating and fitting the cap. CPT guidance states that CPT code 0662T should be billed once per chemotherapy session, which we interpret to mean once per course of chemotherapy. Therefore, if a course of chemotherapy involves, for example, 6 or 18 sessions, HOPDs should report CPT 0662T only once for those 6 or 18 therapy sessions. We note that CPT code 0663T (Scalp cooling, mechanical; placement of device, monitoring, and removal of device (List separately in addition to code for primary procedure)) describes an ancillary service and is assigned to status indicator “N” to indicate that OPPS payment is packaged into the payment for the primary service. We assigned CPT code 0662T to APC 1519 (New Technology--Level 19 ($1,701- $1,800)) with a payment rate of $1,750.50 and CPT code 0663T to status indicator “N” for CY 2025.

Beginning January 1, 2026, CPT codes 0662T and 0663T will be deleted and replaced with three new Category I CPT codes:

97007 (formerly placeholder 9XX01)--Mechanical scalp cooling, including individual cap supply with head measurement, fitting, and patient education.

97008 (formerly placeholder 9XX02)--Mechanical scalp cooling; including hair preparation, individual cap placement, therapy initiation, and precooling period).

97009 (formerly placeholder 9XX03)--Mechanical scalp cooling; provided after discontinuation of chemotherapy, each 30 minutes (List separately in addition to code for primary procedure).

In the CY 2026 OPPS/ASC proposed rule, we stated that we believed that CPT code 97007 most closely describes the primary service currently described by CPT code 0662T, while CPT codes 97008 and 97009 describe ancillary services for which payment would be packaged in the primary service. Therefore, for CY 2026, we proposed to assign CPT code 97007 to APC 1517 (New Technology--Level 17 ($1,501-$1,600)) with a $1,550.50 payment rate based on existing claims data for CPT code 0662T. We also proposed to assign status indicator “N” to CPT codes 97007 and 97009 to align with our current packaging policies generally, and specifically with regard to our current packaging of CPT code 0663T. Finally, we noted that because CPT is deleting CPT codes 0662T and 0663T, we would similarly delete the temporary codes under the OPPS/ASC payment systems.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters expressed concerns with the proposal to assign the new CPT codes to lower payment rates based on low claim volumes and requested that we withhold any payment reductions until the volume of claims increases. Other commenters supported the proposed APC assignment for CPT code 97007 based on claims data for CPT code 0662T but took issue with the proposal to package payment for CPT code 97008. These commenters requested that we assign CPT code 97008 to APC 1506 (New Technology--Level 6 ($401-$500)) and status indicator “S” instead of the proposed status indicator “N.” The commenter stated that there is no service to which CPT code 97008 can be packaged into, while also explaining that it is reported once for each chemotherapy session for an average of 5 to 7 sessions per patient. Per the commenters, scalp cooling is a

standalone treatment that requires specialized nursing resources and significant chair time, with an average cost of $500 outside of the chemotherapy service. The commenters emphasized that there is no service to which scalp cooling can be appropriately packaged, as it is not ancillary to any other procedure. They also highlighted certain concerns about patient access if the proposal to package payment for CPT code 97008 were to be finalized, noting that packaging this service would create financial barriers for Medicare beneficiaries and limit hospitals' ability to offer this treatment.

Response: With regard to the proposed APC assignment for CPT code 97007, we thank the commenters for their support to utilize claims data for CPT code 0662T and assign CPT code 97007 to APC 1517. Since the CY 2026 OPPS/ASC proposed rule was released, 15 additional CY 2024 claims for CPT code 0662T have been processed upon which to base the APC assignment for CPT code 97007. The revised geometric mean cost for CPT code 97007 is approximately $1,410. Therefore, we are finalizing our proposal to use available claims data for CPT code 0662T to finalize the APC assignment for CPT code 97007 to APC 1516 (New Technology-- Level 16 ($1,401-$1,500) with a payment rate of $1,450.50 and status indicator “S.”

With regard to comments on the status indicator assignment for CPT code 97008, we disagree with comments asserting that there is no service to which scalp cooling can be appropriately packaged. Scalp cooling is always furnished in conjunction with chemotherapy administration, for the purpose of addressing a side effect of chemotherapy treatment. Unlike CPT code 97007 describing the fitting of the cap, which is performed on a date of service distinct from the chemotherapy administration and for which we proposed separate payment, CPT codes 97008 and 97009 would always be performed on the same date of service as the chemotherapy treatment. We acknowledge commenters' concerns regarding the resources required to furnish scalp cooling and potential impacts to patient access; however, we believe that the costs associated with the scalp cooling service are appropriately captured within the packaged payment for chemotherapy treatment. Therefore, we believe it is appropriate to package payment for CPT codes 97008 and 97009 with the primary chemotherapy service.

In summary, for CY 2026, we are finalizing our proposal to use available claims data for CPT code 0662T to finalize the APC assignment for CPT code 97007 to APC 1516 (New Technology--Level 16 ($1,401- $1,500) with a payment rate of $1,450.50 and status indicator “S.” We are also finalizing our proposals to assign CPT codes 97008 and 97009 to status indicator “N” for CY 2026. These changes are reflected in Table 76.

The final CY 2026 OPPS payment rate for all the codes payable under the OPPS can be found in Addendum B to this final rule with comment period. In addition, we refer readers to Addendum D1 to this final rule with comment period for the SI meanings for all codes reported under the OPPS. Addendum D1 is available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.094

Respiratory Related Services and Procedures 49. Group Respiratory Therapy, HCPCS G0239 (APC 5732)

HCPCS code G0239 (Therapeutic procedures to improve respiratory function or increase strength or endurance of respiratory muscles, two or more individuals (includes monitoring)) describes a medical service for two or more patients to improve their breathing and strengthen their respiratory muscles, conducted in a group setting under the supervision of a healthcare professional. For the CY 2026 OPPS/ASC proposed rule, HCPCS code G0239 had a geometric mean cost of around $43.00, and we proposed to continue to assign the procedure to APC 5732 (Level 2 Minor Procedures), which has a payment rate of around $39.00.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A commenter expressed concern that the payment amount for APC 5732 dropped by 2.5 percent, from $39.96 in CY 2025 to $38.91 in CY 2026. The commenter requested that CMS provide further explanation for what is driving the decrease in payment for APC 5732 and, specifically, for HCPCS code G0239.

Response: There are a number of factors pertinent to the OPPS that may cause geometric mean costs to change from one year to the next. Some of these are a reflection of hospital behavior, and some of them are a reflection of fundamental characteristics of the OPPS, as defined in statute. For example, the OPPS payment rates are based on hospital cost report and claims data. However, hospital costs and charges change each year and this results in both changes to the cost-to-

charge ratios (CCRs) taken from the most currently available cost reports and also differences in the charges on the claims that are the basis of the calculation of the geometric mean costs on which OPPS rates are based. Similarly, hospitals adjust their mix of services from year to year by offering new services, and ceasing to furnish services, or changing the proportion of the various services they furnish, which has an impact on the CCRs that we derive from their cost reports. CMS cannot stabilize these hospital-driven fundamental inputs to the calculation of OPPS payment rates. Moreover, there are other essential elements of the OPPS which contribute to the changes in relative weights each year. These include, but are not limited to, reassignments of HCPCS codes to APCs to rectify 2 times violations as required by the law, to address the costs of new services, to address differences in hospitals' costs that may result from changes in medical practice, and to respond to public comments. In summary, after consideration of the public comment, we are finalizing our proposal without modification. Specifically, we are continuing to assign HCPCS code G0239 to APC 5732 (Level 2 Minor Procedures) with a payment rate of $38.16. We note that we review the APC assignments for all items and services paid under the OPPS on an annual basis.

Table 77 shows the finalized status indicator and APC assignment for this HCPCS code. We refer readers to Addendum B to this final rule with comment period for the payment rates for all codes reportable under the OPPS. Addendum B is available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.095

CPT code 31647 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), initial lobe) describes a procedure used for conditions such as severe emphysema or persistent bronchopleural air leaks, where a device is placed to control airflow into a portion of the lung. For the CY 2026 OPPS/ASC proposed rule, CPT code 31647 had a geometric mean cost of $11,385.22 and we proposed to continue to assign the procedure to APC 5155 (Level 5 Airway Endoscopy) and status indicator J1, which has a payment rate of around $7,269.

We note that at the August 25, 2025, HOP Panel Meeting, a presentation was made requesting the reassignment of CPT code 31647 from APC 5155 to New Technology APC 1575 (New Technology Level 38). Based on the information presented at the meeting, the Panel recommended this reassignment.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Commenters recommended that CMS reassign CPT code 31647 from APC 5155 to New Technology APC 1575 (New Technology Level 38).

The commenters noted that the cost of the procedure exceeds payment by approximately $4,000 and expressed concern that this discrepancy would result in patient access to the procedure being limited, particularly considering that the alternatives for severe emphysema patients involve much more invasive and expensive treatment options.

A commenter stated that the reassignment to a New Technology APC was necessary because (1) there is no higher-level APC in the Airway Endoscopy APC family and (2) there is no other clinical APC that would be an appropriate clinical and resource fit.

The commenter claimed that the geometric mean costs for CPT code 31647 have been stable and significantly more than the geometric mean cost for the APC into which it maps (APC 5155). While acknowledging that there is not a 2-times rule violation (given the number of single frequency claims for the procedure), the commenter noted that the GMC for CPT code 31647 is significantly above the GMC of the other procedures assigned to APC 5155 and more than double that for many procedures in the APC.

The commenter stated that they considered an alternative clinical APC but could not identify a clinically and resource cohesive clinical APC into which to move it.

The commenter stated that with no appropriate clinical APC to use as an alternative, CMS should assign the procedure to a new technology APC that more closely aligns with its GMC. The commenter concluded that APC 1575 is the appropriate new technology APC for the service given that the GMC for CPT code 31647 has been in the $11,000-$12,000 range for the past 3 plus years and is $11,385 in the 2024 claims data that CMS released.

Response: As recognized by one of the commenters, APC 5155 does not currently have a 2 times rule violation in the final rule data and APC 5155 appears to be the best clinical fit for CPT code 31647 of any existing clinical APC.

After consideration of the public comments we received and discussion and input from our Medical Officers, we are finalizing our proposal without modification to assign CPT code 31647 to APC 5155. We note that we review the APC assignments for all items and services paid under the OPPS on an annual basis. We will reevaluate the APC assignment for CPT code 31647 in the next rulemaking cycle. Table 78 shows the finalized status indicator and APC assignment for this procedure code. We refer readers to Addendum B to this final rule with comment period for the payment rates for all codes reportable under the OPPS. Addendum B is available via the internet on the CMS website.

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Effective July 1, 2024, the AMA CPT Editorial Panel established CPT code 0893T (Noninvasive assessment of blood oxygenation, gas exchange efficiency, and cardiorespiratory status, with physician or other qualified health care professional interpretation and report) to describe a non-invasive method for assessing a patient's blood oxygenation, gas exchange efficiency, and overall cardiorespiratory status using a special breathing device and monitor, with the resulting data interpreted and reported by a healthcare professional. We assigned CPT code 0893T to APC 5733 (Level 3 Minor Procedures) in the CY 2025 OPPS/ASC final rule. For the CY 2026 OPPS/ASC proposed rule, we did not have any claims for rate setting, so we proposed to continue to assign the procedure to APC 5733 (Level 3 Minor Procedures), which has a proposed payment rate of around $61.00 and status indicator Q1 (STV- Packaged Codes; Paid under OPPS).

We note that at the August 25, 2025, HOP Panel Meeting, a presentation was made requesting the reassignment to APC 5723 (Level 3 Diagnostic Tests and Related Services) for CPT code 0893T. Based on the information presented at the meeting, the Panel made no recommendation on the APC assignment for the code.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comments: Commenters requested that CPT code 0893T be reassigned from APC 5733 (Level 3 Minor Procedures) to APC 5723 (Level 3 Diagnostic Tests and Related Services) with a proposed payment rate of around $382.00. The commenters stated that the cost of the procedure is approximately $350 to $360 and therefore the proposed payment rate of $61.00 falls far short of adequate reimbursement and threatens patient access to the procedure. Some commenters additionally stated that the current APC assignment is inappropriate because there are no clinically similar procedures in that classification. These commenters stated that CPT 0893T involves exhaled gas analysis of oxygen, carbon dioxide, non- invasive blood oxygenation (PO2) and A-a gradient calculations and state that this procedure is comparable to CPT 94681 (oxygen uptake with exhaled gas analysis including carbon dioxide to assess lung function). According to these commenters, these two procedures utilize the same methodology and measure the physiological impairment parameters involving integrated cardiopulmonary assessment, supporting reclassification to APC 5723 (Level 3 Diagnostic Tests and Related Services).

Response: While we note that we do not have any claims for rate setting, based upon the input provided by commenters, we agree that CPT code 0893T should be reassigned to an APC that better reflects the costs of the procedure. However, we do not agree that the appropriate APC is 5723 (Level 3 Diagnostic Tests and Related Services). We are also not persuaded that the device is diagnostic in nature. While it provides additional information about a patient's oxygen level and other factors that may be helpful in formulating a diagnosis, it is not itself diagnosing a specific condition.

Accordingly, after consideration of the public comments we received and discussion and input from our Medical Officers, we have decided to reassign 0893T to APC 5734 (Level 4 Minor Procedures) with a payment amount of around $136. We note that we review the APC assignments for all items and services paid under the OPPS on an annual basis.

Table 79 shows the finalized status indicator and APC assignment for this procedure code. We refer readers to Addendum B to this final rule with comment period for the payment rates for all codes reportable under the OPPS. Addendum B is available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.097

SaaS Imaging 52. 3D Anatomical Segmentation Imaging Software Service, HCPCS Code C8001 (APC 5721)

In the January 2025 update, we established HCPCS code C8001 to describe the 3D anatomical segmentation imaging intended as software for preoperative surgical planning and as software for the intraoperative display of multi-dimensional digital images. We initially assigned HCPCS code C8001 to APC 5521 (Level 1 Imaging without Contrast) with a status indicator of `S' (Procedure or Service, Not Discounted When Multiple; Paid under OPPS; separate APC payment). After receiving feedback from external parties, we reassigned HCPCS code C8001 to APC 5721 (Level 1 Diagnostic Tests and Related Services) for the April 2025 quarterly update.

For CY 2026, we proposed to continue to assign HCPCS code C8001 to APC 5721 which has a proposed rate of around $132. We note that because this is a new service, we do not have any claims data.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A commenter requested for HCPCS code C8001 to be reassigned from APC 5721 (Level 1 Diagnostic Tests and Related Services) to APC 5723 (Level 3 Diagnostic Tests and Related Services). The commenter cited the technical expertise required by the technologist and the additional hardware and software costs as justification for the higher-level APC assignment. The code describes 3D anatomical segmentation imaging for preoperative planning, data preparation, and transmission obtained from previous diagnostic computed tomographic or magnetic resonance examination of the same anatomy.

Response: After careful review of the request to reassign C8001 from APC 5721 to APC 5723, we do not believe it would be appropriate to reassign the APC for C8001 until we have claims data for this service. We will continue to monitor claims and utilization patterns for C8001 and may reconsider the APC assignment in future notice-and-comment rulemaking.

In summary, after consideration of the public comment we received, we are finalizing the APC assignment for HCPCS code C8001 without modification. The final CY 2026 payment rates for this code can be found in Addendum B to this final rule with comment period. In addition, we refer readers to Addendum D1 to this final rule with comment period for the SI definitions for all codes reported under the OPPS. Addenda B and D1 are available via the internet on the CMS website. Refer to Table 80 for code descriptor, APC assignment and status indicator assignment for HCPCS code C8001 for CY 2026. [GRAPHIC] [TIFF OMITTED] TR25NO25.098

53. 3D Image Generation Used in Surgical Planning and Navigation for Placement of Implants and Devices (BoneMRI), HCPCS Code G0566 (APC 5721)

In CY 2025, we established HCPCS code G0566 (3D radiodensity-value bone imaging, algorithm derived, from previous magnetic resonance examination of the same anatomy) to describe the BoneMRI software as a service (Change Request 13993).\26\ This service provides 3D radiodensity-value bone imaging from previous magnetic resonance images. For CY 2025, HCPCS code G0566 was assigned to APC 5721 (Level 1 Diagnostic Tests and Related Services) with the status indicator “S” (separate APC payment).

\26\ https://www.cms.gov/files/document/r13135cp.pdf.

As HCPCS code G0566 is a new code in 2025, we have no claims data. For CY 2026, we proposed to assign HCPCS Code G0566 to APC 5721 (Level 1 Diagnostic Tests and Related Services).

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Several commenters expressed concern with the low payment rate for this service which commenters stated may provide a financial barrier for providers to adopt this new technology into their practice and limit access. A commenter stated the proposed payment rate is not comparable to other SaaS technologies payment, such as EchoGo Heart Failure (CPT code 0932T) or HeartFlow FFRct (CPT code 75580), which ranges from about $316 to $879. The commenter stated the payment rate for BoneMRI does not reflect the value and resources for this service. The commenters recommended that HCPCS code be reassigned to APC 5723 (Level 3 Diagnostic Tests and Related Services) as that APC reflects the clinical value and cost of this service.

Response: In determining the appropriate APC placement for CPT/ HCPCS codes, we rely on input from a variety of sources, including, but not limited to, review of the resource costs and clinical similarity of the service to existing procedures; input from CMS medical advisors; and information from interested specialty societies. We evaluated the recommendations, modeled the suggestions, analyzed the cost results of the suggested APC reassignments, and received additional input from our medical advisors. We note the SaaS codes that the commenter mentioned were assigned to their respective APCs based on similar clinical and resource similarity. While we recognize that there is not currently a one-to-one match to crosswalk to the new codes, we based the proposed APC assignments for HCPCS code G0566 on crosswalks to CPT/HCPCS codes that have similar service and resource

elements to the new codes. Based on our review of the service compared to other services assigned to the Diagnostic Tests and Related Services Series, we believe HCPCS code C8001 (3d anatomical segmentation imaging for preoperative planning, data preparation and transmission, obtained from previous diagnostic computed tomographic or magnetic resonance examination of the same anatomy) is an appropriate crosswalk code for HCPCS code G0566, which is currently assigned to APC 5721 (Level 1 Diagnostic Tests and Related Services).

After consideration of the public comments we received, we are finalizing our proposed APC assignment and status indicator for HCPCS code G0566 to APC 5721 without modification. Refer to Table 81 for the final OPPS APC and status indicator assignment for HCPCS code G0566 for CY 2026. We refer readers to Addendum B to this final rule with comment period for the payment rates for all codes reportable under the OPPS. Addendum B is available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.099

In the CY 2026 OPPS/ASC proposed rule, we proposed to continue assigning CPT code 0877T (Augmentative analysis of chest computed tomography (ct) imaging data to provide categorical diagnostic subtype classification of interstitial lung disease; obtained without concurrent ct examination of any structure contained in previously acquired diagnostic imaging) to APC 1508 (New Technology--Level 8 ($601-$700)) with a proposed payment rate of $650.50 and status indicator “S”.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A commenter requested that CMS remove CPT Code 0877T from the current OPPS rule and fee schedule because according to the commenter, this service is best categorized as an ambulatory service, not an outpatient service to be reviewed and priced under the OPPS. That is, there are currently no hospitals that can provide the type of service described in CPT code 0877T. For this reason, any claims billed for this service in the hospital setting were billed in error and are the result of miscoding.

They also stated that CPT code 0877T is currently designated as contractor-priced under the Medicare Physician Fee Schedule (PFS), meaning that the local Medicare contractors determine payment rates for the service within the PFS geographic areas in their jurisdiction. Since IMVARIA's IDTF is located in Texas, Novitas Solutions, Inc., the local Medicare Administrative Contractor (MAC), is solely responsible for evaluating coverage and payment for CPT 0877T.

Finally, they stated that the rate posted by OPPS for 0877T appears potentially based on an inaccurate and unrelated crosswalk to the published rate for CPT code 0721T, which bears no clinical, procedural, or technological relationship to the Fibresolve test or the commenter's area of focus.

Another commenter supported CMS' proposal and urged CMS to finalize the proposed payment structure for CPT code 0877T which enables facilities to bill for state-of-the-art ILD diagnostic services.

They also noted that it came to their attention that there was a comment submitted to CMS that claimed that there are currently no hospitals that can provide the type of service described in CPT code 0877T. For this reason, any claims billed for this service in the hospital setting were billed in error and are the result of miscoding. The commenter noted that their company is not operating as an Independent Diagnostic Testing Facility (IDTF) but rather entering into contractual agreements with facilities to offer e-Lung as a software- as-a-medical-device (SaMD) for which the hospitals will then submit claims as the provider. Therefore, another commenter's claim that existing claims were billed in error, and the result of miscoding is not accurate.

Response: Based on our review and input from our medical advisors, we believe that there may be other services that could be described by CPT code 0877T and therefore, we continue to believe that the current assignment of CPT code 0877T to APC 1508 with status indicator “S” is appropriate. Therefore, we are finalizing without modification our proposal to assign CPT code 0877T to APC 1508 for CY 2026. The final payment rates for the codes can be found in Addendum B to this final rule with comment period.

In addition, we refer to Addendum D1 to this final rule with comment period for the status indicator (SI) meanings for all codes reported under the OPPS. Addenda B and D1 are available via the internet on the CMS website. 55. Noninvasive Arterial Plaque Analyses, CPT Code 0712T (5722)

Established in 2022, Category III CPT code 0712T is related to noninvasive arterial plaque analysis and describes the steps required for a software as a service (SaaS) imaging service that uses data from computed tomography angiography (CTA) to produce clinical information about arterial plaque for providers. See Table 82 for the CPT code, its long descriptor, and the proposed payment assignments.

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For CY 2026, we proposed to assign CPT code 0712T to APC 5521 (Level 1 Imaging without Contrast), which has a proposed payment rate of approximately $89. The issue of payment for CPT code 0712T was brought to the Advisory Panel on Hospital Outpatient Payment (also known as HOP Panel) in August 2025 for CY 2026 rulemaking. At the 2025 HOP Panel, several presenters provided information to the Panel regarding 0712T and advised the Panel to request that CMS reassign 0712T to New Technology APC 1511 with a payment rate of $950.50. Based on the information presented, the HOP Panel did not make a recommendation to CMS to reassign 0712T to a different APC for CY 2026.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Several commenters requested that CMS reassign CPT code 0712T to a New Technology APC 1511 with a payment rate of $950.50. Commenters detailed the procedural methodology and stated that the procedure involves segmentation, quantification, and assessment of high-risk biomarkers such as lipid-rich necrotic core plaque, which are critical for predicting strokes and other cardiovascular events. Several commenters recommended using CPT code 0625T (Automated quantification and characterization of coronary atherosclerotic plaque to assess severity of coronary disease, using data from coronary computed tomographic angiography; computerized analysis of data from coronary computed tomographic angiography) as a crosswalk code for CPT code 0712T, as they believe that CPT code 0625T and CPT code 0712T resemble each other in methodology, clinical purpose, and resource demands. Additionally, commenters stated that the current APC assignment fails to cover the cost of performing noninvasive arterial plaque analysis from CTA data and that hospitals cannot absorb the financial loss associated with this service. Further, commenters stated that undervaluing the complexity and resource cost of CPT code 0712T would discourage adoption, limit data collection, and impede CMS's ability to monitor utilization and outcomes.

Response: After consideration of the public comments, additional review of the procedures, and input from our CMS Medical Officers, we do not agree with the recommended crosswalk code of CPT code 0625T. Based on our review of the clinical characteristics of the procedure and input from our medical advisors, we believe that CPT code 0712T is more similar clinically and in terms of resource requirements and procedure costs to the procedures assigned to APC 5722 (Level 2 Diagnostic Tests).

We remind hospitals that we review, on an annual basis, the APC assignments for all items and services paid under the OPPS and we will continue to monitor the claims data as they become available.

In summary, after consideration of the public comments we received, we are finalizing our proposal with modification and reassigning CPT code 0712T to APC 5722 (Level 2 Diagnostic tests). The final CY 2026 payment rates for these codes can be found in Addendum B to this final rule with comment period. In addition, we refer readers to Addendum D1 to this final rule with comment period for the status indicator definitions for all codes reported under the OPPS. Addenda B and D1 are available via the internet on the CMS website.

Refer to Table 83 for code descriptors, APC assignments and status indicator assignments for CPT code 0712T. [GRAPHIC] [TIFF OMITTED] TR25NO25.101

Urology Related Services 56. Aquabeam Waterjet Ablation Procedure, CPT Code 52597 (APC 5376)

CPT code 0421T (Transurethral waterjet ablation of prostate, including control of post-operative bleeding, including ultrasound guidance, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included when performed) describes the Aquabeam waterjet ablation procedure. According to the manufacturer, Aquabeam is for treating lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) by using a high-velocity water stream to ablate and remove tissue from enlarged prostates. Effective January 1, 2026, CPT code 0421T will be replaced with CPT code 52XX1 (52597), Transurethral robotic-assisted waterjet resection of prostate, including intraoperative planning, ultrasound guidance, control of postoperative bleeding, complete, including vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy, when performed. We will assign the underlying claims associated with HCPCS code 0421T to CPT code 52XX1 (52597).

For the CY 2026 OPPS/ASC proposed rule, we estimated the geometric mean cost for CPT code 0421T to be $10,342 based on 7,557 single claims and proposed to assign the service to APC 5376 (Level 6 Urology and Related Services), which has a geometric mean cost of $9,746.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Several commenters requested CMS reassign CPT code 52597 (0421T) from APC 5376 (Level 6 Urology and Related Services) to APC 5377 (Level 7 Urology and Related Services) in the CY 2026 OPPS/ASC final rule with comment period. The commenters stated that CPT code 52597 (0421T) requires greater complexity and more resource than other CPT codes 55880 (Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (hifu), including ultrasound guidance) and 55873 (Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)) that are currently in APC 5376 (Level 6 Urology and Related Services). The commenters stated that CPT code 52597 (0421T) is similar both clinically and in resource use to the procedures assigned to APC 5377 (Level 7 Urology and Related Services), citing CPT code 55882 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation; with insertion of transurethral ultrasound transducer for delivery of thermal ultrasound, including suprapubic tube placement and placement of an endorectal cooling device, when performed).

Response: We appreciate the commenter's recommendation regarding the APC assignment of CPT code 52597 (0421T) but we disagree that the clinical complexity and resource required for CPT code 52597 (0421T) is comparable to CPT code 55882. We believe that CPT code 52597 (0421T) fits more appropriately in APC 5376 rather than in APC 5377 based on resource cost and clinical similarity and to the procedures in APC 5376. We note that while both CPT code 52597 (0421T) and CPT code 55882 CPT provides imaging guidance, we believe that the use of magnetic resonance imaging guidance in CPT code 55882 necessitates greater resource than ultrasound guidance.

After consideration of the public comment we received, we are finalizing our proposal without modification to assign CPT code 52597 (0421T) to APC 5376. Refer to Table 84 for the final OPPS APC and status indicator assignment for CPT code 52597 (0421T) for CY 2026. We refer readers to Addendum B to this final rule with comment period for the payment rates for all codes reportable under the OPPS. Addendum B is available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.102

CPT code 0991T (Cystourethroscopy, with low-energy lithotripsy and acoustically actuated microspheres, including imaging) describes the lithotripsy with acoustically actuated microspheres in an approved investigational device exemption (IDE) study (NCT06942949). According to the manufacturer, this prospective, single arm study utilizes low pressure ultrasound to actuate proprietary microbubble to fragment urinary stones. The AMA CPT Editorial Panel established CPT code 0991T effective January 1, 2026.

As this is a new code in 2026, we have no claims data for CPT code 0991T. For CY 2026, we proposed to assign CPT Code 0991T with the status indicator “E1.”

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A few commenters stated that CPT code X432T has transitioned to CPT code 0991T, effective July 1, 2025 and that CMS incorrectly assigned status indicator “E1” to CPT code X432T in the CY 2026 OPPS/ASC proposed rule. Additionally, the commenters requested the assignment of CPT code 0991T to APC 5376 (Level 6 Urology and Related Services), based on the commenter's resource cost of

$10,131, and be designated as device intensive with a device offset of 44 percent.

Response: We note that according to the AMA, CPT code 0991T will replace CPT code X432T, effective January 1, 2026. While CPT code 0991T was released on the AMA website on July 1, 2025, the code is not effective until January 1, 2026. We also note that our status indicator assignment of “E1” for CPT code 0991T (X432T) was appropriate in the CY 2026 OPPS/ASC proposed rule. During our CY 2026 OPPS/ASC proposed rule assessment of CPT code X432T, we determined that the enhanced lithotripsy service involved a non-FDA approved device not excepted by any IDE status and therefore not payable under the OPPS/ASC because non-FDA approved devices are considered not reasonable and necessary under Section 1862(a)(1)(A) of the Act. The Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones (NCT06942949) did not receive CMS category B IDE approval until August 1, 2025. Therefore, status indicator “E1” was an appropriate assignment for a service involving a non-FDA approved device. The definition of the OPPS status indicators can be found in Addendum D to this final rule with comment period via the internet on the CMS website.

In determining the appropriate APC placement for new codes, we rely on input from a variety of sources, including, but not limited to, review of the resource costs and clinical similarity of the service to existing procedures; input from CMS medical advisors; and information from interested specialty societies. We evaluated the recommendations, modeled the suggestions, analyzed the cost results of the suggested APC reassignments, and received additional input from our medical advisors. We agree with the commenter's request to assign CPT code 0991T (X432T) to APC 5376 (Level 6 Urology and Related Services). While we recognize that there is not currently a one-to-one match to crosswalk to the new codes, we based our APC assignment for CPT code 0991T (X432T) on crosswalks to CPT codes that have similar service and resource elements, as well as required staff, to the new codes. Based on our review of the enhanced lithotripsy service compared to other services assigned to the Urology and Related Services series, we believe HCPCS code C9761 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy, with lithotripsy, and ureteral catheterization for steerable vacuum aspiration of the kidney, collecting system, ureter, bladder, and urethra if applicable (must use a steerable ureteral catheter)) is an appropriate crosswalk code for CPT code 0991T (X432T), which is currently assigned to APCs 5376 (Level 6 Urology and Related Services).

For this service's device offset, we refer readers to section IV.B. of this final rule with comment period.

After consideration of the public comment we received, we are finalizing our proposal with modification to assign CPT code 0991T (X432T) to APCs 5376 (Level 6 Urology and Related Services) with a status indicator of “J1”. Refer to Table 85 for the final OPPS APC and status indicator assignment for CPT code 0991T (X432T) for CY 2026. We refer readers to Addendum B to this final rule with comment period for the payment rates for all codes reportable under the OPPS. Addendum B is available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.103

CPT code 52282 (Cystourethroscopy, with insertion of permanent urethral stent) describes the insertion of a permanent urethral stent using an endoscope procedure. CPT code 52282 became effective January 1, 1998. For the CY 2026 OPPS/ASC proposed rule, we estimated the geometric mean cost for CPT code 52282 to be approximately $3,382 based on 111 single claims and proposed to continue to assign the service to APC 5374 (Level 4 Urology and Related Services), which had a proposed geometric mean cost of $3,686.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Several commenters requested the APC reassignment of CPT code 52282 to APC 5376 (Level 6 Urology and Related Services). The commenter stated that the current payment rate of APC 5374 (Level 4 Urology and Related Services) and the lack of device intensive status do not cover the cost of the stent and the procedure. The commenters stated CPT code 52282 is similar in device intensity to CPT code 53865. The commenters further stated that the inappropriate low payment creates a patient access issue which may push patients to other higher cost treatment options for both Medicare and beneficiaries. Furthermore, the low payment in ASCs for this treatment drives patients to HOPDs which can be more costly for the both Medicare and beneficiaries.

Another commenter stated that there has not been a permanent urethral stent device on the US market for the past decade. The commenter stated the 2024 claims showed CPT code 52282 had a mean device cost of $485, which is far below the price that will be available in the Q4 2025 and 2026. The commenter reported that about 33 percent of the 2024 claims are female patients, which indicate that these were incorrect

billings and that they should be removed from CY 2026 claims accounting. The commenter further stated that their analysis of the OPPS CPT 52282 claims revealed diagnosis codes do not correspond to treatment with a permanent urethral stent. The commenter also reported that their analysis of the CPT 52282 claims included device codes such as HCPCS code C2617 (Stent, non-coronary, temporary, without delivery system) and HCPCS code C1758 (Catheter, ureteral) that do not correspond to the treatment represented by CPT code 52282. The commenter suggested the following: (1) CMS exclude all CPT code 52282 claims for ratesetting, and device offset calculations, reassign CPT code 52282 to APC 5376, and use the manufacturer's price as a device offset or use CPT code 53865 that has a temporary urethral stent) until accurate claims are available; (2) Create a new device code for a permanent urethral stent with the suggested descriptor (Stent, prostatic, permanent with integrated transurethral delivery system); (3) Conduct annual reviews of device offset and review all surgical procedures; and (4) Coordinate with the FDA and AMA CPT Editorial Panel when devices are withdrawn from the market.

Response: We appreciate the commenters' suggestions regarding CPT code 52282. We rely on hospitals and providers to accurately report the use of HCPCS codes in accordance with their code descriptors, and CPT and CMS instructions, and to report services accurately on claims and charges and costs for the services on their Medicare hospital cost report. We defer to the clinicians and providers to provide the appropriate course of treatment, at the appropriate site of treatment. We will take the commenter's concerns regarding the US market availability of a permanent urethral stent and the claims surrounding CPT code 52282 into consideration for future rulemaking. We note that all comments requesting the reassignment of CPT code 52282 to APC 5376 were related to a device that has not received FDA approval or any exceptions such as an Investigational Device Exemptions (IDE) or PMA/ 510K Exemptions, and so those comments are out of the scope for this final rule with comment period.

For this service's device offset, we refer readers to section IV.B of this final rule with comment period.

After consideration of the public comments we received, we are finalizing our proposed APC assignment and status indicator for CPT code 52282 without modification. Refer to Table 86 for the final OPPS APC and status indicator assignment for CPT code 52282 for CY 2026. We refer readers to Addendum B to this final rule with comment period for the payment rates for all codes reportable under the OPPS. Addendum B is available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.104

CPT code 54417 (Removal and replacement of non-inflatable (semi- rigid) or inflatable (self-contained) penile prosthesis through an infected field at the same operative session, including irrigation and debridement of infected tissue) describes the removal and replacement of penile implant and debridement of infected tissue.

For the CY 2026 OPPS/ASC proposed rule, we calculated the geometric mean for CPT code 54417 to be about $18,732, and we proposed to assign the service to APC 5377 (Level 7 Urology and Related Services), which has a geometric mean cost of $13,635. There were 11 single claims used to calculate the geometric mean cost for CPT code 54417.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A commenter requested that CMS reassign CPT code 54417 to APC 5478. The commenter stated CPT code 54417 is similar to CPT codes 54411 (Removal and replacement of all components of a multi-component inflatable penile prosthesis through an infected field at the same operative session, including irrigation and debridement of infected tissue) and 54416 (Removal and replacement of non-inflatable (semi- rigid) or inflatable (self-contained) penile prosthesis at the same operative session) both clinically and in resource utilization. The commenter stated CPT code 54417 is a low frequency procedure, which is the expected utilization pattern, but its geometric mean has been increasing year over year. The commenter stated all three procedures involve the similar operative complexity of removing and replacing a penile prosthesis, while CPT codes 54411 and 54417 also includes irrigation and debridement of an infected tissue. The commenter stated that CPT code 54417 has the highest geometric mean cost in APC 5377, that exceeds CPT code 54416 and is closer to the geometric mean cost of APC 5378.

Response: We agree with the commenter that CPT code 54417 is similar clinically and in resource utilization to CPT codes 54411 and 54416. APC 5378 (Level 8 Urology and Related Services) is a more appropriate placement for CPT code 54417 due to the clinical work and resources utilized to furnish the removal and replacement of penile implant and/or debridement of infected tissue irrigation, which is clinically similar to CPT codes 54411 and 54416. We also agree with the commenters that the geometric mean cost of CPT code 54417 more closely matches the geometric mean cost of APC 5378 than APC 5377. Therefore, we will be reassigning CPT code 54417 to APC 5378 for CY 2026.

After consideration of the public comment we received, we are finalizing

a modification to our proposal to assign CPT code 54417 to APC 5378 (Level 8 Urology and Related Services) with a status indicator of “J1”. Refer to Table 87 for the final OPPS APC and status indicator assignment for CPT code 54417 for CY 2026. We refer readers to Addendum B to this final rule with comment period for the payment rates for all codes reportable under the OPPS. Addendum B is available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.105

For 2026, the AMA CPT Editorial Panel established four new codes to describe the various services related to report prostate biopsy to replace CPT code 55770 (Biopsy, prostate; needle or punch, single or multiple, any approach) which will be retired December 31, 2025. The four new codes are effective January 1, 2026, and describe the biopsy of the prostate with various imaging guidance. The codes and their complete long descriptors are listed in Table 88. When determining the proposed status indicators and APC assignments for CY 2026, we reviewed the clinical and resource characteristics of the procedures, we considered input from our medical advisors and reviewed existing APC classifications to identify similar and closely related procedures.

We note that CPT codes 55712, 55713, 55714, and 55715 were listed as placeholder codes 5XX07, 5XX08, 5XX09, and 5XX10 respectively, in OPPS Addendum B and Addendum O that were released with the CY 2026 OPPS/ASC proposed rule. Because we had not received the final CPT code numbers from AMA for the new codes that would be effective January 1, 2026, in time for the publication of the CY 2026 OPPS/ASC proposed rule, we listed the new CPT codes with their respective placeholder codes in OPPS Addendum B and Addendum O.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Some commenters sought clarification on the new prostate biopsy CPT codes with more detailed code descriptors for high-field and low-field MRI technologies, including in-office MRI systems.

Response: We thank the commenters for their input, but these comments are out of scope of this OPPS/ASC final rule with comment period. We note the CPT code descriptors are copyright property of the American Medical Association and we do not have the ability to modify CPT codes.

After consideration of the public comments we received, we are finalizing our proposal without modification for CPT codes 55712 through 55715. Table 88 shows the finalized status indicators and APC assignments for all the four prostate biopsy codes. The final CY 2026 payment rates for these codes can be found in Addendum B to this final rule with comment period. We also refer readers to Addendum D1 to this final rule with comment period for the SI meanings for all codes reported under the OPPS. Addenda B and D1 are available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.106

The ureteroscopy procedure addresses kidney stones and may apply catheterization to vacuum aspirate the fragmented kidney stones. HCPCS code C9761 (Cystourethroscopy, with ureteroscopy and/or, with lithotripsy, and ureteral catheterization for steerable vacuum aspiration of the kidney, collecting system, ureter, bladder, and urethra if applicable (must use a steerable ureteral catheter) became effective October 1, 2020.

For CY 2026, the OPPS payment rates were proposed based on available CY 2024 claims data. For the CY 2026 OPPS/ASC proposed rule, we found a total of 721 single frequency claims and a geometric mean cost of approximately $9,470 for HCPCS code C9761. For CY 2026, we proposed to continue to assign HCPCS code C9761 to APC 5376 (Level 6 Urology and Related Services) with a proposed payment rate of approximately $9,746.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Commenters requested CMS provide coding guidance on the appropriate device billed under HCPCS code C9761.

Response: Comments on coding guidance are out of scope of this OPPS/ASC final rule with comment period. We note that if hospitals have questions about appropriate coding that they cannot resolve on their own, the appropriate first step would be to review the HCPCS codes or consult a Medicare Administrative Contractor (MAC). 62. Water Vapor Thermotherapy CPT Code 0582T (APC 5377)

CPT code 0582T (Transurethral ablation of malignant prostate tissue by high-energy water vapor thermotherapy, including intraoperative imaging and needle guidance) describes an Category B IDE study where water vapor is used to ablate localized prostate cancer. It was designated a Category B IDE study (NCT05683691) on October 12, 2023. The purpose of this prospective, single arm study is to evaluate the safety and effectiveness of utilizing water vapor ablation delivered transurethrally in patients with immediate risk, localized prostate cancer.

For CY 2025, CPT code 0582T was assigned status indicator “E1.” For the CY 2026 OPPS/ASC proposed rule, we proposed to continue assigning CPT code 0582T with the status indicator “E1.”

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A commenter requested CPT code 0582T be reassigned to APC 5378 (Level 8 Urology and Related Services) with a status indicator of J1 where other clinically and cost similar procedures are assigned. The commenter stated that this service is currently an approved Category B IDE study, Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (VAPOR 2) [G220303-NCT05683691]. Furthermore, the commenter stated the procedure cost ranges between $21,672 to $22,233, including the device cost of $16,415 and requested device intensive status and a device offset percentage of 74 percent.

Response: We thank the commenter for the notification that CPT code 0582T represents a Category B IDE study. While we recognize that there is not currently a one-to-one match to crosswalk to the new codes, we based the APC assignment on crosswalks to CPT codes that have similar service and resource elements to the new codes. Based on our review of the service compared to other services assigned to the Urology and Related Services APC series, we believe CPT code 55882 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation; with insertion of transurethral ultrasound transducer for delivery of thermal ultrasound, including suprapubic tube placement and placement of an endorectal cooling device, when performed) is an appropriate crosswalk code for CPT code 0582T. CPT code 55882 is currently assigned to APC 5377 (Level 7 Urology and Related Services).

After consideration of the public comment we received, we are finalizing our proposed APC assignment and status indicator for CPT code 0582T with modification to assign CPT code 0582T to APC 5377 (Level 7 Urology and Related Services) with a status indicator of “J1”. Refer to Table 89 for the final OPPS APC and status indicator assignment for CPT code 0582T for CY 2026. We refer readers to Addendum B to this final rule with comment period for the payment rates for all codes reportable under the OPPS. Addendum B is available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.107

Vascular Procedures 63. Arteriovenous Fistula (AVF) Creation Procedures, CPT Codes 36836 and 36837 (APC 5194)

CPT codes 36836 (Percutaneous arteriovenous fistula creation, upper extremity, single access of both the peripheral artery and peripheral vein, including fistula maturation procedures (eg, transluminal balloon angioplasty, coil embolization) when performed, including all vascular access, imaging guidance and radiologic supervision and interpretation) and 36837 (Percutaneous arteriovenous fistula creation, upper extremity, separate access sites of the peripheral artery and peripheral vein, including fistula

maturation procedures (e.g., transluminal balloon angioplasty, coil embolization) when performed, including all vascular access, imaging guidance and radiologic supervision and interpretation) describe a percutaneous arteriovenous fistula creation of an upper extremity. CPT code 36836 became effective January 1, 2023 and replaced HCPCS codes C9754 and G2170, while CPT code 36837 became effective January 1, 2023, and replaced HCPCS codes C9755 and G2171.

In the CY 2020 OPPS/ASC final rule with comment period (84 FR 61246 through 61247), in response to public comment, input from our medical advisors, and the available claims data, we reassigned C9754 and C9755 from APC 5193 to APC 5194. In the CY 2021 OPPS/ASC final rule with comment period (85 FR 85954 through 95955), we used our equitable adjustment authority to maintain the assignment of HCPCS codes G2170 and G2171 to APC 5194 (Level 4 Endovascular Procedures), given that both procedures are for ESRD patients that need dialysis, the predecessor codes had very similar median costs, and there were low claims data available. We continued the assignment of CPT codes 36836 and 36837 to APC 5194, with commenter support, for CY 2022.

In the CY 2023 OPPS/ASC final rule with comment period (87 FR 71863 through 71864), we assigned the newly established CPT codes 36836 and 36837 to APC 5194 based on our assessment of the CY 2023 geometric mean cost of predecessor codes HCPCS codes G2170 ($12,055.90) and G2171 ($13,486.08) and their APC assignment. For CYs 2024 and 2025, we continued assignment to APC 5194 for CPT codes 36836 and 36837, with commenter support.

For CY 2026, we proposed to continue assignment of both CPT codes 36836 and 36837 to APC 5194 (Level 4 Endovascular) with a proposed payment rate of $18,791.32. For the CY 2026 OPPS/ASC proposed rule, CPT code 36836 had 170 single claims for ratesetting, a geometric mean cost (GMC) of around $11,260, and CPT code 36837 had 77 single claims for ratesetting and a GMC of around $19,615.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A commenter requested that CMS reassign CPT code 36836 to APC 5193 (Level 3 Endovascular Procedures) stating that there is a significant cost differential between CPT codes 36836 and 36837.

Response: At this time, we continue to believe that both CPT codes 36836 and 36837 are assigned to appropriate APCs. We will continue to monitor the geometric mean costs and claims data and revise their APC assignments as appropriate.

In summary, after consideration of the public comment we received, we are finalizing the APC assignments for CPT codes 36836 and 36837 without modification. Specifically, we are finalizing the APC assignment of CPT codes 36836 and 36837 to APC 5194 (Level 4 Endovascular Services).

Refer to Table 90 for the code descriptor, proposed and final status indicator (SI) assignment, and proposed and final APC assignment. The final CY 2026 payment rates for the codes can be found in Addendum B to this final rule with comment period. In addition, we refer readers to Addendum D1 to this final rule with comment period for the SI definitions for all codes reported under the OPPS. Addenda B and D1 are available via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.108

CPT code 92924 (Percutaneous transluminal coronary atherectomy, with coronary angioplasty when performed; single major coronary artery or branch) describes a procedure to treat coronary artery disease by removing plaque from the coronary vessels.

For the CY 2026 OPPS/ASC proposed rule, CPT code 92924 had a geometric mean cost (GMC) of around $16,262 based on 498 single frequency claims. We proposed to maintain the APC assignment to APC 5193 (Level 3 Endovascular Procedures), with a proposed payment of around $11,873.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Commenters requested that CMS reassign CPT code 92924 to APC 5194 (Level 4 Endovascular Procedures). The commenters stated that CPT code 92924 is a technically demanding complex procedure and is more clinically similar to other procedures assigned to APC 5194 (Level 4 Endovascular Procedures). They note that in the CY 2026 OPPS/ASC proposed 2 Times Rule File, CPT code 92924 has the 3rd highest GMC in its current APC assignment (APC 5193) and has a higher GMC than 7 other procedures assigned to APC 5194. Based on the GMC of CPT code 92924, the commenters believe it is more appropriate to assign CPT code 92924 to

APC 5194 (Level 4 Endovascular Procedures).

Response: After reviewing the comments, we believe that CPT code 92924 is more clinically similar to the procedures assigned to APC 5193. As with many APC families, there may be services and procedures that have higher GMCs than other procedures in the next level. We determine APC assignments based on resource and clinical homogeneity and review and revise the services within each APC group and the APC assignments under the OPPS.

In summary, after consideration of the public comments we received, we are finalizing our proposal without modification, to assign CPT code 92924 to APC 5193 (Level 3 Endovascular Procedures).

The final CY 2026 payment rates for this code can be found in Addendum B to this final rule with comment period. In addition, we refer readers to Addendum D1 to this final rule with comment period for the SI definitions for all codes reported under the OPPS. Addenda B and D1 are available via the internet on the CMS website.

Refer to Table 91 for code descriptor, APC assignment and status indicator assignment for CPT 92924 code for CY 2026. [GRAPHIC] [TIFF OMITTED] TR25NO25.109

The CPT Editorial Panel created 2 new Category I codes 92930 and 92945, effective January 1, 2026. The new final CPT codes (along with their placeholder codes) are as follows:

92930 (92X01): Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed, single major coronary artery and/or its branch(es); 2 or more distinct coronary lesions with 2 or more coronary stents deployed in 2 or more coronary segments, or a bifurcation lesion requiring angioplasty and/or stenting in both the main artery and the side branch; and

92945 (92X02): Percutaneous transluminal revascularization of chronic total occlusion, single coronary artery, coronary artery branch, or coronary artery bypass graft, and/or subtended major coronary artery branches of the bypass graft, any combination of intracoronary stent, atherectomy and angioplasty; combined antegrade and retrograde approaches.

For CY 2026, we proposed to assign both of these procedures to APC 5193 (Level 3 Endovascular Procedures) and a status indicator (SI) of `J1' with a proposed payment of $11,873.70.

We note that at the August 25, 2025, HOP Panel Meeting, a presentation was made requesting the APC reassignment of CPT codes 92930 (92X01) and 92945 (92X02). Based on the information presented at the meeting, the HOP Panel recommended that we reassign both CPT codes 92930 and 92945 from APC 5193 (Level 3 Endovascular Procedures) to APC 5194 (Level 4 Endovascular Procedures).

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Commenters requested that CMS reassign CPT codes 92930 and 92945 to APC 5194 (Level 4 Endovascular Procedures) to better reflect the increased complexity of these procedures and resource utilization.

The commenters noted that while CMS crosswalked these codes to the straightforward versions of these procedures, the new codes include additional procedural work and resources that warrant a higher APC assignment. They note that CPT code 92930 includes 2 or more lesions with 2 or more stents deployed in 2 or more coronary segments versus the crosswalk code CPT code 92928 (Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch) which only refers to a single coronary artery or branch.

Commenters also pointed to the multiple procedural approaches (antegrade and retrograde) with CPT code 92945, whereas the crosswalk CPT code 92943 (Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty; single vessel) is only a single approach (antegrade).

A commenter suggested using C9607 (Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of drug-eluting intracoronary stent, atherectomy and angioplasty; single vessel) as a crosswalk code for CPT code 92945. Commenters urged CMS to not undervalue these services from the outset and that CMS should reassign these codes to APC 5194 (Level 4 Endovascular Procedures and monitor the claims data to ensure that these codes are assigned to an appropriate APC based on clinical and resource homogeneity.

Response: After review of the public comments and input from our Medical Officers, we agree with the commenters that CPT code 92930 is more complex and utilizes more resources (that is, additional stents) than its crosswalk code. However, we disagree with commenters that more resources are used with CPT 92945. As we do every year, we will monitor the claims data and reevaluate the APC assignments for these codes in the next rulemaking cycle to determine if a more appropriate APC assignment is warranted.

In summary, after consideration of the public comments we received, input from our Medical Officers, and the HOP Panel recommendation, we are finalizing the APC and status indicators for CPT codes 92930 and 92945 with modification. Specifically, we are assigning CPT 92930 to APC 5194 and continuing to assign CPT 92945 to APC 5193.

The final CY 2026 payment rates for these codes can be found in Addendum B to this final rule with comment period. In addition, we refer readers to

Addendum D1 to this final rule with comment period for the SI definitions for all codes reported under the OPPS. Addenda B and D1 are available via the internet on the CMS website.

Refer to Table 92 for code descriptor, APC assignment and status indicator assignments for CPT codes 92930 and 92945 for CY 2026. [GRAPHIC] [TIFF OMITTED] TR25NO25.110

For CY 2026, the CPT Editorial Panel deleted 16 CPT codes that described lower extremity revascularization and replaced them with 46 new codes. The new codes establish an additional peripheral vessel territory as well as being more granular in describing the procedures. The 16 revascularization codes will be deleted December 31, 2025, and replaced with the new CPT codes effective January 1, 2026.

The deleted revascularization CPT codes are listed in Table 93, along with their current APC and status indicator assignments. Table 94 lists the new revascularization CPT code (along with its placeholder), the long descriptor, status indicator, APC assignment, and the crosswalk code that was used to determine the proposed APC assignment. BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Commenters were supportive that CMS used the corresponding codes that are being deleted as crosswalks for the new codes, noting that we have extensive claims history for the codes that are being deleted, and this approach provides payment stability.

A commenter requested that CMS reassign CPT codes 37263, 37265, and 37269 to APCs 5193, 5194, and 5194, respectively because of the complexity of these codes and the additional resources used during these procedures.

Several of the commenters had comments related to complexity adjustments and device offset percentages involving these new codes. We refer the readers to the applicable sections in this final rule with comment period for responses to those comments.

Response: We reviewed the commenter's request to reassign CPT codes 37263, 37265, and 37269 to APCs 5193, 5194, and 5194 respectively. After review and discussion with our CMS Medical Officers, we believe that we assigned these codes to appropriate APCs utilizing the predecessor codes as crosswalks.

In summary, after consideration of the public comments we received, we are finalizing our proposals without modification, to assign CPT codes 37254 through 37299 to the APCs and status indicators noted in Table 94. The final CY 2026 payment rates for these codes can be found in Addendum B to this final rule with comment period. In addition, we refer readers to Addendum D1 to this final rule with comment period for the SI definitions for all codes reported under the OPPS. Addenda B and D1 are available via the internet on the CMS website. 67. Percutaneous Transcatheter Therapeutic Drug Delivery (CPT Code 0913T)

The CPT Editorial Panel created CPT code 0913T (Percutaneous transcatheter therapeutic drug delivery by intracoronary drug-delivery balloon (e.g., drug-coated, drug-eluting), including mechanical dilation by nondrug-delivery balloon angioplasty, endoluminal imaging using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) when performed, imaging supervision, interpretation, and report, single major coronary artery or branch) effective January 1, 2025. For CY 2026, we proposed to assign CPT code 0913T to APC 5192 (Level 2 Endovascular Procedures) based on the crosswalk code CPT 92920 (Percutaneous transluminal coronary angioplasty; single major coronary artery or branch) which is assigned to APC 5192 (Level 2 Endovascular Procedures) and a status indicator of “J1” (Hospital Part B Services Paid through a Comprehensive APC; Paid under OPPS).

For the CY 2026 OPPS/ASC proposed rule, the OPPS payment rates were proposed based on available CY 2024 claims data. Because CPT code 0913T became effective January 1, 2025, we have no claims for ratesetting. We also note that the device associated with this procedure (AGENTTM Paclitaxel-Coated Balloon Catheter) received device pass-through status effective January 1, 2025 (89 FR 91434 through 91439).

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Commenters requested that CMS reassign CPT code 0913T to APC 5193 (Level 3 Endovascular Procedures). Commenters stated that CPT code 0913T was more clinically coherent with procedures assigned to Level 3 Endovascular Procedures than Level 2 Endovascular Procedures. To support their requested APC changes, commenters suggested that CMS consider crosswalking CPT code 0913T to HCPCS C9600 (Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch). Commenters stated that both services are performed in addition to angioplasty, suggesting that both drug-coated balloon and stent placement serve a separate and distinct purpose, as compared to coronary angioplasty alone. Commenters also provided an analysis of 294 single frequency claims and indicated that the geometric mean cost of those claims was $11,000. Moreover, commenters stated that assignment of CPT code 0913T to APC 5192 would pose a two times rule violation. In addition to the APC reassignment request, commenters also requested a complexity adjustment for CPT code 0913T and procedure code 93459.

Response: We note that APC 5192 does not currently have a two times rule violation in the final rule data. In addition, CPT code 0913T does not meet the requirements for cost significance for 2 times rule violation purposes, under the requirements described in section III.B.2. of this final rule with comment period. After consideration of the public comments, additional review of the procedures, and input from our CMS Medical Officers, we believe that the resource costs of CPT code 0913T is more aligned with the procedures in APC 5193, which includes HCPCS code C9600 (Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch).

We remind hospitals that we review, on an annual basis, the APC assignments for all items and services paid under the OPPS and we will continue to monitor the claims data for APC 5193 as they become available. Additionally, we refer readers to XIII.C. of this final rule with comment period for a discussion of the complexity adjustment policies.

In summary, after consideration of the public comments we received, we are finalizing our proposal with modification and reassigning CPT code 0913T to APC Level 5193. The final CY 2026 payment rates for these codes can be found in Addendum B to this final rule with comment period. In addition, we refer readers to Addendum D1 to this final rule with comment period for the status indicator definitions for all codes reported under the OPPS.

Addenda B and D1 are available via the internet on the CMS website.

Refer to Table 95 for code descriptors, APC assignments and status indicator assignments for CPT code 0913T. [GRAPHIC] [TIFF OMITTED] TR25NO25.123

Each year, in accordance with section 1833(t)(9)(A) of the Act, we review and revise the services within each APC group and the APC assignments under the OPPS. As a result of our annual review of the services and the APC assignments, we may reassign some services to another APC or maintain the current APC assignment.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: Commenters supported the proposed CY 2026 assignments for various HCPCS and CPT codes and requested that CMS finalize the payment assignments for CY 2026 as proposed.

Response: We thank the commenters for their input.

Therefore, for CY 2026, we are finalizing without modification the APCs and status indicators for the CPT codes listed in Table 96. The final CY 2026 payment rates for the codes listed below can be found in Addendum B to this final rule with comment period. In addition, we refer readers to Addendum D1 to this final rule with comment period for all codes reported under the OPPS. Addenda B and D1 are available via the internet on the CMS website. BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C 69. Dialysis Related Services and Technologies a. Dialysis-Related Amyloidosis (DRA) Treatment With Lixelle[supreg] Apheresis Columns

LIXELLE[supreg] [beta]2-microglobulin Apheresis Column is indicated for use in the treatment of dialysis-related amyloidosis (DRA), a disease that affects people with end-stage renal disease (ESRD). DRA is a metabolic disorder from the failure of the kidney to filter and remove [beta]2-microglobulin, typically from chronic hemodialysis (typically 5 years or longer). The LIXELLE[supreg] device is used in an apheresis procedure that selectively removes [beta]2-microglobulin from circulating blood and is used in accordance with a physician prescription in conjunction with hemodialysis. It is intended to be used at each hemodialysis session (that is, frequency of treatment is expected to be 3 times per week). In March 2015, FDA approved LIXELLE[supreg] as a Class III Humanitarian Use Device (HUD) with an approved Humanitarian Device Exemption (HDE). For CY 2026, there are currently no specific HCPCS or CPT codes that represent the LIXELLE[supreg] apheresis service.

We received public comments on this topic. The following is a summary of the comments we received and our responses.

Comment: Several interested parties commented requesting coverage for Lixelle[supreg] apheresis columns for treating dialysis-related amyloidosis (DRA). Commenters noted that Lixelle[supreg] has FDA Humanitarian Use Device approval and has been successfully utilized in Japan.

Response: We recognize the clinical need for effective treatments for dialysis-related amyloidosis and appreciates the information provided regarding Lixelle[supreg] apheresis columns. We acknowledge that DRA represents a serious complication for long-term dialysis patients and that treatment options have been limited. We are actively reviewing coverage pathways for innovative treatments that address unmet medical needs in the ESRD population, including those with FDA Humanitarian Use Device designations. We note this complex, ongoing issue is still under consideration and continues to merit a thorough evaluation to ensure an appropriate Medicare benefit category and payment pathway for the service is determined. b. Dialysis Technologies

We received public comments on this topic. The following is a summary of the comments we received and our responses.

Comment: A commenter supported the payment of dialysis technologies not included in the End Stage Renal Disease (ESRD) bundle through the OPPS. The commenter noted that CMS continues to evaluate potential avenues of payment for treatments using medical devices administered during dialysis procedures that are not considered “renal dialysis services” under the Medicare statute and requested that CMS provides payment for such services through the OPPS.

Response: We appreciate the input regarding coverage and payment for medical device technologies used in conjunction with dialysis services. We recognize the importance of ensuring appropriate payment pathways for innovative treatments that may be administered during dialysis but fall outside the definition of a renal dialysis service under Sec. [thinsp]413.171 and thus are not paid for under the ESRD PPS. We will continue to evaluate the appropriate payment mechanisms for such technologies for future rulemaking.

CPT code 36821 (Arteriovenous anastomosis, open; direct, any site (e.g., Cimino type) (separate procedure) describes an open surgical fistula creation for hemodialysis procedures. CPT code 36821 is currently assigned to APC 5183 (Level 3 Vascular Procedures) with a proposed payment of around $3,254, and a status indicator of `J1' (Hospital Part B Services Paid Through a Comprehensive APC; Paid under OPPS).

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A commenter expressed concern about payment disparities between traditional surgical arteriovenous fistula (AVF) creation and endovascular procedures. The commenter noted that ASC payment for endovascular creation can be substantially higher than traditional fistula creation, despite the benefits that surgical AVFs may offer to both patients and providers, particularly the greater versatility that surgical AVFs can offer in placement locations when compared to endovascular AVFs. The commenter expressed concern that low payment may cause skilled surgeons to preferentially choose better-paying procedures and potentially diminish the availability of AVF creation.

Response: We acknowledge the concerns regarding payment disparities between surgical and endovascular fistula creation procedures. We recognize that both approaches serve important clinical roles in vascular access for dialysis patients. We will continue to evaluate payment rates for these procedures to ensure appropriate payment that reflects the clinical value and resource costs associated with each approach. d. Peritoneal Dialysis (PD) Catheter Placement

There are a number of CPT codes that describe placing a catheter for peritoneal dialysis. These codes and their payment assignments include the following:

49324--Laparoscopy, surgical; with insertion of tunneled intraperitoneal catheter; assigned to APC 5361 (Level 1 Laparoscopy and Related Services) and status indicator `J1' (Hospital Part B Services Paid Through a Comprehensive APC; Paid under OPPS);

49418--Insertion of tunneled intraperitoneal catheter (e.g., dialysis, intraperitoneal chemotherapy instillation, management of ascites), complete procedure, including imaging guidance, catheter placement, contrast injection when performed, and radiological supervision and interpretation, percutaneous; assigned to APC 5341 (Level 1 Abdominal/Peritoneal/Biliary and Related Procedures) and status indicator `J1' (Hospital Part B Services Paid Through a Comprehensive APC; Paid under OPPS); and

49421--Insertion of tunneled intraperitoneal catheter for dialysis, open; assigned to APC 5341 (Level 1 Abdominal/Peritoneal/ Biliary and Related Procedures) and status indicator `J1' (Hospital Part B Services Paid Through a Comprehensive APC; Paid under OPPS).

For CY 2026, we proposed to continue to assign these codes to their current payment assignments.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A commenter expressed concern that current CMS payment for peritoneal dialysis (PD) catheter placement may have created a disincentive for performing the procedure. The commenter specifically noted that low payment for PD catheter placement relative to vascular access procedures may create barriers to patients receiving more convenient home-based treatment. The commenter requested that CMS equalize payment between PD catheter procedures and vascular access procedures to avoid possible disincentives to home treatment and provide patients with additional quality care options.

Response: We support policies that facilitate appropriate home- based dialysis care when clinically appropriate. We recognize the importance of ensuring that payment policies do not inadvertently create barriers to home dialysis modalities, including peritoneal dialysis. We will review the current payment rates for PD catheter placement procedures and consider any adjustments that better align with the clinical value and resource requirements of these services for future notice-and-comment rulemaking. 70. Mobile Stroke Units

Mobile stroke units (MSU) are specialized ambulances equipped with various skilled healthcare personnel, specialized equipment, including imaging capability to diagnose and treat acute stroke in the prehospital setting.\27\

\27\ See https://www.ahajournals.org/doi/10.1161/STROKEAHA.121.037376.

We received public comments on this topic. The following is a summary of the comments we received and our responses.

Comment: A commenter requested that MSU services be reimbursed as hospital outpatient services rather than ambulance transport services. The commenter noted that the current Ambulance Fee Schedule (AFS) payment does not cover the cost of CT scans and other essential components of an MSU, leading to financial challenges for MSU operators. The commenter cited clinical evidence pointing to improved outcomes associated with the use of MSUs.

Response: We appreciate the detailed comment regarding MSU payment challenges. We appreciate the thoughtful recommendations and will consider them for future rulemaking. We note that MSUs are currently paid under the AFS.

In recent years, there have been rapid developments in the use of software-based technologies with new functionalities, including artificial intelligence, to support clinical decision-making in the outpatient and physician office settings. Medicare refers to these software-based technologies as software as a service (SaaS). Prior to CY 2018, SaaS procedures were considered supportive or ancillary services, and therefore, payment for the SaaS was packaged into the payment for the underlying clinical service. For example, payment for image processing software that visually enhances an image in an existing MRI, would be packaged into the payment for the MRI service. In recent years, CMS has paid separately for SaaS procedures under the OPPS through New Technology APCs, which are cost bands that allow us to provide appropriate and consistent payment for designated new procedures that are not yet reflected in our claims data, and various clinical APCs based on clinical and resource similarity to existing services, including Imaging APCs and Diagnostic Tests and Related Services APCs. We currently do not have a payment methodology specifically for SaaS, and as these technologies have continued to evolve and diversify, some interested parties have stated that the lack of a consistent payment policy for SaaS can be an impediment to patient access when these services are otherwise approved by the FDA. Interested parties have requested that CMS consider development of a payment policy for these services that is stable and

consistent across settings of care, payment systems, and types of SaaS.

In the CY 2026 OPPS/ASC proposed rule, we welcomed public comment as we consider how to appropriately pay for these services, including any applicable lessons or best practices from risk-bearing payment arrangements, how we can determine that Medicare payments for SaaS truly reflect the value of the technologies to medical practice, and how to ensure that any payment policies on this topic demonstrate fiscal responsibility and good stewardship by promoting high-value, cost-effective care. For pricing new technologies where we do not have substantive supporting data, there are ambiguities regarding the service costs for purposes of setting a payment rate. For example, we have observed wide variations in the purported costs of clinically similar SaaS technologies. The various costs that manufacturers consider when pricing their technologies, including research and development as well as software maintenance, are often not publicly verifiable. It is also unclear to what extent Medicare should pay for the research and development costs of SaaS that could be frequently used by non-Medicare beneficiaries in hospital outpatient departments and ambulatory surgical center settings. Additionally, due to the novel and evolving nature of these technologies, there are rarely existing medical items or services that can be utilized for comparison purposes to determine clinical and resource similarity. Finally, while there has been a rapid increase in the development and coding of these services in recent years, there is a very limited amount of Medicare claims data for these services.

Given these issues and our interest in developing payment policies that seek to reflect the underlying value of a service or technology to the practice of medicine, we requested public comment on future SaaS payment ideas, including:

What factors could Medicare consider when setting payment rates for SaaS?

What APCs, existing or new, should we use to pay for SaaS?

How should we assess the costs of SaaS, and how can we account for hospital acquisition costs?

What cost or claims data should be used to establish the payment rates for the services?

Why are the geometric mean costs, as provided in our claims data, for SaaS currently assigned to APCs (both clinical and New Technology APCs) consistently lower than the manufacturers' purported costs of the technologies?

Is there an alternative data source outside of the limited Medicare claims data currently available and hospital invoices provided by manufacturers, which may not fully depict total hospital acquisition costs, that can accurately reflect the costs of the SaaS?

What kinds of efficiencies, if any, would SaaS provide for services performed in hospital outpatient departments and ambulatory surgical centers?

In the context of setting Medicare payment rates, how can CMS best reflect the quality and efficacy of SaaS technologies?

We welcomed input from interested parties on these questions as well as any additional suggestions that would enhance our ability to provide accurate and consistent payment for SaaS procedures. Finally, we noted that there is a similar comment solicitation on a payment policy for SaaS under the Physician Fee Schedule, and directed readers to the CY 2026 PFS proposed rule to provide comments.

We received public comments on this topic. The following is a summary of the comments we received and our responses.

Comment: Several commenters requested that CMS more explicitly define the technologies we would consider to be SaaS. Some commenters suggested that CMS use an alternative term to refer to these technologies, such as “Software as a Medical Device” in conformance with FDA definitions, or “clinical decision support tools.” Some commenters provided suggestions on how CMS should categorize these types of services in terms of payment. Suggestions included classifying the technologies by the type of solution they provide, such as diagnostic, therapeutic, augmentative, patient-facing, operational. Commenters encouraged CMS to work with interested parties to establish definitions to help clarify which technologies are payable, while maintaining flexibility to adopt definitions as technologies evolve.

Generally, commenters supported a dedicated payment policy for innovative technologies. Commenters requested that CMS create an evidence-based, flexible framework that encourages the use and innovation of SaaS while maintaining fair and adequate payment for the services in which they are incorporated. Commenters offered ideas for potential payment policies. For example, most commenters recommended that CMS assign all SaaS to New Technology APCs for a certain amount of time, usually between 3 to 5 years, to allow for CMS to gather sufficient claims data upon which to make an appropriate clinical APC assignment. Some commenters supported and referenced the payment pathway outlined in The Health Tech Investment Act (S. 1399). Another suggestion was for CMS to treat SaaS technologies as ancillary items and package payment with the related primary services as long as patient access was not adversely affected. In general, commenters encouraged CMS to adopt a payment approach that balances innovation, patient access, and value to the Medicare program.

Many commenters urged CMS to exercise caution and consider several factors in creating a payment methodology specifically for SaaS. Several commenters explained that costs for these technologies are difficult to determine. For example, some commenters explained the different variations in pricing models for SaaS, noting that some services are invoiced as a subscription or per-click fee as opposed to a one-time purchase of software or equipment. Commenters also stated that appropriately accounting for research and development costs in Medicare payments would be challenging. Many commenters addressed why they believe even current Medicare claims data may be unreliable for setting payment rates for SaaS, including that hospitals may be reporting various revenue center codes with different cost-to-charge ratios. To address the lack of price transparency across vendors and practice types, and to collect real-world cost data, a commenter encouraged CMS to work with the Congress to establish authority to incentivize standardized vendor disclosures, stratified by practice or facility size, setting, and geography. Other commenters suggested that CMS consider creating new revenue codes to facilitate more accurate hospital cost reporting for AI-based services. Others requested that CMS establish a unique cost center for AI-based diagnostic and decision-support services within the cost reporting structure to enable the collection of accurate, disaggregated cost and charge data specific to these technologies. Many commenters requested detailed guidance regarding charging and cost reporting practices for these services given the various pricing models available.

Some commenters were concerned about the potential for costs to increase if CMS were to finalize a new payment policy specific to SaaS. A commenter explained that providing separate payment for SaaS items under the OPPS, rather than packaging payment for SaaS with the related primary service for which it is used, would not

provide any downward pricing pressures on SaaS developers to provide value to the Medicare program. Commenters urged that, if not carefully designed, such a policy for SaaS could create significant financial risk, administrative burden, and access issues, without delivering clear clinical value. To that end, some commenters suggested CMS package payment when tools are integral to a service or pursue value- based payment models and risk-based contracts that reward outcomes and efficient care delivery.

Regarding coding, some commenters believe CMS should develop broad HCPCS codes to describe multiple SaaS technologies. Commenters also encouraged CMS to pursue future code development for SaaS and valuation through the American Medical Association CPT/RUC process, which allows for transparency and dialogue with involved interested parties. Commenters also requested new codes for certain SaaS technologies.

Finally, many commenters recommended that CMS adopt a site-neutral payment policy for SaaS across the facility and non-facility settings.

Response: The comments received illustrate the complexity intrinsic to paying for SaaS, and we will proceed with awareness of these challenges. We continue to recognize the need for a payment policy that accounts for the unique and heterogenous characteristics of SaaS, and we remain interested in ensuring that any such payment policy reflects the value provided to Medicare providers and beneficiaries. We intend to take the comments submitted into consideration as we develop our proposals for future rulemaking.

Section 603 of the Bipartisan Budget Act of 2015 (Pub. L. 114-74) (BBA, 2015) (hereinafter referred to as “section 603”) amended section 1833(t) of the Act by adding a new clause (v) to paragraph (1)(B) and adding a new paragraph (21). As a general matter, under sections 1833(t)(1)(B)(v) and (t)(21) of the Act, applicable items and services furnished by certain off-campus outpatient departments of a provider on or after January 1, 2017, are not considered covered OPD services as defined under section 1833(t)(1)(B) of the Act for purposes of payment under the OPPS. Instead such items are paid “under the applicable payment system” under Medicare Part B if the requirements for such payment are otherwise met. Section 603 amended section 1833(t)(1)(B) of the Act by adding a new clause (v), which excludes from the definition of “covered OPD services” applicable items and services (defined in paragraph (21)(A) of the section) that are furnished on or after January 1, 2017, by an off-campus PBD, as defined in paragraph (21)(B) of the section.

In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79699 through 79719), we adopted a number of policies to implement section 603. Broadly, we: (1) defined applicable items and services in accordance with section 1833(t)(21)(A) of the Act for purposes of determining whether such items and services are covered OPD services under section 1833(t)(1)(B)(v) of the Act or whether payment for such items and services will instead be made under the applicable payment system designated under section 1833(t)(21)(C) of the Act; (2) defined off-campus PBD for purposes of sections 1833(t)(1)(B)(v) and (t)(21) of the Act; and (3) established policies for payment for applicable items and services furnished by an off-campus PBD (nonexcepted items and services) under section 1833(t)(21)(C) of the Act. To do so, we finalized policies that define whether certain items and services furnished by a given off-campus PBD may be considered excepted and, thus, continue to be paid under the OPPS; established the requirements for the off-campus PBDs to maintain excepted status (both for the excepted off-campus PBDs and for the items and services furnished by such excepted off-campus PBDs); and described the applicable payment system for nonexcepted items and services (generally, the PFS).

To effectuate payment for nonexcepted items and services, in the CY 2017 interim final rule with comment period (81 FR 79720 through 79729), we established a new set of payment rates under the PFS that reflected the relative resource costs of furnishing the technical component of a broad range of services to be paid under the PFS specific to the nonexcepted off-campus PBDs of a hospital. Specifically, we established a PFS Relativity Adjuster that is applied to the OPPS rate for the billed nonexcepted items and services furnished in a nonexcepted off-campus PBD in order to calculate payment rates under the PFS. The PFS Relativity Adjuster reflects the estimated overall difference between the payment that would otherwise be made to a hospital under the OPPS for the nonexcepted items and services furnished in nonexcepted off-campus PBDs and the resource-based payment under the PFS for the technical aspect of those services with reference to the difference between the facility and nonfacility (office) rates and policies under the PFS. Nonexcepted items and services furnished by nonexcepted off-campus PBDs are generally paid under the PFS at the applicable OPPS payment rate adjusted by the PFS Relativity Adjuster of 40 percent (that is, 60 percent less than the OPPS rate) (82 FR 53030).

In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79719 and 79725), we created modifier “PN” to collect data for purposes of implementing section 603 but also to trigger payment under the newly adopted PFS-equivalent rates for nonexcepted items and services. Nonexcepted off-campus PBDs bill for nonexcepted items and services on the institutional claim utilizing modifier “PN” to indicate that an item or service is a nonexcepted item or service.

For a full discussion of our initial implementation of section 603, we refer readers to the CY 2017 OPPS/ASC final rule with comment period (81 FR 79699 through 79719) and the interim final rule with comment period (79720 through 79729). For a detailed discussion of the current PFS Relativity Adjuster related to payments under section 603, we refer readers to the CY 2018 OPPS/ASC final rule with comment period (82 FR 52356 through 52637) and the CY 2019 PFS final rule with comment period (82 FR 59505 through 59513). 2. Payment for Radiation Therapy Services Furnished at Nonexcepted Off- Campus PBDs

The PFS Relativity Adjuster is not applied to radiation therapy services (radiation treatment delivery and related imaging guidance services) furnished by nonexcepted off-campus PBDs. Due to section 1848(c)(2)(K) of the Act, which required maintenance of the CY 2016 coding and payment inputs for these services for CY 2017 and CY 2018 under the PFS, when the section 603 requirements were implemented in the CY 2017 final OPPS rule, we instructed nonexcepted off-campus PBDs to bill the PFS G-codes for these services. As we explained in that rule:

“. . . [S]everal radiation treatment delivery and imaging guidance services also are reported using different codes under the MPFS and the OPPS. CMS established HCPCS Level II G-codes to describe radiation treatment delivery services when furnished in the physician office setting (79 FR 67666

through 67667). However, these HCPCS G-codes are not recognized under the OPPS; rather, CPT codes are used to describe these services when furnished in the HOPD. Both sets of codes were implemented for CY 2015 and were maintained for CY 2016. Under the MPFS, there is a particular statutory provision under section 1848(c)(2)(K) of the Act that requires maintenance of the CY 2016 coding and payment inputs for these services for CY 2017 and CY 2018. Accordingly, the finalized CY 2017 MPFS rates for these services were calculated based on the maintenance of the CY 2016 coding payment inputs. On that basis, we are establishing payment amounts for nonexcepted items and services consistent with the payments that would be made to other facilities under the MPFS. That is, an off-campus PBDs submitting claims for nonexcepted items and services will bill the HCPCS G-codes established under the MPFS to describe radiation treatment delivery procedures. However, the off-campus PBD must append modifier “PN” to each applicable claim line for nonexcepted items and services. The payment amount for these services will be set to reflect the technical component rate for the code under the MPFS.” (81 FR 79726).”

As discussed in the CY 2026 Physician Fee Schedule (PFS) final rule, we are finalizing our proposal to delete radiation therapy G- codes (G6001 through G6017) that describe imaging guidance for radiation treatment (G6001, G6002, G6017) and radiation treatment delivery (G6003-G6015) because CPT codes 77402, 77407, and 77412 have been revised and may be used to report these services instead. See Table 97 for the long descriptors of the G codes that we are deleting effective January 1, 2026 and Table 98 for the current and revised long descriptors for CPT codes 77402, 77407, and 77412. The final CY 2026 payment rates for the radiation treatment delivery codes can be found in Addendum B to this final rule via the internet on the CMS website.

As we noted in the CY 2026 OPPS/ASC proposed rule, nonexcepted off- campus PBDs currently use the above referenced G codes to report radiation therapy services and, were we to finalize our proposal to delete them, they would no longer be available after December 31, 2025. To continue paying the PFS-equivalent rate for these services to these departments, we proposed that, effective January 1, 2026, nonexcepted off-campus PBDs would use the revised CPT codes described in the CY 2026 PFS proposed rule. In other words, because the G codes are being eliminated, we proposed that the revised CPT codes be used to preserve the existing policy of paying nonexcepted off-campus PBDs a specific radiation treatment rate, which is the technical component for the code under the Medicare PFS (MPFS). Crosswalk information between the G codes and the revised CPT codes is available under the Downloads section \28\ of the CY 2026 PFS proposed rule, under “CY 2025 Analytic Crosswalk to CY 2026.” We additionally proposed that nonexcepted off- campus PBDs would continue to append the “PN” modifier to each applicable claim line for these services. We emphasized in the CY 2026 OPPS/ASC proposed rule that this was not a new policy but rather a continuation of current policy adjusting for the newly revised CPT codes and the corresponding deletion of the G codes.

\28\ https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices.

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BILLING CODE 4120-01-C

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A commenter opined that the continuation of the policy was essential to preserve access for patients with cancer who might otherwise face long travel burdens and encouraged CMS to monitor visit utilization rates after implementation to ensure that beneficiaries with multiple chronic conditions do not lose timely access to complex management in outpatient settings.

Response: We thank the commenter for their support.

Comment: A commenter supported the deletion of the G codes and the use of the revised CPT codes by all radiation treatment providers. However, the commenter requested that CMS not apply the PFS Relativity Adjustor to the revised codes when billed by nonexcepted off-campus provider-based departments. The commenter expressed concern that doing so would have an “untenable impact on payment” to these departments because, based on the proposed radiation treatment delivery APCs in CY 2026, the reimbursement for IMRT in these locations would fall to $110 per treatment which is well below cost. The commenter contended that it is not logical to use OPPS data to set PFS rates for offices and then reduce those rates by 60 percent. The commenter recommended that, since CMS plans to use OPPS data for developing MPFS Practice Expense Relative Value Units (PE RVUs), CMS should not apply the PFS adjustor to the new radiation treatment codes and simply pay the MPFS PE rates for these services when billed with modifier PN.

Response: We appreciate the commenter's concerns for the application of the PFS Relativity Adjustor to the new radiation treatment codes when billed by nonexcepted off-campus PBDs. We note that, while the off-campus PBD must append modifier “PN” to each applicable claim line for the new radiation treatment codes, the payment amount for these services when billed with modifier “PN” will be set to reflect the technical component rate for the code under the MPFS. We do not intend for radiation therapy services furnished by nonexcepted off-campus PBDs to be paid any differently than they were paid previously when billed as G codes. We believe that the commenter's concerns for adequate payment to these departments for codes involving IMRT is further addressed by our final APC assignments for CPT codes 77407 and 77412 discussed in section III.E. of this final rule with comment period.

After consideration of the public comments we received, we are finalizing, without modification, our proposal that, effective January 1, 2026, nonexcepted off-campus PBDs use the revised radiation treatment CPT codes described in the CY 2026 PFS proposed rule and append modifier “PN” to each applicable claim line for nonexcepted items and services. The payment amount for these services when billed with the “PN” modifier will be set to reflect the technical component rate for the code under the MPFS.