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

CPT codes 0721T (Quantitative computed tomography (CT) tissue characterization, including interpretation and report, obtained without concurrent CT examination of any structure contained in previously acquired diagnostic imaging) and 0722T (Quantitative computed tomography (CT) tissue characterization, including interpretation and report, obtained with concurrent CT examination of any structure contained in the concurrently acquired diagnostic imaging dataset (list separately in addition to code for primary procedure)) became effective July 1, 2022, and are associated with the Optellum LCP technology. The Optellum LCP applies an algorithm to a patient's CT scan to produce a raw risk score for a patient's pulmonary nodule. The physician uses the risk score to quantify the risk of lung cancer and to determine what the next management step should be for the patient (for example, CT surveillance versus invasive procedure). In accordance with our SaaS add-on codes policy (87 FR 72032 to 72033), SaaS CPT add-on codes are assigned to the same APCs and status indicators as their standalone codes. Thus, CPT code 0722T, the add-on code for the Optellum LCP service, is assigned to the identical APC and status indicator as CPT code 0721T, the standalone code for the same service. For CY 2024, we assigned CPT codes 0721T and 0722T to APC New Technology 1508 (New Technology--Level 8 ($601-$700)).

For CY 2025, we continued to assign CPT codes 0721T and 0722T to APC 1508 (New Technology--Level 8 ($601-$700)) with a payment rate of $650.50 based on our CY 2025 policy to maintain New Technology APC assignments for CY 2025 for New Technology APC services with fewer than 10 claims in the 4-year lookback period applicable for the universal low-volume APC policy.

For CY 2026, OPPS payment rates were proposed based on available CY 2024 claims data. There were 496 combined claims for CPT codes 0721T and 0722T for CY 2024: 7 claims for CPT code 0721T and 489 claims for 0722T. The geometric mean cost of CPT code 0721T is $30.24 and the geometric mean cost for CPT code 0722T is $60.47. Based on the geometric mean cost for CPT code 0722T, which has a significantly greater number of claims than 0721T, we would assign CPT codes 0721T and 0722T to APC 1502 (New Technology--Level 2 ($51-$100) with a payment rate of $75.50. However, assigning these SaaS technologies based on the geometric costs would decrease the payment rate by close to 90 percent in 1 year. We recognize that software-based technologies, like those described by CPT codes 0721T and 0722T, continue to evolve and that the limited claims data that we have may not truly represent the cost of this service. We issued a comment solicitation in section III.F. of the CY 2026 OPPS/ASC proposed rule to collect information on alternative and consistent payment methods that seek to reflect the underlying value of SaaS under the OPPS to consider in future rulemaking. We hope to identify whether specific adjustments to our payment policies for SaaS technologies are needed to more accurately and appropriately pay for these products and services across settings of care.

While we recognize that there are certain unknowns regarding the cost of technologies like the Optellum LCP service, we believe it would be unlikely for the cost to be 90 percent less than the initial estimated costs based on our

review of the information provided in the New Technology APC application. Therefore, we proposed to use our authority under section 1833(t)(2)(E) for CY 2026 to continue to assign CPT codes 0721T and 0722T to APC 1508 (New Technology--Level 8 ($601-$700)) with a payment rate of $650.50 based on the information provided to us by the manufacturer in their application, which we believed may better reflect the cost of the service at the time of the CY 2026 OPPS/ASC proposed rule than the available claims data.

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

Comment: Commenters were supportive of the proposal to use our equitable adjustment authority to continue to assign CPT codes 0721T and 0722T to APC 1508. Commenters believe the proposed APC assignment aligned with the cost of the service. Commenters expressed concern that the claims data do not accurately reflect the true cost to hospitals and imaging providers of delivering the service. A commenter stated that they believe the inaccurate claims data was the result of hospitals reporting inappropriate revenue codes for the service and expressed support for the creation of a new cost center with revenue codes for AI-based services.

Response: While CMS does not provide billing advice to hospitals, we encourage manufacturers and distributors to provide outreach to hospitals regarding billing practices that are most appropriate for their individual technologies. We will consider the commenter's suggestion to create a new cost center for AI-based services as we explore how to appropriately pay for software as a service in future rulemaking. We note that we solicited comments on payment policies for “software as a service” in the CY 2026 OPPS/ASC proposed rule and refer readers to section III.F. of this final rule with comment period for a summary of the comments received.

After consideration of the public comments, we are finalizing our proposal without modification. Specifically, for CY 2026, we are finalizing our proposal to assign CPT codes 0721T and 0722T to APC 1508 (New Technology--Level 8 ($601-$700)) with a payment rate of $650.50. [GRAPHIC] [TIFF OMITTED] TR25NO25.048

Refer to Table 30 for the proposed and final OPPS New Technology APC and status indicator assignments for HCPCS codes 0721T and 0722T for CY 2026. The final CY 2026 payment rates can be found in Addendum B to this final rule with comment period via the internet on the CMS website. o. Quantitative Magnetic Resonance (QMR) for Analysis of Tissue Composition (APC 1511)

Effective January 1, 2022, CPT codes 0697T (Quantitative magnetic resonance for analysis of tissue composition (e.g., fat, iron, water content), including multiparametric data acquisition, data preparation and transmission, interpretation and report, obtained without diagnostic mri examination of the same anatomy (e.g., organ, gland, tissue, target structure) during the same session; multiple organs) and 0698T (Quantitative magnetic resonance for analysis of tissue composition (e.g., fat, iron, water content), including multiparametric data acquisition, data preparation and transmission, interpretation and report, obtained with diagnostic mri examination of the same anatomy (e.g., organ, gland, tissue, target structure); multiple organs (list separately in addition to code for primary procedure)) are associated with the CoverScan Software as a medical Service (SaaS). This service is a medical image management and processing software package that analyzes MR data and provides quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas, and kidney. For CY 2024, we assigned CPT codes 0697T and 0698T to APC 1511 (New Technology--Level 11 ($900-$1,000)).

For CY 2025, there were fewer than 100 claims for ratesetting and because we recognized that the number of claims used to apply our universal low volume policy (using the highest of the geometric mean cost, arithmetic mean cost, or median cost based on up to 4

years of claims data) may not have represented the cost of this SaaS, we used our equitable adjustment authority under section 1833(t)(2)(E) to continue to assign CPT codes 0697T and 0698T to APC 1511 (New Technology--Level 11 ($900-$1,000)) with a payment of $950.50. In accordance with our SaaS add-on codes policy (87 FR 72032 to 72033), SaaS CPT add-on codes are assigned to the same APCs and status indicators as their standalone codes. Thus, CPT code 0698T, the add-on code for CoverScan was assigned to the identical APC and status indicator as CPT code 0697T, the standalone code for the same service.

For CY 2026, the proposed OPPS payment rates were based on available CY 2024 claims data. We identified 55 single frequency claims for CPT code 0698T and no claims for CPT code 0697T in CY 2024. Because the SaaS standalone and add-on services are identical, we believe it is important for purposes of ratesetting to use the data that is available, whether it is associated with the standalone code or the add-on code. As the 55 single frequency claims are below the threshold of 100 claims for a service within a year, we would have proposed applying our universal low volume APC policy and would have used the highest of the geometric mean cost, arithmetic mean cost, or median cost based on up to 4 years of claims data to assign CPT codes 0697T and 0698T to the appropriate New Technology APC. Our analysis of the combined data, zero claims for CPT code 0697T and 137 claims for CPT code 0698T, yielded a geometric mean cost of approximately $422, an arithmetic mean cost of approximately $600, and a median cost of approximately $777. The median cost is the statistical methodology that estimated the highest cost for CPT codes 0697T and 0698T. Based on the median cost, we would have proposed to assign CPT codes 0697T and 0698T to APC 1509 (New Technology--Level 9 ($701-$800)) with a payment of $750.50.

As in CY 2025, for the CY 2026 OPPS/ASC proposed rule, we recognized that the few claims available for CPT codes 0697T and 0698T may not have truly represented the cost of this SaaS. We recognized that software-based technologies, like those described by CPT codes 0697T and 0698T, are unique and rapidly evolving and that a significant fluctuation in payment may hinder patient access to these new services. We issued a comment solicitation in section III.F of the CY 2026 OPPS/ ASC proposed rule to collect information on alternative and consistent payment methods that seek to reflect the underlying value of SaaS under the OPPS to consider in future rulemaking. We hoped to identify whether specific adjustments to our payment policies for SaaS are needed to more accurately and appropriately pay for these products and services across settings of care.

Because we have continued to have the same concerns about payment variability and the possible effects the payment may have on patient access to SaaS, we proposed to use our authority under section 1833(t)(2)(E) for CY 2026 to continue to assign CPT codes 0697T and 0698T to APC 1511 (New Technology--Level 11 ($900-$1,000)) with a payment of $950.50 which we believe best reflects the cost of the service at this time.

Comment: A commenter provided possible explanations for the payment variability, including the inappropriate use of CPT codes and distorted data due to inappropriate cost to charge ratios and stated the need for reliable claims data for ratesetting. While concerns were expressed as to the payment variability, the commenter supported the proposed APC assignment to APC 1511 (New Technology--Level 11 ($900-$1,000)) with a payment of $950.50. The commenter indicated that this APC assignment provides adequate payment for this service which enables beneficiaries to have continued access to these technologies.

Response: We appreciate the commenter's input and support for the proposed APC assignment. We hope to glean valuable information from the SaaS comment solicitation that will help us understand the potential factors that affect payment consistency. We hope by having this additional information, we can put forth a policy in future rulemaking that provides a more stable payment method for SaaS technologies.

After consideration of the public comment we received, we are finalizing our proposal without modification. We will use our equitable adjustment authority under section 1833(t)(2)(E) to continue to assign CPT codes 0697T and 0698T to New Technology APC 1511 (New Technology-- Level 11 ($901-$1,000) with a payment rate of $950.50 for CY 2026. Refer to Table 31 for the OPPS New Technology APC and status indicator assignments for CPT codes 0697T and 0698T for CY 2026. The final CY 2026 payment rates can be found in Addendum B to this final rule with comment period via the internet on the CMS website. In addition, we refer readers to Addendum D1 to this final rule with comment period for the status indicator meanings for all codes reported under the OPPS. Addendum D1 can also be found via the internet on the CMS website.

[GRAPHIC] [TIFF OMITTED] TR25NO25.049

Effective July 1, 2022, CPT codes 0723T (Quantitative magnetic resonance cholangiopancreatography (QMRCP) including data preparation and transmission, interpretation and report, obtained without diagnostic magnetic resonance imaging (MRI) examination of the same anatomy (e.g., organ, gland, tissue, target structure) during the same session) and 0724T (Quantitative magnetic resonance cholangiopancreatography (QMRCP), including data preparation and transmission, interpretation and report, obtained with diagnostic magnetic resonance imaging (MRI) examination of the same anatomy (e.g., organ, gland, tissue, target structure) (list separately in addition to code for primary procedure)) are associated with the QMRCP Software as a medical Service (SaaS). The service performs quantitative assessment of the biliary tree and gallbladder. It uses a proprietary algorithm that produces a three-dimensional reconstruction of the biliary tree and pancreatic duct and also provides precise quantitative information of biliary tree volume and duct metrics. In accordance with our SaaS add-on codes policy (87 FR 72032 to 72033), SaaS CPT add-on codes are assigned to the same APCs and status indicators as their standalone codes. Consistent with our SaaS add-on codes policy, CPT code 0724T, the add-on code for QMRCP is assigned to the identical APC and status indicator as CPT code 0723T, the standalone code for the same service. For CY 2024, we assigned CPT codes 0723T and 0724T to APC 1511 (New Technology--Level 11 ($900-$1,000)). For CY 2025, we continued to assign CPT codes 0723T and 0724T to APC 1511 (New Technology--Level 11 ($900-$1,000)) based on there being fewer than 10 claims in the 4-year lookback period and the exception from the universal low-volume APC policy.

For CY 2026, the OPPS payment rates were proposed to be based on available CY 2024 claims data. There were only four new claims for HCPCS code 0724T and no claims for CPT code 0723T. Given our proposal to maintain current New Technology APC assignments for CY 2026 for New Technology APC services with fewer than 10 claims in the 4-year lookback period due to an exception from the universal low-volume APC policy, we proposed, for CY 2026, to continue to assign CPT codes 0723T and 0724T to APC 1511 (New Technology--Level 11 ($901-$1000)), with a payment rate of $950.50.

Comment: A commenter supported the proposals to continue to assign 0723T and 0724T to APC 1511.

Response: We thank the commenter for their support.

Our updated claims data for the 4-year lookback period for the universal low volume APC policy shows no claims for HCPCS code 0723T and four single claims for 0724T. Because we are finalizing our proposal to maintain current New Technology APC assignments for CY 2026 for New Technology APC services with fewer than 10 claims in the 4-year lookback period, we are continuing to assign HCPCS code 0723T and 0724T to APC 1511.

Refer to Table 32 for the final OPPS New Technology APC and status indicator assignments for CPT codes 0723T and 0724T for CY 2026. The final CY 2026 payment rates can be found in Addendum B to this final rule with comment period via the internet on the CMS website.

[GRAPHIC] [TIFF OMITTED] TR25NO25.050

On March 5, 2019, FDA approved Spravato\TM\ (esketamine) nasal spray, used in conjunction with an oral antidepressant.\22\ for treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression (TRD)). This is the first FDA approval of esketamine for any use.

\22\ Subsequently, the FDA approved a prior approval supplemental new drug application (sNDA) providing for the following labeling modification: expansion of the indication to include monotherapy of Spravato\TM\ (esketamine) for treatment resistant depression (TRD). See https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211243Orig1s016ltr.pdf.

Esketamine is a noncompetitive N-methyl D-aspartate (NMDA) receptor antagonist. It is a nasal spray supplied as an aqueous solution of esketamine hydrochloride in a vial with a nasal spray device. Each device delivers two sprays containing a total of 28 mg of esketamine. Patients would require either two (2) devices (for a 56 mg dose) or three (3) devices (for an 84 mg dose) per treatment.

Because of the risk of serious adverse outcomes resulting from sedation and dissociation and respiratory depression caused by esketamine nasal spray administration, and the potential for abuse and misuse of the product, it is only available through a restricted distribution system under a Risk Evaluation and Mitigation Strategy (REMS). A REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. The Spravato\TM\ REMS program requires, among other requirements, that the esketamine nasal spray be dispensed and administered to enrolled patients in health care settings that are certified in the REMS. See www.fda.gov for more information regarding the Spravato\TM\ REMS program requirements.

A treatment session of esketamine consists of instructed nasal self-administration by the patient followed by a period of at least 2 hours post-administration observation of the patient under direct supervision of a health care professional in the certified health care setting. Refer to the CY 2020 PFS final rule and interim final rule for more information about supervised visits for esketamine nasal spray self-administration (84 FR 63102 through 63105); see also the Spravato REMS document and Spravato labeling available on the FDA website.\23\

\23\ The REMS document is available at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems, and labeling can be found at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.

To facilitate prompt beneficiary access to the new, potentially life-saving treatment for TRD using esketamine, we created two new HCPCS G codes, G2082 and G2083, effective January 1, 2020. HCPCS code G2082 is for an outpatient visit for the evaluation and management of an established patient who requires the supervision of a physician or other qualified health care professional and provision of up to 56 mg of esketamine through nasal self-administration and includes two hours of post-administration observation. HCPCS code G2083 describes a similar service to HCPCS code G2082 but involves the administration of more than 56 mg of esketamine.

For CY 2025, HCPCS code G2082 was assigned to APC 1513 (New Technology--Level 13 ($1101-$1200)) with a payment rate of $1,150.50 and HCPCS code G2083 was assigned to APC 1516 (New Technology--Level 16 ($1401-$1,500)) with a payment rate of $1,450.50.

For CY 2026, the OPPS payment rates were proposed based on available CY 2024 claims data as the available single frequency claims exceed the 100 claims threshold generally used for our universal low volume policy. Therefore, for CY 2026, we proposed to assign HCPCS codes G2082 and G2083 to New Technology APCs based on each of the codes' geometric mean costs. Specifically, we proposed to assign HCPCS code G2082 to APC 1512 (New Technology--Level 12 ($1001-$1100)) with a payment rate of $1,050.50 based on its geometric mean cost of $1,019, which was calculated using the available 558 single frequency claims from CY 2024 claims data. We also proposed to assign HCPCS code G2083 to APC 1517 (New Technology--Level 17 ($1501-$1600)) with a payment rate

of $1,550.50 based on its geometric mean cost of $1,549, which was calculated using the available 4,138 single frequency claims from CY 2024 claims data. As we continue to gather adequate claims data on these codes, we invited public comment on the appropriate clinical APC assignments for HCPCS codes G2082 and G2083.

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

Comment: Commenters supported the proposed APC assignment. They encouraged CMS to continue to provide adequate payment and not to undervalue this needed treatment, as that would cause access issues for beneficiaries in need of this service. Some commenters requested that we maintain the APC assignment for HCPCS code G2082 in APC 1513 (New Technology--Level 13 ($1101-$1200)) with a payment of $1,150.50, stating that adequate payment is needed to preserve access while additional cost data is collected. Another commenter suggested that we create a new clinical APC family with two levels that are specific to this service. The commenter stated that the creation of the new APC would ensure clinical and resource homogeneity and provide an opportunity in the future for similar services to be placed in the same APC.

Response: As readers are aware, we have been contemplating potential clinical APC assignments for the past number of rulemaking cycles but are not convinced as to what clinical APC would be appropriate in terms of clinical and resource homogeneity. We appreciate the public's suggestion of creating a new APC for this service.

We note the geometric mean costs for both HCPCS codes G2082 and G2083 have changed since the CY 2026 OPPS/ASC proposed rule. Based on the updated claims data available for this final rule, the geometric mean cost for HCPCS code G2082 is around $1,015 and the geometric mean cost for HCPCS code G2083 is around $1,612. Based on updated claims data available for this final rule with comment period, we are finalizing a New Technology APC assignment for HCPCS code G2083 to APC 1518 (New Technology--Level 18 ($1601-$1700)) with a payment of $1,650.50.

Finally, we note that because we have gathered additional claims data and seen increases in claims volume, we will continue to consider potential clinical APC placements for HCPCS codes G2082 and G2083 through future rulemaking.

Refer to Table 33 for the CY 2026 proposed and final APC and status indicator assignments for HCPCS codes G2082 and G2083. The CY 2026 payment rates can be found in Addendum B to this final rule with comment period via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.051

HCPCS code C9780 (Insertion of central venous catheter through central venous occlusion via inferior and superior approaches (e.g., inside-out technique), including imaging guidance) describes the procedure associated with the use of the Surfacer[supreg] Inside- Out[supreg] Access Catheter System that is designed to address central venous occlusion. HCPCS code C9780 was established on October 1, 2021, and since its establishment the code has been assigned to APC 1534 (New Technology--Level 34 ($8001-$8500)).

For the CY 2026 OPPS/ASC proposed rule, there were only three new claims for HCPCS code C9780. Therefore, there are only seven single frequency claims available for HCPCS code C9780 in the 2 years of data since the code has been available. Given our proposal to maintain current New Technology APC

assignments for CY 2026 for New Technology APC services with fewer than 10 claims in the 4-year lookback period applicable for the universal low-volume APC policy, we proposed for CY 2026 to continue to assign HCPCS code C9780 to APC 1534 (New Technology--Level 34 ($8001-$8500)) with a payment rate of $8,250.50.

We did not receive any public comments on our proposal to continue to assign CPT code C9870 to APC 1534 (New Technology--Level 34 ($8001- $8500)). We note that there were no additional claims in our updated claims data. Therefore, given our policy to maintain current New Technology APC assignments for CY 2026 for New Technology APC services with fewer than 10 claims in the 4-year lookback period applicable for the universal low volume APC policy, we are finalizing as proposed to continue to assign CPT code C9870 to APC 1534. Refer to Table 34 for the final OPPS New Technology APC and status indicator assignment for HCPCS code C9780. The final CY 2026 payment rates can be found in Addendum B to this final rule with comment period via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.052

The Transcatheter Atrial Shunt System (TASS) is a nitinol self- expanding cardiovascular implant consisting of four arms including two left atrial (LA) arms and two coronary sinus (CS) arms placed between the left atrium and coronary sinus to create a 7mm flow diameter channel for blood to flow from the high pressure region of the left atrium to the lower pressure region of the right atrium via the coronary sinus.

TASS was designated as a Category A IDE clinical study (NCT03523416) on July 31, 2019. Effective October 1, 2023 CMS created HCPCS code C9792 (Blinded or nonblinded procedure for symptomatic New York Heart Association (NYHA) Class II, III, IVa heart failure; transcatheter implantation of left atrial to coronary sinus shunt using jugular vein access, including all imaging necessary to intra procedurally map the coronary sinus for optimal shunt placement (e.g., TEE or ICE ultrasound, fluoroscopy), performed under general anesthesia in an approved investigational device exemption (IDE) study) to describe the TASS service and assigned it to APC 1537 (New Technology-- Level 37 ($9501-$10000)) with a payment rate of $9750.50. Since devices in Category A IDE studies are not covered by Medicare during the study, the payment for HCPCS code C9792 reflects only the cost of the service that is performed each time it is reported on a claim.

For CY 2025, there were no claims available, so we maintained the APC assignment for HCPCS code C9792 to APC 1537 (New Technology--Level 37 ($9501-$10000)).

For CY 2026, the proposed OPPS payment rates are based on available CY 2024 claims data. We do not have any claims data for HCPCS code C9792. Therefore, for CY 2026, we proposed to continue to assign HCPCS code C9792 to APC 1537 (New Technology--Level 37 ($9501-$10000)) with a payment rate of $9,750.50.

We did not receive public comments on this provision, and therefore, we are finalizing as proposed. HCPCS Code C9792 will remain assigned to APC 1537 (New Technology--Level 37 ($9,501-$10,000)) with a payment rate of $9,750.50.

Refer to Table 35 for the final OPPS New Technology APC and status indicator assignment for HCPCS code C9792. The final CY 2026 payment rates can be found in Addendum B to this final rule with comment period via the internet on the CMS website.

[GRAPHIC] [TIFF OMITTED] TR25NO25.053

HCPCS code C9791 (Magnetic resonance imaging with inhaled hyperpolarized xenon-129 contrast agent, chest, including preparation and administration of agent) was established on October 1, 2023. For CY 2023, we assigned HCPCS code C9791 to APC 1551 (New Technology--Level 14 ($1201-$1300)). Due to the effective date of the service of October 1, 2023, there were no claims available for HCPCS code C9791 for rate setting in CY 2024. Therefore, in CY 2024, we continued to assign HCPCS code C9791 to APC 1551(New Technology--Level 14 ($1201-$1300)). There were no claims available for HCPCS code C9791 when we were setting rates for CY 2025, so we continued to assign HCPCS code C9791 to APC 1551 (New Technology--Level 14 ($1201-$1300)).

For CY 2026, the proposed OPPS payment rates were based on the available CY 2024 data. There were only four new claims for HCPCS code C9791. Given our proposal to maintain current New Technology APC assignments for CY 2026 for New Technology APC services with fewer than 10 claims in the 4-year lookback period applicable for the universal low-volume APC policy, we proposed for CY 2026 to continue to assign HCPCS code C9791 to APC 1551--New Technology--Level 14 ($1201-$1300)), with a payment rate of $1,250.50.

We did not receive public comments on our proposal to continue to assign HCPCS code C9791 to APC 1551.

Our updated claims data for the 4-year lookback period for the universal low volume APC policy shows only five claims for HCPCS code C9791. Because we are finalizing our proposal to maintain current New Technology APC assignments for CY 2026 for New Technology APC services with fewer than 10 claims in the 4-year lookback period, we are finalizing our proposal without modification to continue to assign HCPCS code C9791 to APC 1551.

Refer to Table 36 for the final OPPS New Technology APC and status indicator assignment for HCPCS code C9791 for CY 2026. The final CY 2026 payment rates can be found in Addendum B to this final rule with comment period via the internet on the CMS website. In addition, we refer readers to Addendum D1 to this final rule with comment period for the status indicator meanings for all codes reported under the OPPS. Addendum D1 can also be found via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.054

The SAINT Neuromodulation System is a non-invasive repetitive transcranial magnetic stimulation (rTMS) system that identifies an individualized target and delivers navigationally directed repetitive magnetic pulses to that individualized target located within the left dorsolateral prefrontal cortex to treat major depressive disorder (MDD). The patient first receives structural MRI and functional MRI scans that are analyzed by the provider to identify and localize the personalized stimulation target in the patient's dorsolateral prefrontal cortex. Once the areas targeted for treatment are identified, the patient

receives non-invasive magnetic stimulation in the targeted area. The patient has 10 treatment sessions per day with each treatment session lasting 10 minutes followed by 50 minutes of rest before another treatment session occurs. The treatment is administered over five days for a total of 50 sessions of non-invasive magnetic stimulation therapy. There are four CPT codes listed in Table 37 that describe the MRI scans that are used to target the treatment and describe the administration of the non-invasive magnetic stimulation therapy. [GRAPHIC] [TIFF OMITTED] TR25NO25.055

For CY 2025, the OPPS payment rates were proposed based on available CY 2023 claims data. However, CPT codes 0889T, 0890T, 0891T, and 0892T did not become effective until July 1, 2024, which means there were no claims data for the procedures described these CPT codes. We assigned our proposed rates for these services based on our evaluation of the resources needed to perform these services.

For CY 2026, the OPPS payment rates were proposed based on available CY 2024 claims data. There were only five claims for CPT code 0889T and three claims for CPT code 0892T within this period. Given our proposal to maintain current New Technology APC assignments for CY 2026 for New Technology APC services with fewer than 10 claims in the 4-year lookback period applicable for the universal low-volume APC policy, we proposed to continue to assign CPT code 0889T to APC 1511 (New Technology--Level 11 ($901-$1000)) with a payment of $950.50 and CPT code 0892T to APC 1525 (New Technology--Level 25 ($3501-$4000)) with a payment of $3750.50.

There were 12 single frequency claims for CPT 0890T and 39 single frequency claims for CPT 0891T. As this is above the threshold of 10 claims and below the threshold of 100 claims for a service within a year, we proposed to apply our universal low volume New Technology APC policy and use the highest of the geometric mean cost, arithmetic mean cost, or median cost based on up to 4 years of claims data to assign CPT codes 0890T and 0891T to the appropriate New Technology APCs.

Using available claims data from CY 2024, our analysis found the geometric mean cost of CPT 0890T was approximately $1,646, the median cost was approximately $1,009, and the arithmetic mean cost was approximately $1,950. The arithmetic mean was the statistical methodology that estimates the highest cost for the service. Therefore, we proposed, for CY 2026, to assign CPT code 0890T to APC 1521 (New Technology--Level 21 ($1901-$2000)) with a payment rate of $1,950.50.

For CPT 0891T, using the available claims data from CY 2024, our analysis found the geometric mean cost was approximately $1,692, the median cost was approximately $1,009, and the arithmetic mean cost was approximately $2,010. The arithmetic mean was the statistical methodology that estimated the highest cost for the service. Therefore, we proposed, for CY 2026, to assign CPT code 0891T to APC 1522 (New Technology--Level 22 ($2001-$2500)) with a payment rate of $2,250.50.

Since the CY 2026 OPPS/ASC proposed rule was published, we note that CPT code 0889T now has 11 single frequency claims; CPT code 0890T has an updated geometric mean cost of $1,687; and CPT code 0891T now has 41 single frequency claims and a geometric mean cost of around $1,690. There were no changes to the claims information for CPT code 0892T.

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

Comment: Many commenters requested that CMS maintain the current New Technology APC assignments as the current assignments more appropriately reflect the resources required to provide this highly resource intensive therapy. Commenters noted that if CMS finalized the proposed rates, it would result in a 40-48 percent decrease in payment for two of the SAINT codes. They indicated that not only would the payment reduction affect current access to these services for patients who are suffering from major depressive disorder and treatment- resistant depression, but it would also impede providers from implementing SAINT. As a result, this would further widen the disparities in care, especially in rural and underserved communities where treatment options may be limited.

Commenters stated that the limited claims data (less than 1 year) does not accurately reflect the costs of providing SAINT and that CMS should not use the small dataset that is available for determining the rates for CY 2026. A commenter noted that one of the early providers of SAINT confirmed with

them that their reported costs were made in error and were highly inaccurate. The commenter stated that the charges and revenue code assignments for CPT codes 0890T and 0891T dramatically under-reported costs for SAINT, potentially by 80 percent of actual costs for providing this service.

Response: We agree that the proposed rates based on a partial year of claims do not accurately reflect the costs for implementing, providing, and maintaining this service.

After consideration of the public comments we received, we are not finalizing our proposal for CY 2026. For CY 2026, we are using our equitable adjustment authority under section 1833(t)(2)(E) of the Act to maintain the current APC assignments for CPT codes 0889T, 0890T, 0891T, and 0892T. Refer to Table 38 for the proposed and final OPPS New Technology APC and status indicator assignments for CPT codes 0889T, 0890T, 0891T, and 0892T. 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. BILLING CODE 4120-01-P [GRAPHIC] [TIFF OMITTED] TR25NO25.056

BILLING CODE 4120-01-C v. Implantable Glucose Monitoring System (APC 1563)

Effective January 1, 2017, the AMA CPT Editorial Panel established CPT codes 0446T (Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training) and 0448T (Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation) to describe an implantable glucose sensor for patients with diabetes. These codes were used to describe sensors with a 90-day or 180-day battery life. Although these CPT codes were effective January 1, 2017, the implantable interstitial glucose sensor did not receive FDA approval for marketing until June 6, 2019. For CY 2021, we assigned CPT codes 0446T and 0448T to APC 5054 (Level 4 Skin Procedures) and a status indicator of

“T” (Procedure or Service, Multiple Procedure Reduction Applies; Paid under OPPS; separate APC payment.) and have maintained these APC assignments since then.

In the CY 2025 OPPS/ASC final rule with comment period, we created the following two HCPCS G codes effective January 1, 2025, to describe the implantable interstitial glucose sensor with a 365-day battery life.

G0546 (Creation of subcutaneous pocket with insertion of 365 day implantable interstitial glucose sensor, including system activation and patient training); and

G0565 (Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new 365 day implantable sensor, including system activation).

We assigned HCPCS codes G0564 and G0565 to APC 1561 (New Technology--Level 24 ($3001-$3500)) with a payment rate of $3,250.50.

For the April 1, 2025, quarterly update, we deleted HCPCS codes G0564 and G0565 and assigned 0446T and 0448T to APC 1561 (New Technology--Level 24 ($3001-$3500)) with a payment rate of $3,250.50 to describe the new implantable interstitial glucose sensor with a 365-day battery life. The 365-day glucose sensor replaced previous versions of the implantable interstitial glucose sensor with shorter battery lives. Therefore, the 365-day sensor is the only sensor on the market and can only be described by CPT codes 0446T and 0448T.

For CY 2026, the proposed OPPS payment rates were based on available CY 2024 claims data. As CPT codes 0446T and 0448T were assigned to New Technology APCs to describe this new sensor for the April 2025 quarterly update and the G codes describing this service were only effective for one quarter, we do not have any claims data for the service. Therefore, for CY 2026, we proposed to continue to assign CPT codes 0446T and 0448T to APC 1561 (New Technology--Level 24 ($3001- $3500)) with a payment rate of $3,250.50.

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 codes 0446T and 0448T to APC 1530 (New Technology--Level 30 ($6001-$6500)). The commenter cited the increased cost of the implanted 365-day glucose sensor as the reason for their request and the value of the longer sensor duration, including fewer insertion and removal procedures and better adherence to therapy. They explained that extensive research and development, along with high manufacturing costs, have contributed to the cost of the implantable continuous glucose monitoring system (iCGM system) which they state is $6,800. The commenter also requested that the OPPS payment align with the PFS payment (approximately $5,800) to provide consistent payment regardless of setting.

Response: We appreciate the public comment and understand the implicated value that a longer life sensor brings to Medicare beneficiaries. We agree that there would be inherently increased costs to hospitals for the new technology of a 365-day system, but we do not agree that the costs to hospitals would be almost double the costs of the 180-day system.

In summary, after consideration of the public comment we received, we are finalizing our proposal with modification based on our statutory authority set out at section 1833(t)(2)(E) of the Act, to assign CPT code 0446T and 0448T to APC 1563 (New Technology--Level 26 ($4001- $4500)) with a payment of $4,250.50. We remind hospitals that we review, on an annual basis, the APC assignments for all items and services paid under the OPPS. Refer to Table 39 for code descriptor, APC assignment and status indicator assignments for CPT codes 0446T and 0448T for CY 2026. 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. [GRAPHIC] [TIFF OMITTED] TR25NO25.057

Effective January 1, 2025, both CPT code 15013 (Preparation of skin cell suspension autograft, requiring enzymatic processing, manual mechanical disaggregation of skin cells, and filtration; first 25 sq cm or less of harvested skin) and HCPCS code C8002 (Preparation of skin cell suspension autograft, automated, including all enzymatic processing and device components (do not report with manual suspension preparation)) describe the preparation step of a skin cell suspension autograft (SCSA) procedure to treat acute thermal burn injuries. Both codes describe the preparation step of a three-step SCSA procedure: harvesting, preparation, and

application. The difference between the codes is that CPT code 15013 describes the manual preparation of the SCSA, and HCPCS code C8002 describes the automated preparation of the SCSA. Due to the similarities between the procedures, in the CY 2025 OPPS/ASC final rule with comment period, we assigned both CPT code 15013 and HCPCS code C8002 to APC 1567 (New Technology--Level 30 ($6,001-$6,500)) with a payment rate of $6,250.50 and status indicator “T”. In the CY 2025 OPPS/ASC final rule with comment period, we noted that we believed the sum of the payment rates for the three-step process should approximate $10,000. However, because of the effect of the multiple procedure reduction, the total payment for the skin cell suspension autograft furnished using the RECELL System would have been approximately $8,000, contrary to the intended target of $10,000 as stated in the CY 2025 OPPS/ASC final rule with comment period. To correct this error, in the CY 2025 OPS/ASC Correction Notice, we assigned both CPT code 15013 and HCPCS code C8002 to APC 1532 (New Technology--Level 32 ($7,001-$7,500)) with a payment rate of $7,250.50 and status indicator “S” (Procedure or service, not discounted when multiple, paid under OPPS; separate APC payment).

For CY 2026, the OPPS payment rates are proposed to be based on available CY 2024 claims data. Since CPT code 15013 and HCPCS code C8002 were not effective until January 1, 2025, we did not have any claims for either code for CY 2024. Therefore, for CY 2026, we proposed to continue to assign CPT code 15013 and HCPCS code C8002 to APC 1532 (New Technology--Level 32 ($7,001-$7,500)) with a payment rate of $7,250.50.

We did not receive public comments on this provision, and therefore, we are finalizing as proposed.

Refer to Table 40 for the proposed and final OPPS New Technology APC and status indicator assignments for CPT code 15013 and HCPCS code C8002 for CY 2026. The final CY 2026 payment rates can be found in Addendum B to this final rule via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.058

HCPCS code C9790 (Histotripsy (that is, non-thermal ablation via acoustic energy delivery) of malignant renal tissue, including image guidance) was created October 1, 2023, and was used to describe the Medicare approved Category B IDE (investigational device exemption) clinical study involving the renal histotripsy procedure associated with the use of the HistoSonics Edison System. CPT code 0888T (Histotripsy (i.e., non-thermal ablation via acoustic energy delivery) of malignant renal tissue, including image guidance) replaced HCPCS code C9790 effective July 1, 2024.

Renal histotripsy is a non-invasive, non-thermal, mechanical process that uses a focused beam of sonic energy to destroy solid renal tumors and is currently in a prospective, multi-center, single-arm pivotal trial designed to evaluate the effectiveness and safety of the device for the destruction of kidney tissue by treating primary solid renal tumors.\24\ Because the renal histotripsy clinical study is designated as a Category B (non-experimental/investigational) IDE study, the Medicare payment for CPT code 0888T reflects payment for both the service that is performed, and the device used each time it is reported on a claim. For CY 2025 we assigned CPT code 0888T to APC 1576 (New Technology--Level 39 ($15,001-$20,000)) with a payment rate of $17,500.50 based on the previous APC and status indicator assignments for HCPCS code C9790.

\24\ See “The HistoSonics System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY) at https://clinicaltrials.gov/study/NCT05820087.

For CY 2026, the proposed OPPS payment rates were based on available CY 2024 claims data. We identified one single frequency claim for HCPCS code C9790 and six single frequency claims for CPT code 0888T. Since the CY 2026 OPPS/ASC proposed rule has been published, we have eight single frequency claims for CPT code 0888T. Given our proposal to maintain current New Technology APC assignments for CY 2026 for New Technology services with fewer than 10 claims in the 4-year lookback period applicable for the universal low-volume APC policy, we proposed to continue to assign CPT code 0888T to APC 1576 (New Technology--Level 39 ($15,001-$20,000)) with a payment rate of $17,500.50.

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

Comment: A commenter supported the proposed New Technology APC assignment.

Response: We thank the commenter for their support.

In summary, we are finalizing our proposal without modification. We will continue to assign CPT code 0888T to APC 1576 with a status indicator of `S' for CY 2026.

The New Technology APC and status indicator assignment for CPT code 0888T is shown in Table 41. The final CY 2026 payment rates for this CPT code can be found in Addendum B to this final rule via the internet on the CMS website. In addition, we refer readers to Addendum D1 to this final rule with comment period for the status indicator meanings reported under OPPS. Addendum D1 can also be found via the internet on the CMS website. [GRAPHIC] [TIFF OMITTED] TR25NO25.059

In the CY 2022 OPPS/ASC final rule with comment period (86 FR 63743 through 63747), we adopted a policy to designate clinical and brachytherapy APCs as low volume APCs if they have fewer than 100 single claims that can be used for ratesetting purposes in the claims year used for ratesetting for the prospective year. For the CY 2026 OPPS/ASC proposed rule, CY 2024 claims were generally the claims used for ratesetting; and clinical and brachytherapy APCs with fewer than 100 single claims from CY 2024 that can be used for ratesetting would be low volume APCs subject to our universal low volume APC policy. As we stated in the CY 2022 OPPS/ASC final rule with comment period, we adopted this policy to reduce the volatility in the payment rate for those APCs with fewer than 100 single claims. Where a clinical or brachytherapy APC has fewer than 100 single claims that can be used for ratesetting, under our low volume APC payment adjustment policy, we determine the APC cost as the greatest of the geometric mean cost, arithmetic mean cost, or median cost based on up to 4 years of claims data. We excluded APC 5853 (Partial Hospitalization for CMHCs) and APC 5863 (Partial Hospitalization for Hospital-based PHPs) from our universal low volume APC policy given the different nature of policies that affect the partial hospitalization program. We also excluded APC 2698 (Brachytx, stranded, nos) and APC 2699 (Brachytx, non-stranded, nos) as our current methodology for determining payment rates for non- specified brachytherapy sources is appropriate.

Based on claims data available for the CY 2026 OPPS/ASC proposed rule, we proposed to designate six brachytherapy APCs and five clinical APCs as low volume APCs under the OPPS (90 FR 33561 through 33562). The six brachytherapy APCs and five clinical APCs meet our criteria of having fewer than 100 single claims in the claims' year used for ratesetting (CY 2024 for the CY 2026 OPPS/ASC proposed rule). Ten of the 11 APCs were designated as low volume APCs in CY 2025. Based on data for the CY 2026 OPPS/ASC proposed rule, APC 2645 (Brachytx, non- stranded, gold-198) had 103 single claims and no longer met our criteria to be designated as a low volume APC; however, APC 2643 (Brachytx, non-stranded, c-131) had only 88 single claims and met our criteria to be designated as a low volume APC.

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

Comment: Commenters supported our proposal to continue our low volume APC policy.

Response: We thank commenters for their support.

After consideration of public comments, based on CY 2024 claims data available for this final rule with comment period, we are finalizing our proposal to designate six brachytherapy APCs and five clinical APCs as low volume APCs under the OPPS. Table 42 includes the CY 2024 claims available for ratesetting for each of the APCs we are designating as low volume APCs for CY 2026. The final cost statistics for our CY 2026 low volume APCs, such as the median, arithmetic mean, and geometric mean cost are available for download with this final rule with comment period on the CMS website. We refer readers to our website at https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices; click on the relevant regulation to download the low volume APC cost statistics under the comprehensive (OPPS) ratesetting methodology in the downloads section of the web page.

[GRAPHIC] [TIFF OMITTED] TR25NO25.060

1. APC Structure a. Diagnostic Tests and Related Services (APCs 5721 Through 5724)

The Diagnostic Tests and Related Services APC series was created as part of the APC restructuring and consolidation in the CY 2016 OPPS (80 FR 70384 through 70386). Since its initial establishment, we have maintained a four-level APC structure for the series. In the CY 2026 OPPS, as part of our standard process of reviewing the OPPS structure based on updated claims data, we proposed to make changes to the APC series, and included those changes in the associated cost statistics files and addenda made available with each proposed and final rule via the internet on the CMS website.

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 does not finalize the proposed changes to the Diagnostic Tests and Related Services APC series. They requested that CMS refrain from shifting services in the APC family until there was sufficient opportunity for meaningful public comment on such changes. Commenters noted the impact on geometric mean costs for each of the APCs. Other commenters requested that CMS delay the changes and conduct further analysis so that the public can evaluate them. A commenter requested that CMS rerun the cost modeling for the APCs excluding low volume or anomalous facility reports and consider volatility guards, public analysis regarding observed changes, and maintain payment levels that preserve beneficiary access until stable cost data can be established.

Commenters noted individual impacts on codes related to the changes in the Diagnostic Tests and Related Services APCs. A commenter noted the impact on CPT code 95924 (Testing of autonomic nervous system function; combined parasympathetic and sympathetic adrenergic function testing with at least 5 minutes of passive tilt), which had an expected decrease in payment of 29 percent. Another commenter noted CPT code 93017 (Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise, continuous electrocardiographic monitoring, and/or pharmacological stress; tracing only, without interpretation and report) which had an expected decrease of about 29 percent in its payment rate, which the commenter wanted maintained at $311.40. A few commenters recommended that CPT code 90870 (Electroconvulsive therapy (includes necessary monitoring)) be maintained in its current assignment or moved to a clinically coherent APC since the code represents a therapeutic procedure and not a diagnostic test.

Response: As discussed earlier in this rule, section 1833(t) of the Act requires CMS to annually review and update the payment rates for services payable under the OPPS. Section 1833(t)(2)(B) of the Act provides that the Secretary may establish groups of covered OPD services within this classification system, so that services classified within each group are comparable clinically and with respect to the use of resources. In addition, section 1833(t)(2) of the Act provides that, subject to certain exceptions, the items and services within an APC group cannot be considered comparable regarding the use of resources if the highest cost for an item or service in the group is more than 2 times greater than the lowest cost for an item or service within the same group (referred to as the “2 times rule”).

As part of that review and update process we made changes to the APC assignments within the APC series such that the cost and clinical APC groupings would be more reflective of the codes assigned to them. We note that the changes in geometric mean costs for these APCs are associated with the APC recalibrations so that the services with clinical cost patterns that are more similar to each other are assigned to the same APC. In general, we do not believe that the alternative cost modeling the commenter requested is appropriate for ratesetting for these APCs. In the broader OPPS ratesetting process we generally aim to use as much as data is available that is appropriate for ratesetting, and typically only remove claims data from that process through the systematic trims that are described in the claims accounting narrative document made available on the CMS website.

We believe that sufficient opportunity for public notice and comment was provided, as the proposed changes to the APC assignments and the APC levels are reflected through the cost statistics and two times files we make available with each proposed and final rule. In addition, any changes associated with individual codes are noted in the

Addendum B through the Change Indicator column.

CPT codes 95924 and 93017 were both proposed to be placed in APC 5722 (Level 2 Diagnostic Tests and Related Services) in the CY 2026 OPPS/ASC proposed rule, which has a cost significant range from approximately $165 to $298. (The addenda for CY 2026 OPPS/ASC proposed rule can be found on the CMS website located at https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices/cms-1834-p.) In the final rule claims data available for OPPS ratesetting CPT code 95924 has a geometric mean cost of $281.10, while CPT code 93017 has a geometric mean cost of $271.62. While we recognize that APC geometric mean costs can fluctuate based on a variety of factors, including updated claims and cost report data update, APC level recalibration, and others, the geometric mean costs of both codes suggests that they are appropriately placed in the Level 2 APC based on their estimated resource costs. We note that we generally do not set APC payment rates at predetermined rates for clinical APCs.

In the claims available for OPPS ratesetting for this final rule, CPT code 90870 has an estimated geometric mean cost of $713.14 based on 52,518 single claims. The geometric mean cost of APC 5724 (Level 4 Diagnostic Tests and Related Services) is $884.07. We believe that the proposed placement of CPT code 90870 in APC 5724 remains appropriate based on its geometric mean cost relative to that of the APC and the similarity of its resource costs relative to other procedures assigned to the APC and clinical similarity to some of the related services assigned to the APC series more broadly. As a result, we are finalizing the assignment of CPT code 90870 to APC 5724.

We note that we will continue to monitor the APC series as more claims data are available for the procedures assigned to this series and continue to be interested in suggestions regarding changes to those assignments for future years.

After consideration of the public comments we received, we are finalizing the proposed APC recalibration changes for the Diagnostics Tests and Related Procedures APC series. In addition, we are finalizing the assignments of CPT codes 95924 and 93017 to APC 5722, and CPT code 90870 to APC 5724. b. Nerve Procedures (APCs 5431 Through 5432)

The current APC structure of the Nerve Procedures series was developed during the broader CY 2016 OPPS reorganization and consolidation of APCs. Since that time, it has maintained that same two-level APC structure (89 FR 70379 through 70380).

Comment: A few commenters noted that there was a significant decrease in the estimated geometric mean cost of the Level 2 Nerve Procedures APC due to the impact of a new eligible complexity adjustment code combination. They requested that CMS either map the complexity adjustment 6471R back into the Level 1 Nerve Procedures APC (APC 5431) or alternatively develop a level 3 APC that could accommodate some of the higher cost procedures in the current Level 2, such that there was less of an impact on some portion of the procedures.

Commenters had requested that these codes be included in that level 3 APC:

61215--Insertion of subcutaneous reservoir, pump or continuous infusion system for connection to ventricular catheter

63741--Creation of shunt, lumbar, subarachnoid-peritoneal, - pleural, or other; percutaneous, not requiring laminectomy

64864--Suture of facial nerve; extracranial

64885--Nerve graft (includes obtaining graft), head or neck; up to 4 cm in length

64886--Nerve graft (includes obtaining graft), head or neck; more than 4 cm length

64890--Nerve graft (includes obtaining graft), single strand, hand or foot; up to 4 cm length

64891--Nerve graft (includes obtaining graft), single strand, hand or foot; more than 4 cm length

64892--Nerve graft (includes obtaining graft), single strand, arm or leg; up to 4 cm length

64895--Nerve graft (includes obtaining graft), multiple strands (cable), hand or foot; up to 4 cm length

64896--Nerve graft (includes obtaining graft), multiple strands (cable), hand or foot; more than 4 cm length

64897--Nerve graft (includes obtaining graft), multiple strands (cable), arm or leg; up to 4 cm length

64898--Nerve graft (includes obtaining graft), multiple strands (cable), arm or leg; more than 4 cm length

64907--Nerve pedicle transfer; second stage

64912--Nerve repair; with nerve allograft, each nerve, first strand (cable)

A commenter also requested special consideration for CPT code 64912, and that the CPT code be included in the Level 3 Nerve Procedures APC.

Response: While we note that APC geometric mean cost changes are expected under the current structure of the C-APCs and the complexity adjustments, we agree that a Level 3 Nerve Procedures APC is appropriate, in particular to resolve what would otherwise be a significant “two times rule” violation in the Level 2 APC. We are including the above requested codes in the Level 3 APC. We believe that there are several additional codes for which it would appropriate from a clinical and resource cost similarity perspective to include in the Level 3 APC. We are finalizing the inclusion of the following additional codes into the Level 3 APC:

61720--Creation of lesion by stereotactic method, including burr hole(s) and localizing and recording techniques, single or multiple stages; globus pallidus or thalamus

62230--Replacement or revision of cerebrospinal fluid shunt, obstructed valve, or distal catheter in shunt system

62350--Implantation, revision or repositioning of tunneled intrathecal or epidural catheter, for long-term medication administration via an external pump or implantable reservoir/infusion pump; without laminectomy

64840--Suture of posterior tibial nerve

64856--Suture of major peripheral nerve, arm or leg, except sciatic; including transposition

64905--Nerve pedicle transfer; first stage

64910--Nerve repair; with synthetic conduit or vein allograft (e.g., nerve tube), each nerve

64911--Nerve repair; with autogenous vein graft (includes harvest of vein graft), each nerve

0442T--Ablation, percutaneous, cryoablation, includes imaging guidance; nerve plexus or other truncal nerve (e.g., brachial plexus, pudendal nerve)

Under the current C-APC methodology, complexity adjustments are mapped to the next higher cost APC within the clinical family. Within this structure, we currently do not have a mechanism for removing eligibility complexity adjustments by assigning them to alternative APCs including the originating primary APC. Therefore, we do not currently believe it is appropriate to manually assign the complexity adjustment represented by 6471 to APC 5431. Despite this, we understand that there are potential opportunities to

refine the C-APC and complexity adjustment methodology to address cost modeling concerns. We continue to remain interested in suggestions regarding the C-APC and complexity adjustment methodology, as noted in section II.A.2.b. of this final rule with comment period.

After consideration of the comments, we are finalizing a 3-Level APC structure for the Nerve Procedures APC series. c. Endovascular Procedures (APCs 5191 Through 5194)

The Endovascular Procedures APC series was initially mapped and assigned as a 3 level series in the CY 2016 OPPS. In the CY 2017 OPPS, an additional APC level was created. Since that time the Endovascular Procedures APC series has been maintained as a 4-level APC series.

Comment: A commenter requested that APC 5200 (Implantation Wireless PA Pressure Monitor) be converted into a Level 5 Endovascular Procedures APC, and that the following codes be included into that APC:

C9774--Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel(s), when performed.

C9775--Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular lithotripsy and transluminal stent placement(s), and atherectomy, includes angioplasty within the same vessel(s), when performed.

C9767--Revascularization, endovascular, open or percutaneous, lower extremity artery(ies), except tibial/peroneal; with intravascular lithotripsy and transluminal stent. placement(s), and atherectomy, includes angioplasty within the same vessel(s), when performed.

C9797--Vascular embolization or occlusion procedure with use of a pressure-generating catheter (e.g., one-way valve, intermittently occluding), inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction.

They believe that doing so would be appropriate based on the similarity of the codes' geometric mean costs. That commenter also stated that with the proposal to eliminate the inpatient only list over three years beginning in 2026, creating a Level 5 Endovascular Procedures APC could allow for appropriate clinical APC placement for procedures being removed from the list.

Response: We note that the APC geometric mean cost of APC 5194 (Level 4 Endovascular Procedures) is $18,872.40 while that of APC 5200 (Implantation Wireless PA Pressure Monitor) is $29,529.47. We recognize that the general approximate geometric mean costs for inclusion in the requested Level 5 APC would range from about $24,500 to $27,900. However, that level 5 APC payment weight would still continue to be primarily driven by the estimated costs of the currently assigned HCPCS code 33289 (Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed), which has a geometric mean cost of $29,529.47.

We recognize the commenter concerns around procedure codes potentially being removed from the IPO list requiring appropriate clinical APC placements. For the CY 2026 OPPS, we do not believe that the procedures being removed from the IPO list would require the level 5 Endovascular Procedures APC that the commenter requested.

At this time, we do not believe that it is appropriate to convert the APC 5200 (Implantation Wireless PA Pressure Monitor) into a level 5 Endovascular Procedures APC. However, we will continue to monitor the available claims and cost data for the APC series and in the context of codes being removed for the IPO list.

After consideration of the comments, we are finalizing the 4-level APC structure of the Endovascular Procedures APC series as proposed. d. Laparoscopy and Related Services (APCs 5361 Through 5362)

As part of the CY 2016 OPPS APC restructuring process, the four level APC series for Laparoscopy and Related Services was consolidated into a 2-level APC series (80 FR 70379) through. Since that time, we have maintained that 2-level APC structure based on the clinical and resource homogeneity of the services assigned to those APCs.

Comment: A commenter requested that CMS create a Level 3 Laparoscopy and Related Services APCs that would include the highest cost and complexity services in the current Level 2 APC. The commenter believes that this would restore the previously existing structure of the Laparoscopy and Related Services APCs while allowing potential placements for services being removed from the IPO list. The commenter believes that it would be appropriate to place services with geometric mean costs of $12,000 or more into that level 3 APC.

Response: While we monitor the structure of the OPPS and the various APCs, we note that some of the principles guiding the CY 2016 OPPS APC restructuring and consolidation included improved resource and clinical homogeneity, as well as reduced resource overlap in APCs within a clinical family (80 FR 70379).

The Level 2 Laparoscopy and Related Services APC has an estimated geometric mean cost of $10,943.41, with a range of geometric mean costs for two times rule purposes ranging from $8,909.96 for CPT code 58552 (Laparoscopy, surgical, with vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s) and/or ovary(s)) to $13,085.27 for CPT code 55866 (Laparoscopy, surgical, with vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s) and/or ovary(s)). While some of the services in the cost range indicated by the commenter have significant claims volume, we do not believe that there is a current need for an additional APC level given that the estimated geometric mean cost of the requested Level 3 APC would be significantly distinct from a cost perspective.

We note that we are not removing any services from the IPO list in CY 2026 that would require assignments to the Laparoscopic and Related Services APC series. However, we will continue to monitor the claims data as they become available and the need for additional APC levels in the future.

After consideration of the public comments, we are finalizing the 2-level APC structure for the Laparoscopy and Related Services APC series in this final rule with comment period as proposed. 2. ActiGraft System, HCPCS Code G0465 (APC 5054)

Effective April 2021, HCPCS code G0465 (Autologous platelet rich plasma (PRP) or other blood-derived product for diabetic chronic wounds/ulcers, using an FDA-cleared device for this indication, (includes as applicable administration, dressings, phlebotomy, centrifugation or mixing, and all other preparatory procedures, per treatment) describes autologous blood derived products for chronic non- healing wounds. For CY 2026, we proposed to assign HCPCS code G0465 to APC 5054

(Level 4 Skin Procedures) and status indicator “T.”

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 change the status indicator from “T,” which allows for multiple procedure discounting, to a status indicator that pays the full payment rate each time the service is billed on a claim. The commenter explained that CMS recognized that HCPCS code G0465 could be billed twice on the same claim by revising the Medically Unlikely Edit (MUE) for HCPCS code G0465 from “1” to “2” in April 2025. Per the commenter, when more than one treatment is required for a patient with a single large wound or multiple wounds, providers would need to bill HCPCS code G0465 twice on the same claim to reflect the multiple treatments. The commenter believes that applying a multiple procedure discount to HCPCS code G0465 is inappropriate because the cost of the treatment kit would not be paid fully if billed multiple times. The commenter notes that CPT code 43877, which is also proposed to be assigned to APC 5054, is assigned a status indicator other than “T,” specifically “Q2,” to demonstrate that CMS has assigned codes in APC 5054 a status indicator other than “T.” Finally, the commenter requested that CMS revise the place of service (POS) codes for G0465 to allow for the service to be furnished in the nursing home setting.

Response: With regard to the commenter's request to revise the POS codes for HCPCS code G0465, changes to allow for services to be paid in facilities other than the hospital outpatient department or ambulatory surgical center are outside the scope of this rule.

With regard to the request to not finalize the assignment of the proposed status indicator of “T” to HCPCS code G0465, we note that the OPPS uses certain payment principles, including packaging and multiple procedure discounting, in an effort to control costs and promote more efficient care. HCPCS code G0465 describes a service that may be billed more than once on a claim in particular instances when the patient has multiple or large wounds that would require additional product. In reviewing the other services that are assigned to APC 5054, we note there are many other similar skin services (for example, HCPCS code G0460) that are also assigned to status indicator “T” and that are described on a “per treatment” basis, like HCPCS code G0465. To align with the 80 other similar skin procedure codes assigned to APC 5054 and status indicator “T,” we are finalizing our proposal to assign status indicator “T” to HCPCS code G0465 as reflected in Table 43.

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] TR25NO25.061

Audiology Related Procedures and Services 3. Audiology-Related Services, CPT Codes 92540, 92579, 92588 (APC 5722)

For CY 2025, we assigned CPT codes 92540 (Basic vestibular evaluation, includes spontaneous nystagmus test with eccentric gaze fixation nystagmus, with recording, positional nystagmus test, minimum of 4 positions, with recording, optokinetic nystagmus test, bidirectional foveal and peripheral stimulation, with recording, and oscillating tracking test, with recording) and 92579 (Visual reinforcement audiometry (vra)) to APC 5721 (Level 1 Diagnostic Tests and Related Services) with a payment rate of $156.46. CPT code 92588 (Distortion product evoked otoacoustic emissions; comprehensive diagnostic evaluation (quantitative analysis of outer hair cell function by cochlear mapping, minimum of 12 frequencies), with interpretation and report) was assigned to APC 5722 (Level 2 Diagnostic Tests and Related Services) with a payment rate of $311.40.

In the CY 2026 OPPS/ASC proposed rule, we proposed to assign all three CPT codes to APC 5722 (Level 2 Diagnostic Tests and Related Services) with a proposed payment rate of $221.14.

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

Comment: A commenter stated that they were concerned with the placement of CPT code 92540 in APC 5721 because the time and resources required to perform CPT 92540 are clinically analogous to the electrophysiological tests in APC 5722. Therefore, the commenter requested a reassignment of CPT 92540 from APC 5721 to APC 5722. The same commenter supported the placement of CPT codes 92579 and 92588 to APC 5722 and urged CMS to finalize the assignment.

Response: As we have already proposed to assign CPT code 92540 to APC 5722, we are finalizing our proposal without modification to assign CPT codes 92540, 92579 and 92588 to APC 5722 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. 4. Fully Implanted Active Middle Ear Implant (FI-AMEI), CPT Codes 0951T-0955T

Effective July 1, 2025, The AMA CPT Editorial Board created five new Category III CPT codes to report total implantation, revision or replacement with or without mastoidectomy; replacement of sound processor only; and removal, including all implant components of a FI- AMEI. Specifically, the following CPT codes were created:

0951T--Totally implantable active middle ear hearing implant; initial placement, including mastoidectomy, placement of and attachment to sound processor;

0952T--Totally implantable active middle ear hearing implant; revision or replacement, with mastoidectomy and replacement of sound processor;

0953T--Totally implantable active middle ear hearing implant; revision or replacement, without mastoidectomy and replacement of sound processor;

0954T--Totally implantable active middle ear hearing implant; replacement of sound processor only, with attachment to existing transducers; and

0955T--Totally implantable active middle ear hearing implant; removal, including removal of sound processor and all implant components.

In the CY 2026 OPPS/ASC proposed rule, we proposed to assign CPT codes 0951T-0955T to status indicator “E1” to indicate that these codes are not paid by Medicare when submitted on outpatient claims (any outpatient bill type) because we believe that these codes meet the definition of a hearing aid and therefore are not covered by Medicare.

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

Comment: A commenter stated that FI-AMEI is not a hearing aid but instead is a prosthetic device that meets the definition of an osseointegrated implant, and therefore, should be covered by Medicare.

The commenter stated that an FI-AMEI is a prosthetic device because it produces the perception of sound by replacing the function of the middle ear. More specifically, the commenter stated that an FI-AMEI is an osseointegrated implant.

The commenter requested that CMS change the proposed OPPS status indicator assignment for CPT codes 0951T-0955T from status indicator “E1” to status indicator “S” given the FI-AMEI is a covered prosthetic device as defined by the Medicare Benefit Policy Manual.

The commenter requested CMS assign codes 0951T-0953T to New Technology APC 1577, code 0954T to New Technology APC 1575, and code 0955T to New Technology APC 1534.

Response: We thank the commenter for their input. Section 1862(a)(7) of the Act excludes hearing aids from Medicare coverage. Certain devices that produce perception of sound by replacing the function of the middle ear, cochlea or auditory nerve are excepted and payable by Medicare. Cochlear implants and auditory brainstem implants that replace the function of the cochlea or auditory nerve and provide electrical stimulation to auditory nerve fibers are excepted. Osseointegrated implants that replace the function of the middle ear and provide vibratory mechanical energy through the skull to both cochleae are excepted. Middle ear implants, including fully implanted active middle ear hearing devices, do not function like osseointegrated implants and are not excepted.

Therefore, we are finalizing the assignment of status indicator “E1” for CPT codes 0951T-0955T without modification to indicate that these codes are not paid by Medicare when submitted on outpatient claims (any outpatient bill type).

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. Breast and Lymph Procedures 5. Ablation of Breast Tumor Procedures, CPT Codes 0970T and 0971T (APC 5091)

Effective July 1, 2025, the AMA CPT Editorial Panel established the CPT codes 0970T and 0971T. CPT codes 0970T (Ablation, benign breast tumor (e.g., fibroadenoma), percutaneous, laser, including imaging guidance when performed, each tumor) and 0971T (Ablation, malignant breast tumor(s), percutaneous, laser, including imaging guidance when performed, unilateral) describe procedures for the ablation of breast tumors. For CY 2026, we proposed to maintain both CPT codes in APC 5091 (Level 1 Breast/Lymphatic Surgery and Related Procedures).

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 codes 0970T and 0971T to APC 5093 (Level 3 Breast/Lymphatic Surgery and Related Procedures), which had a proposed payment rate of $6,575.63. The commenter stated that the device associated with these procedures had a cost of around $2,700 and the total costs of the procedure would be more appropriately covered by the payment rate of APC 5093.

Response: After clinical review of these procedures, we continue to believe that these procedures are appropriately assigned to APC 5091. Therefore, we are finalizing our proposal, without modification, to continue to assign CPT codes 0970T and 0971T to APC 5091 (Level 1 Breast/Lymphatic Surgery and Related Procedures). Table 44 shows the finalized status indicator and APC assignment for the procedure codes. 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] TR25NO25.062

The CPT Editorial Panel created Category III CPT code 1019T (placeholder code X476T) (Lymphovenous bypass, including robotic assistance, when performed, per extremity) effective January 1, 2026. For CY 2026, we proposed to assign CPT code 1019T to APC 5091 (Level 1 Breast/Lymphatic Surgery and Related Procedures) with a proposed payment of around $4,049 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: Several commenters requested higher payment for this procedure providing the following rationale to support their request:

The procedure is a curative procedure versus managing the condition of lymphedema.

The procedure requires 2 to 5 hours of operative time.

The procedure is performed by surgeons who have advanced surgical training in this specialty area.

The procedure is resource intensive utilizing a highly specialized and expensive equipment (for example, microscope and robot).

A couple of commenters suggested alternative crosswalk codes to determine APC placement such as, CPT code 19357 (Tissue expander placement in breast reconstruction, including subsequent expansion(s)) and CPT code 35883 (Revision, femoral anastomosis of synthetic arterial bypass graft in groin, open; with nonautogenous patch graft (e.g., polyester, ePTFE, bovine pericardium). The commenter suggested using the claims information for CPT code 35883 and the cost information associated with that procedure as a basis for determining an appropriate New Technology APC assignment.

Response: After review of the comments, we believe that CPT code 1019T should be reassigned to APC 5092, noting that there are currently other lymph procedures assigned to APC 5092. We do not believe a New Technology APC assignment would be appropriate as the procedure is described by a Category III CPT code and can be assigned to a clinical APC.

In summary, after consideration of the public comments we received, we are finalizing our proposal with modification, to assign CPT code 1019T to APC 5092 as reflected in Table 45. 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. [GRAPHIC] [TIFF OMITTED] TR25NO25.063

Cardiac Related Procedures and Services 7. Cardiac CT Services, CPT Codes 75572, 75573, and 75574 (APC 5572)

Cardiac computed tomography services are described by the following Category I CPT codes and have been effective since January 1, 2010:

75572--Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology (including 3D image postprocessing, assessment of cardiac function, and evaluation of venous structures, if performed);

75573--Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology in the setting of congenital heart disease (including 3D image postprocessing, assessment of left ventricular [LV] cardiac function, right ventricular [RV] structure and function and evaluation of vascular structures, if performed); and

75574--Computed tomographic angiography, heart, coronary arteries and bypass grafts (when present), with contrast material, including 3D image postprocessing (including evaluation of

cardiac structure and morphology, assessment of cardiac function, and evaluation of venous structures, if performed).

In prior rulemaking, we have received comments noting that the payment for these codes has declined since 2017. Comments on previous OPPS proposed rules have indicated that the payment amount is insufficient to cover the cost of providing the service and have stated that the payment amount does not consider the hospital resources required to perform these services, including the use of the equipment, medication administration, staff time, and scanner time. We have maintained over the years that an analysis of our claims data for these three codes have shown geometric mean costs consistent with the geometric mean cost for the APC to which they were assigned to since 2015.

We have also received comments in the past urging CMS to allow hospitals the flexibility to submit charges for cardiac CT services with a revenue code other than CT scan (035X) and Radiology Diagnostic (032X) revenue codes, implying that MACs had applied edits to the cardiac CT codes that prevented hospitals from reporting a cardiology (048X) revenue code when appropriate. It is longstanding CMS policy that hospital outpatient facilities are responsible for reporting the appropriate cost centers and revenue codes on claims. As stated in section 20.5 in Chapter 4 (Part B Hospital) of the Medicare Claims Processing Manual, CMS “does not instruct hospitals on the assignment of HCPCS codes to revenue codes for services provided under OPPS since hospitals' assignments of cost vary. Where explicit instructions are not provided, HOPDs should report their charges under the revenue code that will result in the charges being assigned to the same cost center to which the cost of those services are assigned in the cost report.” We have consistently stated that hospital outpatient facilities must determine the most appropriate cost center and revenue code for the cardiac CT codes (87 FR 71849, 88 FR 81664 and 89 FR 94058).

After we issued the CY 2024 OPPS/ASC final rule, interested parties notified us of a specific claims edit that may have limited the revenue codes reported with the cardiac CT codes in prior years' claims data. We removed the outdated revenue code edit in early December 2023 to allow for the cardiac CT codes to be billed with any appropriate revenue code. We informed the public of our findings and the changes that we made in the January 2024 OPPS Update (Transmittal 12421, Change Request 13488), dated December 21, 2023. We believe the edit may have prevented some providers from reporting the cardiology revenue code (048X), which maps to the cardiology cost center (03140), when billing for cardiac CT services. In the past, commenters have indicated that the cardiology cost center has a higher cost-to-charge ratio (CCR) than the imaging cost centers, and they believe the inability to report the cardiology revenue code has resulted in a lower payment rate for cardiac CT services. Since the OPPS ratesetting process utilizes the applicable cost center's CCR to reduce the charges on the claim to estimated cost, utilizing cost centers with lower CCRs results in a lower OPPS payment compared to utilizing cost centers with higher CCRs. With the edit no longer in place, we stated that hospitals may bill for cardiac CT services with whichever revenue code they believe appropriate, including cardiology revenue code 048X.

In CY 2025 rulemaking, we conducted studies to calculate HCPCS geometric mean costs for the cardiac CT codes based on a simulation that assumed that differing numbers of HOPDs (specifically 25 percent, 50 percent, and 75 percent of the total number of HOPDs billing for these services) would have assigned these services to the cardiology revenue code (048X) and cardiology cost center (03410). Based upon the results of the studies, we found that if 50 percent or more of HOPDs had billed these services with the cardiology revenue code (048X) and cardiology cost center (03140), the geometric mean cost for these codes would have increased and would have resulted in a revised APC assignment from APC 5571 (Level 1 Imaging with Contrast) to APC 5572 (Level 2 Imaging with Contrast).

We were persuaded by the public comments submitted that a majority of the providers who bill these codes would have preferred to bill them with the cardiology revenue code but were not able to do so due to the prior revenue code edit and the remaining procedural hurdles that flowed from the prior revenue code edit.

For CY 2025, we used our equitable adjustment authority under section 1833(t)(2)(E) of the Act to utilize an alternative methodology to calculate the payment for the cardiac CT services in CY 2025. We finalized temporary reassignment of the cardiac CT codes (CPT codes 75572, 75573, and 75574) to APC 5572 (Level 2 Imaging with Contrast).

For CY 2026, CPT code 75572 had 33,272 single claims for ratesetting and a geometric mean cost of around $152. CPT code 75573 had 488 single claims for ratesetting and a geometric mean cost of around $216. CPT code 75573 had 94,419 single claims for ratesetting and a geometric mean cost of around $187. Review of the current claims data indicates that there are providers who are utilizing the cardiology revenue codes.

For CY 2026, we proposed to continue assignment of CPT codes 75572, 75573, and 75574 to APC 5572 (Level 2 Imaging with Contrast) with a proposed payment rate of $358.35, noting as we did in last year's final rule that we anticipate that it may take 3 to 4 years to see an impact from changes in billing practices.

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

Comments: Several commenters supported the APC assignment of CPT codes 75572, 75573, and 75574 to APC (Level 2 Imaging with Contrast). Commenters stated that accurate and stable reimbursement is essential in ensuring that Medicare beneficiaries benefit from evidence-based innovations that improve cardiovascular care. Providers believe that the current APC assignment provides adequate reimbursement that appropriately reflects the clinical complexity and resource requirements to provide these services.

Many commenters believe that these services are underutilized, in part due to historical underpayment and billing restrictions that they encountered in the past and expressed concern about the continued challenges with making changes to billing patterns. Commenters requested that CMS provide a specific timeline of when to expect that these codes would be reassigned to APCs, based on their geometric mean costs, if there is not a notable shift in their geometric mean costs over time. Some commenters shared that they have been working with the various departments within their facilities to effectuate the changes in billing practices, but notable changes are slow. Another commenter shared that they are working with major chargemaster software and advice companies to ensure that providers and facilities are aware that may choose the revenue code that they believe is most appropriate for the services provided. This commenter has also reached out to the National Uniform Billing Committee (NUBC) to suggest new revenue codes that better capture mixed modality services. Commenters noted that because the descriptors for these codes contain “CT”, staff are hesitant to use a revenue code that is not an imaging revenue code.

Many commenters requested educational materials and guidance that specifically indicates that it is appropriate to bill the cardiology revenue codes with cardiac CT services. A commenter suggested specific language that they would like to see CMS use.

Response: We agree with commenters that effectuating change in any size health system can be challenging. As stated in the CY 2025 OPPS/ ASC final rule, we will continue to monitor the claims data for these services, anticipating that it may take 3 to 4 years before we see changes in the claims data. While we have seen a number of providers utilizing the cardiology revenue codes for these services, we do not believe that it would be beneficial to provide a specific timeline or deadline for when we would anticipate moving these codes based on their geometric mean costs. If we believe that providers continue to need more time to overcome procedural and logistical hurdles with billing the cardiology revenue codes, we do not believe that a `fixed' timeline should be the determining factor of whether we allow that flexibility or not. We will continue to monitor the claims data for changes in billing practices. If we do not see a significant change in the geometric mean costs after several years, we would revert payment for these services to the standard OPPS payment methodology and assign the cardiac CT codes to the appropriate APCs based on their geometric mean costs.

Many commenters requested guidance from CMS (Medicare Learning Network or “MLN”) that explicitly states that it is appropriate to use the cardiology revenue codes when billing for cardiac CT services. We acknowledge that we had stated in last year's final rule that we would provide public education and instruction through MLN and anticipate that we will do so. As a reminder to our readers, we do not provide specific coding guidance. We refer our readers to section 20.5 in Chapter 4 (Part B Hospital) of the Medicare Claims Processing Manual, CMS “does not instruct hospitals on the assignment of HCPCS codes to revenue codes for services provided under OPPS since hospitals' assignments of cost vary. Where explicit instructions are not provided, HOPDs should report their charges under the revenue code that will result in the charges being assigned to the same cost center to which the cost of those services are assigned in the cost report.” We have consistently stated that hospital outpatient facilities must determine the most appropriate cost center and revenue code for the cardiac CT codes (87 FR 71849, 88 FR 81664).

In summary, for CY 2026, we are finalizing our proposal without modification and assigning CT codes 75572, 75573, and 75574 to APC 5572 (Level 2 Imaging with Contrast). See Table 46 for the CY 2026 final OPPS status indicator and APC assignments. 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. [GRAPHIC] [TIFF OMITTED] TR25NO25.064

For CY 2026, we proposed to continue to assign the following cardiac magnetic resonance imaging (MRI) CPT codes to APC 5523, 5524, 5572, and 5573 respectively:

CPT code 75557--(Cardiac magnetic resonance imaging for morphology and function without contrast material) to APC 5523 (Level 3 Imaging without Contrast) with a proposed payment of $245.72 based on a geometric mean cost of around $299 and 1,452 single frequency claims used for ratesetting;

CPT code 75559--(Cardiac magnetic resonance imaging for morphology and function without contrast material; with stress imaging) to APC 5524 (Level 4 Imaging without Contrast) with a proposed payment of $562.07 based on a geometric mean cost of around $479 and 22 single frequency claims used for ratesetting;

CPT code 75561--(Cardiac magnetic resonance imaging for morphology and function without contrast material(s), followed by contrast material(s) and further sequences) to 5572 (Level 2 Imaging

with Contrast) with a proposed payment of $358.35 based on a geometric mean cost of around $459 and 29,162 single frequency claims used for ratesetting; and

CPT code 75563--(Cardiac magnetic resonance imaging for morphology and function without contrast material(s), followed by contrast material(s) and further sequences; with stress imaging) to APC 5573 (Level 3 Imaging with Contrast) with a proposed payment of $802.38 based on a geometric mean cost of around $819 and 3,202 single frequency claims used for ratesetting.

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

Comment: Commenters requested that CPT codes 75557, 75559, 75561, 75563 be reassigned to the Nuclear Medicine and Related Services APC family because cardiac MRI procedures are not clinically similar or similar in resource use to the other procedures assigned to the current APCs. The commenter indicated that the cardiac MRI procedures are more resource intensive because of stress protocols, continuous patient monitoring, specialized staff to care for patients undergoing these procedures, longer procedure room time, and post-stress observation time and many of the other procedures that are in these APCs are lower- acuity, non-cardiac tests. The commenter believes that their current APC assignments are directly responsible for the low use of cardiac MRIs in cardiac patients. The commenter stated that reassigning these procedures to APC 5593 (Level 3 Nuclear Medicine and Related Services) would restore appropriate payment for similar advanced cardiac imaging modalities and resolve the distorted payment signals (that is, blended geometric mean costs are suppressed by high-volume, low-acuity studies).

Alternatively, the commenter suggested creating a cardiac imaging sub-APC that would include cardiac MRI services, stress echocardiography, and nuclear cardiology services that include patient monitoring and recovery. In addition, the commenter had several recommendations for CMS to implement in the interim to improve the accuracy of ratesetting:

Issue sub-regulatory guidance encouraging hospitals to map cardiac MRI charges to cardiac/stress imaging cost centers rather than generic MRI;

Ensure packaged items are consistently captured in the claims data; and

Consider a complexity adjustment or modality-neutral cardiac imaging APC framework.

Response: The OPPS payment rates were proposed based on available CY 2024 claims data. Our claims data shows that APC 5593 (Level 3 Nuclear Medicine and Related Services) has a geometric mean cost of around $1,332 which is significantly higher than the geometric mean costs for the cardiac MRI codes ($299 to $819).

We do not believe that cardiac MRI with stress imaging is very similar to myocardial perfusion imaging because both tests are performed under a stress protocol and therefore should be assigned to APC 5593. APC 5593 contains procedures that describe nuclear medicine tests, not MRI services. We have noted in previous rulemaking that we do not believe MRI services should be assigned to the nuclear medicine APCs (81 FR 79630).

In response to issuing sub-regulatory guidance encouraging HOPDs to utilize a certain revenue code or map charges to a certain cost center, we refer readers to the Medicare Claims Processing Manual, Chapter 4 (Part B Hospital), section 20.5, where we state, “Generally, CMS does not instruct hospitals on the assignment of HCPCS codes to revenue codes for services provided under OPPS since hospitals' assignment of cost vary. Where explicit instructions are not provided, providers should report their charges under the revenue code that will result in the charges being assigned to the same cost center to which the cost of those services are assigned in the cost report.”

In summary, after consideration of the public comment, we are finalizing our proposal without modification to maintain the APC assignments for the cardiac MRI codes for CY 2026. 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 47 for code descriptor, APC assignment and status indicator assignment for CPT codes 75557, 75559, 75561, and 75563 for CY 2026. [GRAPHIC] [TIFF OMITTED] TR25NO25.065

CPT code 0897T (Noninvasive augmentative arrhythmia analysis derived from quantitative computational cardiac arrhythmia simulations, based on selected intervals of interest from 12-lead electrocardiogram and uploaded clinical parameters, including uploading clinical parameters with interpretation and report) utilizes ECG data to identify potential arrhythmia focal points for patients. The vMap provides augmented information which enables physicians to characterize arrhythmia and assists in triage and treatment of abnormal rhythm. CPT code 0897T became effective July 1, 2024, and since its establishment, the code has been assigned to APC 5724 (Level 4 Diagnostic Tests and Related Services) for CY 2024. For CY 2025, we maintained the APC assignment to APC 5724 (Level 4 Diagnostic Tests and Related Services). For CY 2026, we proposed maintaining the current APC assignment noting that there were no single frequency claims for ratesetting under OPPS and 34 multiple frequency claims, meaning the procedure was completed with other primary services.

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

Comment: The manufacturer requested that CMS reassign CPT code 0897T to a New Technology APC when the procedure is performed on the day of but separate from the ablation procedure itself until there are sufficient claims data available to support an appropriate clinical APC assignment. The commenter believes that the vMap procedure meets the New Technology APC criteria based on the demonstrated costs of the procedure and that there is precedent for SaaS technologies. In addition to vMap, the commenter urged that CMS pay for all SaaS technologies separately from any underlying procedures and assign these services to New Technology APCs until there are sufficient claims data to support an appropriate clinical APC assignment.

Response: We thank the manufacturer for their input. We do not believe that the vMap procedure meets the New Technology APC criteria based on the costs of the service or because there is precedent for SaaS technologies. There are no cost criteria for a New Technology APC placement. We review the information provided to determine if a service is “truly new” meaning there is not a code or combination of codes to describe the complete service. (We refer readers to the final rule in the November 30, 2001, Federal Register (66 FR 59897) for a full discussion of the criteria and information needed for a New Technology APC assignment.) All New Technology APC applications are reviewed to determine if they meet the criteria for a New Technology APC placement. The vMap procedure has a Category III CPT code which we crosswalked to CPT code 75580 (HeartFlow[supreg]) (Noninvasive estimate of coronary fractional flow reserve (FFR) derived from augmentative software analysis of the data set from a coronary computed tomography angiography, with interpretation and report by a physician or other qualified health care professional) and assigned to APC 5724 (Level 4 Diagnostic Tests and Related Services).

In summary, after consideration of the public comment we received, we are finalizing our proposal without modification, to assign CPT code 0897T to APC 5724 (Level 4 Diagnostic Tests and Services as reflected in Table 48.

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. [GRAPHIC] [TIFF OMITTED] TR25NO25.066

Fractional Flow Reserve Derived from Computed Tomography (FFRct), also known by the trade name HeartFlow[supreg], is a noninvasive diagnostic service that allows physicians to measure coronary artery disease in a patient through the use of coronary CT scans. The HeartFlow[supreg] service is indicated for clinically stable symptomatic patients with coronary artery disease, and, in many cases, may avoid the need for an invasive coronary angiogram procedure. HeartFlow[supreg] uses a proprietary data analysis process performed at a central facility to develop a three-dimensional image of a patient's coronary arteries, which allows physicians to identify the fractional flow reserve to assess whether patients should undergo further invasive testing (that is, a coronary angiogram).

HeartFlow[supreg] is described by CPT code 75580 (Noninvasive estimate of coronary fractional flow reserve (FFR) derived from augmentative software analysis of the data set from a coronary computed tomography angiography, with interpretation and report by a physician or other qualified health care professional) effective January 1, 2024. CPT code 0503T was the predecessor code for HeartFlow[supreg].

HeartFlow[supreg] was assigned to APC 5724 (Level 4 Diagnostic Tests and Related Services) for CY 2024 and CY 2025. In last year's rule, we received a comment stating that several of the Medicare Administrative Contractors (MACs) had an edit in place that prohibited the use of the cardiology revenue code (0480) when billing CPT code 75580 as evidenced by claims

denials with “Invalid Revenue Code” errors. Based on the information the commenter provided, we were able to identify the outdated edit and removed it. We reminded readers that it is longstanding CMS policy that hospital outpatient facilities are responsible for reporting the appropriate cost centers and revenue codes on claims. We referred readers to Section 20.5 in Chapter 4 (Part B Hospital) of the CMS Medicare Claims Processing Manual, where we state CMS “does not instruct hospitals on the assignment of HCPCS codes to revenue codes for services provided under OPPS since hospitals' assignment of cost vary. Where explicit instructions are not provided, HOPDs should report their charges under the revenue code that will result in the charges being assigned to the same cost center to which the cost of those services are assigned in the cost report.”

We proposed for CY 2026 to continue to assign HeartFlow[supreg] (CPT code 75580) to APC 5724 (Level 4 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.

Comments: Commenters were supportive of the continued APC assignment to APC 5724 (Level 4 Diagnostic Tests and Related Services); however, the commenters universally requested that CMS exclude the “flawed” or “erroneous” data due to the claims edit that was in place that prohibited them for choosing a revenue center that they deemed most appropriate for the service provided. Several commenters also requested guidance when choosing a revenue center code. They note that this would ensure accurate claims reporting and support reliable data for future ratesetting.

Response: As noted previously in this final rule with comment period, we removed the outdated edit as soon as we were aware that there was an edit in place. HOPDs can use whatever revenue code they believe is most appropriate. We generally do not exclude available claims data, based on the assumption that what is being billed to Medicare is in compliance with coding and billing guidance. We acknowledge that there are a number of procedural and logistical hurdles associated with changing billing practices and will continue to monitor the claims data.

Comment: Many commenters expressed concerns about the lower reimbursement rate for APC 5724 and the movement of services within the APC family. We refer the readers to section III.E.1. of this final rule with comment period for a full discussion about the movement of services within the APC family and the payment variability.

In summary, after consideration of the public comments we received, we are finalizing our proposal without modification to continue to assign CPT 75580 to APC 5724 (see Table 49). 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. [GRAPHIC] [TIFF OMITTED] TR25NO25.067

Chimeric Antigen Receptor T-Cell (CAR T-cell) therapy is a cell- based gene therapy in which T-cells are collected and genetically engineered to express a chimeric antigen receptor that will bind to a certain protein on a patient's cancerous cells. The CAR T-cells are then administered to the patient to attack certain cancerous cells, and the individual is observed for potential serious side effects that would require medical intervention. We refer readers to previous discussions in the OPPS/ASC final rules with comment period for background regarding the specific CAR T-cell products, including the CY 2020 OPPS/ASC final rule with comment period (84 FR 61231 through 61234) and the CY 2019 OPPS/ASC final rule with comment period (83 FR 58904 through 58908). The AMA created four Category III CPT codes that are related to CAR T-cell therapy, effective January 1, 2019. We also finalized that the procedures described by CPT code 0540T would be assigned status indicator “S” (Procedure or Service, Not Discounted when Multiple) and APC 5694 (Level 4 Drug Administration) from CY 2019 through CY 2024 and did not propose to change the APC assignment for CY 2025 when CPT code 0540T was replaced by CPT code 38228.

As listed in Addendum B to the CY 2026 OPPS/ASC proposed rule, we proposed to continue to assign CPT code 38228 to status indicator “S” (Procedure or Service, Not Discounted when Multiple) and APC 5694 (Level 4 Drug Administration).

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

Comment: Several commenters recommended the reassignment of CPT code 38228 to APC 5242 (Level 2 Blood Product Exchange and Related Services). A commenter suggested that rationale for the reassignment of CPT code 38228 to APC 5242 is that APC more accurately reflects the higher facility costs associated with the significant nurse monitoring for the outpatient administration of CAR T-cell therapy. The commenter supported this claim as the AMA placed CPT code 38228 in the same section as stem cell transplant codes, which were initially

recognized in the inpatient setting under MS-DRGs 016 and 017. Another commenter also stated CPT code 38228 is analogous to CPT code 38241 (Hematopoietic progenitor cell (hpc); autologous transplantation) and that CMS initially assigned CAR-T related codes to autologous stem cell transplant MS-DRGs 016 and 017, which they believe is the appropriate crosswalk for OPPS.

Another commenter disagreed with the current APC 5694 assignment and stated that CPT code 38338 (and CPT codes 67028 and 67516) do not have the facility NA indicator in the Medicare Physician Fee Schedule and the RUC assigned both facility and non-facility RVUs. Thus, the commenter stated that physicians perform and document the services when they perform the services in facilities.

Response: We continue to believe that the procedures described by CPT codes 38225, 38226, and 38227 describe the various steps required to collect and prepare the genetically modified T-cells, and Medicare does not generally pay separately for each step used to manufacture a drug or biological product. We believe CPT code 38228 is appropriately assigned to APC 5694, which shares similar clinical and resource use as other complex cancer drug administrations. We note that the IPPS established MS-DRG 018 for CAR-T and other immunotherapies and CAR-T therapies are no longer assigned to MS-DRGs 016 and 017. We also disagree that CPT code 38228 is similar clinically and in resource to CPT code 38241 because we view CPT code 38228 as the administration of the CAR-T drugs, while CPT code 38241 involves the transplantation of hematopoietic progenitor cells. Therefore, we are not convinced by the commenter's reason to reassign CPT code 38228 to APC 5242. Furthermore, we believe it is inappropriate to use the IPPS MS-DRGs as an analog to the APC assignments in the OPPS because there are significant differences in resource consumption between the HOPD and inpatient setting.

We are also not compelled to reassign CPT code 38228 to APC 5242 because of the lack of the NA indicator in the Medicare Physician Fee Schedule and because the RUC assignment of both facility and non- facility RVUs do not support the reassignment of CPT codes 38338, 67028 and 67516 to APC 5242. We rely on input from a variety of sources for our APC assignments, 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 that the drug administration codes that the commenter mentioned were assigned to their respective APCs with similar clinical and resource similarity. Furthermore, the commenter only suggested an APC reassignment for CPT code 38228 but did not provide any APC suggestions for CPT codes 67028 and 67516.

After consideration of the public comments we received, we are finalizing our proposed APC assignment and status indicator for CPT code 38228 to APC 5694 without modification. Refer to Table 50 for the final OPPS APC and status indicator assignment for CPT code 38228 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] TR25NO25.068

The CVi[supreg] Contrast Delivery System is an automated Contrast Management System with multiuse syringes. Contrast Management Systems are designed to assist physicians in infusing iodinated contrast media administered to patients in common angiograph procedures. Contrast with angiography procedures is often administered through a handheld, manual injection device. Automated contrast management systems use variable rate technology to deliver a specific amount of contrast.

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 CMS establish a G-code to provide additional payment to recognize the cost of automated contrast management systems with angiography procedures. The commenter stated that providing additional payment through the establishment of a new code would facilitate expanded patient access to automated systems that address important policy goals and address significant unmet needs such as reducing the incidence of Acute Kidney Injury (CA-AKI), reducing costs related to CA-AKI related hospitalization, reducing contrast waste, alleviating contrast media shortages precipitated by supply chain issues and reducing physician radiation exposure. The commenter stated that it is necessary to establish a G-code because existing Medicare payment policies for Percutaneous Coronary Intervention (PCI) and other procedures do not differentiate procedures that involve an automated variable rate contrast injector

with multiuse syringe for the administration of iodinated contrast media. They also noted that these procedures are coded and paid identically, regardless of whether the provider has invested in automated contrast management systems that they state provide better health outcomes.

Response: After reviewing the information provided by the commenter and following consultation with our medical officers, we have determined that this equipment is only used in conjunction with another procedure and would be packaged for payment consistent with our policy of packaging items and services that are typically integral, ancillary, supportive, dependent, or adjunctive to a primary service.

Therefore, we are not creating a G-code to describe the use of an automated variable rate contrast injector with multiuse syringe for the administration of iodinated contrast media for CY 2026. Dental Related Procedures 13. Malignant Tumor/Lesion Removal Dental Procedures, CDT Codes D7440- D7441 (APC 5164)

Effective January 1, 2024, we made over 200 additional dental codes payable under the OPPS when payment and coverage requirements are met, as provided in the relevant PFS payment rules regarding Medicare Part B payment for dental services (88 FR 81540-82185). Of these payable dental codes, we assigned Current Dental Terminology (CDT) codes D7440 (Excision of malignant tumor-lesion diameter up to 1.25cm) and D7441(Excision of malignant tumor- lesion diameter greater than 1.25 cm) to APC 5164 (Level 4 ENT Procedures) and status indicator “J1.” For CY 2026, we proposed to continue to assign CDT codes D7440 and D7441 to APC 5164 and status indicator “J1.”

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 add CDT codes D7440 and D7441 to the list of covered outpatient services for CY 2026.

Response: We are clarifying that CDT codes D7440 and D7441 are already payable when performed in the outpatient hospital department and coverage requirements are met. Our proposal would maintain the APC and status indicator assignments for CY 2026.

Therefore, we are finalizing our proposal to continue to assign CDT codes D7440 and D7441 to APC 5164 and status indicator “J1” for CY 2026. Endoscopy Procedures 14. Biliary Endoscopy Procedure, CPT Code 47555 (APC 5341)

CPT code 47555 (Biliary endoscopy, percutaneous via T-tube or other tract; with dilation of biliary duct stricture(s) without stent) describes the procedure for dilation of bile ducts using an endoscope. Using CY 2024 claims data, CPT code 47555 had geometric mean cost of $8,577.51 in the CY 2026 OPPS/ASC proposed rule. For CY 2026, we believed this procedure was still appropriately assigned to APC 5341 (Level 1 Abdominal/Peritoneal/Biliary and Related Procedures), which had a proposed payment rate of $3,698.49. Therefore, we proposed to continue assigning CPT code to APC 5341.

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 47555 to APC 5342 (Level 2 Abdominal/Peritoneal/Biliary and Related Procedures), which had a proposed payment rate of $6,667. The commenter stated that the cost of this procedure exceeded the payment rate for APC 5341.

Response: CPT code 47555 has an updated GMC of $8,068.88. After further clinical review, we agree with the commenter that resources and costs associated with CPT code 47555 would be more appropriately reflected by APC 5342. In summary, we are finalizing our proposal with modification to assign CPT code 47555 to APC 5342 (Level 2 Abdominal/ Peritoneal/Biliary and Related Procedures) for CY 2026. Table 51 shows the finalized status indicator and APC assignment for the 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] TR25NO25.069

CPT code 43252 (Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy) describes a service that is used to visualize the upper portions of the GI tract from the esophagus to the duodenum. Using CY 2024 claims data, CPT code 43252 had geometric mean cost of $1,739.85 in the CY 2026 OPPS/ASC proposed rule. For CY 2026, we believed this procedure was still appropriately assigned to APC 5302 (Level 2 Upper GI Procedures), which had a proposed payment rate of $1,975.59. Therefore, we proposed to continue assigning CPT code to APC 5302.

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

Comment: A few commenters requested that CMS assign CPT code 43252 to APC 5303 (Level 3 Upper GI Procedures) with a payment rate of around $4,002 for CY 2026. The commenters stated that hospitals have historically underreported the costs for this procedure, therefore skewing the GMC for CPT code 43252.

Response: We have stated regularly over the history of the OPPS, it is the responsibility of providers and other interested parties and not CMS to resolve potential claims and reporting issues for individual CPT codes and medical services payable by Medicare. The updated GMC for the service, which is around $1,737.41, is lower than the payment rate for APC 5302 which is

around $1,960. Therefore, we are finalizing our proposal, without modification, to continue to assign CPT code 43252 to APC 5302 (Level 2 Upper GI Procedures). Table 52 shows the finalized status indicator and APC assignment for the procedure codes. 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] TR25NO25.070

CPT code 43265 (Endoscopic retrograde cholangiopancreatography (ERCP); with destruction of calculi, any method (eg., mechanical, electrohydraulic, lithotripsy)) describes the procedure for destruction of stone of bile or pancreatic ducts. Using CY 2024 claims data, CPT code 43265 had geometric mean cost of $9,011.93 in the CY 2026 OPPS/ASC proposed rule. For CY 2026, we believed this procedure was still appropriately assigned to APC 5331 (Complex GI Procedures), which had a proposed payment rate of $6,276.20. Therefore, we proposed to continue assigning CPT code to APC 5331.

Comment: A commenter requested that CMS reassign CPT code 43265 to APC 5362 (Level 2 Laparoscopy and Related Services), which had a proposed payment rate of $10,966.50, due to the similarity to CPT code 47554 (Biliary endoscopy, percutaneous via t-tube or other tract; with removal of calculus/calculi).

Response: We thank the commenter for their input. CPT code 43265 has an updated geometric mean cost of $8,754.94. After clinical review of this procedure, we continue to believe that this procedure is appropriately assigned to the APC 5331. Therefore, we are finalizing our proposal, without modification, to continue to assign CPT codes 43265 to APC 5331 (Complex GI Procedures). Table 53 shows the finalized status indicator and APC assignment for the procedure codes. 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] TR25NO25.071

We established HCPCS code C9779 (Endoscopic submucosal dissection (ESD), including endoscopy or colonoscopy, mucosal closure, when performed) effective October 1, 2021, to describe the endoscopic submucosal dissection (ESD) performed during an endoscopy or colonoscopy. HCPCS code C9779 was established based on a New Technology application that was submitted to CMS for New Technology consideration under the OPPS. Based on our assessment, we assigned the code to APC 5313 (Level 3 Lower GI Procedures) because we believed the ESD procedure had similar clinical characteristics and resource costs as the surgical procedures assigned to APC 5313. We announced the assignment to APC 5313 in the October 2021 OPPS quarterly update CR (Transmittal 10997, Change Request 12436, dated September 16, 2021). In CY 2022, we continued to assign the code to APC 5313.

For CY 2023, we assigned HCPCS code C9779 to APC 5303 (Level 3 Upper GI Procedures) after receiving public comments that stated that the ESD procedure's resource requirements and geometric mean cost were more similar to the resource requirements and geometric mean costs of procedures found in APC 5303. Further, commenters noted that the ESD procedure is technically more demanding, requires advanced skills to perform, and is clinically similar to CPT code 43497 (Lower esophageal myotomy, transoral (i.e., peroral endoscopic myotomy [POEM])), which was assigned to APC 5303. For CY 2026, we proposed to maintain HCPCS code C9779, which had a geometric mean cost of $5,516.81, in APC 5303 (Level 3 Upper GI Procedures). APC 5303 had a proposed CY 2026 payment rate of $4,002.57.

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 HCPCS code C9779 to APC 5331 (Complex GI procedures), which had a proposed payment rate of

$6,276.20. The commenters reasoned that HCPCS code C9779 would be more appropriately placed in APC 5331 due to its similarity to CPT code 43479. Additionally, the commenters stated that as HCPCS code C9779 includes both combined upper and lower GI ESD procedures, there is great variability in the costs reported by hospitals which could affect the accuracy of the geometric mean cost.

Response: HCPCS code C9779 has an updated geometric mean cost of $5,182.09. While the geometric mean cost for HCPCS code C9779 is slightly closer to the payment rate for APC 5331, we continue to believe that HCPCS code C9779 is appropriately assigned, based on both clinical and resource similarity, to APC 5303 (Level 3 Upper GI Procedures). Therefore, we are finalizing our proposal, without modification, to continue to assign CPT code C9779 to APC 5303 (Level 3 Upper GI Procedures). Table 54 shows the finalized status indicator and APC assignment for the procedure codes. 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] TR25NO25.072