Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the relative value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes (PMVC) under the PFS, using the same criteria used to identify PMVC, and to make appropriate adjustments.

As outlined in section II.E. of the proposed rule, under Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association (AMA)/Specialty Society Relative Value Scale (RVS) Update Committee (referred to as the RUC), MedPAC, and other interested parties. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by- code

basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by statute. We may also consider analyses of work time, work RVUs, or direct practice expense (PE) inputs using other data sources, such as the Veterans Health Administration (VHA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive Payment System (MIPS) data. In addition to considering the most recent available data, we assessed the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other interested parties such as from the general medical-related community and the public. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.

In its March 2006 Report to the Congress (https://www.medpac.gov/document/report-to-the-congress-2006-medicare-payment-policy/), MedPAC discussed the importance of appropriately valuing physicians' services, stating that misvalued services can distort the market for physicians' services, as well as for other health care services that physicians order, such as hospital services. In that same report, MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, “When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” We believe services can also become overvalued when PE costs decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases, or PE costs rise.

As MedPAC noted in its March 2009 Report to Congress (https://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since MedPAC made the initial recommendations, CMS and the RUC have taken several steps to improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories:

Codes that have experienced the fastest growth.

Codes that have experienced substantial changes in PE.

Codes that describe new technologies or services within an appropriate time-period (such as 3 years) after the relative values are initially established for such codes.

Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.

Codes with low relative values, particularly those that are often billed multiple times for a single treatment.

Codes that have not been subject to review since implementation of the fee schedule.

Codes that account for the majority of spending under the PFS.

Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.

Codes for which there may be a change in the typical site of service since the code was last valued.

Codes for which there is a significant difference in payment for the same service between different sites of service.

Codes for which there may be anomalies in relative values within a family of codes.

Codes for services where there may be efficiencies when a service is furnished at the same time as other services.

Codes with high intraservice work per unit of time.

Codes with high PE RVUs.

Codes with high cost supplies.

Codes as determined appropriate by the Secretary.

Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using current processes for consideration of coding changes), which may involve consolidating individual services into bundled codes for payment under the PFS. 2. Progress in Identifying and Reviewing Potentially Misvalued Codes

To fulfill our statutory mandate, we have identified and reviewed numerous PMVC as specified in section 1848(c)(2)(K)(ii) of the Act, and we intend to continue our work examining PMVC in these areas over the upcoming years. As part of our current process, we identify PMVC for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies PMVC for review. Through our public nomination process for PMVC established in the CY 2012 PFS final rule with comment period (76 FR 73026, 73058 through 73059), other individuals and groups submit nominations for review of PMVC as well. Individuals and groups may submit codes for review under the PMVC initiative to CMS in one of two ways. Nominations may be submitted to CMS via email or through postal mail. Email submissions should be sent to the CMS emailbox at [email protected], with the phrase “Potentially Misvalued Codes” and the CPT code number(s) and/or the CPT descriptor(s) in the subject line. Physical letters for nominations should be sent via the U.S. Postal Service to the Centers for Medicare & Medicaid Services, Mail Stop: C4-01-26, 7500 Security Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination letters must be labeled “Attention: Division of Practitioner Services, Potentially Misvalued Codes.”

Nominations for consideration in our next annual rule cycle should be received by our February 10th deadline. Since CY 2009, as a part of the annual PMVC review and 5-Year Review process, we have reviewed over 1,700 PMVC to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of PMVC is included in the CY 2012 PFS final rule with comment period (76 FR 73052 through 73055). In the same CY 2012 PFS final rule with comment period, we finalized our policy to consolidate the review of physician work and PE at the same time and established a process for the annual public nomination of potentially misvalued services.

In the CY 2013 PFS final rule with comment period (77 FR 68892, 68896 through 68897), we built upon the work we began in CY 2009 to review PMVC that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes” \16\). In the CY 2009 PFS proposed rule (73 FR 38589), we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes. In the fourth 5-Year Review of Work RVUs published in a separate notice (76 FR 32419), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 services. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized for review a list of PMVC that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work that have listed work time). We continue each year to consider and finalize a list of PMVC that have or will be reviewed and revised as appropriate in future rulemaking.

\16\ The research team and panels of experts at the Harvard School of Public Health developed the original work RVUs for most CPT codes, in a cooperative agreement with the Department of Health and Human Services (HHS). Experts from both inside and outside the Federal Government obtained input from numerous physician specialty groups. This input was incorporated into the initial PFS, which was implemented on January 1, 1992.

In the CY 2012 PFS final rule with comment period (76 FR 73058 through 73059), we finalized a process for the public to nominate PMVC. In the CY 2015 PFS final rule with comment period (79 FR 67606 through 67608), we modified this process whereby the public and interested parties may nominate PMVC for review by submitting the code with supporting documentation by February 10th of each year. Supporting documentation for codes nominated for the annual review of PMVC may include the following:

Documentation in peer reviewed medical literature or other reliable data that demonstrate changes in physician work due to one or more of the following: technique, knowledge and technology, patient population, site-of-service, length of hospital stay, and work time.

An anomalous relationship between the code being proposed for review and other codes.

Evidence that technology has changed physician work.

Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.

Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.

Prices for certain high-cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.

Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, VA, NSQIP, the STS National Database, and the MIPS data).

National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.

We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be PMVC appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate for each nominated code whether we agree with its inclusion as a PMVC. The public has the opportunity to comment on these and all other proposed PMVC. In each year's final rule, we finalize our list of PMVC. a. Public Nominations

In each proposed rule, we seek nominations from the public and from interested parties of codes that they believe we should consider as potentially misvalued. We receive public nominations for PMVC by February 10th and we display these nominations on our public website (https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending), where we include the submitter's name, their associated organization and the submitted studies for full transparency. We sometimes receive submissions for specific PE-related inputs for codes, and discuss these PE-related submissions, as necessary under the Determination of PE RVUs section of the rule. We summarize below this year's submissions under the PMVC initiative. For CY 2026, we received 12 requests concerning various codes as PMVC. The nominations are as follows: (1) Maxillofacial Prosthetic Services (CPT Codes 21076, 21077, 21079, 21080, 21081, 21082, 21083, 21084, 21085, 21086, 21087)

An interested party nominated CPT codes 21076 (Impression and custom preparation; surgical obturator prosthesis), 21077 (Impression and custom preparation; orbital prosthesis), 21079 (Impression and custom preparation; interim obturator prosthesis), 21080 (Impression and custom preparation; definitive obturator prosthesis), 21081 (Impression and custom preparation; mandibular resection prosthesis), 21082 (Impression and custom preparation; palatal augmentation prosthesis), 21083 (Impression and custom preparation; palatal lift prosthesis), 21084 (Impression and custom preparation; speech aid prosthesis), 21085 (Impression and custom preparation; oral surgical splint), 21086 (Impression and custom preparation; auricular prosthesis), and 21087 (Impression and custom preparation; nasal prosthesis) as potentially misvalued based on what they believe to be missing, outdated, and undervalued practice expense inputs. The nominator stated that these misvalued PE inputs (equipment, supplies, and clinical staff time) result in inadequate payment rates to clinicians who furnish these services, which limits patient access to necessary care. The nominator indicated that the physician work values remain accurate for all of the nominated codes.

According to the nominator, maxillofacial prosthodontists provide specialized rehabilitation care for patients with compromised oral and facial anatomy due to conditions such as cancer, trauma, or congenital defects, addressing both physical and psychological challenges experienced by such patients. Custom prosthetic obturators are medical devices that restore vital oral functions in cancer patients with palatal defects. These implant-retained devices are prescribed based on the location of the defect: maxillary obturators for hard palate issues, pharyngeal obturators for soft palate problems, or a combination for both. The primary purpose of the intraoral prostheses is to enable patients to speak, eat, and swallow more naturally. The nominator stated that these implants can improve patients' quality of life and may eliminate the need for feeding tubes.

The nominator was concerned that CMS payment rates for maxillofacial prosthetic services, which were last reviewed in 1995, are outdated. In particular, the nominator stated that CPT codes 21080 and 21081 have undergone significant changes since the development of their PE values in the mid-1990s. At that time, mandibular reconstruction was rare, and removable prostheses were used to align the jaw. Microvascular reconstruction and virtual surgical planning have since transformed the procedures described by CPT codes 21080 and 21081, allowing precise prosthetic rehabilitation during surgery and improving oral function, speech, and quality of life. The nominator asserted that the PE inputs for CPT codes 21080 and 21081 did not account for these advancements, which did not exist in 1995 when the codes were valued. Furthermore, they stated that when these maxillofacial prosthetic services were valued in 1995, CMS used inaccurate inputs, which they believe did not account for the appropriate clinical staff time and materials required for prostheses. They stated that changes in clinical staff time, supplies, and equipment require the direct PE inputs to be updated.

The nominator stated that significant technological advancements have also occurred for extraoral prostheses, such as orbital (CPT code 21077), auricular (CPT code 21086), and nasal prostheses (CPT code 21087). For orbital prostheses, hand sculpting and painting remain time-intensive tasks, with limited use of 3D technology. In auricular prostheses, 3D technology has significantly improved the waxing process. For nasal prostheses, preoperative scanning now helps to shape the prosthesis, leading to better cosmetic outcomes. All extraoral prostheses (for example, orbital, auricular, and nasal) now commonly use 3D technology, craniofacial implants, and color-matching devices, which were not standard in the 1990s. The nominator asserted that the practice expense inputs for these codes fail to account for these advancements.

Additionally, the nominator asserts that there are other instances where the nominated codes fail to reflect the significant technological advancements in treatment delivery since 1995. The nominator requested an update to the PE inputs for all of the nominated codes, stating that the dental x-ray (ER071), valued at $128,020.91, has been replaced by various pieces of capital equipment. For example, they listed a “CMS Planmeca CBCT Imaging” system, which costs $163,767.66, and stated that this takes the place of the x-ray unit, highlighting a notable price difference between the x-ray machine and the CT. Furthermore, they provided a lengthy list of additional equipment (for example, 3D printer) that is not accounted for in the PE inputs for all of the nominated codes, underscoring the extensive modernization in service delivery since 1995.

To support their nomination, the nominator included information on what they believe to be more accurate PE inputs, including invoices for supplies and equipment. For items where invoices paid were unavailable, price quotes from a supplier were included. In addition, their appendices included recommendations for deleting and adding supplies, equipment, and clinical staff time. For more information, we refer readers to the submitted nomination, which is posted in the public use files for this proposed rule available on our public website under PFS Federal Regulation Notices at https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices.

Although the nomination stated that the work RVUs are accurate as currently valued, because these codes have not been reviewed in the last 30 years, we believe it is appropriate to examine both PE and work inputs. Given the technological advancements the nominator described, there may also be resulting changes in the physician work involved in performing these services, and therefore, a comprehensive review of both practice expense and work values would be appropriate. While we proposed not to nominate these codes as potentially misvalued, we requested public comments and recommendations, including those from the RUC, to better understand these codes, particularly regarding typical direct PE inputs and work values.

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

Comment: Several commenters stated that the current PE inputs for the maxillofacial prosthodontic codes are outdated and undervalued. They emphasized that the codes have not been reviewed since 1995 and stated that the technology and materials used to fabricate maxillofacial prostheses have changed dramatically in the last 30 years. They stated that many of the supplies and equipment now required are not reflected in the existing PE inputs, leading to undervaluation.

A commenter stated that if CMS declines to adopt their submitted recommendations for direct PE inputs, they request that CMS at least designate the codes as misvalued and refer them to the RUC for a full review of both work and practice expenses. They also noted that maxillofacial prosthodontists currently lack representation on the RUC, which further underscores the need for CMS to step in to ensure proper valuation.

Another commenter supported updating CPT code 21085, which is commonly performed by oral and maxillofacial surgeons in conjunction with orthognathic procedures and endorsed the nominator's PE recommendations, noting that the submission was developed in alignment with the RUC's traditional PE format.

Some commenters further suggested that CMS address the practice expense inputs, since the submission followed the RUC's standard format and provided sufficient detail; however, another commenter encouraged CMS to engage with specialty interested parties before initiating revisions. Overall, the commenters emphasized that leaving these codes unreviewed for more than 30 years has limited access to life-altering prostheses, and that updated valuation is needed in the near future to restore fair access to care given technological advances.

Response: Upon review of the interested parties' request for CPT codes 21076 to 21087, we identified several concerns with the proposed PE inputs. The proposed clinical staff times, such as patient greeting, room preparation, and instruction review, exceed standard times without explanation. We note high and potentially overlapping clinical staff time requests. Additionally, many of the suggested new supply items may not be typically

necessary for all head prosthetic codes. Although commenters removed dental X-rays from the PE inputs, they recommended retaining most previous equipment items, supplies, and times, even with the addition of new supplies and equipment. Overall, these substantial resource additions were submitted without supporting documentation and did not include corresponding adjustments to physician work values, despite the integration of advanced technologies that could impact physician work and time. Furthermore, the absence of input from other relevant medical specialties could undermine the completeness and reliability of these PE recommendations.

Comment: The RUC noted that these services are very low volume-- some with fewer than 100 Medicare claims annually--and are offered at only a limited number of centers, making them difficult to survey. However, because they are critically important, the RUC is willing to support valuation and direct PE inputs. They also noted that CMS could rely on the detailed and properly formatted PE data already submitted by the commenter.

Response: We appreciate the RUC for its feedback.

After consideration of the public comments and our concerns associated with the practice expense inputs, we are finalizing our proposal not to nominate these codes as potentially misvalued. We reiterate that the RUC expressed willingness to review the valuation and direct PE inputs for maxillofacial prosthetic services and we look forward to reviewing their recommendations in the future. (2) Supervision of Preparation and Provision of Antigens for Allergen Immunotherapy (CPT Codes 95145, 95146, 95147, 95148, 95149)

An interested party nominated the professional supervision of preparation and provision of stinging insect venom for allergen immunotherapy described by CPT codes 95145 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); single stinging insect venom), 95146 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 2 single stinging insect venoms), 95147 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 3 single stinging insect venoms), 95148 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 4 single stinging insect venoms), and 95149 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 5 single stinging insect venoms) as potentially misvalued, stating that the current payment rates for these CPT codes do not accurately reflect the practice expenses required for these procedures. The nominator indicated that the cost to manufacture venom therapy has drastically increased since the last time these codes were reviewed by the RUC in 2001, citing higher labor and raw material costs.

Venom immunotherapy, used for treating insect stings, involves extracting venom from various stinging insects like honeybees and wasps. According to the nominator, the manufacturing process is labor- intensive, requiring 520 staff hours to manually extract venom from 130,000 insects per batch, along with substantial equipment investment. The final product is packaged in single, five, or twelve-dose vials for medical use. For more information, we refer readers to the submitted nomination, which is posted in the public use files for the proposed rule available on our public website under PFS Federal Regulation Notices at https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices.

The nominator stated that before 1995, venom products were paid under product-specific HCPCS J-codes, but due to infrequent use and limited budget impact on the Medicare trust funds, CMS retired the J- codes and instead bundled venom products within CPT codes 95145, 95146, 95147, 95148, and 95149. According to the nominator, the current payment rates for these codes are based on the Harvard valuation and have not been surveyed by the RUC since February 2001. The nominator stated that when surveyed in 2001, the PE inputs for these codes only accounted for swab-pad, antigen, syringe, and gloves. In contrast, the nominator indicated that CPT code 95165 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses), which was more recently reviewed in 2016 and shares similar PE inputs as the nominated codes, includes additional items such as a surgical cap, gown, mask, alcohol, paper towel, and vial transport envelope. The nominator stated that, according to the 2019 standards for allergen extract compounding under USP Chapter 797,\17\ the procedures described by CPT codes 95145, 95146, 95147, 95148, and 95149 require additional supplies and practice expenses, such as sterile powder-free gloves, face mask, hair net/beard net, gown/sterile garb, isopropyl alcohol, paper towel, sterile empty vials, and albumin saline, in addition to the allergenic extract. The nominator stated that these standards also mandate significantly more annual training for providers, including competency observation, media fill test, gloved fingertip test, and corrective actions. Furthermore, the nominator asserted that the overall cost of venom therapy has increased substantially and submitted invoices to support this statement.

\17\ https://college.acaai.org/wp-content/uploads/2021/01/Section-21-USP-Compounding-Allergenic-Extracts.pdf.

At that time, we did not propose the CPT codes submitted by the nominator as potentially misvalued. CPT codes 95145 to 95149 are typically billed in conjunction with CPT codes 95115 and 95117. We noted that the nominator has listed PE inputs that are also included in the inputs for CPT codes 95115 and 95117 and these same inputs may overlap with inputs included in CPT codes 95145 to 95149. While the PE inputs that overlap between CPT codes 95145 to 95149 and 95115 and 95117 may contain the necessary elements, we sought feedback regarding these overlapping PE inputs in relation to billing frequencies and the possibility of duplicative payment. Specifically, we requested comments on whether these inputs overlap and what potential adjustments should be made to avoid duplicative payment. We requested comments regarding the standard minutes for clinical activity code CA008 (Perform regulatory mandated quality assurance activity (pre-service)) and the standard unit measurement for supply code SH004 (albumin saline). Additionally, we sought input regarding the establishment of clinical activity codes for two specific procedures requested by the nominator: cleaning and disinfecting the compounding area, and sterile preparation of compounds.

Furthermore, anomalies were identified related to the clinical activities described by CA021 (Perform procedure/service--NOT directly related to physician work time). Specifically, the typical times associated with these activities in the RUC database are as follows: 2.3 minutes for CPT code 95145, 3.3 minutes for CPT code 95146, 2.3 minutes for CPT code 95147, 3.3 minutes for CPT code 95148,

and 4.3 minutes for CPT code 95149. The nominator has requested 10 minutes for all of the nominated CPT codes without providing any justification for this time. Regarding the clinical labor direct inputs (L037D), we sought comments on several aspects of dosage preparation, including but not limited to: the typical number of dosages, the time required for preparation, the number of vials or dosages that can be prepared from each vial, and the total time needed for preparation of these vials and dosages. Additionally, we sought information about the derivation of the 2.3-minute time. This information would help inform the appropriate time for both clinical labor activities.

We received several invoices for mixed and single venom prices from the nominator; however, we are unable to determine the number of individual venoms in the mixed venom preparations. Specifically, supply codes SH009 (antigen, venom) and SH010 (antigen, venom, tri-vespid) are currently priced at $35.58 and $69.21 respectively, with prices last updated in the CY 2024 PFS final rule (88 FR 78967). The nominator stated that the venom cost has increased to $481.50 for a 5-dose wasp venom as of April 1, 2024, and submitted invoices to support this claim to update the current price. Since we are unsure whether these invoices are for mixed or single venom prices, we requested additional invoices and comments regarding the methodology for calculating venom prices using mixture invoices. We requested feedback to gain a broader understanding of these codes, including how standards of practice have evolved over time, as this information can help identify related coding issues.

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

Comment: A few commenters agreed with CMS that CPT codes 95145 to 95149, which were last reviewed by the RUC in 2001, should be reassessed to accurately reflect physician work and practice expenses. They emphasized the need to update the PE inputs to align with current USP 797 sterile compounding standards and avoid overlap with injection codes 95115 and 95117. Commenters stated that payment for compounding services (CPT codes 95145 to 95149) should remain separate from injection services (CPT codes 95115 and 95117) because compounding occurs before or after injection visits, while injection codes capture injection-room resources and observation only. According to commenters, these are distinct clinical activities that often occur on different days, demonstrating that the payments for compounding activities and injection services are not duplicative.

Commenters identified specific new tasks per compounding session required under USP 797 section 21, including routine cleaning and disinfection, hand hygiene and garbing, daily temperature logging, and periodic environmental cleaning, and recommended adding new clinical activity codes to reflect these requirements. They proposed specific time allocations for these activities, such as 2 to 5 minutes for cleaning, 5 to 8 minutes for garbing and hygiene, and 15 minutes per surface category for periodic environmental cleaning, amortized per surface category.

Regarding clinical activity times and supervision, commenters provided CMS with information that a typical sterile compounding session for new-patient venom build requires approximately 46 minutes of direct activity, extending to up to 86 minutes when periodic tasks are included, with about 20 minutes involving physician supervision during pre-service review and sterile preparation. They recommended scaling assumptions to add an extra 2 or 3 minutes per vial beyond the standard three-vial setup to account for the additional complexity of multi-vial builds.

Overall, commenters recommended that CMS refine the PE inputs for the codes describing compounding services to reflect USP 797 and avoid overlap with injection services. Since the direct PE inputs have not been reviewed in over 20 years, commenters recommended updating the PE inputs and clinical activity codes to capture USP-required cleaning/ disinfection, garbing, temperature logging, and periodic environmental cleaning. Commenters also recommended establishing scalable time assumptions tied to vial counts and dose complexity and further recognizing 20 supervised minutes per routine compounding session.

Response: We appreciate commenters for their feedback and the information submitted.

After consideration of public comments, we have concerns regarding the specific requests made by commenters. Regarding clinical activity time, we received multiple data sources such as USP 797 standards, commenters' requested additions, and RUC standard times.

We are also unsure as to whether USP standards are required in physician offices. Furthermore, because billing is done on a per-test basis and multiple tests may typically be performed at the same time, we are unclear on the typical times associated with the USP 797 standards per code (as opposed to per batch). At present, we do not have sufficient information to translate the commenters' recommendations into direct PE inputs, and welcome additional information on the typical number of tests performed for these procedures.

We invited the original nominator or other interested parties to resubmit their nomination with information providing additional clarity for consideration in future rulemaking. Therefore, for CY 2026, we are finalizing our proposal not to nominate these codes as potentially misvalued. (3) Electronic Analysis of Implanted Neurostimulator Pulse Generator/ Transmitter (CPT Codes 95970, 95976, 95977)

CPT codes 95970 (Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming), 95976 (Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with simple cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional), and 95977 (Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with complex cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional) were

nominated as potentially misvalued for two reasons identified by the nominator: there has been a significant shift in the clinical specialties utilizing these codes, and the PE inputs currently assigned to these codes may not accurately reflect the costs associated with analyzing and programming the hypoglossal nerve stimulation (HGNS) system.

The nominator stated that, from 2017 to 2023, there has been a significant change in the clinical specialties that utilize these codes in the non-facility setting. According to the nominator, while CPT codes 95970, 95976, and 95977 were primarily billed by neurologists when last surveyed by the RUC in 2017, the usage of these codes has shifted away from neurologists toward sleep specialists. The nominator asserted that this shift necessitates changes to the work RVUs and PE inputs for these codes. In addition, the nominator stated that many sleep specialists believe CPT codes 95970, 95976, and 95977 do not appropriately reflect the practice expenses involved in furnishing these services. According to the nominator, a survey conducted among several high-volume sleep specialists (the details of which the nominator did not share with CMS) showed unanimous agreement that these codes do not accurately reflect the practice expense inputs. These three codes currently have 0 minutes of clinical staff time included in the direct PE inputs. However, the nominator stated that based on the survey results the typical clinical staff time spent for patient care was 35 minutes for CPT code 95970, 37 minutes for CPT code 95976, and 46 minutes for CPT code 95977. The nominator stated that CPT codes 95970, 95976, and 95977 should reflect the same clinical staff time as similar analysis and programming procedures, such as CPT codes 93150 (Therapy activation of implanted phrenic nerve stimulator system, including all interrogation and programming), 93151 (Interrogation and programming (minimum one parameter) of implanted phrenic nerve stimulator system), and 93153 (Interrogation without programming of implanted phrenic nerve stimulator system). The nominator stated that these codes more accurately account for the clinical staff time.

We stated that we appreciated the nominator sharing their survey results from high-volume sleep specialists, which may indicate potential inaccuracies in the direct PE inputs for CPT codes 95970, 95976, and 95977. However, our review of the submitted information reveals a lack of survey details (for example, sampling methods, data collection procedures), so it is difficult to understand the context of the information provided by the nominator and identify potential biases of this survey. While we acknowledge potential changes in the specialties utilizing these codes, and sleep medicine's Medicare specialty percentage has grown over time, neurology remains the dominant billing practitioner type. For these reasons, we proposed not to consider these codes as potentially misvalued. We did, however, seek comments and additional information on the information provided by the nominator. This includes any analysis or studies demonstrating that one or more of these codes meet the criteria listed in section II.C.3. of the proposed rule, under “Identification and Review of Potential Misvalued Services,” particularly regarding changes in practice expense inputs for service delivery.

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

Comment: Commenters highlighted that CMS correctly observed that neurologists remain the dominant billing practitioners for these codes, despite the nominator's claims. They noted that while sleep medicine physicians frequently manage patient selection, diagnostic evaluation, and longitudinal care, the initial technical electronic analysis of the device is not generally performed by the sleep medicine physician. They thanked CMS for not designating the codes as potentially misvalued based on incomplete evidence and reiterated that the RUC process remains the appropriate and transparent way to evaluate whether services are misvalued and update PE inputs accordingly.

Commenters supported ensuring that the PE inputs reflect current medical practice but stressed that any changes must be based on a transparent and rigorous survey process. They stated that the data submitted by the nominator was incomplete and recommended that CMS request and review detailed survey data referenced by the nominator to assess whether the codes appropriately reflect the intensity, expertise, and time and engage multiple specialty societies in future deliberations to ensure code valuations reflect clinical practice realities.

Response: After consideration of public comments, we do not believe CPT codes 95970, 95976, and 95977 are potentially misvalued. We believe that the current valuation of PE inputs is still appropriate and that neurologists remain the dominant billing practitioner type; therefore, for CY 2026, we are finalizing our proposal not to designate these codes as potentially misvalued. However, we appreciate the comments and encourage interested parties to submit information, such as detailed survey data, for consideration in future rulemaking to ensure accurate valuation. (4) Excimer Laser Treatment for Psoriasis (CPT Codes 96920, 96921, 96922)

An interested party nominated CPT codes 96920 (Excimer laser treatment for psoriasis; total area less than 250 sq cm), 96921 (Excimer laser treatment for psoriasis; 250 sq cm to 500 sq cm), and 96922 (Excimer laser treatment for psoriasis; over 500 sq cm) as potentially misvalued, due to the CPT Editorial Panel's recent modifications to the code descriptor and allegedly inaccurate data used by CMS in valuing these services.

According to the nominator, the misvaluation of these codes creates a significant healthcare access barrier by reducing payment for excimer laser therapy, which disproportionately impacts vulnerable populations while potentially increasing overall healthcare costs. The nominator stated that the low payment rates for these codes make it financially unfeasible for dermatologists to offer this FDA-approved treatment, effectively making it unavailable to Medicare beneficiaries despite its proven effectiveness and potential cost savings.

We discussed our review of these codes and our rationale for finalizing the current work RVUs and direct PE extensively in the CY 2025 PFS final rule (89 FR 97797 through 97801). We stated that we disagreed with the RUC recommended work RVUs for CPT codes 96920, 96921, and 96922 of 1.00, 1.07, and 1.32. The RUC noted that there have been multiple reviews of these CPT codes, and the valuation of the codes is currently based on the original valuation over two decades ago in 2002 where the physician time values were lower than the current times. A subsequent review in 2012 adopted new survey times while maintaining the work RVUs from 2002 for CPT codes 96920 and 96922. The RUC noted that for both CPT code 96921 and 96922, with the largest treatment area, the total times had not changed since first implemented more than 20 years ago. At the time we also believed that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure had increased, significant decreases in time should be reflected in decreases to work RVUs. We noted that our proposed

work RVU of 0.83 maintained the intensity associated with the 2002 review of CPT code 96920, which we believed to be more appropriate than the significant increase in intensity that results from the RUC- recommended work RVU of 1.00 which nearly doubled the current intensity of the code (89 FR 97797). We had no evidence to indicate that the intensity of CPT code 96920 had increased to this degree given how the surveyed work time had substantially decreased.

For CY 2026, the nominator raised two issues related to these codes. First, according to the nominator, a coding change by the CPT Editorial Panel that was released in 2024 and effective January 1, 2025, modified the code descriptor from “Laser treatment for inflammatory skin disease(psoriasis)” to “Excimer laser treatment for psoriasis.” We remind readers that, in April 2022, the RUC referred CPT codes 96920, 96921, and 96922 to the CPT Editorial Panel to capture expanded indications beyond what was currently noted in the codes' descriptions to include laser treatment for other inflammatory skin disorders such as vitiligo, atopic dermatitis, and alopecia areata, and those expanded indications could reflect changes in physician work as compared to the codes' current descriptors. The coding change application was subsequently withdrawn from the September 2022 CPT Editorial Panel meeting when it was determined that existing literature was insufficient and did not support expanded indications at that time. Therefore, these CPT codes were re-surveyed and reviewed at the April 2023 RUC meeting without any revisions to their code descriptors. We note that, according to the CPT Editorial Panel and the RUC's publicly available meeting notes, since the descriptors for CPT codes 96920, 96921, and 96922 were established in 2002, psoriasis is the only approved indication and use for this treatment modality.\18\

\18\ https://www.ama-assn.org/system/files/ap-2023-ruc-meeting-minutes.pdf.

While the nominator is working with the CPT Editorial Panel again to expand the indications for excimer laser treatment beyond psoriasis to include other inflammatory skin conditions, they stated that they believe establishing a temporary G- code for interim coverage is necessary and therefore requested that CMS create coding to more accurately reflect the clinically appropriate use of the excimer laser. The nominator states that this would ensure patients with skin conditions other than psoriasis can access excimer laser treatments without delay.

To provide more evidence as to the accuracy of including non- psoriasis inflammatory skin diseases in the code definition, the nominator provided a data compendium supporting the excimer laser's versatility and key studies demonstrating positive outcomes for conditions like vitiligo, atopic dermatitis, leukoderma, and alopecia areata. Reviewing these submitted studies, the nominator stated that sufficient clinical evidence exists to support expanding coverage for excimer laser treatment beyond just psoriasis. The nominator requested that CMS create additional coding to describe the expanded indications for the excimer laser treatment, because the nominator believes that the standard CPT process is time-consuming and could leave many patients without adequate care in the interim; thus, implementing a temporary G-code would ensure continued access to this essential therapy for these patients.

Second, the nominator provided additional invoices and data detailing PE costs related to the excimer laser devices. The nominator claimed that their own analysis relies on real-world data (which was not shared with CMS) and shows that CMS has overestimated the utilization rate of excimer lasers. Using their own survey, they found that on average, dermatologists perform 244 excimer laser treatments per device annually, with each treatment requiring approximately 38 to 46 minutes of excimer laser use. This amounts to nearly 15,000 minutes of total utilization per year, resulting in an effective utilization rate of 10 percent, rather than the 50 percent rate currently used by CMS. As stated in section II.B. of the proposed rule, we currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act.

Based on their real-world device utilization data, the nominator calculated the direct PE cost using CMS' standard equipment formula. The calculated equipment costs are $99.88 for CPT code 96920, $105.14 for CPT code 96921, and $120.91 for CPT code 96922. The nominator also stated that CMS currently assumes a maintenance cost of $7,560 for excimer lasers, based on a 5 percent maintenance rate applied to a purchase price of $151,200. However, the nominator stated that excimer lasers are technical devices with substantially higher maintenance costs. According to the nominator, the annual service cost for the excimer laser is $30,000, and they claimed that a laser chamber replacement service costs $44,000; however, as discussed in section II.B. of the proposed rule, we finalized a 5 percent factor for annual maintenance in the CY 1998 PFS final rule with comment period (62 FR 33164). As we previously stated in the CY 2016 PFS final rule with comment period (80 FR 70897), we do not believe the annual maintenance factor for all equipment is precisely 5 percent, and we stated that this estimate likely understates the true cost of maintaining some equipment. We also noted that we believe it likely overstates the maintenance costs for other equipment. When we solicited comments regarding data sources containing equipment maintenance rates, commenters could not identify an auditable, robust data source that CMS could use on a wide scale. As a result, in the absence of publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining a different maintenance factor, a variable maintenance factor for equipment cost per minute pricing was not proposed as we did not believe that we had sufficient information at that present time. Therefore, we reminded readers that we did not believe voluntary submissions regarding the maintenance costs of individual equipment items would be an appropriate methodology for determining costs.

Moreover, the nominator asserted that CMS currently does not include the costs of consumable gas (code EQ154) and the optical delivery system (code EQ155) in the direct practice expense cost for these services. Based on our review of the January 2012 RUC recommendations submitted to CMS, it appears that these equipment items were removed by RUC PE Subcommittee for CY 2013. The requestor stated that the gas cylinder (EQ154) costs $6,300 (excluding labor and shipping costs), and the optical delivery system (EQ155) costs $7,429; however, no supporting invoices or evidence of the typicality of the equipment items' usage for these services were provided to support the equipment items' reintegration into the codes' direct practice expense.

Based on this information, the nominator recommended creating a G- code for excimer laser treatment of inflammatory skin diseases. Furthermore, they requested to include their own real-world data on excimer laser utilization rates in the practice expense calculation, adjust the maintenance cost in the practice

expense calculation to reflect the actual cost of maintaining excimer laser devices, and reinstate the costs of consumable gas (code EQ154) and the optical delivery system (code EQ155) in the practice expense calculation.

We appreciate the detailed information submitted by the nominator. However, we stated that we continue to disagree that CPT codes 96920, 96921, and 96922 are potentially misvalued. We noted that the CPT code change request was withdrawn from the AMA in September 2022 due to insufficient supporting literature for expanded indications. Additionally, according to RUC's publicly available meeting notes, psoriasis is the only approved indication and use for this treatment modality since the descriptors for CPT codes 96920, 96921, and 96922 were established in 2002. When the codes were resurveyed in April 2023, no descriptor revisions were made, as the available 2021 Medicare claims data indicated that the typical patient was being treated for psoriasis (96920, psoriasis = 79.3 percent).\19\ Additionally, there have been numerous CPT Editorial Panel applications and actions since the withdrawn application at the September 2022 meeting,\20\ including a February 2025 action.\21\ However, at the time of drafting the proposed rule, the request for expanded indications does not appear to have been re-submitted or revisited by the specialty societies. We sought comments on whether creating a new HCPCS G-code that is not condition-specific would improve payment accuracy for this technology when used to treat conditions other than psoriasis. We also sought information regarding possible barriers to coding changes undertaken through the CPT Editorial Panel process. We sought information regarding the nominator's assertion that equipment items EQ154 and EQ155 are necessary and typical for these services, and invoices to support the nominator's asserted purchase prices, so as to provide a comprehensive understanding of the overall costs associated with these services. We note that, effective for January 1, 2027, based on the publicly available Summary of CPT Editorial Panel Actions from the February 2025 meeting,\22\ the codes' descriptors will change from “Excimer laser treatment for psoriasis” to “Laser treatment for psoriasis,” absent subsequent CPT Editorial Panel actions. Therefore, we believe it is important for comments to support the typicality of these equipment items regardless of the type of laser used for these services.

\19\ https://www.ama-assn.org/system/files/ap-2023-ruc-meeting-minutes.pdf.

\20\ https://www.ama-assn.org/system/files/september-2022-cpt-summary-panel-actions.pdf.

\21\ https://www.ama-assn.org/system/files/feb-2025-summary-of-panel-actions.pdf.

\22\ https://www.ama-assn.org/system/files/feb-2025-summary-of-panel-actions.pdf.

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

Comment: Many commenters noted the FDA approval of the excimer laser for vitiligo, including its proven safety and effectiveness, and patients' reliance on the laser if they cannot tolerate stronger systemic medicines. At its May 2025 meeting, the CPT Editorial Panel approved revisions to these code descriptors to include inflammatory and autoimmune skin indications beyond psoriasis, with the updates effective January 1, 2027 and the majority of commenters supported the CPT Editorial Panel process and affirmed support for the RUC's valuation of physician services.

Many commenters expressed support for establishing an interim G- code for excimer laser treatment (CPT codes 96920, 96921, 96922) to ensure immediate patient access while permanent CPT code revisions are being developed which would sunset upon implementation of the revised CPT code descriptors. Without a G-code, commenters noted that they are forced to bill under the unlisted CPT code 96999, which creates an administrative burden for prior authorizations and results in inconsistent reimbursement. Other recommendations included reassessing utilization and maintenance inputs to reflect real-world conditions and adding essential equipment items omitted in practice expense calculations. Commenters stated that by making excimer laser therapy financially unsustainable for dermatology practices, CMS is unintentionally pushing patients toward more aggressive and significantly more expensive treatments, such as biologics.

Response: We appreciate the support for the CPT editorial panel's revisions and look forward to reviewing them, and the subsequent RUC recommended values when we receive them for the subsequent years' rulemaking (for CY 2027, this would be by February 10, 2026). Although we recognize that there may be a “gap” in specific coding for these services for the period of time between when the CPT editorial panel completes their revisions and CMS is able to finalize updated valuation, as of the publication of this final rule, the code descriptor changes referenced by the commenters has not been finalized by CPT and creation of a G-code may only cause further confusion.

Regarding valuation of the existing CPT codes, commenters stated that excimer laser therapy typically requires around 15 sessions (depends on patient response to treatment), with a national average (current) reimbursement of $136.83 to $182.76 per treatment, which brings the total cost of excimer laser therapy to $2,000 to $2,750. Other commenters stated that average excimer treatments per site amount to roughly 10 to 30 minutes (6 to 12 treatments x 40 to 45 minutes per treatment) per year. Some commenters recommended CMS adopt the RUC- recommended work RVUs and that the proposed work RVUs (0.83, 0.90, and 1.15 respectively) grossly undervalue the intensity of excimer therapy, which some commenters stated requires 40 to 60 minutes of precise dosing, repositioning, and sparing healthy skin--often in patients with multiple comorbidities. Several commenters stated that the RUC's practice expense values ($80, $83, and $100 respectively) align with the real costs incurred and that CMS' standard assumption of 50 percent utilization is unrealistic.

Other commenters requested that CMS update the PE inputs for the existing CPT codes to reinstate the costs of the consumable gas cylinder (EQ154) and optical delivery system (EQ155) into the direct practice expense (PE) inputs for CPT codes 96920 to 96922. They recommended CMS incorporate EQ154 and EQ155 into a supply-based reimbursement structure that is applied only when excimer laser systems are used when furnishing these services. A few commenters noted that excimer lasers are gas-based lasers that rely on a mixture of noble gases, including high-purity neon, to generate precise, targeted monochromatic ultraviolet (UVB) light at wavelength of 308 nanometers. This specific wavelength is critically important for the effective treatment of vitiligo, psoriasis, and other dermatological conditions by targeting and suppressing the autoimmune response in affected skin areas without the need for broad-spectrum light therapy.

Response: We appreciate the information provided by commenters regarding the valuation of the existing CPT codes describing these services. As these codes are likely to be reviewed by the RUC, and recommendations provided for future rulemaking, we will not be making any changes to the valuation at this time.

After consideration of public comments, for CY 2026, we are finalizing our proposal not to nominate

CPT codes 96920, 92921, and 96922 as potentially misvalued. (5) Optical Coherence Tomography (OCT) of Retina (CPT Code 0605T)

CPT code 0605T (Optical coherence tomography (OCT) of retina, remote, patient-initiated image capture and transmission to a remote surveillance center, unilateral or bilateral; remote surveillance center technical support, data analyses and reports, with a minimum of 8 daily recordings, each 30 days) was submitted as potentially misvalued. This code is a temporary CPT category III code and is assigned procedure status “C” (contractor priced) under the PFS. The nominator generally expressed concern that the initial pricing by the contractor was inaccurate and did not appropriately consider the cost of the OCT device when provided by the independent diagnostic testing facility (IDTF). The nominator requested that CMS revise the valuation of this code to properly account for the cost of the OCT imaging device used to provide this remote diagnostic retinal monitoring service.

The nominator stated that remote OCT allows for better management of patients with neovascular age-related macular degeneration (NV-AMD) and improved management has been shown to result in reduction in treatments.23 24 According to the nominator, one of the Medicare Administrative Contractors who priced the service did not appropriately consider the cost of the OCT device provided by the IDTF, resulting in an inadequate payment rate that did not cover the direct operating costs. The nominator asserted that this code is misvalued because the contractor established its value by crosswalking to the valuation for remote physiological monitoring (RPM) CPT code 99454 (Remote monitoring of physiologic parameter(s) (eg, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days). The nominator stated that CPT code 99454 represents a distinct type of service and falls under a different benefit category than remote OCT. The nominator stated that while remote OCT is a diagnostic service that is provided by an IDTF, CPT code 99454 is an E/ M service that is not permitted to be furnished by IDTFs. In addition, the device used to furnish remote OCT performs retinal imaging comparable to that performed in the physician office, has a useful life of 5 years, and costs $40,000. The nominator provided an invoice to support this claim. In contrast, the nominator indicated that the device used in the service described by CPT code 99454 captures simple physiologic data and costs $1,000. The nominator provided a device equipment cost per month of $666.67 for the device used to furnish remote OCT. Using the device cost calculation, the nominator estimated an unadjusted rate of $632.22 by following CMS' valuation methodology.

\23\ Holekamp, Nancy M., et al. “Prospective trial of Home OCT guided management of treatment experienced nAMD patients.” RETINA (2022): 10-1097.

\24\ Heier, Jeffrey S., et al. “Clinical Use of Home OCT Data to Manage Neovascular Age-Related Macular Degeneration.” Journal of VitreoRetinal Diseases (2024): 24741264241302858.

Overall, the nominator stated that CPT code 99454 is not an accurate crosswalk for remote OCT and recommended that CMS revise the valuation of CPT code 0605T to properly account for the higher cost of the OCT imaging device used to provide this remote diagnostic retinal monitoring service. The nominator stated that due to the current undervaluation, the prescribing physicians and their patients in need of remote monitoring of a treatable sight-threatening retinal disease do not have access to this service.

We did not propose CPT code 0605T as a potentially misvalued code. We note that the nominator submitted a single invoice in support of its assertions, which may not be reflective of typical costs, and we encourage interested parties to provide additional information. including invoices for the OCT devices. Also, we welcomed comments on whether this code should be nationally priced and what inputs should be used if we were to set a national rate for this service.

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

Comment: Many commenters supported establishing a national payment rate for remote OCT technology (CPT code 0605T) that reflects its clinical value and operational costs. The commenters emphasized that while CPT codes exist for remote OCT services, current payment rates are inadequate and payment implementation has lagged, limiting patient access to this innovative technology. Commenters stated that neovascular age-related macular degeneration (nAMD) is highly prevalent in the Medicare population and that remote OCT technology allows retina specialists to monitor patients more frequently while reducing in- person visits by 40 to 50 percent. They noted that this remote OCT enables earlier detection of disease reactivation, timely as-needed treatment, and prevention of irreversible vision loss, thereby preserving patients' vision and quality of life.

Many commenters supported the invoice provided by the nominator indicating a price of $40,000 for the purchase of the remote OCT device and stated that the current rate of $47.77 provided by some MACs was inaccurate. Commenters stated that $40,000 is a reasonable cost for the innovative technology which incorporates high-resolution imaging, AI analysis, and secure data systems. Another commenter stated they submitted an invoice for an OCT system that costs $44,500. Commenters stated that for this technology to be widely available, CMS should recognize its value through an appropriate national price for the technical component 0605T.

Some commenters highlighted that RPM is not the right comparator for OCT. They stated that CPT code 99454 pays for monitoring physiologic metrics like blood pressure or weight and for longitudinal care-management time; they are not diagnostic imaging tests with acquisition, interpretation, and report requirements, which are not comparable to OCT based remote monitoring. They suggested that using a cardiology service is a more likely comparator, for example mobile cardiovascular telemetry (MCT) CPT code 93229 (technical support for connection and patient instructions for use, attended surveillance, analysis and transmission of daily and emergent data reports as prescribed by a physician or other qualified health care professional). CPT code 93229 describes a 30-day diagnostic monitoring episode with remote attended surveillance center analysis and reporting, which commenters suggest would be an operational match to OCT's remote surveillance center model.

Response: We appreciate the feedback from commenters and for highlighting that this innovative remote in-home OCT device can be particularly beneficial for patients with nAMD. We agree that the comparator RPM code, CPT code 99454, may not fully account for the resources and expertise involved, or the OCT devices and/or systems as described by CPT code 0605T and that the current payment is inadequate to reflect the OCT device used to monitor nAMD in patients in the home setting. After consideration of public comments, for CY 2026, we are finalizing national pricing for CPT code 0605T for CY 2026. We agree with commenters that CPT

code 93229 has similar resources costs, and therefore, we are establishing inputs for CPT code 0605T using CPT code 93229 as a direct crosswalk for valuation. (6) Mechanical Separation of Plasma From Blood (CPT Code 36514)

An interested party nominated CPT code 36514 (Therapeutic apheresis; for plasma pheresis) as potentially misvalued for two PE- related reasons. The first concern involves the assigned clinical labor code, L056A (RN/OCN), which the nominator states undervalues the therapeutic apheresis nurse's operating wage cost. The second concern relates to the equipment code, EQ084 (cell separator system), specifically its price and equipment utilization rate.

The nominator presented differences in therapeutic plasmapheresis or plasma exchange (TPE) procedure payments between settings, with 50 percent to 75 percent of the 100,000 annual TPE procedures occurring in hospital outpatient settings. The nominator stated that the payment differential is substantial: under the Hospital OPPS, the average CY 2025 Medicare payment rate for TPE performed in a hospital outpatient department is $1,639.28, excluding compensation for the supervising physician. In contrast, under the PFS, the average CY 2025 Medicare payment rate for the same procedure performed in a non-facility setting is $663.43. According to the nominator, the differences in payment rates have forced patients to receive treatment in more expensive hospital outpatient settings, as physicians cannot financially sustain the costs of performing TPE services in non-facility settings under the current payment rates. The nominator asserted that this payment structure not only limits patient access to care but also results in higher overall costs to the Medicare program, as procedures are channeled to the more expensive hospital outpatient setting where payment rates are nearly 2.5 times higher than non-facility rates.

The nominator stated that TPE is a complex extracorporeal blood therapy procedure used to treat patients with serious hematological, oncologic, neurological, rheumatologic, cardiac and autoimmune disorders. Therapeutic apheresis nurses performing this procedure require extensive specialized training to independently handle patients with a wide spectrum of serious illnesses and comorbidities. They must be trained and highly skilled in evaluating patients and managing clinical issues and adverse events that commonly arise during the procedure, particularly in patients with comorbid anemia, renal failure, cardiovascular disease, serum protein abnormalities or other risk factors.\25\ Their key responsibilities include advanced vascular access, continuous management of the extracorporeal circuit, troubleshooting, patient assessment to manage adverse events, and medication administration. The nominator emphasized that therapeutic apheresis nurses' training and skill level are distinct from nurses collecting blood products from healthy donors.

\25\ Chhibber V and King KE. Management of the therapeutic apheresis patient (Chapter 12). In: Apheresis: Principles and Practice, 3rd Edition. Bethesda, MD: AABB Press, 2010.

The nominator summarized the wide range of median annual and hourly base salaries ($92,525 to nearly $125,000) for “Apheresis Nurse” or “Apheresis RN” positions identified across four leading online employment recruiting firms. According to the nominator, this variability likely stems from the differing mixes of higher-paid therapeutic apheresis nurse job postings versus lower-paid postings for nurses collecting blood products from healthy donors at community blood centers across these firms. Based on the listed position openings, the nominator found that the rate per minute for a therapeutic apheresis nurse, inclusive of benefits, likely ranges between $1.30 and $1.50 per minute, well over 60 percent higher than the $0.81 per minute valuation currently assigned to CPT code 36514 with the L056A labor code. Also, the nominator claimed that to accurately assess therapeutic apheresis nurse wages, other surveys could be employed focusing on nurses performing therapeutic procedures while excluding those working in blood/plasma collection centers from healthy volunteer donors, as the latter typically receive lower compensation despite using similar equipment.

The nominator proposed that CMS collaborate with the Department of Labor to accurately assess therapeutic apheresis nurse salaries and establish a new clinical labor code with appropriate per-minute rates. This would replace the current L056A labor code used for CPT code 36514, which the nominator asserts undervalues these specialized nurses' wages and benefits. The new code would specifically exclude non-patient-facing nurses who perform blood product collection, ensuring more accurate compensation for this specialized role.

According to the nominator, the current Medicare payment rate for CPT code 36514 in the non-facility setting fails to adequately account for direct PE costs. First, based on fourth quarter 2024 U.S. sales data, the nominator requested updating the CMS Equipment File price for the cell separator system equipment code (EQ084) from $81,656.40 to $93,321.35, reflecting current market conditions. According to the nominator, the current rate of 0.5 for equipment code EQ084 implies that facilities perform 426 procedures per year per device; however, data from major hospitals, including the three largest-volume hospitals in the U.S., demonstrates that facilities average only 181 procedures per year per device, suggesting a more accurate utilization rate of 0.21. This discrepancy can significantly impact on the calculated costs and subsequent payment rates for equipment code EQ084.

After reviewing the nominator's submission, we did not believe that we had enough information to evaluate whether CPT code 36514 is potentially misvalued, and thus we did not propose the code as potentially misvalued at this time. To assist us in further considering whether CPT code 36514 is potentially misvalued, we sought information on the direct practice expense inputs, particularly regarding the clinical labor code L056A and equipment code EQ084. Specifically, we sought comments on whether to establish a new therapeutic apheresis nurse clinical labor code in the non-facility setting. Also, we sought invoices and other associated information that could be used to update the cell separator system equipment code EQ084 to reflect current market costs. We do not believe an update to the equipment utilization rate is necessary. We disagreed with the nominator that an equipment utilization rate of 21 percent would be typical for the cell separator system. As we stated previously, we currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act. As we discussed in the CY 2021 PFS final rule, it would distort relativity to assign a utilization rate of 21 percent for the cell separator system equipment, as this would have the same effect as doubling the overall price of the equipment (85 FR 84629).

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

Comment: A few commenters supported CMS's decision in the CY 2025 final rule to adopt the RUC-recommended direct practice expense

inputs for CPT code 36514 (therapeutic apheresis, plasma pheresis), which utilizes the L056A (RN/oncology nurse) clinical labor category, affirming and assuming that the code is appropriately valued. They encouraged CMS to continue reviewing and updating these codes as necessary.

Response: After consideration of public comments, we are finalizing our proposal not to nominate this code as potentially misvalued. (7) Remote Interrogation Device Evaluation (CPT Code 93296)

An interested party nominated CPT code 93296 (Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system, leadless pacemaker system, or implantable defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results) as potentially misvalued, because the service has experienced substantial changes in PE. The nominator emphasized that the current direct practice expense inputs do not accurately represent either the current standard of care or the actual resources required to provide the service, necessitating an urgent review of the code's resource input valuations.

CPT code 93296 is a technical component-only code describing remote monitoring of cardiac devices over 90 days. The nominator stated that this service enables healthcare providers to remotely evaluate implanted cardiac defibrillators and pacemakers, review device data, communicate with patients, and share findings with physicians. The monitoring helps prevent emergencies and reduces hospitalizations through early intervention and timely device adjustments. According to the nominator, the code's direct costs, last reviewed by RUC in 2016 and implemented in 2018, no longer reflect current service delivery requirements because technological advancements and expanded monitoring protocols have significantly increased service complexity and resource requirements.

Additionally, according to the nominator, the service delivery for CPT code 93296 has evolved significantly, requiring enhanced organizational infrastructure and specialized clinical expertise. They stated that modern service delivery involves complex data management, with each transmission requiring 32 distinct tasks \26\ for complete patient care. The increased service complexity stems from advanced technology requirements, expanded patient monitoring needs, and more frequent device interrogation, shifting from quarterly to more regular intervals. These changes have created a notable disparity between current resource costs and existing valuations, necessitating updated mechanisms for data management and prioritization.

\26\ Aileen M. Ferrick et al., 2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic (2023), https://www.hrsonline.org/guidance/clinical-resources/2023-hrsehraaphrslahrs-expert-consensus-statement-practical-management-remote-device-clinic?gad_source=1&gclid=Cj0KCQiAkoe9BhDYARIsAH85cDOusU-vRRcEnwoXzUmN2COkX0_DiRVHuOM8cYMf8riBNXW-KrFagnAaAs5NEALw_wcB.

According to the nominator, the direct cost inputs for clinical labor and equipment do not reflect the current direct costs required to furnish the services. The nominator stated that the total direct cost of $25.84 (including clinical labor and equipment) exceeds the CY 2025 national non-facility PFS payment rate of $19.41. They stated that the current valuations do not reflect modern clinical staffing needs and equipment requirements for this pacemaker interrogation system service, despite similar updates being approved for comparable diagnostic services. To assess resource requirements, the nominator conducted an independent study among IDTFs, using standardized data collection and a volume-weighted analysis of 2023 service data. The nominator claimed that their findings demonstrate a significant disparity between current valuations and actual service delivery costs, supporting the need for comprehensive input review.

The study of IDTFs conducted by the nominator revealed that CPT code 93296 requires 83.66 minutes of non-physician clinical labor time, significantly more than CMS' current value of 28 minutes. This time encompasses eleven distinct tasks, from patient enrollment to quality assurance, with the most time-intensive activities being data review and analysis (25.25 minutes) and unscheduled alert management (21.84 minutes). [GRAPHIC] [TIFF OMITTED] TR05NO25.008

Furthermore, the nominator stated that while the valuation for CPT code 93296 is currently based on electrodiagnostic technologists (L037A) at $0.44 per minute, the service is typically performed by cardiovascular technicians (L038B), who receive $0.60 per minute. Thus, the nominator believes that updating both the time and clinical staff classification is needed for accurate service valuation and consistency with other implantable device monitoring services.

Finally, the nominator requested two updates to the equipment costs for CPT

code 93296. First, they recommended adjusting the equipment usage time to align with the updated clinical labor time for remote interrogation device evaluation. Second, they recommended changing the assigned equipment code from “pacemaker interrogation, system” (EQ320) priced at $123,250 to “pacemaker follow-up system” (EQ198) priced at $279,453. We note that no invoices were submitted to support these prices. The nominator believes that these changes would align the equipment valuation with actual costs and match similar CMS-approved device monitoring services.

Overall, the nominator stated that a review of CPT code 93296 current inputs reveals significant undervaluation in several key areas. According to the nominator, the existing resource costs for clinical labor times, labor types, and equipment costs do not adequately reflect the current service requirements. Based on the submitted information, however, we proposed not to nominate this code as potentially misvalued. We requested that the nominator submit a complete report detailing the associated direct practice expense input assessment data to enable us to more fully consider whether the code is potentially misvalued. Additionally, we requested comments, including any analysis or studies from the broader medical community, including the RUC, regarding whether this service has experienced substantial changes in practice expenses since its last review.

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

Comment: Numerous commenters suggested that CMS re-evaluate and accurately value CPT code 93296, noting that the current valuation significantly understates the time, skill, and resources needed to provide remote monitoring of pacemakers and implantable cardioverter defibrillators (ICDs). Commenters stated that the CMS assumption of an electrodiagnostic technologist (L037A) spending 28 minutes to complete a full 90-day monitoring cycle does not reflect reality. Commenters provided a number of recommendations regarding the time associated with the electrodiagnostic technologist completing the full 90-day monitoring cycle. The most commonly reported time was over 80 minutes, while some commenters reported a range of 10 to 30 minutes. A few commenters stated that clinicians may spend a minimum of 10 minutes or up to 100 minutes per patient over a 90-day cycle, performing tasks such as data review, triage of alerts, patient communication, documentation, and integration with the electronic medical record.

Commenters also stated that these evaluations cannot be effectively performed by electrodiagnostic technicians (L037A) alone but instead require skilled professionals, at minimum certified cardiovascular technicians (L038B), due to the complexity of interpreting cardiac rhythms and device functionality with high levels of quality and accuracy. They highlighted that this distinction impacts both labor costs and the quality of care, as specialized expertise is necessary to ensure timely intervention, prevent hospitalizations, and optimize patient outcomes.

Commenters also stated that technology has evolved beyond the basic transmitters assumed in the original valuation. According to the commenters, pacemaker and ICD monitoring today requires the same integrated hardware-and-software platforms used for implantable loop recorders, systems capable of continuous data acquisition, algorithmic event detection, alert management, and secure data sharing, but the current equipment code (EQ320; pacemaker interrogation, system) does not reflect this infrastructure. Some commenters stated that they use a universal remote monitoring software, such as MURJ, EPIC, and Medtronic CareLink, and noted that there is no functional difference in the tools or infrastructure required for these services.

Overall, commenters suggested that CMS revise the valuation for CPT code 93296 to more accurately reflect the actual time, technician level, and tools required. They suggest CMS work with professional societies to adopt valuations that better reflect the scope of care and modern standards of practice and immediately update the PE inputs for CPT code 93296 or refer the code to the RUC for full review.

Response: After considering public comments, we found significant variation in the evaluation time estimates submitted by commenters, ranging from 10 to 100 minutes per patient for a comprehensive 90-day remote evaluation of a pacemaker or implantable cardioverter- defibrillator (ICD), making it difficult to identify a typical evaluation time. We welcome additional feedback from interested parties on the typical times associated with this clinical labor activity.

Based on the supporting evidence, we agree with commenters that the technician for this code should be a cardiovascular technician (L038B) rather than an electrodiagnostic technician (L037A). In addition, we agree that the current equipment code EQ320 should be updated to EQ198, as suggested, and therefore, we are making these updates for CY 2026.

Comment: The RUC stated that it reviewed the direct PE inputs for these services in January 2018. Since the RUC did not receive any interest from the specialties that perform this service to review it again, it has no plans to reassess CPT code 93296 or provide further commentary on it at this time.

Response: We appreciate the RUC for their feedback.

Based on our review of public comments we are finalizing our proposal not to nominate these services as potentially misvalued. However, we are finalizing updates to the clinical labor types and equipment types as described previously. (8) Fine Needle Aspiration (FNA) (CPT Codes 10021, 10004, 10005, 10006)

An interested party requested that CMS reconsider CPT codes 10021 (Fine needle aspiration biopsy, without imaging guidance; first lesion), 10004 (Fine needle aspiration biopsy, without imaging guidance; each additional lesion), 10005 (Fine needle aspiration biopsy, including ultrasound guidance; first lesion) and 10006 (Fine needle aspiration biopsy, including ultrasound guidance; each additional lesion) for nomination as potentially misvalued, citing significant undervaluation since 2019. The nominator submitted a request to CMS for the reevaluation of these codes, stating that the payment changes have created a concerning cascade of negative consequences impacting the care of patients with thyroid nodules and cancer. Specifically, the nominator questions the fundamental basis of CMS' 2019 work RVU reductions for FNA procedures. While the RUC recommended work RVUs of 1.20 for CPT code 10021 and 1.63 for CPT code 10005, CMS instead implemented lower values of 1.03 and 1.46, respectively. The nominator strongly disagreed with CMS' methodology, particularly its comparison to CPT code 36440 (neonatal blood transfusion). The nominator stated that this crosswalk comparison is inappropriate because the neonatal procedure represents a fundamentally different type of service with distinct work intensity levels, requires different expertise, is rarely billed to Medicare, and serves an entirely different patient population than FNA procedures.

The nominator further emphasized that when the work RVU for CPT code

10005 was reduced by 10.5 percent (from 1.94 to 1.46), it triggered a much larger 35.7 percent drop in payment. This substantial decrease has forced a significant shift in where these procedures are performed, moving from office-based settings to hospital facilities. Using claims data, the nominator stated that there has been a shift in the site of service for FNA procedures between 2018 and 2023; the percentage of procedures performed in facility settings increased from 52.06 percent in 2018 to 57.05 percent in 2023. Conversely, services performed in office settings declined from 47.05 percent in 2018 to 42.40 percent in 2023. The nominator claimed that this shift in performance of FNA from the office setting to hospital outpatient departments resulted in Medicare paying 524 percent more for the same procedure. With an additional cost of $584.92 per procedure at facility locations, the nominator claimed that this shift has resulted in increased Medicare expenses of $4.17 million.

Beyond the financial implications, the nominator stated that the low valuation of this code family has resulted in a shift to facility settings raising Medicare costs, reducing access, and reducing quality of care. According to the nominator, most concerning is the long-term impact on medical education, as new endocrinologists and surgeons are now avoiding learning FNA procedures altogether. Furthermore, the nominator referenced a study,\27\ which discusses the potentially negative consequences of code devaluation on patient care and healthcare spending. Overall, to address these issues, the nominator specifically requested that CMS restore the work RVU values to those originally recommended by the RUC in 2019, stating that CMS' previous crosswalk to neonatal transfusion described by CPT code 36440 (Push transfusion, blood, 2 years or younger) was inappropriate given the significant differences in work intensity levels and required expertise between the procedures.

\27\ THYROID Volume 34 Number 11, 2024 https://doi.org/10.1089/thy.2024.0442 Eldeiry, et al. “Impact of Changes in Fine Needle Aspiration Biopsy Reimbursement on Clinical Care of Patients with Thyroid Nodules in the United States”.

We appreciate the comprehensive information provided by the nominator, including their reference to recent research and detailed trend analysis. However, we note that these codes have undergone multiple recent reviews. Our review of these codes and our rationale for finalizing the current values are extensively discussed in the CY 2019 PFS final rule (83 FR 59517) and CY 2021 PFS final rule (85 FR 84599). Furthermore, this code family was previously nominated two times as potentially misvalued and discussed in the CY 2020 PFS final rule (84 FR 62625) and CY 2025 PFS final rule (89 FR 97743). For more information, we encourage the nominator to reference the discussions in previous rulemaking. We maintained our position and were not proposing this code family as potentially misvalued. We acknowledged the shift in site of service for FNA procedures between 2018 and 2023. We will continue to monitor the site-of-service trends closely. Should these patterns persist or accelerate, a new survey in the future may be necessary to accurately reflect these changes in practice patterns. We requested public comments and recommendations, including those from the RUC, regarding whether these codes should be re-reviewed in light of the information submitted by the nominator.

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

Comment: The RUC stated that it received notification of interest from a specialty society to re-review CPT codes 10005 and 10006. While the RUC indicated that it would place the fine needle aspiration codes (CPT codes 10005 and 10006) on its next Level of Interest (LOI) to review these services and submit recommendations for CY 2027, the RUC strongly suggests CMS to correct the previous error in valuing these services. The RUC reiterated that it has repeatedly commented on a mathematical error by CMS in valuing the fine needle aspiration codes, where CMS double-counted utilization data for codes with bundled image guidance, leading to incorrect assertions about a 20 percent physician work increase. The RUC suggested CMS to correct this computational error and accept its previously recommended work RVU values of 1.63 for CPT code 10005, 2.43 for CPT code 10009, and 1.20 for CPT code 10021. A few commenters stated that the codes are undervalued due to a double- counting error and expressed disapproval of CMS' refinement methodology, emphasizing that CMS should correct the mathematical error underlying the current work RVUs for CPT codes 10005, 10009, and 10021 and adopt the 2019 RUC-recommended values of 1.63, 2.43, and 1.20, respectively, which would resolve the issue.

Response: We reiterate that our review of these codes and our rationale for finalizing the current values were discussed in the CY 2019 PFS final rule (83 FR 59517 through 59521) and the CY 2021 PFS final rule (85 FR 84602 through 84604). We further explained this issue in the CY 2025 PFS final rule (89 FR 97743 through 97745).

Comment: A few commenters supported our proposal not to nominate the fine needle aspiration code family as potentially misvalued.

Response: We appreciate commenters for this feedback.

We appreciate the RUC placing the fine needle aspiration codes on its next LOI for CY 2026, and we are finalizing our proposal not to nominate these codes as potentially misvalued. (9) Nasal Sinus Irrigation (CPT Codes 31000 and 31002)

An interested party nominated CPT codes 31000 (Lavage by cannulation; maxillary sinus (antrum puncture or natural ostium)), and 31002 (Lavage by cannulation; sphenoid sinus) as potentially misvalued. The interested party expressed concern that these codes are undervalued due to missing pricing data for essential lavage supplies and stated that they are not currently priced in the non-facility setting.

Regarding both codes, the interested party identified two issues. They stated that this procedure uses the Cyclone[supreg] sinonasal suction and irrigation system, and requires additional tools, staff time and supplies. For CPT code 31000, the interested party stated that while the current PE supplies are valued at $33.68, this amount should be $333.68, reflecting a $300 increase to include the Cyclone device cost. Similarly, for CPT code 31002, the interested party proposed increasing the supply price from $26.74 to $326.74 to incorporate the Cyclone device cost. To support this claim, the interested party has provided seven paid invoices demonstrating the actual cost of the system.

The interested party also claimed that both codes do not have non- facility RVUs but are primarily performed in non-facility settings. According to the AMA's RUC database's procedure volume data, CPT code 31002 is performed in the non-facility setting 81.4 percent of the time and CPT code 31000 is reported 77.2 percent of the time in the non- facility setting.\28\

\28\ AMA RBRVS DataManager. American Medical Association. (2025, January 15). https://www.ama-assn.org/.

The interested party emphasized that these misvaluations have real- world implications for patient care. The current valuations may limit physicians' ability to provide these services in both facility and non- facility settings, potentially affecting patient access to

care, particularly for those who can only receive treatment in physician offices. Thus, the interested party requested a revaluation of the PE components for both codes and the establishment of non- facility PE inputs for these services.

Although we proposed not to designate these codes as potentially misvalued, we acknowledged the interested party's concerns about their current valuation. Specifically, these concerns could stem from missing pricing data and observed changes in the typical site of service and dominant specialty since the last valuation. We noted that CPT code 31000 is typically performed in the non-facility setting but question whether the Cyclone device is either typically used or necessary for the performance of this procedure. We noted that CPT code 31002 does not have non-facility PE inputs, however it seems to typically be performed in the office setting with the dominant specialty listed as Allergy/Immunology and not Otolaryngology. We also questioned whether the Cyclone device is either typically used or necessary for the performance of this procedure. We believed that both codes would require a comprehensive review to address these potential changes in typical site of service and dominant specialty, as well as PE valuation. We requested public comments regarding these issues concerning CPT codes 31000 and 31002. Interested parties were encouraged to submit relevant documentation, such as invoices or other evidence that demonstrates the typical resource costs for providing these services.

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

Comment: A few commenters, including the RUC, supported our proposal. The RUC stated that they did not receive any interest from allergy/immunology or otolaryngology specialties that perform these services. According to the RUC, the specialties noted that publicly available CMS data suggest a single allergy practice is primarily driving the use of CPT code 31002. If the allergy practice utilization is removed, otolaryngology is still the dominant specialty for this service. Additionally, the specialties agree with CMS that it is unclear whether the Cyclone product is “typical” for these procedures. Therefore, the RUC stated they will not review CPT codes 31000 and 31002 or comment on them further at this time. Another commenter noted the absence of non-facility payment for CPT code 31002, stating that this code should be valued in the non-facility setting.

Response: We appreciate the commenters for their feedback, specifically as it relates to the lack of non-facility payment for CPT code 31002 and may consider the commenters' feedback in future rulemaking.

After consideration of public comments, we are finalizing our proposal not to nominate nasal sinus irrigation (CPT codes 31000 and 31002) as potentially misvalued. (10) Portable X-Ray Services (HCPCS Codes R0070, R0075)

In the CY 2025 PFS final rule, we acknowledged that several portable x-ray (PXR) suppliers and trade organizations continue to express longstanding concerns with how payment is established for transportation services related to PXR as described by HCPCS codes R0070 and R0075 (89 FR 97809). We also noted interested parties' request for greater consistency in the pricing of these services (89 FR 97809 through 97810). We suggested that interested parties may best engage with the MACs on these issues by appropriately reporting cost data in the MAC requested format. We also recognized that we should maintain consistency in pricing these services that are more indicative of changes in costs that occur yearly. In the proposed rule, we sought comments on whether we should assign national pricing under the PFS for PXR transportation services; specifically, for HCPCS code R0070 (Transportation of portable x-ray equipment and personnel to home or nursing home, per trip to facility or location, one patient seen) and HCPCS code R0075 (Transportation of portable x-ray equipment and personnel to home or nursing home, per trip to facility or location, more than one patient seen). We believed that national pricing would be conducive to ensuring consistency in payment rates across localities and also create payment stability for these services.

To nationally price HCPCS codes R0070 and R0075, we could use reference codes that have only PE values and no work RVUs because these codes describe only the transportation services associated with PXR. Since these codes are currently paid using contractor pricing, we could also analyze the average MAC payment for them to inform national pricing. For example, we observed that HCPCS code R0070 was priced between $215 to 230 per service while HCPCS code R0075 was priced between $80 to 90 per service. Using these valuations could help to inform us of potential crosswalk codes to maintain consistency with the rates currently being paid. By converting the dollar payment for HCPCS codes R0070 and R0075 from Medicare Part B claims data into RVUs through the usage of our current conversion factor under the PFS, we identified potential crosswalk codes. For HCPCS code R0070, we could use a crosswalk to CPT code 93243 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; scanning analysis with report), which has a total national non-facility payment rate of $226.43 for CY 2025, and for HCPCS code R0075, we could use a crosswalk to CPT code 92582 (Conditioning play audiometry), which has a total national non-facility payment rate of $86.69 for CY 2025.

We requested comments from the public on whether we should consider national pricing for HCPCS codes R0070 and R0075, as well as whether these potential crosswalk codes would appropriately value these services, and any other factors we should consider.

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

Comment: All commenters mentioned they greatly appreciated CMS' recent updates to the Medicare Claims Processing Manual (MCPM) Chapters 13 and 23, consolidating prior manual chapters into chapter 13, section 90.3. Commenters stated the updates to the MCPM on the periodic review process, annual updates, and payment rate publication timelines, have allowed for greater transparency and collaboration between PXR suppliers and the MACs. However, given the recently updated MCPM guidelines that both MACs and PXR are operating under, commenters urged CMS to allow this process to proceed before establishing any national payment rate for HCPCS codes R0070 and R0075. Commenters state that establishing a national payment rate would fail to capture accurate resource costs for PXR services in rural and underserved areas. They also noted that national payment rates would not sufficiently account for geographic cost differences and would rely on inaccurate cost data.

Furthermore, we received a few comments in response to our comment solicitation to potentially crosswalk HCPCS codes R0070 and R0075 to CPT codes 93243 and 92582, respectively. Commenters opposed the idea and stated any attempt to crosswalk would not accurately reflect the costs of these services and potentially prevent access for our beneficiaries. In conclusion, all commenters were in support of operating under our updated MCPM

guidelines for PXR services and oppose any establishment of national rates for CY 2026.

Response: We appreciate commenters for their support on CMS' recent updates to the Medicare Claims Processing Manual (MCPM) chapters 13 and 23, consolidating prior manual chapters into chapter 13, section 90.3. We note that these recent MCPM manual updates are a result of longstanding concerns with how payment is established for transportation services related to PXR and we look forward to the increased collaboration between PXR suppliers and the MACs. Additionally, we recognize the MCPM manual updates for PXR services are recent and understand the preference for the framework to operate before establishing any national payment rates. However, we do want to also acknowledge that historically, under the PFS, various sources of information have helped inform payment for specific services used to establish direct PE inputs. These different methods can be used to derive pricing for specific products that are more reflective of their costs, such as performing market research, utilizing the invoice submission process, and reviewing cost information on Medicare claims. Therefore, the flexibility to use a variety of cost information to develop national rates under the PFS ratesetting methodology can help maintain resource costs for services and access to care for our beneficiaries.

After consideration of public comments, we will take into account the concerns raised by commenters to help inform any establishment of a national payment rate in future rulemaking. We also look forward to the continued dialogue between the MACs and PXR suppliers under the updated MCPM guidelines. (11) Cryoablation Therapy To Treat Postoperative Pain

An interested party requested we establish a code to describe the additional intraoperative time required by the surgeon to perform adjunctive cryoablation therapy for postoperative pain management. According to the interested party, intraoperative cryoablation therapy is performed as a supplemental procedure alongside primary surgical procedures to provide postoperative pain relief for up to 60 days. The therapy works by freezing nerves near the surgical site without causing permanent damage, temporarily blocking pain signals during the patient's recovery period. The interested party stated that this procedure requires an additional 20 to 30 minutes of intraoperative time for the surgeon beyond the primary surgical procedure. The interested party referenced clinical evidence highlighting the use of intraoperative cryoablation to reduce the need for opioids in postsurgical patients, as well as recent guideline recommendations.29 30

\29\ Miller DL, Hutchins J, Ferguson MA, Barhoush Y, Achter E, Kuckelman JP. Intercostal Nerve Cryoablation During Lobectomy for Postsurgical Pain: A Safe and Cost-Effective Intervention. Pain Ther. 2025 Feb;14(1):317-328. doi: 10.1007/s40122-024-00694-3.

\30\ Dunning J, Burdett C, Child A, Davies C, Eastwood D, Goodacre T, Haecker FM, Kendall S, Kolvekar S, MacMahon L, Marven S, Murray S, Naidu B, Pandya B, Redmond K, Coonar A. The pectus care guidelines: best practice consensus guidelines from the joint specialist societies SCTS/MF/CWIG/BOA/BAPS for the treatment of patients with pectus abnormalities. Eur J Cardiothorac Surg. 2024 66(1):ezae166.

Currently, there is no specific code to account for the additional physician work associated with intraoperative cryoablation therapy. According to the nomination letter, we included the Cryo Nerve Block Therapy (CryoNB) on the list of devices eligible for temporary additional payments under the Non-Opioids Prevent Addiction in the Nation (NO PAIN) Act \31\ in the CY 2025 OPPS final rule (89 FR 94353 through 94354). However, the interested party stated barriers still exist for physician adoption mainly because there is currently no code to account for the 20 to 30 additional minutes of physician work associated with the intraoperative administration and delivery of cryoablation therapy.

\31\ CY 2025 OPPS Final Rule, 89 FR 93912, 94354 (Nov. 27, 2024) (CMS specifically affirmed that “the CryoNB System meets the statutory requirements and should be paid separately under this provision.”).

Also, the interested party stated that many practitioners incorrectly interpret Medicare's anesthesia rules as prohibiting payment for extra professional services when the same surgeon provides ancillary cryoablation therapy.\32\ According to the nominator, while CMS typically does not allow separate payments for anesthesia services when the same physician performs both the surgical procedure and anesthesia, this limitation does not apply to cryoablation therapy for postoperative pain management.\33\ However, according to the interested party, ongoing confusion regarding this policy's application creates an unnecessary barrier to cryoablation procedures that could reduce or replace opioid use for Medicare beneficiaries.

\32\ See Medicare NCCI 2024 Coding Policy Manual, Chapter 13, pgs. 6-7 (revised Jan. 1, 2025), available at: https://www.cms.gov/files/document/13-chapter13-ncci-medicare-policy-manual-2025finalcleanpdf.pdf.

\33\ AHA Coding Clinic[supreg], Q3 2024 vol. 11, no. 3 (effective with discharges Aug. 1, 2024).

The interested party stated that establishment of a G-code for physician work associated with intraoperative cryoablation therapy for postoperative pain would facilitate greater access for patients who require or prefer non-opioid alternatives for pain relief. The interested party further stated that such a G-code would help promote patient access to this alternative to opioids by clarifying that Medicare anesthesia rules do not apply to cryoablation for postoperative pain when furnished by the same surgeon. We sought public comments on whether a new G-code is needed to account for the additional intraoperative time required to perform cryoablation therapy, including service elements and valuation of work and practice expense, including potential crosswalk codes.

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

Comment: Numerous commenters were in favor of establishing a G-code as they emphasized intraoperative intercostal nerve cryoablation being a clinically valuable adjunct therapy that significantly improves patient outcomes. Many commenters reported benefits to patients' post- operative recovery and pain control, particularly in reducing opioid use, and shorter length of stays. They emphasized that these benefits extend well beyond the immediate postoperative period and contribute to broader public health goals of reducing opioid dependence.

Commenters identified several significant barriers limiting their ability to offer this therapy. Commenters reported that cryoablation adds 20 to 40 minutes of surgical time, with most commenters noting an average of 20 to 30 minutes of additional surgical and anesthesia time per case that is not reflected in current coding. Commenters also stated that the procedure requires specialized equipment and staff training that is not reflected in the resource costs associated with the primary surgical procedure. Also, the commenters stated that misinterpretation of Medicare anesthesia rules and global surgery package guidelines has led many providers to incorrectly believe that cryoablation cannot be billed separately.

Based on this information, commenters made three recommendations: (1) establish a G-code for intraoperative cryoablation that recognizes the additional physician work and time required to perform this procedure during surgery; (2) include clarifying language in the CY 2026 PFS

or OPPS proposed rules to align physician billing guidelines with established American Hospital Association (AHA) coding guidance; and (3) confirm that Medicare anesthesia rules and global surgery rules do not apply to cryoablation performed for postoperative pain management.

Regarding the request that CMS establish a G-code to account for the additional physician work and time required to perform cryoablation, a commenter suggested CPT codes 32664 (Thoracoscopy, surgical; with thoracic sympathectomy) or 64809 (Sympathectomy, thoracolumbar) as reasonable crosswalks for establishing appropriate valuation, given similarities in time, intensity, and resources. Another commenter suggested valuing the code using crosswalk to an add- on (ZZZ Global) code within 20 to 35 minutes of intra-service time such as: CPT code 33268 (Exclusion of left atrial appendage, open, performed at the time of other sternotomy or thoracotomy procedure(s), any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) (List separately in addition to code for primary procedure)), CPT code 32667 (Thoracoscopy, surgical; with therapeutic wedge resection (eg, mass or nodule), each additional resection, ipsilateral (List separately in addition to code for primary procedure)), CPT code 32507 (Thoracotomy; with diagnostic wedge resection followed by anatomic lung resection (List separately in addition to code for primary procedure)), CPT code 33509 (Harvest of upper extremity artery, 1 segment, for coronary artery bypass procedure, endoscopic), CPT code 64643 (Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s) (List separately in addition to code for primary procedure)), CPT code 64645 (Chemodenervation of one extremity; each additional extremity, 5 or more muscles (List separately in addition to code for primary procedure)), and CPT code 64913 (Nerve repair; with nerve allograft, each additional strand (List separately in addition to code for primary procedure)).

In addition to creating a payment code, commenters requested that CMS provide billing guidance in the CY 2026 PFS or OPPS Proposed Rules that aligns with the established AHA coding guidance, explicitly allowing surgeons to bill separately for cryoablation when performed for postoperative pain management. According to the commenter, this intervention serves a distinct therapeutic purpose with different techniques, equipment, and clinical objectives than standard anesthesia administration.

Commenters also recommended that CMS confirm that Medicare global surgery rules and anesthesia rules do not restrict billing for intraoperative cryoablation. These commenters explained that cryoablation is a separate surgical objective from the primary procedure and should not be bundled, noting that this procedure serves a distinct clinical purpose separate from anesthesia.

Overall, commenters stated that, adopting these changes would align with the intent of the NO PAIN Act (section 4135 of the Consolidated Appropriations Act (CAA), 2023) and CMS' recognition of cryoablation devices in recent payment rules, ultimately accelerating adoption of evidence-based, non-opioid pain management strategies while supporting innovation in patient care. Commenters noted that as cryoablation represents a significant advancement in non-opioid care pain management, removing these barriers by implementing their recommendations can expand patient access to safe non-opioid alternatives, and align payment policy with strong clinical evidence supporting improved outcomes and reduced opioid use.

Response: We agree with commenters that an intraoperative intercostal nerve cryoablation is a clinically valuable adjunct therapy that significantly improves patient outcomes, with many reporting benefits to patients' post-operative recovery and pain control. Thus, we are finalizing the creation of a new add-on G code, HCPCS code G0571 (Intraoperative nerve(s) cryoablation for post-surgical pain relief (list separately in addition to code for primary service)) to be billed with a surgical procedure to account for additional time and resources required to perform cryoablation. For an add-on G code, we believe that CPT code 64645 (Chemodenervation of one extremity; each additional extremity, 5 or more muscles (List separately in addition to code for primary procedure)), with an intra-service time of 25 minutes and a work RVU of 1.39, is an appropriate crosswalk reference to capture the additional intraoperative time and complexity involved in furnishing this service. As this service would only be furnished in the Facility setting, we are not finalizing the direct PE inputs based on this crosswalk reference.

Also, we note that the cryoablation device is paid as a qualifying non-opioid treatment for pain relief under the OPPS/ASC as authorized by the NO PAIN Act. In the context of and in accordance with the NO PAIN Act, cryoablation for the purpose of postoperative pain management is separately billable by the interventionalist/surgeon performing another procedure. (12) Sleep Study (CPT Code 95800)

For CY 2026, an interested party re-nominated CPT code 95800 (Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone, and sleep time). This code was recently nominated two times as potentially misvalued in the CY 2024 PFS proposed rule (88 FR 52283 through 52284) and the CY 2025 PFS proposed rule (89 FR 61618 through 61619).

For the CY 2024 and CY 2025 PFS final rules, we stated that we were unable to properly assess whether CPT code 95800 is potentially misvalued and further stated that we could not identify whether disposable or reusable home sleep apnea testing (HSAT) devices are more commonly used based on the evidence submitted with the original nominations and subsequent comments that CMS received. To confirm whether disposable devices were more commonly used, the nominator commissioned a consulting group to conduct an independent survey of sleep medicine providers, developed with input from the American Academy of Sleep Medicine (AASM), which found that 60 percent of procedures reported with CPT code 95800 used fully disposable HSAT equipment among respondents who reported this service in 2023.

The nominator stated that CPT code 95800 is misvalued because there has been a fundamental shift in clinical practice from reusable equipment to disposable HSAT devices, but the current direct practice expense (PE) inputs still reflect the older reusable technology assumptions. The nominator stated that CMS currently models' payment for CPT code 95800 based on the use of a reusable sleep testing device (the WatchPAT 200) with a consumable component (WatchPAT probe), but the survey data demonstrates that the majority of procedures now use fully disposable devices like the WatchPAT ONE. According to the nominator, this misalignment between current medical practice and the direct PE inputs has resulted in inaccurate direct practice expenses for CPT code 95800 and created access challenges for Medicare beneficiaries, particularly in rural and remote areas, since the payment structure does not accurately reflect the actual costs and technologies used in contemporary sleep study practices. The

nominator recommended deleting the current equipment codes for reusable devices and adding a new supply code for the disposable WatchPAT ONE device to ensure that Medicare reimbursement rates align with the “typical procedure” methodology that now involves disposable rather than reusable equipment. For more details, we refer to the CY 2025 PFS final rule (89 FR 97741 through 97743). Also, we refer readers to the submitted nomination, which is posted in the public use files for this proposed rule available on our public website under PFS Federal Regulation Notices at https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices. [GRAPHIC] [TIFF OMITTED] TR05NO25.009

While we appreciate the survey, we note that there are several limitations that can influence the survey's generalizability, validity, and reliability. Some key limitations include a small sample of 25 complete responses with a low 12 percent survey engagement rate, and methodological constraints such as the short 17-day survey period.

Given that we only have access to the nominator's summary of their internal data and survey results with a few notable limitations, we propose to maintain the current direct PE supply and equipment inputs for CPT code 95800. We did not propose to nominate the code as potentially misvalued. We welcomed public comments, published studies, other surveys, and data on whether the typical procedure described by CPT code 95800 now involves the use of a disposable HSAT device rather than reusable equipment.

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

Comment: Several commenters supported our proposal to not nominate CPT code 95800 as potentially misvalued and advised us to continue monitoring this issue. They recommended CMS hold any adjustments to CPT code 95800 until after the RUC submits its final recommendations for the CY 2027 PFS proposed rule.

Response: We appreciate commenters for their feedback and look forward to reviewing the RUC recommendations per our standard process.

Comment: A commenter stated that the manufacturer and distributor of home sleep apnea testing (HSAT) devices conducted an independent survey of HSAT providers that specifically evaluated the practices of sleep medicine providers that billed CPT code 95800 in the prior year (2023). The purpose of the Survey was to evaluate the relative utilization of reusable vs. disposable HSAT devices used in procedures reported with CPT code 95800. The survey, which was developed with the input of the American Academy of Sleep Medicine (AASM) and was under the control of KNG Health through its design and implementation, concluded that 60 percent of procedures reported with CPT code 95800 used fully disposable HSAT equipment.

The commenter noted that there were 25 complete responses to their provider survey, which CMS cited as a small sample size. The commenter stated that CMS did not recognize that the 25 responses represented the practices and volume of 35 sleep practitioners, since certain respondents were practice administrators answering on behalf of multiple sleep practitioners. The commenter noted that the number of respondents is common in RUC surveys valuing new CPT codes. In addition, the commenter pointed out that the provider survey targeted a universe limited only to a random sample of accredited sleep providers who billed CPT code 95800 in 2023 for a Medicare FFS patient. According to the commenter, because of these specific parameters, the reported device use of the 35 total clinician respondents was more representative of the typical 95800 procedure. The commenter stated that the survey response rate of 12 percent of a targeted survey universe materially exceeds the typical RUC survey response rate used by CMS to value new or modified services. The commenter cited a U.S. Government Accountability Office (GAO) report found that the median response rate of RUC surveys was 2.2 percent, and more than 10 percent of RUC surveys had under 30 respondents.\34\ The commenter continued noting CMS's concern on the short 17-day period in the field, which according to the commenter is generally consistent with the in-field period for a RUC survey, where surveys must be distributed, collected, analyzed, and developed into recommendations to the RUC within approximately one month. The commenter described the RUC surveys as in the field for 2 to 3 weeks, consistent with their own survey. The commenter stated that they engaged an independent health consulting firm with experience in conducting provider surveys, as the manager of the survey. They also stated that they received assistance from the AASM CPT and RUC advisors, as well as health policy staff, who provided updates and additions to the survey before it was distributed. They stated that the survey was not overly restrictive in scope, as it gathered data on types of devices used, device brands, practice size, and typical HSAT volume across multiple HSAT testing codes and that survey recipients were not limited to a specific manufacturer's customers or sales contacts.

\34\ GAO, Medicare Physician Payment Rates: Better Data and Greater Transparency Could Improve Accuracy, GAO15-434, Medicare Physician Payment Rates: Better Data and Greater Transparency Could Improve Accuracy, U.S. GAO.

In conjunction with the details of the survey, the same commenter provided full-year sales data from 2024, which showed that more than 52 percent of WatchPAT tests were performed with

disposable devices. They also included data from the first half of 2025, which showed that more than 56 percent of WatchPAT tests used the disposable device rather than a reusable device confirming the trend of steadily increasing use of disposable HSAT devices. To reflect the shift in clinical practice associated with the use of disposable HSAT devices, the commenter provided an updated list of supply input changes. [GRAPHIC] [TIFF OMITTED] TR05NO25.010

They stated that establishing direct PE inputs consistent with the adjusted equipment and supply inputs described previously for code 95800, while retaining current labor and malpractice inputs, would result in an accurate valuation that reflects the costs associated with disposable HSAT device services.

Response: We appreciate all of the information provided, both as part of the initial request and alongside public comments. After additional consideration, we agree with commenters that the survey conducted by the device manufacturer provides additional data that augments what we received as part of the RUC recommendation. As the practice of medicine evolves to in some cases reflect a shift from reusable to disposable HSAT equipment, we believe that the direct practice expense inputs should reflect those changes. Therefore, based on the information provided by commenters regarding the outdated nature of the code and supply input pricing, and the additional information provided in public comments, we are finalizing an update to the PE inputs as described in Table A-C3 for CY 2026.

We inadvertently omitted the RUC requests listed below (see Table A-C4) from the proposed rule. We acknowledge receipt of these requests; however, because these codes were not addressed in the CY 2026 PFS proposed rule, we may consider them in future rulemaking.

[GRAPHIC] [TIFF OMITTED] TR05NO25.011

Lastly, we received several comments nominating codes as potentially misvalued for review and revaluation by CMS. These code families were not addressed in the CY 2026 PFS proposed rule; therefore, these comments are out of scope for this final rule. However, we note that commenters are welcome to submit these codes by February 10 of the coming year for consideration as potentially misvalued services in the CY 2027 PFS proposed rule. See the discussion at (TO BE ADDED) for more information on how to submit a nomination for a potentially misvalued code.