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

The Consolidated Appropriations Act (CAA), 2023 (Pub. L. 117-328), was signed into law on December 29, 2022. Section 4135(a) and (b) of the CAA, 2023, titled Access to Non-Opioid Treatments for Pain Relief, amended section 1833(t)(16) and section 1833(i) of the Act, respectively, to provide for temporary additional payments for non- opioid treatments for pain relief (as that term is defined in section 1833(t)(16)(G)(i) of the Act). In particular, section 1833(t)(16)(G) of the Act provides that with respect to a non-opioid treatment for pain relief furnished on or after January 1, 2025, and before January 1, 2028, the Secretary shall not package payment for the non-opioid treatment for pain relief into payment for a covered OPD service (or group of services) and shall make an additional payment for the non- opioid treatment for pain relief as specified in clause (ii) of that section. Clauses (ii) and (iii) of section 1833(t)(16)(G) of the Act provide for the amount of additional payment and set a limitation on that amount.

Paragraph (10) of section 1833(i) of the Act cross-references the OPPS provisions about the additional payment amount and payment limitation for non-opioid treatments for pain relief and applies them to payment under the ASC payment system. In particular, paragraph (A) of paragraph (10) of section 1833(i) of the Act, as added by section 4135(b) of the CAA, 2023, provides that in the case of surgical services furnished on or after January 1, 2025, and before January 1, 2028, additional payments shall be made under the ASC payment system for non-opioid treatments for pain relief in the same amount provided in clause (ii) and subject to the limitation in clause (iii) of section 1833(t)(16)(G) of the Act for the OPPS. Paragraph (B) of section 1833(i)(10) of the Act provides that a drug or biological that meets the requirements of 42 CFR 416.174 and is a non-opioid treatment for pain relief shall also receive additional payment in the amount provided in clause (ii) and subject to the limitation in clause (iii) of section 1833(t)(16)(G) of the Act.

Additional payments under this policy began on January 1, 2025. As stated in the CY 2025 OPPS/ASC final rule with comment period (89 FR 94343 through 94344), the statute directs CMS to provide “additional payment”, and for purposes of this policy, we interpret this language to be equivalent to “separate payment,” since CMS provides an additional payment by unpackaging the product and then making a separate payment. “Separate payment” is the more commonly used terminology in the OPPS rule and likely more familiar to readers. To avoid confusion, we will continue to use “separate payment” throughout the rest of this section, which we believe to be synonymous with “additional payment.” Under section 1833(t)(2)(E) of the Act, the temporary separate payments must be made in a budget neutral manner.

For background information on the ASC Payment Policy for Non-Opioid Post-Surgery Pain Management Drugs and Biologicals prior to CY 2025, please see the summary provided in the CY 2025 OPPS/ASC final rule with comment period (89 FR 94342 through 94343). 2. Final CY 2025 Non-Opioid Policy Implementation of Section 4135 of the CAA, 2023

In CY 2025, CMS finalized our implementation methodology for section 4135 of CAA, 2023 (89 FR 94343 through 94361) to provide for temporary separate payments for certain non-opioid treatment for pain relief in the hospital outpatient department and ambulatory surgical center settings on a temporary basis from January 1, 2025 through December 31, 2027. CMS also finalized regulation text at 42 CFR 416.174 and 42 CFR 419.43(k), which outline the payment for non-opioid pain management drugs, biologicals, and medical devices under both the ASC payment system and OPPS, respectively. a. Drugs and Biologicals Subject to the ASC Non-Opioid Policy (42 CFR 416.174)

Section 1833(i)(10)(B), titled “Transition”, provides that a drug or biological that meets the requirements of the regulation at 42 CFR 416.174, the current ASC non-opioid policy, and also meets the definition of a non-opioid treatment for pain relief at section 1833(t)(16)(G)(iv) of the Act shall receive separate payments under section 4135 of the CAA, 2023, subject to the payment limitation. In light of this requirement, we finalized in the CY 2025 OPPS/ASC final rule with comment period that drugs and biologicals that meet the definition of a non-opioid treatment for pain relief for purposes of section 4135 of the CAA, 2023 that were subject to the ASC policy for non-opioid treatments authorized by section 6082 of the SUPPORT Act in CY 2024, would instead receive separate payments, subject to the limitation, for the duration of the payment period for section 4135 of the CAA, 2023 (89 FR 94344). The policy was finalized to be in effect for the duration of the payment period for section 4135 of the CAA, 2023. b. Definition of Non-Opioid Treatment for Pain Relief

Section 1833(t)(16)(G)(iv) of the Act defines a non-opioid treatment for pain relief for a drug, biological product, or medical device, and requires, in part, that such a treatment not receive transitional pass-through payment and has payment packaged into a payment for a covered OPD service (or group of services). In addition, in order for a drug or biological product to qualify as a non-opioid treatment for pain relief, pursuant to section 1833(t)(16)(G)(iv)(I), the product must have “a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body's opioid receptors”. In order for a medical device to qualify as a non- opioid treatment for pain relief, pursuant to section 1833(t)(16)(G)(iv)(II) of the Act, it must, in part, be “used to deliver a therapy to reduce postoperative pain, or produce post- surgical or regional analgesia”. A medical device must also, pursuant to section 1833(t)(16)(G)(iv)(II)(aa) and (bb) of the Act have both “an application under section 515 of the Federal Food, Drug, and Cosmetic Act that has been approved with respect to the device, been cleared for market under section 510(k) of such Act, or is exempt from the requirements of section 510(k) of such Act pursuant to subsection (l) or (m) or section 510 of such Act or section 520(g) of such Act” and “demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed

in a clinical trial or through data published in a peer-reviewed journal”. c. Evidence Requirement for Medical Devices

To determine whether a medical device fulfills the statutory requirement that it has demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal, we finalized in the CY 2025 OPPS/ASC final rule with comment period (89 FR 94345) a policy to review all data submitted during the public comment period to determine if the device demonstrates the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids. In CY 2025, we encouraged interested parties submitting non-opioid device recommendations to submit any relevant literature that demonstrates that the named medical device replaces, reduces, or avoids opioid use per this statutory provision with their public comments. We review any literature submitted and determine whether it meets this evidence criterion. There is no requirement that commenters submit any data or literature with their device recommendations. If there is no data or literature submitted for a medical device, or if the materials submitted do not demonstrate any ability of the medical device to replace, reduce, or avoid opioids, the medical device would not meet this evidence criterion and would not qualify for separate payment under section 4135 of the CAA, 2023. d. Non-Opioid Product Indications (1) FDA-Approved Indications for Drugs and Biologicals

Section 1833(t)(16)(G)(iv)(I) of the Act specifies that to meet the definition of a non-opioid treatment for pain relief and to be eligible for separate payment, a drug or biological product must have a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body's opioid receptors.

Given these statutory requirements, we finalized a policy in the CY 2025 OPPS/ASC final rule with comment period (89 FR 94345 through 94346) only to approve separate payment for drug or biological products with an FDA-approved indication that closely aligns with the statutorily required indication language to reduce post-operative pain or produce post-surgical or regional analgesia. We noted that products with an indication that does not meet this statutory requirement would not qualify. We specifically stated that products with only a general pain indication will not qualify.

As discussed in the CY 2025 OPPS/ASC final rule with comment period (89 FR 94345 through 94346), we note that the Congress specifically included language at section 1833(t)(16)(G)(iv)(I) of the Act requiring that drugs or biologicals have “a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body's opioid receptors”. Therefore, products with an indication that does not meet the statutory requirement will not qualify. (2) Intended Use for Medical Devices

Regarding medical devices, section 1833(t)(16)(G)(iv)(II) of the Act specifies that such a device must be used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia to qualify for separate payment under section 4135 of the CAA, 2023. It also must have an application approved under section 515 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), have been cleared for market under section 510(k) of the FD&C Act, or be exempt from the requirements of section 510(k) of the FD&C Act pursuant to section 510(l) or (m) or 520(g) of the FD&C Act. For CY 2025, for medical devices, we finalized without modification our proposal that a device must be used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia to qualify for separate payment under section 4135 of the CAA, 2023 (89 FR 94346 through 94347). We also finalized that the medical device must have an application approved under section 515 of the FD&C Act, which has been cleared for market under section 510(k) of the FD&C Act, or be exempt from the requirements of section 510(k) of the FD&C Act pursuant to section 510(l) or (m) or 520(g) of the FD&C Act. (89 FR 94346 through 94347). This is consistent with the regulation text at 42 CFR 419.43(k)(2)(i) through (iv). e. Amount of Payment

Section 1833(t)(16)(G)(ii)(I) of the Act provides that, for a non- opioid treatment for pain relief that is a drug or biological product, the amount of separate payment is the amount of payment for such product determined under section 1847A of the Act that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the drug or biological, subject to a limitation, as described in the next section. Section 1833(t)(16)(G)(ii)(II) of the Act provides that, for a non-opioid treatment for pain relief that is a medical device, the amount of separate payment is the amount of the hospital's charges for the device, adjusted to cost, that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the device, subject to a limitation, as described in the next section.

In the CY 2025 OPPS/ASC final rule with comment period, we finalized a policy to assign a payment offset of zero dollars for the qualifying drugs, biologicals, and devices for CY 2025 (89 FR 94347 through 94348). A zero dollar offset means that we would not offset or remove the amount that the non-opioid product represents from the procedure payment rate when setting payment rates. We finalized a zero dollar offset for the initial year of the policy as some of these products are new products or newly separately paid in the OPPS setting and their costs may not be fully reflected yet in the cost of procedures in which they may be used. Therefore, we stated that the separate payment for a drug or biological would be determined by subtracting from the amount calculated using the methodology outlined in section 1847A of the Act the portion of the otherwise applicable Medicare OPD fee schedule associated with the drug or biological, which as previously discussed, we finalized to be zero dollars for CY 2025. For the amount of payment for a medical device, since we are unable to reduce charges to costs for ASCs, we stated that the separate payment amount would be contractor-priced by the ASC's Medicare Administrative Contractor reduced by the portion of the otherwise applicable Medicare OPD fee schedule amount associated with the medical device, which as previously discussed, we finalized to be zero dollars for CY 2025. These separate payment amounts are all subject to the payment limitation, described in the subsequent section.

Section 1833(i)(10) of the Act establishes the same separate payment for the ASC setting as for hospital outpatient departments, as described in section 1833(t)(16)(G)(ii) of the Act. Both separate payments are subject to the limitation in section 1833(t)(16)(G)(iii) of the Act, which specifies that the separate payment amount shall not exceed the estimated average of 18 percent of the OPD fee schedule amount for the OPD service (or

group of services) with which the non-opioid treatment for pain relief is furnished. Given this statutory requirement, starting on January 1, 2025 through December 31, 2027, we finalized paying the same separate payment amount for qualifying non-opioid products in both the HOPD and ASC settings.

As the statute requires separate payment for these non-opioid treatments for pain relief, these products cannot be packaged into the procedure payment. Under our current threshold packaging policy, if the estimated per day cost for a drug or biological is less than or equal to the applicable OPPS drug packaging threshold, we package payment for the drug or biological into the payment for the associated procedure. Similarly, under our comprehensive APC (C-APC) policy, we package all payments for services integral, ancillary, supportive, dependent, and adjunctive to the primary service into a single payment for the primary comprehensive service. For CY 2025, we finalized that non-opioid treatments for pain relief would not be subject to the threshold packaging policy and would also be separately paid when used during a comprehensive APC (C-APC) procedure in the HOPD setting (89 FR 94347 through 94348). See section V.B.1.a. of this final rule with comment period for more information regarding the drug packaging threshold. Section II.A.2.b. of this final rule with comment period contains further information on C-APC packaging. f. Payment Limitation

Section 1833(t)(16)(G)(iii) of the Act states that the separate payment amount specified in clause (ii), (which is described in the previous section) shall not exceed the estimated average of 18 percent of the OPD fee schedule amount for the OPD service (or group of services) with which the non-opioid treatment for pain relief is furnished, as determined by the Secretary.

In the CY 2025 OPPS/ASC final rule with comment period, we finalized a policy to base the 18 percent payment limitation on the volume weighted average of the payment rates of the top five primary procedures by volume into which a non-opioid treatment for pain relief would have their payment packaged, absent this policy. We also finalized applying the 18 percent payment limitation per date of service billed (89 FR 94349). g. Payment Limitation With No Claims Data

For drugs, biologicals, and devices with no claims data, such as for newly FDA-approved and marketed products or products that did not previously have their own product-specific HCPCS code by which to track payment and utilization data, we finalized in the CY 2025 OPPS/ASC final rule with comment period (89 FR 94350) a policy where CMS will utilize the services with which a product would be expected to be furnished and would typically be packaged absent this policy, to calculate the payment limitation based on expected clinical use patterns. The finalized policy stated that CMS will determine the service, or group of services, to use to calculate the payment limitation through engagement with interested parties and a review by CMS Medical Officers and clinical staff during annual rulemaking. In the absence of engagement from interested parties, we will determine clinically appropriate procedures with which we would expect the drug or device to be frequently used in order to determine the payment limitation, including review of FDA approval materials, procedures identified in literature available to CMS, and other relevant materials. We noted that we may update the payment limitation amount in future rulemaking as we gather additional claims data on the utilization of and payment for this product. 3. Final CY 2026 Non-Opioid Policy Implementation of Section 4135 of the CAA, 2023

For CY 2026, we proposed to continue the policies finalized in the CY 2025 OPPS ASC final rule without modification (90 FR 33745).

We stated in the CY 2026 OPPS/ASC proposed rule that we continue to believe a zero-dollar offset is appropriate for all qualifying products regulated under the non-opioid policy as some of these products are new products or newly separately paid in the OPPS setting and their costs may not be fully reflected yet in the cost of procedures in which they may be used. Additionally, the data used for CY 2026 ratesetting is derived from CY 2024 claims, which was prior to the effective date of this policy in CY 2025. Accordingly, we proposed to edit the regulation text at 42 CFR 416.174(c)(1) to remove the following text: “which is determined to be zero dollars for calendar year 2025”. We proposed to remove this language pertaining to the portion of the otherwise applicable Medicare OPD fee schedule amount for CY 2025, as we will discuss the appropriate amount in each year's rulemaking.

We noted that the final payment limitation calculation in the CY 2026 OPPS/ASC final rule with comment period would be based on the proposed procedure payment rates and utilization data available in the CY 2026 OPPS/ASC proposed rule. Therefore, the values included in Table 133, previously published as Table 83 in the CY 2026 OPPS/ASC proposed rule (90 FR 33748 and 33749), are approximate payment limitations based on the best data available at the time of writing the CY 2026 OPPS/ASC proposed rule. We note that the final payment limitations for the CY 2026 OPPS/ASC final rule with comment period are also based on the proposed payment rates in the CY 2026 OPPS/ASC proposed rule.

Table 131, previously published as Table 82 in the CY 2026 OPPS/ASC proposed rule (90 FR 33746 and 33747), includes citations to the indications of the drugs and biologicals proposed to have met the statutory requirements and qualify for separate payment for the CY 2026 OPPS/ASC proposed rule. We welcomed public comment on all of these policies, including the procedures used to determine the payment limitations that are detailed in Table 133.

We welcomed comments regarding additional drugs or devices that readers believe meet the criteria at 42 CFR 416.174 and 42 CFR 419.43(k) and should qualify as non-opioid treatments for pain relief. In the CY 2026 OPPS/ASC proposed rule, we stated we would review those comments, evaluate the products against the criteria, and, if appropriate, would finalize additional drugs and devices that meet these criteria as non-opioid treatments for pain relief in the CY 2026 OPPS/ASC final rule with comment period to begin payment in CY 2026.

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

Comment: Commenters were generally supportive of CMS paying for drugs paid under the ASC non-opioid treatment policy authorized by section 6082 of the SUPPORT Act under the policy authorized by section 4135 of the CAA, 2023 for the second year, including the C-APC exclusion of qualifying products. Commenters recommended that CMS begin to assess its authority for continuing a policy for the payment of non- opioid treatments for pain relief in future rulemaking, starting in CY 2028 and beyond, including making the current policy

permanent. Several commenters provided suggestions on how CMS could craft a policy to pay for non-opioid treatments for pain relief starting in CY 2028 and beyond.

Response: We thank commenters for their support. Comments about possible future funding, payments, and policies are outside the scope of this CY 2026 rule.

Comment: A commenter requested that CMS approve products for this policy off-cycle in order to provide more immediate access to new non- opioid products. This commenter suggested that adding new products upon approval will guarantee that patients have access to new non-opioid options as soon as possible. Many commenters stated that there needs to be access to all qualifying non-opioid treatments for pain relief, and noted the general importance of the availability of non-opioid alternatives.

Response: We thank the commenters for their insights regarding the importance of access to non-opioid treatments for pain relief, as well as the commenter's suggestion for us to approve products off-cycle to provide more immediate access. As we have noted in past rules, it is our priority to address the opioid epidemic and we are committed to evaluating and adjusting our current processes, if necessary, in order to ensure appropriate care or access for beneficiaries amidst the current opioid epidemic. We would expect the majority of non-opioid products that meet the statutory criteria to have already been addressed under this policy; however, we acknowledge there could be a small number of products that could newly meet the established criteria throughout the calendar year. Therefore, given our priorities in addressing the opioid epidemic, and the potential development of new non-opioid products, we believe it may be reasonable to consider a pathway to approve new products or products newly meeting the statutory requirements on a quarterly basis. We welcome engagement from the public on products that newly meet the qualifying criteria and should be paid according to the statute under this policy. Such engagement could include: (1) documentation verifying appropriate FDA status, including the required FDA-approved indication for drugs; (2) qualifying peer-reviewed literature for medical devices and that the medical device is used to deliver a therapy to reduce postoperative pain, or produce postsurgical or regional analgesia; (3) suggestions for the top 5 most frequent procedures for purposes of calculating a payment limitation; (4) verification that the product does not have transitional pass-through status; (5) confirmation that the product has payment that is packaged into a payment for a covered OPD service, and (6) the current HCPCS code describing the product or recommendations for a new HCPCS code to describe the product. Please see 42 CFR 419.43(k) and 416.174 for the full established criteria. As we are considering evaluating and updating the CY 2026 qualifying non-opioid treatments for pain relief, we are modifying the regulation text accordingly. Specifically, we are removing the phrase “through that year's rulemaking” and “for an applicable calendar year” from 42 CFR 419.43(k)(1), 419.43(k)(2), 416.174(a), and 416.174(b).

We anticipate that if any non-opioid treatments for pain relief qualify during CY 2026, our review process would be similar to the other existing quarterly approval processes, such as OPPS New Technology APC process or the CMS HCPCS application process, where CMS evaluates and approves products on a more frequent basis than annual rulemaking. A quarterly implementation process will be necessary to create new HCPCS codes and implement the necessary claims processing changes to effectuate the calculated payment rates as well as the required payment limitations. We will make payment, according to the statute, retroactively effective to the date that we determine that a product meets the criteria, with the earliest effective payment date being January 1, 2026. Once these determinations are made by us, we will make them publicly available on the CMS OPPS website.\213\ Payment will be made according to the statute, and established regulation text, and will be effectuated in the applicable quarterly OPPS/ASC update.

\213\ https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/restated-drug-biological-payment-rates.

Comment: We received many comments recommending CMS increase access to non-opioid products including commenters emphasizing the benefits of a broader interpretation of the statutory language requiring drugs and biologicals to have an FDA-approved indication to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body's opioid receptors. Several commenters requested that we allow drugs and biologicals, including those that are orally administered, that have FDA-approved indications for “acute pain” or other pain indications to qualify under this policy, rather than only those with the FDA-approved label indications to “reduce postoperative pain” or to “produce postsurgical or regional analgesia” that is prescribed by the Congress. Some commenters argued that products may receive a broader label that indicates their ability to treat moderate or severe acute pain with the intention of being used in every setting in which pain presents, including postoperatively. Commenters asserted that requiring non-opioid drugs to have a specific indication to reduce postoperative pain, or produce post-surgical or regional analgesia limits patient access to FDA-approved non-opioid treatments with broader indications, including in rural settings.

Several commenters stated their belief that FDA guidance provides that general pain indications can encompass situations in which analgesia or pain management is provided post operatively, and that general indications are often approved based on clinical trials in patients with postoperative pain. One commenter stated that they had discussed with the FDA and were not able to revise their FDA-approved indication. They believed that FDA did not consider it appropriate to add an express reference to postoperative or postsurgical use, due to the fact that adding additional specific language to the FDA-approved indication could be viewed as narrowing the approved indication. Commenters also argued that CMS does not require that the FDA-approved label state that the product must not act upon the body's opioid receptors and, therefore, should not require the indication to have an express reference to postoperative or postsurgical use.

Commenters also noted their belief that the FDA has issued guidance, which CMS understands to be labeled as draft guidance by the FDA, on the approval and labeling of general acute pain therapies, which states that such an indication is appropriate for a product that is supported by at least two successful clinical trials, including trials in postoperative pain. Commenters believed this FDA guidance made it clear that there was a need for a more expansive interpretation of the NO PAIN Act to ensure that products with broader labeling are taken fully into consideration by CMS for purposes to satisfying the criteria set forth by the NO PAIN Act. Commenters encouraged CMS consider FDA-approved labeling that includes products that have been studied in two successful clinical trials in postoperative pain.

Overall, commenters did not think it was appropriate for CMS to require the

indications specified in section 1833(t)(16)(G)(iv) of the Act strictly, and they believed that a broader label indication would still satisfy the requirements. Several commenters believed that drugs with more general pain indications, or indications that did not align with those as listed in the NO PAIN Act, satisfied the criteria of the Act and of the criteria CMS finalized. The drugs mentioned by commenters included Sprix, Caldolor, Journavx, gabapentinoids, Prialt, Celecoxib, XIFYRM, and acetaminophen.

Response: We thank the commenters for their input. As we discussed in section XIII.F.2. of the CY 2025 OPPS/ASC final rule with comment period (89 FR 94344 through 94347), the postoperative pain or postsurgical requirement, referred to in the public comments, is in section 1833(t)(16)(G)(iv) of the Act. The Congress specifically included language stating that, to meet the definition of a “non- opioid treatment for pain relief,” drugs or biologicals must have “a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body's opioid receptors”. We codified this provision at Sec. 419.43(k)(1)(i).

As we stated in the CY 2025 OPPS/ASC final rule with comment period (89 FR 94246), we “only approve separate payment for drug or biological products with an FDA-approved indication to reduce post- operative pain or produce post-surgical or regional analgesia. Products such as those with only a general pain indication will not qualify”. As we explained, if there is no mention of postoperative or post- surgical use in the FDA-approved indications for the products being evaluated, they do not meet the statutory requirement. For CY 2026, we continue to believe this approach conforms with the statute. While some commenters have asserted that a broad pain indication could include a more specific one, we do not agree that we can infer from a broad acute, or general, pain indication that the FDA also intended that the drug is indicated to reduce post-operative pain or produce post- surgical or regional analgesia, as that specific pain indication is not provided. We defer to the FDA to approve indications for drugs and biological products, based on the relevant statutory and regulatory authorities, and it is not within our purview to infer alternative or more specific pain indications that have not been specifically finalized in the FDA's review. Therefore, while we understand the commenters' concerns regarding revising the payment indication, determining whether the specific pain indications is met under a broader indication is not within our purview.

Because the statute is clear that an indication to reduce post- operative pain or product post-surgical or regional analgesia is required for separate Medicare payment under section 4135 of the CAA, 2023, we do not believe that we can look outside of the specific indication provided or to other sources that are not the FDA-approved Drug Label. Therefore, given the current labeling for the following products, we are not finalizing separate payment for the following products under the OPPS and ASC payment systems in this rule: Sprix, Caldolor, Journavx, gabapentinoids, Prialt, Celecoxib, XIFYRM, and acetaminophen. We note that these products may still be able to be paid under the OPPS/ASC payment system, for example, through packaged payments, but they do not currently qualify for additional separate payment under this provision.

After consideration of public comments, we are finalizing our proposal to continue the policies finalized in the CY 2025 OPPS ASC final rule with comment period with a minor modification to permit more timely consideration of payment requests.

Comment: Commenters supported our proposal to continue to set a zero-dollar offset for CY 2026. Additionally, we received a comment requesting that we keep the zero-dollar offset for qualifying products for CY 2026 and CY 2027. The commenter stated that by extending the policy, CMS removes potential financial barriers that could discourage the use of safer, non-opioid pain control options, which are particularly important in health outcomes for women.

Response: We thank commenters for their support. We will evaluate the need to continue to assign a zero-dollar offset in future rulemaking.

Comment: A commenter provided CMS suggestions and recommendations on how to best complete the Report to Congress assessing the impact of the Act, mandated by subsection C of section 4135 of the CAA, 2023.

Response: We appreciate this engagement on this component of the statute and look forward to continued collaboration with interested parties regarding this issue. We will take this information into consideration for future rulemaking. a. Qualifying Products for CY 2026

The following table, Table 134, previously published as Table 82 in the CY 2026 OPPS/ASC proposed rule (90 FR 33746 and 33747), lists the non-opioid alternatives that we proposed would receive separate payment as a non-opioid pain management drug or device under section 4135 criteria for CY 2026.

CMS routinely receives public comments with detailed rationales on why commenters believe a particular drug, biological, medical device, or other item or service should receive separate payment. As such, we solicited comment in the CY 2026 OPPS/ASC proposed rule on whether there are any additional drugs, biologicals, or medical devices that meet the statutory requirements outlined in sections 1833(t)(16)(G) and 1833(i)(10) of the Act. In addition to soliciting comment on the actual product and how it meets the criteria at 42 CFR 416.174 and 42 CFR 419.43(k), we solicited comment on the top five procedures used to calculate the payment limitation, as well as HCPCS coding for the product, which CMS could use to establish the payment rate, if CMS determines that the product discussed in the comment qualifies as a non-opioid treatment for pain relief, listed in Table 135.

As discussed previously in this section, there are specific requirements that must be met in order for the product to qualify for separate payment. In the CY 2026 OPPS/ASC proposed rule, we stated that interested parties that believed that a product not addressed in the proposed rule met the statutory requirements were encouraged to submit information during the comment period indicating how the product meets the statutory eligibility requirements. In the proposed rule, we stated that if CMS determines that the product(s) does in fact meet the statutory eligibility requirements, we would finalize separate payment for the product(s) in the CY 2026 OPPS/ASC final rule with comment period.

We stated that for drugs and biological products not addressed in the CY OPPS/ASC proposed rule, if no comment was submitted that outlines how that drug or biological meets the statutory criteria, then CMS would not finalize separate payment for such product for CY 2026. Additionally, for medical devices not addressed in the CY 2026 OPPS/ASC proposed rule, unless a comment was submitted that both outlines how that device meets the statutory criteria, including literature that demonstrates that the device has the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal,

CMS would not finalize separate payment for such device for CY 2026.

We proposed that the HCPCS codes describing the qualifying devices and drugs in Table 134 would be placed on the ASC covered ancillary procedures list. We noted that Medicare Administrative Contractors (MACs) determine whether a drug, device, procedure, or other service meets all program requirements and conditions for coverage and payment. HOPDs and ASCs only receive payment for qualifying drugs, biologicals, and medical devices when the appropriate MAC determines that the service meets the relevant conditions for coverage and payment. As we have consistently stated in past OPPS/ASC final rules with comment period (see, for example, 87 FR 71879 and 88 FR 81660 through 81661), the fact that a drug, device, procedure or service is assigned a HCPCS code and a payment rate under the OPPS does not imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the program (see, for example, Pub 100-04 Medicare Claims Processing, Transmittal 11937). BILLING CODE 4120-01-P

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

Comment: Commenters were generally supportive of our proposals on the qualifying products in Table 82 of the CY 2026 OPPS/ASC proposed rule, republished as Table 134 in this final rule with comment period, and they recommended that we finalize those products for separate payment for CY 2026. These commenters were also generally supportive of most aspects of the implementation of this policy, including the payment amounts for these products and the payment limitations.

Response: We thank the commenters for their support, and we are finalizing those products for separate payment, with updates to their product specific payment limitations as listed in Table 137.

Comment: A commenter requested clarification regarding the established descriptor for HCPCS code C9806 (Rotary peristaltic infusion pump (e.g., ambIT Pump), including catheter and all disposable system components, non-opioid medical device (must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) and whether it could be used to describe both reusable and disposable versions of the ambIT pump. This commenter stated that the literature provided concludes lowered opioid usage with both versions of the pump, disposable and reusable.

Response: We thank the commenter for their question and input. We believe that it is appropriate to create a new C-code to describe the reusable version of the ambIT pump. Specifically, we are creating C9816 (Rotary peristaltic infusion pump (e.g., reusable ambIT Pump) including all disposable system components, reusable non-opioid medical device (must be a qualifying Medicare non-opioid medical device for post- surgical pain relief in accordance with section 4135 of the CAA, 2023)) to describe the reusable version of the pump. Please see Table 137 for the payment limitation calculation and the new C-code used to describe the device.

Comment: A commenter supported the continuation of the products described by HCPCS Code C9808 (Nerve cryoablation probe (e.g., cryoice,

cryosphere, cryosphere max, cryoice cryosphere, cryoice cryo2), including probe and all disposable system components, non-opioid medical device (must be a qualifying medicare non-opioid medical device for post-surgical pain relief in accordance with section 4135 of the CAA, 2023)) as qualifying non-opioid treatments for pain relief. This commenter requested that CMS add the CryoXT cryoablation probe to that HCPCS code descriptor. This commenter stated that this product was not widely available on the market at the time that the CY 2025 OPPS/ASC final rule with comment period was published, but they believe that this device should also meet the qualifying criteria. They state this device has the same mechanism of action as the cryoNB probes that were studied in the clinical literature, previously submitted by this same commenter, and since this new device is substantially equivalent, and is a predicate device, to devices that were studied in the literature, the commenter believed that the CryoXT should also qualify for separate payment.

Response: Based on the comment received, we find that the CryoXT medical device is used to deliver a therapy, cryoablation, as stated in the device's 510k summary, to reduce postoperative pain or produce post-surgical or regional analgesia. Accordingly, we confirmed that this device has FDA clearance.\214\ However, the supporting literature does not specifically name the CryoXT medical device or demonstrate that this device, specifically, has the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal.\215\ \216\ \217\ \218\ \219\ \220\ \221\ We believe that the device demonstrating the ability to reduce, replace, or avoid opioid use in a clinical trial or peer-reviewed journal must be the same device as the one being studied in order to qualify for separate payment under section 4135. Therefore, we are not finalizing a change to the descriptor of HCPCS code C9808 to include CryoXT as requested by this commenter for CY 2026.

\214\ FDA approval letter, April 10, 2025, (K250371) https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250371.pdf.

\215\ O'Connor LA, Dua A, Orhurhu V, Hoepp LM, Quinn CC. Opioid Requirements After Intercostal Cryoanalgesia in Thoracic Surgery. J Surg Res. 2022; 274:232-241.

\216\ Maxwell CM, Weksler B, Houda J, Fernando HC. Intercostal Cryoablation During Video-Assisted Lung Resection Can Decrease Postoperative Opioid Use. Innovations 2023 18(4):352-356.

\217\ Jaroszewski DE, Bostoros P, Farina JM, Botros MM, Aly MR, Peterson M, Lackey J, Pulivarthi KV, Smith B, Craner R, Stearns JD. Evolution of Pain Control for Adult Pectus Excavatum Repair. Ann Thorac Surg. 2024;117(4):829-837.

\218\ Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation during the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatric Surg. 2019 Nov;54(11):2250- 2256.

\219\ 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.

\220\ Kleiboeker HL, Hall DJ, Lowery EM, Hayney MS, Maloney JD, DeCamp MM, McCarthy DP. Intercostal nerve cryoablation as part of an opioid-sparing protocol reduces opioid and epidural use after lung transplant. JHLT Open. 2024;4:100084.

\221\ Notrica DM, McMahon LE, Hahn A, Ndikintum N, Dua M, Jaroszewski DE. Intercostal Nerve Cryoablation During Pectus Excavatum Surgery for Postoperative Pain Management: A Systematic Review and Meta-Analysis. Ann Surg. 2025; doi: 10.1097/ SLA.0000000000006855. Epub ahead of print.

Comment: Commenters requested that we evaluate and approve the SapphireTM infusion system manufactured by Eitan Medical, under our non-opioid treatment for pain relief separate payment policy. Per the manufacturer, among other uses, the SapphireTM infusion system is used to deliver therapies to reduce post-surgical pain and/or product post-surgical or regional analgesia in the outpatient setting. The manufacturer provided that the SapphireTM infusion system has been cleared by the FDA under 510(k) as a Class II device (K192860) \222\ and has supporting literature. The manufacturer explained that a range of surgeries requiring postoperative analgesia including shoulder, knee and ankle arthroplasties, thoracic surgery, gynecological surgeries, and spine surgery have been supported with anesthesia and postoperative pain control with the SapphireTM infusion system. The manufacturer provided four HCPCS procedure codes with which they believed the SapphireTM infusion system could be used for post-surgical pain management.

\222\ FDA Approval Letter, November 7, 2020, http://www.accessdata.fda.gov/cdrh_docs/pdf19/K192860.pdf.

Response: Based on comments received, we find that this medical device is used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia. We confirmed that this product is FDA cleared \223\ and has supporting literature demonstrating the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer reviewed journal.\224\ The medical device does not currently receive transitional passthrough status and we believe it would have payment that is otherwise packaged into a payment for a covered OPD service, absent this policy. Therefore, we believe that the SapphireTM medical device meets the statutory requirements at section 1833(t)(16)(G)(iv) of the Act and we are finalizing that it will be paid separately under this provision. We appreciate the commenter's suggestions regarding the top five procedures on which to base the payment limitation. Based on our review of the device, as well as the volume of services in which the device is most likely to be used, we believe that the top five procedures to base the payment limitation on are: HCPCS codes 27447 (Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty)), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 29827 (Arthroscopy, shoulder, surgical; with rotator cuff repair), and 29881 (Arthroscopy, knee, surgical; with meniscectomy (medial OR lateral, including any meniscal shaving) including debridement/shaving of articular cartilage (chondroplasty), same or separate compartment(s), when performed). We will assume an equal utilization of the device with these five procedures for the payment limitation calculation, as shown in Table 137 at the end of this section. We note that in the absence of utilization data for the top five procedures, we believe it is reasonable to assume equal utilization for purposes of calculating the payment limitation until claims data are available. Please see Table 137 for the payment limitation calculation and the new C-code used to describe the device.

\223\ FDA Approval Letter, November 7, 2020, http://www.accessdata.fda.gov/cdrh_docs/pdf19/K192860.pdf.

\224\ Liang, T.-W., Shen, C.-H., Wu, Y.-S., Chang, Y.-T. (2024) Erector spinae plane block reduces opioid consumption and improves incentive spirometry volume after cardiac surgery: A 4 [verbar] Page Eitan Medical North America Inc. 65 Enterprise--STE 485, Aliso Viejo, CA 92656 www.eitanmedical.com Tel. 877-541-9944 [verbar] Fax. 949-288-5482 retrospective cohort study. Journal of the Chinese Medical Association, 87(5): 550-557. DOI: ad10.1097/ JCMA.0000000000001086.

Comment: Commenters requested that we evaluate and approve the AvosetTM infusion system manufactured by Eitan Medical, under our non-opioid treatment for pain relief separate payment policy. They noted that the AvosetTM infusion system is a compact ambulatory infusion pump, similar to Eitan Medical's SapphireTM infusion system. Like the SapphireTM infusion system, the AvosetTM infusion system is used to deliver therapies to reduce post-surgical pain and/or product post- surgical or regional analgesia in the outpatient setting. The AvosetTM infusion system has been cleared by the FDA under 510(k) as a Class II device. The manufacturer provided four HCPCS procedure codes with which they believed the AvosetTM infusion system could be used for post-surgical pain management.

The manufacturer pointed to the clinical evidence submitted for the SapphireTM infusion system as evidence that the AvosetTM infusion system has the ability to replace, reduce, or avoid intraoperative or postoperative opioid use in a clinical trial or through data published in a peer-reviewed journal. Per the commenter, the evidence for the SapphireTM device also provides evidence for the AvosetTM device since SapphireTM was one of the predicate devices deemed substantially equivalent to the AvosetTM device by the FDA. The manufacturer noted their plans to submit data on the AvosetTM device to the November 2025 American Society of Regional Anesthesia 24th Annual Pain Medicine Meeting. The manufacturer also submitted articles providing supportive evidence for electronic infusion pumps, generally, which do not name either the SapphireTM or AvosetTM infusion systems. The commenter urged us to interpret the statutory language in section 4135 of the CAA, 2023 to allow for evidence of the effectiveness of therapies using infusion devices to reduce or eliminate opioid use for postoperative pain, even if the device named in the trial or data is not the same infusion device for which separate payment is requested. The commenter believes that an expanded interpretation of the literature requirement will allow for greater access to non-opioid postoperative pain therapies and lower costs to the Medicare program.

Response: Based on the comments received, we find that the Avoset medical device is used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia. We confirmed that the device has FDA clearance.\225\ However, the supporting literature does not demonstrate that the AvosetTM device specifically has the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer reviewed journal. While we acknowledge that SapphireTM may be the predicate device for the AvosetTM infusion system, we believe that the device demonstrating the ability to reduce, replace, or avoid opioid use in a clinical trial or peer-reviewed journal must be the same device as the one being studied in order to qualify for separate payment under section 4135 of the CAA, 2023. Therefore, we believe that the AvosetTM medical device does not meet the statutory requirements at section 1833(t)(16)(G)(iv)(II) of the Act and are not finalizing separate payment for it under this provision. We understand that peer reviewed literature may be forthcoming for this device, but it was not available at the time of writing of this final rule with comment period. We can take new clinical evidence regarding the named device into consideration for future rulemaking.

\225\ FDA Approval Letter, March 10, 2023, https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213744.pdf.

Ultrasound-Visible Nerve Block Needles (SonoPlex, SonoBlock, SonoTap)

Comment: A commenter recommended CMS evaluate and approve ultrasound-visible nerve block needles, specifically the SonoPlex, SonoBlock, and SonoTap medical devices manufactured by PAJUNK, under our non-opioid treatment for pain relief separate payment policy. The commenter stated that the nerve block needles are cleared by the FDA as 510(k) devices to inject local anesthetic to achieve regional analgesia and have supporting literature.

The commenter provided five HCPCS codes with which they requested CMS establish the payment limitation. These CPT codes are: 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 27447 (Arthroplasty, knee, condyle and plateau; medial and lateral compartments with or without patella resurfacing (total knee arthroplasty)), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), 27792 (Open treatment of distal fibular fracture (lateral malleolus), includes internal fixation, when performed), and 19301 (Mastectomy, partial (e.g., lumpectomy, tylectomy, quadrantectomy, segmentectomy)).

Response: Based on comments received, we find that ultrasound- visible nerve block needles are used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia. We confirmed that the three named ultrasound-visible nerve block needles, SonoPlex, SonoBlock, and SonoTap, are FDA cleared 226 227 228 and have supporting literature demonstrating the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer reviewed journal.229 230 231 The medical device does not currently receive transitional passthrough status and we believe it would have payment that is otherwise packaged into a payment for a covered OPD service, absent this policy. Therefore, we believe that the three named ultrasound-visible nerve block needles, specifically the SonoPlex, SonoBlock, and SonoTap medical devices, meet the statutory requirements at section 1833(t)(16)(G)(iv) of the Act and are finalizing that they will be paid separately under this provision. We appreciate the commenter's suggestions regarding the top five procedures on which to base the payment limitation. Based on our review of the devices, as well as the volume of services in which the devices are most likely to be used, we believe that the top five procedures to base the payment limitation on are: HCPCS codes 27447 (Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty)), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft

or allograft), 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 29827 (Arthroscopy, shoulder, surgical; with rotator cuff repair), and 29881 (Arthroscopy, knee, surgical; with meniscectomy (medial OR lateral, including any meniscal shaving) including debridement/shaving of articular cartilage (chondroplasty), same or separate compartment(s), when performed). We will assume an equal utilization of the devices with these 5 procedures for the payment limitation calculation, as shown in Table 137 at the end of this section. We note that in the absence of utilization data for the top 5 procedures, we believe it is reasonable to assume equal utilization for purposes of calculating the payment limitation until claims data are available. Please see Table 137 for the payment limitation calculation and the new C-code used to describe the ultrasound-visible nerve block needle devices.

\226\ FDA Approval Letter (SonoPlex), June 27, 2025, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243682.

\227\ FDA Approval Letter (SonoBlock), November 11, 2024, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241954.

\228\ FDA Approval Letter (SonoTap), March 24, 2025, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243525.

\229\ Sahap et al. (2023), Ultrasound-guided vs Laparoscopic- assisted Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: A Randomized Prospective Study.

\230\ Cosarcan (2024), The effect of ultrasound-guided rectus sheath block on postoperative analgesia in robot assisted prostatectomy: A randomized controlled trial.

\231\ Kukreja et al. (2023), Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial.

Perforated Continuous Infusion Catheter Set (InfiltraLong)

Comment: A commenter recommended CMS evaluate and approve a perforated continuous infusion catheter set, specifically the InfiltraLong medical device manufactured by PAJUNK, under our non- opioid treatment for pain relief separate payment policy. The commenter stated that the InfiltraLong device is a self-contained system intended for continuous or intermittent pre-operative, peri-operative, or post- operative delivery of a local anesthetic at the surgical site. Per the commenter, the device's distribution of local anesthetic optimizes patient analgesia and improves outcomes while reducing opioid consumption. The commenter stated that the InfiltraLong device is cleared by the FDA and has supporting literature.

The commenter provided five HCPCS codes with which they requested CMS establish the payment limitation. These CPT codes are: 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 27447 (Arthroplasty, knee, condyle and plateau; medial and lateral compartments with or without patella resurfacing (total knee arthroplasty)), 49650 (Laparoscopy, surgical; repair initial inguinal hernia), 15847 (Excision, excessive skin and subcutaneous tissue (includes lipectomy), abdomen (e.g., abdominoplasty) (includes umbilical transposition and fascial plication) (list separately in addition to code for primary procedure)), and 21601 (Excision of chest wall tumor including rib(s)).

Response: Based on comments received, we find that this medical device is used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia. We confirmed that this product is FDA cleared \232\ and has supporting literature demonstrating the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer reviewed journal.\233\ The medical device does not currently receive transitional passthrough status and we believe it would have payment that is otherwise packaged into a payment for a covered OPD service, absent this policy. Therefore, we believe that the InfiltraLong medical device meets the statutory requirements at section 1833(t)(16)(G)(iv) of the Act and are finalizing that it will be paid separately under this provision. We appreciate the commenter's suggestions regarding the top five procedures on which to base the payment limitation. Based on our review of the device, as well as the volume of services in which the device is most likely to be used, we believe that the top five procedures to base the payment limitation on are: HCPCS codes 27447 (Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 29827 (Arthroscopy, shoulder, surgical; with rotator cuff repair), and 29881 (Arthroscopy, knee, surgical; with meniscectomy (medial OR lateral, including any meniscal shaving) including debridement/shaving of articular cartilage (chondroplasty), same or separate compartment(s), when performed). We will assume an equal utilization of the device with these five procedures for the payment limitation calculation, as shown in Table 137 at the end of this section. We note that in the absence of utilization data for the top five procedures, we believe it is reasonable to assume equal utilization for purposes of calculating the payment limitation until claims data are available. Please see Table 137 for the payment limitation calculation and the new C-code used to describe the device.

\232\ FDA approval letter, June 20, 2008, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K080675.

\233\ Narayan et al (2021), Continuous Wound Infusion as an Alternative to Continuous Epidural Infusion for Postoperative Analgesia in Renal Transplant Surgery: A Prospective Randomized Controlled Trial.

Atraumatic Spinal Anesthesia Needle (Sprotte)

Comment: A commenter recommended CMS evaluate and approve an atraumatic spinal anesthesia needle, specifically the Sprotte medical device manufactured by PAJUNK, under our non-opioid treatment for pain relief separate payment policy. The commenter stated that the Sprotte device is used to administer anesthetic agents to the subarachnoid space in spinal anesthesia procedures. Per the commenter, the Sprotte device enables physicians to more effectively use spinal anesthesia, which allows for longer, controlled pain relief compared to post- surgical IV opioids. The commenter stated that the Sprotte device is cleared by the FDA 234 235 and has supporting literature.

\234\ FDA approval letter, May 4, 1992, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K911202.

\235\ FDA approval letter, March 14, 2025, https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250774.pdf.

The commenter provided five HCPCS codes with which they requested CMS establish the payment limitation. These CPT codes are: 27447 (Arthroplasty, knee, condyle and plateau; medial and lateral compartments with or without patella resurfacing (total knee arthroplasty)), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), 52601 (Transurethral electrosurgical resection of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included)), 52235 (Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of; medium bladder tumor(s) (2.0 to 5.0 cm)), and 52000 (Cystourethroscopy (separate procedure)).

Response: Based on the comments received, we find that this medical device is used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional anesthesia. We confirmed that this device has 510(k) approval by the FDA.\236\ However, the

supporting literature does not demonstrate that the Sprotte device specifically has the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer- reviewed journal. In one of the articles submitted, it is not possible to verify whether the patients in the intervention group were using the Sprotte device or an alternative needle, called the Quincke. Therefore, we cannot attribute the study results to either device. The other article that was submitted only compared the efficacy between the Sprotte and Quincke needles, and therefore, we similarly could not find clinical evidence to demonstrate that the Sprotte device specifically has the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed.

\236\ FDA approval letter, May 4, 1992, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K911202.

Therefore, we believe that the atraumatic spinal anesthesia needle, specifically the Sprotte medical device, does not meet the statutory requirements at section 1833(t)(16)(G)(iv)(II) of the Act and are not finalizing separate payment for it under this provision. Continuous Anesthesia Conduction Catheter Sets (SonoLong, E-Cath)

Comment: A commenter recommended CMS evaluate and approve continuous anesthesia conduction catheter sets, specifically the SonoLong and E-Cath medical devices manufactured by PAJUNK, under our non-opioid treatment for pain relief separate payment policy. Per the commenter, the SonoLong and E-Cath devices are similar to the SonoPlex, SonoBlock, and SonoTAP nerve block needles, which improve needle and catheter placement, except that SonoLong and E-Cath stay in the nerve block site to provide pain relief days after surgery. The commenter provided that the catheter sets are cleared by the FDA. Per the commenter, the intended use of the SonoLong device is the delivery of continuous conduction anesthesia and/or analgesia of peripheral nerves for up to 72 hours, while the intended use of the E-Cath device is the delivery of medication for regional anesthesia and pain management. The commenter submitted literature to advance their claim that both devices have the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal.

The commenter provided 5 HCPCS codes with which they requested CMS establish the payment limitation. These CPT codes are: 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 27447 (Arthroplasty, knee, condyle and plateau; medial and lateral compartments with or without patella resurfacing (total knee arthroplasty)), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), 27792 (Open treatment of distal fibular fracture (lateral malleolus), includes internal fixation, when performed), and 21811 (Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 1-3 ribs).

Response: Based on comments received, we find that both of these medical devices are used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia. We confirmed that the products are FDA cleared.237 238 We also confirmed that the SonoLong device has supporting literature demonstrating the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer reviewed journal.\239\ However, we were not able to confirm that the E-Cath device had supporting literature. While one of the two articles submitted did not study the E-Cath device specifically,\240\ the other article submitted by the commenter did not differentiate between the two studied devices.\241\ We cannot attribute any result to the E-Cath device because it was either not studied at all in one study, or unclear whether it was utilized over another device in the other study. Therefore, we believe that the E-Cath medical device does not meet the statutory requirements at section 1833(t)(16)(G)(iv)(II) of the Act and are not finalizing separate payment for it under this provision.

\237\ FDA approval letter (E-Cath), July 13, 2016, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152952.

\238\ FDA approval letter (SonoLong), March 1, 2012, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113188.

\239\ Al Ja'bari et al. (2019), A randomised controlled trial of the pectoral nerves-2 (PECS-2) block for radical mastectomy.

\240\ Id.

\241\ Kim et al. (2022), Initiation Timing of Continuous Interscalene Brachial Plexus Blocks in Patients Undergoing Shoulder Arthroplasty: A Retrospective Before and-After Study.

The rest of this discussion is only applicable to the SonoLong device. The SonoLong device does not currently receive transitional passthrough status and we believe it would have payment that is otherwise packaged into a payment for a covered OPD service, absent this policy. Therefore, we believe that the SonoLong medical device meets the statutory requirements at section 1833(t)(16)(G)(iv) of the Act and are finalizing that it will be paid separately under this provision. We appreciate the commenter's suggestions regarding the top five procedures on which to base the payment limitation. Based on our review of the device, as well as the volume of services in which the device is most likely to be used, we believe that the top five procedures to base the payment limitation on are: HCPCS codes 27447 (Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 29827 (Arthroscopy, shoulder, surgical; with rotator cuff repair), and 29881 (Arthroscopy, knee, surgical; with meniscectomy (medial OR lateral, including any meniscal shaving) including debridement/shaving of articular cartilage (chondroplasty), same or separate compartment(s), when performed). We will assume an equal utilization of the device with these five procedures for the payment limitation calculation, as shown in Table 137 at the end of this section. We note that in the absence of utilization data for the top five procedures, we believe it is reasonable to assume equal utilization for purposes of calculating the payment limitation until claims data are available. Please see Table 137 for the payment limitation calculation and the new C-code used to describe the device. CADD-Solis Ambulatory Infusion Pump

Comment: Commenters recommended CMS evaluate and approve the CADD- Solis infusion pump manufactured by ICU Medical, under our non-opioid treatment for pain relief separate payment policy. Per the commenters, the CADD-Solis infusion pump is a medical device designed to deliver medication to reduce postoperative pain or produce postsurgical or regional analgesia. One commenter provided that the CADD-Solis infusion pump has FDA clearance and is indicated for intravenous, intra- arterial, subcutaneous, intraperitoneal, in close

proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space or subarachnoid space. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses. The manufacturer submitted literature to demonstrate that the CADD-Solis infusion pump has the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer reviewed journal.

The commenter provided five HCPCS codes with which they requested CMS establish the payment limitation. These CPT codes are: 27447 (Arthroplasty, knee, condyle and plateau; medial and lateral compartments with or without patella resurfacing (total knee arthroplasty)), 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 29827 (Arthroscopy, shoulder, surgical; with rotator cuff repair), 49505 (Repair initial inguinal hernia, age 5 years or older; reducible), and 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft).

Response: Based on comments received, we find that this medical device is used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia. We confirmed that this product is FDA cleared \242\ and has supporting literature demonstrating the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer reviewed journal.\243\ The medical device does not currently receive transitional passthrough status and we believe it would have payment that is otherwise packaged into a payment for a covered OPD service, absent this policy. Therefore, we believe that the CADD-Solis infusion pump meets the statutory requirements at section 1833(t)(16)(G)(iv) of the Act and are finalizing that it will be paid separately under this provision. We appreciate the commenter's suggestions regarding the top five procedures on which to base the payment limitation. Based on our review of the device, as well as the volume of services in which the device is most likely to be used, we believe that the top five procedures to base the payment limitation on are: HCPCS codes 27447 (Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 29827 (Arthroscopy, shoulder, surgical; with rotator cuff repair), and 29881 (Arthroscopy, knee, surgical; with meniscectomy (medial OR lateral, including any meniscal shaving) including debridement/shaving of articular cartilage (chondroplasty), same or separate compartment(s), when performed). We will assume an equal utilization of the device with these 5 procedures for the payment limitation calculation, as shown in Table 137 at the end of this section. We note that in the absence of utilization data for the top five procedures, we believe it is reasonable to assume equal utilization for purposes of calculating the payment limitation until claims data are available. Please see Table 137 for the payment limitation calculation and the new C-code used to describe the device.

\242\ FDA approval letter, August 24 2017, https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170982.pdf.

\243\ Abbasian, et al (2022). Multimodal continuous ambulatory erector spinae catheter pain protocol for early recovery following Nuss procedure: a retrospective cohort study; American Society of Regional Anesthesia & Pain Medicine.

Comment: We received a comment recommending CMS evaluate and approve the Altius System[supreg] manufactured by Neuros, under our non-opioid treatment for pain relief separate payment policy. Per the commenter, the Altius System[supreg] is designed for the treatment of chronic post-amputation pain. The commenter stated that the Altius System[supreg] has FDA approval \244\ through the premarket process and is intended as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees. Per the commenter, FDA approval for the Altius System[supreg] was supported by the QUEST study, which was a prospective, multicenter, double-blind, randomized, active-sham-controlled clinical trial designed to evaluate the safety and efficacy of the Altius System[supreg] for the treatment of severe chronic post-amputation pain relief in lower limb adult amputees in the U.S. The commenter explained that the QUEST study demonstrated that the use of a high frequency nerve block system provides significant improvement in pain and functional outcomes in patients with amputations experiencing chronic pain.\245\

\244\ FDA Approval letter, June 30, 2023, https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230020A.pdf.

\245\ Kapural L, Melton J, Kim B, Mehta P, Sigdel A, Bautista A, Petersen EA, Slavin KV, Eidt J, Wu J, Elshihabi S, Schwalb JM, Garrett HE Jr, Veizi E, Barolat G, Rajani RR, Rhee PC, Guirguis M, Mekhail N. Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post- Amputation Pain. J Pain Res. 2024;17:2001-2014. https://doi.org/10.2147/JPR.S463727.

Response: Based on the comment received, we do not believe that this medical device is used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia because the supporting information provided demonstrates that this therapy is used to treat chronic rather than post-operative or post- surgical or regional analgesia. For example, in the QUEST study, the key inclusion criteria specified individuals with chronic post- amputation pain, defined as “6-months with exacerbations lasting 60- minutes with a frequency of 4 episodes per week with >5 Numerical Rating Scale (NRS).\246\ Additionally, as the commenter noted, the device's FDA-approved indication specifies that the device is intended as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain. Therefore, we believe that Altius System[supreg] does not meet the statutory requirements at section 1833(t)(16)(G)(iv)(II) of the Act and are not finalizing separate payment for it under this provision.

\246\ Id.

Comment: We received one comment recommending CMS evaluate and approve ReActiv8 Implantable Neurostimulation System, manufactured by Mainstay Medical, under our non-opioid treatment for pain relief separate payment policy. Per the commenter, ReActiv8 addresses the root cause of pain for patients experiencing multifidus muscle dysfunction through efferent stimulation of the medial branch nerve of the dorsal ramus, triggering the multifidus muscle to contract, which over time, improves the multifidus' ability to stabilize the spine. The commenter stated that the ReActiv8

has FDA approval \247\ through the premarket process and is indicated for bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the transverse process at L3 as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy and are not candidates for spine surgery. The commenter submitted clinical literature to demonstrate that ReActive8 therapy drives a reduction in opioid use.

\247\ FDA Approval Letter, June 16, 2020. https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190021A.pdf.

Response: Based on the comment received, we do not believe that this medical device is used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia because the supporting information provided demonstrates that this therapy is used to treat chronic low back pain associated with multifidus muscle dysfunction, rather than post-operative or post- surgical or regional analgesia. For example, in a study submitted by the commenter, the study participants were adults “with a diagnosis of moderate-to-severe, disabling, refractory, predominantly mechanical chronic low back pain . . . with pain on at least half of the days in the year before baseline”.\248\ Further, the study participants had persistent chronic low back pain, lasting “a minimum of 90 days of conservative medical management that included at least medication and physical therapy, and they were not considered candidates for spine surgery”. Therefore, we believe that ReActiv8 does not meet the statutory requirements at section 1833(t)(16)(G)(iv)(II) of the Act and are not finalizing separate payment for it under this provision.

\248\ Gilligan, et al. 2024. Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction. Neuromodulation. 2024 Jul;27(5):930- 943. doi: 10.1016/j.neurom.2024.01.006. Epub 2024 Mar 12. PMID: 38483366.

Comment: We received a comment recommending CMS evaluate and approve the Game Ready System manufactured by Avanos Medical, Inc., under our non-opioid treatment for pain relief separate payment policy. Per the commenter, the Game Ready System is an electronically controlled, integrated cryotherapy and intermittent pneumatic compression system designed for clinical use. The manufacturer provided that the Game Ready System has FDA clearance and is indicated for to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. The manufacturer submitted literature to demonstrate that the Game Ready System has the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer reviewed journal.

The commenter provided five HCPCS codes with which they requested CMS establish the payment limitation. These CPT codes are: 27447 (Arthroplasty, knee, condyle and plateau; medial and lateral compartments with or without patella resurfacing (total knee arthroplasty)), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 29888 (Arthroscopically aided anterior cruciate ligament repair/augmentation or reconstruction), and 29827 (Arthroscopy, shoulder, surgical; with rotator cuff repair).

Response: Based on the comment received, we find that this medical device is used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia. We confirmed that this product is FDA cleared \249\ and has supporting literature demonstrating the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer reviewed journal.\250\ The medical device does not currently receive transitional passthrough status and we believe it would have payment that is otherwise packaged into a payment for a covered OPD service, absent this policy. Therefore, we believe that the Game Ready System meets the statutory requirements at section 1833(t)(16)(G)(iv) of the Act and are finalizing that it will be paid separately under this provision.

\249\ FDA 510(k) clearance K192114, 2019, https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192114.pdf.

\250\ Khan, et al., Cryo-Pneumatic Compression Results in a Significant Decrease in Opioid Consumption After Shoulder Surgery: A Multicenter Randomized Controlled Trial. Am J Sports Med. 2024 Sep;52(11):2860-2865.

We appreciate the commenter's suggestions regarding the top five procedures on which to base the payment limitation. Based on our review of the device, as well as the volume of services in which the device is most likely to be used, we believe that the top five procedures to base the payment limitation on are: HCPCS codes 27447 (Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 29827 (Arthroscopy, shoulder, surgical; with rotator cuff repair), and 29881 (Arthroscopy, knee, surgical; with meniscectomy (medial OR lateral, including any meniscal shaving) including debridement/shaving of articular cartilage (chondroplasty), same or separate compartment(s), when performed). We will assume an equal utilization of the device with these 5 procedures for the payment limitation calculation, as shown in Table 137 at the end of this section. We note that in the absence of utilization data for the top five procedures, we believe it is reasonable to assume equal utilization for purposes of calculating the payment limitation until claims data are available. Please see Table 137 for the payment limitation calculation and the new C-code used to describe the device. Additional Non-Opioid Device Comments

Comment: A few commenters requested payments related to physician office payments and long-term care payments to ensure the continued advancement of these safer and more effective techniques related to non-opioid treatments for pain relief.

Response: We appreciate the feedback from commenters, but note that these payment systems are outside the scope of the statutory provision at section 1833(t)(16)(G)(iv) of the Act and this final rule with comment period.

Comment: A commenter suggested that CMS revise the code descriptors of qualifying non-opioid treatment for pain relief products to ensure that it was clear that only the qualifying products were to be appropriately described by these HCPCS codes. This commenter stated, that because “e.g.” is used to identify an example of an inclusive universe, rather than narrowing or defining the general category of device to that specifically named device, providers suggest that other devices

beyond the brand name product may qualify--despite the additional parenthetical stating the device must be a qualifying device under section 4135 of the CAA, 2023.

Response: We thank the commenter for their suggestion. We believe the language of the long descriptors makes it clear that the device being billed by the HCPCS code must be a device reviewed and approved by CMS through notice and comment rulemaking, particularly the language CMS includes within all long code descriptors stating that the specific product “. . . must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with section 4135 of the CAA, 2023” clarifies which devices that should be billing that particular HCPCS code. The qualifying Medicare non-opioid medical devices for post surgical pain relief with separate payment starting or continuing on January 1, 2026, are those listed in table 136 of this final rule with comment period. However, we appreciate the commenter's suggestions and we may consider modifications to the descriptors in the future.

Comment: Commenters also recommended other products to CMS but did not provide any supporting documentation or information on the products. Some commenters suggested services or general practices that should be supported as the commenters believed they provided appropriate pain management and could decrease opioid usage. Other commenters requested that we consider alternative non-opioid treatments, such as acupuncture, occupational therapy, physical therapy, and cognitive behavioral therapy for separate payment under section 4135 of the CAA, 2024.

Response: For those products suggested by commenters who did not provide supplemental information, we are unable to fully evaluate the product against the statutory criteria for inclusion in this policy and therefore are not finalizing separate payment for any of these products. This policy covers drugs, biologicals, and medical devices; therefore, many services suggested by commenters are out of scope for purposes of this final rule with comment period. However, in general, if an item or service discussed by commenters does not qualify for separate payment under this provision, that does not mean that there are not other appropriate methods of coverage and payment available under the Medicare Act.

Comment: A commenter mentioned our proposed regulation text edits and noted that the changes discussed in the preamble did not align with what was included in the regulation text at the end of the proposed rule and suggested that there may have been an inadvertent drafting error.

Response: We thank the commenter for their suggested edit. As discussed in the CY 2026 OPPS/ASC proposed rule, we proposed to edit the regulation text at 42 CFR 416.174(c)(1) to remove the following text: “which is determined to be zero dollars for calendar year 2025” (90 FR 33745). This information is correct; however, the commenter is also correct that there was an inadvertent drafting error in the proposed rule where this information was not carried over correctly to the proposed rule regulation text (90 FR 33862). We thank the commenter for identifying this drafting error, and we are updating the regulation text to be consistent with our proposal.

After consideration of public comments, for CY 2026, we are finalizing the proposed lists of qualifying products and payment limitations, with modifications. See Table 136 for a list of the final qualifying products for CY 2026, and please see Table 135 for a list of the final payment limitations for qualifying products for CY 2026. This final list of payment limitations contains updated claims data as available for this final rule with comment period, and is using the CY 2026 OPPS/ASC proposed rule payment rates.

Additionally, we are finalizing our proposed edit to the regulation text at 42 CFR 416.174(c)(1) to remove the following text: “which is determined to be zero dollars for calendar year 2025.” We are removing this language pertaining to the portion of the otherwise applicable Medicare OPD fee schedule amount for CY 2025, as we will discuss the appropriate amount in each year's rulemaking. Additionally, as we are considering evaluating and updating the CY 2026 qualifying non-opioid treatments for pain relief, we are modifying the regulation text accordingly. Specifically, we are removing the phrase “through that year's rulemaking” and “for an applicable calendar year” from 42 CFR 419.43(k)(1), 419.43(k)(2), 416.174(a), and 416.174(b).

We note that we are placing the HCPCS codes describing the qualifying devices and drugs in Table 136 on the ASC covered ancillary procedures list. We note that Medicare Administrative Contractors (MACs) determine whether a drug, device, procedure, or other service meets all program requirements and conditions for coverage and payment. HOPDs and ASCs only receive payment for qualifying drugs, biologicals, and medical devices when the appropriate MAC determines that the service meets the relevant conditions for coverage and payment.

As discussed in greater detail earlier in this section, we believe it may be reasonable to consider a pathway to approve new products or products newly meeting the statutory requirements on a quarterly basis. We welcome engagement from the public, including on topics relating to products that newly meet the qualifying criteria and should be paid according to the statute under this policy. Such engagement could include: (1) documentation verifying appropriate FDA status, including the required FDA-approved indication for drugs; (2) qualifying peer- reviewed literature for medical devices and that the medical device is used to deliver a therapy to reduce postoperative pain, or produce postsurgical or regional analgesia; (3) suggestions for the top five most frequent procedures for purposes of calculating a payment limitation; (4) verification that the product does not have transitional pass-through status; (5) confirmation that the product has payment that is packaged into a payment for a covered OPD service, and (6) the current HCPCS code describing the product or recommendations for a new HCPCS code to describe the product. Please see 42 CFR 419.43(k) and 416.174 for the full established criteria.

We anticipate that if any non-opioid treatments for pain relief qualify during CY 2026, any potential CMS review process would be similar to the other existing quarterly approval processes, such as OPPS New Technology APC process or the CMS HCPCS application process, where CMS evaluates and approves products on a more frequent basis than annual rulemaking. A quarterly implementation process will be necessary to create new HCPCS codes and implement the necessary claims processing changes to effectuate the calculated payment rates as well as the required payment limitations. We will make payment, according to the statute, retroactively effective to the date that we determine that a product meets the criteria, with the earliest effective payment date being January 1, 2026. Once these determinations are made by CMS, we will make them publicly available on the CMS OPPS website.\251\ Payment will be made according to the statute, and established regulation text,

and will be effectuated in the applicable quarterly OPPS/ASC update.

\251\ https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/restated-drug-biological-payment-rates.

BILLING CODE 4120-01-P

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New Technology Intraocular Lenses (NTIOLs) are intraocular lenses that replace a patient's natural lens that has been removed in cataract surgery and that also meet the requirements listed in Sec. 416.195. 1. NTIOL Application Cycle

Our process for reviewing applications to establish new classes of NTIOLs is as follows:

Applicants submit their NTIOL requests for review to CMS by the annual deadline which is announced in the annual OPPS/ASC final rule with comment period. For a request to be considered complete, we require submission of the information requested in the guidance document titled “Application Process and Information Requirements for Requests for a New Class of NTIOLs or Inclusion of an IOL in an Existing NTIOL Class” posted on the CMS website at https://www.cms.gov/medicare/payment/prospective-payment-systems/ambulatory-surgical-center-asc/new-technology-intraocular-lenses-ntiols.

We announce annually, in the CY OPPS/ASC proposed rule updating the ASC and OPPS payment rates for the following calendar year, a list of all requests to establish new NTIOL classes accepted for review during the calendar year in which the proposal is published. In accordance with section 141(b)(3) of Pub. L. 103-432 and our regulations at Sec. 416.185(b), the deadline for receipt of public comments is 30 days following publication of the list of requests to establish a new NTIOL class as published in the proposed rule.

In the final rule with comment period updating the ASC and OPPS payment rates for the following calendar year, we--

++ Provide a list of determinations made as a result of our review of all new NTIOL class requests and public comments.

++ When a new NTIOL class is created, identify the predominant characteristic of NTIOLs in that class that sets them apart from other IOLs (including those previously approved as members of other expired or active NTIOL classes) and that is associated with an improved clinical outcome.

++ Set the date of implementation of a payment adjustment in the case of approval of an IOL as a member of a new NTIOL class prospectively as of 30 days after publication of the ASC payment update final rule, consistent with the statutory requirement.

++ Announce the deadline for submitting requests for review of an application for a new NTIOL class for the following calendar year. 2. Requests To Establish New NTIOL Classes for CY 2026

We did not receive any requests for review to establish a new NTIOL class for CY 2026 by March 1, 2025, the due date published in the CY 2025 OPPS/ASC final rule with comment period (89 FR 94361). 3. Payment Adjustment

The current payment adjustment for a 5-year period from the implementation date of a new NTIOL class is $50 per lens. Since implementation of the process for adjustment of payment amounts for NTIOLs in 1999, we have not revised the payment adjustment amount, and we did not propose to revise the payment adjustment amount for CY 2026.

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

Comment: Multiple commenters requested that CMS increase the NTIOL

add-on payment from the current $50 per lens (established in 1999) to between $95.69-$100 for CY 2026, stating that the payment has not been adjusted for over 2 decades despite significant inflation and increased research and development costs associated with bringing new IOL technologies to market. The commenters noted that in real dollar terms, the flat rate payment for NTIOLs has significantly lagged the overall economic inflation rate, with consumer inflation increasing by 138.6 percent since 2010 and manufacturing costs rising due to labor inflation and increased material costs. The commenters also requested that CMS update the NTIOL payment annually going forward.

Response: We responded to this comment in the CY 2024 OPPS/ASC final rule with comment period (88 FR 81955 through 81956). We refer readers to that final rule with comment period for our response on an increase to the NTIOL $50 per lens payment adjustment. 4. Announcement of CY 2027 Deadline for Submitting Requests for CMS Review of Applications for a New Class of NTIOLs

In accordance with Sec. 416.185(a) of our regulations, CMS announces that in order to be considered for payment effective beginning in CY 2027, request for review of applications for a new class of new technology IOLs must be received by 5 p.m. Eastern Standard Time, on March 1, 2026. Send requests via email to [email protected] or by mail to ASC/NTIOL, Division of Outpatient Care, Mailstop C4-05-07, Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. To be considered, requests for NTIOL reviews must include information requested on the CMS website at: https://www.cms.gov/medicare/payment/prospective-payment-systems/ambulatory-surgical-center-asc/newtechnology-intraocular-lenses-ntiols.