Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency -codes, and G-Codes Effective January 1, 2026. We invite public comments on the proposed payment indicators for the new HCPCS codes that were recognized as ASC covered ancillary services in April 2025 through the quarterly update CRs, as listed in Table 73 (New Level II HCPCS Codes for ASC Covered Surgical Procedures and Ancillary Services Effective April 1, 2025) of this proposed rule. We propose to finalize their payment indicators in the CY 2026 OPPS/ASC final rule with comment period. BILLING CODE 4120–01–P 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00226 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33701 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k BILLING CODE 4120–01–C 3. July 2025 HCPCS Codes Proposed Rule Comment Solicitation In the July 2025 ASC quarterly update (Transmittal 13259, Change Request 14101, June 6, 2025), we added several separately payable CPT and Level II HCPCS codes to the list of covered surgical procedures and covered ancillary services. Table 74 (New HC 13259, Change Request 14101, June 6, 2025), we added several separately payable CPT and Level II HCPCS codes to the list of covered surgical procedures and covered ancillary services. Table 74 (New HCPCS Codes for ASC Covered Surgical Procedures and Ancillary Services Effective July 1, 2025) of this proposed rule, lists the new HCPCS codes that are effective July 1, 2025. The proposed comment indicators, payment indicators, and payment rates for the codes can be found in Addendum AA and Addendum BB to this proposed rule. The list of ASC payment indicators and corresponding definitions can be found in Addendum DD1 to this proposed rule. These new codes that are effective July 1, 2025, are assigned to VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00227 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00228 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00229 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00230 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00230 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00231 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00232 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33707 Payment rates for office-based procedures (payment indicators ‘‘P2,’’ ‘‘P3,’’ and ‘‘R2’’) are the lower of the PFS nonfacility PE RVU-based amount or the amount calculated using the ASC standard rate setting methodology for the procedure. As detailed in section XIII.C.3.b. of this proposed rule, we update the payment amounts for office- based procedures (payment indicators ‘‘P2,’’ ‘‘P3,’’ and ‘‘R2’’) using the most recent available MPFS and OPPS data. We compare the estimated current year rate for each of the office-based procedures, calculated according to the ASC standard rate settin and ‘‘R2’’) using the most recent available MPFS and OPPS data. We compare the estimated current year rate for each of the office-based procedures, calculated according to the ASC standard rate setting methodology, to the PFS nonfacility PE RVU-based amount to determine which is lower and, therefore, would be the current year payment rate for the procedure under our final policy for the revised ASC payment system (§ 416.171(d)). The rate calculation established for device-intensive procedures (payment indicator ‘‘J8’’) is structured so only the service (non-device) portion of the rate is subject to the ASC conversion factor. We update the payment rates for device- intensive procedures to incorporate the most recent device offset percentages calculated under the ASC standard ratesetting methodology, as discussed in section XIII.C.4. of this proposed rule. In the CY 2014 OPPS/ASC final rule with comment period (78 FR 75081), we finalized our proposal to calculate the CY 2014 payment rates for ASC covered surgical procedures according to our established methodologies, with the exception of device removal procedures. For CY 2014, we finalized a policy to conditionally package payment f s for ASC covered surgical procedures according to our established methodologies, with the exception of device removal procedures. For CY 2014, we finalized a policy to conditionally package payment for device removal procedures under the OPPS. Under the OPPS, a conditionally packaged procedure (status indicators ‘‘Q1’’ and ‘‘Q2’’) describes a HCPCS code where the payment is packaged when it is provided with a significant procedure but is separately paid when the service appears on the claim without a significant procedure. Because ASC services always include a covered surgical procedure, HCPCS codes that are conditionally packaged under the OPPS are always packaged (payment indicator ‘‘N1’’) under the ASC payment system. Under the OPPS, device removal procedures are conditionally packaged and, therefore, would be packaged under the ASC payment system. There is no Medicare payment made when a device removal procedure is performed in an ASC without another surgical procedure included on the claim; therefore, no Medicare payment would be made if a device was removed but not replaced. To ensure that the ASC payment system provides separate payment for surgical procedures that only inv the claim; therefore, no Medicare payment would be made if a device was removed but not replaced. To ensure that the ASC payment system provides separate payment for surgical procedures that only involve device removal— conditionally packaged in the OPPS (status indicator ‘‘Q2’’)—we have continued to provide separate payment since CY 2014 and assign the current ASC payment indicators associated with these procedures. b. Update to ASC Covered Surgical Procedure Payment Rates for CY 2026 We propose to update ASC payment rates for CY 2026 and subsequent years using the established rate calculation methodologies under § 416.171 and using our definition of device-intensive procedures, as discussed in section XIII.C.4. of this proposed rule. As the proposed OPPS relative payment weights are generally based on geometric mean costs, we propose that the ASC payment system will generally use the geometric mean cost to determine proposed relative payment weights under the ASC standard methodology. We propose to continue to use the amount calculated under the ASC standard ratesetting methodology for procedures assigned payment indicators ‘‘A2’’ and ‘‘G2.’’ We propose to calculate payment rate y. We propose to continue to use the amount calculated under the ASC standard ratesetting methodology for procedures assigned payment indicators ‘‘A2’’ and ‘‘G2.’’ We propose to calculate payment rates for office-based procedures (payment indicators ‘‘P2,’’ ‘‘P3,’’ and ‘‘R2’’) and device-intensive procedures (payment indicator ‘‘J8’’) according to our established policies and to identify device-intensive procedures using the methodology discussed in section XIII.C.4. of this proposed rule. Therefore, we propose to update the payment amount for the service portion (the non-device portion) of the device- intensive procedures using the standard ASC ratesetting methodology and the payment amount for the device portion based on the proposed CY 2026 device offset percentages that have been calculated using the standard OPPS APC ratesetting methodology. We propose that payment for office-based procedures would be at the lesser of the proposed CY 2026 MPFS nonfacility PE RVU-based amount or the proposed CY 2026 ASC payment amount calculated according to the ASC standard ratesetting methodology. As we did for CYs 2014 through 2025, for CY 2026, we propose to continue our policy for device r e proposed CY 2026 ASC payment amount calculated according to the ASC standard ratesetting methodology. As we did for CYs 2014 through 2025, for CY 2026, we propose to continue our policy for device removal procedures, such that device removal procedures that are conditionally packaged in the OPPS (status indicators ‘‘Q1’’ and ‘‘Q2’’) will be assigned the current ASC payment indicators associated with those procedures and will continue to be paid separately under the ASC payment system. c. Proposed Payment for ASC Add-On Procedures Eligible for Complexity Adjustments Under the OPPS In this section, we discuss the policy to provide increased payment under the ASC payment system for combinations of certain ‘‘J1’’ service codes and add-on procedure codes that are eligible for a complexity adjustment under the OPPS. (1) OPPS C–APC Complexity Adjustment Policy Under the OPPS, complexity adjustments are utilized to provide increased payment for certain comprehensive services. As discussed in section II.A.2.b. of this proposed rule, we apply a complexity adjustment by promoting qualifying paired ‘‘J1’’ service code combinations or paired code combinations of ‘‘J1’’ services and add-on cod section II.A.2.b. of this proposed rule, we apply a complexity adjustment by promoting qualifying paired ‘‘J1’’ service code combinations or paired code combinations of ‘‘J1’’ services and add-on codes from the originating Comprehensive APC (C–APC) (the C– APC to which the designated primary service is first assigned) to the next higher paying C–APC in the same clinical family of C–APCs. A ‘‘J1’’ status indicator refers to a hospital outpatient service paid through a C–APC. We package payment for all add-on codes, which are codes that describe a procedure or service always performed in addition to a primary service or procedure, into the payment for the C– APC. However, certain combinations of primary service codes and add-on codes may qualify for a complexity adjustment. We apply complexity adjustments when the paired code combination represents a complex, costly form or version of the primary service when the frequency and cost thresholds are met. The frequency threshold is met when there are 25 or more claims reporting the code combination, and the cost threshold is met when there is a violation of the 2 times rule, as specified in section 1833(t)(2) of the Act and described in there are 25 or more claims reporting the code combination, and the cost threshold is met when there is a violation of the 2 times rule, as specified in section 1833(t)(2) of the Act and described in section III.A.2.b. of this proposed rule, in the originating C– APC. These paired code combinations that meet the frequency and cost threshold criteria represent those that exhibit materially greater resource requirements than the primary service. After designating a single primary service for a claim, we evaluate that service in combination with each of the other procedure codes reported on the claim that are either assigned to status indicator ‘‘J1’’ or add-on codes to determine if there are paired code combinations that meet the complexity adjustment criteria. Once we have determined that a particular combination of ‘‘J1’’ services, or combinations of a ‘‘J1’’ service and add- VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00233 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33708 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules on code, represents a complex version 2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33708 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules on code, represents a complex version of the primary service because it is sufficiently costly, frequent, and a subset of the primary comprehensive service overall according to the criteria described previously, we promote the claim to the next higher cost C–APC within the clinical family unless the primary service is already assigned to the highest cost APC within the C–APC clinical family or assigned to the only C–APC in a clinical family. We do not create new C–APCs with a comprehensive geometric mean cost that is higher than the highest geometric mean cost (or only) C–APC in a clinical family just to accommodate potential complexity adjustments. Therefore, the highest payment for any claim including a code combination for services assigned to a C–APC would be the highest paying C–APC in the clinical family (79 FR 66802). As previously stated, we package payment for add-on codes into the C– APC payment rate. If any add-on code reported in conjunction with the ‘‘J1’’ primary service code does not qualify for a complexit As previously stated, we package payment for add-on codes into the C– APC payment rate. If any add-on code reported in conjunction with the ‘‘J1’’ primary service code does not qualify for a complexity adjustment, payment for the add-on service continues to be packaged into the payment for the primary service and the primary service code reported with the add-on code is not reassigned to the next higher cost C– APC. We list the proposed complexity adjustments for ‘‘J1’’ and add-on code combinations for CY 2026, along with all of the other proposed complexity adjustments, in Addendum J to this proposed rule (which is available via the internet on the CMS website at https://www.cms.gov/medicare/ payment/prospective-payment-systems/ hospital-outpatient/regulations-notices). (2) CY 2026 ASC Special Payment Policy Proposal for OPPS Complexity- Adjusted C–APCs For CY 2026, we propose to continue the special payment policy and methodology for OPPS complexity- adjusted C–APCs that was finalized in the CY 2023 OPPS/ASC final rule with comment period (87 FR 72078 through 72080). For those ASC complexity adjustment codes for which we have claims data, we propose to use the claims data to calc d in the CY 2023 OPPS/ASC final rule with comment period (87 FR 72078 through 72080). For those ASC complexity adjustment codes for which we have claims data, we propose to use the claims data to calculate the code combination utilization and estimated payments for the ASC payment system budget neutrality calculations for CY 2026. The ASC complexity adjustment budget neutrality calculations are discussed further in section XIII.H.2.a. of this proposed rule. The full list of the proposed ASC complexity adjustment codes for CY 2026 can be found in the CY 2026 proposed ASC Addendum AA and the supplemental policy file, which also includes both the existing ASC complexity adjustment codes and proposed additions and published with the proposed rule on the CMS website at https://www.cms.gov/medicare/ medicare-fee-for-service-payment/ ascpayment/asc-regulations-and- notices. Since the complexity adjustment assignments change each year under the OPPS, the proposed list of ASC complexity adjustment codes eligible for the proposed payment policy has changed slightly from the previous year. Additionally, since complexity adjustment assignments may change between the proposed rule and final rul ent codes eligible for the proposed payment policy has changed slightly from the previous year. Additionally, since complexity adjustment assignments may change between the proposed rule and final rule under the OPPS, the final list of ASC complexity adjustment codes eligible for this payment policy may be slightly different than the proposed list of ASC complexity adjustment codes. d. Proposed Low Volume APCs and Limit on ASC Payment Rates for Procedures Assigned to Low Volume APCs As stated in section XIII.D.1.b. of the CY 2025 OPPS/ASC proposed rule, the ASC payment system generally uses OPPS geometric mean costs under the standard methodology to determine proposed relative payment weights under the standard ASC ratesetting methodology. low volume APC policy for CY 2022 and subsequent calendar years. Under our policy, we expanded the low volume adjustment policy that is applied to procedures assigned to New Technology APCs to also apply to clinical and brachytherapy APCs. Specifically, a clinical APC or brachytherapy APC with fewer than 100 claims per year would be designated as a low volume APC. For items or services assigned to a low volume APC, we use up to 4 years of claims ly, a clinical APC or brachytherapy APC with fewer than 100 claims per year would be designated as a low volume APC. For items or services assigned to a low volume APC, we use up to 4 years of claims data to establish a payment rate for the APC as we currently do for low volume services assigned to New Technology APCs. The payment rate for a low volume APC or a low volume New Technology procedure would be based on the highest of the median cost, arithmetic mean cost, or geometric mean cost calculated using multiple years of claims data. Based on claims data available for this proposed rule, we propose to designate six brachytherapy APCs and four clinical APCs as low volume APCs under the ASC payment system. The four clinical APCs and six brachytherapy APCs meet our criteria of having fewer than 100 single claims in the relevant claims year (CY 2024 for this CY 2026 OPPS/ASC proposed rule) and therefore, we propose that they would be subject to our universal low volume APC policy and the APC cost metric would be based on the greater of the median cost, arithmetic mean cost, or geometric mean cost using up to 4 years of claims data. Nine of the ten APCs were designated as low volume e APC cost metric would be based on the greater of the median cost, arithmetic mean cost, or geometric mean cost using up to 4 years of claims data. Nine of the ten APCs were designated as low volume APCs in CY 2025. Based on data for this CY 2026 OPPS/ASC proposed rule, APC 2645 (Brachytx, non-stranded, gold-198) has 103 single claims and no longer meets our criteria to be designated as a low volume APC; however, APC 2643 (Brachytx, non-stranded, c-131) has only 88 single claims and does meet our criteria to be designated as a low volume APC. Table 76 includes the CY 2024 claims In the CY 2022 OPPS/ASC final rule with comment period (86 FR 63743 through 63747), we adopted a universal available for ratesetting for each of the APCs we are proposing to designate as a low volume APC for CY 2026. 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00234 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33709 2. Proposed Payment for Covered Ancillary Services a. Background Our payment policies under the ASC payment system for cove Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33709 2. Proposed Payment for Covered Ancillary Services a. Background Our payment policies under the ASC payment system for covered ancillary services generally vary according to the particular type of service and its payment policy under the OPPS. Our overall policy provides separate ASC payment for certain ancillary items and services integrally related to the provision of ASC covered surgical procedures that are paid separately under the OPPS and provides packaged ASC payment for other ancillary items and services that are packaged or conditionally packaged (status indicators ‘‘N,’’ ‘‘Q1,’’ and ‘‘Q2’’) under the OPPS. In the CY 2013 OPPS/ASC rulemaking (77 FR 45169 and 77 FR 68457 through 68458), we further clarified our policy regarding the payment indicator assignment for procedures that are conditionally packaged in the OPPS (status indicators ‘‘Q1’’ and ‘‘Q2’’). Under the OPPS, a conditionally packaged procedure describes a HCPCS code where the payment is packaged when it is provided with a significant procedure but is separately paid when the service appears on the claim without a significant procedure. dure describes a HCPCS code where the payment is packaged when it is provided with a significant procedure but is separately paid when the service appears on the claim without a significant procedure. Because ASC services always include a surgical procedure, HCPCS codes that are conditionally packaged under the OPPS are generally packaged (payment indicator ‘‘N1’’) under the ASC payment system (except for device removal procedures, as discussed in the CY 2022 OPPS/ASC proposed rule (86 FR 42083)). Thus, our policy generally aligns ASC payment bundles with those under the OPPS (72 FR 42495). In all cases, in order for ancillary items and services also to be paid, the ancillary items and services must be provided integral to the performance of ASC covered surgical procedures for which the ASC bills Medicare. Our ASC payment policies generally provide separate payment for drugs and biologicals that are separately paid under the OPPS at the OPPS rates and package payment for drugs and biologicals for which payment is packaged under the OPPS. However, as discussed in the CY 2022 OPPS/ASC final rule with comment period, for CY 2022, we finalized a policy to unpackage and pay separately a ogicals for which payment is packaged under the OPPS. However, as discussed in the CY 2022 OPPS/ASC final rule with comment period, for CY 2022, we finalized a policy to unpackage and pay separately at ASP plus 6 percent for the cost of non-opioid pain management drugs and biologicals that function as a supply when used in a surgical procedure as determined by CMS under § 416.174 (86 FR 63483). We generally pay for separately payable radiology services at the lower of the PFS nonfacility PE RVU-based (or technical component) amount or the rate calculated according to the ASC standard ratesetting methodology (72 FR 42497). However, as finalized in the CY 2011 OPPS/ASC final rule with comment period (75 FR 72050), payment indicators for all nuclear medicine procedures (defined as CPT codes in the range of 78000 through 78999) that are designated as radiology services that are paid separately when provided integral to a surgical procedure on the ASC list are set to ‘‘Z2’’ so that payment is made based on the ASC standard ratesetting methodology rather than the MPFS nonfacility PE RVU amount (‘‘Z3’’), regardless of which is lower (§ 416.171(d)(1)). Similarly, we also finalized our poli is made based on the ASC standard ratesetting methodology rather than the MPFS nonfacility PE RVU amount (‘‘Z3’’), regardless of which is lower (§ 416.171(d)(1)). Similarly, we also finalized our policy to set the payment indicator to ‘‘Z2’’ for radiology services that use contrast agents so that payment for these procedures will be based on the OPPS relative payment weight using the ASC standard ratesetting methodology and, therefore, will include the cost for the contrast agent (§ 416.171(d)(2)). ASC payment policy for brachytherapy sources mirrors the payment policy under the OPPS. ASCs are paid for brachytherapy sources provided integral to ASC covered surgical procedures at prospective rates adopted under the OPPS or, if OPPS rates are unavailable, at contractor- priced rates (72 FR 42499). Since December 31, 2009, ASCs have been paid for brachytherapy sources provided integral to ASC covered surgical procedures at prospective rates adopted under the OPPS. Our ASC policies also provide separate payment for: (1) certain items and services that CMS designates as contractor-priced, including, but not limited to, the procurement of corneal tissue; and (2) certain implantable items ovide separate payment for: (1) certain items and services that CMS designates as contractor-priced, including, but not limited to, the procurement of corneal tissue; and (2) certain implantable items that have pass-through payment status under the OPPS. These categories do not have prospectively established ASC payment rates according to ASC payment system policies (72 FR 42502 and 42508 through 42509; § 416.164(b)). Under the ASC payment system, we have designated corneal tissue acquisition and hepatitis B vaccines as contractor-priced. Corneal tissue acquisition is contractor-priced based on the invoice costs for acquiring the corneal tissue for transplantation. Hepatitis B vaccines are contractor- priced based on invoiced costs for the vaccine. Devices that are eligible for pass- through payment under the OPPS are separately paid under the ASC payment system and are contractor-priced. Under VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00235 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00236 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 1 M\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00236 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33711 offices. We have included CPT code 21930 in our list of surgical procedures we propose to permanently designate as office-based for CY 2026 in Table 77. As discussed in the August 2, 2007 ASC final rule with comment period (72 FR 42533 through 42535), we finalized our policy to designate certain new surgical procedures as temporarily office-based until adequate claims data are available to assess their predominant sites of service, whereupon if we confirm their office-based nature, the procedures are permanently assigned to the list of office-based procedures. In the absence of claims data, we use other available information, including our clinical advisors’ judgment, predecessor CPT and Level II HCPCS codes, information submitted by representatives of specialty societies and professional associations, and information sub including our clinical advisors’ judgment, predecessor CPT and Level II HCPCS codes, information submitted by representatives of specialty societies and professional associations, and information submitted by commenters during the public comment period. In Table 153 of the CY 2025 OPPS/ ASC final rule with comment period, we finalized assigning temporary office- based designations to nine surgical procedures for CY 2025 (89 FR 94325 through 94326). As discussed in section XIII.B. of this proposed rule, two of the nine procedures were deleted effective April 2025—HCPCS codes G0564 and G0565. For two of the remaining seven surgical procedures, interested parties submitted information that suggested CPT code 15013 (Preparation of skin cell suspension autograft, requiring enzymatic processing, manual mechanical disaggregation of skin cells, and filtration; first 25 sq cm or less of harvested skin) and its automated counterpart HCPCS C8002 (Preparation of skin cell suspension autograft, automated, including all enzymatic processing and device components (do not report with manual suspension preparation)) are not most similar to CPT code 11310 (Shaving of epidermal or dermal lesion, sin tomated, including all enzymatic processing and device components (do not report with manual suspension preparation)) are not most similar to CPT code 11310 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.5 cm or less) as we stated in the CY 2025 OPPS/ ASC final rule with comment period (89 FR 94322 through 94324) since CPT code 15013 must be performed with other skin cell suspension autograft procedure codes and the entirety of the procedure—harvesting of skin, preparation and application of the skin cell suspension autograft—is not expected to be predominantly performed in an office setting. After reviewing the information and consulting with our medical officers, we agree that the entirety of the procedure is not expected to be performed in a physician office setting and that CPT code 11310 would not be an accurate crosswalk for site-of-service utilization. Therefore, as shown in Table 78, in this proposed rule, we propose to permanently remove the temporarily office-based designation for CPT code 15013 and HCPCS code C8002. We reviewed CY 2024 volume and utilization data for the remaining five surgical p le, we propose to permanently remove the temporarily office-based designation for CPT code 15013 and HCPCS code C8002. We reviewed CY 2024 volume and utilization data for the remaining five surgical procedures designated as temporarily office-based in the CY 2025 OPPS/ASC final rule with comment period. As shown in Table 77 and Table 78, for one of the five surgical procedures—CPT code 0864T—there are greater than 50 claims available and the volume and utilization indicated this procedure was performed predominantly in the office setting. Therefore, we propose to no longer designate this procedure as temporarily office-based and to permanently designate this procedure as office-based and assign one of the office-based payment indicators, specifically ‘‘P2’’, ‘‘P3’’, or ‘‘R2.’’ 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00237 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00238 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00239 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S 16, 2025 Jkt 265001 PO 00000 Frm 00238 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00239 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00240 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33715 and is consistent with the OPPS policy that was in effect until CY 2014. We refer readers to the CY 2008 OPPS/ASC final rule with comment period (72 FR 66845 through 66848) for a full discussion of the ASC payment adjustment policy for no cost/full credit and partial credit devices. ASC payment is reduced by 100 percent of the device offset amount when a hospital furnishes a specified device without cost or with a full credit and by 50 percent of the device offset amount when the hospital receives partial credit in the amount of 50 percent or more of the cost for the specified device. Effective CY 2014, under the OPPS, we finalized our proposal to r vice offset amount when the hospital receives partial credit in the amount of 50 percent or more of the cost for the specified device. Effective CY 2014, under the OPPS, we finalized our proposal to reduce OPPS payment for applicable APCs by the full or partial credit a provider receives for a device, capped at the device offset amount. Although we finalized our proposal to modify the policy of reducing payments when a hospital furnishes a specified device without cost or with full or partial credit under the OPPS, in the CY 2014 OPPS/ ASC final rule with comment period (78 FR 75076 through 75080), we finalized our proposal to maintain our ASC policy for reducing payments to ASCs for specified device-intensive procedures when the ASC furnishes a device without cost or with full or partial credit. Unlike the OPPS, there is currently no mechanism within the ASC claims processing system for ASCs to submit to CMS the amount of the actual credit received when furnishing a specified device at full or partial credit. Therefore, under the ASC payment system, we finalized our proposal for CY 2014 to continue to reduce ASC payments by 100 percent or 50 percent of the device offset amount whe t full or partial credit. Therefore, under the ASC payment system, we finalized our proposal for CY 2014 to continue to reduce ASC payments by 100 percent or 50 percent of the device offset amount when an ASC furnishes a device without cost or with full or partial credit, respectively. Under current ASC policy, all ASC device-intensive covered surgical procedures are subject to the no cost/ full credit and partial credit device adjustment policy. Specifically, when a device-intensive procedure is performed to implant or insert a device that is furnished at no cost or with full credit from the manufacturer, the ASC appends the HCPCS ‘‘FB’’ modifier on the line in the claim with the procedure to implant or insert the device. The contractor reduces payment to the ASC by the device offset amount that we estimate represents the cost of the device when the necessary device is furnished without cost or with full credit to the ASC. We continue to believe that the reduction of ASC payment in these circumstances is necessary to pay appropriately for the covered surgical procedure furnished by the ASC. In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59043 through 59044) we adopt ese circumstances is necessary to pay appropriately for the covered surgical procedure furnished by the ASC. In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59043 through 59044) we adopted a policy to reduce the payment for a device- intensive procedure for which the ASC receives partial credit by one-half of the device offset amount that would be applied if a device was provided at no cost or with full credit if the credit to the ASC is 50 percent or more (but less than 100 percent) of the cost of the new device. The ASC will append the HCPCS ‘‘FC’’ modifier to the HCPCS code for the device-intensive surgical procedure when the facility receives a partial credit of 50 percent or more (but less than 100 percent) of the cost of a device. To report that the ASC received a partial credit of 50 percent or more (but less than 100 percent) of the cost of a new device, ASCs have the option of either: (1) submitting the claim for the device-intensive procedure to their Medicare contractor after the procedure’s performance, but prior to manufacturer acknowledgment of credit for the device, and subsequently contacting the contractor regarding a claim adjustment, once the credit ontractor after the procedure’s performance, but prior to manufacturer acknowledgment of credit for the device, and subsequently contacting the contractor regarding a claim adjustment, once the credit determination is made; or (2) holding the claim for the device implantation or insertion procedure until a determination is made by the manufacturer on the partial credit and submitting the claim with the ‘‘FC’’ modifier appended to the implantation procedure HCPCS code if the partial credit is 50 percent or more (but less than 100 percent) of the cost of the device. Beneficiary coinsurance would be based on the reduced payment amount. As finalized in the CY 2015 OPPS/ASC final rule with comment period (79 FR 66926), to ensure our policy covers any situation involving a device-intensive procedure where an ASC may receive a device at no cost or receive full credit or partial credit for the device, we apply our ‘‘FB’’/‘‘FC’’ modifier policy to all device-intensive procedures. In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59043 through 59044) we stated we would reduce the payment for a device- intensive procedure for which the ASC receives partial credit by one-half of th OPPS/ASC final rule with comment period (83 FR 59043 through 59044) we stated we would reduce the payment for a device- intensive procedure for which the ASC receives partial credit by one-half of the device offset amount that would be applied if a device was provided at no cost or with full credit, if the credit to the ASC is 50 percent or more (but less than 100 percent) of the cost of the device. In the CY 2020 OPPS/ASC final rule with comment period, we finalized continuing our existing policies for CY 2020. We note that we inadvertently omitted language that this policy would apply not just in CY 2019 but also in subsequent calendar years. We intended to apply this policy in CY 2019 and subsequent calendar years. Therefore, we finalized our proposal to apply our policy for partial credits specified in the CY 2019 OPPS/ASC final rule with comment period (83 FR 59043 through 59044) in CY 2022 and subsequent calendar years (86 FR 63775 through 63776). Specifically, for CY 2022 and subsequent calendar years, we would reduce the payment for a device- intensive procedure for which the ASC receives partial credit by one-half of the device offset amount that would be applied if a dev ubsequent calendar years, we would reduce the payment for a device- intensive procedure for which the ASC receives partial credit by one-half of the device offset amount that would be applied if a device was provided at no cost or with full credit, if the credit to the ASC is 50 percent or more (but less than 100 percent) of the cost of the device. To report that the ASC received a partial credit of 50 percent or more (but less than 100 percent) of the cost of a device, ASCs have the option of either: (1) submitting the claim for the device intensive procedure to their Medicare contractor after the procedure’s performance, but prior to manufacturer acknowledgment of credit for the device, and subsequently contacting the contractor regarding a claim adjustment, once the credit determination is made; or (2) holding the claim for the device implantation or insertion procedure until a determination is made by the manufacturer on the partial credit and submitting the claim with the ‘‘FC’’ modifier appended to the implantation procedure HCPCS code if the partial credit is 50 percent or more (but less than 100 percent) of the cost of the device. Beneficiary coinsurance would be based on t odifier appended to the implantation procedure HCPCS code if the partial credit is 50 percent or more (but less than 100 percent) of the cost of the device. Beneficiary coinsurance would be based on the reduced payment amount. We are not proposing any changes to our policies related to no cost/full credit or partial credit devices for CY 2026. 5. Requirement in the Physician Fee Schedule CY 2026 Proposed Rule for HOPDs and ASCs To Report Discarded Amounts of Certain Single-dose or Single-use Package Drugs Section 90004 of the Infrastructure Investment and Jobs Act (Pub. L. 117– 9, November 15, 2021) (‘‘the Infrastructure Act’’) amended section 1847A of the Act to re-designate subsection (h) as subsection (i) and insert a new subsection (h), which requires manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single-dose container or single-use package drug. The CY 2026 PFS proposed rule includes proposals related to the discarded drug refund policy, including proposals that may impact hospital outpatient departments (HOPDs) and VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00241 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S ncluding proposals that may impact hospital outpatient departments (HOPDs) and VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00241 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33716 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules ambulatory surgical centers (ASCs). Similar to our CY 2023, CY 2024, and CY 2025 notices in the OPPS/ASC proposed rules (87 FR 71988, 88 FR 49760, and 89 FR 59421 through 59422), we are including a notice in this CY 2026 proposed rule to ensure interested parties are aware of these proposals and know to refer to the CY 2026 Physician Fee Schedule proposed rule for a full description of the proposed policy. Interested parties are asked to submit comments on any proposals to further implement section 90004 of the Infrastructure Act to the CY 2026 PFS proposed rule. Public comments on these proposals will be addressed in the CY 2026 PFS final rule with comment period. We note that this same notice appeared in section V.B. of this proposed rule. D. Proposed Additions to ASC Covered Surgical Procedures and Covered Ancillary Services Lists 1. rule with comment period. We note that this same notice appeared in section V.B. of this proposed rule. D. Proposed Additions to ASC Covered Surgical Procedures and Covered Ancillary Services Lists 1. Current Review Process for the List of ASC Covered Surgical Procedures Section 1833(i)(1) of the Act requires us, in part, to specify, in consultation with appropriate medical organizations, surgical procedures that are appropriately performed on an inpatient basis in a hospital but that can also be safely performed in an ASC, a CAH, or an HOPD, and to review and update the list of ASC covered surgical procedures at least every 2 years. We evaluate the ASC covered procedures list (ASC CPL) each year to determine whether procedures should be added to or removed from the list, and changes to the list are often made in response to specific concerns raised by interested parties. Under our regulations at §§ 416.2 and 416.166, covered surgical procedures furnished on or after January 1, 2022, are surgical procedures that meet the general standards specified in § 416.166(b) and are not excluded under the general exclusion criteria specified in § 416.166(c). Specifically, under § 416.166(b), re surgical procedures that meet the general standards specified in § 416.166(b) and are not excluded under the general exclusion criteria specified in § 416.166(c). Specifically, under § 416.166(b), the general standards provide that covered surgical procedures are surgical procedures specified by the Secretary and published in the Federal Register and/ or via the internet on the CMS website that are separately paid under the OPPS, that would not be expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure. Section 416.166(c) sets out the general exclusion criteria used under the ASC payment system to evaluate the safety of procedures for performance in an ASC. The general exclusion criteria provide that covered surgical procedures do not include those surgical procedures that: (1) generally result in extensive blood loss; (2) require major or prolonged invasion of body cavities; (3) directly involve major blood vessels; (4) are generally emergent or life-threaten ures that: (1) generally result in extensive blood loss; (2) require major or prolonged invasion of body cavities; (3) directly involve major blood vessels; (4) are generally emergent or life-threatening in nature; (5) commonly require systemic thrombolytic therapy; (6) are designated as requiring inpatient care under § 419.22(n); (7) can only be reported using a CPT unlisted surgical procedure code; or (8) are otherwise excluded under § 411.15. In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59029 through 59030), we defined a surgical procedure under the ASC payment system as any procedure described within the range of Category I CPT codes that the CPT Editorial Panel of the AMA defines as ‘‘surgery’’ (CPT codes 10000 through 69999) (72 FR 42476), as well as procedures that are described by Level II HCPCS codes or by Category I CPT codes or by Category III CPT codes that directly crosswalk or are clinically similar to procedures in the CPT surgical range that we determined met the general standards established in previous years for addition to the ASC CPL. For a detailed discussion of the history of our policies for adding surgical procedures to the ASC CPL, we refer ed met the general standards established in previous years for addition to the ASC CPL. For a detailed discussion of the history of our policies for adding surgical procedures to the ASC CPL, we refer readers to the CY 2021 through CY 2025 OPPS/ASC final rules with comment period (85 FR 86143 through 86145; 86 FR 63777 through 63805; 87 FR 72068 through 72076; 88 FR 81923 through 81945; and 89 FR 94331 through 94334). 2. Proposed Changes to the List of ASC Covered Surgical Procedures for CY 2026 Historically, we have reviewed the clinical characteristics of procedures and consulted with appropriate medical organizations, other interested parties, and our clinical advisors to determine if those procedures would meet our existing regulatory criteria under 42 CFR 416.2 and 42 CFR 416.166. In the CY 2021 OPPS/ASC final rule with comment period, we significantly revised our policy for adding surgical procedures to the ASC CPL to provide that the general exclusion and general standard criteria that we used to identify covered surgical procedures would be safety factors for physicians to consider for a specific beneficiary when determining whether to perform a covered surgical procedure ( ia that we used to identify covered surgical procedures would be safety factors for physicians to consider for a specific beneficiary when determining whether to perform a covered surgical procedure (85 FR 86143 through 86153). We also stated that we would add surgical procedures when we identified a surgical procedure that met general standards criteria or when we were notified of a surgical procedure that could meet general standards criteria and we confirmed that the procedure met those requirements. In the CY 2022 OPPS/ASC final rule with comment period, we reinstated the general standard and general exclusion criteria as part of the review process, rather than safety factors for physicians to consider, and renamed the notifications process finalized in the CY 2021 rule as a nominations process, later re-named the ‘‘Pre-Proposed Rule CPL Recommendation Process’’ (86 FR 63776 through 63782). Under this process, which became effective in CY 2024, an external party can recommend a surgical procedure by March 1 of a calendar year for the list of ASC covered surgical procedures for the following calendar year. As a result of the reinstatement of the general standard and general excl gical procedure by March 1 of a calendar year for the list of ASC covered surgical procedures for the following calendar year. As a result of the reinstatement of the general standard and general exclusion criteria, we finalized the removal of 255 procedures that had been added to the ASC CPL in CY 2021. We also maintained these criteria and the Pre-Proposed Rule CPL Recommendation Process during the CY 2023 through CY 2025 rulemaking cycles. In the CY 2022 OPPS/ASC final rule with comment period, commenters were largely split on the issue of reinstating the general standard and general exclusion criteria at § 416.166 that were in place prior to CY 2021. Many commenters opposed this proposal and recommended that CMS not re-adopt these criteria. Commenters contended that this policy may substitute administrative criteria for physician clinical judgment, reduce beneficiary choice, and increase costs since the lack of payment in the ASC setting may push these procedures to be performed in the higher-cost hospital setting. For CY 2026, we propose to revise our regulatory criteria at 42 CFR 416.166 to evaluate potential additions to the ASC CPL, similar to the changes we finalized in th the higher-cost hospital setting. For CY 2026, we propose to revise our regulatory criteria at 42 CFR 416.166 to evaluate potential additions to the ASC CPL, similar to the changes we finalized in the CY 2021 OPPS/ASC final rule with comment period. Specifically, we propose to revise our regulatory criteria by removing certain general standard and general exclusion criteria at 42 CFR 416.166(b) and (c), moving them to a new section as nonbinding physician considerations for patient safety. Under the revised criteria, we propose to add certain surgical procedures to the ASC CPL, beginning in CY 2026, in order to expand access, while maintaining the safety for Medicare beneficiaries VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00242 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33717 through the nonbinding physician considerations for patient safety. a. ASC CPL Review Process for CY 2026 (1) Proposed Changes to General Standards and Exclusion Criteria for CY 2026 For CY 2026, we are continuing to build on our effort siderations for patient safety. a. ASC CPL Review Process for CY 2026 (1) Proposed Changes to General Standards and Exclusion Criteria for CY 2026 For CY 2026, we are continuing to build on our efforts to maximize patient and physician choice and access to care by exploring broader approaches to adding procedures to the ASC CPL in order to further increase the availability of ASCs as an alternative and often lower cost site of care for Medicare beneficiaries. An expansion of the ASC CPL would maximize the ability of ASCs to divert patients that can be safely treated in an ASC setting away from the hospital setting, which would preserve the capacity of hospitals to treat more acute patients. Expanding the procedures placed on the ASC CPL would also build on the policy changes we have made in recent years to further site neutrality between the HOPD and ASC settings. In light of these objectives, we propose to modify the existing general standard criteria under 42 CFR 416.166(b) that currently require covered surgical procedures to be surgical procedures specified by the Secretary and published in the Federal Register and/or via the internet on the CMS website, separately paid under t ently require covered surgical procedures to be surgical procedures specified by the Secretary and published in the Federal Register and/or via the internet on the CMS website, separately paid under the OPPS, not expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure. We would retain the condition that procedures be separately paid under the OPPS and move the latter two standards to a new section outlining possible physician considerations in making site- of-service decisions. We also propose to eliminate five of the current general exclusion criteria at 42 CFR 416.166(c)(1) through (c)(5) and move them to the new physician considerations section. We believe these five exclusionary criteria may no longer be necessary to determine what procedures can be safely added to the ASC CPL because many ASCs are currently able to safely provide services with these characteristics, based on prior interested parties’ feedback and public comments we have received. This would to the ASC CPL because many ASCs are currently able to safely provide services with these characteristics, based on prior interested parties’ feedback and public comments we have received. This would also allow physicians practicing in the ASC setting, who have the greatest familiarity and insight into the needs of individual beneficiaries, to use their complex medical judgement to determine whether they can safely perform a procedure in the ASC, given the entirety of the circumstances, including the clinical profile of the patient, the surgical back-up available at the ASC, and the ability to safely and timely respond to unexpected complications. Under this proposal, we would keep the remaining three general exclusion criteria at 42 CFR 416.166(c)(6) through (c)(8) because the original reasons we adopted them in CY 2008 continue to exist, subject to the proposed modifications to 416.166(c)(6). These criteria would continue to exclude certain procedures from the ASC CPL, namely those that are designated as requiring inpatient care under 42 CFR 419.22(n), can only be reported using a CPT unlisted surgical procedure code, or are otherwise excluded under 42 CFR 411.15. We believe that hat are designated as requiring inpatient care under 42 CFR 419.22(n), can only be reported using a CPT unlisted surgical procedure code, or are otherwise excluded under 42 CFR 411.15. We believe that these proposed criteria are sufficient guardrails to ensure, along with appropriate patient selection and complex medical judgement of the physician, that the procedure can be performed safely on an ambulatory basis, including procedures that involve these five currently excluded characteristics. We believe that this proposal could advance the goals of increasing physician and patient choice and expanding site neutral options in conjunction with patient safety considerations. With respect to the existing general exclusion at 42 CFR 416.166(c)(6), which excludes procedures designated as requiring inpatient care under 42 CFR 419.22(n) from classification as covered surgical procedures, this proposal would modify this standard since the IPO list is proposed for elimination beginning in CY 2026 with a 3-year transition period, as described in section IX. of this proposed rule. While we recognize the need to revisit the criterion at 42 CFR 416.166(c)(6) following the elimination of the IPO 26 with a 3-year transition period, as described in section IX. of this proposed rule. While we recognize the need to revisit the criterion at 42 CFR 416.166(c)(6) following the elimination of the IPO list, we believe that maintaining this criterion for CY 2026 would allow for consistency between the two lists during the 3-year phaseout period. We note that if a service comes off the IPO list at any time, then the general exclusion at 42 CFR 416.166(c)(6) would cease to apply to the service. We acknowledge that this approach is a departure from the existing criteria that we established effective beginning in 2008, and from our policy finalized in the CY 2022 OPPS/ASC rule. However, we believe that this approach would expand and build upon our 2008 policy intent. Although there are some differences when comparing our CY 2008 criteria and the proposed CY 2026 criteria, such as removing the general standards and several of the original general exclusion criteria, permitting the addition of procedures to the ASC CPL that would have been prohibited by those criteria, and the different accreditation requirements and conditions of participation requirements between HOPDs and ASCs, these c f procedures to the ASC CPL that would have been prohibited by those criteria, and the different accreditation requirements and conditions of participation requirements between HOPDs and ASCs, these concerns have largely been addressed by the progress in medical practice and ASC capabilities in the 17 years since the criteria were developed as previously noted. In particular, given advances in the practice of medicine and the evolving nature of ASCs, we believe ASCs are now better equipped to safely perform procedures that were once too complex or risky to be performed safely on Medicare beneficiaries in the ASC setting. As previously mentioned, although ASCs and hospitals have different health and safety requirements, many ASCs often undergo accreditation as a condition of state licensure and share some similar licensure and compliance requirements with hospitals. Each of these requirements provides additional safeguards for the health and safety of Medicare beneficiaries receiving surgical procedures in an ASC. Additionally, in the CY 2022 OPPS/ASC final rule with comment period, when we reinstated the ASC CPL criteria that were in effect during CY 2020, we stated that many of th rgical procedures in an ASC. Additionally, in the CY 2022 OPPS/ASC final rule with comment period, when we reinstated the ASC CPL criteria that were in effect during CY 2020, we stated that many of the surgical procedures added to the list in CY 2021 may pose a significant safety risk to a typical Medicare beneficiary when performed in an ASC (86 FR 63777). However, we believe that these procedures are safe to perform in an ASC setting because all procedures identified are already payable in the HOPD setting and, therefore, are already safely performed on an ambulatory basis, consistent with the statutory requirement under section 1833(i)(1) of the Act. In addition, while several of the identified procedures may typically require hospital care that lasts beyond midnight, we expect that appropriately selected patient populations in the ASC setting would be healthier and less complex and would likely not require active monitoring or medical care past midnight beyond the procedure. (2) Proposed Review Process CMS will add surgical procedures to the ASC CPL in rulemaking as we become aware of new surgical procedures that meet the four requirements at § 416.166(b)(2). A member of the pu oposed Review Process CMS will add surgical procedures to the ASC CPL in rulemaking as we become aware of new surgical procedures that meet the four requirements at § 416.166(b)(2). A member of the public may also notify CMS of a surgical procedure they believe meets the requirements at new § 416.166(b)(2) through the pre- proposed rule recommendation process VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00243 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33718 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules or the public comment period. CMS will confirm whether the procedure does meet those requirements and will add it to the ASC CPL if it does meet that criteria. In accordance with the new proposed regulatory text at § 416.166(d), physicians would then assess whether their specific patients can or cannot safely receive such covered surgical procedure in the ASC setting based on patient-specific considerations. b. Proposed Procedure Additions for CY 2026 For CY 2026, we proposed to update the ASC CPL by adding 276 potential surgery or surgery-like codes to the l ting based on patient-specific considerations. b. Proposed Procedure Additions for CY 2026 For CY 2026, we proposed to update the ASC CPL by adding 276 potential surgery or surgery-like codes to the list that we believe would meet the proposed revised ASC CPL criteria under 42 CFR 416.166. This includes procedures submitted through our pre- proposed rule nominations process for addition to the ASC CPL under the proposed revised criteria. c. Summary of Proposals For CY 2026, we propose to revise the ASC CPL criteria under 42 CFR 416.166, modifying the general standard criteria and eliminating five of the general exclusion criteria. Using these revised criteria, we propose to add approximately 276 potential surgery or surgery-like codes to the CPL that are not on the CY 2025 IPO list. Additionally, we propose to add 271 surgery or surgery-like codes to the CPL that are currently on the IPO list, if we finalize our proposal to remove these services from the IPO list for CY 2026. These codes, along with their long descriptors and proposed payment indicator assignments, are listed in Tables 80 and 81. We believe that these proposed policies will increase the flexibility for physicians t es, along with their long descriptors and proposed payment indicator assignments, are listed in Tables 80 and 81. We believe that these proposed policies will increase the flexibility for physicians to exercise their complex medical judgment, factoring in patient safety considerations, and for patients to choose from more settings of care in which to receive surgical procedures. BILLING CODE 4120–01–P 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00244 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33719 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00245 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00246 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00247 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00248 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > 16, 2025 Jkt 265001 PO 00000 Frm 00247 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00248 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00249 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00250 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00251 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00252 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00253 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00254 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00255 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00256 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00257 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 Jkt 265001 PO 00000 Frm 00256 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00257 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00258 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00259 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00260 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00261 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00262 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00263 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00264 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00265 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00266 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul PO 00000 Frm 00265 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00266 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00267 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00268 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33743 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. As noted in the preceding paragraphs, section 4135 of the CAA, 2023, provides for temporary separate payments for certain non-opioid treatments for pain relief in both the hospital outpatient department and ambulatory surgical center settings from January 1, 2025, through December 31, 2027. Specifically, these separate payments are for qualifyi r pain relief in both the hospital outpatient department and ambulatory surgical center settings from January 1, 2025, through December 31, 2027. Specifically, these separate payments are for qualifying drugs, biologicals, and devices that, among other requirements, have their payment packaged into payment for a covered OPD service (or group of services). Pursuant to 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, we finalized our implementation of Section 4135 of CAA, 2023 (89 FR 94343 through 94361) to provide for separate payments for certain non-opioid treatment for pain relief in the hospital outpatient department and ambulatory surgical center settings on a temporary basis. These payment policies and the statutory language authorizing their implementation are discussed in the he hospital outpatient department and ambulatory surgical center settings on a temporary basis. These payment policies and the statutory language authorizing their implementation are discussed in the following sections. These policies are also outlined in regulation text finalized at 42 CFR 416.174 and 419.43. 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) shall receive separate payments under section 4135 of the CAA, 2023, subject to the payment limitation. In light of this requirement, we finalized that drugs and biologicals that meet the definition of a non-opioid treatment for pain relief for purposes of section 4135 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. The policy tments 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. The policy was finalized to be in effect for the duration of the payment period for section 4135. 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. 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)(bb), the medical devices must be ‘‘used to deliver a therapy to reduce postoperative pain, or produce post-surgical or regional analgesia.’’ This subparagraph also defines such a device as having ‘‘an application under section 515 of the Federal Food, Drug, and Cosmetic Act that has been a or produce post-surgical or regional analgesia.’’ This subparagraph also defines such a device as having ‘‘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 urnal, 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. d. Non-Opioid Product Indications (1) FDA-Approved Indications for Drugs and Biologicals Section 1833(t)(16)(G)(iv) is evidence criterion and would not qualify for separate payment under section 4135. 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 w oes 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 Congress specifically included language 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. We also noted that many patients who receive services paid under the OPPS and ASC payment system are often in a post-surgical environment, given the nature of the procedures typically performed in an ASC or HOPD. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00269 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33744 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules (2) Intended Use for Medical Devices Regarding medical devices, section 1833 4 1 S 7 W 9 K S D n o d n o m m a h k 33744 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules (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 (FDCA), have been cleared for market under section 510(k) of the FDCA, or be exempt from the requirements of section 510(k) of the FDCA pursuant to section 510(l) or (m) or 520(g) of the FDCA. 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 Federal Food, Drug, and Cosmetic Act (FDCA), which has been c AA, 2023 (89 FR 94346 through 94347). We also finalized that the medical device must have an application approved under section 515 of the Federal Food, Drug, and Cosmetic Act (FDCA), which has been cleared for market under section 510(k) of the FDCA, or be exempt from the requirements of section 510(k) of the FDCA pursuant to section 510(l) or (m) or 520(g) of the FDCA. (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 ) 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. 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, the separate payment for a drug or biological will be determined by subtracting from the amount calculated using the methodology outlined in section 1847A of the Act the portion of the otherwise applica e separate payment for a drug or biological will 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, the separate payment amount will 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 e d 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, 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 2 PC) 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 proposed rule for more information regarding the drug packaging threshold. Section II.A.2.b. of this proposed rule contains further information on threshold packaging and 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, we finalized a policy to base the 18 percent payment limitation on the volume weighted average atment for pain relief is furnished, as determined by the Secretary. In the CY 2025 OPPS/ASC final rule, 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 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 e 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 VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00270 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33745 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. Proposed CY 2026 Non-Opioid Policy Implementation of Section 4135 of the CAA, 2023 For CY 20 uture rulemaking as we gather additional claims data on the utilization of and payment for this product. 3. Proposed CY 2026 Non-Opioid Policy Implementation of Section 4135 of the CAA, 2023 For CY 2026, we propose to continue the policies finalized in the CY 2025 OPPS ASC final rule without modification. 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 propose 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 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. We note that the final payment limitation calculation in t f the otherwise applicable Medicare OPD fee schedule amount for CY 2025, as we will discuss the appropriate amount in each year’s rulemaking. We note 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 this proposed rule. Therefore, the values included in Table 83 are approximate payment limitations based on the best data available at the time of writing this proposed rule. We note that the final payment limitations for the CY 2026 OPPS/ASC final rule will also be based on the proposed payment rates in this proposed rule. Table 82 includes citations to the indications of the drugs and biologicals proposed to have met the statutory requirements and qualify for separate payment for this CY 2026 OPPS/ASC proposed rule. We welcome public comment on all of these policies, including the procedures used to determine the payment limitations that are detailed in Table 83. We welcome 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 pa in Table 83. We welcome 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. We will review these comments, evaluate the products against the criteria, and, if appropriate, will 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 note that CMS finalized the regulation text at 42 CFR 416.174, which states that CMS will determine if the eligibility requirements are met through that year’s rulemaking, due to this required review of materials, the need for input from the public, and the need to maintain budget neutrality per section 1833(t)(2)(E) of the Act. a. Qualifying Products for CY 2026 The following table, Table 82, lists the non-opioid alternatives that we propose will 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 they believe a particular drug, biological, medical device, n management drug or device under section 4135 criteria for CY 2026. CMS routinely receives public comments with detailed rationales on why they believe a particular drug, biological, medical device, or other item or service should receive separate payment. As such, we solicit comment 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 solicit comment on the top 5 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. As discussed previously in this section, there are specific requirements that must be met in order for the product to qualify for separate payment. Interested parties that believe that a product not addressed in this proposed rule meets the statutory requirements are encouraged to submit information during the comment pe ify for separate payment. Interested parties that believe that a product not addressed in this proposed rule meets the statutory requirements are encouraged to submit information during the comment period indicating how the product meets the statutory eligibility requirements. If CMS determines that the product(s) does in fact meet the statutory eligibility requirements, we will finalize separate payment for the product(s) in the CY 2026 OPPS/ASC final rule with comment period. For drugs and biological products not addressed in the proposed rule, if no comment is submitted that outlines how that drug or biological meets the statutory criteria, then CMS will not finalize separate payment for such product for CY 2026. Additionally, for medical devices not addressed in the proposed rule, unless a comment is submitted that both outlines how that device meets the statutory criteria and includes 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 will not finalize separate payment for such dev erative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer- reviewed journal, CMS will not finalize separate payment for such device for CY 2026. We note that we propose that the HCPCS codes describing the qualifying devices and drugs in Table 82 will be placed 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 we have consistently stated in past OPPS/ASC final rules (see, e.g., 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, e.g., Pub 100–04 Medicare Claims Processing, Transmitt 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, e.g., Pub 100–04 Medicare Claims Processing, Transmittal 11937). BILLING CODE 4120–01–P VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00271 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33746 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00272 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00273 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00274 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00275 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00276 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2. \FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00276 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33751 Bulletin No. 23–01 will increase the integrity of the ASC wage index system by creating a more accurate representation of current geographic variations in wage levels. In addition to adopting the revised delineations based on OMB Bulletin No. 23–01, we also finalized our proposal to limit year-to- year ASC wage index value changes to no more than a 5-percent decrease, similar to the policy of other Medicare payment systems under Parts A and B. This 5-percent cap, implemented in a budget neutral manner through the wage index scalar, mitigates any large negative impacts of adopting the new delineations and prevents large year-to- year declines in wage index values as a means to reduce volatility in Medicare payments. The proposed CY 2026 ASC wage indexes fully reflect the OMB labor market area delineations (including t ear-to- year declines in wage index values as a means to reduce volatility in Medicare payments. The proposed CY 2026 ASC wage indexes fully reflect the OMB labor market area delineations (including the revisions to the OMB labor market delineations discussed previously, as set forth in OMB Bulletin No. 23–01). We note that, in certain instances, there might be urban or rural areas for which there is no IPPS hospital that has wage index data that could be used to set the wage index for that area. When all of the areas contiguous to the urban CBSA of interest are rural and there is no IPPS hospital that has wage index data that could be used to set the wage index for that area, our policy has been to determine the ASC wage index by calculating the average of all wage indexes for urban areas in the State (75 FR 72058 through 72059). In other situations, where there are no IPPS hospitals located in a relevant labor market area, we apply our current policy of calculating an urban or rural area’s wage index by calculating the average of the wage indexes for CBSAs (or metropolitan divisions where applicable) that are contiguous to the area with no wage index. For example, for CY 2026, we area’s wage index by calculating the average of the wage indexes for CBSAs (or metropolitan divisions where applicable) that are contiguous to the area with no wage index. For example, for CY 2026, we are proposing that we continue to apply a proxy wage index based on this methodology to ASCs located in CBSA 25980 (Hinesville, GA) and in CBSA 35 (Rural North Dakota). Further, the proposed CY 2026 ASC wage index includes our policy finalized in the CY 2025 OPPS/ASC final rule with comment period that limits wage index changes to decrease by no more than 5 percent from the final CY 2025 ASC wage index value. 2. Calculation of the ASC Payment Rates a. Updating the ASC Relative Payment Weights for CY 2026 and Future Years We update the ASC relative payment weights each year using the national OPPS relative payment weights (and PFS nonfacility PE RVU-based amounts, as applicable) for that same calendar year and uniformly scale the ASC relative payment weights for each update year to make them budget neutral (72 FR 42533). The OPPS relative payment weights are scaled to maintain budget neutrality for the OPPS. We then scale the OPPS relative payment weights again to establish the ASC rel em budget neutral (72 FR 42533). The OPPS relative payment weights are scaled to maintain budget neutrality for the OPPS. We then scale the OPPS relative payment weights again to establish the ASC relative payment weights. To accomplish this, we hold estimated total ASC payment levels constant between calendar years for purposes of maintaining budget neutrality in the ASC payment system. That is, we apply the weight scalar to ensure that projected expenditures from the updated ASC payment weights in the ASC payment system are equal to what would be the current expenditures based on the scaled ASC payment weights. In this way, we ensure budget neutrality and that the only changes to total payments to ASCs result from increases or decreases in the ASC payment update factor. As discussed in section II.A.1.a. of this proposed rule, we are using the CY 2024 claims data to be consistent with the OPPS claims data for the proposed rule. Consistent with our established policy, we propose to scale the CY 2026 relative payment weights for ASCs according to the following method. Holding ASC utilization, the ASC conversion factor, and the mix of services constant from CY 2024, we propose to com le the CY 2026 relative payment weights for ASCs according to the following method. Holding ASC utilization, the ASC conversion factor, and the mix of services constant from CY 2024, we propose to compare the estimated total payment using the CY 2025 ASC relative payment weights with the estimated total payment using the CY 2026 ASC relative payment weights to take into account the changes in the OPPS relative payment weights between CY 2025 and CY 2026. In consideration of our policy to provide a higher ASC payment rate with ASC complexity adjustment codes for certain primary procedures when performed with add-on packaged services, we incorporated estimated total spending and estimated utilization for these codes in our budget neutrality calculation for CYs 2023 and 2024. For this proposed rule, our estimated change in ASC spending related to our proposed ASC complexity adjustment codes for CY 2026 did not impact the ASC weight scalar. Additionally, as discussed in section XIII.E. of the CY 2025 OPPS/ASC final rule with comment period (89 FR 94342 through 94361), section 4135(a) and (b) of the CAA, 2023, titled ‘‘Access to Non- Opioid Treatments for Pain Relief,’’ amended section the CY 2025 OPPS/ASC final rule with comment period (89 FR 94342 through 94361), 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 separate payments for non-opioid treatments for pain relief. As discussed in further detail in section XIII.E. of the CY 2025 OPPS/ASC final rule, for qualifying non-opioid products, we finalized applying an 18 percent payment limitation on the volume weighted payment average of the top 5 services associated with the use of the qualifying non-opioid product. In CY 2024, four of these qualifying nonopioid products were separately payable without the 18 percent payment limitation—HCPCS Codes C9089 (Bupivacaine implant, 1 mg), C9290 (Inj, bupivacaine liposome), J1096 (Dexametha opth insert 0.1 mg), and J1097 (Phenylep ketorolac opth soln). Therefore, to maintain budget neutrality, we estimated the total anticipated reduction in ASC spending for these qualifying non-opioid products for CY 2025 as a result of the 18 percent payment limitation required by section 4135 of the CAA, 2023. Based on the updated 18 ated reduction in ASC spending for these qualifying non-opioid products for CY 2025 as a result of the 18 percent payment limitation required by section 4135 of the CAA, 2023. Based on the updated 18 percent payment limitations and CY 2024 utilization, we estimate that the proposed CY 2026 payment limitations will not impact the ASC weight scalar. In section XIII.C.2.b. of this proposed rule, we discuss our proposal to unpackage and pay separately for groups of skin substitute products under the ASC payment system beginning January 1, 2026. Currently, these products are packaged into payment for the primary covered surgical procedures. To maintain budget neutrality under the OPPS, the reduction in any APC’s relative weights from the loss of skin substitute costs in the APC’s geometric mean cost will be offset by an increase in the OPPS weight scalar. To maintain budget neutrality, this increase in the OPPS weight scalar will be offset by a reduction in estimated new OPPS payment for skin substitute APC groups. Since we ask ASCs not to report packaged items and services on ASC claims, we are unable to perform a similar adjustment and determine existing utilization of skin substitute in substitute APC groups. Since we ask ASCs not to report packaged items and services on ASC claims, we are unable to perform a similar adjustment and determine existing utilization of skin substitute products from ASC claims. To resolve this limitation but maintain budget neutrality within the ASC payment system, we multiplied the change in the geometric mean costs of covered surgical skin procedure in the ASC setting from unpackaging skin substitute products by the utilization of such skin procedures in the ASC setting to approximate the estimated skin substitute payments in the ASC setting. Based on existing surgical procedure utilization and our estimated utilization of skin substitute products in the ASC setting, our estimated separate payments VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00277 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33752 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules for skin substitutes in the ASC setting did not impact the ASC weight scalar. We propose to use the ratio of estimated CY 2025 to estimated CY 2026 total payments (the , July 17, 2025 / Proposed Rules for skin substitutes in the ASC setting did not impact the ASC weight scalar. We propose to use the ratio of estimated CY 2025 to estimated CY 2026 total payments (the weight scalar) to scale the ASC relative payment weights for CY 2026. The proposed CY 2026 ASC weight scalar is 0.842. As discussed further in the CY 2025 OPPS/ ASC final rule with comment period (89 FR 94363 through 94364), we have historically displayed this figure rounded to the nearest ten thousandth; however, we believe this level of specificity is unnecessarily burdensome for an ASC payment system that is less than one-tenth the size of the OPPS (in which the weight scalar is rounded to the nearest ten-thousandth). Consistent with historical practice, we propose to scale, using this method (with an ASC weight scalar rounded to the nearest thousandth), the ASC relative payment weights of covered surgical procedures, covered ancillary radiology services, and certain diagnostic tests within the medicine range of CPT codes, which are covered ancillary services for which the ASC payment rates are based on OPPS relative payment weights. We propose that we would not scale ASC payment f ithin the medicine range of CPT codes, which are covered ancillary services for which the ASC payment rates are based on OPPS relative payment weights. We propose that we would not scale ASC payment for separately payable covered ancillary services that have a predetermined national payment amount (that is, their national ASC payment amounts are not based on OPPS relative payment weights), such as drugs and biologicals that are separately paid or services that are contractor-priced or paid at reasonable cost in ASCs. Any service with a predetermined national payment amount, which includes the device portion of device-intensive procedures, would be included in the ASC budget neutrality comparison, but scaling of the ASC relative payment weights would not apply to those services or the portion of those services. The ASC payment weights for those services without predetermined national payment amounts would be scaled to eliminate any difference in the total payment between the current year and the update year. However, as discussed in sections V.B.8.i. and XIII.C.4. of this proposed rule, we propose that the OPPS payment rates used for ratesetting under the ASC payment system for CY 2 r and the update year. However, as discussed in sections V.B.8.i. and XIII.C.4. of this proposed rule, we propose that the OPPS payment rates used for ratesetting under the ASC payment system for CY 2026 and subsequent years would not incorporate the two percent prospective offset to the OPPS conversion factor, as a result of the 340B remedy offset that we are proposing to implement in this proposed rule. Historically, the ASC payment system has generally adopted the OPPS conversion factor used for determining the proposed or final OPPS payment rates for determining the device portions for device-intensive procedures under the ASC payment system. A two percent reduction in the OPPS conversion factor would otherwise reduce ASC payments for device-intensive procedures by approximately one percent; the non- device portions for all covered surgical procedures would otherwise be increased to offset reduction to device portions for device-intensive procedures. For CY 2026, we estimate the reduction to device portions from the two percent prospective offset would have reduced proposed CY 2026 ASC expenditures for device-intensive procedures by approximately $42 million and would have othe duction to device portions from the two percent prospective offset would have reduced proposed CY 2026 ASC expenditures for device-intensive procedures by approximately $42 million and would have otherwise increased the ASC weight scalar by 0.1 percent to offset such reduction. For any given year’s ratesetting, we typically use the most recent full calendar year of claims data to model budget neutrality adjustments. We propose to use the CY 2024 claims data to model our budget neutrality adjustment for CY 2026. b. Updating the ASC Conversion Factor Under the OPPS, we typically apply a budget neutrality adjustment for provider-level changes, most notably a change in the wage index values for the upcoming year, to the conversion factor. Consistent with our final ASC payment policy, for the CY 2017 ASC payment system and subsequent years, in the CY 2017 OPPS/ASC final rule with comment period (81 FR 79751 through 79753), we finalized our policy to calculate and apply a budget neutrality adjustment to the ASC conversion factor for supplier-level changes in wage index values for the upcoming year, just as the OPPS wage index budget neutrality adjustment is calculated and applied to the djustment to the ASC conversion factor for supplier-level changes in wage index values for the upcoming year, just as the OPPS wage index budget neutrality adjustment is calculated and applied to the OPPS conversion factor. For CY 2026, we calculated the proposed adjustment for the ASC payment system by using the most recent CY 2024 claims data available and estimating the difference in total payment that would be created by introducing the proposed CY 2026 ASC wage indexes. Specifically, holding CY 2024 ASC utilization, service-mix, and the proposed CY 2026 national payment rates after application of the weight scalar constant, we calculated the total adjusted payment using the CY 2025 ASC wage indexes and the total adjusted payment using the proposed CY 2026 ASC wage indexes which included the 5-percent cap on wage index declines. We used the 50 percent labor-related share for both total adjusted payment calculations. We then compared the total adjusted payment calculated with the CY 2025 ASC wage indexes to the total adjusted payment calculated with the proposed CY 2026 ASC wage indexes and applied the resulting ratio of 0.9999 (the proposed CY 2026 ASC wage index budget neutral 2025 ASC wage indexes to the total adjusted payment calculated with the proposed CY 2026 ASC wage indexes and applied the resulting ratio of 0.9999 (the proposed CY 2026 ASC wage index budget neutrality adjustment) to the CY 2025 ASC conversion factor to calculate the proposed CY 2026 ASC conversion factor. Section 1833(i)(2)(D)(v) of the Act requires that the ASC conversion factor be reduced by a productivity adjustment in each calendar year. Section 1886(b)(3)(B)(xi)(II) of the Act defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity (MFP). We finalized the methodology for calculating the productivity adjustment in the CY 2011 PFS final rule with comment period (75 FR 73394 through 73396) and revised it in the CY 2012 PFS final rule with comment period (76 FR 73300 through 73301) and the CY 2016 OPPS/ASC final rule with comment period (80 FR 70500 through 70501). The proposed productivity adjustment for CY 2026 was projected to be 0.8 percentage point, as published in the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18266) based on IGI’s 2024 fourth quarter forecast. Sectio productivity adjustment for CY 2026 was projected to be 0.8 percentage point, as published in the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18266) based on IGI’s 2024 fourth quarter forecast. Section 1833(i)(2)(C)(i) of the Act requires that, if the Secretary has not updated amounts established under the revised ASC payment system in a calendar year, the payment amounts shall be increased by the percentage increase in the Consumer Price Index for all urban consumers (CPI–U), U.S. city average, as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved. The statute does not mandate the adoption of any particular update mechanism, but it requires the payment amounts to be increased by the CPI–U in the absence of any update. Because the Secretary updates the ASC payment amounts annually, we adopted a policy, which we codified at § 416.171(a)(2)(ii)), to update the ASC conversion factor using the CPI–U for CY 2010 and subsequent calendar years. In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59075 through 59080), we finalized a policy to apply the hospital market basket update (which is the inpatient hospital market basket percen the CY 2019 OPPS/ASC final rule with comment period (83 FR 59075 through 59080), we finalized a policy to apply the hospital market basket update (which is the inpatient hospital market basket percentage increase reduced by the productivity adjustment) to ASC payment system rates for an interim period of 5 years (CY 2019 through CY 2023), during which we would assess whether there was a migration of the performance of procedures from the VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00278 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33753 hospital setting to the ASC setting as a result of the use of a hospital market basket update, as well as whether there were any unintended consequences, such as less than expected migration of the performance of procedures from the hospital setting to the ASC setting. At that time, the most recently available full year of claims data to assess the expected migration applying the productivity-adjusted hospital market basket update during the interim period was within the period f the most recently available full year of claims data to assess the expected migration applying the productivity-adjusted hospital market basket update during the interim period was within the period from CY 2019 through CY 2022. However, the impact of the COVID–19 PHE on health care utilization, CY 2020 in particular, was tremendously profound, particularly for elective surgeries, because many beneficiaries avoided healthcare settings, when possible, to avoid possible infection from the SARS-CoV– 2 virus. As a result, it was nearly impossible to disentangle the effects from the COVID–19 PHE in our analysis of whether the higher update factor for the ASC payment system caused increased migration to the ASC setting. To analyze whether procedures migrated from the hospital setting to the ASC setting, we needed to use claims data from a period during which the COVID–19 PHE had less of an impact on health care utilization. Therefore, for CY 2024, we finalized our proposal to extend the 5-year interim period an additional 2 years through CY 2024 and CY 2025. We believed hospital outpatient and ASC utilization data from CYs 2023 and 2024 would enable us to more accurately analyze whether ar interim period an additional 2 years through CY 2024 and CY 2025. We believed hospital outpatient and ASC utilization data from CYs 2023 and 2024 would enable us to more accurately analyze whether the application of the hospital market basket update to the ASC payment system had an effect on the migration of services from the hospital setting to the ASC setting. We revised our regulations at 42 CFR 416.171(a)(2)(iii), (iv), (vi), (vii), and (viii) which establish the annual update to the ASC conversion factor, to reflect this 2-year extension. For this CY 2026 OPPS/ASC proposed rule, we propose to extend our utilization of the hospital market basket update factor in the ASC payment system for one additional year, through CY 2026, as we continue to review and evaluate hospital outpatient and ASC utilization data, as well as the migration of surgical procedures between settings. In conjunction with our proposal, we are revising our regulations at 42 CFR 416.171(a)(2)(iii), (iv), (vi), (vii), and (viii), which establish the annual update to the ASC conversion factor, the 2.0 percentage point reduction for ASCs that fail to meet the standards for reporting ASC quality measures, and (vii), and (viii), which establish the annual update to the ASC conversion factor, the 2.0 percentage point reduction for ASCs that fail to meet the standards for reporting ASC quality measures, and the productivity adjustment, to reflect this one year extension. 2. CY 2026 Proposed ASC Conversion Factor For CY 2026, we propose to utilize the proposed inpatient hospital market basket percentage increase of 3.2 percent reduced by the proposed productivity adjustment of 0.8 percentage point, resulting in a proposed hospital market basket update of 2.4 percent for ASCs meeting the quality reporting requirements. Therefore, we propose to apply a proposed 2.4 percent hospital market basket update factor to the CY 2025 ASC conversion factor for ASCs meeting the quality reporting requirements to determine the CY 2026 ASC payment amounts. The ASCQR Program affected payment rates beginning in CY 2014 and, under this program, there is a 2.0 percentage point reduction to the hospital market basket update factor for ASCs that fail to meet the ASCQR Program requirements. We refer readers to section XIV.E. of the CY 2019 OPPS/ASC final rule with comment period (83 FR 59138 through 59139) and se et update factor for ASCs that fail to meet the ASCQR Program requirements. We refer readers to section XIV.E. of the CY 2019 OPPS/ASC final rule with comment period (83 FR 59138 through 59139) and section XIV.E. of this proposed rule for a detailed discussion of our policies regarding payment reduction for ASCs that fail to meet ASCQR Program requirements. We propose to utilize the proposed inpatient hospital market basket percentage increase of 3.2 percent reduced by 2.0 percentage points for ASCs that do not meet the quality reporting requirements and then reduced by the proposed 0.8 percentage point productivity adjustment. Therefore, we propose to apply a 0.4 percent hospital market basket update factor to the CY 2025 ASC conversion factor for ASCs not meeting the quality reporting requirements. We also propose that if more recent data are subsequently available (for example, a more recent estimate of the inpatient hospital market basket percentage increase or productivity adjustment), we would use such data, if appropriate, to determine the CY 2026 ASC update for the CY 2026 OPPS/ASC final rule with comment period. For CY 2026, we are adjusting the CY 2025 ASC conversion fact ent), we would use such data, if appropriate, to determine the CY 2026 ASC update for the CY 2026 OPPS/ASC final rule with comment period. For CY 2026, we are adjusting the CY 2025 ASC conversion factor ($54.895) by a wage index budget neutrality factor of 0.9999 in addition to the productivity-adjusted hospital market basket update of 2.4 percent, discussed previously, which results in a proposed CY 2026 ASC conversion factor of $56.207 for ASCs meeting quality reporting requirements. For ASCs not meeting quality reporting requirements, we are adjusting the CY 2025 ASC conversion factor ($54.895) by the wage index budget neutrality factor of 0.9999 in addition to the reduced productivity- adjusted hospital market basket update of 0.4 percent, discussed above, which results in a proposed CY 2026 ASC conversion factor of $55.109 for ASCs not meeting the quality reporting requirements. 3. Display of the Proposed CY 2026 ASC Payment Rates Addenda AA and BB to this proposed rule (which are available on the CMS website) display the proposed ASC payment rates for CY 2026 for covered surgical procedures and covered ancillary services, respectively. The proposed payment rates included in A available on the CMS website) display the proposed ASC payment rates for CY 2026 for covered surgical procedures and covered ancillary services, respectively. The proposed payment rates included in Addenda AA and BB to this proposed rule reflect the full ASC payment update and not the reduced payment update used to calculate payment rates for ASCs not meeting the quality reporting requirements under the ASCQR Program. These Addenda contain several types of information related to the proposed CY 2026 payment rates. Specifically, in Addendum AA, a ‘‘Y’’ in the column titled ‘‘To be Subject to Multiple Procedure Discounting’’ indicates that the surgical procedure would be subject to the multiple procedure payment reduction policy. As discussed in the CY 2008 OPPS/ASC final rule with comment period (72 FR 66829 through 66830), most covered surgical procedures are subject to a 50 percent reduction in the ASC payment for the lower-paying procedure when more than one procedure is performed in a single operative session. The values displayed in the column titled ‘‘Proposed CY 2026 Payment Weight’’ are the proposed relative payment weights for each of the listed services for CY 2026. The p n a single operative session. The values displayed in the column titled ‘‘Proposed CY 2026 Payment Weight’’ are the proposed relative payment weights for each of the listed services for CY 2026. The proposed relative payment weights for all covered surgical procedures and covered ancillary services where the ASC payment rates are based on OPPS relative payment weights were scaled for budget neutrality. Therefore, scaling was not applied to the device portion of the device-intensive procedures; services that are paid at the MPFS nonfacility PE RVU-based amount; separately payable covered ancillary services that have a predetermined national payment amount, such as drugs and biologicals and brachytherapy sources that are separately paid under the OPPS; or services that are contractor-priced or paid at reasonable cost in ASCs. This includes separate payment for non-opioid pain management drugs. To derive the proposed CY 2026 payment rate displayed in the ‘‘Proposed CY 2026 Payment Rate’’ VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00279 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33754 Federa VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00279 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33754 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules column, each ASC payment weight in the ‘‘Proposed CY 2026 Payment Weight’’ column was multiplied by the proposed CY 2026 conversion factor. The conversion factor includes a budget neutrality adjustment for changes in the wage index values and the annual update as reduced by the productivity adjustment. The proposed CY 2026 ASC conversion factor uses the proposed CY 2026 productivity-adjusted hospital market basket update factor of 2.4 percent (which is equal to the inpatient hospital market basket percentage increase of 3.2 percent reduced by the productivity adjustment of 0.8 percentage point). We also propose that if more recent data subsequently become available (for example, a more recent estimate of the inpatient hospital market basket percentage increase and the productivity adjustment), we would use such data, if appropriate, to determine the CY 2026 ASC conversion factor in the final rule. In Addendum BB, hospital market basket percentage increase and the productivity adjustment), we would use such data, if appropriate, to determine the CY 2026 ASC conversion factor in the final rule. In Addendum BB, there are no relative payment weights displayed in the ‘‘Proposed CY 2026 Payment Weight’’ column for items and services with predetermined national payment amounts, such as separately payable drugs and biologicals. The ‘‘Proposed CY 2026 Payment’’ column displays the proposed CY 2026 national unadjusted ASC payment rates for all items and services. The proposed CY 2026 ASC payment rates listed in Addendum BB for separately payable drugs and biologicals are based on the most recently available data used for payment in physicians’ offices. For CY 2021, we finalized adding a new column to ASC Addendum BB titled ‘‘Drug Pass- Through Expiration during Calendar Year’’ where we flag through the use of an asterisk each drug for which pass- through payment is expiring during the calendar year (that is, on a date other than December 31st). Addendum EE to this proposed rule provides the HCPCS codes and short descriptors for surgical procedures that are to be excluded from payment in ASCs for CY t is, on a date other than December 31st). Addendum EE to this proposed rule provides the HCPCS codes and short descriptors for surgical procedures that are to be excluded from payment in ASCs for CY 2026. Addendum FF to this proposed rule displays the OPPS payment rate (based on the standard ratesetting methodology), the APC device offset percentage, the device offset percentage for determining device-intensive status (based on the standard ratesetting methodology), and the device portion of the ASC payment rate for CY 2026 for covered surgical procedures. XIV. Cross-Program Proposals for the Hospital Outpatient Quality Reporting (OQR), Rural Emergency Hospital Quality Reporting (REHQR), and Ambulatory Surgical Center Quality Reporting (ASCQR) Programs A. Background We refer readers to sections XV., XVI., and XVII. of this proposed rule for program specific background information, including the statutory authorities, and previously finalized and newly proposed measure sets, for the Hospital Outpatient Quality Reporting (OQR), Rural Emergency Hospital Quality Reporting (REHQR), and Ambulatory Surgical Center Quality Reporting (ASCQR) Programs, respectively. B. Measure Concepts Unde spital Outpatient Quality Reporting (OQR), Rural Emergency Hospital Quality Reporting (REHQR), and Ambulatory Surgical Center Quality Reporting (ASCQR) Programs, respectively. B. Measure Concepts Under Consideration for Future Years in the Hospital OQR, REHQR, and ASCQR Programs—Request for Information (RFI): Well-Being and Nutrition We are seeking input on well-being and nutrition measures for consideration in future rulemaking for the Hospital OQR, REHQR, and ASCQR Programs. Well-being is a comprehensive approach to disease prevention and health promotion, as it integrates mental and physical health while emphasizing preventative care to proactively address potential health issues.141 This comprehensive approach emphasizes person-centered care by promoting the well-being of patients and family members. We are seeking comments on tools and measures that assess overall health, happiness, and satisfaction in life, which could include aspects of emotional well-being, social connections, purpose, and fulfillment. We would like to receive input and comments on the applicability of tools and constructs that assess the integration of complementary and integrative health, skill building, purpose, and fulfillment. We would like to receive input and comments on the applicability of tools and constructs that assess the integration of complementary and integrative health, skill building, and self-care. We are also seeking comments on tools and measures that assess optimal nutrition and preventive care in the Hospital OQR, REHQR, and ASCQR Programs. Assessments for nutritional status may include strategies, guidelines, and practices that promote healthy eating habits and ensure individuals receive the necessary nutrients for maintaining health, growth, and overall well-being. Such assessments may also include aspects of health that support or mediate 141 Centers for Disease Control and Prevention. (May 2024). About Emotional Well-Being. Available at https://www.cdc.gov/emotional-well-being/about/ #cdc_behavioral_basics_types-health-benefits. Accessed: April 30, 202.5. nutritional status, such as physical activity and sleep. In this context, preventive care plays a vital role by proactively addressing factors that may lead to poor nutritional status or related health issues. These efforts not only support optimal nutrition but also work to prevent conditions that could o e by proactively addressing factors that may lead to poor nutritional status or related health issues. These efforts not only support optimal nutrition but also work to prevent conditions that could otherwise hinder an individual’s health and nutritional needs. While we will not be responding to specific comments in response to this RFI in the CY 2026 OPPS/ASC final rule, we intend to use this input to inform our future measure development efforts. C. Proposed Changes to the Hospital OQR, REHQR, and ASCQR Program Measure Sets 1. Proposed Removal of the COVID–19 Vaccination Coverage Among Healthcare Personnel (HCP) Measure From the Hospital OQR and ASCQR Programs Beginning With the CY 2024 Reporting Period/CY 2026 Payment Determination We refer readers to the CY 2022 OPPS/ASC final rule where we adopted the COVID–19 Vaccination Coverage Among HCP measure into the Hospital OQR and ASCQR Programs (86 FR 63824 through 63833 and 86 FR 63875 through 63883, respectively) and the CY 2024 OPPS/ASC final rule with comment period where we modified the COVID–19 Vaccination Coverage Among HCP measure to account for updated vaccine guidance (88 FR 81963 through 81968 and 88 FR 82013 through 8201 ASC final rule with comment period where we modified the COVID–19 Vaccination Coverage Among HCP measure to account for updated vaccine guidance (88 FR 81963 through 81968 and 88 FR 82013 through 82017, respectively). For the Hospital OQR and ASCQR Programs, we propose to remove the COVID–19 Vaccination Coverage Among HCP measure beginning with the CY 2024 reporting period/CY 2026 payment determination under removal Factor 8, the costs associated with a measure outweigh the benefit of its continued use in the program (§§ 419.46(i)(3)(i)(H) and 416.320(c)(2)(viii), respectively). Reporting on this measure currently requires reporting data on COVID–19 Vaccination Coverage Among HCP for at least 1 week every month. This requires healthcare facilities to track current vaccination status for all employees, licensed independent practitioners, adult students/trainers and volunteers, and other contract personnel and log in to the National Healthcare Safety Network (NHSN) system to report the data monthly, either manually in NHSN or by uploading a comma-separated value (CSV) file.142 The estimated 142 Centers for Disease Control and Prevention. (2025). Weekly COVID–19 Vaccination Module for ata monthly, either manually in NHSN or by uploading a comma-separated value (CSV) file.142 The estimated 142 Centers for Disease Control and Prevention. (2025). Weekly COVID–19 Vaccination Module for VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00280 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33755 burden of collecting this information annually across all 3,200 hospitals in the Hospital OQR Program is between $1,446,400 and $1,687,680. Across the 4,590 ASCs in the ASCQR Program, the estimated annual burden is between $2,074,680 and $2,420,766. We refer readers to section XXIII. of this proposed rule for more details on this estimated burden calculation. When we first adopted the COVID–19 Vaccination Coverage Among HCP measure for the Hospital OQR and ASCQR Programs, the U.S. was in the midst of a Public Health Emergency (PHE) that incurred millions of cases and over 718,000 COVID–19 deaths (86 FR 63825 and 86 FR 63875 through 63876, respectively).143 While preventing the spread of COVID–19 remains a public heal gency (PHE) that incurred millions of cases and over 718,000 COVID–19 deaths (86 FR 63825 and 86 FR 63875 through 63876, respectively).143 While preventing the spread of COVID–19 remains a public health goal, the PHE ended on May 11, 2023.144 In addition, the number of deaths due to COVID–19 in the U.S. has decreased since the adoption of this measure. In August 2021, when this measure was being proposed, the U.S. was averaging over 6,000 deaths related to COVID–19 per week.145 In April 2023, the last full month of the PHE, weekly number of deaths attributed to COVID–19 averaged around 1,300.146 With the end of the PHE and the decrease in COVID–19 deaths, we believe the continued costs and burden to healthcare facilities of tracking and monthly reporting on this measure outweigh the benefit of continued information collection on COVID–19 vaccination coverage among HCP. As it may be costly for hospitals and ASCs to continue to report on the COVID–19 Vaccination Coverage Among HCP measure, removal of this measure would allow for the Hospital OQR and ASCQR Programs to focus on other clinical goals. If this proposal is finalized as proposed, hospitals and ASCs that do not report their e, removal of this measure would allow for the Hospital OQR and ASCQR Programs to focus on other clinical goals. If this proposal is finalized as proposed, hospitals and ASCs that do not report their CY 2024 reporting period data for the COVID–19 Healthcare Personnel. Available at https:// www.cdc.gov/nhsn/pdfs/hps/covidvax/2025-hcp- combined-protocol-508.pdf. Accessed: April 30, 2025. 143 Centers for Disease Control and Prevention. (2025). COVID Data Tracker. Available at https:// covid.cdc.gov/covid-data-tracker/#trends_ totaldeaths_select_00. Accessed: April 30, 2025. 144 U.S. Department of Health and Human Services. (2023). COVID–19 Public Health Emergency. Available at https://www.hhs.gov/ coronavirus/covid-19-public-health-emergency/ index.html. Accessed: April 30, 2025. 145 Centers for Disease Control and Prevention. (2025). COVID Data Tracker. Available at https:// covid.cdc.gov/covid-data-tracker/#trends_ weeklydeaths_select_00. Accessed: April 30, 2025. 146 Centers for Disease Control and Prevention. (2025). COVID Data Tracker. Available at https:// covid.cdc.gov/covid-data-tracker/#trends_ weeklydeaths_select_00. Accessed: April 30, 2025. Vaccination Coverage Among HCP m e Control and Prevention. (2025). COVID Data Tracker. Available at https:// covid.cdc.gov/covid-data-tracker/#trends_ weeklydeaths_select_00. Accessed: April 30, 2025. Vaccination Coverage Among HCP measure to CMS would not be considered noncompliant with the measure for their CY 2026 payment determination (that is, hospitals and ASCs that do not report CY 2024 reporting period data would not be penalized for CY 2026 payments due to this measure). Any COVID–19 Vaccination Coverage Among HCP measure data received by CMS would not be used for public reporting or payment purposes. If this proposal is not finalized as proposed, hospitals and ASCs that do not report their CY 2024 reporting data for the COVID–19 Vaccination Coverage Among HCP measure to CMS would be considered noncompliant with the measure for their CY 2026 payment determination and would receive a letter of noncompliance. Payment adjustments would apply to CY 2026 payment determination for fee-for- service claims as previously finalized. We invite public comment on this proposal. 2. Proposed Removal of the Hospital Commitment to Health Equity (HCHE) Measure From the Hospital OQR and REHQR Programs and the Facility Commi sly finalized. We invite public comment on this proposal. 2. Proposed Removal of the Hospital Commitment to Health Equity (HCHE) Measure From the Hospital OQR and REHQR Programs and the Facility Commitment to Health Equity (FCHE) Measure From the ASCQR Program Beginning With the CY 2025 Reporting Period/CY 2027 Payment or Program Determination We refer readers to the CY 2025 OPPS/ASC final rule with comment period where we adopted the Hospital Commitment to Health Equity (hereafter referred to as HCHE) measure into the Hospital OQR and REHQR Programs and the Facility Commitment to Health Equity (hereafter referred to as FCHE) measure into the ASCQR Program (89 FR 94368 through 94381). For the Hospital OQR, REHQR, and ASCQR Programs, we propose to remove the HCHE and FCHE measures beginning with the CY 2025 reporting period/CY 2027 payment or program determination under removal Factor 8, due to the costs associated with achieving a high score on the measure outweighing the benefit of its continued use in the program (§§ 419.46(i)(3)(i)(H), 419.95(e)(3)(i)(H), and 416.320(c)(2)(viii), respectively). When adopted, we intended the collection of data described in the five domains of the s continued use in the program (§§ 419.46(i)(3)(i)(H), 419.95(e)(3)(i)(H), and 416.320(c)(2)(viii), respectively). When adopted, we intended the collection of data described in the five domains of these measures to provide hospital, REH, and ASC leadership with meaningful and actionable health data to drive quality improvements to eliminate health disparities. Based on feedback received from hospitals, REHs, and ASCs, as well as a re-focus on clinical outcomes and direct patient care, for which the HCHE and FCHE measures, as structural measures, do not directly measure, the burden of collecting these measures may outweigh the benefits. Removal of these measures would alleviate an estimated annual burden of approximately 533 hours, at a cost of $22,518, across all participating hospitals (89 FR 94523); 6 hours, at a cost of $332, across all participating REHs (89 FR 94530); and 746 hours, at a cost of $41,313 across all participating ASCs (89 FR 94534). An important goal of the Hospital OQR, REHQR, and ASCQR Programs is moving forward in the least burdensome manner possible while maintaining a parsimonious set of meaningful quality measures and continuing to incentivize improvement OQR, REHQR, and ASCQR Programs is moving forward in the least burdensome manner possible while maintaining a parsimonious set of meaningful quality measures and continuing to incentivize improvement in the quality of care provided to patients. Removing these measures from the Hospital OQR, REHQR and ASCQR Programs serves this goal. Our priority is a re-focus on measurable clinical outcomes as well as identifying quality measures on topics of prevention, nutrition, and well-being. As such we refer readers to our request for comment on ‘‘Measure Concepts under Consideration for Future Years in the Hospital OQR, REHQR, and ASCQR Programs—Request for Information (RFI): Well-Being and Nutrition’’ in section XIV.B. of this proposed rule. We acknowledge that some hospitals, REHs, and ASCs may have expended resources to implement some or all of the activities described in the HCHE and FCHE measures attestation statements in order to be able to attest ‘‘yes’’ for measure reporting purposes. If this proposal is finalized as proposed, hospitals, REHs, and ASCs that do not report their CY 2025 reporting period data for the HCHE or FHCE measure to CMS would not be considered noncompliant with this proposal is finalized as proposed, hospitals, REHs, and ASCs that do not report their CY 2025 reporting period data for the HCHE or FHCE measure to CMS would not be considered noncompliant with the measure for purposes of their CY 2027 payment or program determination (that is, hospitals, REHs, or ASCs that do not report CY 2025 reporting period data would not be penalized for CY 2027 payments due to this measure, if applicable). Any HCHE or FCHE measure data received by CMS would not be used for public reporting or payment purposes. If this proposal is not finalized as proposed, hospitals, REHs, or ASCs that do not report their CY 2025 reporting data for the HCHE or FCHE measures to CMS would be considered noncompliant with the measure for their CY 2027 payment or program determination and would receive a letter of noncompliance. Payment adjustments would apply to CY 2027 payment determination fee-for-service (FFS) claims as previously finalized in VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00281 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33756 Federal Register / Vol. 90, No. 135 2025 Jkt 265001 PO 00000 Frm 00281 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33756 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules the Hospital OQR and ASCQR Programs. We invite public comment on these proposals. 3. Proposed Removal of Two Social Drivers of Health Measures From the Hospital OQR, REHQR, and ASCQR Programs Beginning With the CY 2025 Reporting Period We propose to remove two social drivers of health (SDOH) process measures from the Hospital OQR, REHQR, and ASCQR Programs beginning with the CY 2025 reporting period: Screening for Social Drivers of Health (adopted at 89 FR 94381 through 94398); and Screen Positive Rate for Social Drivers of Health (adopted at 89 FR 94398 through 94403). We propose to remove the SDOH measures beginning with the CY 2025 reporting period under removal Factor 8, the costs associated with the measure outweigh the benefit of its continued use in these programs (§§ 419.46(i)(3)(i)(H), 419.95(e)(3)(i)(H), and 416.320(c)(2)(viii), respectively). We have heard from some hospitals, REHs, and ASCs concerned with the costs and resources as ed use in these programs (§§ 419.46(i)(3)(i)(H), 419.95(e)(3)(i)(H), and 416.320(c)(2)(viii), respectively). We have heard from some hospitals, REHs, and ASCs concerned with the costs and resources associated with screening patients via manual processes, manually storing such data, training staff, and altering workflows for these measures. In the CY 2025 OPPS/ASC final rule with comment period, we estimated a total annual burden of 6,878,055 hours at a cost of $168,460,032 in the Hospital OQR Program (89 FR 94523 and 94524), 12,984 hours at a cost of $318,163 in the REHQR Program (89 FR 94530 and 94531), and 711,479 hours at a cost of $17,447,164 in the ASCQR Program (89 FR 94534 and 94535), to screen all admitted patients in accordance with measure specifications for Screening for Social Drivers of Health and report the measure data. For Screen Positive Rate for Social Drivers of Health, we estimated a total annual burden of 533 hours at a cost of $29,518 in the Hospital OQR Program (89 FR 94524), 6 hours at a cost of $332 in the REHQR Program (89 FR 94531 and 94532), and 746 hours at a cost of $41,313 in the ASCQR Program (89 FR 94535), to report the measure data. We note that th 89 FR 94524), 6 hours at a cost of $332 in the REHQR Program (89 FR 94531 and 94532), and 746 hours at a cost of $41,313 in the ASCQR Program (89 FR 94535), to report the measure data. We note that the HQR system calculates the rate for these two measures, and that hospitals, REHs, and ASCs’ responsibility is to report the aggregate number of patients screened, the aggregate number of patients that screened positive, and their total patient population. Further, we note that these measures document an administrative process and report aggregate level results, and do not shed light on the extent to which providers are ultimately connecting patients with resources or services and whether patients are benefiting from these screenings. We have concluded that the costs of the continued use of these measures in the Hospital OQR, REHQR, and ASCQR Programs outweigh the benefits to facilities and patients. Removal of these measures would alleviate the burden on hospitals, REHs, and ASCs to manually screen each patient and submit data each reporting cycle, allowing hospitals, REHs, and ASCs to focus resources on measurable clinical outcomes and direct patient care. This will also remove the p lly screen each patient and submit data each reporting cycle, allowing hospitals, REHs, and ASCs to focus resources on measurable clinical outcomes and direct patient care. This will also remove the patient burden associated with repeated SDOH screenings across multiple healthcare facilities. We refer readers to our request for comment, ‘‘Measure Concepts under Consideration for Future Years in the Hospital OQR, REHQR, and ASCQR Programs— Request for Information (RFI): Well- Being and Nutrition’’ in section XIV.B. of this proposed rule for more information regarding our areas of focus for new measures. We acknowledge that some hospitals, ASCs and REHs may have expended resources to implement SDOH screenings, however, hospitals that had already implemented such screenings prior to adoption of the measures would not have expended similar resources. The objectives of the Hospital OQR Program continue to incentivize the improvement of care quality and health outcomes for all patients through transparency and use of appropriate quality measures. We invite public comment on these proposals. D. Proposed Updates to the Extraordinary Circumstances Exception (ECE) Policy for the Hospital OQR gh transparency and use of appropriate quality measures. We invite public comment on these proposals. D. Proposed Updates to the Extraordinary Circumstances Exception (ECE) Policy for the Hospital OQR, REHQR, and ASCQR Programs 1. Background Under our current Extraordinary Circumstances Exception (ECE) regulations, we have granted exceptions to data submission deadlines and requirements for the Hospital OQR, REHQR, and ASCQR Programs in the event of extraordinary circumstances beyond the control of a hospital, REH, or ASC (42 CFR 419.46(e); 419.95(g); 416.310(d), respectively). Extraordinary circumstances may include, but are not limited to, natural disasters or systemic problems with data collection systems.147 We refer readers to the CY 147 Centers for Medicare & Medicaid Services. (May 2024). Quality Program Extraordinary Circumstances Exceptions (ECE) Request Form. QualityNet. Available at https://qualitynet.cms.gov/ files/677e843f50ed8df7419f60e1?filename=HQR_ ECE_Req_Form_CY_2025.pdf. Accessed: April 30, 2025. 2022 OPPS/ASC final rule with comment period (86 FR 63873), the CY 2024 OPPS/ASC final rule with comment period (88 FR 82076), and the CY 2018 OPPS/ASC final rule with .pdf. Accessed: April 30, 2025. 2022 OPPS/ASC final rule with comment period (86 FR 63873), the CY 2024 OPPS/ASC final rule with comment period (88 FR 82076), and the CY 2018 OPPS/ASC final rule with comment period (82 FR 59474 through 59475) for further background about the ECE policies for Hospital OQR, REHQR, and ASCQR Programs, respectively. We also refer readers to the QualityNet website for program-specific requirements for submitting an ECE request.148 Our ECE policy provides flexibility for Hospital OQR, REHQR, and ASCQR Program participants toward meeting program requirements in the event of an extraordinary circumstance. For instance, we recognize that, in circumstances where a full exception is not applicable, it is beneficial for a hospital, REH, or ASC to report data later than the reporting deadline. Delayed reporting authorized under our ECE policy allows temporary relief for a hospital, REH, or ASC experiencing an extraordinary circumstance while preserving the benefits of data reporting, such as transparency and informed decision-making for beneficiaries and providers alike. Accordingly, we propose to update our regulations to specify that an ECE could take the for of data reporting, such as transparency and informed decision-making for beneficiaries and providers alike. Accordingly, we propose to update our regulations to specify that an ECE could take the form of an extension of time for a hospital, REH, or ASC to comply with a data reporting requirement if CMS determines that this type of relief would be appropriate under the circumstances. 2. Proposal To Update the Extraordinary Circumstances Exception (ECE) Policy for the Hospital OQR, REHQR, and ASCQR Programs We propose to update the current Hospital OQR, REHQR, and ASCQR Program ECE policies codified at 42 CFR 419.46(e); 419.95(g); and 416.310(d), respectively, to include extensions of time as a form of relief and to further clarify the policy. Specifically, we propose to update the regulations at 42 CFR 419.46(e)(1); 419.95(g)(1); and 416.310(d)(1) to state that CMS may grant an ECE with respect to reporting requirements in the event of an extraordinary circumstance—defined as an event beyond the control of a hospital, REH, or ASC (for example, a 148 Centers for Medicare & Medicaid Services. Hospital OQR Program Extraordinary Circumstances Exceptions (ECE) Policy: https:// qualityne beyond the control of a hospital, REH, or ASC (for example, a 148 Centers for Medicare & Medicaid Services. Hospital OQR Program Extraordinary Circumstances Exceptions (ECE) Policy: https:// qualitynet.cms.gov/outpatient/oqr/ participation%23tab2#tab2; REHQR Program Extraordinary Circumstances Exceptions (ECE) Policy: https://qualitynet.cms.gov/reh/rehqr/ participation#tab2; and ASCQR Program Extraordinary Circumstances Exceptions (ECE) Policy: https://qualitynet.cms.gov/asc/ascqr/ participation%23tab3#tab2. Accessed: April 30, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00282 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33757 natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing)—that affected the ability of the hospital, REH, or ASC to comply with one or more applicable reporting requirements with respect to a calendar year. We propose that the steps for requesting or granting an ECE would remain the same as the current ECE process, detailed by CMS at the Qual icable reporting requirements with respect to a calendar year. We propose that the steps for requesting or granting an ECE would remain the same as the current ECE process, detailed by CMS at the QualityNet website or a successor website.149 However, at proposed § 419.46(e)(2)(i); 419.95(g)(2)(i); and 416.310(d)(2)(i), we propose that a hospital, REH, or ASC, respectively, may request an ECE within 30-calendar days of the date that the extraordinary circumstance occurred. Our current policy allows a request within 90 days; this proposed change would align the Hospital OQR, REHQR, and ASCQR policy with CMS systems implementation requirements across all quality reporting programs. Under this proposed codified policy, we clarify that CMS retains the authority to grant an ECE as a form of relief at any time after the extraordinary circumstance has occurred. For the Hospital OQR, REHQR, and ASCQR Programs, at proposed §§ 419.46(e)(2)(ii); 419.95(g)(2)(ii); and 416.310(d)(2)(ii), respectively, we propose that CMS notify the requestor with a decision in writing. If CMS grants an ECE to the hospital, REH or ASC, the written decision will specify whether the hospital, REH, or ASC is exempte y, we propose that CMS notify the requestor with a decision in writing. If CMS grants an ECE to the hospital, REH or ASC, the written decision will specify whether the hospital, REH, or ASC is exempted from one or more reporting requirements or whether CMS has granted the hospital, REH, or ASC an extension of time to comply with one or more reporting requirements. Additionally, at §§ 419.46(e)(3); 419.95(g)(3); and 416.310(d)(3), we propose that CMS may grant an ECE to one or more hospitals, REHs, or ASCs that have not requested an ECE if CMS determines that: a systemic problem with a CMS data collection system directly impacted the ability of the hospital, REH, or ASC to comply with a quality data reporting requirement, or that an extraordinary circumstance has affected an entire region or locale. As is the case under our current policy, any ECE granted will specify whether the 149 Centers for Medicare & Medicaid Services. Hospital OQR Program Extraordinary Circumstances Exceptions (ECE) Policy: https:// qualitynet.cms.gov/outpatient/oqr/ participation%23tab2#tab2; REHQR Program Extraordinary Circumstances Exceptions (ECE) Policy: https://qualitynet.cms.gov/reh/rehqr/ participatio CE) Policy: https:// qualitynet.cms.gov/outpatient/oqr/ participation%23tab2#tab2; REHQR Program Extraordinary Circumstances Exceptions (ECE) Policy: https://qualitynet.cms.gov/reh/rehqr/ participation#tab2; and ASCQR Program Extraordinary Circumstances Exceptions (ECE) Policy: https://qualitynet.cms.gov/asc/ascqr/ participation%23tab3#tab2. Accessed: April 30, 2025. affected hospitals, REHs, or ASCs are exempted from one or more reporting requirements or whether CMS has granted the hospital, REH, or ASC an extension of time to comply with one or more reporting requirements. This proposed ECE policy would provide further reporting flexibility for a hospital, REH, or ASC and clarify the ECE process. We invite public comment on these proposals. XV. Hospital Outpatient Quality Reporting (OQR) Program A. Background and History of the Hospital OQR Program The Hospital Outpatient Quality Reporting (OQR) Program is a pay-for- reporting program intended to ensure transparency and quality of care furnished at hospital outpatient departments (HOPDs). Section 1833(t)(17)(A) of the Social Security Act (the Act) states that subsection (d) hospitals (as defined under section 1886(d)(1)(B) of the re furnished at hospital outpatient departments (HOPDs). Section 1833(t)(17)(A) of the Social Security Act (the Act) states that subsection (d) hospitals (as defined under section 1886(d)(1)(B) of the Act) that do not submit data required for measures selected with respect to such a year, in the form and manner required by the Secretary, will incur a 2.0-percentage point reduction to their annual Outpatient Department (OPD) fee schedule increase factor. We refer readers to the CY 2011 OPPS/ASC final rule with comment period (75 FR 72064 through 72065) for a detailed discussion of the statutory history of the Hospital OQR Program. The Hospital OQR Program requirements are codified at 42 CFR 419.46. We also refer readers to the CMS website at https://www.cms.gov/ medicare/quality/initiatives/hospital- quality-initiative/hospital-outpatient- quality-reporting-program for general background on the Hospital OQR Program, as well as the CMS QualityNet Hospital OQR website at https://quality net.cms.gov/outpatient for current program requirements and measure specifications. B. Proposed Changes to the Hospital OQR Program Measure Set We propose to adopt the Emergency Care Access & Timelines et.cms.gov/outpatient for current program requirements and measure specifications. B. Proposed Changes to the Hospital OQR Program Measure Set We propose to adopt the Emergency Care Access & Timeliness electronic clinical quality measure (eCQM) beginning with voluntary reporting for the CY 2027 reporting period followed by mandatory reporting beginning with the CY 2028 reporting period/CY 2030 payment determination. In addition, we propose to remove the Median Time from Emergency Department (ED) Arrival to ED Departure for Discharged ED Patients (Median Time for Discharged ED Patients) measure and the Left Without Being Seen measure, beginning with the CY 2028 reporting period/CY 2030 payment determination, if the Emergency Care Access & Timeliness eCQM is finalized as proposed. We propose to modify the Excessive Radiation Dose or Inadequate Image Quality for Diagnostic Computed Tomography (CT) in Adults (Hospital Level—Outpatient) measure (Excessive Radiation eCQM) from mandatory reporting to voluntary reporting beginning with the CY 2027 reporting period. We also refer readers to section XIV.C. of this proposed rule, Cross-Program Proposals, where we discuss our proposals to remo rting to voluntary reporting beginning with the CY 2027 reporting period. We also refer readers to section XIV.C. of this proposed rule, Cross-Program Proposals, where we discuss our proposals to remove the following Hospital OQR Program measures: (1) COVID–19 Vaccination Coverage Among Healthcare Personnel (HCP) measure beginning with the CY 2024 reporting period/CY 2026 payment determination; (2) Hospital Commitment to Health Equity (HCHE) measure beginning with the CY 2025 reporting period/CY 2027 payment determination; (3) Screening for Social Drivers of Health (SDOH) measure beginning with the CY 2025 reporting period; and (4) Screen Positive Rate for SDOH measure beginning with the CY 2025 reporting period. 1. Proposed Adoption of the Emergency Care Access & Timeliness eCQM Beginning With Voluntary Reporting for the CY 2027 Reporting Period Followed by Mandatory Reporting Beginning With the CY 2028 Reporting Period/CY 2030 Payment Determination a. Background Occupancy and boarding rates in U.S. emergency departments (EDs) continue to worsen and exceed pre-pandemic levels.150 ED boarding, defined as holding a patient in the ED after the patient is admitted or placed into obser g rates in U.S. emergency departments (EDs) continue to worsen and exceed pre-pandemic levels.150 ED boarding, defined as holding a patient in the ED after the patient is admitted or placed into observation status at a hospital, often occurs due to shortages of inpatient beds and staff and contributes to ED crowding, leading to safety risks for patients and stressful working conditions for healthcare personnel.151 A recent report from the Agency for Healthcare Research and Quality (AHRQ) characterized patient ED boarding as a growing public health 150 Moore, C. & Heckmann R. (2025). Hospital Boarding In The ED: Federal, State, And Other Approaches. Health Affairs Forefront. Available at https://www.healthaffairs.org/content/forefront/ hospital-boarding-ed-federal-state-and-other- approaches. Accessed: April 30, 2025. 151 Moore, C. & Heckmann R. (2025). Hospital Boarding In The ED: Federal, State, And Other Approaches. Health Affairs Forefront. Available at https://www.healthaffairs.org/content/forefront/ hospital-boarding-ed-federal-state-and-other- approaches. Accessed: April 30, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00283 Fmt 4701 Sfmt 4702 E:\FR\FM\17 /content/forefront/ hospital-boarding-ed-federal-state-and-other- approaches. Accessed: April 30, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00283 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33758 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules crisis and engaged interested parties to address the strain on the U.S. healthcare system.152 Recent studies indicate that delays in the timeliness of ED care are associated with patient harm.153 154 Long ED wait times are also one of the most cited reasons for patients leaving an ED without being evaluated by a clinician.155 Increased ED length of stay (LOS) is also a strong predictor of poor timeliness of care and is significantly impacted by ED boarding. One study found that for every patient boarded, the median ED LOS for all admitted patients increased by at least 12 minutes.156 Furthermore, ED boarding and crowding have been associated with poor patient outcomes, such as increased mortality,157 delays in needed care,158 and negative patient and staff experiences.159 160 For instance, 152 Agency for Healthc wding have been associated with poor patient outcomes, such as increased mortality,157 delays in needed care,158 and negative patient and staff experiences.159 160 For instance, 152 Agency for Healthcare Research and Quality. (2025). Technical Report: AHRQ Summit To Address Emergency Department Boarding. Available at https://www.ahrq.gov/sites/default/ files/wysiwyg/topics/ed-boarding-summit- report.pdf. Accessed: April 30, 2025. 153 Gaieski, D.F., Agarwal, A.K., Mikkelsen, M.E., Drumheller, B., Cham Sante, S., Shofer, F.S., Goyal, M., & Pines, J.M. (2017). The impact of ED crowding on early interventions and mortality in patients with severe sepsis. The American Journal of Emergency Medicine, 35(7), 953–960. Available at https://doi.org/10.1016/j.ajem.2017.01.061. Accessed: April 30, 2025. 154 Laam L.A., Wary A.A., Strony R.S., Fitzpatrick M.H., & Kraus C.K. (2021). Quantifying the impact of patient boarding on emergency department length of stay: All admitted patients are negatively affected by boarding. Journal of American College Emergency Physicians, 2(2):e12401. Available at https://doi.org/10.1002/emp2.12401. Accessed: April 30, 2025. 155 Janke, A.T., Melnick, E.R., & Venkat affected by boarding. Journal of American College Emergency Physicians, 2(2):e12401. Available at https://doi.org/10.1002/emp2.12401. Accessed: April 30, 2025. 155 Janke, A.T., Melnick, E.R., & Venkatesh, A.K. (2022). Monthly Rates of Patients Who Left Before Accessing Care in U.S. Emergency Departments, 2017–2021. JAMA, 5(9), e2233708. Available at https://doi.org/10.1001/ jamanetworkopen.2022.33708. Accessed: April 30, 2025. 156 Laam L.A., Wary A.A., Strony R.S., Fitzpatrick M.H., & Kraus C.K. (2021). Quantifying the impact of patient boarding on emergency department length of stay: All admitted patients are negatively affected by boarding. Journal of American College Emergency Physicians, 2(2):e12401. Available at https://doi.org/10.1002/emp2.12401. Accessed: April 30, 2025. 157 Hsuan, C., Segel, J.E., Hsia, R.Y., Wang, Y., & Rogowski, J. (2023). Association of emergency department crowding with inpatient outcomes. Health Services Research, 58(4), 828–843. Available at https://doi.org/10.1111/1475-6773.14076. Accessed: April 30, 2025. 158 Gaieski, D.F., Agarwal, A.K., Mikkelsen, M.E., Drumheller, B., Cham Sante, S., Shofer, F.S., Goyal, M., & Pines, J.M. (2017). The impact of ED rg/10.1111/1475-6773.14076. Accessed: April 30, 2025. 158 Gaieski, D.F., Agarwal, A.K., Mikkelsen, M.E., Drumheller, B., Cham Sante, S., Shofer, F.S., Goyal, M., & Pines, J.M. (2017). The impact of ED crowding on early interventions and mortality in patients with severe sepsis. The American Journal of Emergency Medicine, 35(7), 953–960. Available at https://doi.org/10.1016/j.ajem.2017.01.061. Accessed: April 30, 2025. 159 Reznek, M.A., Larkin, C.M., Scheulen, J.J., Harbertson, C.A., & Michael, S.S. (2021). Operational factors associated with emergency department patient satisfaction: Analysis of the Academy of Administrators of Emergency evidence shows that ED crowding can harm sepsis patients by delaying administration of lifesaving intravenous (IV) fluids and antibiotics.161 Due to growing concerns about the quality and timeliness of care in the ED, as well as the burden associated with two chart-abstracted ED measures adopted in the Hospital OQR Program measure set, the Median Time for Discharged ED Patients measure and the Left Without Being Seen measure, CMS is assessing additional ways to support efforts that reduce patient harm and improve outcomes for patients requiring eme for Discharged ED Patients measure and the Left Without Being Seen measure, CMS is assessing additional ways to support efforts that reduce patient harm and improve outcomes for patients requiring emergency care. b. Measure Overview The Emergency Care Access & Timeliness eCQM 162 is specified for the hospital setting and calculates the proportion of four outcome metrics that quantify access to and timeliness of care in an ED setting against specified thresholds, including: (1) patient wait time—1 hour; (2) whether the patient left the ED without being evaluated; (3) patient boarding time in the ED (as defined by a Decision to Admit (order) to ED departure for admitted patients)— 4 hours; and (4) patient ED LOS (time from ED arrival to ED physical departure, as defined by the ED departure timestamp)—8 hours. The Emergency Care Access & Timeliness eCQM provides HOPDs with data for each of these individual numerator components, which are described in Medicine/Association of Academic Chairs of Emergency Medicine national survey. Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine, 28(7), 753–760. Available at https://doi.org/10.1111/acem.14278. s of Emergency Medicine national survey. Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine, 28(7), 753–760. Available at https://doi.org/10.1111/acem.14278. Accessed: April 30, 2025. 160 Loke, D.E., Green, K.A., Wessling, E.G., Stulpin, E.T., & Fant, A.L. (2023). Clinicians’ Insights on Emergency Department Boarding: An Explanatory Mixed Methods Study Evaluating Patient Care and Clinician Well-Being. Joint Commission Journal on Quality and Patient Safety, 49(12), 663–670. Available at https://doi.org/ 10.1016/j.jcjq.2023.06.017. Accessed: April 30, 2025. 161 Gaieski, D.F., Agarwal, A.K., Mikkelsen, M.E., Drumheller, B., Cham Sante, S., Shofer, F.S., Goyal, M., & Pines, J.M. (2017). The impact of ED crowding on early interventions and mortality in patients with severe sepsis. The American Journal of Emergency Medicine, 35(7), 953–960. Available at https://doi.org/10.1016/j.ajem.2017.01.061. Accessed: April 30, 2025. 162 The Emergency Care Access and Timeliness eCQM was previously named the Emergency Care Capacity and Quality (ECCQ) eCQM. The name of the measure has been updated to better reflect the purpose of the measure based on feedback s and Timeliness eCQM was previously named the Emergency Care Capacity and Quality (ECCQ) eCQM. The name of the measure has been updated to better reflect the purpose of the measure based on feedback from the Pre-Rulemaking Measure Review (PRMR) Hospital Recommendation Group Meeting on January 16, 2025. Available at https://p4qm.org/sites/default/ files/2025-02/PRMR-Hospital-Recommendation- Group-Meeting-Summary.pdf. Accessed: April 30, 2025. greater detail in section XV.B.1.c. of this proposed rule. The numerator components of the Emergency Care Access & Timeliness eCQM overlap with the patient population and measure specifications of two chart-abstracted measures in the Hospital OQR Program: (1) the Median Time for Discharged ED Patients measure, and (2) the Left Without Being Seen measure. The Median Time for Discharged ED Patients measure assesses the time patients spent in the ED before being sent home, also known as ED throughput. The Left Without Being Seen measure assesses the percentage of patients who leave the ED without being evaluated by a physician/ advanced practice nurse/physician’s assistant (physician/APN/PA). Numerator component (2) overlaps with the Left Without percentage of patients who leave the ED without being evaluated by a physician/ advanced practice nurse/physician’s assistant (physician/APN/PA). Numerator component (2) overlaps with the Left Without Being Seen patient population, and numerator component (4) overlaps with the Median Time for Discharged ED Patients measure. In addition to capturing the same data elements as the Median Time for Discharged ED Patients and Left Without Being Seen measures, the Emergency Care Access & Timeliness eCQM measures boarding time in the ED, numerator component (3), and time from arrival to placement in a treatment room, numerator component (1), which are not currently captured by any other measure currently in the Hospital OQR Program measure set.163 The proposed removal of two chart- abstracted measures in conjunction with the proposed adoption of the Emergency Care Access & Timeliness eCQM would reduce HOPD burden by requiring the reporting of one digital quality measure instead of two chart-abstracted measures. While the Median Time for Discharged ED Patients and the Left Without Being Seen measures require manual intervention to retrieve data from clinical documentation, the Emergency Car stracted measures. While the Median Time for Discharged ED Patients and the Left Without Being Seen measures require manual intervention to retrieve data from clinical documentation, the Emergency Care Access & Timeliness eCQM allows for automated extraction of patient-level data directly from the electronic health record (EHR). We acknowledge that updating EHRs with new measures requires some initial investment from hospitals, but in the long-term it would automate timely collection of more granular quality information. In addition, we refer readers to the eCQI Resource Center for eCQM implementation guidance: https://ecqi.healthit.gov/oqr?qt-tabs_ oqr=ecqm-resources&global_measure_ group=eCQMs. We also refer readers to 163 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00284 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33759 section XV.B.2. of this proposed rule for more S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33759 section XV.B.2. of this proposed rule for more information on these contingent measure removals. For more information about the testing, feasibility, scientific acceptability, meaningfulness, and validity of the Emergency Care Access & Timeliness eCQM, we refer readers to https://p4qm.org/measures/4625e. c. Measure Calculation The measure denominator includes all ED encounters associated with patients of all ages, for all-payers, during a 12-month period of performance. Patients can have multiple encounters during a period of performance, and each encounter is eligible to contribute to the calculation of the measure.164 The measure numerator includes any ED encounter in the denominator where the patient experiences any one of the following: (1) the patient waited longer than 1 hour after arrival to the ED to be placed in a treatment room or dedicated treatment area that allows for audiovisual privacy during history- taking and physical examination; (2) the patient left the ED without being evaluated; (3) the patient boarded in the oom or dedicated treatment area that allows for audiovisual privacy during history- taking and physical examination; (2) the patient left the ED without being evaluated; (3) the patient boarded in the ED for longer than 4 hours; and (4) the patient had an ED LOS of longer than 8 hours.165 An encounter is considered part of the numerator if it includes any one of the four numerator events, with events not being mutually exclusive and each contributing only once to the numerator. ED encounters with ED observation stays 166 are excluded from components (3) and (4) but are included in the denominator. Patients who have a ‘‘decision to admit’’ after an ED observation stay remain excluded from criteria (3) calculations.167 These four outcomes were selected based on published literature demonstrating that each numerator component is associated with patient 164 For proposed measure specifications, we refer readers to the CMS QualityNet Hospital OQR Program website at https://qualitynet.cms.gov/ outpatient. 165 For proposed measure specifications, we refer readers to the CMS QualityNet Hospital OQR Program website at https://qualitynet.cms.gov/ outpatient. 166 ED observations stays are defi / outpatient. 165 For proposed measure specifications, we refer readers to the CMS QualityNet Hospital OQR Program website at https://qualitynet.cms.gov/ outpatient. 166 ED observations stays are defined as an observation encounter where the patient remains physically in an area under control of the ED and under the care of an ED clinician inclusive of observation in a hospital bed. Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/ measures/4625e. Accessed: April 30, 2025. 167 Specific codes required to calculate the numerator are outlined in the value set data dictionary and eCQM package (Quality Data Model—QDM output). Please refer to the ‘‘Measure Calculation’’ Section for information: https:// p4qm.org/measures/4625e. Accessed: April 30, 2025 harm,168 as well as input from clinical experts including ED experts and statistical and methodological experts and a Technical Expert Panel (TEP) that was convened by the measure developer.169 A Patient and Family Engagement (PFE) Work Group provided feedback on experiences with emergency care, noting long wait times to be seen by a provider, long wait times to be transferred, and gap r.169 A Patient and Family Engagement (PFE) Work Group provided feedback on experiences with emergency care, noting long wait times to be seen by a provider, long wait times to be transferred, and gaps in the discharge processes. The numerator thresholds were developed according to evidence and consensus-based clinical guidelines for ED time thresholds, including guidelines developed by The Joint Commission (TJC), the American College of Emergency Physicians (ACEP), and the Emergency Department Benchmarking Alliance as well as input from a TEP, literature reviews, and environmental scans. For example, the four-hour threshold for numerator component (3), boarding time, was developed according to recommendations from TJC and ACEP.170 171 Measure testing for the Emergency Care Access & Timeliness eCQM was conducted by the measure developer across 32 hospital-based EDs, representing a diverse mix of geographic regions, rurality, hospital size, teaching status, trauma level, and EHR vendors, demonstrating that the measure is reliable, valid, and feasible for all required data elements.172 Measure testing results showed a wide range in overall scores, and across all strata, indicating va , demonstrating that the measure is reliable, valid, and feasible for all required data elements.172 Measure testing results showed a wide range in overall scores, and across all strata, indicating variation in performance and implying room for quality improvement.173 The measure score is first calculated at the individual ED level as the proportion of ED encounters where any 168 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. 169 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. 170 The Joint Commission. (2012). Patient Flow through the Emergency Department. Available at https://www.jointcommission.org/-/media/tjc/ documents/%20standards/r3-reports/r3_report_ issue_4.pdf. Accessed: April 30, 2025. 171 American College of Emergency Physicians. (2024). Emergency Department Boarding and Crowding. Available at https://www.acep.org/ administration/crowding-boarding. Accessed: April 30, 2025. 172 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.o Available at https://www.acep.org/ administration/crowding-boarding. Accessed: April 30, 2025. 172 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. 173 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. one of the four outcomes occurred. Raw measure scores are then standardized by ED case volume using z-scores. The z- score, or standard score, indicates how many standard deviations a data point is from the mean of a normal distribution. It is calculated by subtracting the mean from a data point, then dividing the result by the standard deviation. For the Emergency Care Access & Timeliness eCQM, a volume- adjusted z-score shows how an ED’s performance compares to the average for similar-volume EDs, addressing differences in patient population in HOPDs and ensuring fair ‘‘like to like’’ comparisons between EDs of similar size. ED volume strata are defined in volume bands of 20,000 ED visits, and each ED is assigned to only one volume stratum. For CMS Certification Numbers (CCNs) with more than o between EDs of similar size. ED volume strata are defined in volume bands of 20,000 ED visits, and each ED is assigned to only one volume stratum. For CMS Certification Numbers (CCNs) with more than one ED, volume- adjusted z-scores are then combined as a weighted average for that CCN.174 The results of the Emergency Care Access & Timeliness eCQM are stratified into four groups, two by age (18 years and older, and under 18 years) and two by mental health diagnoses (with, and without).175 The stratification of results by age and mental health diagnosis, as well as standardization of measure performance scores by volume, is sufficient to account for differences between hospitals without further need for risk adjustment. For more detail on the proposed measure specifications, we refer readers to the CMS QualityNet Hospital OQR Program website at https:// qualitynet.cms.gov/outpatient. d. Pre-Rulemaking Measure Review (PRMR) As required under section 1890A of the Act, the Secretary must establish and follow a pre-rulemaking process for selection of quality and efficiency measures, including for the Hospital OQR Program. The pre-rulemaking process, which we refer to as the Pre- Rulemaki tablish and follow a pre-rulemaking process for selection of quality and efficiency measures, including for the Hospital OQR Program. The pre-rulemaking process, which we refer to as the Pre- Rulemaking Measure Review (PRMR), includes a review of measures published on the publicly available ‘‘Measures Under Consideration List’’ (MUC List) by one of several committees convened by the consensus-based entity (CBE), with which we contract in accordance with section 1890 of the Act, 174 For proposed measure specifications, we refer readers to the CMS QualityNet Hospital OQR Program website at https://qualitynet.cms.gov/ outpatient. 175 The principal diagnosis (first listed diagnosis at ED discharge) will be used to define strata inclusion. For this measure’s purpose, mental health diagnoses do not include substance use disorder diagnoses. Mental health refers to mental health diagnoses, life stressors and crises, and stress-related physical symptoms. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00285 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33760 Federal Register / Vol. 90, No. 135 / Thursday 265001 PO 00000 Frm 00285 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33760 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules for the purpose of providing interested parties input to the Secretary on the selection of quality and efficiency measures under consideration for use in certain Medicare quality programs, including the Hospital OQR Program. We refer readers to the CY 2025 OPPS/ ASC final rule with comment period (89 FR 94372) for details on the PRMR process, including the voting procedures used to reach consensus on measure recommendations. The PRMR Hospital Recommendation Group met on January 15 and 16, 2025, to review measures included by the Secretary on the publicly available 2024 MUC List, including the Emergency Care Access & Timeliness eCQM (MUC2024–075), and provided additional recommendations on the potential use of this measure.176 The voting results of the PRMR Hospital Recommendation Group for the proposed Emergency Care Access & Timeliness eCQM within the Hospital OQR Program were: 10 members recommended adopting the measure into the Hospital OQR Program; Hospital Recommendation Group for the proposed Emergency Care Access & Timeliness eCQM within the Hospital OQR Program were: 10 members recommended adopting the measure into the Hospital OQR Program; 10 members recommended adoption with conditions; 7 members voted not to recommend the measure for adoption. No voting category reached 75 percent or greater, including the combination of the recommend and the recommend with conditions categories and thus, the Hospital Recommendation Group did not reach consensus.177 The PRMR Hospital Recommendation Group noted in their deliberations that the measure will provide important insights into ED wait times which impact experience of care. The Group expressed concern that this measure may cause an increase in cost of care due to patients being transferred from the ED to observation.178 While we acknowledge that patients transferred from the ED to observation may result in increased short-term costs due to additional monitoring and extended stays, the measure is designed to address significant issues surrounding the access to timely care which have been proven to reduce long-term costs.179 Hospital Recommendation Group members also expressed co the measure is designed to address significant issues surrounding the access to timely care which have been proven to reduce long-term costs.179 Hospital Recommendation Group members also expressed concern about the lack of CBE endorsement. We note that we submitted the Emergency Care Access & Timeliness eCQM for CBE endorsement for review in the Fall 2024 cycle and the CBE endorsed the measure with conditions on February 12, 2025.180 The Hospital Recommendation Group discussed conditions specific to the Hospital OQR Program, including changing the name of the measure to better reflect the measure’s focus.181 We agree with this feedback and have changed the name of the measure from the Emergency Care Capacity and Quality eCQM to Emergency Care Access & Timeliness. Group members also recommended refraining from including the Emergency Care Access & Timeliness eCQM in Overall Hospital Quality Star Ratings (Star Ratings) due to the possible duplication of data with existing measures. We note that we propose to remove two existing measures in the Hospital OQR Program, the Median Time for Discharged ED Patients and the Left Without Being Seen measures, to avoid duplicative data collecti ote that we propose to remove two existing measures in the Hospital OQR Program, the Median Time for Discharged ED Patients and the Left Without Being Seen measures, to avoid duplicative data collection and reporting. We also note that the Emergency Care Access & Timeliness measure would only be included in the Star Ratings calculation after the existing measures are removed. We refer readers to section XV.B.2. of this proposed rule for more information on the removal of the Median Time for Discharged ED Patients and the Left Without Being Seen measures. The Hospital Recommendation Group also recommended revising the measure specifications to create separate measure components and explore alternative measures for patient boarding time and patient ED LOS. We acknowledge the Hospital Recommendation Group’s concerns and note that multiple TEPs and interested parties supported the 176 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. 177 Par Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. 177 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. 178 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. 179 Dyas, S.R., Greenfield, E., Messimer, S., Thotakura, S., Gholston, S., Doughty, T., Hays, M., Ivey, R., Spalding, J., & Phillips, R. (2015). Process- Improvement Cost Model for the Emergency Department. Journal of Healthcare Management, 60(6): 442–57. Available at https://doi.org/10.1097/ 00115514-201511000-00011. Accessed: April 30, 2025. 180 Partnership for Quality Measurement. (2024). 2024 P ment. Journal of Healthcare Management, 60(6): 442–57. Available at https://doi.org/10.1097/ 00115514-201511000-00011. Accessed: April 30, 2025. 180 Partnership for Quality Measurement. (2024). 2024 Pre-Rulemaking Measure Review Preliminary Assessment. Available at https://p4qm.org/sites/ default/files/2024-12/PRMR-PA-MUC2024-075.pdf. Accessed: April 30, 2025. 181 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. inclusion of more than one numerator component as a strategy for internally balancing the measure and that the time thresholds for patient boarding time and ED LOS are based on more than a decade of consensus work. Lastly, Group members recommended stratifying the measure by factors such as care type, region, and hospital or trauma level designation. We emphasize that the approach to stratification by age and mental health diagnosis, as well as volume standardization of the measure performance scores, is sufficient to account fo level designation. We emphasize that the approach to stratification by age and mental health diagnosis, as well as volume standardization of the measure performance scores, is sufficient to account for differences between hospitals without further need for additional stratification.182 e. Measure Endorsement Section 1833(t)(17)(C)(i) of the Act provides that the Hospital OQR Program shall include measures that reflect consensus among affected parties and, to the extent feasible and practicable, shall include measures set forth by one or more national consensus-based entities. A TEP consisting of interested parties, experts, and consumer advocates contributed their input through the Emergency Care Access & Timeliness eCQM measure design process.183 The Emergency Care Access & Timeliness eCQM was submitted to the CBE for endorsement review in the Fall 2024 cycle (CBE #4625e), and the CBE endorsed the measure with conditions for use in the Hospital OQR Program on February 12, 2025. The conditions include that the measure developer explore within 3 years: (1) the unintended consequences to patients and providers, including burden, by engaging with the patient community and accountable nditions include that the measure developer explore within 3 years: (1) the unintended consequences to patients and providers, including burden, by engaging with the patient community and accountable entities (for instance, qualitative assessments and empirical analyses); and (2) the data elements to identify and address where challenges may persist, including engaging accountable entities. If the proposal to adopt the Emergency Care Access & Timeliness eCQM for the Hospital OQR Program is finalized, CMS will monitor the burden on patients and providers and identify areas where challenges may 182 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. 183 Yale New Haven Health Services Corporation. (September 2024). Technical Expert Panel (TEP) Evaluation of Measure Emergency Care Capacity and Quality Electronic Clinical Quality Measure (eCQM). Available at https://mmshub.cms.gov/ sites/default/files/ECCQ-TEP-Summary-Report- 081624.pdf. Access aluation of Measure Emergency Care Capacity and Quality Electronic Clinical Quality Measure (eCQM). Available at https://mmshub.cms.gov/ sites/default/files/ECCQ-TEP-Summary-Report- 081624.pdf. Accessed: April 30, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00286 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33761 persist as part of the standard measure maintenance. f. Data Collection, Submission, and Reporting The Emergency Care Access & Timeliness eCQM is specified in a standard electronic format, utilizing data extracted electronically from EHRs, with all data coming from defined fields in electronic sources. We note that eCQMs allow for retrieval of data directly from an EHR, reducing administrative burden on hospitals and minimizing errors due to manual abstraction of data.184 We propose to adopt the Emergency Care Access & Timeliness eCQM beginning with voluntary reporting for the CY 2027 reporting period followed by mandatory reporting beginning with the CY 2028 reporting period/CY 2030 payment determ ncy Care Access & Timeliness eCQM beginning with voluntary reporting for the CY 2027 reporting period followed by mandatory reporting beginning with the CY 2028 reporting period/CY 2030 payment determination. We believe this would provide HOPDs sufficient time to test and integrate the eCQM into existing clinical workflows. Additionally, limiting voluntary reporting to 1 year prioritizes addressing long ED wait times and ED boarding as well as removing two chart-abstracted measures from the Hospital OQR Program measure set to reduce HOPD burden. We refer readers to section XV.C.2. of this proposed rule for a discussion of proposed Emergency Care Access and Timeliness eCQM form, manner, and timing of data submission and reporting requirements. We refer readers to section XVI.B.1. of this proposed rule where we propose adoption of a similar measure for the Rural Emergency Hospital Quality Reporting Program. We invite public comment on this proposal. 2. Proposed Removals of the Median Time From ED Arrival to ED Departure for Discharged ED Patients (Median Time for Discharged ED Patients) Measure and the Left Without Being Seen Measure Beginning With the CY 2028 Reporting Period/CY 203 e From ED Arrival to ED Departure for Discharged ED Patients (Median Time for Discharged ED Patients) Measure and the Left Without Being Seen Measure Beginning With the CY 2028 Reporting Period/CY 2030 Payment Determination The Emergency Care Access & Timeliness eCQM, if finalized as proposed, would serve as a replacement for two existing chart-abstracted measures in the Hospital OQR Program. The Median Time for Discharged ED Patients measure (75 FR 72086) and the Left Without Being Seen measure (75 FR 184 Centers for Medicare & Medicaid Services. (2023). Electronic Clinical Quality Measures (eCQMs) Specification, Testing, Standards, Tools, and Community. Available at https:// mmshub.cms.gov/sites/default/files/eCQM- Specifications-Testing-Standards-Tools- Community.pdf. Accessed: April 30, 2025. 72088 through 72089) were adopted in the CY 2011 OPPS/ASC final rule with comment period to promote transparency, improve patient care and access to EDs, and reduce avoidable delays in the emergency care setting. The Median Time for Discharged ED Patients measure assesses the time patients spent in the ED before being sent home, also known as ED throughput. The Left Without Being Seen meas rgency care setting. The Median Time for Discharged ED Patients measure assesses the time patients spent in the ED before being sent home, also known as ED throughput. The Left Without Being Seen measure assesses the percentage of patients who leave the ED without being evaluated by a physician/advanced practice nurse/physician’s assistant (physician/APN/PA). Both measures are chart-abstracted, requiring human review and manual intervention to extract data elements from clinical documentation. In the CY 2024 OPPS/ASC final rule with comment period (88 FR 81963), we did not finalize our proposal to remove the Left Without Being Seen measure due in part to public comments emphasizing the importance of the measure in addressing ED overcrowding and boarding. We stated our intention to identify a more granular measure that could replace the Left Without Being Seen measure, which can now be achieved through the adoption of the Emergency Care Access & Timeliness eCQM. We note that Hospital OQR Program measure specifications can be found at https://qualitynet.cms.gov/ outpatient. As stated in section XV.B.1. of this proposed rule, the Emergency Care Access & Timeliness eCQM is specified fo R Program measure specifications can be found at https://qualitynet.cms.gov/ outpatient. As stated in section XV.B.1. of this proposed rule, the Emergency Care Access & Timeliness eCQM is specified for the hospital setting and calculates the proportion of four outcome metrics that quantify access to and timeliness of care in an ED setting against specified thresholds. The numerator components of the Emergency Care Access & Timeliness eCQM overlap with data elements of the Median Time for Discharged ED Patients and the Left Without Being Seen measures. The numerator of the Emergency Care Access & Timeliness eCQM is comprised of any ED visit in the denominator where the patient experiences any one of the following: (1) waited longer than 1 hour to be placed in a treatment room or a dedicated treatment area that allows for audiovisual privacy history-taking and physical examination; (2) left the ED without being evaluated by a physician/ advanced practice nurse/physician’s assistant; (3) boarded (defined as time from a Decision to Admit (order) to ED departure for admitted patients) for longer than 4 hours; or (4) had an ED LOS (time from ED arrival to ED physical departure as defined boarded (defined as time from a Decision to Admit (order) to ED departure for admitted patients) for longer than 4 hours; or (4) had an ED LOS (time from ED arrival to ED physical departure as defined by the ED departure timestamp) of longer than 8 hours. Numerator component (2) overlaps with the Left Without Being Seen patient population and numerator component (4) overlaps with the Median Time for Discharged ED Patients measure. The Emergency Care Access & Timeliness eCQM also incorporates additional metrics to enhance its comprehensiveness and analytic value, including boarding time in the ED, numerator component (3), and time from arrival to placement in a treatment room, numerator component (1), which are not currently captured by any other measure in the Hospital OQR Program.185 The Emergency Care Access & Timeliness eCQM therefore provides an alternative approach to quality measurement used to address ED boarding and barriers to emergency care by capturing multiple components of quality and capacity. In addition, the Emergency Care Access & Timeliness eCQM allows for retrieval of patient- level data directly from the EHR. As a result, the Emergency Care Access & Timeliness e quality and capacity. In addition, the Emergency Care Access & Timeliness eCQM allows for retrieval of patient- level data directly from the EHR. As a result, the Emergency Care Access & Timeliness eCQM, along with our previously adopted eCQMs, advances the Hospital OQR Program toward the use of EHR data for quality measurement, leading to more accurate quality data as well as reduced burden for providers. The adoption of the Emergency Care Access & Timeliness eCQM would allow us to employ a more precise assessment of the timeliness and appropriateness of ED visits and to provide additional information important to patients and hospitals on ED boarding and ED LOS. Our measure removal policy, codified at 42 CFR 419.46(i)(3), identifies eight factors CMS will consider in the removal of quality measures. Removal Factor 4, described at § 419.46(i)(3)(i)(D), is the availability of a more broadly applicable (across settings, populations, or conditions) measure for the topic. Compared to the Median Time for Discharged ED Patients measure and the Left Without Being Seen measure, the Emergency Care Access & Timeliness eCQM is a more broadly applicable measure for the topic. We therefore pr Median Time for Discharged ED Patients measure and the Left Without Being Seen measure, the Emergency Care Access & Timeliness eCQM is a more broadly applicable measure for the topic. We therefore propose that, if the Emergency Care Access & Timeliness eCQM is adopted in the Hospital OQR Program as proposed in section XV.B.1. of this proposed rule, we would remove the Median Time for Discharged ED Patients measure and the Left Without Being Seen measure under removal Factor 4. We propose that these measure 185 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00287 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33762 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules removals would begin with the CY 2028 reporting period/CY 2030 payment determination, when reporting for the Emergency Care Access & Timeliness eCQM is proposed to become mandatory. We invite public comment on these proposals. 3. Modify the Excessive Radiation Dos ayment determination, when reporting for the Emergency Care Access & Timeliness eCQM is proposed to become mandatory. We invite public comment on these proposals. 3. Modify the Excessive Radiation Dose or Inadequate Image Quality for Diagnostic Computed Tomography (CT) in Adults (Hospital Level—Outpatient) Measure (Excessive Radiation eCQM) From Mandatory Reporting Beginning With the CY 2027 Reporting Period/CY 2029 Payment Determination To Continue Voluntary Reporting in the CY 2027 Reporting Period and Subsequent Years In the CY 2024 OPPS/ASC final rule with comment period, we finalized our proposal to adopt the Excessive Radiation eCQM with voluntary reporting beginning with the CY 2025 reporting period and mandatory reporting beginning with the CY 2027 reporting period/CY 2029 payment determination, one year later than originally proposed (88 FR 81992). We explained our delay in implementing mandatory reporting of the Excessive Radiation eCQM was in response to commenters’ concerns regarding the burden associated with implementing the eCQM. In this proposed rule, we propose to modify the reporting requirements for the Excessive Radiation eCQM in the Hospital OQR Program by main regarding the burden associated with implementing the eCQM. In this proposed rule, we propose to modify the reporting requirements for the Excessive Radiation eCQM in the Hospital OQR Program by maintaining voluntary reporting instead of mandatory reporting of the measure, beginning with the CY 2027 reporting period. Our proposal to maintain indefinite voluntary reporting of this measure arises from continued feedback expressing concerns about the complex interfaces necessary to develop, maintain, and report the Excessive Radiation eCQM, including the financial burden and operational feasibility needed to translate CT radiology data into standardized eCQM-consumable data used by the measure. In January 2025, we issued a notice to clarify that hospitals and clinicians who choose to report this eCQM can use any vendor’s translation software to calculate this measure,186 consistent with the measure’s specifications, and stated our intent to monitor measure results to ensure that all reported data for the Excessive Radiation eCQM are both reliable and valid.187 The proposed modification from mandatory to voluntary reporting of the Excessive Radiation eCQM beginning with the CY 2027 re rted data for the Excessive Radiation eCQM are both reliable and valid.187 The proposed modification from mandatory to voluntary reporting of the Excessive Radiation eCQM beginning with the CY 2027 reporting period would allow HOPDs additional time to 186 eCQI Resource Center. Excessive Radiation Dose or Inadequate Image Quality for Diagnostic Computed Tomography in Adults eCQM—Measure Clarification. Available at https://ecqi.healthit.gov/ excessive-radiation-dose-or-inadequate-image- quality-diagnostic-computed-tomography-adults- ecqm-measure-clarification. Accessed June 5, 2025. 187 In that notice, we also clarified that while CMS is not requiring vendors to demonstrate their software’s capabilities to CMS, hospitals and clinicians that choose to do so may request information from a vendor about a specific software’s ability to generate and transform the radiology data into the necessary format. integrate, adequately test, and gain experience with implementing the eCQM. This modification would also provide CMS with additional time to monitor implementation progress, including data collection burden and response rates. We will continue to consider feedback regarding this measure a tion would also provide CMS with additional time to monitor implementation progress, including data collection burden and response rates. We will continue to consider feedback regarding this measure and may propose additional changes in future rulemaking. We invite public comment on this proposal. 4. Summary of Previously Finalized and Newly Proposed Hospital OQR Program Measure Set for CY 2026 to CY 2031 Payment Determinations Table 84 summarizes the previously finalized and newly proposed Hospital OQR Program measure set for the CY 2026 to CY 2031 payment determinations, which would remove the HCHE, Screening for SDOH, Screen Positive Rate for SDOH, and COVID–19 Vaccination Coverage Among HCP measures as discussed in section XIV.C. of this proposed rule; modify reporting requirements for the Excessive Radiation eCQM from mandatory to voluntary reporting beginning with the CY 2027 reporting period, as discussed in section XV.B.3 of this proposed rule; remove the Left Without Being Seen and the Median Time for Discharged ED Patients measures as discussed in section XV.B.2. of this proposed rule; and add the Emergency Care Access & Timeliness eCQM as discussed in section XV.B.1. of