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 sing the national annual burden to 400,464 hours and $36,519,350.40. We estimate that hospitals will incur an additional one-time cost to update their processes and systems to (1) identify and collect six new data elements and (2) encode the standard charge information for the newly proposed elements in the CMS standard template. This one-time burden estimate, as demonstrated in section ‘‘XXII. Collection of Information’’ of this proposed rule is 37,080 hours for all hospitals (5 hours × 7,416 hospitals) at a cost of $3,545,441.28 (7,416 hospitals × [($87.52 × 4 hours) + ($128.00 × 1 hour)]). We note that hospitals have been required to publicize their standard charges in a standardized template since July 1, 2024, as specified in the CY 2024 OPPS/ASC final rule with comment period, and therefore expect minimal hospital burden to modify the existing template. In addition, four of the new proposed data elements, the median, 10th percentile, and 90th percentile allowed amounts, as well as the count of allowed amounts, are applicable only in the limited instances when a hospital’s payer- specific negotiated charge for an item or service is based on an algorithm or a percentage. The fi s the count of allowed amounts, are applicable only in the limited instances when a hospital’s payer- specific negotiated charge for an item or service is based on an algorithm or a percentage. The fifth and sixth new data elements, the hospital NPI and the name of name of the chief executive officer, president or senior official designated to oversee the encoding of true, accurate and complete data in the MRF, would be required at the hospital level, not a separate entry for each item or service. CMS therefore believes this estimate to be an accurate estimate of the one-time burden for a hospital to collect the new data elements and encode them in the CMS standard template. c. Benefit of Proposals Although we cannot quantify the benefits of including additional data elements and encoding such data in the CMS required MRF template, we believe any opportunity to provide further context about standard charges, including through the addition of contextual information when the payer- specific negotiated charge is based on a percentage or algorithm, would be helpful to all consumers of the MRF as they analyze the data to identify cost savings and ways to stimulate market competition. We fic negotiated charge is based on a percentage or algorithm, would be helpful to all consumers of the MRF as they analyze the data to identify cost savings and ways to stimulate market competition. We believe strengthening the existing affirmation statement and requiring a senior official to publicly attest to the accuracy and completeness of the data encoded within the file will reduce public confusion related to whether all standard charges for hospital items and services are included within the MRF as dollar amounts, if possible, and the hospital has provided all necessary information available to the hospital for the public to be able to derive the dollar amount, including, but not limited to, the specific fee schedule or components referenced in such percentage, algorithm or formula. We also believe the addition of the NPI data element would catalyze more fulsome HPT and Transparency in Coverage (TiC) analysis. (1) Benefits to Hospitals Hospitals, either directly or through management or actuarial consultants, are consuming the data released in the MRFs for their own operational purposes. Hospitals consume and analyze MRF data to improve negotiation strategies with employers a ment or actuarial consultants, are consuming the data released in the MRFs for their own operational purposes. Hospitals consume and analyze MRF data to improve negotiation strategies with employers and third party payers, improve contracting strategies, and demonstrate value in the negotiation process.351 352 Hospitals also use the MRF data to determine pricing strategies and to identify and hone their competitive advantage,353 as well as to improve their revenue cycle efficiency.354 Further, we believe that, for those hospitals that are assessed a CMP, the proposed reduction of the CMP if the hospital elects not to appeal CMS’ findings, would offset some of the hospital financial burden, including legal fees and costs associated with challenging the imposition— including requesting and defending a hearing before an Administrative Law Judge (ALJ) and any subsequent appeals. (2) Benefits to Other Interested Parties As discussed in the CY 2020 HPT final rule (84 FR 65538), we believe public access to hospital standard charge information can be useful to the public, including patients who need to obtain services from a hospital, consumers of healthcare who wish to view hospital stand blic access to hospital standard charge information can be useful to the public, including patients who need to obtain services from a hospital, consumers of healthcare who wish to view hospital standard charge information prior to selecting a hospital, employers and state governments searching for lower cost options for health care coverage, and other users of the MRF who may develop consumer- friendly price transparency tools or perform price analyses to uncover disparities or drive value-based policy development. Since the effective date of the HPT regulations, innovators have been compiling HPT data sets and making them available for employers, researchers, and journalists to perform cost comparison studies and publish findings. Feedback from interested parties, specifically innovators and researchers, has illuminated the need to detangle complex hospital contracting methods through the provision of data elements that help define the algorithm or percentage set forth in hospital MRFs. The proposed allowed amount data elements would support a better understanding of the range of payer- specific negotiated charge dispersion, which would further assist employers and consumers to u Fs. The proposed allowed amount data elements would support a better understanding of the range of payer- specific negotiated charge dispersion, which would further assist employers and consumers to understand a hospital’s value as compared to other hospitals, stimulating competition and potentially resulting in price 351 Clarify Insights Center. (2023, August 15). How hospitals can use price transparency data to negotiate better contracts with payers. Retrieved from https://clarifyhealth.com/insights/blog/how- hospitals-can-use-price-transparency-data-to- negotiate-better-contracts-with-payers/. 353 Xiao, F. (2024, October 25). Is price transparency helping? Here are three ways to tell: Let’s explore our biggest indicators of change: competition, pricing, and power. Turquoise Health Blog. Retrieved from https://blog.turquoise.health/ is-price-transparency-helping-heres-three-ways-to- tell/. 352 Gomes, C. (2023, July 31). Why healthcare providers should harness price transparency data. Medlyze—Price Transparency Data and Analysis for the Healthcare Industry Insights. Retrieved from https://www.medlyze.com/blog/why-healthcare- providers-should-harness-the-power-of-price- transparenc Medlyze—Price Transparency Data and Analysis for the Healthcare Industry Insights. Retrieved from https://www.medlyze.com/blog/why-healthcare- providers-should-harness-the-power-of-price- transparency-data. 354 Healthcare Financial Management Association. (2023, August 28). Leverage healthcare price transparency data to promote financial sustainability. Retrieved from https:// www.hfma.org/price-transparency/leverage- healthcare-price-transparency-data-to-promote- financial-sustainability/. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00382 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 33857 convergence to drive more predictable and consistent health care costs.355 With regard to the proposals to strengthen the affirmation statement requirement, beginning January 1, 2026, by replacing it with an attestation in the MRF that would contain new specifications (relative to existing affirmation requirements) and to require hospitals to encode the name of the chief executive officer, president or senior official designat that would contain new specifications (relative to existing affirmation requirements) and to require hospitals to encode the name of the chief executive officer, president or senior official designated to oversee the encoding of true, accurate and complete data in the MRF, we believe this will provide the necessary reassurance that hospitals have provided in their MRFs meaningful, accurate information to users of the MRF about their standard charges for health care items and services. With regard to the NPI data element, including identifiers used for financial transactions in the MRF would make it easier for key participants in price negotiations (for example, employers and payers) to programmatically identify hospitals in their internal financial databases, such as claims data, to conduct more in-depth payment and volume analyses to support contract negotiations and potentially reduce healthcare costs for consumers. A standard identifier could also help CMS, researchers, and innovators reduce dependence on manual processes for identifying the hospital and the hospital locations and increase opportunities for automated processes. d. Limitations of Our Analysis As stated in the CY ors reduce dependence on manual processes for identifying the hospital and the hospital locations and increase opportunities for automated processes. d. Limitations of Our Analysis As stated in the CY2024 OPPS/ASC final rule with comment period (88 FR 82174), it would be difficult for us to conduct a detailed quantitative analysis of the impact of requiring hospitals to make HPT information publicly available, given the lack of studies at the national level on the impact of the HPT regulations. Thus, in assessing the impact of our proposals, we rely on qualitative evidence of, and experiences with, the use of the public HPT data and feedback from consumers of the MRFs as well as our own experiences reviewing the MRFs. Specifically, we have noted through our own reviews that many hospital MRFs lack dollar values when the standard charge for an item or service is based on an algorithm or percentage and have heard from interested parties the limitations of drawing meaningful comparisons without necessary context to help understand the standard charge in 355 Xiao, F. (2024, October 25). Is price transparency helping? Here are three ways to tell. Turquoise Health. Retrieved from https:/ ithout necessary context to help understand the standard charge in 355 Xiao, F. (2024, October 25). Is price transparency helping? Here are three ways to tell. Turquoise Health. Retrieved from https:// blog.turquoise.health/is-price-transparency-helping- heres-three-ways-to-tell/. dollars for such items or services. We also have received comments from MRF users since the effective date of the 2024 OPPS/ASC final rule with comment period indicating that requiring hospitals to make a good faith effort did not go far enough to convey CMS’ intent that all standard charge information available must be encoded in the MRF, with commenters suggesting our requirement to allow a good faith estimate may actually deter hospitals from providing fully complete and accurate standard charge data in their MRF. We also heard users of the MRFs who questioned a hospital’s inability to encode dollar amounts for the payer- specific negotiated charge data elements, and whether the complex contracting methodologies used by hospitals and payer organizations could only be expressed through an algorithm or formula, and not a dollar amount. We understand that users of the MRF may find the addition of algorith logies used by hospitals and payer organizations could only be expressed through an algorithm or formula, and not a dollar amount. We understand that users of the MRF may find the addition of algorithms make price comparisons among hospitals challenging when only an algorithm is available because the algorithms may not be consumer friendly. We believe that our proposal to require an attestation, as opposed to merely requiring an affirmation statement, may enhance users’ confidence that the data encoded is accurate and complete. In addition, in discussions with innovators and researchers, we have heard that the addition of an NPI as a hospital unique identifier would allow more effective data crosswalking between hospital HPT MRFs and TiC MRFs, as well as to other CMS datasets that contain hospital quality data. We believe this regulation would provide the additional context needed for consumers of the MRFs to create meaningful dollar comparisons that would ultimately benefit consumers through development of cost comparison tools, increased competition, or improved price negotiations with employers. e. Alternatives Considered The proposed revisions to the HPT regulations are designe through development of cost comparison tools, increased competition, or improved price negotiations with employers. e. Alternatives Considered The proposed revisions to the HPT regulations are designed to further address some of the barriers identified that limit price transparency, with a goal of increasing competition among healthcare providers to bring down costs. Specifically, this proposed rule aims to make meaningful price information via hospital standard charges more readily available to the public by providing additional contextual information, displayed as a dollar value, in those instances where standard charges are based on a percentage or an algorithm, as well as provide needed hospital identifier values to enable innovators and researchers to combine the HPT data with other claims and quality data to further empower consumer decision- making. We considered a number of alternative approaches, including other methodologies and lookback periods for calculating the allowed amount data elements, and whether to display specific counts of allowed amounts or ranges. We discuss these alternatives in section XIX. of this proposed rule. Specifically, we considered EDI 835 ERA tr ount data elements, and whether to display specific counts of allowed amounts or ranges. We discuss these alternatives in section XIX. of this proposed rule. Specifically, we considered EDI 835 ERA transaction data lookback period alternatives of 3 months, 6 months, as well as requiring hospitals to use a rolling 12-month period prior to when the MRF posted. We sought comment on data sources other than the EDI 835 ERA transaction data to use to derive the allowed amount data elements. We also considered whether hospitals could encode a range of allowed amounts, as opposed to the exact count of allowed amounts, to achieve our objective of providing needed context to the allowed amount data element values. We considered several alternative options to updating the required affirmation within the MRF, as discussed in section XIX. of this proposed rule. We considered asking the official to submit their MRF attestation directly to CMS, using a CMS developed template that would provide evidence of the accuracy and completeness of the MRF, and we also considered requiring the hospitals to post a more detailed attestation document that is signed by a senior official on the publicly availabl ce of the accuracy and completeness of the MRF, and we also considered requiring the hospitals to post a more detailed attestation document that is signed by a senior official on the publicly available website that hosts the MRF. However, we believe these alternatives to be less useful than our proposals as they would either not meet the stated need to alert the public to the hospital’s declaration of the accuracy and completeness of the data encoded within the MRF, or the attestation would not ‘‘travel’’ inside the MRF like the affirmation statement. In addition, we considered different types of hospital identifiers, specifically the Employer identification Number and the CMS Certification Number. Ultimately, however, we determined that the alternatives would either limit the usefulness of hospital standard charge information or increase burden for hospitals without any additional benefit for users of MRF standard charge information. D. Regulatory Review Cost Estimation Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year’s proposed rule will be the number of ertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year’s proposed rule will be the number of reviewers of this VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00383 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 33858 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year’s rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule. For these reasons we believe that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We welcome any comments on the approach in estimating the number of entities which will review this proposed rule. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore for the purposes of our estimate we assume posed rule. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We seek comments on this assumption. Using the wage information from the Bureau of Labor Statistics (BLS) for medical and health service managers (Code 11–9111), we estimate that the cost of reviewing this rule is $113.42 per hour, including overhead and fringe benefits (https://www.bls.gov/oes/ current/oes_nat.htm). Assuming an average reading speed, we estimate that it would take approximately 8 hours for the staff to review half of this proposed rule. For each entity that reviews the rule, the estimated cost is $907.36 (8 hours x $113.42). Therefore, we estimate that the total cost of reviewing this regulation is $3,175,760 ($907.36 x 3,500). E. Regulatory Flexibility Act (RFA) Analysis The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that many hospitals and CAHs are con options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that many hospitals and CAHs are considered small businesses either by the Small Business Administration’s size standards with total revenues of $41.5 million or less in any single year or by the hospital’s not-for-profit status. Most ASCs and most CMHCs are considered small businesses with total revenues of $16.5 million or less in any single year. While we note the limited availability of certain information for OPPS providers, we estimate that approximately 3,000 OPPS providers included in the impact analysis would be considered small entities. As the small entity category would represent the majority of the providers in the table, the individual impact table categories would provide more specific estimated hospital impacts. While the estimated impacts of the proposed rule vary by OPPS provider category, many of those categories will be within the range of 1.5 to 2.5 percent. For details, we refer readers to the Small Business Administration’s ‘‘Table of Size Standards’’ at http://www.sba.gov/ content/small-business-s egories will be within the range of 1.5 to 2.5 percent. For details, we refer readers to the Small Business Administration’s ‘‘Table of Size Standards’’ at http://www.sba.gov/ content/small-business-size-standards. Individuals and States are not included in the definition of a small entity. As its measure of significant economic impact on a substantial number of small entities, HHS uses a change in revenue of more than 3 to 5 percent. We believe that this threshold would not be reached by the requirements in this proposed rule, since as noted earlier in this section, most estimated changes would be below that range. Therefore, the Secretary has certified that this proposed rule would not have a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and m to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has 100 or fewer beds. We estimate that this proposed rule would increase payments to small rural hospitals by approximately 1.9 percent; therefore, it should have a negligible impact on approximately 528 small rural hospitals. We note that the estimated payment impact for any category of small entity will depend on both the services that they provide as well as the payment policies and/or payment systems that may apply to them. Therefore, the most applicable estimated impact may be based on the specialty, provider type, or payment system. The analysis above, together with the remainder of this preamble, provides a regulatory flexibility analysis and a regulatory impact analysis. F. Unfunded Mandates Reform Act (UMRA) Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2025 uires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2025, that threshold is approximately $187 million. This proposed rule would not impose a mandate that will result in the expenditure by State, local, and Tribal Governments, in the aggregate, or by the private sector, of more than $187 million in any 1 year.’’ G. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have examined the OPPS and ASC provisions included in this proposed rule in accordance with Executive Order 13132, Federalism, and have determined that they would not have a substantial direct effect on State, local, or tribal governments, preempt State law, or otherwise have a federalism implication. As reflected in Table 111 of this proposed rule, we estimate that OPPS payments to governmental hospitals (including State and local g s, preempt State law, or otherwise have a federalism implication. As reflected in Table 111 of this proposed rule, we estimate that OPPS payments to governmental hospitals (including State and local governmental hospitals) would increase by 2.0 percent under this proposed rule. While we do not know the number of ASCs or CMHCs with government ownership, we anticipate that it is small. The analyses we have provided in this section of this proposed rule, in conjunction with the remainder of this document, demonstrate that this rule is consistent with the regulatory philosophy and principles identified in Executive Order 12866, the RFA, and section 1102(b) of the Act. This proposed rule would affect payments to a substantial number of small rural hospitals and a small number of rural ASCs, as well as other classes of hospitals, CMHCs, and ASCs, and some effects may be significant. However, as noted in section XXV. of this proposed rule, this rule should not have a significant effect on small rural hospitals. H. E.O. 14192, ‘‘Unleashing Prosperity Through Deregulation’’ Executive Order 14192, entitled ‘‘Unleashing Prosperity Through Deregulation’’ was issued on January 31, 2025, and req ll rural hospitals. H. E.O. 14192, ‘‘Unleashing Prosperity Through Deregulation’’ Executive Order 14192, entitled ‘‘Unleashing Prosperity Through Deregulation’’ was issued on January 31, 2025, and requires that ‘‘any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.’’ This proposed rule, if finalized as proposed, is expected to be an E.O. 14192 deregulatory action. We estimate that this proposed rule would generate $2.54 million in annualized cost savings at a 7 percent discount rate, discounted relative to year 2024 over a perpetual time horizon. Mehmet Oz, Administrator of the Centers for Medicare & Medicaid VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00384 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 33859 Services, approved this document on July 10, 2025. List of Subjects 42 CFR Part 410 Diseases, Health facilities, Health professions, Laboratories, Medicare, Reporting and r 2025 / Proposed Rules 33859 Services, approved this document on July 10, 2025. List of Subjects 42 CFR Part 410 Diseases, Health facilities, Health professions, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays. 42 CFR Part 412 Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements. 42 CFR Part 413 Diseases, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements. 42 CFR Part 415 Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 416 Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 419 Hospitals, Medicare, Reporting and recordkeeping requirements. 45 CFR Part 180 Hospital Price Transparency. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as follows: PART 410—SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS ■ 1. The authority citation for part 410 continues to read as follows: Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd. ■ 2. Section 410.27 is amended by revis L INSURANCE (SMI) BENEFITS ■ 1. The authority citation for part 410 continues to read as follows: Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd. ■ 2. Section 410.27 is amended by revising paragraph (a)(1)(iv)(B)(1) to read as follows: § 410.27 Therapeutic outpatient hospital or CAH services and supplies incident to a physician’s or nonphysician practitioner’s service: Conditions. (a) * * * (1) * * * (iv) * * * (B) * * * (1) For purposes of this section, direct supervision means that the physician or nonphysician practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician or nonphysician practitioner must be present in the room when the procedure is performed. For pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, direct supervision must be furnished as specified in §§ 410.47 and 410.49, respectively. The presence of the physician or nonphysician practitioner for the purpose of the supervision of pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services includes virtual presence through ian or nonphysician practitioner for the purpose of the supervision of pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services includes virtual presence through audio/video real-time communications technology (excluding audio-only); and * * ■ 3. Section 410.28 is amended by revising paragraph (e)(2)(iii) to read as follows: * * * § 410.28 Hospital or CAH diagnostic services furnished to outpatients: Conditions. * * * (e) * * * (2) * * * (iii) The presence of the physician or * * nonphysician practitioner under paragraphs (e)(2)(i) and (ii) of this section includes virtual presence through audio/video real-time communications technology (excluding audio-only) for services without a 010 or 090 global surgery indicator. * * * * * PART 412—PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES ■ 4. The authority citation for part 412 continues to read as follows: Authority: 42 U.S.C. 1302 and 1395hh. ■ 5. Section 412.3 is amended by revising paragraph (d)(2) to read as follows: § 412.3 Admissions. * * * * (d) * * * (2) An inpatient admission for a * surgical procedure specified by Medicare as inpatient only under § 419.22(n) of this chapter agraph (d)(2) to read as follows: § 412.3 Admissions. * * * * (d) * * * (2) An inpatient admission for a * surgical procedure specified by Medicare as inpatient only under § 419.22(n) of this chapter is generally appropriate for payment under Medicare Part A regardless of the expected duration of care. Procedures no longer specified as inpatient only under § 419.22(n) of this chapter are appropriate for payment under Medicare Part A in accordance with paragraph (d)(1) or (3) of this section. Claims for services and procedures removed from the inpatient only list under § 419.22 of this chapter on or after January 1, 2021 are exempt from certain medical review activities until the Secretary determines that the service or procedure is more commonly performed * * in the outpatient setting than the inpatient setting. * * ■ 6. Section 412.105 is amended by— ■ a. Revising paragraphs (f)(1)(i)(A), (B), and (C); and ■ b. Adding paragraph (f)(1)(i) (E). * The revisions and addition read as follows: * * * § 412.105 Special treatment: Hospitals that incur indirect costs for graduate medical education programs. * * (f) * * * (1) * * * (i) * * * (A) Is approved by one of the national organizatio ws: * * * § 412.105 Special treatment: Hospitals that incur indirect costs for graduate medical education programs. * * (f) * * * (1) * * * (i) * * * (A) Is approved by one of the national organizations listed in § 415.152 of this chapter, provided that the national organization does not use accreditation criteria that promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. (B) May count towards certification of the participant in a specialty or subspecialty listed in the current edition of either of the following publications: (1) The Directory of Graduate Medical Education Programs published by the American Medical Association. (2) The Annual Report and Reference Handbook published by the American Board of Medical Specialties. Provided that listing in either of those publications, or in successor information sources, does not require the program to promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which s t require the program to promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. (C) Is approved by the Accreditation Council for Graduate Medical Education (ACGME), or other organization designated by the Secretary, as a fellowship program in geriatric medicine, provided that the Council or other organization does not use accreditation criteria that promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. * * (E) Is a program that would be accredited except for the accrediting agency’s reliance upon an accreditation standard that requires an entity to promote or emphasize diversity, equity, inclusion, or awareness based on race, * * * VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00385 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 33860 Federal Register / Vol. 90, No. 135 / T 25 Jkt 265001 PO 00000 Frm 00385 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 33860 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules * * color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. * * * ■ 7. Section 412.190 is amended by— ■ a. Revising paragraph (a)(2); ■ b. Adding paragraph (a)(3); ■ c. Redesignating paragraph (a)(5) as (6), and paragraph (a)(6) as (5); ■ d. Revising paragraph (b)(1); ■ e. Adding paragraph (d)(9); and f. Revising paragraphs (e) and (f). The revisions and additions read as follows: § 412.190 Overall Hospital Quality Star Rating. (a) * * * (2) To update the methodology that will be used to calculate the Overall Hospital Quality Star Ratings to emphasize the contribution of the Safety of Care measure group to the Overall Hospital Quality Star Rating. This change aims to address the issue of hospitals receiving a high Star Rating despite performance in the lowest quartile of the Safety of Care measure group. (3) The guiding principles of the Overall Hospital Quality St ddress the issue of hospitals receiving a high Star Rating despite performance in the lowest quartile of the Safety of Care measure group. (3) The guiding principles of the Overall Hospital Quality Star Rating are as follows. In developing and maintaining the Overall Hospital Quality Star Ratings, we strive to: (i) Use scientifically valid methods that are inclusive of hospitals and measure information and able to accommodate underlying measure changes; (ii) Align with Care Compare on Medicare.gov and CMS programs; (iii) Provide transparency of the methods for calculating the Overall Hospital Quality Star Rating; and (iv) Be responsive to stakeholder input. * * * (b) * * * (1) * * * Measures are selected from * * * * those publicly reported on Care Compare on Medicare.gov through certain CMS hospital inpatient and outpatient quality programs: * * * (d) * * * (9) Emphasize Safety of Care. (i) Apply a 4-star cap for hospitals in the lowest quartile of the Safety of Care measure group performance in Calendar Year 2026. Any hospital that is assigned 5 stars in step eight but has a lowest quartile Safety of Care score (based on at least three Safety of Care measures) would be reassigned formance in Calendar Year 2026. Any hospital that is assigned 5 stars in step eight but has a lowest quartile Safety of Care score (based on at least three Safety of Care measures) would be reassigned to 4 stars. (ii) Apply a blanket 1-Star reduction for hospitals in the lowest quartile of Safety of Care measure group performance beginning in Calendar Year 2027 and later years. Any hospital assigned a 2, 3, 4, or 5-star rating in step eight, but with a lowest quartile Safety of Care score (based on at least three Safety of Care measures) would be reduced to 1, 2, 3, or 4 stars, respectively. (e) Preview period prior to publication. CMS provides hospitals the opportunity to preview their Overall Hospital Quality Star Rating prior to publication. Hospitals have at least 30 days to preview their results, and if necessary, can reach out to CMS with questions. (f) Suppression of Overall Hospital Quality Star Rating— (1) Subsection (d) hospitals. CMS may consider suppressing Overall Hospital Quality Star Rating for subsection (d) hospitals only under extenuating circumstances that affect numerous hospitals (as in, not an individualized or localized issue) as determined by CMS, or when CM Quality Star Rating for subsection (d) hospitals only under extenuating circumstances that affect numerous hospitals (as in, not an individualized or localized issue) as determined by CMS, or when CMS is at fault, including but not limited to when: (i) There is an Overall Hospital Quality Star Rating calculation error by CMS; (ii) There is a systemic error at the CMS quality program level that substantively affects the Overall Hospital Quality Star Rating calculation; or; (iii) If a Public Health Emergency substantially affects the underlying measure data. (2) CAHs. (i) CAHs may request to withhold their Overall Hospital Quality Star Rating from publication on Care Compare on Medicare.gov so long as the request for withholding is made, at the latest, during the Overall Hospital Quality Star Rating preview period. (ii) CAHs may request to have their Overall Hospital Quality Star Rating withheld from publication on Care Compare on Medicare.gov, as well as their data from the public input file, so long as the request is made during the CMS quality program-level 30-day confidential preview period for the Care Compare refresh data used to calculate the Overall Hospital Quality Star Rat t file, so long as the request is made during the CMS quality program-level 30-day confidential preview period for the Care Compare refresh data used to calculate the Overall Hospital Quality Star Ratings. PART 413—PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END–STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING FACILITIES; PAYMENT FOR ACUTE KIDNEY INJURY DIALYSIS ■ 8. The authority citation for part 413 continues to read as follows: Authority: 42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395m, 1395x(v), 1395x(kkk), 1395hh, 1395rr, 1395tt, and 1395ww. ■ 9. Section 413.20 is amended by revising paragraph (d)(3) to read as follows: § 413.20 Financial data and reports. * * * * (d) * * * (3)(i) The provider must furnish the * contractor— (A) Upon request, copies of patient service charge schedules and changes thereto as they are put into effect; and (B) Its median payer-specific negotiated charge by MS–DRG for payers that are Medicare Advantage (MA) organizations, as applicable, and changes thereto as they are put into effect. (ii) The contractor evaluates the * * charge schedules as specified in paragraph (d)(3) that are Medicare Advantage (MA) organizations, as applicable, and changes thereto as they are put into effect. (ii) The contractor evaluates the * * charge schedules as specified in paragraph (d)(3)(i) of this section to determine the extent to which they may be used for determining program payment. * * ■ 10. Section 413.75 is amended in paragraph (b)— ■ a. By revising the definition of ‘‘Approved geriatric program’’; and ■ b. In the definition of ‘‘Approved medical residency program’’ by revising paragraphs (1), (2), and (3), and adding paragraph (5). * The revisions and addition read as follows: § 413.75 Direct GME payments: General requirements. * * * (b) * * * * * * * * * * Approved geriatric program means a fellowship program of one or more years in length that is approved by one of the national organizations listed in § 415.152 of this chapter under that respective organization’s criteria for geriatric fellowship programs, provided that the national organization does not use accreditation criteria that promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which creditation criteria that promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. Approved medical residency program means a program that meets one of the following criteria: (1) Is approved by one of the national organizations listed in § 415.152 of this chapter, provided that the national organization does not use accreditation criteria that promote or emphasize diversity, equity, inclusion, or VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00386 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 33861 awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. (2) May count towards certification of the participant in a specialty or subspecialty listed in the current edition of either of the following publications: (i) The Directory of Graduate Medical Educ (2) May count towards certification of the participant in a specialty or subspecialty listed in the current edition of either of the following publications: (i) The Directory of Graduate Medical Education Programs published by the American Medical Association, and available from American Medical Association, Department of Directories and Publications, 515 North State Street, Chicago, Illinois 60610; or (ii) The Annual Report and Reference Handbook published by the American Board of Medical Specialties, and available from American Board of Medical Specialties, One Rotary Center, Suite 805, Evanston, Illinois 60201. Provided that listing in either of those publications, or in successor information sources, does not require the program to promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. (3) Is approved by the Accreditation Council for Graduate Medical Education (ACGME), or other organization designated by the Secretary, as a fellowship program in geriatric medicine, or other organization designated by the Secretary, p n Council for Graduate Medical Education (ACGME), or other organization designated by the Secretary, as a fellowship program in geriatric medicine, or other organization designated by the Secretary, provided that the Council or other organization does not use accreditation criteria that promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. * * * * (5) Is a program that would be accredited except for the accrediting agency’s reliance upon an accreditation standard that requires an entity to promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. * * * * * * PART 415—SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN CERTAIN SETTINGS ■ 11. The authority citation for part 415 continues to read as follows: Authority: 42 U.S.C. 1302 and 1395h(h). ■ 12. In § 415.152 amend the definition of ‘‘Approved graduate m NTS IN CERTAIN SETTINGS ■ 11. The authority citation for part 415 continues to read as follows: Authority: 42 U.S.C. 1302 and 1395h(h). ■ 12. In § 415.152 amend the definition of ‘‘Approved graduate medical education (GME) program’’ by revising paragraph (1) to read as follows: * § 415.152 Definitions. * * Approved graduate medical education (GME) program * * * * * (1) A residency program approved by the Accreditation Council for Graduate Medical Education, by the American Osteopathic Association, by the Commission on Dental Accreditation of the American Dental Association, or by the Council on Podiatric Medical Education of the American Podiatric Medical Association, or other organization determined by the Secretary, provided that the applicable organization does not use accreditation criteria that promote or emphasize diversity, equity, inclusion, or awareness based on race, color, sex, sexual orientation or identity, national origin, or any other characteristic which serves as a proxy to achieve the same ends. * * * * * PART 416—AMBULATORY SURGICAL SERVICES ■ 13. The authority citation for part 416 is revised to read as follows: Authority: 42 U.S.C. 273, 1302, 1320b–8, and 1395h xy to achieve the same ends. * * * * * PART 416—AMBULATORY SURGICAL SERVICES ■ 13. The authority citation for part 416 is revised to read as follows: Authority: 42 U.S.C. 273, 1302, 1320b–8, and 1395hh. ■ 14. Section 416.164 is amended by— ■ a. Revising paragraphs (a)(5), (b)(5) and (6); ■ c. Adding paragraph (b)(7). The revisions and addition read as follows: § 416.164 Scope of ASC services. (a) * * * (5) Medical and surgical supplies not on pass-through status under subpart G of part 419 of this subchapter and not covered ancillary skin substitute supplies under paragraph (b) of this section; * * * (b) * * * (5) Certain radiology services and * * certain diagnostic tests for which separate payment is allowed under the OPPS; (6) Non-opioid pain management drugs, biologicals, and medical devices as determined by CMS under § 416.174; and (7) Groups of skin substitute supply * products. * ■ 15. Section 416.166 is revised to read as follows: * * * § 416.166 Covered surgical procedures. (a) Covered surgical procedures. (1) Effective for services furnished on or after January 1, 2008, through December 31, 2025, covered surgical procedures are those procedures that meet the general stand ) Covered surgical procedures. (1) Effective for services furnished on or after January 1, 2008, through December 31, 2025, covered surgical procedures are those procedures that meet the general standards described in paragraph (b)(1) of this section (whether commonly furnished in an ASC or a physician’s office) and are not excluded under paragraph (c) of this section; and (2) Effective for services furnished on or after January 1, 2026, covered surgical procedures are those procedures that meet the requirements described in paragraph (b)(2) of this section (whether commonly furnished in an ASC or a physician’s office). (b) Requirements for covered surgical procedures. (1) General Standards. Effective for services furnished on or after January 1, 2008 through December 21, 2025, subject to the exclusions in paragraph (c) of this section, 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 practi 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 required active medical monitoring and care at midnight following the procedure. (2) Effective for services furnished on or after January 1, 2026, covered surgical procedures are surgical procedures specified by the Secretary that are published in the Federal Register and/or via the internet on the CMS website and that: (i) Are separately paid under the OPPS; and (ii) Are not: (A) Currently designated as requiring inpatient care under § 419.22(n) of this subchapter; (B) Only able to be reported using a CPT unlisted surgical procedure code; or (C) Otherwise excluded under § 411.15 of this chapter. (c) General exclusions effective January 1, 2008, through December 31, 2025. Notwithstanding paragraph (b)(1) of this section, 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 m overed 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; VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00387 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 33862 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules (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) of this subchapter; (7) Can only be reported using a CPT unlisted surgical procedure code; or (8) Are otherwise excluded under § 411.15 of this chapter. (d) Physician considerations beginning January 1, 2026. Physicians consider the following safety factors as to a specific beneficiary when determining whether to perform a covered surgical procedure. The covered procedure: (1) Is not expected to pose a significant safety risk when performed in an ASC; (2) Is one of which standard medical practice dictates the beneficiary woul d surgical procedure. The covered procedure: (1) Is not expected to pose a significant safety risk when performed in an ASC; (2) Is one of which standard medical practice dictates the beneficiary would not typically be expected to required active medical monitoring and care at midnight following the procedure; (3) Generally results in extensive blood loss; (4) Requires major or prolonged invasion of body cavities; (5) Directly involves major blood vessels; (6) Is generally emergent or life- threatening in nature; and (7) commonly requires systemic thrombolytic therapy. (e) Additions to the list of ASC covered surgical procedures beginning January 1, 2026. On or after January 1, 2026, CMS adds surgical procedures to the list of ASC covered procedures as follows: (1) CMS identifies a surgical procedure that meets the requirements at paragraph (b)(2) of this section. (2) CMS is notified of a surgical procedure that could meet the requirements at paragraph (b)(2) of this section and CMS confirms that such surgical procedure meets those requirements. ■ 16. Section 416.171 is amended by revising paragraphs (a)(2)(iii) through (viii) to read as follows: § 416.171 Determination of payment nfirms that such surgical procedure meets those requirements. ■ 16. Section 416.171 is amended by revising paragraphs (a)(2)(iii) through (viii) to read as follows: § 416.171 Determination of payment rates for ASC services. (a) * * * (2) * * * (iii) For CY 2019 through CY 2026, the update is the hospital inpatient market basket percentage increase applicable under section 1886(b)(3)(B)(iii) of the Act. (iv) For CY 2027 and subsequent years, the update is the Consumer Price Index for All Urban Consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved. (v) For CY 2014 through CY 2018, the Consumer Price Index for All Urban Consumers update determined under paragraph (a)(2)(ii) of this section is reduced by 2.0 percentage points for an ASC that fails to meet the standards for reporting of ASC quality measures as established by the Secretary for the corresponding calendar year. (vi) For CY 2019 through CY 2026, the hospital inpatient market basket percentage increase determined under paragraph (a)(2)(iii) of this section is reduced by 2.0 percentage points for an ASC that fails to meet the standards for reporting o pital inpatient market basket percentage increase determined under paragraph (a)(2)(iii) of this section is reduced by 2.0 percentage points for an ASC that fails to meet the standards for reporting of ASC quality measures as established by the Secretary for the corresponding calendar year. (vii) For CY 2027 and subsequent years, the Consumer Price Index for All Urban Consumers update determined under paragraph (a)(2)(iv) of this section is reduced by 2.0 percentage points for an ASC that fails to meet the standards for reporting of ASC quality measures as established by the Secretary for the corresponding calendar year. (viii)(A) For CY 2011 through CY 2018, the Consumer Price Index for All Urban Consumers determined under paragraph (a)(2)(ii) of this section, after application of any reduction under paragraph (a)(2)(iv) of this section, is reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. (B) For CY 2019 through CY 2026, the hospital inpatient market basket percentage increase determined under paragraph (a)(2)(iii) of this section, after application of any reduction under paragraph (a)(2)(v) of this section, is reduced by the productivi ent market basket percentage increase determined under paragraph (a)(2)(iii) of this section, after application of any reduction under paragraph (a)(2)(v) of this section, is reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. (C) For CY 2027 and subsequent years, the Consumer Price Index for All Urban Consumers determined under paragraph (a)(2)(iv) of this section, after application of any reduction under paragraph (a)(2)(vii) of this section, is reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. * * * ■ 17. Section 416.174 is amended by revising paragraph (c)(1) to read as follows: * * § 416.174 Payment for non-opioid pain management drugs, biologicals, and medical devices. * * * (c) * * * (1) For a qualifying medical device as defined in paragraph (b) of this section, the amount of 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 amount, subject to paragraph (c)(3) of this section. * * * ■ 18. Section 416.310 is amended by revising paragraph (d) to read as follows: * * § 416.310 Da therwise applicable Medicare OPD fee schedule amount, subject to paragraph (c)(3) of this section. * * * ■ 18. Section 416.310 is amended by revising paragraph (d) to read as follows: * * § 416.310 Data collection and submission requirements under the ASCQR Program. * * (d) Extraordinary circumstance * * * exception (ECE). (1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the ASC. For purposes of this paragraph (d), an extraordinary circumstance is an event beyond the control of an ASC (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the ASC to comply with one or more applicable reporting requirements with respect to a calendar year. (2) Process for requesting an ECE. (i) An ASC may request an ECE within 30 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. (ii) CMS notifies the ASC of its decision on the request, in writing, via email. In the event that CMS grants an d by submitting the information specified by CMS at QualityNet or a successor website. (ii) CMS notifies the ASC of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the ASC, the written decision specifies whether the ASC is exempted from one or more reporting requirements or whether CMS has granted the ASC an extension of time to comply with one or more reporting requirements. (3) Authority to Grant an ECE. CMS may grant an ECE to one or more ASCs that have not requested an ECE if CMS determines that— (i) A systemic problem with a CMS data collection system directly impacted the ability of the ASC to comply with a quality data reporting requirement; or (ii) An extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (d)(3) specifies whether the affected ASCs are exempted from one or more reporting requirements or whether CMS has granted the ASCs an extension of time to comply with one or more reporting requirements. * * * * * VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00388 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 rting requirements. * * * * * VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00388 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 33863 PART 419—PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT DEPARTMENT SERVICES ■ 19. The authority citation for part 419 continues to read as follows: Authority: 42 U.S.C. 1302, 1395l(t), and 1395hh. ■ 20. Section 419.2 is amended by revising paragraph (b)(16) to read as follows: * * § 419.2 Basis of payment. * * * (b) * * * (16) Drugs and biologicals that function as supplies when used in a surgical procedure including, but not limited to, products, excluding skin substitutes, that aid wound healing. * * ■ 21. Section 419.22 is amended by revising paragraph (n) to read as follows: * * * § 419.22 Hospital services excluded from payment under the hospital outpatient prospective payment system. * * * * * (n) Services and procedures that the Secretary designates as requiring inpatient care. Effective beginning on January 1, 2026, the Secretary shall eliminate the list of services and pr stem. * * * * * (n) Services and procedures that the Secretary designates as requiring inpatient care. Effective beginning on January 1, 2026, the Secretary shall eliminate the list of services and procedures designated as requiring inpatient care through a 3-year transition, with the list eliminated in its entirety by January 1, 2029. * ■ 22. Section 419.23 is removed. * * * * § 419.23 [Removed]. ■ 23. Section 419.32 is amended by revising paragraph (b)(1)(iv)(B)(12) to read as follows: § 419.32 Calculation of prospective payment rates for hospital outpatient services. * * * (b) * * * (1) * * * (iv) * * * (B) * * * (12) Beginning in calendar year 2026, * * a multifactor productivity adjustment (as determined by CMS), and 2.0- percentage point reduction, except that the 2.0-percentage point reduction shall not apply to hospital outpatient items and services furnished by a hospital with a CMS certification number (CCN) effective date of January 2, 2018, or later. This reduction and associated exception to the reduction will be in effect until the estimated payment reduction reaches $7.769 billion, as further described in each calendar year’s rule. * * * * * ■ 24. Section 419.46 is a ciated exception to the reduction will be in effect until the estimated payment reduction reaches $7.769 billion, as further described in each calendar year’s rule. * * * * * ■ 24. Section 419.46 is amended by revising paragraph (e) to read as follows: § 419.46 Requirements under the Hospital Outpatient Quality Reporting (OQR) Program. * * (e) Extraordinary circumstance * * * exception (ECE). (1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (e), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a calendar year. (2) Process for requesting an ECE. (i) A hospital may request an ECE within 30 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. (ii) CMS notifies the ho st an ECE within 30 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. (ii) CMS notifies the hospital of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the hospital, the written decision specifies whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements. (3) Authority to Grant an ECE. CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that— (i) A systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement; or (ii) An extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (e)(3) specifies whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. * ■ 25. Section 419.49 is added to read as follows: one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. * ■ 25. Section 419.49 is added to read as follows: * * * * § 419.49 Additional payment for technetium-99m (Tc-99m) derived from domestically produced molybdenum-99 (Mo-99). (a) General rule. CMS provides for an additional payment (as specified in this section § 419.49) beyond the standard payment to a hospital for a dose of Tc- 99m derived from Mo-99, if at least 50 percent of the Mo-99 in the Tc-99m generator that produced the dose was both irradiated and processed in the United States. (1) Domestically produced Mo-99 refers to Mo-99 that was both irradiated and processed in the United States. (2) Irradiated refers to the process of bombarding a uranium or molybdenum target with radiation in order to produce Mo-99. Irradiation is typically performed with a nuclear reactor or particle accelerator. (3) Processed refers to the purification of Mo-99 from irradiated material. (b) Exclusions. A dose of Tc-99m does not qualify for the add-on payment if more than 50 percent of the Mo-99 in the Tc-99m generator was irradiated or processed out of Mo-99 from irradiated material. (b) Exclusions. A dose of Tc-99m does not qualify for the add-on payment if more than 50 percent of the Mo-99 in the Tc-99m generator was irradiated or processed outside the United States, even if the Mo-99 has been loaded into a Tc-99m generator in the United States or if the Tc-99m has been eluted at a radiopharmacy in the United States. (1) Eluted refers to the process by which Tc-99m is chemically separated from Mo-99 within the generator and collected in an elution vial. (2) [Reserved]. ■ 26. Section 419.64 is amended by removing paragraph (a)(4)(iv). § 419.64 Transitional pass-through payments: Drugs and biologicals. [Amended] ■ 27. Section 419.95 is amended by revising paragraph (g) and adding paragraph (h) to read as follows: § 419.95 Requirements under the Rural Emergency Hospital Quality Reporting (REHQR) Program. * * (g) Extraordinary circumstance * * * exception (ECE). (1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the REH. For purposes of this paragraph (g), an extraordinary circumstance is an event beyond the contro quirements under this section in the event of extraordinary circumstances beyond the control of the REH. For purposes of this paragraph (g), an extraordinary circumstance is an event beyond the control of an REH (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the REH to comply with one or more applicable reporting requirements with respect to a calendar year. (2) Process for requesting an ECE. (i) An REH may request an ECE within 30 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00389 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 33864 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules (ii) CMS notifies the REH of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the REH, the written decision specifies whether the REH is exempted from one or more reporting requirements or wheth ision on the request, in writing, via email. In the event that CMS grants an ECE to the REH, the written decision specifies whether the REH is exempted from one or more reporting requirements or whether CMS has granted the REH an extension of time to comply with one or more reporting requirements. (3) Authority to Grant an ECE. CMS may grant an ECE to one or more REHs that have not requested an ECE if CMS determines that— (i) A systemic problem with a CMS data collection system directly impacted the ability of the REH to comply with a quality data reporting requirement; or (ii) An extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (g)(3) specifies whether the affected REHs are exempted from one or more reporting requirements or whether CMS has granted the REHs an extension of time to comply with one or more reporting requirements. (h) Requirements for submission of electronic clinical quality measures (eCQMs) under the REHQR Program. When reporting eCQMs under the REHQR Program, REHs must adhere to the following requirements: (1) REHs must utilize technology certified to the Office of the National Coordinator for Health Informat . When reporting eCQMs under the REHQR Program, REHs must adhere to the following requirements: (1) REHs must utilize technology certified to the Office of the National Coordinator for Health Information Technology’s (ONC’s) health information technology (IT) certification criteria, as adopted and updated in 45 CFR 170.315, for reporting eCQMs under the REHQR Program. (2) REHs must use health IT certified to all eCQMs that are available to report under the REHQR Program. (3) REHs must use the most recent version of the eCQM electronic measure specifications for the applicable reporting period available on the Electronic Clinical Quality Improvement Resource Center website at https://ecqi.healthit.gov/, or another website as designated by CMS. (4) The requirements set forth in paragraphs (h)(1) through (3) of this section apply only where an REH opts to report an eCQM. For the reasons set forth in the preamble, the Department of Health and Human Services proposes to amend 45 CFR part 180 as set forth below: PART 180—HOSPITAL PRICE TRANSPARENCY ■ 28. The authority citation for part 180 continues to read as follows: Authority: 42 U.S.C. 300gg–18, 42 U.S.C. 1302. ■ 29. Section 180.20 i 0 as set forth below: PART 180—HOSPITAL PRICE TRANSPARENCY ■ 28. The authority citation for part 180 continues to read as follows: Authority: 42 U.S.C. 300gg–18, 42 U.S.C. 1302. ■ 29. Section 180.20 is amended by adding definitions for ‘‘Median allowed amount’’, ‘‘Ninetieth (90th) percentile allowed amount’’, and ‘‘Tenth (10th) percentile allowed amount’’ in alphabetical order to read as follows. § 180.20 Definitions. * * * * * Median allowed amount means the median of the total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the machine- readable file. Should the calculated median fall between two observed allowed amounts, the median allowed amount is the next highest observed value. Ninetieth (90th) percentile allowed amount means the 90th percentile of the total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the machine-readable file. Should the calculated percentile fall between two observed allowed amounts, the 90th percentile allowed amount r a time period no longer than the 12 months prior to posting the machine-readable file. Should the calculated percentile fall between two observed allowed amounts, the 90th percentile allowed amount is the next highest observed value. Tenth (10th) percentile allowed amount means the 10th percentile of the total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the machine-readable file. Should the calculated percentile fall between two observed allowed amounts, the 10th percentile allowed amount is the next highest observed value. * * * ■ 30. Section 180.50 is amended by revising paragraphs (a)(3), (b)(2)(i)(A), and (b)(2)(ii)(C) to read as follows: * * § 180.50 Requirements for making public hospital standard charges for all items and services. (a) * * * (3) Each hospital must: (i) Prior to January 1, 2026, make a good faith effort to ensure that the standard charge information encoded in the machine-readable file is true, accurate, and complete as of the date indicated in the machine-readable file. (ii) Prior to January 1, 2026, affirm in its machine-readable file formation encoded in the machine-readable file is true, accurate, and complete as of the date indicated in the machine-readable file. (ii) Prior to January 1, 2026, affirm in its machine-readable file that, to the best of its knowledge and belief, the hospital has included all applicable standard charge information in accordance with the requirements of this section, and that the information encoded is true, accurate, and complete as of the date indicated in the machine-readable file. (iii) Beginning January 1, 2026, attest in its machine-readable file the following: This hospital has included all applicable standard charge information in accordance with the requirements of 45 CFR 180.50, and the information encoded is true, accurate, and complete as of the date in the file. This hospital has included all payer-specific negotiated charges in dollars that can be expressed as a dollar amount. For payer- specific negotiated charges that cannot be expressed as a dollar amount in the machine-readable file or not knowable in advance, the hospital attests that the payer-specific negotiated charge is based on a contractual algorithm, percentage or formula that precludes the provision of a e-readable file or not knowable in advance, the hospital attests that the payer-specific negotiated charge is based on a contractual algorithm, percentage or formula that precludes the provision of a dollar amount and has provided all necessary information available to the hospital for the public to be able to derive the dollar amount, including, but not limited to, the specific fee schedule or components referenced in such percentage, algorithm or formula. (iv) Beginning January 1, 2026, encode the name of the hospital chief executive officer, president or senior official designated to oversee the encoding of true, accurate, and complete data as directed in in paragraph (a)(3)(iii) of this section. (b) * * * (2) * * * (i) * * * (A) Hospital name, license number, location name(s) and address(es) under the single hospital license to which the list of standard charges applies, and beginning January 1, 2026, Type 2 (organizational) National Provider Identifier(s) (NPI). Location name(s) and address(es) must include, at minimum, all inpatient facilities and stand-alone emergency departments; and * * * (ii) * * * (C) Whether the standard charge indicated should be interpreted by the use nd address(es) must include, at minimum, all inpatient facilities and stand-alone emergency departments; and * * * (ii) * * * (C) Whether the standard charge indicated should be interpreted by the user as a dollar amount, or if the standard charge is based on a percentage or algorithm. If the standard charge is based on a percentage or algorithm, the machine-readable file (MRF) must also describe the percentage or algorithm that determines the dollar amount for the item or service, and * * (1) Beginning January 1, 2025 through December 31, 2025, calculate and encode an estimated allowed amount in dollars for that item or service; and (2) Beginning January 1, 2026, calculate and encode the tenth (10th) percentile allowed amount, the median allowed amount, and the ninetieth (90th) percentile allowed amount in dollars for that item or service. Hospitals must also calculate and encode the total number of allowed VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00390 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 33865 * * a t 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 33865 * * amount remittances that were used to calculate the 10th percentile allowed amount, median allowed amount, and 90th percentile allowed amount. * * ■ 31. Section 180.90 is amended by— ■ a. Adding new paragraph (c)(4); ■ b. Revising paragraph (d)(1); ■ c. Redesignating paragraphs (d)(2) and (3) as paragraphs (d)(3) and (4), respectively; and ■ d. Adding new paragraph (d)(2). * The additions and revision read as follows: * * § 180.90 Civil monetary penalties. * * * (c) * * * (4) Except as provided in this paragraph, the amount of a civil monetary penalty is reduced by 35 percent if the hospital submits a written notice to CMS requesting to waive its right to a hearing under § 180.100 within 30-calendar days of the date of the notice of imposition of the civil monetary penalty. A hospital that receives a 35 percent reduction in a civil monetary penalty under this paragraph is not eligible to receive a 35 percent reduction for any civil monetary penalties imposed pursuant to continuing violat eceives a 35 percent reduction in a civil monetary penalty under this paragraph is not eligible to receive a 35 percent reduction for any civil monetary penalties imposed pursuant to continuing violations according to § 180.90(f) and also waives its right to appeal under § 180.100 any civil monetary penalties imposed for such continuing violations. A hospital is not eligible to request that CMS reduce the amount of a civil monetary penalty imposed by CMS upon the hospital if— (i) The hospital does not request to waive its right to a hearing in accordance with this paragraph; or (ii) CMS imposed the CMP because the hospital failed to make public an MRF as required at § 180.40(a) or failed to make public a consumer-friendly list of standard charges as required at § 180.40(b). (d) * * * (1) A hospital that does not meet the criteria to receive a reduction to the civil monetary penalty that had been imposed upon it as set forth in paragraph (c)(4) of this section must pay the civil monetary penalty in full within 60 calendar days after the date of the notice of imposition of a civil monetary penalty from CMS under paragraph (b) of this section. (2) A hospital that meets the criteria to y penalty in full within 60 calendar days after the date of the notice of imposition of a civil monetary penalty from CMS under paragraph (b) of this section. (2) A hospital that meets the criteria to receive a reduction to the civil monetary penalty that had been imposed upon it as set forth in paragraph (c)(4) of this section must pay the civil monetary penalty, as reduced in accordance with paragraph (c)(4) of this section, within 60 calendar days after the date of the notice of imposition of a civil monetary penalty from CMS under paragraph (b) of this section. * * * * * Robert F. Kennedy, Jr., Secretary, Department of Health and Human Services. [FR Doc. 2025–13360 Filed 7–15–25; 4:15 pm] 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 00391 Fmt 4701 Sfmt 9990 E:\FR\FM\17JYP2.SGM 17JYP2