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

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 amends 42 CFR chapter IV as follows:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0 1. The authority citation for part 410 continues to read as follows:

Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

0 2. Section 410.27 is amended by revising paragraph (a)(1)(iv)(B)(1) to read as follows:

Sec. [thinsp]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 Sec. Sec. 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 audio/video real-time communications technology (excluding audio-only); and * * * * *

0 3. Section 410.28 is amended by revising paragraph (e)(2)(iii) to read as follows:

Sec. 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

0 4. The authority citation for part 412 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0 5. Section 412.3 is amended by revising paragraph (d)(2) introductory text and removing paragraphs (d)(2)(i) and (ii) to read as follows:

Sec. 412.3 Admissions.

* * * * *

(d) * * *

(2) An inpatient admission for a surgical procedure specified by Medicare as inpatient only under Sec. 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 Sec. 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 Sec. 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. * * * * *

0 6. Section 412.105 is amended by-- 0 a. Revising paragraphs (f)(1)(i)(A) through (C); and 0 b. Adding paragraph (f)(1)(i)(E).

The revisions and addition read as follows:

Sec. 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 Sec. 415.152 of this chapter, provided that the national organization does not use accreditation criteria that promote or encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits.

(B) May count towards certification of the participant in a specialty or subspecialty listed in the current edition of either of the following publications, provided that listing in either of those publications, or in successor information sources, does not require the program to promote or encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits:

(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.

(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 encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits. * * * * *

(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 encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits. * * * * *

0 7. Section 412.190 is amended by-- 0 a. Revising paragraph (a)(2); 0 b. Adding paragraph (a)(3); 0 c. Revising paragraph (b)(1) introductory text; 0 d. Redesignating paragraph (d)(5) as (d)(6), and paragraph (d)(6) as (d)(5); 0 e. Adding paragraph (d)(9); and 0 f. Revising paragraphs (e) and (f).

The revisions and additions read as follows

Sec. 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 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) Sources of Data. 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 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 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 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

0 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.

0 9. Section 413.20 is amended by revising paragraph (d)(3) to read as follows:

Sec. 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)(i) of this section to determine the extent to which they may be used for determining program payment. * * * * *

0 10. Section 413.75 is amended in paragraph (b) by revising the definitions of “Approved geriatric program” and “Approved medical residency program” to read as follows:

Sec. 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 Sec. 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 encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits.

Approved medical residency program means a program that meets one of the following criteria:

(i) Is approved by one of the national organizations listed in Sec. 415.152 of this chapter, provided that the national organization does not use accreditation criteria that promote or encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits.

(ii) May count towards certification of the participant in a specialty or subspecialty listed in the current edition of either of the following publications, provided that listing in either of those publications, or in successor information sources, does not require the program to promote or encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a

selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits:

(A) 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

(B) 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.

(iii) 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, provided that the Council or other organization does not use accreditation criteria that promote or encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits.

(iv) Is a program that would be accredited except for the accrediting agency's reliance upon an accreditation standard that requires an entity to perform an induced abortion or require, provide, or refer for training in the performance of induced abortions, or make arrangements for such training, regardless of whether the standard provides exceptions or exemptions.

(v) 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 encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits. * * * * *

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN CERTAIN SETTINGS

0 11. The authority citation for part 415 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0 12. Section 415.152 is amended by revising the definition of “Approved graduate medical education (GME) program” to read as follows:

Sec. 415.152 Definitions.

* * * * *

Approved graduate medical education (GME) program means one of the following:

(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 encourage discrimination on the basis of race, color, national origin, sex, age, disability, or religion, including the use of those characteristics or intentional proxies for those characteristics as a selection criterion for employment, program participation, resource allocation, or similar activities, opportunities, or benefits.

(2) A program otherwise recognized as an “approved medical residency program” under Sec. 413.75(b) of this chapter. * * * * *

PART 416--AMBULATORY SURGICAL SERVICES

0 13. The authority citation for part 416 is revised to read as follows:

Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.

0 14. Section 416.164 is amended by-- 0 a. Revising paragraphs (a)(5), (b)(5) and (6); and 0 b. Adding paragraph (b)(7).

The revisions and addition read as follows:

Sec. 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 Sec. 416.174; and

(7) Groups of skin substitute supply products. * * * * *

0 15. Section 416.166 is revised to read as follows:

Sec. 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 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 practice dictates that the beneficiary would not typically be expected to require 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 Sec. 419.22(n) of this subchapter;

(B) Only able to be reported using a CPT unlisted surgical procedure code; or

(C) Otherwise excluded under Sec. 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 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 Sec. 419.22(n) of this subchapter;

(7) Can only be reported using a CPT unlisted surgical procedure code; or

(8) Are otherwise excluded under Sec. 411.15 of this chapter.

(d) Physician considerations beginning January 1, 2026. Physicians should 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 would not typically be expected to require 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.

0 16. Section 416.171 is amended by revising paragraphs (a)(2)(iii) through (viii) to read as follows:

Sec. 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 was reduced by 2.0 percentage points for ASCs that failed 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 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, was 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 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. * * * * *

0 17. Section 416.174 is amended by revising paragraphs (a) introductory text, (b) introductory text, and (c)(1) and (2) to read as follows:

(a) Eligibility for separate payment for non-opioid pain management drugs and biologicals. From January 1, 2025, through December 31, 2027, a non-opioid drug or biological is eligible for separate payment if CMS determines it meets the following requirements: * * * * *

(b) Eligibility for separate payment for non-opioid medical devices. From January 1, 2025, through December 31, 2027, a medical device is eligible for separate payment if CMS determines it meets all of the following requirements: * * * * *

(c) * * *

(1) For a qualifying drug or biological as defined in paragraph (a) of this section, the amount of payment is the amount determined under section 1847A of the Act for the drug or biological that exceeds the portion of the otherwise applicable Medicare OPD fee schedule amount, subject to paragraph (c)(3) of this section.

(2) 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. * * * * *

0 18. Section 416.310 is amended by revising paragraph (d) to read as follows:

Sec. 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 60 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 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. * * * * *

PART 419--PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT DEPARTMENT SERVICES

0 19. The authority citation for part 419 continues to read as follows:

Authority: 42 U.S.C. 1302, 1395l(t), and 1395hh.

0 20. Section 419.2 is amended by revising paragraphs (b)(16) and (18) to read as follows:

Sec. 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; * * * * *

(18) Certain services described by add-on codes (excluding skin substitute product add-on codes that are assigned to status indicator “S1”). * * * * *

0 21. Section 419.22 is amended by revising paragraph (n) to read as follows:

Sec. 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 procedures designated as requiring inpatient care through a 3-year transition, with the list eliminated in its entirety by January 1, 2029. * * * * *

Sec. 419.23 [Removed]

0 22. Section 419.23 is removed.

0 23. Section 419.43 is amended by revising paragraphs (k)(1) introductory text and (k)(2) introductory text to read as follows:

Sec. 419.43 Adjustments to national program payment and beneficiary copayment amounts.

* * * * *

(k) * * *

(1) Eligibility for separate payment for non-opioid pain management drugs and biologicals. From January 1, 2025, through December 31, 2027, a drug or biological is eligible for separate payment if CMS determines it meets the following requirements: * * * * *

(2) Eligibility for separate payment for non-opioid medical devices. From January 1, 2025, through December 31, 2027, a medical device is eligible for separate payment if CMS determines it meets the following requirements: * * * * *

0 24. Section 419.46 is amended by revising paragraph (e) to read as follows:

Sec. 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 60 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. * * * * *

0 25. Section 419.47 is amended by revising the section heading and paragraph (a) and to read as follows:

Sec. [thinsp]419.47 Coding and payment for Category B Investigational Device Exemption (IDE) studies.

(a) Creation of a new HCPCS code for Category B IDE studies that have a treatment arm and a placebo control arm. CMS will create a new HCPCS code, or revise an existing HCPCS code, to describe a Category B IDE study, which will include both the treatment and placebo control arms, related device(s) of the study, as well as routine care items and services, as specified under Sec. [thinsp]405.201 of this chapter, when CMS determines that:

(1) The Medicare coverage IDE study criteria in Sec. [thinsp]405.212 of this chapter are met; and

(2) A new or revised code is necessary to preserve the scientific validity of such a study, such as by preventing the unblinding of the study. * * * * *

0 26. Section 419.49 is added to read as follows:

Sec. 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 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 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]

Sec. 419.64 [Amended]

0 27. Section 419.64 is amended by removing paragraph (a)(4)(iv).

0 28. Section 419.95 is amended by revising paragraph (g) and adding paragraph (h) to read as follows:

Sec. 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 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 60 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 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 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 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 amends 45 CFR part 180 as set forth below:

PART 180--HOSPITAL PRICE TRANSPARENCY

0 29. The authority citation for part 180 continues to read as follows:

Authority: 42 U.S.C. 300gg-18, 42 U.S.C. 1302.

0 30. Section[thinsp]180.20 is amended by adding definitions of “Median allowed amount”, “Ninetieth (90th) percentile allowed amount”, and “Tenth (10th) percentile allowed amount” in alphabetical order to read as follows.

Sec. 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 less than 12 months and no longer than 15 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 less than 12 months and no longer than 15 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 less than 12 months and no longer than 15 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. * * * * *

0 31. Section 180.50 is amended by revising paragraphs (a)(3), (b)(2)(i)(A), and (b)(2)(ii)(C) to read as follows:

Sec. 180.50 Requirements for making public hospital standard charges for all items and services.

(a) * * *

(3) Each hospital must:

(i) Beginning January 1, 2024 through December 31, 2025, 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) Beginning January 1, 2024 through December 31, 2025, 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: To the best of its knowledge and belief, 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 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 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 amount remittances that were used to calculate the 10th percentile allowed amount, median allowed amount, and 90th percentile allowed amount. * * * * *

0 32. Section 180.90 is amended by-- 0 a. Adding paragraph (c)(4); 0 b. Revising paragraph (d)(1); 0 c. Redesignating paragraphs (d)(2) and (3) as paragraphs (d)(3) and (4), respectively; and 0 d. Adding new paragraph (d)(2).

The additions and revision read as follows:

Sec. 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 Sec. 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 subsequent civil monetary penalties imposed pursuant to continuing violations according to Sec. 180.90(f) and also waives its right to appeal under Sec. 180.100 any subsequent 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 by 35 percent in accordance with this paragraph 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 Sec. 180.40(a) or failed to make public a consumer-friendly list of standard charges as required at Sec. 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 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. 2025-20907 Filed 11-21-25; 4:15 pm]

BILLING CODE 4120-01-P