Section 416.320 - [Effective 1/1/2025] Retention and removal of quality measures under the ASCQR Program(a)General rule for the retention of quality measures. Quality measures adopted for an ASCQR Program measure set for a previous payment determination year are retained in the ASCQR Program for measure sets for subsequent payment determination years, except when they are removed, suspended, or replaced as set forth in paragraphs (b) and (c) of this section.(b)Immediate measure suspension. If CMS determines that the collection and reporting activities related to a measure potentially raise patient safety concerns, CMS will immediately suspend the measure from the ASCQR Program and promptly notify ASCs and the public of the suspension. CMS will propose to retain, modify, or remove the suspended measure in the next feasible rulemaking cycle.(c)Removal of quality measures - (1)General rule for the removal of quality measures. Unless a measure raises specific safety concerns as set forth in paragraph (b) of this section, CMS will use the regular rulemaking process to remove, suspend, or replace quality measures in the ASCQR Program to allow for public comment.(2)Factors for consideration of removal of quality measures. CMS will weigh whether to remove measures based on the following factors: (i)Factor 1. Measure performance among ASCs is so high and unvarying that meaningful distinctions and improvements in performance can no longer be made (topped-out measures);(ii)Factor 2. Performance or improvement on a measure does not result in better patient outcomes;(iii)Factor 3. A measure does not align with current clinical guidelines or practice;(iv)Factor 4. The availability of a more broadly applicable (across settings, populations, or conditions) measure for the topic;(v)Factor 5. The availability of a measure that is more proximal in time to desired patient outcomes for the particular topic;(vi)Factor 6. The availability of a measure that is more strongly associated with desired patient outcomes for the particular topic;(vii)Factor 7. Collection or public reporting of a measure leads to negative unintended consequences other than patient harm; and(viii)Factor 8. The costs associated with a measure outweigh the benefit of its continued use in the program.(3)Criteria to determine topped-out measures. For the purposes of the ASCQR Program, a measure is considered to be topped-out under paragraph (c)(2)(i) of this section when it meets both of the following criteria:(i) Statistically indistinguishable performance at the 75th and 90th percentiles (defined as when the difference between the 75th and 90th percentiles for an ASC's measure is within two times the standard error of the full data set); and(ii) A truncated coefficient of variation less than or equal to 0.10.(4)Application of measure removal factors. The benefits of removing a measure from the ASCQR Program will be assessed on a case-by-case basis. A measure will not be removed solely on the basis of meeting any specific factor or criterion. 80 FR 70604 , Nov. 13, 2015, as amended at 83 FR 59178 , Nov. 21, 2018; 88 FR 82179 , Nov. 22, 2023 83 FR 59178 , 1/1/2019; 88 FR 82179 , 1/1/2024; 89 FR 94589 , 1/1/2025