Title 42

SECTION 416.320

416.320 Retention and removal of quality measures under the ASCQR Program.

§ 416.320 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 removal. In cases where CMS believes that the continued use of a measure as specified raises patient safety concerns, CMS will immediately remove a quality measure from the ASCQR Program and will promptly notify ASCs and the public of the removal of the measure and the reasons for its removal through the ASCQR Program ListServ and the ASCQR Program QualityNet Web site. CMS will confirm the removal of the measure for patient safety concerns in the next ASCQR Program rulemaking.

(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]

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