(a) Measures required. The quality rating system implemented by the State—

(1) Must include the measures that are:

(i) In the mandatory QRS measure set identified and described by CMS in the Medicaid and CHIP managed care quality rating system technical resource manual, and

(ii) Applicable to the State because the measures assess a service or action covered by a managed care program established by the State.

(2) May include other measures identified by the State as provided in § 438.520(c)(1).

(b) Subregulatory process to update mandatory measure set. Subject to paragraph (d) of this section, CMS will—

(1) At least every other year, engage with States and other interested parties (such as State officials, measure experts, health plans, beneficiary advocates, tribal organizations, health plan associations, and external quality review organizations) to evaluate the current mandatory measure set and make recommendations to CMS to add, remove or update existing measures based on the criteria and standards in paragraph (c) of this section; and

(2) Provide public notice and opportunity to comment through a call letter (or similar subregulatory process using written guidance) on any planned modifications to the mandatory measure set following the engagement described in paragraph (b)(1) of this section.

(c) Standards for adding mandatory measures. Based on available relevant information, including the input received during the process described in paragraph (b) of this section, CMS will add a measure in the mandatory measure set when each of the standards described in (c)(1) through (3) of this section are met.

(1) The measure meets at least 5 of the following criteria:

(i) Is meaningful and useful for beneficiaries or their caregivers when choosing a managed care plan;

(ii) Aligns, to the extent appropriate, with other CMS programs described in § 438.505(c);

(iii) Measures health plan performance in at least one of the following areas: customer experience, access to services, health outcomes, quality of care, health plan administration, and health equity;

(iv) Presents an opportunity for managed care plans to influence their performance on the measure;

(v) Is based on data that are available without undue burden on States, managed care plans, and providers such that it is feasible to report by many States, managed care plans, and providers;

(vi) Demonstrates scientific acceptability, meaning that the measure, as specified, produces consistent and credible results;

(2) The proposed measure contributes to balanced representation of beneficiary subpopulations, age groups, health conditions, services, and performance areas within a concise mandatory measure set, and

(3) The burdens associated with including the measure does not outweigh the benefits to the overall quality rating system framework of including the new measure based on the criteria listed in paragraph (c)(1) of this section.

(4) When making the determinations required under paragraphs (c)(2) and (3) of this section, to add, remove, or update a measure, CMS may consider the measure set as a whole, each specific measure individually, or a comparison of measures that assess similar aspects of care or performance areas.

(d) Removing mandatory measures. CMS may remove existing mandatory measures from the mandatory measure set if—

(1) After following the process described in paragraph (b) of this section, CMS determines that the measure no longer meets the standards described in paragraph (c) of this section;

(2) The measure steward (other than CMS) retires or stops maintaining a measure;

(3) CMS determines that the clinical guidelines associated with the specifications of the measure change such that the specifications no longer align with positive health outcomes; or

(4) CMS determines that the measure shows low statistical reliability under the standard identified in §§ 422.164(e) and 423.184(e) of this chapter.

(e) Updating existing mandatory measures. CMS will modify the existing mandatory measures that undergo measure technical specifications updates as follows—

(1) Non-substantive updates. CMS will update changes to the technical specifications for a measure made by the measure steward; such changes will be in the technical resource manual issued under paragraph (f) of this section and § 438.530. Examples of non-substantive updates include those that:

(i) Narrow the denominator or population covered by the measure.

(ii) Do not meaningfully impact the numerator or denominator of the measure.

(iii) Update the clinical codes with no change in the target population or the intent of the measure.

(iv) Provide additional clarifications such as:

(A) Adding additional tests that would meet the numerator requirements;

(B) Clarifying documentation requirements;

(C) Adding additional instructions to identify services or procedures; or

(D) Adding alternative data sources or expanding of modes of data collection to calculate a measure.

(2) Substantive updates. CMS may adopt substantive updates to a mandatory measure not subject to paragraphs (e)(1)(i) through (iv) of this section only after following the process specified in paragraph (b) of this section.

(f) Finalization and display of mandatory measures and updates. CMS will finalize modifications to the mandatory measure set and the timeline for State implementation of such modifications in the technical resource manual. For new or substantively updated measures, CMS will provide each State with at least 2 calendar years from the start of the measurement year immediately following the release of the annual technical resource manual in which the modification to the mandatory measure set is finalized to display measurement results and ratings using the new or updated measure(s).