(a) The Secretary shall—

(1) Identify, and annually update, the quality measures to be included in the Child, Adult, and Health Home Core Sets; and update the Child and Adult Core Sets beginning no later than January 1, 2024 and annually no later than January 1 thereafter.

(2) Consult annually with States and other interested parties identified in paragraph (e) of this section to—

(i) Establish priorities for the development and advancement of the Core Sets;

(ii) Identify any gaps in the measures included in the Core Sets;

(iii) Identify measures which should be removed as they no longer strengthen the Core Sets; and

(iv) Ensure that all measures included in the Core Sets reflect an evidence-based process including testing, validation, and consensus among interested parties; are meaningful for States; and are feasible for State-level and/or Health Home program level reporting, as appropriate.

(3) In consultation with States, develop and update annually the reporting guidance described in paragraph (b) of this section.

(4) Not later than September 30, 2025 and annually by September 30 thereafter, collect, analyze, and make publicly available the information reported by States on the Child and Adult Core Sets as described in § 437.15.

(5) Annually, collect, analyze, and make publicly available the information reported by States on the Health Home Core Sets as described in § 437.15.

(b) Annual reporting guidance will include all of the following:

(1) Identification of all measures in all the Core Sets, including:

(i) Measures newly added and measures removed from the prior year's Core Sets;

(ii) Measures included in the Adult Core Set that are identified as behavioral health measures;

(iii) The specific measures for which reporting is mandatory for the Child, Adult, and 1945 and 1945A Health Home Core Sets;

(iv) The measures for which the Secretary will complete reporting on behalf of States and the measures for which States may elect to have the Secretary report on their behalf; and

(v) The frequency of reporting for survey-based measures, which will be no more frequent than annually.

(2) Guidance to States on how to collect and calculate the data on the Core Sets.

(3) Standardized format for reporting measure data required under this subpart.

(4) Procedures that State agencies must follow in reporting measure data required under this subpart.

(5) Identification of the populations for which States may, but are not required to, report the Child and Adult Core Set measures identified by the Secretary under paragraph (b)(1) of this section for a specific year in accordance with paragraph (c) of this section.

(i) Additionally, CMS will include guidance to States on how to request a 1-year exemption from reporting one or more Child and/or Adult Core Set measures for specific populations in accordance with § 437.15(a)(4)(ii) and (6) of this part.

(ii) [Reserved]

(6) Attribution rules for determining how States must report on measures for beneficiaries who are included in more than one population, during the reporting period.

(7) The subset of measures within the measures in the Child Core Set, among the behavioral health measures in the Adult Core Set, and among the measures in the Health Home Core Sets that must be stratified by race, ethnicity, sex, age, rural/urban status, disability, language, or such other factors as may be specified by the Secretary and informed by annual consultation with States and interested parties in accordance with paragraphs (a)(2) and (d) of this section.

(c) In issuing the guidance described in paragraph (b) of this section, the Secretary may provide that Child and Adult Core Sets reporting for certain populations of beneficiaries described in paragraph (b)(5) of this section will be voluntary for a specific year, considering the level of difficulty in accessing the data required for such Child and Adult Core Sets State reporting.

(d) In specifying which measures, and by which factors, States must report stratified measures consistent with paragraph (b)(7) of this section, the Secretary will consider whether stratification can be accomplished based on valid statistical methods and without risking a violation of beneficiary privacy and, for measures obtained from surveys, whether the original survey instrument collects the variables necessary to stratify the measures, and such other factors as the Secretary determines appropriate; the Secretary will require stratification of 25 percent of the measures on each of the Core Sets (the Child Core Set, behavioral health measures within the Adult Core Set, and Health Home Core Sets) for which the Secretary has specified that reporting should be stratified by the second year of annual reporting after the effective date of these regulations, 50 percent of such measures for the third and fourth years of annual reporting after the effective date of these regulations, and 100 percent of measures beginning in the fifth year of annual reporting after the effective date of these regulations.

(e) For purposes of paragraph (a)(2) of this section, the Secretary must consult with interested parties as described in this paragraph to include the following:

(1) States;

(2) Pediatricians, children's hospitals, and other primary and specialized pediatric health care professionals (including members of the allied health professions) who specialize in the care and treatment of children and adolescents, particularly children with special physical, mental, and developmental health care needs;

(3) Dental professionals, including pediatric dental professionals;

(4) Health care providers that furnish primary health care to children and families who live in urban and rural medically underserved communities or who are members of distinct population sub-groups at heightened risk for poor health outcomes;

(5) National organizations representing children and/or adolescents, including children with disabilities and children with chronic conditions;

(6) National organizations representing consumers and purchasers of children's health care;

(7) National organizations and individuals with expertise in pediatric health quality measurement;

(8) Voluntary consensus standards setting organizations and other organizations involved in the advancement of evidence-based measures of health care;

(9) With respect only to guidance on the Health Home Core Sets, providers of health home services under sections 1945 and 1945A of the Act;

(10) Such other interested parties as the Secretary may determine appropriate.