(a) Statutory basis. This subpart is based on sections 1139A, 1139B, 1902(a)(6), 1945(c)(4)(B), 1945(g), and 1945A(g) of the Act.

(b) Scope. This subpart sets forth specifications for issuance and updates to the Core Set of Children's Health Care Quality Measures for Medicaid and CHIP (Child Core Set), the Core Set of Adult Health Care Quality Measures for Medicaid (Adult Core Set), and the 1945 and 1945A Core Sets of Health Home Quality Measures for Medicaid (Health Home Core Sets) by the Secretary. It also sets forth requirements related to annual reporting by States of measures in all of the Core Sets, and requirements related to provider reporting to States on the Health Home Core Sets.

(c) Purpose. (1) The purpose of the Medicaid and CHIP Child Core Set and the Medicaid Adult Core Set is to measure the overall national quality of care for beneficiaries, monitor performance at the State-level, and improve the quality of health care.

(2) The purpose of the Health Home Core Sets is to measure the overall program quality of health home services for Medicaid beneficiaries enrolled in a health home program under section 1945 or 1945A of the Act, monitor the impact of these two optional State plan benefits, monitor performance of these two benefits at the program level, and improve the quality of health care.

(d) Applicability. The provisions of this subpart apply as follows:

(1) For the Child and Adult Core Sets, State includes the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, and Guam.

(2) For the Health Home Core Sets, State includes any State (as defined under section 1101 of the Act for purposes of Title XIX of the Act) with an approved Medicaid Health Home State Plan Amendment under section 1945 or 1945A of the Act.

(e) Applicability dates. States must comply with the requirements of this subpart by no later than State reporting on the 2024 Core Sets, which must be submitted and certified by December 31, 2024.

As used in this subpart—

1945 Health Home Core Set means the Core Set of Health Home Quality Measures related to the Medicaid health home benefit under section 1945 of the Act, established and updated annually as described in § 437.10(a).

1945A Health Home Core Set means the Core Set of Health Home Quality Measures related to the Medicaid health home benefit under section 1945A of the Act, established and updated annually as described in § 437.10(a).

Adult Core Set means the Core Set of Adult Health Care Quality Measures for Medicaid established and updated annually as described in § 437.10(a).

Attribution rules means the process Medicaid and CHIP and other payers use to assign beneficiaries to a specific health care program or delivery system for the purpose of calculating the measures on the Core Sets.

Behavioral health means a beneficiary's whole emotional and mental well-being, which includes, but is not limited to, the prevention, treatment, and recovery of mental disorders including substance use disorders.

Behavioral health measure means a quality measure that could be used to evaluate the quality of and improve the health care provided to beneficiaries with, or at-risk for a behavioral health disorder(s).

Child Core Set means the Core Set of Health Care Quality Measures for Children in Medicaid and CHIP, established and updated annually as described in § 437.10(a).

Core Sets means the Child Core Set, the Adult Core Set, the section 1945 Health Home Core Set, and the section 1945A Health Home Core Set, collectively.

Health Home Core Sets means, collectively, the two Core Sets of Health Home Quality Measures related to the two Medicaid health home benefits under sections 1945 and 1945A of the Act, established and updated annually as described in § 437.10(a).

Standardized format means the format provided by the reporting system that States are required to utilize to submit Core Sets data to CMS.

(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.

(a) General rules. (1) Except as provided in paragraphs (a)(2) and (a)(4) of this section, the agency—

(i) Must report by December 31, 2024, on all measures on the 2024 Child Core Set and the behavioral health measures in the Adult Core Set;

(ii) In subsequent years, must report annually, by December 31st, on all measures on the Child Core Set and the behavioral health measures in the Adult Core Set that are identified by the Secretary pursuant to § 437.10(b)(1)(iii);

(iii) Must report annually, by December 31st, on all measures in the 1945 or 1945A Health Home Core Sets (as applicable) that are identified by the Secretary pursuant to § 437.10(b)(1)(iii), if the agency has elected to offer health home services under the State plan under section 1945 or section 1945A of the Act, and if the applicable health home program has an effective date and has been implemented more than 6 months prior to the December 31st reporting deadline; and

(iv) May report on all other measures in the Adult Core Set that are not described in paragraphs (a)(1)(i) and (ii) of this section.

(2) Measures identified per § 437.10(b)(1)(iv) will be reported by the Secretary on behalf of the agency.

(3) The agency must adhere to the reporting guidance described in § 437.10(b), except as described in paragraph (a)(4) of this section, when reporting on measures in the Core Sets.

(4) In reporting on all Child and Adult Core Set measures, the agency is required to report on all Medicaid and CHIP beneficiaries, including those enrolled in fee-for-service and managed care, unless—

(i) The Secretary specifies in annual guidance that the population is not required to be reported in accordance with § 437.10(b)(5); or

(ii) The Secretary grants the agency an exemption from reporting one or more Child and Adult Core Set measures for a specific population in accordance with paragraph (a)(6) of this section.

(5) In reporting on all 1945 and 1945A Health Home Core Sets measures, the agency is required to report on all beneficiaries enrolled in an approved health home program.

(6)(i) The agency may request a 1-year exemption from reporting for a specific population defined by the State for one or more Child and/or Adult Core Set measures if the agency demonstrates that it:

(A) Is unable to obtain access to data required to report the relevant Child and Adult Core Set measure or measures for that population despite making reasonable efforts to do so; and

(B) Has a reasonable timeline of actions underway to resolve data access problems.

(ii) The agency must submit a request for an exemption by September 1st of the applicable reporting year.

(iii) If the Secretary determines that the agency satisfies the conditions set forth in paragraph (6)(i) of this section, the Secretary will approve the exemption only for that year's Child and/or Adult Core Set reporting and the exemption will apply only for the specific population for which the State requests an exemption. If the Secretary determines that the agency does not satisfy the conditions set forth in paragraph (a)(6)(i) of this section, the Secretary will communicate a denial of the exemption request to the agency, and the agency will be expected to include the relevant population in that year's Child and Adult Core Sets reporting.

(iv) The agency may request an exemption to reporting Child and Adult Core Set measures for the same population in accordance with this paragraph in more than one reporting year.

(b) Reporting of Medicaid and CHIP beneficiaries. In States that have implemented a separate child health program (“separate CHIP”) under part 457 of this chapter:

(1) The agency must report, in accordance with attribution rules established by the Secretary pursuant to § 437.10(b)(6), on measures included in the Child Core Set for—

(i) The Medicaid beneficiaries (including those for whom the State claims Federal financial participation under both Title XIX and Title XXI) in the age range to which the measure applies, as per reporting guidance described in paragraph § 437.10(b)(2); and

(ii) The beneficiaries in the State's separate CHIP in the age range to which the measure applies, as per reporting guidance described in paragraph § 437.10(b)(2).

(2) If the separate CHIP elects to report on Adult Core Set measures for individuals enrolled in their separate CHIP, the agency must report on individuals described in paragraphs (b)(1)(i) and (ii) of this section.

(a) The State plan must specify that:

(1) The agency will report on the Child and Adult Core Sets in accordance with § 437.15.

(2) If health home services are covered under the State plan pursuant to section 1945 or 1945A of the Act, the agency will report on the applicable Health Home Core Set or Sets in accordance with § 437.15 of this subpart.

(3) If health home services are covered under the State plan pursuant to section 1945 or 1945A of the Act, the agency requires health home services providers to report to the agency on all populations served by the health home providers and on the measures in the applicable Health Home Core Set or Sets that are identified by the Secretary pursuant to § 437.10(b)(1)(iii), as a condition for receiving payment for health home services.

(b) [Reserved]