--- kind: "section" citation: "42 C.F.R. § 438.358" title: "42" number: "438.358" heading: "Activities related to external quality review." url: "https://uscodex.org/cfr/42/438.358" --- # §438.358. Activities related to external quality review. - (a) **General rule.** - (1) The State, its agent that is not an MCO, PIHP, or PAHP or an EQRO may perform the mandatory and optional EQR-related activities in this section. - (2) The data obtained from the mandatory and optional EQR-related activities in this section must be used for the annual EQR in [§ 438.350](/cfr/42/438.350.md) and must include, at a minimum, the elements in [§ 438.364(a)(2)(i) through (iv)](/cfr/42/438.364.md?p=a-2-i..a-2-iv). - (3) For the EQR-related activities described in [paragraph (b)(1)](#b-1) of this section (except [paragraph (b)(1)(iii)](#b-1-iii) of this section), the review period begins on the first day of the most recently concluded contract year or calendar year, whichever is nearest to the date of the EQR-related activity and is twelve months in duration. - (b) **Mandatory activities.** - (1) For each MCO, PIHP, or PAHP the following EQR-related activities must be performed in the 12 months preceding the finalization of the annual report: - (i) Validation of performance improvement projects required in accordance with [§ 438.330(b)(1)](/cfr/42/438.330.md?p=b-1) that were underway during the EQR review period per [paragraph (a)(3)](#a-3) of this section. - (ii) Validation of MCO, PIHP, or PAHP performance measures required in accordance with [§ 438.330(b)(2)](/cfr/42/438.330.md?p=b-2) or MCO, PIHP, or PAHP performance measures calculated by the State during the EQR review period described in [paragraph (a)(3)](#a-3) of this section. - (iii) A review, conducted within the previous 3-year period, to determine the MCO's, PIHP's, or PAHP's compliance with the standards set forth in [subpart D](/cfr/42/subpartD.md) of this part, the disenrollment requirements and limitations described in [§ 438.56](/cfr/42/438.56.md), the enrollee rights requirements described in [§ 438.100](/cfr/42/438.100.md), the emergency and post-stabilization services requirements described in [§ 438.114](/cfr/42/438.114.md), and the quality assessment and performance improvement requirements described in [§ 438.330](/cfr/42/438.330.md). - (iv) Validation of MCO, PIHP, or PAHP network adequacy during the EQR review period per [paragraph (a)(3)](#a-3) of this section to comply with requirements set forth in [§ 438.68](/cfr/42/438.68.md) and, if the State enrolls Indians in the MCO, PIHP, or PAHP, [§ 438.14(b)(1)](/cfr/42/438.14.md?p=b-1). - (2) For each PCCM entity (described in [§ 438.310(c)(2)](/cfr/42/438.310.md?p=c-2)), the EQR-related activities in paragraphs [(b)(1)(ii)](#b-1-ii) and [(iii)](#b-1-iii) of this section may be performed. - (3) For the EQR-related activities described in [paragraph (b)(1)](#b-1) of this section (except [paragraph (b)(1)(iii)](#b-1-iii) of this section), the review period begins on the first day of the most recently concluded contract year or calendar year, whichever is nearest to the date of the EQR-related activity and is 12 months in duration. - (c) **Optional activities.** For each MCO, PIHP, PAHP, and PCCM entity (described in [§ 438.310(c)(2)](/cfr/42/438.310.md?p=c-2)), the following activities may be performed: - (1) Validation of encounter data reported by an MCO, PIHP, PAHP, or PCCM entity (described in [§ 438.310(c)(2)](/cfr/42/438.310.md?p=c-2)). - (2) **Administration or validation of consumer or provider surveys of quality of care.** - (3) Calculation of performance measures in addition to those reported by an MCO, PIHP, or PAHP and validated by an EQRO in accordance with [paragraph (b)(1)(ii)](#b-1-ii) of this section. - (4) Conduct of performance improvement projects in addition to those conducted by an MCO, PIHP or PAHP and/or validated by an EQRO in accordance with [paragraph (b)(1)(i)](#b-1-i) of this section. - (5) Conduct of studies on quality that focus on a particular aspect of clinical or nonclinical services at a point in time. - (6) **Assist with the quality rating of MCOs, PIHPs, and PAHPs consistent with 42 CFR part 438, subpart G.** - (7) Assist with evaluations required under §§ [438.16(e)(1)](/cfr/42/438.16.md?p=e-1), [438.340(c)(2)(i)](/cfr/42/438.340.md?p=c-2-i), and [438.6(c)(2)(iv)](/cfr/42/438.6.md?p=c-2-iv) and [(v)](/cfr/42/438.6.md?p=c-2-v) pertaining to outcomes, quality, or access to health care services. - (d) **Technical assistance.** The EQRO may, at the State's direction, provide technical guidance to groups of MCOs, PIHPs, PAHPs, or PCCM entities (described in [§ 438.310(c)(2)](/cfr/42/438.310.md?p=c-2)) to assist them in conducting activities related to the mandatory and optional activities described in this section that provide information for the EQR and the resulting EQR technical report. ## Notes ### Amendments [81 FR 27853, May 6, 2016, as amended at 82 FR 39, Jan. 3, 2017; 82 FR 12510, Mar. 6, 2017; 85 FR 72841, Nov. 13, 2020; 89 FR 41278, May 10, 2024] ### Source Source: 81 FR 27853, May 6, 2016, unless otherwise noted. ### Authority Authority: 42 U.S.C. 1302. ### Source Source: 67 FR 41095, June 14, 2002, unless otherwise noted. ### Amendments [81 FR 27853, May 6, 2016, as amended at 82 FR 39, Jan. 3, 2017; 82 FR 12510, Mar. 6, 2017; 85 FR 72841, Nov. 13, 2020; 89 FR 41278, May 10, 2024]