42 C.F.R. § 414.1400
(a) General.
(1) MIPS data may be submitted on behalf of a MIPS eligible clinician, group, virtual group, subgroup, or APM Entity by any of the following third party intermediaries:
(2) Third party intermediary approval criteria—
(i) To be approved as a third party intermediary, an organization must meet the following requirements:
(ii) The determination of whether to approve an entity as a third party intermediary for a MIPS payment year may take into account:
(3) For third-party intermediary program requirements:
(ii) All data submitted to CMS by a third party intermediary must be submitted in the form and manner specified by CMS.
(iv) Prior to discontinuing services to any MIPS eligible clinician, group, virtual group, subgroup, or APM Entity during a performance period, a third party intermediary must support the transition of such MIPS eligible clinician, group, virtual group, subgroup, or APM Entity to an alternate third party intermediary, submitter type, or, for any measure on which data has been collected, collection type according to a CMS approved transition plan by a date specified by CMS. The transition plan must address the following issues, unless different or additional information is specified by CMS:
(B) Impacted entities:
(1) The number of clinicians, groups, virtual groups, subgroups or APM entities (inclusive of MIPS eligible, opt-in and voluntary participants) that would need to find another way to report.
(2) As applicable, identify any QCDRs that were granted licenses to QCDR measures which would no longer be available for reporting due to the transition.
(v) As a condition of its qualification and approval to participate in MIPS as a third party intermediary, a third party intermediary must:
(b) Additional requirements for QCDRs and qualified registries—(1) General.
(i) Beginning with the CY 2021 performance period/2023 MIPS payment year, QCDRs and qualified registries must be able to submit data for all of the following MIPS performance categories:
(A) Quality, except:
(1)The CAHPS for MIPS survey; and
(2) For qualified registries, QCDR measures;
(ii)
(B) Beginning with the CY 2026 performance period/2028 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data no later than 1 year after finalization of the MVP in accordance with the current requirement.
(1) QCDRs and qualified registries may also support the APP.
(2) A QCDR or qualified registry must support all measures and activities included in the MVP with the following exceptions:
(i) If an MVP is intended for reporting by multiple specialties, a QCDR or a qualified registry are required to report those measures pertinent to the specialty of its MIPS eligible clinicians.
(ii) If an MVP includes a QCDR measure, it is not required to be reported by a QCDR other than the measure owner.
(3) Conditions for approval.
(v) Beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct annual data validation audits in accordance with this paragraph (b)(3)(v).
(E) The QCDR or qualified registry must conduct each data validation audit using a sampling methodology that meets the following requirements:
(1) Uses a sample size of at least 3 percent of a combination of the individual MIPS eligible clinicians, groups, virtual groups, subgroups and APM entities for which the QCDR or qualified registry will submit data to CMS, except that the sample size may be no fewer than a combination of 10 individual clinicians, groups, virtual groups, subgroups and APM entities, no more than a combination of 50 individual clinicians, groups, virtual groups, subgroups and APM entities.
(2) Uses a sample that includes at least 25 percent of the patients of each individual clinician, group, virtual group, subgroup or APM entity in the sample, except that the sample for each individual clinician, group, virtual group, subgroup or APM entity must include a minimum of 5 patients and need not include more than 50 patients.
(F) Each QCDR or qualified registry data validation audit must include the following:
(1) Verification of the eligibility status of each eligible clinician, group, virtual group, subgroup, opt-in participant, and voluntary participant.
(2) Verification of the accuracy of TINs and NPIs.
(3) Calculation of reporting and performance rates.
(4) Verification that only the MIPS quality measures and QCDR measures, as applicable, that are relevant to the performance period will be used for MIPS submission.
(G) In a form and manner and by a deadline specified by CMS, the QCDR or qualified registry must report the results of each data validation audit, including the overall data deficiencies or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by any deficiency or error, and, how and when each deficiency or data error type was corrected.
(1) QCDRs and qualified registries must conduct validation on the data they intend to submit for the MIPS performance period and provide the results of the executed data validation plan by May 31st of the year following the performance period.
(2) [Reserved]
(vi) Beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct targeted audits in accordance with this paragraph (b)(3)(vi).
(x) A QCDR or a qualified registry must be able to submit to CMS data for at least six quality measures including at least one outcome measure.
(xiii) A QCDR or a qualified registry must maintain records of their authorization to submit data to CMS for the purpose of MIPS participation for each NPI whom the QCDR or qualified registry will submit data to CMS for. The records must:
(xvi) A QCDR or qualified registry must attest to the following:
(4) QCDR measures for the quality performance category—(i) QCDR measure self-nomination requirements. For the CY 2018 performance period/2020 MIPS payment year and future years, at the time of self-nomination an entity seeking to become a QCDR must submit the following information for any measure it intends to submit for the payment year.
(iii) QCDR measure approval criteria.
(A) QCDR measure requirements for approval are:
(1) QCDR measures that are beyond the measure concept phase of development.
(2) QCDR measures that address significant variation in performance.
(3) Beginning with the CY 2022 performance period/2024 MIPS payment year, CMS may approve a QCDR measure only if the QCDR measure meets face validity. Beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR measure approved for a previous performance year must be fully developed and tested, with complete testing results at the clinician level, prior to self-nomination.
(4) Beginning with the CY 2022 performance period/2023 MIPS payment year, QCDRs are required to collect data on a QCDR measure, appropriate to the measure type, prior to submitting the QCDR measure for CMS consideration during the self-nomination period.
(5) Beginning with the CY 2020 performance period/2022 MIPS payment year, CMS may provisionally approve the individual QCDR measures for 1 year with the condition that QCDRs address certain areas of duplication with other approved QCDR measures or MIPS quality measures in order to be considered for the program in subsequent years. If such areas of duplication are not addressed, CMS may reject the duplicative QCDR measure.
(B) QCDR measure considerations for approval include, but are not limited to:
(1) Measures that are outcome-based rather than clinical process measures.
(2) Measures that address patient safety and adverse events.
(3) Measures that identify appropriate use of diagnosis and therapeutics.
(4) Measures that address the domain of care coordination.
(5) Measures that address the domain for patient and caregiver experience.
(6) Measures that address efficiency, cost, and resource use.
(7) Beginning with the CY 2021 performance period/2023 MIPS payment year -
(i) That QCDRs link their QCDR measures as feasible to at least one cost measure, improvement activity, or an MVP at the time of self-nomination.
(ii) In cases where a QCDR measure does not have a clear link to a cost measure, improvement activity, or an MVP, CMS would consider exceptions if the potential QCDR measure otherwise meets the QCDR measure requirements and considerations.
(8) Beginning with the CY 2020 performance period/2022 MIPS payment year CMS may consider the extent to which a QCDR measure is available to MIPS eligible clinicians reporting through QCDRs other than the QCDR measure owner for purposes of MIPS. If CMS determines that a QCDR measure is not available to MIPS eligible clinicians, groups, and virtual groups reporting through other QCDRs, CMS may not approve the measure.
(9) Greater consideration is given to measures for which QCDRs:
(i) Conducted an environmental scan of existing QCDR measures; MIPS quality measures; quality measures retired from the legacy Physician Quality Reporting System (PQRS) program; and
(ii) Utilized the CMS Quality Measure Development Plan Annual Report and the Blueprint in the CMS Measures Management System to identify measurement gaps prior to measure development.
(10) Beginning with the CY 2020 performance period/2022 MIPS payment year, CMS places greater preference on QCDR measures that meet case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive CY performance periods. Those that do not, may not continue to be approved.
(i) Beginning with the CY 2020 performance period/2022 MIPS payment year, in instances where a QCDR believes the low-reported QCDR measure that did not meet benchmarking thresholds is still important and relevant to a specialist's practice, that the QCDR may develop and submit a QCDR measure participation plan for our consideration. This QCDR measure participation plan must include the QCDR's detailed plans and changes to encourage eligible clinicians and groups to submit data on the low-reported QCDR measure for purposes of the MIPS program.
(ii) [Reserved]
(iv) QCDR measure rejection criteria. Beginning with the CY 2020 performance period/2022 MIPS payment year, QCDR measure rejection considerations include, but are not limited to:
(c) Additional requirements for Health IT vendors.
(1) Beginning with the CY 2021 performance period/2023 MIPS payment year, health IT vendors must be able to submit data for the MIPS performance categories as follows:
(i) Health IT vendors that support MVPs must be able to submit data for all of the MIPS performance categories:
(A) Quality, except:
(1) The CAHPS for MIPS survey; and
(2) QCDR measures;
(C) Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless:
(1) The third party intermediary's MIPS eligible clinicians, groups, virtual groups, or subgroups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)(4)(i) through (iii) or (c)(2)(i)(C)(1) through (7) or (c)(2)(i)(C)(9).
(2) [Reserved]
(d) Additional requirements for CMS-approved survey vendors.
(3) The entity must have sufficient experience, capability, and capacity to accurately report CAHPS data, including all of the following:
(iv) Experience administering surveys in English and at least one other language for which a translation of the CAHPS for MIPS survey is available;
(v) Use equipment, software, computer programs, systems, and facilities that can verify addresses and phone numbers of sampled beneficiaries, monitor interviewers, collect data via CATI, electronically administer the survey and schedule call-backs to beneficiaries at varying times of the day and week, track fielded surveys, assign final disposition codes to reflect the outcome of data collection of each sampled case, and track cases from mail surveys through telephone follow-up activities; and
(vi) Employment of a program manager, information systems specialist, call center supervisor and mail center supervisor to administer the survey.
(e) Remedial action and termination of third party intermediaries.
(1) If CMS determines that a third party intermediary has ceased to meet one or more of the applicable criteria for approval, failed to comply with the program requirements of this section, has submitted a false certification under paragraph (a)(3) of this section, or has submitted data that are inaccurate, unusable, or otherwise compromised, CMS may take one or more of the following remedial actions after providing written notice to the third party intermediary:
(i) Require the third party intermediary to submit a corrective action plan (CAP) by a date specified by CMS. The CAP must address the following issues, unless different or additional information is specified by CMS:
(ii) Publicly disclose as follows:
(2) CMS may immediately or with advance notice terminate a third party intermediary for one or more of the following reasons:
[86 FR 65677, Nov. 19, 2021, as amended at 87 FR 70229, Nov. 18, 2022; 88 FR 79536, Nov. 16, 2023; 90 FR 50011, Nov. 5, 2025]