Title 42—Public Health--Volume 1
PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
§ 414.1380   Scoring.
(a) General. MIPS eligible clinicians are scored under MIPS based on their performance on measures and activities in four performance categories. MIPS eligible clinicians are scored against performance standards for each performance category and receive a final score, composed of their performance category scores, and calculated according to the final score methodology.
(1) Performance standards. (i) For the quality performance category, measures are scored between zero and 10 measure achievement points. Performance is measured against benchmarks. Prior to the CY 2023 performance period/2025 MIPS payment year, measure bonus points are available for submitting high-priority measures and submitting measures using end-to-end electronic reporting. Measure bonus points are available for small practices that submit data on at least 1 quality measure. Beginning with the 2020 MIPS payment year, improvement scoring is available in the quality performance category.
(ii) For the cost performance category, measures are scored between 1 and 10 points. Performance is measured against a benchmark. Beginning with the 2025 MIPS payment year, improvement scoring is available in the cost performance category.
(iii) For the improvement activities performance category, each improvement activity is assigned a certain number of points. The points for all submitted activities are summed and scored against a total potential performance category score of 40 points.
(iv) For the Promoting Interoperability performance category, each measure is scored against a maximum number of points. The points for all submitted measures are summed and scored against a total potential performance category score of 100 points.
(2) [Reserved]
(b) Performance categories. MIPS eligible clinicians are scored under MIPS in four performance categories.
(1) Quality performance category —(i) Measure achievement points. For the CY 2017 through 2022 performance periods/2019 through 2024 MIPS payment years, MIPS eligible clinicians receive between 3 and 10 measure achievement points (including partial points) for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340 and for each administrative claims-based measure that has a benchmark at paragraph (b)(1)(ii) of this section and meets the case minimum requirement at paragraph (b)(1)(iii) of this section. Except as provided under paragraph (b)(1)(i)(C) of this section, beginning with the CY 2023 performance period/2025 MIPS payment year, MIPS eligible clinicians receive between 1 and 10 measure achievement points (including partial points) for each such measure. The number of measure achievement points received for each such measure is determined based on the applicable benchmark decile category and the percentile distribution. MIPS eligible clinicians receive zero measure achievement points for each measure required under § 414.1335 on which no data is submitted in accordance with § 414.1325. MIPS eligible clinicians that submit data in accordance with § 414.1325 on a greater number of measures than required under § 414.1335 are scored only on the required measures with the greatest number of measure achievement points. Beginning with the CY 2019 performance period/2021 MIPS payment year, MIPS eligible clinicians that submit data in accordance with § 414.1325 on a single measure via multiple collection types are scored only on the data submission with the greatest number of measure achievement points.
(A) Lack of benchmark or case minimum.
( 1 ) Except as provided in paragraphs (b)(1)(i)(A)( 2 ) and ( 3 ) of this section, for the CY 2017 through 2022 performance periods/2019 through 2024 MIPS payment years, MIPS eligible clinicians receive 3 measure achievement points for each submitted measure that meets the data completeness requirement, but does not have a benchmark or meet the case minimum requirement. Beginning with the CY 2023 performance period/2025 MIPS payment year, MIPS eligible clinicians other than small practices receive 0 measure achievement points for each such measure, and small practices receive 3 measure achievement points for each such measure.
( 2 ) The following measures are excluded from a MIPS eligible clinician's total measure achievement points and total available measure achievement points:
( i ) Each submitted CMS Web Interface-based measure that meets the data completeness requirement, but does not have a benchmark or meet the case minimum requirement, or is redesignated as pay-for-reporting for all Shared Savings Program accountable care organizations by the Shared Savings Program; and
( ii ) Each administrative claims-based measure that does not have a benchmark or meet the case minimum requirement.
( 3 ) Beginning with the CY 2022 performance period/2024 MIPS payment year, MIPS eligible clinicians receive 7 measure achievement points for each submitted measure in its first year in MIPS and 5 measure achievement points for each submitted measure in its second year in MIPS that meets the data completeness requirement, but does not have a benchmark or meet the case minimum requirement.
(B) Lack of complete data. ( 1 ) Except as provided in paragraph (b)(1)(i)(B)( 2 ) of this section, for each submitted measure that does not meet the data completeness requirement:
( i ) For the 2019 MIPS payment year, MIPS eligible clinicians receive 3 measure achievement points;
( ii ) For the 2020 and 2021 MIPS payment years, MIPS eligible clinicians other than small practices receive 1 measure achievement point, and small practices receive 3 measure achievement points; and
( iii ) Beginning with the 2022 MIPS payment year, MIPS eligible clinicians other than small practices receive zero measure achievement points, and small practices receive 3 measure achievement points.
( 2 ) MIPS eligible clinicians receive zero measure achievement points for each submitted CMS Web Interface-based measure that does not meet the data completeness requirement.
(C) New measures. Beginning with the CY 2022 performance period/2024 MIPS payment year, for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340, a MIPS eligible clinician receives between 7 and 10 measure achievement points (including partial points) for each such measure in its first year in MIPS and between 5 and 10 measure achievement points for each such measure in its second year in MIPS.
(ii) Benchmarks. Except as provided in paragraphs (b)(1)(ii)(B) through (F) of this section, benchmarks will be based on performance by collection type, from all available sources, including MIPS eligible clinicians and APMs, to the extent feasible, during the applicable baseline or performance period.
(A) Each benchmark must have a minimum of 20 individual clinicians or groups who reported the measure meeting the case minimum requirement at paragraph (b)(1)(iii) of this section and the data completeness requirement at § 414.1340 and having a performance rate that is greater than zero.
(B) CMS Web Interface collection type uses benchmarks from the corresponding reporting year of the Shared Savings Program.
(C) Beginning with the 2022 MIPS payment year, for each measure that has a benchmark that CMS determines may have the potential to result in inappropriate treatment, CMS will set benchmarks using a flat percentage for all collection types where the top decile is higher than 90 percent under the methodology at paragraph (b)(1)(ii) of this section.
(D) Beginning with the CY 2023 performance period/2025 MIPS payment year, CMS will calculate a benchmark for an administrative claims quality measure using the performance on the measures during the current performance period.
(E) Beginning with the CY 2025 performance period/2027 MIPS payment year, CMS will publish a list in the Federal Register of topped out measures determined to be impacted by limited measure choice on a yearly basis. Measures included in the list are scored from 1 to 10 measure achievement points according to defined topped out measure benchmarks calculated from performance data in the baseline period in which a performance rate of 97 percent corresponds to 10 percent of the performance threshold for the corresponding performance year.
(F) Beginning in the CY 2025 performance period/2027 MIPS payment year, measures of the Medicare CQM collection type use flat benchmarks for their first two performance periods in MIPS.
(iii) Minimum case requirements. Except as otherwise specified in the MIPS final list of quality measures described in § 414.1330(a)(1), the minimum case requirement is 20 cases.
(iv) Topped out measures. CMS will identify topped out measures in the benchmarks published for each Quality Payment Program year.
(A) For the 2020 MIPS payment year, each topped out measure specified by CMS through rulemaking receives no more than 7 measure achievement points, provided that the benchmark for the applicable collection type is identified as topped out in the benchmarks published for the 2018 MIPS performance period.
(B) Beginning with the 2021 MIPS payment year, except as provided for in paragraph (b)(1)(iv)(C) of this section, each measure (except for measures in the CMS Web Interface) for which the benchmark for the applicable collection type is identified as topped out for 2 or more consecutive years receives no more than 7 measure achievement points in the second consecutive year it is identified as topped out, and beyond.
(C) Beginning with the CY 2025 performance period/2027 MIPS payment year, measures impacted by limited measure choice as specified in paragraph (b)(1)(ii)(E) of this section are not subject to the 7 measure achievement point cap specified in paragraph (b)(1)(iv)(B) of this section.
(v) Measure bonus points. MIPS eligible clinicians receive measure bonus points for the following measures, except as otherwise required under § 414.1335, regardless of whether the measure is included in the MIPS eligible clinician's total measure achievement points.
(A) High priority measures. Subject to paragraph (b)(1)(v)(A)( 1 ) of this section, for the CY 2017 through 2021 MIPS performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 2 measure bonus points for each outcome and patient experience measure and 1 measure bonus point for each other high priority measure. Beginning in the 2021 MIPS payment year, MIPS eligible clinicians do not receive such measure bonus points for CMS Web Interface measures. Beginning in the 2022 performance period/2024 MIPS payment year, MIPS eligible clinicians will no longer receive these measure bonus points.
(B) End-to-end electronic reporting. Subject to paragraph (b)(1)(v)(B)( 1 ) of this section, for the CY 2017 through 2021 MIPS performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 1 measure bonus point for each measure (except claims-based measures) submitted with end-to-end electronic reporting for a quality measure under certain criteria determined by the Secretary.
( 1 ) Limitations. ( i ) For the 2019 through 2023 MIPS payment years, the total measure bonus points for measures submitted with end-to-end electronic reporting cannot exceed 10 percent of the total available measure achievement points.
( ii ) Beginning with the 2021 MIPS payment year, MIPS eligible clinicians that collect data in accordance with § 414.1325 on a single measure via multiple collection types receive measure bonus points only once.
( iii ) Beginning in the 2024 MIPS payment year, MIPS eligible clinicians will no longer receive measure bonus for submitting using end-to-end electronic reporting.
(C) Small practices. Beginning with the 2021 MIPS payment year, MIPS eligible clinicians in small practices receive 6 measure bonus points if they submit data to MIPS on at least 1 quality measure.
(vi) Improvement scoring. Improvement scoring is available to MIPS eligible clinicians that demonstrate improvement in performance in the current MIPS performance period compared to performance in the performance period immediately prior to the current MIPS performance period based on measure achievement points.
(A) Improvement scoring is available when the data sufficiency standard is met, which means when data are available and a MIPS eligible clinician has a quality performance category achievement percent score for the previous performance period and the current performance period.
( 1 ) Data must be comparable to meet the requirement of data sufficiency which means that the quality performance category achievement percent score is available for the current performance period and the previous performance period and quality performance category achievement percent scores can be compared.
( 2 ) Quality performance category achievement percent scores are comparable when submissions are received from the same identifier for two consecutive performance periods.
( 3 ) If the identifier is not the same for 2 consecutive performance periods, then for individual submissions, the comparable quality performance category achievement percent score is the highest available quality performance category achievement percent score associated with the final score from the prior performance period that will be used for payment for the individual. For group, virtual group, and APM Entity submissions, the comparable quality performance category achievement percent score is the average of the quality performance category achievement percent score associated with the final score from the prior performance period that will be used for payment for each of the individuals in the group.
( 4 ) Improvement scoring is not available for clinicians who were scored under facility-based measurement in the performance period immediately prior to the current MIPS performance period.
(B) The improvement percent score may not total more than 10 percentage points.
(C) The improvement percent score is assessed at the performance category level for the quality performance category and included in the calculation of the quality performance category score as described in paragraph (b)(1)(vii) of this section.
( 1 ) The improvement percent score is awarded based on the rate of increase in the quality performance category achievement percent score of MIPS eligible clinicians from the previous performance period to the current performance period.
( 2 ) An improvement percent score is calculated by dividing the increase in the quality performance category achievement percent score from the prior performance period to the current performance period by the prior performance period quality performance category achievement percent score multiplied by 10 percent.
( 3 ) An improvement percent score cannot be lower than zero percentage points.
( 4 ) Beginning with the CY 2018 performance period/2020 MIPS payment year, we will assume a quality performance category achievement percent score of 30 percent if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year.
( 5 ) The improvement percent score is zero if the MIPS eligible clinician did not fully participate in the quality performance category for the current performance period.
(D) For the purpose of improvement scoring methodology, the term “quality performance category achievement percent score” means the total measure achievement points divided by the total available measure achievement points, without consideration of measure bonus points or improvement percent score.
(E) For the purpose of improvement scoring methodology, the term “improvement percent score” means the score that represents improvement for the purposes of calculating the quality performance category score as described in paragraph (b)(1)(vii) of this section.
(F) For the purpose of improvement scoring methodology, the term “fully participate” means the MIPS eligible clinician met all requirements in §§ 414.1335 and 414.1340.
(vii) Quality performance category score. A MIPS eligible clinician's quality performance category score is the sum of all the measure achievement points assigned for the measures required for the quality performance category criteria plus the measure bonus points in paragraph (b)(1)(v) of this section and Complex Organization Adjustment in paragraph (b)(1)(vii)(C) of this section. The sum is divided by the sum of total available measure achievement points. The improvement percent score in paragraph (b)(1)(vi) of this section is added to that result. The quality performance category score cannot exceed 100 percentage points.
(A) For each measure that is submitted, if applicable, and impacted by significant changes or errors prior to the applicable data submission deadline at § 414.1325(e), performance is based on data for 9 consecutive months of the applicable CY performance period. If such data are not available or CMS determines that they may result in patient harm or misleading results, the measure is excluded from a MIPS eligible clinician's total measure achievement points and total available measure achievement points. For purposes of this paragraph (b)(1)(vii)(A), “significant changes or errors” means changes to or errors in a measure that are outside the control of the clinician and its agents and that CMS determines may result in patient harm or misleading results. Significant changes or errors include, but are not limited to, changes to codes (such as ICD-10, CPT, or HCPCS codes) or the active status of codes, the inadvertent omission of codes or inclusion of inactive or inaccurate codes, or changes to clinical guidelines or measure specifications. CMS will publish on the CMS website a list of all measures scored under this paragraph (b)(1)(vii)(A) as soon as technically feasible, but by no later than the data submission deadline at § 414.1325(e)(1).
(B) Beginning with the 2021 MIPS payment year, for groups that submit 5 or fewer measures and register for the CAHPS for MIPS survey but do not meet the minimum beneficiary sampling requirements, the total available measure achievement points are reduced by 10 points.
(C) Beginning in the CY 2025 performance period/2027 MIPS payment year, a Virtual Group and an APM Entity receives one measure achievement point for each eCQM submitted that meets the case minimum requirement at paragraph (b)(1)(iii) of this section and the data completeness requirement at § 414.1340. Each measure may not exceed 10 measure achievement points. The total adjustment to the Virtual Group or APM Entity's quality performance category score under this paragraph (b)(1)(vii)(C) may not exceed 10 percent of the total available measure achievement points.
(2) Cost performance category. For each cost measure attributed to a MIPS eligible clinician, the clinician receives one to ten achievement points based on the clinician's performance on the measure during the performance period compared to the measure's benchmark. Achievement points are awarded based on which benchmark range the MIPS eligible clinician's performance on the measure is in. CMS assigns partial points based on where the MIPS eligible clinician's performance falls between the top and bottom of the benchmark ranges.
(i) Cost measure benchmarks are determined by CMS based on cost measure performance during the performance period. At least 20 MIPS eligible clinicians or groups must meet the minimum case volume specified under § 414.1350(c) for a cost measure in order for a benchmark to be determined for the measure. If a benchmark is not determined for a cost measure, the measure will not be scored.
(A) For the 2019 through 2025 MIPS payment years, CMS determines cost measure benchmark ranges based on linear percentile distributions.
(B) Beginning with the 2026 MIPS payment year, for each cost measure, CMS determines 10 benchmark ranges based on the median cost of all MIPS eligible clinicians attributed the measure, plus or minus standard deviations. CMS awards achievement points based on which benchmark range a MIPS eligible clinician's average cost for a cost measure corresponds. Additionally, CMS awards achievement points equivalent to 10 percent of the performance threshold for a MIPS eligible clinician whose average cost attributed under a cost measure is equal to the median cost for all MIPS eligible clinicians attributed the measure.
(ii) A MIPS eligible clinician must meet the minimum case volume specified under § 414.1350(c) to be scored on a cost measure.
(iii) The cost performance category score is the sum of the following, not to exceed 100 percent:
(A) The total number of achievement points earned by the MIPS eligible clinician divided by the total number of available achievement points; and
(B) The cost improvement score, as determined under paragraph (b)(2)(iv) of this section.
(iv) The cost improvement score is determined for a MIPS eligible clinician that demonstrates improvement in performance in the current MIPS performance period compared to their performance in the immediately preceding MIPS performance period.
(A) The cost improvement score is determined at the category level for the cost performance category.
(B) The cost improvement score is calculated only when data sufficient to measure improvement are available. Sufficient data are available when a MIPS eligible clinician or group participates in MIPS using the same identifier in 2 consecutive performance periods and is scored on the cost performance category for 2 consecutive performance periods. If the cost improvement score cannot be calculated because sufficient data are not available, then the cost improvement score is zero.
(C) The cost improvement score is determined at the category-level by subtracting the cost performance category score from the previous performance period from the cost performance category score from the current performance period, then by dividing the difference by the cost performance category score from the previous performance period, and multiplying the result with the maximum available cost improvement score.
(D) The cost improvement score cannot be lower than zero percentage points.
(E) The maximum cost improvement score for the 2020, 2021, 2022, 2023, and 2024 MIPS payment year is zero percentage points. The maximum cost improvement score beginning with the 2025 MIPS payment year is 1 percentage point.
(v) A cost performance category score is not calculated if a MIPS eligible clinician or group is not attributed any cost measures for the performance period because the clinician or group has not met the minimum case volume specified by CMS for any of the cost measures or a benchmark has not been created for any of the cost measures that would otherwise be attributed to the clinician or group.
(A) Beginning with the 2024 MIPS payment year, if data used to calculate a score for a cost measure are impacted by significant changes during the performance period, such that calculating the cost measure score would lead to misleading or inaccurate results, then the affected cost measure is excluded from the MIPS eligible clinician's or group's cost performance category score. For purposes of this paragraph (b)(2)(v)(A), “significant changes” are changes external to the care provided, and that CMS determines may lead to misleading or inaccurate results. Significant changes include, but are not limited to, rapid or unprecedented changes to service utilization, and will be empirically assessed by CMS to determine the extent to which the changes impact the calculation of a cost measure score that reflects clinician performance.
(B) Beginning with the 2026 MIPS payment year, if data used to calculate a score for a cost measure are impacted by significant changes or errors affecting the performance period, such that calculating the cost measure score would lead to misleading or inaccurate results, then the affected cost measure is excluded from the MIPS eligible clinician's or group's cost performance category score. For purposes of this paragraph (b)(2)(v)(B), “significant changes or errors” are changes or errors external to the care provided, and that CMS determines may lead to misleading or inaccurate results that negatively impact the measure's ability to reliably assess performance. Significant changes or errors include, but are not limited to, rapid or unprecedented changes to service utilization, the inadvertent omission of codes or inclusion of codes, or changes to clinical guidelines or measure specifications. CMS will empirically assess the affected cost measure to determine the extent to which the changes or errors impact the calculation of a cost measure score such that calculating the cost measure score would lead to misleading or inaccurate results that negatively impact the measure's ability to reliably assess performance.
(3) Improvement activities performance category. Subject to paragraphs (b)(3)(i) and (ii) of this section, the improvement activities performance category score equals the total points for all submitted improvement activities divided by 40 points, multiplied by 100 percent. In the CY 2023 through 2024 performance periods/2025 through 2026 MIPS payment years, MIPS eligible clinicians (except for non-patient facing MIPS eligible clinicians, small practices, and practices located in rural areas and geographic HPSAs) receive 10 points for each medium-weighted improvement activity and 20 points for each high-weighted improvement activity required under § 414.1360 on which data is submitted in accordance with § 414.1325. Non-patient facing MIPS eligible clinicians, small practices, and practices located in rural areas and geographic HPSAs receive 20 points for each medium-weighted improvement activity and 40 points for each high-weighted improvement activity required under § 414.1360 on which data is submitted in accordance with § 414.1325. Beginning in the CY 2025 performance period/2027 MIPS payment year, MIPS eligible clinicians (except for non-patient facing MIPS eligible clinicians, small practices, and practices located in rural areas and geographic HPSAs) receive 20 points for each improvement activity required under § 414.1360 on which data is submitted in accordance with § 414.1325. Non-patient facing MIPS eligible clinicians, small practices, and practices located in rural areas and geographic HPSAs receive 40 points for each improvement activity required under § 414.1360 on which data is submitted in accordance with § 414.1325.
(i) For MIPS eligible clinicians participating in APMs, the improvement activities performance category score is at least 50 percent. MIPS eligible clinicians participating in APMs must attest to having completed an improvement activity or submit data for the quality and Promoting Interoperability performance categories in order to receive such credit.
(ii) For MIPS eligible clinicians in a practice that is certified or recognized as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, the improvement activities performance category score is 100 percent. For the 2019 MIPS payment year, at least one practice site within a group's TIN must be certified or recognized as a patient-centered medical home or comparable specialty practice. For the 2020 MIPS payment year and future years, at least 50 percent of the practice sites within a group's TIN must be recognized as a patient-centered medical home or comparable specialty practice. MIPS eligible clinicians that wish to claim this status for purposes of receiving full credit in the improvement activities performance category must attest to their status as a patient-centered medical home or comparable specialty practice in order to receive this credit. A practice is certified or recognized as a patient-centered medical home if it meets any of the following criteria:
(A) The practice has received accreditation from an accreditation organization that is nationally recognized.
(B) The practice is participating in a Medicaid Medical Home Model or Medical Home Model.
(C) The practice is a comparable specialty practice that has received recognition through a specialty recognition program offered through a nationally recognized accreditation organization; or
(D) The practice has received accreditation from other certifying bodies that have certified a large number of medical organizations and meet national guidelines, as determined by the Secretary. The Secretary must determine that these certifying bodies must have 500 or more certified member practices, and require practices to include the following:
( 1 ) Have a personal physician/clinician in a team-based practice.
( 2 ) Have a whole-person orientation.
( 3 ) Provide coordination or integrated care.
( 4 ) Focus on quality and safety.
( 5 ) Provide enhanced access.
(4) Promoting Interoperability performance category. (i) For the 2019 and 2020 MIPS payment years, a MIPS eligible clinician's Promoting Interoperability performance category score equals the sum of the base score, performance score, and any applicable bonus scores, not to exceed 100 percentage points. A MIPS eligible clinician cannot earn a performance score or bonus score unless they have earned a base score.
(A) A MIPS eligible clinician earns a base score by reporting for each base score measure, as applicable: The numerator (of at least one) and denominator, or a yes/no statement, or an exclusion.
(B) A MIPS eligible clinician earns a performance score by reporting on the performance score measures specified by CMS. A MIPS eligible clinician may earn up to 10 or 20 percentage points as specified by CMS for each performance score measure reported.
(C) A MIPS eligible clinician may earn the following bonus scores:
( 1 ) A bonus score of 5 percentage points for reporting to one or more additional public health agencies or clinical data registries.
( 2 ) A bonus score of 10 percentage points for attesting to completing one or more improvement activities specified by CMS using CEHRT.
( 3 ) For the 2020 MIPS payment year, a bonus score of 10 percentage points for submitting data for the measures for the base score and the performance score generated solely from CEHRT as defined in § 414.1305 for 2019 and subsequent years.
(ii) Beginning with the 2019 performance period/2021 MIPS payment year, a MIPS eligible clinician's Promoting Interoperability performance category score equals the sum of the scores for each of the required measures and any applicable bonus scores, not to exceed 100 points.
(A) A MIPS eligible clinician earns a score for each measure by reporting, as applicable: the numerator (of at least one) and denominator, or a yes/no statement. If an exclusion is reported for a measure, the points available for that measure are redistributed to another measure(s).
(B) For the 2019 performance period/2021 MIPS payment year through the 2022 performance period/2024 MIPS payment year, each required measure is worth 10, 20, or 40 points, as specified by CMS. For the 2023 performance period/2025 MIPS payment year and subsequent years, each required measure is worth 10, 15, 25 or 30 points, as specified by CMS.
(C) For the 2019 performance period/2021 MIPS payment year through the 2022 performance period/2024 MIPS payment year, each optional measure is worth five or ten bonus points, as specified by CMS. For the 2023 performance period/2025 MIPS payment year and subsequent years, each optional measure is worth five bonus points, as specified by CMS.
(c) Final score calculation. Each MIPS eligible clinician receives a final score of 0 to 100 points for a performance period for a MIPS payment year calculated as follows. If a MIPS eligible clinician is scored on fewer than 2 performance categories, he or she receives a final score equal to the performance threshold.
Table 1 to Paragraph ( c ) Introductory Text
(1) Performance category weights. The weights of the performance categories in the final score are as follows, unless a different scoring weight is assigned under paragraph (c)(2) of this section:
(i) Quality performance category weight is defined under § 414.1330(b).
(ii) Cost performance category weight is defined under § 414.1350(d).
(iii) Improvement activities performance category weight is defined under § 414.1355(b).
(iv) Promoting Interoperability performance category weight is defined under § 414.1375(a).
(2) Reweighting the performance categories. (i) In accordance with paragraph (c)(2)(ii) of this section, a scoring weight different from the weights specified in paragraph (c)(1) of this section will be assigned to a performance category, and its weight as specified in paragraph (c)(1) of this section will be redistributed to another performance category or categories, in the following circumstances:
(A) CMS determines based on the following circumstances that there are not sufficient measures and activities applicable and available under section 1848(q)(5)(F) of the Act.
( 1 ) For the quality performance category, CMS cannot calculate a score for the MIPS eligible clinician because there is not at least one quality measure applicable and available to the clinician.
( 2 ) For the cost performance category, CMS cannot reliably calculate a score for the cost measures that adequately captures and reflects the performance of the MIPS eligible clinician.
( 3 ) Beginning with the 2021 MIPS payment year, for the quality, cost, improvement activities, and Promoting Interoperability performance categories, the MIPS eligible clinician joins an existing practice during the final 3 months of the performance period year that is not participating in MIPS as a group or joins a practice that is newly formed during the final 3 months of the performance period year.
( 4 ) For the Promoting Interoperability performance category:
( i ) For the 2021 through 2025 MIPS payment years, the MIPS eligible clinician is a physical therapist, occupational therapist, clinical psychologist, qualified audiologist, qualified speech-language pathologist, or a registered dietitian or nutrition professional. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.
( ii ) For the 2019 through 2024 MIPS payment years, the MIPS eligible clinician is a nurse practitioner, physician assistant, clinical nurse specialist, or certified registered nurse anesthetist. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.
( iii ) For the 2024 through 2026 MIPS payment years, the MIPS eligible clinician is a clinical social worker. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be distributed.
( 5 ) [Reserved]
( 6 ) Beginning with the 2020 MIPS payment year, for the quality, cost, and improvement activities performance categories, the MIPS eligible clinician demonstrates through an application submitted to CMS that they were subject to extreme and uncontrollable circumstances that prevented the clinician from collecting information that the clinician would submit for a performance category or submitting information that would be used to score a performance category for an extended period of time. Beginning with the 2021 MIPS payment year, in the event that a MIPS eligible clinician submits data for the quality, cost, or improvement activities performance categories, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed, unless an exception applies. Exception: for the 2021 MIPS payment year only, if a MIPS eligible clinician demonstrates through an application submitted to CMS that they have been adversely affected by the Public Health Emergency for the COVID-19 pandemic and also submits data for the quality, cost, or improvement activities performance categories, the preceding sentence will not apply.
( 7 ) For the 2019 MIPS payment year, for the quality and improvement activities performance categories, the MIPS eligible clinician was located in an area affected by extreme and uncontrollable circumstances as identified by CMS. In the event that a MIPS eligible clinician submits data for a performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.
( 8 ) Beginning with the 2020 MIPS payment year, for the quality, cost, and improvement activities performance categories, the MIPS eligible clinician was located in an area affected by extreme and uncontrollable circumstances as identified by CMS. In the event that a MIPS eligible clinician submits data for the quality or improvement activities performance categories, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.
( 9 ) Beginning with the 2020 MIPS payment year, for the quality, cost, and improvement activities performance categories, CMS determines, based on information known to the agency prior to the beginning of the relevant MIPS payment year, that data for a MIPS eligible clinician are inaccurate, unusable or otherwise compromised due to circumstances outside of the control of the clinician and its agents.
( 10 ) Beginning with the 2026 MIPS payment year, for the quality and improvement activities performance categories, CMS determines, based on documentation provided to the agency on or before November 1st of the year preceding the relevant MIPS payment year, that data for a MIPS eligible clinician are inaccessible or unable to be submitted due to circumstances outside of the control of the clinician because the MIPS eligible clinician delegated submission of the data to their third party intermediary, evidenced by a written agreement between the MIPS eligible clinician and third party intermediary, and the third party intermediary did not submit the data for the performance category(ies) on behalf of the MIPS eligible clinician in accordance with applicable deadlines. To determine whether to apply reweighting to the affected performance category(ies), CMS will consider: whether the MIPS eligible clinician knew or had reason to know of the issue with its third party intermediary's submission of the clinician's data for the performance category(ies); whether the MIPS eligible clinician took reasonable efforts to correct the issue; and whether the issue between the MIPS eligible clinician and their third party intermediary caused no data to be submitted for the performance category(ies) in accordance with applicable deadlines.
(B) Under section 1848(q)(5)(E)(ii) of the Act, CMS estimates that the proportion of MIPS eligible clinicians who are physicians as defined in section 1861(r) of the Act and earn a Promoting Interoperability performance category score of at least 75 percent is 75 percent or greater. The estimation is based on data from the performance period that occurs four years before the MIPS payment year and does not include physicians for whom the Promoting Interoperability performance category is weighted at zero percent.
(C) Under section 1848(o)(2)(D) of the Act, a significant hardship exception or other type of exception is granted to a MIPS eligible clinician based on the following circumstances for the Promoting Interoperability performance category. Except as provided in paragraphs (c)(2)(i)(C)( 10 ) and ( 11 ) of this section, in the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.
( 1 ) The MIPS eligible clinician demonstrates through an application submitted to CMS that they lacked sufficient internet access during the performance period, and insurmountable barriers prevented the clinician from obtaining sufficient internet access.
( 2 ) The MIPS eligible clinician demonstrates through an application submitted to CMS that they were subject to extreme and uncontrollable circumstances that caused their CEHRT to be unavailable.
( 3 ) The MIPS eligible clinician was located in an area affected by extreme and uncontrollable circumstances as identified by CMS.
( 4 ) The MIPS eligible clinician demonstrates through an application submitted to CMS that 50 percent or more of their outpatient encounters occurred in practice locations where they had no control over the availability of CEHRT.
( 5 ) The MIPS eligible clinician is a non-patient facing MIPS eligible clinician as defined in § 414.1305.
( 6 ) The MIPS eligible clinician is a hospital-based MIPS eligible clinician as defined in § 414.1305.
( 7 ) The MIPS eligible clinician is an ASC-based MIPS eligible clinician as defined in § 414.1305.
( 8 ) Beginning with the 2020 MIPS payment year, the MIPS eligible clinician demonstrates through an application submitted to CMS that their CEHRT was decertified either during the performance period for the MIPS payment year or during the calendar year preceding the performance period for the MIPS payment year, and the MIPS eligible clinician made a good faith effort to adopt and implement another CEHRT in advance of the performance period. In no case may a MIPS eligible clinician be granted this exception for more than 5 years.
( 9 ) For the 2020 MIPS payment year through the 2023 MIPS payment year the MIPS eligible clinician demonstrates through an application submitted to CMS that they are in a small practice as defined in § 414.1305, and overwhelming barriers prevent them from complying with the requirements for the Promoting Interoperability performance category. Beginning with the 2024 MIPS payment year the MIPS eligible clinician is in a small practice as defined in § 414.1305.
( 10 ) Beginning with the 2020 MIPS payment year, CMS determines, based on information known to the agency prior to the beginning of the relevant MIPS payment year, that data for a MIPS eligible clinician are inaccurate, unusable or otherwise compromised due to circumstances outside of the control of the clinician and its agents.
( 11 ) For the 2021 MIPS payment year only, the MIPS eligible clinician demonstrates through an application submitted to CMS that they have been adversely affected by the Public Health Emergency for the COVID-19 pandemic.
( 12 ) Beginning with the 2026 MIPS payment year, CMS determines, based on documentation provided to the agency on or before November 1st of the year preceding the relevant MIPS payment year, that data for a MIPS eligible clinician are inaccessible or unable to be submitted due to circumstances outside of the control of the clinician because the MIPS eligible clinician delegated submission of the data to their third party intermediary, evidenced by a written agreement between the MIPS eligible clinician and third party intermediary, and the third party intermediary did not submit the data for the performance category on behalf of the MIPS eligible clinician in accordance with applicable deadlines. To determine whether to apply reweighting to the Promoting Interoperability performance category, CMS will consider: whether the MIPS eligible clinician knew or had reason to know of the issue with its third party intermediary's submission of the clinician's data for the performance category; whether the MIPS eligible clinician took reasonable efforts to correct the issue; and whether the issue between the MIPS eligible clinician and their third party intermediary caused no data to be submitted for the performance category in accordance with applicable deadlines.
(ii) A scoring weight different from the weights specified in paragraph (c)(1) of this section will be assigned to a performance category, and its weight as specified in paragraph (c)(1) of this section will be redistributed to another performance category or categories, as follows:
(A) For the 2019 MIPS payment year:
Table 2 to Paragraph (c)(2)(ii)(A)
(B) For the 2020 MIPS payment year:
(C) For the 2021 MIPS payment year:
(D) For the 2022 MIPS payment year:

(E) For the 2023 MIPS payment year:
Table 6 to Paragraph ( c )(2)( ii )(E)
(F) Except as provided in paragraph (c)(2)(ii)(G) of this section, beginning with the 2024 MIPS payment year:
Table 7 to Paragraph (c)(2)(ii)(F)
(G) For small practices beginning with the 2024 MIPS payment year:
Table 8 to Paragraph (c)(2)(ii)(G)
(iii) For the Promoting Interoperability performance category to be reweighted in accordance with paragraph (c)(2)(ii) of this section for a MIPS eligible clinician who elects to participate in MIPS as part of a group or virtual group, all of the MIPS eligible clinicians in the group or virtual group must qualify for reweighting based on the circumstances described in paragraph (c)(2)(i) of this section, or the group or virtual group must meet the definition of a hospital-based MIPS eligible clinician or a non-patient facing MIPS eligible clinician as defined in § 414.1305.
(iv) If CMS has granted an application for a hardship exception or any other type of exception to a MIPS eligible clinician under paragraph (c)(2)(i)(A)( 6 ) or (c)(2)(i)(C)( 2 ) of this section, or has identified a MIPS eligible clinician in a CMS-designated region as being affected by an automatic extreme and uncontrollable circumstances event under paragraph (c)(2)(i)(A)( 8 ) or (c)(2)(i)(C)( 3 ) of this section, CMS will not apply the improvement activities score described in paragraph (b)(3)(i) of this section to the MIPS eligible clinician's score.
(3) Complex patient bonus. For the CY 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, provided that a MIPS eligible clinician, group, virtual group or APM Entity submits data for at least one MIPS performance category for the applicable performance period for the MIPS payment year, a complex patient bonus will be added to the final score for the MIPS payment year, as stated in paragraphs (c)(3)(i) through (iv) of this section. For the CY 2022 MIPS performance period/CY 2024 MIPS payment year, provided that a MIPS eligible clinician, group, subgroup, virtual group or APM Entity submits data for at least one MIPS performance category for the applicable performance period for the MIPS payment year, a complex patient bonus will be added to the final score for the MIPS payment year, if applicable, as described in paragraphs (c)(3)(v) through (viii) of this section. Beginning with the CY 2023 MIPS performance period/CY 2025 MIPS payment year, provided that a MIPS eligible clinician, group, subgroup, virtual group or APM Entity submits data for at least one MIPS performance category for the applicable performance period for the MIPS payment year, or is a facility-based MIPS eligible clinician, a complex patient bonus will be added to the final score for the MIPS payment year, if applicable, as described in paragraphs (c)(3)(v) through (viii) of this section.
(i) For the CY 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, for MIPS eligible clinicians and groups, the complex patient bonus is calculated as follows: [The average HCC risk score assigned to beneficiaries (pursuant to the HCC risk adjustment model established by CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS eligible clinician or seen by clinicians in a group] + [the dual eligible ratio × 5].
(ii) For the CY 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, for APM Entities and virtual groups, the complex patient bonus is calculated as follows: [The beneficiary weighted average HCC risk score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation within the APM Entity or virtual group, respectively] + [the average dual eligible ratio for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM Entity or virtual group, respectively, × 5].
(iii) For the 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, the complex patient bonus cannot exceed 5.0 except as provided in paragraph (c)(3)(iv) of this section.
(iv) For the 2022 and 2023 MIPS payment years and associated performance periods, the complex patient bonus is calculated pursuant to paragraphs (c)(3)(i) and (ii) of this section, and the resulting numerical value is then multiplied by 2.0. The complex patient bonus cannot exceed 10.0.
(v) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, the complex patient bonus is limited to MIPS eligible clinicians, groups, APM Entities and virtual groups; with a risk indicator at or above the risk indicator calculated median. To determine the median for the respective risk indicator (HCC and dual proportion), risk indicators associated with the final score assigned to a clinician from the most recent prior performance period, for all those who have submitted data for at least one MIPS performance category or are facility-based, are used.
(vi) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, for MIPS eligible clinicians and groups, the complex patient bonus components are calculated as follows for the specific risk indicators: Medical complex patient bonus component = 1.5 + 4 * associated HCC standardized score calculated with the average HCC risk score assigned to beneficiaries (pursuant to the HCC risk adjustment model established by CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS eligible clinician or seen by clinicians in a group or subgroup; social complex patient bonus component = 1.5 + 4 * associated dual proportion standardized score. The components are added together to calculate one overall complex patient bonus. A standardized score for each risk indicator is determined based on the mean and standard deviation of the raw risk indicator score and provides a standardized measurement of how far each risk score is from the mean: (raw risk indicator score−risk indicator mean)/risk indicator standard deviation.
(vii) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, for APM Entities and virtual groups, the complex patient bonus components are calculated as follows for the specific risk indicators: Medical complex patient bonus component = 1.5 + 4 * the beneficiary weighted average HCC risk standardized score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation within the APM Entity or virtual group, respectively; social complex patient bonus component = 1.5 + 4 * the average dual proportion standardized score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM Entity or virtual group, respectively. The components are added together to calculate one overall complex patient bonus. A standardized score for each risk indicator is determined based on the mean and standard deviation of the raw risk indicator score and provides a standardized measurement of how far each risk score is from the mean: (raw risk indicator score−risk indicator mean)/risk indicator standard deviation.
(viii) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, the complex patient bonus cannot exceed 10.0 and cannot be below 0.0.
(4) Small practice bonus. A small practice bonus of 5 points will be added to the final score for the 2020 MIPS payment year for MIPS eligible clinicians, groups, virtual groups, and APM Entities that meet the definition of a small practice as defined at § 414.1305 and participate in MIPS by submitting data on at least one performance category in the 2018 MIPS performance period.
(d) Scoring for APM Entities. MIPS eligible clinicians in APM Entities that are subject to the APM scoring standard are scored using the methodology under § 414.1370.
(e) Scoring for facility-based measurement. For the payment in 2021 MIPS payment year and subsequent years and subject to paragraph (e)(6)(vi) of this section, a MIPS eligible clinician or group will be scored under the quality and cost performance categories using the methodology described in this paragraph (e).
(1) General. The facility-based measurement scoring standard is the MIPS scoring methodology applicable for MIPS eligible clinicians identified as meeting the requirements in paragraph (e)(2) of this section.
(i) The measures used for facility-based measurement are the measure set finalized for the fiscal year value-based purchasing program for which payment begins during the applicable MIPS performance period.
(ii) Beginning with the 2021 MIPS payment year, the scoring methodology applicable for MIPS eligible clinicians scored with facility-based measurement is the Total Performance Score methodology adopted for the Hospital VBP Program, for the fiscal year for which payment begins during the applicable MIPS performance period.
(2) Eligibility for facility-based measurement. A MIPS eligible clinician is eligible for facility-based measurement for a MIPS payment year if CMS determines the MIPS eligible clinician to be facility-based as an individual clinician or as part of a group, or beginning with the 2023 performance period/2025 MIPS payment year, a virtual group, as follows:
(i) Facility-based individual determination. A MIPS eligible clinician is facility-based if the clinician meets all of the following criteria:
(A) Furnishes 75 percent or more of his or her covered professional services in sites of service identified by the place of service codes used in the HIPAA standard transaction as an inpatient hospital, on-campus outpatient hospital, or emergency room setting based on claims for a 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the performance period with a 30-day claims run out.
(B) Furnishes at least 1 covered professional service in sites of service identified by the place of service codes used in the HIPAA standard transaction as an inpatient hospital, or emergency room setting.
(C) Can be assigned, under the methodology specified in paragraph (e)(5) of this section, to a facility with a value-based purchasing score for the applicable period.
(ii) Facility-based MIPS eligible group determination. A facility-based MIPS eligible group is a group in which 75 percent or more of its eligible clinician NPIs billing under the group's TIN meet the requirements under paragraph (e)(2)(i) of this section.
(3) [Reserved]
(4) Data submission for facility-based measurement. There are no data submission requirements for a MIPS eligible individual clinician to be scored under facility-based measurement. A MIPS eligible group must submit data in the improvement activities or Promoting Interoperability performance categories in order to be scored as a facility-based MIPS eligible group.
(5) Determination of applicable facility score.
(i) A facility-based MIPS eligible clinician is scored with facility-based measurement using the score derived from the value-based purchasing score for the facility at which the clinician provided services to the most Medicare beneficiaries during the period the claims are drawn from in paragraph (e)(2) of this section. If there is an equal number of Medicare beneficiaries treated at more than one facility, the value-based purchasing score for the highest scoring facility is used.
(ii) A facility-based MIPS eligible group is scored with facility-based measurement using the score derived from the value-based purchasing score for the facility at which the plurality of clinicians identified as facility-based would have had their score determined under paragraph (e)(5)(i) of this section.
(6) MIPS performance category scoring under the facility-based measurement scoring standard —(i) Measures. The quality and cost measures are those adopted under the value-based purchasing program of the facility for the year described in paragraph (e)(1)(i) of this section.
(ii) Benchmarks. The benchmarks are those adopted under the value-based purchasing program of the facility program for the year described in paragraph (e)(1) of this section.
(iii) Performance period. The performance period for facility-based measurement is the performance period for the measures adopted under the value-based purchasing program of the facility program for the year described in paragraph (e)(1) of this section.
(iv) Quality. The quality performance category score is established by determining the percentile performance of the facility in the value-based purchasing program for the specified year as described in paragraph (e)(1) of this section and awarding a score associated with that same percentile performance in the MIPS quality performance category score for those MIPS-eligible clinicians who are not eligible to be scored using facility-based measurement for the MIPS payment year. A MIPS eligible clinician or group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS quality performance category.
(v) Cost. The cost performance category score is established by determining the percentile performance of the facility in the value-based purchasing program for the specified year as described in paragraph (e)(1) of this section and awarding a score associated with that same percentile performance in the MIPS cost performance category score for those MIPS eligible clinicians who are not eligible to be scored using facility-based measurement for the MIPS payment year. A MIPS eligible clinician or MIPS eligible group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS cost performance category.
(A) Other cost measures. MIPS eligible clinicians who are scored under facility-based measurement are not scored on cost measures described in paragraph (b)(2) of this section.
(B) [Reserved]
(vi) Use of score from facility-based measurement. The MIPS quality and cost performance category scores will be based on the facility-based measurement scoring methodology described in paragraph (e)(6) of this section unless:
(A) For the CY 2019 MIPS performance period/2021 MIPS payment year, through the CY 2021 MIPS performance period/2023 MIPS payment year, a MIPS eligible clinician or group receives a higher combined MIPS quality and cost performance category score through another MIPS submission.
(B) Beginning with the CY 2022 MIPS performance period/2024 MIPS payment year, a MIPS eligible clinician or group receives a higher MIPS final score through another MIPS submission.
§ 414.1385   Targeted review and review limitations.
(a) Targeted review. A MIPS eligible clinician, virtual group, subgroup, or group; may request a targeted review of the calculation of the MIPS payment adjustment factor under section 1848(q)(6)(A) of the Act and, as applicable, the calculation of the additional MIPS payment adjustment factor under section 1848(q)(6)(C) of the Act (collectively referred to as the MIPS payment adjustment factors) applicable to such MIPS eligible clinician or group for a year. The process for targeted review is as follows:
(1) A MIPS eligible clinician, virtual group, subgroup, or group; (including their designated support staff), or a third party intermediary as defined at § 414.1305, may submit a request for a targeted review.
(2) All requests for targeted review must be submitted during the targeted review request submission period, which begins on the day CMS makes available the MIPS final score, and ends 30 days after publication of the MIPS payment adjustment factors for the MIPS payment year. The targeted review request submission period may be extended as specified by CMS.
(3) A request for a targeted review may be denied if the request is duplicative of another request for a targeted review; the request is not submitted during the targeted review request submission period; or the request is outside of the scope of the targeted review, which is limited to the calculation of the MIPS payment adjustment factors applicable to the MIPS eligible clinician, virtual group, subgroup, or group; for a year. If the targeted review request is denied, there will be no change to the MIPS final score or associated MIPS payment adjustment factors for the MIPS eligible clinician, virtual group, subgroup, or group. If the targeted review request is approved, the MIPS final score and associated MIPS payment adjustment factors may be revised, if applicable, for the MIPS eligible clinician, virtual group, subgroup, or group.
(4) CMS will respond to each request for a targeted review timely submitted and determine whether a targeted review is warranted.
(5) A request for a targeted review may include additional information in support of the request at the time it is submitted. If CMS requests additional information from the MIPS eligible clinician, virtual group, subgroup. or group that is the subject of a request for a targeted review, the information must be provided and received by CMS within 15 days of CMS' request. Non-responsiveness to CMS' request for additional information may result in a final decision based on the information available, although another non-duplicative request for targeted review may be submitted before the end of the targeted review request submission period.
(6) If a request for a targeted review is approved, CMS may recalculate, to the extent feasible and applicable, the scores of a MIPS eligible clinician, virtual group, subgroup, or group with regard to measures, activities, performance categories, and the final score, as well as the MIPS payment adjustment factors.
(7) Decisions based on the targeted review are final, and there is no further review or appeal. CMS will notify the individual or entity that submitted the request for a targeted review of the final decision.
(8) Documentation submitted for a targeted review must be retained by the submitter for 6 years from the end of the MIPS performance period.
(b) Limitations on review. Except as specified in paragraph (a)(4) of this section, there is no administrative or judicial review under section 1869 or 1879 of the Act, or otherwise of—
(1) The methodology used to determine the amount of the MIPS payment adjustment factor and the amount of the additional MIPS payment adjustment factor and the determination of such amounts;
(2) The establishment of the performance standards and the performance period;
(3) The identification of measures and activities specified for a MIPS performance category and information made public or posted on the Physician Compare Internet Web site of the CMS; and
(4) The methodology developed that is used to calculate performance scores and the calculation of such scores, including the weighting of measures and activities under such methodology.
§ 414.1390   Data validation and auditing.
(a) General. CMS will selectively audit MIPS eligible clinicians and groups on a yearly basis. If a MIPS eligible clinician or group is selected for audit, the MIPS eligible clinician or group will be required to do the following in accordance with applicable law and timelines CMS establishes:
(1) Comply with data sharing requests, providing all data as requested by CMS or our designated entity. All data must be shared with CMS or our designated entity within 45 days of the data sharing request, or an alternate timeframe that is agreed to by CMS and the MIPS eligible clinician or group. Data will be submitted via email, facsimile, or an electronic method via a secure Web site maintained by CMS.
(2) Provide substantive, primary source documents as requested. These documents may include: Copies of claims, medical records for applicable patients, or other resources used in the data calculations for MIPS measures, objectives, and activities. Primary source documentation also may include verification of records for Medicare and non-Medicare beneficiaries where applicable.
(b) Certification. All MIPS eligible clinicians and groups that submit data and information to CMS for purposes of MIPS must certify to the best of their knowledge that the data submitted to CMS is true, accurate, and complete. Such certification must accompany the submission and be made at the time of submission.
(c) Reopening. CMS may reopen and revise a MIPS payment adjustment in accordance with the rules set forth at §§ 405.980 through 405.986 of this chapter.
(d) Record retention. All MIPS eligible clinicians and groups that submit data and information to CMS for purposes of MIPS must retain such data and information for 6 years from the end of the MIPS performance period.
§ 414.1395   Public reporting.
(a) General. (1) CMS posts on Physician Compare, in an easily understandable format, the following:
(i) Information regarding the performance of MIPS eligible clinicians, including, but not limited to, final scores and performance category scores for each MIPS eligible clinician; and
(ii) The names of eligible clinicians in Advanced APMs and, to the extent feasible, the names and performance of such Advanced APMs.
(2) CMS periodically posts on Physician Compare aggregate information on the MIPS, including the range of final scores for all MIPS eligible clinicians and the range of the performance of all MIPS eligible clinicians with respect to each performance category.
(3) The information made available under this section will indicate, where appropriate, that publicized information may not be representative of an eligible clinician's entire patient population, the variety of services furnished by the eligible clinician, or the health conditions of individuals treated.
(b) Maintain existing public reporting standards. With the exception of data that must be mandatorily reported on Physician Compare, for each program year, CMS relies on established public reporting standards to guide the information available for inclusion on Physician Compare. The public reporting standards require data included on Physician Compare to be statistically valid, reliable, and accurate; comparable across collection types; and meet the reliability threshold. And, to be included on the public facing profile pages, the data must also resonate with website users, as determined by CMS.
(c) New measures and activities. (1) CMS does not publicly report any data on new quality or cost measure for the first 2 years in which it is in the program, after which CMS evaluates the measure to determine whether it is suitable for public reporting under paragraph (b) of this section.
(2) CMS does not publicly report any MVP data on new improvement activity or Promoting Interoperability measure, objective, or activity included in an MVP for the first year in which it is included in the MVP.
(d) 30-day preview period. For each program year, CMS provides a 30-day preview period for any clinician or group with Quality Payment Program data before the data are publicly reported on Physician Compare.
§ 414.1400   Third party intermediaries.
(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:
(i) QCDR;
(ii) Qualified registry;
(iii) Before the CY 2025 performance period/2027 payment year, Health IT vendor;
(iv) CMS-approved survey vendor.
(2) Third party intermediary approval criteria—
(i) To be approved as a third party intermediary, an organization must meet the following requirements:
(A) The organization's principal place of business and the location in which it stores data must be in the U.S.
(B) The organization must have the ability to indicate the source of any data it will submit to CMS if the data will be derived from CEHRT, a QCDR, qualified registry, or health IT vendor.
(C) The organization must certify that it intends to provide services throughout the entire performance period and applicable data submission period.
(ii) The determination of whether to approve an entity as a third party intermediary for a MIPS payment year may take into account:
(A) Whether the organization failed to comply with the requirements of this section for any prior MIPS payment year for which it was approved as third party intermediary, including past compliance; and
(B) Whether the entity provided inaccurate information regarding the requirements of this subpart to any eligible clinician.
(iii) Beginning with the 2023 MIPS payment year, third party intermediaries must attend and complete training and support sessions in the form and manner, and at the times, specified by CMS.
(3) For third-party intermediary program requirements:
(i) All data submitted to CMS by a third party intermediary on behalf of a MIPS eligible clinician, group, virtual group, subgroup, or APM Entity must be certified by the third party intermediary as true, accurate, and complete to the best of its knowledge. Such certification must be made in a form and manner and at such time as specified by CMS.
(ii) All data submitted to CMS by a third party intermediary must be submitted in the form and manner specified by CMS.
(A) The submission of data on measures by a third party intermediary to CMS must include data on all of the MIPS eligible clinician's patients, regardless of payer, unless otherwise specified by the collection type.
(B) [Reserved]
(iii) If the clinician chooses to opt-in to participate in MIPS in accordance with § 414.130, the third party intermediary must be able to transmit that decision to 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:
(A) The issues that contributed to the withdrawal mid-performance period or discontinuation of services mid-performance period.
(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.
(C) The steps the third party intermediary will take to ensure that the clinicians, groups, virtual groups, subgroups, or APM Entities identified in paragraph (a)(3)(iv)(B)(1) of this section are notified of the transition in a timely manner, and successfully transitioned to an alternate third party intermediary, submitter type, or, for any measure or activity on which data has been collected, collection type, as applicable.
(D) A detailed timeline that outlines timing for communications, the start of the transition, and completion of the transition of these clinicians, groups, virtual groups, subgroups, or APM Entities.
(E) The third party intermediary must communicate to CMS that the transition was completed by the date included in the detailed timeline.
(v) As a condition of its qualification and approval to participate in MIPS as a third party intermediary, a third party intermediary must:
(A) Make available to CMS the contact information of each MIPS eligible clinician, group, virtual group, subgroup, or APM Entity on behalf of whom it submits data. The contact information must include, at a minimum, the MIPS eligible clinician, group, virtual group, subgroup, or APM Entity phone number, address, and, if available, email.
(B) Retain all data submitted to CMS for purposes of MIPS for 6 years from the end of the MIPS performance period.
(C) Upon request, provide CMS with any records or data retained in connection with its operation as a third party intermediary for up to 6 years from the end of the MIPS performance period.
(vi) Beginning with the 2023 MIPS payment year, third party intermediaries must attend and complete training and support sessions in the form and manner, and at the times, specified by CMS.
(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;
(B) Improvement activities; and
(C) Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless 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).
(ii) Beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data. QCDRs and qualified registries may also support the APP. A QCDR or qualified registry must support all measures and activities included in the MVP with the following exceptions:
(A) 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.
(B) If an MVP includes a QCDR measure, it is not required to be reported by a QCDR other than the measure owner.
(iii) Beginning with the CY 2023 performance period/2025 MIPS payment year, A QCDR or qualified registry must support subgroup reporting.
(2) Self-nomination. For the CY 2019 performance period/2021 MIPS payment year and future years, an existing QCDR or qualified registry that is in good standing may use the Simplified Self-Nomination process form during the self-nomination period, from July 1 and September 1 of the CY preceding the applicable performance period.
(3) Conditions for approval. (i) Beginning with the CY 2020 performance period/2022 MIPS payment year, the QCDR or qualified registry must have at least 25 participants by January 1 of the year prior to the applicable performance period.
(ii) If an entity seeking to qualify as a QCDR or qualified registry uses an external organization for purposes of data collection, calculation, or transmission, it must have a signed, written agreement with the external organization that specifically details the responsibilities of the entity and the external organization. The written agreement must be effective as of September 1 of the year preceding the applicable performance period.
(iii) Beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must provide performance feedback to their clinicians and groups at least 4 times a year, and provide specific feedback to their clinicians and groups on how they compare to other clinicians who have submitted data on a given measure within the QCDR or qualified registry. Exceptions to this requirement may occur if the QCDR or qualified registry submits notification to CMS within the performance period promptly within the month of realization of the impending deficiency and provides sufficient rationale as to why they do not believe they would be able to meet this requirement (for example, if the QCDR does not receive the data from their clinician until the end of the performance period).
(iv) Beginning with the CY 2023 performance period/2025 MIPS payment year, the QCDR or qualified registry must submit a data validation plan annually, at the time of self-nomination for CMS' approval and may not change the plan once approved without the prior approval of the agency.
(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).
(A) The QCDR or qualified registry must conduct data validation for the payment year prior to submitting any data for that payment year to CMS for purposes of the MIPS program.
(B) The QCDR or qualified registry must conduct data validation on data for each performance category for which it will submit data, including if applicable the Quality, Improvement Activities, and Promoting Interoperability performance categories.
(C) The QCDR or qualified registry must conduct data validation on data for each submitter type for which it will submit data, including MIPS eligible clinicians, groups, virtual groups, subgroups, APM entities, voluntary participants, and opt-in participants, if applicable.
(D) The QCDR or qualified registry must use clinical documentation (provided by the clinicians they are submitting data for) to validate that the action or outcome measured actually occurred or was performed.
(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).
(A) If a data validation audit under paragraph (b)(3)(v) of this section identifies one or more deficiency or data error, the QCDR or qualified registry must conduct a targeted audit into the impact and root cause of each such deficiency or data error for that MIPS payment year.
(B) The QCDR or qualified registry must conduct any required targeted audits for the MIPS payment year and correct any deficiencies or data errors identified through such audit prior to the submission of data for that MIPS payment year.
(C) The QCDR or qualified registry must conduct the targeted audit using the sampling methodology that meets the requirements described in paragraph (b)(3)(iv)(E) of this section. The sample for the targeted audit must not include data from the sample used for the data validation audit in which the deficiency or data error was identified.
(D) In a form and manner and by a deadline specified by CMS, the QCDR or qualified registry must report the results of each targeted audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by each deficiency or data error, and how and when each deficiency or data error type was corrected.
(vii) For the CY 2023 performance period/2025 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for any of the 2019 through 2023 MIPS payment years must submit a participation plan for CMS' approval. The participation plan must include the QCDR and/or qualified registry's detailed plans about how the QCDR or qualified registry intends to encourage clinicians to submit MIPS data to CMS through the QCDR or qualified registry.
(viii) Beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval. This participation plan must include the QCDR's and/or qualified registry's detailed plans about how the QCDR or qualified registry intends to encourage clinicians to submit MIPS data to CMS through the QCDR or qualified registry.
(ix) During the self-nomination period, a QCDR or a qualified registry must submit to CMS quality measure numbers, Promoting Interoperability identifiers, improvement activity identifiers and MVP titles.
(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.
(A) If no outcome measure is available, a QCDR or qualified registry must be able to submit to CMS results for at least one other high priority measure.
(B) [Reserved]
(xi) A QCDR or a qualified registry must submit to CMS risk-adjusted measure results when submitting data for measures that include risk adjustment in the measure specification.
(xii) A QCDRs or qualified registry must enter into appropriate Business Associate Agreements with MIPS eligible clinicians to collect and process their data.
(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:
(A) Be annually obtained by the QCDR or qualified registry at the time the clinician or group enters into an agreement with the QCDR or qualified registry for the submission of MIPS data to the QCDR or qualified registry.
(B) Be signed by an eligible clinician, if reporting individually, or by an authorized representative of the reporting group, subgroup, Virtual Group, or APM Entity.
(C) Records of the authorization must be maintained for 6 years after the performance period ends.
(xiv) A QCDR or a qualified registry must attest that the information listed on the qualified posting is accurate.
(xv) A QCDR or a qualified registry must provide to CMS, upon request, the data submitted by the QCDR or qualified registry for purposes of MIPS.
(xvi) A QCDR or qualified registry must attest to the following:
(A) A QCDR or a qualified registry must attest that it has required each MIPS eligible clinician on whose behalf it reports to provide the QCDR or qualified registry with all documentation necessary to verify the accuracy of the data on quality measures that the eligible clinician submitted to the QCDR or qualified registry.
(B) A QCDR or qualified registry must also attest that it has required each MIPS eligible clinician to permit the QCDR or qualified registry to provide the information described in paragraph (b)(3)(xviii)(A) of this section to CMS upon request.
(xvii) A QCDR or a qualified registry must accept and maintain clinician data by January 1 of the applicable performance period.
(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.
(A) For MIPS quality measures, the entity must submit specifications including the MIPS measure IDs and specialty-specific measure sets, as applicable.
(B) For a QCDR measure, the entity must submit for CMS approval measure specifications including: Name/title of measure, descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms. In addition, no later than 15 calendar days following CMS posting of all approved specifications for a QCDR measure, the entity must publicly post the CMS-approved measure specifications for the QCDR measure (including the CMS-assigned QCDR measure ID) and provide CMS with a link to where this information is posted. The approved QCDR measure specifications must remain published through the performance period and data submission period.
(C) For a QCDR measure, the QCDR must provide, if available, data from years prior before the start of the performance period.
(ii) QCDR measure submission requirements. A QCDR must include the CMS-assigned QCDR measure ID when submitting data on any QCDR measure to CMS.
(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]
(C) Beginning with the CY 2021 performance period/2023 MIPS payment year, QCDR measures may be approved for 2 years, at CMS discretion by attaining approval status by meeting QCDR measure considerations and requirements. Upon annual review, CMS may revoke a QCDR measure's second year approval, if the QCDR measure is found to be: Topped out; duplicative of a more robust measure; reflects an outdated clinical guideline; or if the QCDR self-nominating the QCDR measure is no longer in good standing.
(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:
(A) QCDR measures that are duplicative or identical to other QCDR measures or MIPS quality measures that are currently in the program.
(B) QCDR measures that are duplicative or identical to MIPS quality measures that have been removed from MIPS through rulemaking.
(C) QCDR measures that are duplicative or identical to quality measures used under the legacy Physician Quality Reporting System (PQRS) program, which have been retired.
(D) QCDR measures that meet the topped out definition as described at § 414.1305.
(E) QCDR measures that are process-based, with consideration to whether the removal of the process measure impacts the number of measures available for a specific specialty.
(F) Whether the QCDR measure has potential unintended consequences to a patient's care.
(G) Considerations and evaluation of the measure's performance data, to determine whether performance variance exists.
(H) QCDR measures that split a single clinical practice or action into several QCDR measures.
(I) QCDR measures that are “check-box” with no actionable quality action.
(J) QCDR measures that do not meet the case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive years.
(K) QCDR measures with clinician attribution issues, where the quality action is not under the direct control of the reporting clinician.
(L) QCDR measures that focus on rare events or “never events” in the measurement period.
(M) QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period.
(N) If a QCDR measure owner is not approved or is not in good standing, any associated QCDR measures will not be approved.
(O) QCDR measures submitted after self-nomination.
(P) More than 30 QCDR measures are submitted by a single QCDR.
(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;
(B) Improvement activities; and
(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]
(ii) Health IT vendors that do not support MVPs must be able to submit data for at least one of the MIPS performance categories described in paragraphs (c)(1)(i) of this section.
(iii) Beginning with the CY 2023 performance period/2025 MIPS payment year, Health IT vendors must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data. Health IT vendors may also support the APP.
(2) [Reserved]
(d) Additional requirements for CMS-approved survey vendors. (1) CMS-approved survey vendors may submit data on the CAHPS for MIPS survey for the MIPS quality performance category.
(2) Entities seeking to be a CMS-approved survey vendor for any MIPS performance period must submit a survey vendor application to CMS in a form and manner specified by CMS for each MIPS performance period for which it wishes to transmit such data. The application and any supplemental information requested by CMS must be submitted by deadlines specified by CMS. For an entity to be a CMS-approved survey vendor, it must meet the following criteria:
(3) The entity must have sufficient experience, capability, and capacity to accurately report CAHPS data, including:
(i) At least 3 years of experience administering mixed-mode surveys (that is, surveys that employ multiple modes to collect date), including mail survey administration followed by survey administration via Computer Assisted Telephone Interview (CATI);
(ii) At least 3 years of experience administering surveys to a Medicare population;
(iii) At least 3 years of experience administering CAHPS surveys within the past 5 years;
(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.
(4) The entity has certified that it has the ability to maintain and transmit quality data in a manner that preserves the security and integrity of the data.
(5) The entity has successfully completed, and has required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors.
(6) The entity has submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, including cover letters, questionnaires and telephone scripts.
(7) The entity has agreed to participate and cooperate, and has required its subcontractors to participate and cooperate, in all oversight activities related to survey administration conducted by CMS or its contractors.
(8) The entity has sent an interim survey data file to CMS that establishes the entity's ability to accurately report CAHPS data.
(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:
(A) The issues that contributed to the non-compliance.
(B) The impact to individual clinicians, groups, virtual groups, subgroups, or APM Entities, regardless of whether they are participating in the program because they are MIPS eligible, voluntarily participating, or opting in to participating in the MIPS program, and any QCDRs that were granted licenses to the measures of a QCDR upon which a CAP has been imposed.
(C) The corrective actions to be implemented by the third party intermediary to ensure that the non-compliance has been resolved and will not recur in the future.
(D) The detailed timeline for achieving compliance with the applicable requirements.
(E) The communication plan for communicating the impact to the parties identified in paragraph (e)(1)(i)(B) of this section.
(F) Once the issue has been resolved, the detailed final resolution and an update, if any, to the monitoring plan provided pursuant to § 414.1400(e)(1)(i)(C).
(ii) Publicly disclose as follows:
(A) For the purposes of the CY 2025 performance period/2027 MIPS payment year and prior reporting periods and payment years, publicly disclose the entity's data error rate on the CMS website until the data error rate falls below 3 percent.
(B) Beginning with the CY 2025 performance period/2027 MIPS payment year, publicly disclose on the CMS website that CMS took remedial action against or terminated the third party intermediary.
(2) CMS may immediately or with advance notice terminate a third party intermediary for one or more of the following reasons:
(i) CMS has grounds to impose remedial action;
(ii) CMS has not received a CAP within the specified time-period or the CAP is not accepted by CMS; or
(iii) The third party intermediary fails to correct the deficiencies or data errors by the date specified by CMS.
(iv) The third party intermediary has not maintained current contact information for correspondence.
(v) The third party intermediary is on remedial action for 2 consecutive years.
(3) A data submission that contains data inaccuracies affecting the third party intermediary's clinicians may lead to remedial action/termination of the third party intermediary for future program year(s) based on CMS discretion.
(4) For purposes of this paragraph (e), CMS may determine that submitted data are inaccurate, unusable, or otherwise compromised, if the submitted data includes, without limitation, TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies.
(5) Beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that submits a participation plan as required under paragraph (b)(3)(viii) of this section, but does not submit MIPS data for the applicable performance period for which they self-nominated under paragraph (b)(3)(viii) of this section, will be terminated.
(f) Auditing of entities submitting MIPS data. Third party intermediaries may be randomly selected for compliance evaluation or may be selected at the suggestion of CMS if there is an area of concern regarding the third party intermediary. For example, areas of concern could include, but are not limited to: high data errors, support call absences, delinquent deliverables, remedial action status, clinician concerns regarding the third party intermediary, a continuing pattern of Quality Payment Program Service Center inquiries or support call questions, and/or CMS concerns regarding the third party intermediary.
§ 414.1405   Payment.
(a) General. Each MIPS eligible clinician receives a MIPS payment adjustment factor, and if applicable an additional MIPS payment adjustment factor for exceptional performance, for a MIPS payment year determined by comparing their final score to the performance threshold and additional performance threshold for the year.
(b) Performance threshold. A performance threshold will be specified for each MIPS payment year.
(1) MIPS eligible clinicians with a final score at or above the performance threshold receive a zero or positive MIPS payment adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a final score at the performance threshold and an adjustment factor of the applicable percent is assigned for a final score of 100.
(2) MIPS eligible clinicians with a final score below the performance threshold receive a negative MIPS payment adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a final score at the performance threshold and an adjustment factor of the negative of the applicable percent is assigned for a final score of 0; further, MIPS eligible clinicians with final scores that are equal to or greater than zero, but not greater than one-fourth of the performance threshold, receive a negative MIPS payment adjustment factor that is equal to the negative of the applicable percent.
(3) A scaling factor not to exceed 3.0 may be applied to positive MIPS payment adjustment factors to ensure budget neutrality such that the estimated increase in aggregate allowed charges resulting from the application of the positive MIPS payment adjustment factors for the MIPS payment year equals the estimated decrease in aggregate allowed charges resulting from the application of negative MIPS payment adjustment factors for the MIPS payment year.
(4) The performance threshold for the 2019 MIPS payment year is 3 points.
(5) The performance threshold for the 2020 MIPS payment year is 15 points.
(6) The performance threshold for the 2021 MIPS payment year is 30 points.
(7) The performance threshold for the 2022 MIPS payment year is 45 points.
(8) The performance threshold for the 2023 MIPS payment year is 60 points.
(9) Pursuant to the methodology established at paragraph (g) of this section:
(i) The performance threshold for the 2024 MIPS payment year is 75 points. The prior period used to determine the performance threshold is the 2019 MIPS payment year.
(ii) The performance threshold for the 2025 MIPS payment year is 75 points. The prior period used to determine the performance threshold is the 2019 MIPS payment year.
(iii) The performance threshold for the 2026 MIPS payment year is 75 points. The prior period to determine the performance threshold is the 2019 MIPS payment year.
(10) Pursuant to the methodology established at paragraph (g)(2) of this section:
(i) The performance threshold for the 2027 MIPS payment year is 75 points. The prior period used to determine the performance threshold is the 2019 MIPS payment year.
(ii) [Reserved]
(c) Applicable percent. For MIPS payment year 2019, 4 percent. For MIPS payment year 2020, 5 percent. For MIPS payment year 2021, 7 percent. For MIPS payment year 2022 and each subsequent MIPS payment year, 9 percent.
(d) Additional performance threshold. An additional performance threshold will be specified for each of the MIPS payment years 2019 through 2024.
(1) In addition to the MIPS payment adjustment factor, MIPS eligible clinicians with a final score at or above the additional performance threshold receive an additional MIPS payment adjustment factor for exceptional performance on a linear sliding scale such that an additional adjustment factor of 0.5 percent is assigned for a final score at the additional performance threshold and an additional adjustment factor of 10 percent is assigned for a final score of 100, subject to the application of a scaling factor as determined by CMS, such that the estimated aggregate increase in payments resulting from the application of the additional MIPS payment adjustment factors for the MIPS payment year shall not exceed $500,000,000 for each of the MIPS payment years 2019 through 2024.
(2) [Reserved]
(3) The additional performance threshold for the 2019 MIPS payment year is 70 points.
(4) The additional performance threshold for the 2020 MIPS payment year is 70 points.
(5) The additional performance threshold for the 2021 MIPS payment year is 75 points.
(6) The additional performance threshold for the 2022 and 2023 MIPS payment years is 85 points.
(7) The additional performance threshold for the 2024 MIPS payment year is 89 points.
(e) Application of adjustments to payments. Except as specified in paragraph (f) of this section, in the case of covered professional services (as defined in section 1848(k)(3)(A) of the Act) furnished by a MIPS eligible clinician during a MIPS payment year beginning with 2019, the amount otherwise paid under Part B with respect to such covered professional services and MIPS eligible clinician for such year, is multiplied by 1, plus the sum of the MIPS payment adjustment factor divided by 100, and as applicable, the additional MIPS payment adjustment factor divided by 100.
(f) Exception to application of MIPS payment adjustment factors to model-specific payments under section 1115A APMs. Beginning with the 2019 MIPS payment year, the payment adjustment factors specified under paragraph (e) of this section are not applicable to payments that meet all of the following conditions:
(1) Are made only to participants in a model tested under section 1115A of the Act;
(2) Would otherwise be subject to the requirement to apply the MIPS payment adjustment factors if the payment is made with respect to a MIPS eligible clinician participating in a section 1115A model; and
(3) Either have a specified payment amount or are paid according to a methodology for calculating a model-specific payment that is applied in a consistent manner to all model participants, such that application of the MIPS payment adjustment factors would potentially interfere with CMS's ability to effectively evaluate the impact of the APM.
(g) Performance threshold methodology. (1) For each of the 2024, 2025, and 2026 MIPS payment years, the performance threshold is the mean of the final scores for all MIPS eligible clinicians from a prior period as specified under paragraph (b)(9) of this section.
(2) For each of the 2027, 2028, and 2029 MIPS payment years, the performance threshold is the mean of the final scores for all MIPS eligible clinicians from a prior period as specified under paragraph (b)(10) of this section.
§ 414.1410   Advanced APM determination.
(a) General. An APM is an Advanced APM for a payment year if CMS determines that it meets the criteria in § 414.1415 during the QP Performance Period.
(b) Advanced APM determination process. CMS determines Advanced APMs in the following manner:
(1) Advanced APM determination. (i) No later than January 1, 2017, CMS will post on its Web site a list of all Advanced APMs for the first QP Performance Period.
(ii) CMS updates the Advanced APM list on its Web site at intervals no less than annually.
(iii) CMS will include notice of whether a new APM is an Advanced APM in the first public notice of the new APM.
(2) [Reserved]
§ 414.1415   Advanced APM criteria.
(a) Use of certified electronic health record technology (CEHRT) —(1) Required use of CEHRT. To be an Advanced APM, an APM must:
(i) For QP Performance Periods ending with 2018, require at least 50 percent, or for QP Performance Periods beginning with 2019 and ending with 2024, 75 percent, of eligible clinicians in each participating APM Entity group, or for APMs in which hospitals are the APM Entities, each hospital, to use CEHRT to document and communicate clinical care to their patients or health care providers;
(ii) For QP Performance Periods prior to 2019, for the Shared Savings Program, apply a penalty or reward to an APM Entity based on the degree of the use of CEHRT of the eligible clinicians in the APM Entity; and
(iii) For QP Performance Periods beginning with 2025, require use of CEHRT as defined at paragraph (3) under CEHRT at § 414.1305.
(2) [Reserved].
(b) Payment based on quality measures. (1) To be an Advanced APM, an APM must include quality measure performance as a factor when determining payment to participants for covered professional services under the terms of the APM.
(2) At least one of the quality measures used in the payment arrangement as specified in paragraph (b)(1) of this section must:
(i) For QP Performance Periods before January 1, 2020, have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
(A) Used in the MIPS quality performance category, as described in § 414.1330;
(B) Endorsed by a consensus-based entity;
(C) Developed under section 1848(s) of the Act;
(D) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(E) Any other quality measures that CMS determines to have an evidence-based focus and to be reliable and valid; and
(ii) For QP Performance Periods beginning on or after January1, 2020, be:
(A) Finalized on the MIPS final list of measures, as described in § 414.1330;
(B) Endorsed by a consensus-based entity; or
(C) Determined by CMS to be evidenced-based, reliable, and valid.
(3) The quality measures upon which an Advanced APM bases the payment in paragraph (b)(1) of this section must include at least one measure that is an outcome measure unless CMS determines that there are no available or applicable outcome measures included in the MIPS final quality measures list for the Advanced APM's first QP Performance Period. Beginning January 1, 2020, the included outcome measure must satisfy the criteria in paragraph (b)(2) of this section.
(4) A single quality measure that meets the criteria under both paragraphs (b)(2) and (3) of this section may be used to satisfy the requirements of paragraph (b)(1) of this section.
(c) Financial risk. To be an Advanced APM, except as described in paragraph (c)(6) of this section, an APM must either meet the financial risk standard under paragraph (c)(1) or (2) of this section and the nominal amount standard under paragraph (c)(3) or (4) of this section or be an expanded Medical Home Model under section 1115A(c) of the Act.
(1) Generally applicable financial risk standard. Except for paragraph (c)(2) of this section, to be an Advanced APM, an APM must, based on whether an APM Entity's actual expenditures for which the APM Entity is responsible under the APM exceed expected expenditures during a specified QP Performance Period, do one or more of the following:
(i) Withhold payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Reduce payment rates to the APM Entity or the APM Entity's eligible clinicians; or
(iii) Require the APM Entity to owe payment(s) to CMS.
(2) Medical Home Model financial risk standard. The APM Entity participates in a Medical Home Model that, based on the APM Entity's failure to meet or exceed one or more specified performance standards, which may include expected expenditures, does one or more of the following:
(i) Withholds payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Reduces payment rates to the APM Entity or the APM Entity's eligible clinicians;
(iii) Requires the APM Entity to owe payment(s) to CMS; or
(iv) Causes the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.
(3) Generally applicable nominal amount standard. (i) Except as provided in paragraph (c)(4) of this section, the total amount an APM Entity potentially owes CMS or foregoes under an APM must be at least equal to either:
(A) For QP Performance Periods beginning in 2023, 8 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities; or
(B) 3 percent of the expected expenditures for which an APM Entity is responsible under the APM.
(ii) [Reserved]
(4) Medical Home Model nominal amount standard. (i) For a Medical Home Model to meet the Medical Home Model nominal amount standard, the total annual amount that an APM Entity potentially owes CMS or foregoes must be at least the following amounts:
(A) For QP Performance Period 2017, 2.5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(B) For QP Performance Period 2018, 2.5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(C) For QP Performance Period 2019, 3 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(D) For QP Performance Period 2020, 4 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(E) For QP Performance Periods 2021 and later, 5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(ii) [Reserved]
(5) For the purposes of this section, expected expenditures means the beneficiary expenditures for which an APM Entity is responsible under an APM. For episode payment models, expected expenditures means the episode target price. For purposes of assessing financial risk for Advanced APM determinations, the expected expenditures under the terms of the APM should not exceed the Medicare Part A and Part B expenditures for a participant in the absence of the APM. If the expected expenditures under the APM exceed the Medicare Part A and Part B expenditures that an APM Entity would be expected to incur in the absence of the APM, such excess expenditures are not considered when CMS assesses financial risk under the APM for purposes of Advanced APM determinations.
(6) Capitation. A full capitation arrangement meets this Advanced APM criterion. For purposes of this part, a full capitation arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made under the APM for all items and services furnished to a population of beneficiaries during a fixed period of time, and no settlement is performed to reconcile or share losses incurred or savings earned by the APM Entity. Arrangements between CMS and Medicare Advantage Organizations under the Medicare Advantage program (part 422 of this title) are not considered capitation arrangements for purposes of this paragraph (c)(6).
(7) Medical Home Model 50 eligible clinician limit. Beginning in the 2023 QP Performance Period, notwithstanding paragraphs (c)(2) and (4) of this section, if an APM Entity participating in a Medical Home Model is comprised of more than 50 eligible clinicians, as determined by that APM Entity's Participation List on any of the three QP determination dates (March 31, June 30, and August 31 of the QP Performance Period), the requirements of paragraphs (c)(1) and (3) of this section apply.
§ 414.1420   Other payer advanced APM criteria.
(a) Other Payer Advanced APM criteria. A payment arrangement with a payer other than Medicare is an Other Payer Advanced APM for a QP Performance Period if CMS determines that the arrangement meets the following criteria during the QP Performance Period:
(1) Use of CEHRT, as described in paragraph (b) of this section;
(2) Quality measures comparable to measures under the MIPS quality performance category apply, as described in paragraph (c) of this section; and
(3) Either:
(i) Requires APM Entities to bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures as described in paragraph (d) of this section; or
(ii) Is a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act as described in paragraph (d) of this section.
(b) Use of CEHRT. To be an Other Payer Advanced APM:
(1) CEHRT must be used, for QP Performance Periods ending with 2019, by at least 50 percent; and for QP Performance Periods for 2020 through 2024, by at least 75 percent, of participants in each participating APM Entity group, or each hospital if hospitals are the APM Entities, in the other payer arrangement to document and communicate clinical care; and
(2) For QP Performance Periods beginning on or after January 1, 2024, use of CEHRT (as defined in § 414.1305, paragraph (3) in the definition of “Certified Electronic Health Record Technology (CEHRT)”), must be a requirement of participation in the APM.
(c) Use of quality measures. (1) To be an Other Payer Advanced APM, a payment arrangement must apply quality measures comparable to measures under the MIPS quality performance category, as described in paragraph (c)(2) of this section.
(2) At least one of the quality measures used in the payment arrangement as specified in paragraph (c)(1) of this section must:
(i) For QP Performance Period before January 1, 2020, have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
(A) Used in the MIPS quality performance category, as described in § 414.1330;
(B) Endorsed by a consensus-based entity;
(C) Developed under section 1848(s) of the Act;
(D) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(E) Any other quality measures that CMS determines to have an evidence-based focus and to be reliable and valid; and
(ii) For QP Performance Periods beginning on or after January 1, 2020, be:
(A) Finalized on the MIPS final list of measures, as described in § 414.1330;
(B) Endorsed by a consensus-based entity; or
(C) Determined by CMS to be evidenced-based, reliable, and valid.
(3) To meet the quality measure use criterion under paragraph (c)(1) of this section, a payment arrangement must:
(i) For QP Performance Periods before January 1, 2020, use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list. This criterion also applies for payment arrangements determined to be Other Payer Advanced APMs on or before January 1, 2020, but only for the Other Payer Advanced APM determination made with respect to the arrangement for the CY 2020 QP Performance Period (regardless of whether that determination is a single- or multi-year determination).
(ii) For QP Performance Periods on or after January 1, 2020, use at least one measure that is an outcome measure and meets the criteria in paragraph (c)(2)(ii) of this section if there is such an applicable outcome measure on the MIPS quality measure list.
(4) A single quality measure that meets the criteria under both paragraphs (c)(2) and (3) of this section may be used to satisfy the requirements of paragraph (c)(1) of this section.
(d) Financial risk. To be an Other Payer Advanced APM, except as described in paragraph (d)(7) of this section, a payment arrangement must meet either the financial risk standard under paragraph (d)(1) or (2) of this section and the nominal amount standard under paragraph (d)(3) or (4) of this section, or be a Medicaid Medical Home Model with criteria comparable to an expanded Medical Home Model under section 1115A(c) of the Act.
(1) Generally applicable financial risk standard. Except for APM Entities to which paragraph (d)(2) of this section applies, to be an Other Payer Advanced APM, an APM Entity must, based on whether an APM Entity's actual expenditures for which the APM Entity is responsible under the payment arrangement exceed expected expenditures during a specified period of performance do one or more of the following:
(i) Withhold payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Reduce payment rates to the APM Entity or the APM Entity's eligible clinicians; or
(iii) Require direct payment by the APM Entity to the payer.
(2) Medicaid Medical Home Model and Aligned Other Payer Medical Home Model financial risk standard. The APM Entity participates in a Medicaid Medical Home Model or an Aligned Other Payer Medical Home Model that, based on the APM Entity's failure to meet or exceed one or more specified performance standards, does one or more of the following:
(i) Withhold payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Require direct payment by the APM Entity to the payer;
(iii) Reduce payment rates to the APM Entity or the APM Entity's eligible clinicians; or
(iv) Require the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.
(3) Generally applicable nominal amount standard. Except for payment arrangements described in paragraph (d)(2) of this section, the total amount an APM Entity potentially owes a payer or foregoes under a payment arrangement must be at least:
(i) For QP Performance Periods beginning in 2023, 8 percent of the total combined revenues from the payer to providers and other entities under the payment arrangement if financial risk is expressly defined in terms of revenue; or, 3 percent of the expected expenditures for which an APM Entity is responsible under the payment arrangement.
(ii) Except for risk arrangements described under paragraph (d)(2) of this section, the risk arrangement must have a marginal risk rate of at least 30 percent.
(4) Medicaid Medical Home Model and Aligned Other Payer Medical Home Model nominal amount standard. For a Medicaid Medical Home Model or an Aligned Other Payer Medical Home Model to meet the Medicaid Medical Home Model nominal amount standard, the total annual amount that an APM Entity potentially owes a payer or forgoes must be at least the following amounts:
(i) For QP Performance Period 2019, 3 percent of the average estimated total revenue of the participating providers or other entities under the payer.
(ii) For QP Performance Period 2020, 4 percent of the average estimated total revenue of the participating providers or other entities under the payer.
(iii) For QP Performance Periods 2021 and later, 5 percent of the average estimated total revenue of the participating providers or other entities under the payer.
(5) Marginal risk rate. For purposes of this section, the marginal risk rate is defined as the percentage of actual expenditures that exceed expected expenditures for which an APM Entity is responsible under an other payer payment arrangement.
(i) In the event that the marginal risk rate varies depending on the amount by which actual expenditures exceed expected expenditures, the average marginal risk rate across all possible levels of actual expenditures would be used for comparison to the marginal risk rate specified in paragraph (d)(3)(ii) of this section, with exceptions for large losses as described in paragraph (d)(5)(ii) of this section and small losses as described in paragraph (d)(5)(iii) of this section.
(ii) Allowance for large losses. The determination in paragraph (d)(3)(ii) of this section may disregard the marginal risk rates that apply in cases when actual expenditures exceed expected expenditures by an amount sufficient to require the APM Entity to make financial risk payments under the other payer payment arrangement greater than or equal to the total risk requirement under paragraph (d)(3)(i) of this section.
(iii) Allowance for minimum loss rate. The determination in paragraph (d)(3)(ii) of this section may disregard the marginal risk rates that apply in cases when actual expenditures exceed expected expenditures by less than 4 percent of expected expenditures.
(6) Expected expenditures. For the purposes of this section, expected expenditures is defined as the Other Payer APM benchmark. For episode payment models, expected expenditures means the episode target price. For purposes of assessing financial risk for Other Payer Advanced APM determinations, the expected expenditures under the payment arrangement should not exceed the expenditures for a participant in the absence of the payment arrangement. If expected expenditures under the payment arrangement exceed the expenditures that the participant would be expected to incur in the absence of the payment arrangement, such excess expenditures are not considered when assessing financial risk under the payment arrangement for Other Payer Advanced APM determinations.
(7) Capitation. A full capitation arrangement meets this Other Payer Advanced APM criterion. For purposes of paragraph (d)(3) of this section, a full capitation arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made under the payment arrangement for all items and services furnished to a population of beneficiaries during a fixed period of time, and no settlement is performed for the purposes of reconciling or sharing losses incurred or savings earned by the participant. Arrangements made directly between CMS and Medicare Advantage Organizations under the Medicare Advantage program (part 422 of this title) are not considered capitation arrangements for purposes of this paragraph.
(8) Aligned Other Payer Medical Home Model and Medicaid Medical Home Model 50 eligible clinician limit. Beginning with the 2023 QP Performance Period, notwithstanding paragraphs (d)(2) and (4) of this section, if an APM Entity participating in an Aligned Other Payer Medical Home Model or Medicaid Medical Home Model is comprised of 50 or more eligible clinicians is comprised of more than 50 eligible clinicians, as determined by the information submitted for any of the three QP determination dates (March 31, June 30, and August 31 of the QP Performance Period) as specified in § 414.1440(e), the requirements of paragraphs (d)(1) and (3) of this section apply.
§ 414.1425   Qualifying APM participant determination: In general.
(a) List used for QP determination. (1) For Advanced APMs in which all APM Entities may include eligible clinicians on a Participation List, the Participation List is used to identify the APM Entity group for purposes of QP determinations, regardless of whether the APM Entity may also include eligible clinicians on an Affiliated Practitioner List.
(2) For Advanced APMs in which APM Entities do not include eligible clinicians on a Participation List but do include eligible clinicians on an Affiliated Practitioner List, the Affiliated Practitioner List is used to identify the eligible clinicians for purposes of QP determinations.
(3) For Advanced APMs in which some APM Entities may include eligible clinicians on a Participation List and other APM Entities may only include eligible clinicians on an Affiliated Practitioner List depending on the type of APM Entity, paragraph (a)(1) of this section applies to APM Entities that may include eligible clinicians on a Participation List, and paragraph (a)(2) of this section applies to APM Entities that may only include eligible clinicians on an Affiliated Practitioner List.
(b) Group or individual determination under the Medicare Option. (1) APM Entity group determination. Except for paragraphs (b)(2) and (3) of this section and as set forth in § 414.1440, for purposes of the QP determinations for a year, eligible clinicians are grouped and assessed through their collective participation in an APM Entity group that is in an Advanced APM. To be included in the APM Entity group for purposes of the QP determination, an eligible clinician's APM participant identifier must be present on a Participation List of an APM Entity group on one of the dates: March 31, June 30, or August 31 of the QP Performance Period. An eligible clinician included on a Participation List on any one of these dates is included in the APM Entity group even if that eligible clinician is not included on that Participation List at one of the prior or later listed dates. CMS performs QP determinations for the eligible clinicians in an APM entity group three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination dates: March 31, June 30, and August 31. An eligible clinician can only be determined to be a QP if the eligible clinician appears on the Participation List on a date (March 31, June 30, or August 31) CMS uses to determine the APM Entity group and to make QP determinations collectively for the APM Entity group based on participation in the Advanced APM.
(2) Affiliated practitioner individual determination under the Medicare Option. For Advanced APMs to which paragraph (a)(2) of this section applies, QP determinations are made individually for each eligible clinician. To be assessed as an Affiliated Practitioner, an eligible clinician must be identified on an Affiliated Practitioner List on one of the dates: March 31, June 30, or August 31 of the QP Performance Period. An eligible clinician included on an Affiliated Practitioner List on any one of these dates is assessed as an Affiliated Practitioner even if that eligible clinician is not included on the Affiliated Practitioner List at one of the prior or later listed dates. For such eligible clinicians, CMS performs QP determinations during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination dates that the eligible clinician is on the Affiliated Practitioner List: March 31, June 30, and August 31.
(c) QP determination. (1) CMS makes QP determinations as set forth in §§ 414.1435 and 414.1440.
(2) An eligible clinician cannot be both a QP and a Partial QP for a year. A determination that an eligible clinician is a QP means that the eligible clinician is not a Partial QP.
(3) An eligible clinician is a QP for a year under the Medicare Option if the eligible clinician is in an APM Entity group that achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in § 414.1430(a)(1) and (3). An eligible clinician is a QP for the year under the All-Payer Combination Option if the eligible clinician individually, or as part of an APM Entity group, achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in § 414.1430(b)(1) and (3).
(4) Notwithstanding paragraph (c)(3) of this section, an eligible clinician is a QP for a year if:
(i) The eligible clinician is included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the QP payment amount threshold or the QP patient count threshold, or the eligible clinician is an Affiliated Practitioner; and
(ii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the QP payment amount threshold or the QP patient count threshold.
(5) Beginning in the 2020 QP Performance Period, an eligible clinician in an APM Entity is not a QP for a year if:
(i) The APM Entity voluntarily or involuntarily terminates from an Advanced APM before the end of the QP Performance Period; or
(ii) The APM Entity voluntarily or involuntarily terminates from an Advanced APM at a date on which the APM Entity would not bear financial risk for that QP performance period under the terms of the Advanced APM, even if such termination date occurs within such QP Performance Period.
(6) Beginning in the 2020 QP Performance Period, an eligible clinician is not a QP for a year if:
(i) One or more of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the QP Performance Period, and the eligible clinician does not achieve a Threshold Score that meets or exceeds the QP payment amount threshold or QP patient count threshold based on participation in the remaining non-terminating APM Entities; or
(ii) One or more of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM at a date on which the APM Entity would not bear financial risk under the terms of the Advanced APM, and the eligible clinician does not achieve a Threshold Score that meets or exceeds the QP payment amount threshold or QP patient count threshold based on participation in the remaining non-terminating APM Entities.
(7) Advanced APMs that start or end during the QP Performance Period:
(i) Notwithstanding paragraph (a) of this section and §§ 414.1435 and 414.1440, CMS makes QP determinations and Partial QP determinations for the APM Entity group or individual eligible clinician under § 414.1425(b) for Advanced APMs that start or end during the QP Performance Period and that are actively tested for 60 or more continuous days during the QP Performance Period using claims data for services furnished during those dates on which the Advanced APM is actively tested. For Advanced APMs that start active testing during the QP Performance Period, CMS performs QP and Partial QP determinations during the QP Performance Period using claims data for services furnished from the start of active testing of the Advanced APM through each of the QP determination dates that occur on or after the Advanced APM has been actively tested for 60 or more continuous days: March 31, June 30, and August 31. For Advanced APMs that end active testing during the QP Performance Period, CMS performs QP and Partial QP determinations using claims data for services furnished from January 1 or the start of active testing, whichever occurs later, through the final day of active testing of the Advanced APM for each of the QP determination dates that occur on or after the Advanced APM has been actively tested for 60 or more continuous days during that QP Performance Period: March 31, June 30, and August 31.
(ii) For QP determinations specified under paragraph (c)(4) of this section and Partial QP determinations under paragraph (d)(2) of this section, QP determinations are made using claims data for the full QP Performance Period even if the eligible clinician participates in one or more Advanced APMs that start or end during the QP Performance Period.
(d) Partial QP determination. (1) An eligible clinician is a Partial QP for a year under the Medicare Option if the eligible clinician is in an APM Entity group that achieves Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in § 414.1430(a)(2) and (4). An eligible clinician is a Partial QP for the year under the All-Payer Combination Option if the eligible clinician achieves individually, or as part of an APM Entity group, a Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in § 414.1430(b)(2) and (4).
(2) Notwithstanding paragraph (d)(1) of this section, an eligible clinician is a Partial QP for a year if:
(i) The eligible clinician is included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the corresponding QP or Partial QP threshold, or the eligible clinician is an Affiliated Practitioner; and
(ii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the corresponding Partial QP Threshold.
(3) Beginning in the 2020 QP Performance Period, an eligible clinician is not a Partial QP for a year if:
(i) The APM Entity voluntarily or involuntarily terminates from an Advanced APM before the end of the QP Performance Period; or
(ii) The APM Entity voluntarily or involuntarily terminates from an Advanced APM at a date on which the APM Entity would not bear financial risk for that performance period under the terms of the Advanced APM.
(4) Beginning in the 2020 QP Performance Period, an eligible clinician is not a Partial QP for a year if:
(i) One or more of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the QP Performance Period, and the eligible clinician does not achieve a Threshold Score that meets or exceeds the Partial QP payment amount threshold or Partial QP patient count threshold based on participation in the remaining non-terminating APM Entities; or
(ii) One or more of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM at a date on which the APM Entity would not bear financial risk under the terms of the Advanced APM, and the eligible clinician does not achieve a Threshold Score that meets or exceeds the Partial QP payment amount threshold or Partial QP patient count threshold based on participation in the remaining non-terminating APM Entities.
(e) Notification of QP determination. CMS notifies eligible clinicians determined to be QPs or Partial QPs for a year as soon as practicable following each QP determination date in the QP Performance Period.
(f) Order of threshold options. (1) For payment years 2019 and 2020, CMS performs QP determinations for an eligible clinicians only under the Medicare Option described in § 414.1435.
(2) For payment years 2021 and later, CMS performs QP determinations for eligible clinicians under the Medicare Option, as described in § 414.1435 and, except as specified in paragraphs (d)(2)(i) and (ii) of this section, the All-Payer Combination Option, described in § 414.1440.
(i) If CMS determines the eligible clinician to be a QP under the Medicare Option, then CMS does not calculate a Threshold Score for such eligible clinician under the All-Payer Combination Option.
(ii) If the Threshold Score for an eligible clinician under the Medicare Option is less than the amount specified in § 414.1430(b)(2)(ii) and (b)(3)(iii), then CMS does not perform a QP determination for such eligible clinician(s) under the All-Payer Combination Option.
§ 414.1430   Qualifying APM participant determination: QP and partial QP thresholds.
(a) Medicare Option —(1) QP payment amount threshold. The QP payment amount thresholds are the following values for the indicated payment years:
(i) 2019 and 2020: 25 percent.
(ii) 2021 and 2022: 50 percent.
(iii) 2023 and 2024: 50 percent.
(iv) 2025: 50 percent.
(v) 2026: 50 percent.
(vi) 2027 and later: 75 percent.
(2) Partial QP payment amount threshold. The Partial QP payment amount thresholds are the following values for the indicated payment years:
(i) 2019 and 2020: 20 percent.
(ii) 2021 and 2022: 40 percent.
(iii) 2023 and 2024: 40 percent.
(iv) 2025: 40 percent.
(v) 2026: 40 percent.
(vi) 2027 and later: 50 percent.
(3) QP patient count threshold. The QP patient count thresholds are the following values for the indicated payment years:
(i) 2019 and 2020: 20 percent
(ii) 2021 and 2022: 35 percent
(iii) 2023 and 2024: 35 percent.
(iv) 2025: 35 percent.
(v) 2026: 35 percent.
(vi) 2027 and later: 50 percent.
(4) Partial QP patient count threshold. The Partial QP patient count thresholds are the following values for the indicated payment years:
(i) 2019 and 2020: 10 percent
(ii) 2021 and 2022: 25 percent
(iii) 2023 and 2024: 25 percent.
(iv) 2025: 25 percent.
(v) 2026: 25 percent.
(vi) 2027 and later: 35 percent.
(b) All-Payer Combination Option —(1) QP payment amount threshold.
(i) The QP payment amount thresholds are the following values for the indicated payment years:
(A) 2021 through 2026: 50 percent.
(B) 2027 and later: 75 percent.
(ii) To meet the QP payment amount threshold under this option, the eligible clinician must also meet a 25 percent QP payment amount threshold under the Medicare Option.
(2) Partial QP payment amount threshold. (i) The Partial QP payment amount thresholds are the following values for the indicated payment years:
(A) 2021 through 2026: 40 percent.
(B) 2027 and later: 50 percent.
(ii) To meet the QP payment amount threshold under this option, the eligible clinician must also meet a 20 percent Partial QP payment amount threshold under the Medicare Option.
(3) QP patient count threshold. (i) The QP patient count thresholds are the following values for the indicated payment years:
(A) 2021 through 2026: 35 percent.
(B) 2027 and later: 50 percent.
(ii) To meet the QP patient count threshold under this option, the eligible clinician must also meet a 20 percent QP patient count threshold under the Medicare Option.
(4) Partial QP patient count threshold. (i) The Partial QP patient count thresholds are the following values for the indicated payment years:
(A) 2021 through 2026: 25 percent.
(B) 2027 and later: 35 percent.
(ii) To meet the Partial QP patient count threshold under this option, the eligible clinician group or eligible clinician must also meet a 10 percent QP patient count threshold under the Medicare Option.
§ 414.1435   Qualifying APM participant determination: Medicare option.
(a) Payment amount method. The Threshold Score for an APM Entity or eligible clinician is calculated as a percent by dividing the value described under paragraph (a)(1) of this section by the value described under paragraph (a)(2) of this section.
(1) Numerator. The aggregate of payments for Medicare Part B covered professional services furnished by the APM Entity group to attributed beneficiaries during the QP Performance Period.
(2) Denominator. The aggregate of payments for Medicare Part B covered professional services furnished by the APM Entity group to all attribution-eligible beneficiaries during the QP Performance Period.
(3) Claims and adjustments. In the calculations under paragraphs (a)(1) and (2) of this section, CMS compiles claims and treats claims adjustments, supplemental service payments, and alternative payment methods in the same manner as described in § 414.1450.
(b) Patient count method. The Threshold Score for each eligible clinician in an APM Entity group is calculated as a percent under the patient count method by dividing the value described under paragraph (b)(1) of this section by the value described under paragraph (b)(2) of this section.
(1) Numerator. The number of attributed beneficiaries to whom the APM Entity group furnishes Medicare Part B covered professional services or services by a Rural Health Clinic (RHC) or Federally-Qualified Health Center (FQHC) during the QP Performance Period.
(2) Denominator. The number of attribution-eligible beneficiaries to whom the APM Entity group or eligible clinician furnish Medicare Part B covered professional services or services by a Rural Health Clinic (RHC) or Federally-Qualified Health Center (FQHC) during the QP Performance Period.
(3) Unique beneficiaries. For each APM Entity group, a unique Medicare beneficiary is counted no more than one time for the numerator and no more than one time for the denominator.
(4) Beneficiaries count multiple times. Based on attribution under the terms of an Advanced APM, a single Medicare beneficiary may be counted in the numerator or denominator for multiple different APM Entity groups.
(c) Attribution.
(1) Attributed beneficiaries are determined from each Advanced APM Entity's attributed beneficiary lists generated by each Advanced APM's specific attribution methodology except as set forth in this paragraph (c)(1).

(i) Beneficiaries who have been prospectively attributed to an APM Entity for a QP Performance Period will be excluded from the attribution-eligible beneficiary count for any other APM Entity that is participating in an APM where that beneficiary would be ineligible to be added to the APM Entity's attributed beneficiary list.
(ii) [Reserved]
(2) When operationally feasible, this attributed beneficiary list will be the final beneficiary list used for reconciliation purposes in the Advanced APM.
(3) When it is not operationally feasible to use the final attributed beneficiary list, the attributed beneficiary list will be taken from the Advanced APM's most recently available attributed beneficiary list at the end of the QP Performance Period.
(d) Use of methods. CMS calculates Threshold Scores for an APM Entity or eligible clinician as provided by § 414.1425(b) under both the payment amount and patient count methods for each QP Performance Period. CMS then assigns to the eligible clinicians included in the APM Entity group or to the eligible clinician the score that results in the greater QP status. QP status is greater than Partial QP status, and Partial QP status is greater than no QP status.
§ 414.1440   Qualifying APM participant determination: All-payer combination option.
(a) Payments excluded from calculations. (1) These calculations include a combination of both Medicare payments for Part B covered professional services and all other payments for all other payers, except for payments made by:
(i) The Secretary of Defense for the costs of Department of Defense health care programs;
(ii) The Secretary of Veterans Affairs for the cost of Department of Veterans Affairs health care programs; and
(iii) Under Title XIX in a State in which no Medicaid APM or Medicaid Medical Home Model that is an Other Payer Advanced APM is available.
(2) Payments and associated patient counts under paragraph (a)(1)(iii) of this section are included in the numerator and denominator as specified in paragraphs (b)(2) and (3) and paragraphs (c)(2) and (3) of this section for an eligible clinician if CMS determines that there is at least one Medicaid APM or Medicaid Medical Home Model that is an Other Payer Advanced APM available in the county where the eligible clinician sees the most patients during the QP Performance Period, and that the eligible clinician is not ineligible to participate in the Other Payer Advanced APM based on their specialty.
(b) Payment amount method —(1) In general. The Threshold Score for either an APM Entity group or eligible clinician will be calculated by dividing the value described under the numerator by the value described under the denominator as specified in paragraphs (b)(2) and (3) of this section.
(2) Numerator. The aggregate amount of all payments from all payers, except those excluded under paragraph (a) of this section, attributable to the eligible clinician or to the APM Entity group under the terms of all Advanced APMs and Other Payer Advanced APMs during the QP Performance Period.
(3) Denominator. The aggregate amount of all payments from all payers, except those excluded under paragraph (a) of this section, made to the eligible clinician or to the APM Entity group during the QP Performance Period.
(c) Patient count method —(1) In general. The Threshold Score for either an APM Entity group or eligible clinician is calculated by dividing the value described under the numerator by the value described under the denominator as specified in paragraphs (c)(2) and (3) of this section.
(2) Numerator. The number of unique patients to whom an APM Entity group or eligible clinician furnishes services that are included in the measures of aggregate expenditures used under the terms of all Advanced APMs and Other Payer Advanced APMs during the QP Performance Period.
(3) Denominator. The number of unique patients to whom the APM Entity group or eligible clinician furnishes services under all non-excluded payers during the QP Performance Period.
(4) Unique patients. CMS may count a single patient in the numerator and/or denominator for multiple different payers.
(d) QP Determinations under the All-Payer Combination Option. (1) CMS performs QP determinations following the QP Performance Period using payment amount and/or patient count information submitted from January 1 through each of the respective QP determination dates: March 31, June 30, and August 31. CMS will use data for the same time periods for the Medicare and other payer portions of Threshold Score calculations under the All-Payer Combination Option. CMS will use the payment amount or patient count method, applying the more advantageous of the two for both the Medicare and other payer portions of the Threshold score calculation, regardless of the method used for the Medicare Threshold Score calculation.
(2) An APM Entity may request that CMS make QP determinations at the APM Entity level, an eligible clinician may request that CMS make QP determinations at the eligible clinician level, and an eligible clinician or an APM Entity may request that CMS makes QP determinations at the TIN-level in instances where all clinicians who reassigned billing rights to the TIN are participating in a single APM Entity. CMS makes QP determinations at either the APM Entity, eligible clinician, or TIN level. Eligible clinicians assessed at the eligible clinician level under the Medicare Option at § 414.1425(b)(2) will be assessed at the eligible clinician level only under the All-Payer Combination Option. Eligible Clinicians may meet the Medicare and the All-Payer Combination Option thresholds using the payment amount method for both thresholds, the patient account method for both thresholds, or the payment amount method for one threshold and the patient account method for the other threshold.
(3) CMS uses data at the same level for the Medicare and other payer portions of Threshold Score calculations under the All-Payer Combination Option. When QP determinations are made at the eligible clinician or, at the TIN level when all clinicians who have reassigned billing rights to the TIN are included in a single APM Entity; and if the Medicare Threshold score for the APM Entity group is higher than when calculated for the eligible clinician or TIN, CMS makes QP determinations using a weighted Medicare Threshold Score that is factored into an All-Payer Combination Option Threshold Score.
(e) Information used to calculate Threshold Scores under the All-Payer Combination Option. (1) An APM Entity or eligible clinician may request as set forth in § 414.1445(b)(2) that CMS determine whether a payment arrangement in which they participate meets the Other Payer Advanced APM criteria and may demonstrate participation in an Other Payer Advanced APM determined as a result of a request made in § 414.1445(a)(1) or (b)(1) in a form and manner specified by CMS.
(2) To request a QP determination under the All-Payer Combination Option, for each payment arrangement submitted as set forth in paragraph (e)(1) of this section, the APM Entity or eligible clinician must include:
(i) The amount of revenue for services furnished through the payment arrangement, the total revenue received from all payers except those excluded as provided in paragraph (a)(2) of this section, the number of patients furnished any service through the arrangement, and the total number of patients furnished any services, except those excluded as provided in paragraph (a)(2) of this section; and
(ii) In the case of an APM Entity or eligible clinician requesting a QP determination under either a Medicaid Medical Home Model or Aligned Other Payer Medical Home Model pursuant to the criteria in § 414.1420, information specified by CMS for purposes of compliance with the 50 eligible clinician limit specified at § 414.1420(d)(8).
(3) An APM Entity or eligible clinician must submit the information specified in paragraph (e)(2) of this section in a form and manner specified by CMS. An APM Entity or eligible clinician may submit the information specified in paragraph (e)(2) of this section for the following periods of time in the relevant QP Performance Period: January 1 through March 31, January 1 through June 30, and January 1 through August 31.
(4) To request a QP determination under the All-Payer Combination Option, an APM Entity or eligible clinician must submit this information to CMS no later than the QP Determination Submission Deadline, which is December 1 of the calendar year that is 2 years prior to the payment year.
(f) Requirement to submit sufficient information —(1) Sufficient Information. CMS makes a QP determination with respect to the eligible clinician under the All-Payer Combination Option only if the APM Entity or eligible clinician submits the information required under paragraph (e) of this section sufficient for CMS to assess the eligible clinician under either the payment amount or patient count as described in paragraphs (b) and (c) of this section.
(2) Certification. The APM Entity or eligible clinician who submits information to request a QP determination under the All-Payer Combination Option must certify that the information submitted to CMS is true, accurate, and complete. Such certification must accompany the submission and be made at the time of submission. In the case of information submitted by an APM Entity, the certification must be made by an individual with the authority to bind the APM Entity.
(g) Notification of QP determination. CMS notifies eligible clinicians determined to be QPs or Partial QPs for a year as soon as practicable after QP calculations are conducted.
§ 414.1445   Determination of other payer advanced APMs.
(a) Determination of Medicaid APMs. Beginning in 2018, and each year thereafter, at a time determined by CMS, a state, APM Entity, or eligible clinician may request, in a form and manner specified by CMS, that CMS determine whether a payment arrangement authorized under Title XIX is either a Medicaid APM or a Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria as set forth in § 414.1420. A state must submit its request by April 1 of the year prior to the relevant QP Performance Period, and an APM Entity or eligible clinician must submit its request by November 1 of the year prior to the relevant QP Performance Period. CMS will not determine that a payment arrangement is a Medicaid APM or Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria as set forth in § 414.1420 for a year after the relevant QP Performance Period.
(b) Determination of Other Payer Advanced APMs —

(1) Payer initiated Other Payer Advanced APM determination process. Beginning in 2018, and each year thereafter, at a time determined by CMS a payer with a Medicare Health Plan payment arrangement may request, in a form and manner specified by CMS, that CMS determine whether a Medicare Health Plan payment arrangement meets the Other Payer Advanced APM criteria set forth in § 414.1420. A payer with a Medicare Health Plan payment arrangement must submit its requests by the annual Medicare Advantage bid deadline of the year prior to the relevant QP Performance Period. A Medicare Health Plan is a Medicare Advantage plan, a section 1876 cost plan, a PACE organization operated under section 1894, and any similar plan which provides Medicare benefits under demonstration or waiver authority (other than an APM as defined in section 1833(z)(3)(C) of the Act).
(2) Eligible clinician initiated Other Payer Advanced APM determination process. Except as provided by paragraph (a) of this section, at a time specified by CMS, an APM Entity or eligible clinician may request that CMS determine whether a payment arrangement meets the Other Payer Advanced APM criteria as set forth in § 414.1420 in a form and manner specified by CMS. An APM Entity or eligible clinician must submit requests by December 1 of the calendar year of the relevant QP Performance Period.
(c) Information required for Other Payer Advanced APM determinations. (1) In order to make an Other Payer Advanced APM determination as set forth in paragraphs (a) and (b) of this section, a payer, APM Entity, or eligible clinician must submit the information specified by CMS in a form and manner specified by CMS. If a payer, APM Entity, or eligible clinician fails to submit the information required, CMS will not make a determination as to whether a payment arrangement meets the Other Payer Advanced APM criteria as set forth in § 414.1420.
(2) If an eligible clinician submits information showing that a payment arrangement requires that the eligible clinician must use CEHRT as defined in § 414.1305 to document and communicate clinical care, CMS will presume that the CEHRT criterion in § 414.1420(b) is satisfied for that payment arrangement.
(i) Based on the submission by an eligible clinician or payer of evidence that CMS determines sufficiently demonstrates that CEHRT is used as specified in § 414.1420(b) by participants in the payment arrangement, CMS will consider the CEHRT criterion in § 414.1420(b) is satisfied for that payment arrangement.
(ii) [Reserved]
(3) If a payment arrangement has no outcome measure, the payer, APM Entity, or eligible clinician requesting a determination of whether a payment arrangement meets the Other Payer Advanced APM criteria must certify that there is no available or applicable outcome measure on the MIPS measure list.
(d) Certification. A payer, APM Entity, or eligible clinician that submits information pursuant to paragraph (c) of this section must certify that the information it submitted to CMS is true, accurate, and complete. Such certification must accompany the submission and be made at the time of submission. In the case of information submitted by a payer or an APM Entity, the certification must be made by an individual with the authority to bind the payer or the APM Entity.
(e) Timing of Other Payer Advanced APM determinations. CMS makes Other Payer Advanced APM determinations prior to making QP determinations under § 414.1440.
(f) Notification of Other Payer Advanced APM determinations. CMS makes Other Payer Advanced APM determinations and notifies the requesting payer, APM Entity, or eligible clinician of such determinations as soon as practicable following the relevant submission deadline.
§ 414.1450   APM incentive payment.
(a) In general. (1) CMS makes a lump sum payment to QPs in the amount described in paragraph (b) of this section in the manner described in paragraphs (d) and (e) of this section.
(i) For payment years 2019 through 2026, CMS makes a lump sum payment to QPs in the amount described in paragraph (b) of this section in the manner described in paragraphs (d) and (e) of this section.
(ii) [Reserved]
(2) CMS provides notice of the amount of the APM Incentive Payment to QPs as soon as practicable following the calculation and validation of the APM Incentive Payment amount, but in any event no later than 1 year after the incentive payment base period.
(b) APM Incentive Payment amount.
(1) For payment years 2019 through 2024, the amount of the APM Incentive Payment is equal to 5 percent, with respect to payment year 2025, 3.5 percent, or with respect to payment year 2026, 1.88 percent of the estimated aggregate payments for covered professional services as defined in section 1848(k)(3)(A) of the Act furnished during the calendar year immediately preceding the payment year. CMS uses the paid amounts on claims for covered professional services to calculate the estimated aggregate payments on which CMS will calculate the APM Incentive Payment.
(2) The estimated aggregate payment amount for covered professional services includes all such payments to any and all of the TIN/NPI combinations associated with the NPI of the QP.
(3) In calculating the estimated aggregate payment amount for a QP, CMS uses claims submitted with dates of service from January 1 through December 31 of the incentive payment base period, and processing dates of January 1 of the base period through March 31 of the subsequent payment year.
(4) The payment adjustment amounts, negative or positive, as described in sections 1848(m), (o), (p), and (q) of the Act are not included in calculating the APM Incentive Payment amount.
(5) Incentive payments made to eligible clinicians under sections 1833(m), (x), and (y) of the Act are not included in calculating the APM Incentive Payment amount.
(6) Financial risk payments such as shared savings payments or net reconciliation payments are excluded from the amount of covered professional services in calculating the APM Incentive Payment amount.
(7) Supplemental service payments in the amount of covered professional services are included in calculating the APM Incentive Payment amount according to this paragraph (b). Supplemental service payments are included in the amount of covered professional services when calculating the APM Incentive Payment amount when the supplemental service payment meets the following four criteria:
(i) Is payment for services that constitute physicians services authorized under section 1832(a) and defined under section 1861(s) of the Act.
(ii) Is made for only Part B services under the criterion in paragraph (b)(9)(i) of this section.
(iii) Is directly attributable to services furnished to an individual beneficiary.
(iv) Is directly attributable to an eligible clinician, including an eligible clinician that is a group of individual eligible clinicians.
(8) For payment amounts that are affected by a cash flow mechanism, the payment amounts that would have occurred if the cash flow mechanism were not in place are used in calculating the APM Incentive Payment amount.
(c) APM Incentive Payment recipient. CMS will pay the APM Incentive Payment amount for a payment year to a solvent TIN or TINs associated with the QP, identified based on Medicare Part B claims submitted for covered professional services during the base period or payment year, according to this section. If no TIN or TINs with which the QP has an association can be identified at a step, CMS will move to the next and successive steps listed in paragraphs (c)(1) through (8) of this section until CMS identifies a TIN or TINs with which the QP is associated, and to which CMS will make the APM Incentive Payment. If more than one TIN is identified at a step, the payment will be proportionately divided among the TINs according to the relative total paid amounts for Part B covered professional services paid to each TIN for services provided during the base year.
(1) Any TIN associated with the QP that, during the QP Performance Period, is associated with an APM Entity through which the eligible clinician achieved QP status;
(2) Any TIN associated with the QP that, during the APM Incentive Payment base period, is associated with an APM Entity through which the eligible clinician achieved QP status;
(3) Any TIN associated with the QP that, during the APM Incentive Payment base period, is associated with an APM Entity participating in an Advanced APM through which the eligible clinician had achieved QP status;
(4) Any TIN associated with the QP that, during the APM Incentive Payment base period, participated in an APM Entity in an Advanced APM;
(5) Any TIN associated with the QP that, during the APM Incentive Payment base period, participated with an APM Entity in any track of the APM through which the eligible clinician achieved QP status;
(6) Any TIN associated with the QP that, during the APM Incentive Payment base period, participated with an APM Entity in an APM other than an Advanced APM;
(7) Any TIN associated with the QP that submitted a claim for covered professional services furnished by the QP during the APM Incentive Payment base period, even if such TIN has no relationship to any APM Entity or APM; then
(8) If we have not identified any TIN associated with the QP to which we can make the APM Incentive Payment, we will attempt to contact the QP via a public notice to request their Medicare payment information. The QPs identified in the public notice, or any other eligible clinicians who believe that they are entitled to an APM Incentive Payment must then notify CMS of their claim as directed in the public notice by September 1 of the payment year, or 60 days after CMS announces that initial payments for the year have been made, whichever is later. After that time, any claims by a QP to an APM Incentive Payment will be forfeited for such payment year.
(d) Timing of the APM Incentive Payment. APM Incentive Payments made under this section are made as soon as practicable following the calculation and validation of the APM Incentive Payment amount, but in any event no later than 1 year after the incentive payment base period.
(e) Treatment of APM Incentive Payment amount in APMs. (1) APM Incentive Payments made under this section are not included in determining actual expenditures under an APM.
(2) APM Incentive Payments made under this section are not included in calculations for the purposes of rebasing benchmarks in an APM.
(f) Treatment of APM Incentive Payment for other Medicare incentive payments and payment adjustments. APM Incentive Payments made under this section will not be included in determining the amount of incentive payment made to eligible clinicians under section 1833(m), (x), and (y) of the Act.
§ 414.1455   Limitation on review.
(a) There is no right to administrative or judicial review under sections 1869, 1878, or otherwise, of the Act of the following:
(1) The determination that an eligible clinician is a QP or Partial QP under § 414.1425.
(2) The determination of the amount of the APM Incentive Payment under § 414.1450, including any estimation as part of such determination.
(b)(1) An eligible clinician or APM Entity may request targeted review of a QP or Partial QP determination only if they believe in good faith that, due to a CMS clerical error, an eligible clinician was omitted from a Participation List.
(2) If CMS determines that there was such a clerical error, if the QP determination for the eligible clinician would have been made at the APM Entity level under § 414.1425(b)(1), CMS will assign to the eligible clinician the most favorable QP status that was determined at the APM Entity level on any snapshot dates for the relevant QP Performance Period on which the eligible clinician participated in the APM Entity.
(3) The process for targeted review is as follows:
(i) An eligible clinician or APM Entity may submit a request for targeted review.
(ii) All requests for targeted review must be submitted during the targeted review request submission period, which is a 60-day period that begins with the publication of MIPS performance feedback as described at § 414.1385(a)(2). The targeted review request submission period may be extended as specified by CMS.
(iii) All requests for targeted review must be submitted in accordance with the form and manner specified by CMS.
(iv) A request for targeted review may be denied if the request is duplicative of another request for a targeted review; the request is not submitted during the targeted review request submission period; or the request is outside the scope of targeted review specified in this section. If the targeted review request is denied, CMS will make no changes to the QP status of the eligible clinician for whom targeted review was requested.
(v) CMS will respond to each timely submitted request for targeted review.
(vi) A request for targeted review may include additional information in support of the request at the time it is submitted. CMS may also request additional information from the requestor. If CMS requests additional information relating to the eligible clinician or the APM Entity group that is the subject of a request for targeted review, responsive information must be provided and received by CMS within 30 days of the request. If CMS does not receive a timely response to a request for additional information, CMS may make a final decision on the targeted review request based on the information available.
(vii) If targeted review requests reveal a pattern of CMS error with impacts that extend beyond the scope of eligible clinicians or APM Entities that submitted such targeted review requests, CMS may adjust the QP status of other affected eligible clinicians as provided in paragraph (b)(2) of this section.
(viii) Decisions on a targeted review request are final, and not subject to any further administrative or judicial review in accordance with paragraph (a) of this section.
§ 414.1460   Monitoring and program integrity.
(a) Vetting eligible clinicians. Prior to payment of the APM Incentive Payment, CMS determines if eligible clinicians were in compliance with all Medicare conditions of participation and the terms of the relevant Advanced APMs in which they participated during the QP Performance Period. A determination under this provision is not binding for other purposes.
(b) Rescinding QP Determinations. CMS may rescind a QP determination if:
(1) Any of the information CMS relied on in making the QP determination was inaccurate or misleading.
(2) The QP is terminated from an Advanced APM or Other Payer Advanced APM during the QP Performance Period or Incentive Payment Base Period; or
(3) The QP is found to be in violation of the terms of the relevant Advanced APM or any relevant Federal, State, or tribal statute or regulation during the QP Performance Period or Incentive Payment Base Period.
(c) Information submitted for All-Payer Combination Option. Information submitted by payers, APM Entities, or eligible clinicians for purposes of the All-Payer Combination Option may be subject to audit by CMS.
(d) Reducing, denying, and recouping of APM Incentive Payments. (1) CMS may reduce or deny an APM Incentive Payment to an eligible clinician.
(i) Who CMS determines is not in compliance with all Medicare conditions of participation and the terms of the relevant Advanced APM in which they participate during the QP Performance Period or Incentive Payment Base Period;
(ii) Who is terminated by an APM or Advanced APM during the QP Performance Period or Incentive Payment Base Period; or
(iii) Whose APM Entity is terminated by an APM or Advanced APM for non-compliance with any Medicare condition of participation or the terms of the relevant Advanced APM in which they participate during the QP Performance Period or Incentive Payment Base Period.
(2) CMS may reopen, revise, and recoup an APM Incentive Payment that was made in error in accordance with procedures similar to those set forth at §§ 405.980 through § 405.986 and §§ 405.370 through 405.379 of this chapter or as established under the relevant APM.
(e) Maintenance of records. (1) A payer that submits information to CMS under § 414.1445 for assessment under the All-Payer Combination Option must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination. Such information and supporting documentation must be maintained for a period of 6 years after submission.
(2) An APM Entity or eligible clinician that submits information to CMS under § 414.1445 for assessment under the All-Payer Combination Option or § 414.1440 for QP determinations must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination, QP determinations, and the accuracy of APM Incentive Payments for a period of 6 years from the end of the QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later.
(3) A payer, APM Entity or eligible clinician that submits information to CMS under §§ 414.1440 or 414.1445 must provide such information and supporting documentation to CMS upon request.
(f) OIG authority. None of the provisions of this part limit or restrict OIG's authority to audit, evaluate, investigate, or inspect the Advanced APM Entity, its eligible clinicians, and other individuals or entities performing functions or services related to its APM activities.
§ 414.1465   Physician-focused payment models.
(a) Definition. A physician-focused payment model (PFPM) is an Alternative Payment Model:
(1) In which Medicare is a payer;
(2) In which eligible clinicians that are eligible professionals as defined in section 1848(k)(3)(B) of the Act are participants and play a core role in implementing the APM's payment methodology; and
(3) Which targets the quality and costs of services that eligible professionals participating in the Alternative Payment Model provide, order, or can significantly influence.
(b) Criteria. In carrying out its review of physician-focused payment model proposals, the PTAC must assess whether the physician-focused payment model meets the following criteria for PFPMs sought by the Secretary. The Secretary seeks PFPMs that:
(1) Incentives: Pay for higher-value care. (i) Value over volume: provide incentives to practitioners to deliver high-quality health care.
(ii) Flexibility: provide the flexibility needed for practitioners to deliver high-quality health care.
(iii) Quality and Cost: are anticipated to improve health care quality at no additional cost, maintain health care quality while decreasing cost, or both improve health care quality and decrease cost.
(iv) Payment methodology: pay APM Entities with a payment methodology designed to achieve the goals of the PFPM Criteria. Addresses in detail through this methodology how Medicare, and other payers if applicable, pay APM Entities, how the payment methodology differs from current payment methodologies, and why the PFPM cannot be tested under current payment methodologies.
(v) Scope: aim to broaden or expand the CMS APM portfolio by addressing an issue in payment policy in a new way or including APM Entities whose opportunities to participate in APMs have been limited.
(vi) Ability to be evaluated: have evaluable goals for quality of care, cost, and any other goals of the PFPM.
(2) Care delivery improvements: Promote better care coordination, protect patient safety, and encourage patient engagement. (i) Integration and Care Coordination: encourage greater integration and care coordination among practitioners and across settings where multiple practitioners or settings are relevant to delivering care to the population treated under the PFPM.
(ii) Patient Choice: encourage greater attention to the health of the population served while also supporting the unique needs and preferences of individual patients.
(iii) Patient Safety: aim to maintain or improve standards of patient safety.
(3) Information Enhancements: Improving the availability of information to guide decision-making. (i) Health Information Technology: encourage use of health information technology to inform care.
(ii) [Reserved]
§ 414.1500   Basis, purpose, and scope.
This subpart implements section 1861(iii) of the Act with respect to the requirements that must be met for Medicare payment to be made for home infusion services furnished to eligible beneficiaries.
§ 414.1505   Requirement for payment.
In order for home infusion therapy services to qualify for payment under the Medicare program the services must be furnished to an eligible beneficiary by, or under arrangements with, a qualified home infusion therapy supplier that meets the following requirements:
(a) The health and safety standards for qualified home infusion therapy suppliers at § 486.520(a) through (c) of this chapter.
(b) All requirements set forth in §§ 414.1510 through 414.1550.
(c) The home infusion therapy supplier must be enrolled in Medicare consistent with the provisions of § 424.68 and part 424, subpart P of this chapter.
§ 414.1510   Beneficiary qualifications for coverage of services.
To qualify for Medicare coverage of home infusion therapy services, a beneficiary must meet each of the following requirements:
(a) Under the care of an applicable provider. The beneficiary must be under the care of an applicable provider, as defined in section 1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or physician assistant.
(b) Under a physician plan of care. The beneficiary must be under a plan of care that meets the requirements for plans of care specified in § 414.1515.
§ 414.1515   Plan of care requirements.
(a) Contents. The plan of care must contain those items listed in § 486.520(b) of this chapter that specify the standards relating to a plan of care that a qualified home infusion therapy supplier must meet in order to participate in the Medicare program.
(b) Physician's orders. The physician's orders for services in the plan of care must specify at what frequency the services will be furnished, as well as the discipline that will furnish the ordered professional services. Orders for care may indicate a specific range in frequency of visits to ensure that the most appropriate level of services is furnished.
(c) Plan of care signature requirements. The plan of care must be signed and dated by the ordering physician prior to submitting a claim for payment. The ordering physician must sign and date the plan of care upon any changes to the plan of care.
§ 414.1550   Basis of payment.
(a) General rule. For home infusion therapy services furnished on or after January 1, 2021, Medicare payment is made on the basis of 80 percent of the lesser of the following:
(1) The actual charge for the item or service.
(2) The fee schedule amount for the item or service, as determined in accordance with the provisions of this section.
(b) Unit of single payment. A unit of single payment is made for items and services furnished by a qualified home infusion therapy supplier per payment category for each infusion drug administration calendar day, as defined at § 486.505 of this chapter.
(c) Initial establishment of the payment amounts. In calculating the initial single payment amounts for CY 2021, CMS determined such amounts using the equivalent to 5 hours of infusion services in a physician's office as determined by codes and units of such codes under the annual fee schedule issued under section 1848 of the Act as follows:
(1) Category 1. (i) Includes certain intravenous infusion drugs for therapy, prophylaxis, or diagnosis, including antifungals and antivirals; inotropic and pulmonary hypertension drugs; pain management drugs; chelation drugs; and other intravenous drugs as added to the durable medicare equipment local coverage determination (DME LCD) for external infusion pumps.
(ii) Payment equals 1 unit of 96365 plus 4 units of 96366.
(2) Category 2. (i) Includes certain subcutaneous infusion drugs for therapy or prophylaxis, including certain subcutaneous immunotherapy infusions.
(ii) Payment equals 1 unit of 96369 plus 4 units of 96370.
(3) Category 3. (i) Includes intravenous chemotherapy infusions, including certain chemotherapy drugs and biologicals.
(ii) Payment equals 1 unit of 96413 plus 4 units of 96415.
(4) Initial visit. (i) For each of the three categories listed in paragraphs (c)(1) through (3) of this section, the payment amounts are set higher for the first visit by the qualified home infusion therapy supplier to initiate the furnishing of home infusion therapy services in the patient's home and lower for subsequent visits in the patient's home. The difference in payment amounts is a percentage based on the relative payment for a new patient rate over an existing patient rate using the annual physician fee schedule evaluation and management payment amounts for a given year and calculated in a budget neutral manner.
(ii) The first visit payment amount is subject to the following requirements if a patient has previously received home infusion therapy services:
(A) The previous home infusion therapy services claim must include a patient status code to indicate a discharge.
(B) If a patient has a previous claim for HIT services, the first visit home infusion therapy services claim subsequent to the previous claim must show a gap of more than 60 days between the last home infusion therapy services claim and must indicate a discharge in the previous period before a HIT supplier may submit a home infusion therapy services claim for the first visit payment amount.
(d) Required payment adjustments. The single payment amount represents payment in full for all costs associated with the furnishing of home infusion therapy services and is subject to the following adjustments:
(1) An adjustment for a geographic wage index and other costs that may vary by region, using an appropriate wage index based on the site of service of the beneficiary.
(2) Beginning in 2022, an annual increase in the single payment amounts from the prior year by the percentage increase in the Consumer Price Index (CPI) for all urban consumers (United States city average) for the 12-month period ending with June of the preceding year.
(3)(i) An annual reduction in the percentage increase described in paragraph (d)(2) of this section by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.
(ii) The application of the paragraph (c)(3)(i) of this section may result in the both of the following:
(A) A percentage being less than zero for a year.
(B) Payment being less than the payment rates for the preceding year.
(e) Medical review. All payments under this system may be subject to a medical review adjustment reflecting the following:
(1) Beneficiary eligibility.
(2) Plan of care requirements.
(3) Medical necessity determinations.
§ 414.1600   Purpose and definitions.
(a) Purpose. This subpart implements section 1834(z) of the Act and establishes procedures for making benefit category determinations and payment determinations for lymphedema compression treatment items.
(b) Definitions. For purposes of this subpart the following definitions apply:
Benefit category determination means a national determination regarding whether an item or service meets the Medicare definition of lymphedema compression treatment item at section 1861(mmm) of the Act and the rules of this subpart and is not otherwise excluded from coverage by statute.
Lymphedema compression treatment item means an item as described in § 410.2.
§ 414.1650   Payment basis for lymphedema compression treatment items.
(a) General payment rule. For items furnished on or after January 1, 2024, Medicare pays for lymphedema compression treatment items on the basis of 80 percent of the lesser of—
(1) The actual charge for the item; or
(2) The payment amount for the item, as determined in accordance with paragraph (b) of this section.
(b) Payment amounts. The payment amounts for covered lymphedema compression treatment items paid for under this subpart are established based on one of the following:
(1) If payment amounts are available from Medicaid state plans, then 120 percent of the average of the Medicaid payment amounts.
(2) If payment amounts are not available from Medicaid state plans, then 100 percent of the average of average internet retail prices and payment amounts from TRICARE (Department of Defense).
(3) If payment amounts are not available from Medicaid state plans or TRICARE, then 100 percent of average internet retail prices.
(c) Updates to payment amounts. The payment amounts for covered lymphedema compression treatment items established in accordance with paragraph (b) of this section are increased on an annual basis beginning on January 1 of the year subsequent to the year in which the payment amounts are initially established based on the percent change in the Consumer Price Index for all Urban Consumers (CPI-U) for the 12-month period ending with June of the previous year.
§ 414.1660   Continuity of pricing when HCPCS codes are divided or combined.
(a) General rule. If HCPCS codes for lymphedema compression treatment items are divided or combined, the payment amounts for the old codes are mapped to the new codes to ensure continuity of pricing.
(b) Mapping of payment amounts. (1) If there is a single code that describes two or more distinct complete items (for example, two different but related or similar items), and separate codes are subsequently established for each item, then the payment amounts that applied to the single code continue to apply to each of the items described by the new codes.
(2) If the codes for several different items are combined into a single code, then the payment amounts for the new code are established using the average (arithmetic mean), weighted by allowed services, of the payment amounts for the formerly separate codes.
§ 414.1670   Procedures for making benefit category determinations and payment determinations for new lymphedema compression treatment items.
The procedures for determining whether new items and services addressed in a request for a HCPCS Level II code(s) or by other means meet the definition of items and services paid for in accordance with this subpart are as follows:
(a) At the start of a HCPCS coding cycle, CMS performs an analysis to determine if the item is statutorily excluded from coverage under Medicare under section 1862 of the Act.
(1) If not excluded by statute, then CMS determines whether the item is a lymphedema compression treatment item as defined under section 1861(mmm) of the Act.
(2) If excluded by statute, the analysis is concluded.
(b) If a preliminary determination is made that the item is a lymphedema compression treatment item, CMS makes a preliminary payment determination for the item or service.
(c) CMS posts preliminary benefit category determinations and payment determinations on CMS.gov approximately 2 weeks prior to a public meeting.
(d) After consideration of public consultation provided at a public meeting on preliminary benefit category determinations and payment determinations for items, CMS establishes the benefit category determinations and payment determinations for items through program instructions.
§ 414.1680   Frequency limitations.
(a) General rule. With the exception of replacements of items that are lost, stolen, or irreparably damaged, or if needed due to a change in the patient's medical or physical condition, no payment may be made for gradient compression garments or wraps with adjustable straps furnished other than at the frequencies established in paragraphs (b) and (c) of this section.
(b) Initial furnishing of lymphedema compression treatment items. The following frequency limitations apply to items initially furnished to the beneficiary if determined to be reasonable and necessary for the treatment of lymphedema:
(1) Three units of daytime gradient compression garments or wraps with adjustable straps per affected extremity or part of the body.
(2) Two garments for nighttime use per affected extremity or part of the body.
(c) Replacements of lymphedema compression treatment items. The following frequency limitations apply to replacements of lymphedema compression treatment items if determined to be reasonable and necessary for the treatment of lymphedema:
(1) Payment for the replacement of gradient compression garments or wraps with adjustable straps per each affected extremity or part of the body can be made once every 6 months.
(2) Payment for the replacement of nighttime garments per each affected extremity or part of the body can be made once every 2 years.
(d) Replacements of lymphedema compression bandaging systems or supplies. Specific frequency limitations are not established for these items. Determinations regarding the quantity of compression bandaging supplies needed by each beneficiary are made by the DME MAC that processes the claims for the supplies.
§ 414.1690   Application of competitive bidding information.
The payment amounts for lymphedema compression treatment items under § 414.1650(b) may be adjusted using information on the payment determined as part of implementation of the programs under subpart F using the methodologies set forth at § 414.210(g).
§ 414.1700   Basis of payment.
(a) General rule. For home intravenous immunoglobulin (IVIG) items or services furnished on or after January 1, 2024, Medicare payment is made on the basis of 80 percent of the lesser of the following:
(1) The actual charge for the item or service.
(2) The fee schedule amount for the items and services, as determined in accordance with the provisions of this section.
(b) Per visit amount. A single payment amount is made for items and services furnished by a DME supplier per visit.
(c) Initial establishment of the payment amount. In establishing the initial per visit IVIG items and services payment amount for CY 2024, CMS used the CY 2023 bundled payment rate under the IVIG Demonstration updated by the home health payment percentage update for CY 2024.
(d) Annual payment adjustment. The per visit payment amount represents payment in full for all costs associated with the furnishing of home IVIG items and services and is subject to the following adjustment:
(1) Beginning in 2025, an annual increase in the per-visit payment amount from the prior year by the home health update percentage increase for the current calendar year.
(2) [Reserved]